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Past Articles

December 27, 2011

Increasing heart rate over time linked with heart disease mortality: Increases in resting heart rate over a 10-year period are associated with a significant increase in the risk of death from ischemic heart disease, as well as a smaller, but statistically significant, increase in all-cause mortality, according to a new study published in JAMA. For individuals who lowered their resting heart rate, there did not appear to be a benefit in relation to ischemic heart disease mortality. In this prospective study of 13 499 men and 15 826 women without cardiovascular disease the authors assessed the association between long-term longitudinal changes and the risk of ischemic heart disease mortality. Resting heart rate was measured twice, first at baseline and then approximately 10 years later. During a mean follow-up of 12 years, 3098 subjects died. Of these, 975 deaths were the result of cardiovascular disease and 388 deaths due to ischemic heart disease.
Compared with subjects who had a resting heart rate <70 beats per minute (bpm) at both measurements, those who had an increase in resting heart rate at baseline from <70 bpm to >85 bpm during the follow-up visit were nearly two times more likely to die from ischemic heart disease (adjusted hazard ratio [AHR] 1.9; 95% CI 1.0-3.6). The rate of ischemic heart disease mortality for those who retained a resting heart rate of <70 bpm over the 10 years was 8.2 deaths/10 000 person-years, whereas as the rate of ischemic heart disease mortality for those who increased their resting heart rate from <70 bpm to >85 bpm was 17.2 deaths/10 000 person-years.

European CRT Survey Bolsters Support for CRT-D Over CRT-P: Cardiac resynchronization defibrillators (CRT-D) outperformed cardiac resynchronization pacing alone (CRT-P) in an observational study that includes patients not well-represented in the previous randomized trials. The one-year results of the European CRT Survey, published in the January 2012 issue of the European Journal of Heart Failure, shows that worse NYHA functional class, atrial fibrillation, and ischemic etiology were associated with poorer survival. Women in the survey generally had better outcomes than men, and CRT-D patients had better survival rates and reported better symptom control than patients treated with CRT-P. The survey included 2438 patients who had a successful CRT implantation at 141 centers in 13 countries between November 2008 and June 2009. A total of 2111 patients were followed for nine to 15 months. The population included "important groups of patients poorly represented in randomized controlled trials," such as women, elderly patients, and those with prior device implantation, atrial fibrillation, or QRS duration > 120 ms. In addition to the mortality and hospitalization benefits of the devices, patient self-assessment data show that 81% of the patients felt their symptoms improved and only 4% reported deterioration.

First Data to Show Antihypertensive Therapy Prolongs Life: The first long-term data from a high-blood-pressure study, the Systolic Hypertension in the Elderly Program (SHEP), show that each month of chlorthalidone-based therapy was associated with approximately one day of extension in life, free from cardiovascular death. The main findings are that after 22 years of follow-up, when about 60% of the participants in SHEP were dead, there was a prolonged life expectancy in those who took the active treatment for 4.5 years, and that is the first time this has been reported in studies of hypertension. The SHEP trial was conducted between March 1985 and January 1988, and just over 4700 patients aged, on average, 72 years were randomized to active treatment with chlorthalidone--with atenolol added if antihypertensive control was not sufficient--or placebo for 4.5 years. After this time, all patients were asked to go on active therapy. At 22 years later, life-expectancy gain--expressed as the area between the active and placebo survival curves--was 105 days for all-cause mortality and 158 days for cardiovascular death.The active-treatment group had higher survival free from cardiovascular death vs the placebo group (hazard ratio 0.89; p=0.03), but similar survival for all-cause mortality (HR 0.97; p=0.42). There were 1416 deaths (59.9%) in the active-treatment group and 1435 in the placebo group (60.5%). But cardiovascular death was lower in the active-treatment group--669 deaths (28.3%) vs 735 deaths (31.0%) in the placebo group (p=0.03).

December 19, 2011

FDA approves mechanical cardiac assist device for children with heart failure: The U.S. Food and Drug Administration today approved a medical device that supports the weakened heart of children with heart failure to help keep them alive until a donor for a heart transplant can be found. The mechanical pulsatile cardiac assist device is called the EXCOR Pediatric System, made by a German company, Berlin Heart. The device comes in graduated sizes to fit children from newborns to teens.The device consists of one or two external pneumatic (driven by air) blood pumps, multiple tubes to connect the blood pumps to heart chambers and the great arteries, and the driving unit. Heart failure in children is much less common than in adults. Heart transplantation offers effective relief from symptoms. However, far fewer pediatric sized donor hearts are available for transplantation than for adults, limiting the use of heart transplantation in children and prolonging the waiting period until transplant can occur. In infants, the median waiting time for a donor heart is 119 days. Overall a reported 12-17 percent of children and 23 percent of infants die while on the wait list for a heart transplant.

AHA Releases Update of Heart and Stroke Statistics: Americans are more obese and spending more on treatment of cardiovascular disease than ever before, but the rate of mortality from cardiovascular disease continues to decline, the American Heart Association (AHA) reports in its latest update on cardiovascular health in the US which published online in Circulation. The AHA's "Heart Disease and Stroke Statistical Survey 2012shows that cardiovascular disease continues to be a major killer in the US, causing about 2200 deaths a day in the US. The direct and indirect costs of cardiovascular disease and stroke are about $300 billion. Only 6% of US adults are free of risk factors in all of these categories, and 38% of US adults score in the "poor" range for at least three of the seven categories. Obesity in children is an especially worrying trend, as about one in three US kids are overweight and the prevalence of childhood obesity has grown from 4% to over 20% since the early 1980s. Half of children 12 to 19 have at least three of the seven major risk factors.

Although the study shows that Americans are not, in general, doing a great job of taking care of their own cardiovascular health, the mortality rate from cardiovascular disease continues to fall, probably because treatments for MI, congestive heart failure, and other acute cardiovascular conditions has improved. Last year's AHA report showed that heart-disease mortality declined by 27.8% and stroke mortality fell by 44.8% between 1997 and 2007. This year's report shows that the cardiovascular disease mortality rate fell from 30.6% from 1998 to 2008. During that same period, the stroke death rate fell 34.8%.

CPAP benefits in metabolic syndrome: Three months of treatment with continuous positive airway pressure (CPAP) was associated with improvements in many different components of the metabolic syndrome in a new study published in the last issue of the New England Journal of Medicine in patients with both metabolic syndrome and obstructive sleep apnea .In the study, CPAP therapy was associated with a decrease in both systolic and diastolic blood pressure, lipids, glycated hemoglobin, body mass index, and abdominal fat. Following CPAP therapy, 14 patients (20%) no longer met the criteria for metabolic syndrome, with the specific criterion resolved being blood pressure (five patients), fasting blood glucose (two patients), triglycerides (two patients), HDL cholesterol (three patients), triglycerides and HDL cholesterol (one patient), and triglycerides, HDL cholesterol, and fasting blood glucose (one patient).

December 12, 2011

FDA Advisory Panel Votes Against Implantable CardioMEMS HF Pressure Measurement System: Members of the FDA Circulatory System Devices Panel today recommended against approval of the implantable CardioMEMS HF Pressure Measurement System. Although panel members agreed that the device was safe by a 9-1 vote, they voted 7-3 that the device had not been shown to be effective and 6-4 that the benefits did not outweigh the risks. Panel members were basing their decision on the randomized, single-blind, company-sponsored CHAMPION trial. The device keeps track of changes in PA pressures that might alert clinicians to impending decompensation, prompting early adjustments to medications such as vasodilators or diuretics. The trial suggested that the strategy works: patients implanted with the monitor showed a significant drop in risk of heart-failure-related hospitalizations (p<0.0001) over six months with virtually no important device-related complications.

Obese STEMI patients continue to present 'paradox': Extremely obese patients present with STEMI at younger ages, yet have less extensive coronary artery disease and better left ventricular systolic function, adhering to the “obesity paradox,” according to a new study published in the Journal of the American College of Cardiology found. Additionally, obese patients have similar processes and quality of care when compared with normal-weight patients, but see higher risk-adjusted in-hospital mortality rates. In the study were analyzed data from 50,149 STEMI patients from the National Cardiovascular Data Registry (NCDR) ACTION Registry-Get With the Guidelines between Jan.1, 2007, and June 30, 2009, and recorded the relationship between BMI and baseline patient characteristics, treatment patterns and risk-adjusted in-hospital outcomes. During the study, the researchers classified patients with STEMI by BMI categories: 1.6% was underweight, 23.5 % were of normal weight, 38.7 % were overweight, 22.4% were Class I obese, 8.7 % were Class II obese and 5.1% were Class III obese. Those STEMI patients classified with Class III obesity were more than a decade younger than their normal-weight counterparts, and these patients were more likely to be women and African-American. Class III obese patients had a higher prevalence of obesity (three-fold) compared with those who were in normal weight class. Three-fourths of STEMI patients were overweight or obese in the current study and Class III obesity affected one in 20 STEMI patients.

Stroke Risk Reduced With Treatment of Prehypertension: Patients with prehypertension who take blood pressure–lowering therapy have a highly statistically significant 22% reduced risk for stroke according to a a new meta-analysis published online in Stroke Journal. The reduction in stroke risk observed in the study was evident among all classes of antihypertensive drugs studied. Prehypertension is defined as a blood pressure of 120 to 139 mm Hg systolic and 80 to 89 mm Hg diastolic. Current guidelines recommend lowering blood pressure to 140/90 mm Hg or less. The meta-analysis included 16 randomized controlled trials enrolling a total of 70,664 patients. To be considered for the analysis, studies had to have included patients with an average baseline systolic blood pressure of between 120 and 140 mm Hg and a diastolic blood pressure lower than 90 mm Hg. The trials also had to have had at least 1 comparator group treated with placebo, have reported stroke incidence, and used an antihypertensive drug. Eight of the trials studied ACE inhibitors, 4 studied ARBs, 2 studied calcium channel blockers, 1 had both calcium channel blocker and ACE inhibitor groups, and 1 used an ACE inhibitor and/or calcium channel blocker. Both patients and investigators were blinded to treatment allocation in all but 2 trials (Irbesartan in Heart Failure With Preserved Systolic Function [I-PRESERVE] and Appropriate Blood Pressure Control in Diabetes [ABCD]), which were single-blind. The analysis found that compared with patients who received the placebo, those taking antihypertensive treatments had a 22% reduction in incident stroke (relative risk, 0.78; 95% confidence interval, 0.71 - 0.86; P < .000001).

December 5, 2011

ICPES ATHENS 2011, 11-14 DECEMBER 2011

The World Society of Arrhythmias (WSA) organizes its 14th Congress at Athens Hilton, from 11 to 14 December 2011. More than 300 distinguished, Key Opinion Leaders Cardiologists will present the latest research during the Conference. The WSA Secretary General, Professor Panos Vardas announced that the ICPES scientific programme offers an excellent opportunity for participants to share professional knowledge and experience on the latest developments in cardiovascular medicine.

Anticoagulation self-monitoring halves thromboembolic risk: Results of a meta-analysis published online in Lancet showed that self-monitoring of oral anticoagulation by patients was superior to usual care in reducing thromboembolic events, with a risk reduction of 49% . Self-management of anticoagulation, where patients not only self-test international normalized ratios (INR) themselves but actually were trained to self-adjust the warfarin dose based on these results, was superior to self-testing alone, where dose adjustments were made by physicians. Rates of bleeding and mortality were similar between groups. The most striking reductions in risk were seen in patients younger than 55 years and in those taking anticoagulation because of a mechanical heart valve, the authors note, but there was no safety signal from this approach even among the very elderly.

Diet rich in antioxidants may cut stroke risk: Women who eat an antioxidant-rich diet may significantly cut their stroke risk, particularly for those without a history of CVD, new research published online in Stroke Journal suggests. This prospective study found that women with no history of CVD who consumed the highest amount of antioxidants in foods such as fruit, vegetables, tea, whole grains, and chocolate had 17% fewer strokes than those who ate the least amount. Among women with a history of CVD, those who consumed the most antioxidants had 45% fewer hemorrhagic strokes.

Noncardiac chest pain not always a low-risk diagnosis: Patients discharged from the hospital with noncardiac chest pain have always been thought of as low risk, but a new study shows a worrying one-year mortality rate of around 4% in this group, which is higher in patients with a previous psychiatric hospitalization. Around one-third of the deaths were cardiovascular, suggesting that a fairly substantial number of patients with heart disease are being missed when presenting to hospitals with chest pain. The study, published online in the European Heart Journal.

FDA agrees to review apixaban for AF patients: The FDA accepted for review a new drug application (NDA) for the anticoagulant apixaban and assigned a priority review designation. The goal date for issuing a decision is March 28, 2012. Apixaban is a factor Xa inhibitor developed to prevent stroke and systemic embolism in patients with atrial fibrillation (AF). The submission was based on results from two Phase 3 clinical trials, ARISTOTLE and AVERROES. ARISTOTLE found that apixaban reduced the risk of stroke or systemic embolism by 21 percent, major bleeding by 31 percent and death by 11 percent. AVERROES results showed that apixaban significantly reduced the risk of stroke or systemic embolism without increasing the risk of major bleeding or intracranial hemorrhage in AF patients. AVERROES was stopped early, based on the beneficial findings. Apixaban is one of several novel anticoagulants under study as alternatives to warfarin, including direct thrombin inhibitor dabigatran and the factor Xa inhibitor rivaroxaban.

November 28, 2011

UK NICE Gives Nod to Apixaban for DVT Prevention: The UK's National Institute for Health and Clinical Excellence (NICE) has published final draft guidance recommending NHS reimbursement for the use of apixaban as an option for the prevention of venous thromboembolism (VTE) in adults who have undergone planned total hip or total knee replacement surgery .The committee concluded that apixaban was more clinically effective and cheaper than enoxaparin. It also concluded that there was insufficient clinical evidence to determine whether or not apixaban was more or less clinically effective than rivaroxaban and dabigatran. The draft guidance has been sent to the formal consultees for appraisal who have 15 working days to consider whether they wish to appeal against it. Subject to appeal, the draft guidance will be used as the basis for final guidance.

Four Drugs Cause Most Adverse-Event Hospital Stays for Seniors: Adverse drug events (ADEs) cause an estimated 100,000 emergency hospitalizations for seniors each year, yet two thirds involve just a handful of anticoagulants and diabetes medications, according to a study published in the last issue of the New England Journal of Medicine. The study, singles out 4 drugs and drug classes — warfarin, oral antiplatelet medications, insulins, and oral hypoglycemic agents. Alone or together, they account for 67% of emergency ADE hospitalizations of adults 65 years and older. Warfarin was implicated in 33%. In contrast, medications red-flagged as high risk or inappropriate by health authorities explained only 1.2% and 6.6%, respectively, of such hospital admissions. For clinicians, the take-home message of the study is clear: Improved management of antithrombotic and antidiabetes drugs can keep thousands of seniors out of the hospital.

Surgery ups survival in infective endocarditis with heart failure: Around the world, surgery decreased in-hospital mortality by 25% and one-year mortality by more than 50% compared with medical therapy in patients with infective endocarditis and heart failure, new research has found. The cohort study, which included over 4000 patients, probably represents the largest number of people with infective endocarditis ever prospectively followed as a group and published in the last issue of JAMA. Yet, according to an analysis from the International Collaboration on Endocarditis-Prospective Cohort Study, valve-replacement surgery is performed in less than two-thirds of such endocarditis cases with heart failure. Other independent predictors of in-hospital and one-year mortality included older age, diabetes, and a history of stroke; infection with Staphylococcus aureus or fungi also raised both mortality risks, while other types of infection did not. Of note, heart-failure severity was also a mortality predictor, but surgery conferred a significant benefit whether NYHA status was 3-4 or 1-2. The study included 4075 patients with confirmed native- or prosthetic-valve infective endocarditis and known HF status enrolled at 61 centers in 28 countries from 2000 through 2006. Of those patients, 1359 (33.4%) had heart failure, two-thirds of whom had NYHA functional status 3 or 4. Not surprisingly, in-hospital mortality in infective endocarditis rose significantly with the presence of heart failure, with an odds ratio (OR) of 2.80 (95% CI 2.38–3.29) vs no heart failure. However, surgery during that hospitalization cut the risk by a third, with an OR of 0.66 (95% CI 0.56–0.77) vs medical therapy alone. Both risk reductions were significant at p<0.001. The effect was much more pronounced in NYHA 3-4 patients, but remained significant in those who were less symptomatic.

Patients With Prior Stroke and Diabetes Benefits from Thrombolysis after an acute stroke: Ischemic stroke patients with prior stroke and diabetes might still be candidates for thrombolytic therapy according to a new study published in the last issue of Neurology. The study suggests that these patients derive just as much benefit from treatment as those without these conditions. In this study, they used data from the Safe Implementation of Thrombolysis Stroke-International Stroke Thrombolysis Register (SITS-ISTR) on stroke patients who received thrombolytic therapy from December 2002 to November 2009; control stroke patients did not receive thrombolytic therapy but participated in neuroprotection trials registered in the Virtual International Stroke Trials Archive (VISTA). Information from VISTA was limited to trials of neuroprotective agents that weren't vasoactive or expected to interfere with clotting mechanisms, or from the placebo groups.In all, they reviewed the outcomes of 29,500 ischemic stroke patients, looking at age, baseline National Institutes of Health Stroke Scale score, and 90-day Modified Rankin Scale (mRS) outcome score. Benefit was defined as improved distribution of mRS scores for the groups. The adjusted mRS outcomes were better in patients with diabetes, prior stroke, or both who were treated with tPA than in those who were not. These mRS scores were comparable to outcomes in treated stroke patients without diabetes or prior stroke (odds ratio, 1.53; 95% confidence interval, 1.42 to 1.63; P < .0001).

November 21, 2011

Low blood pressure linked to recurrent stroke, boosting J-curve hypothesis: A new study points again to evidence of the fabled J-curve of cardiovascular-event risk associated with blood-pressure levels. Among patients with recent noncardioembolic stroke, systolic blood pressures (SBP) >140 mm Hg and <120 mg Hg were both associated with increased risk of recurrent stroke. The study, a post hoc analysis of data from the Prevention Regimen for Effectively Avoiding Second Strokes (PROFESS) trial, is published in last issue of the Journal of American Medical Association. In this analysis, the authors used data from the PROFESS trial, a 2x2 factorial trial comparing four regimens: a combination of aspirin and extended-release dipyridamole compared with clopidogrel and telmisartan compared with placebo. All patients also received antihypertensive medications at the discretion of the investigator. In all, 20.330 patients from 695 centers in 35 countries were randomized within about 30 days of having a noncardioembolic ischemic stroke. The main results of the trial didn't show any significant difference between these treatments, the authors note, so all patients were combined for this study. Patients were categorized by their mean SBP level over follow-up as very low normal (<120 mm Hg), low normal (120 to <130 mm Hg), high normal (130 to <140 mm Hg), high (140 to <150 mm Hg) and very high (>150 mm Hg). The primary outcome was first recurrence of stroke of any type, and the secondary outcome was a composite of stroke, MI, or death from vascular disease. The adjusted hazard ratio for stroke, MI, or vascular death (95% CI) was 1.31 (1.13-1.52) for patients with Very low- normal blood pressure and 1.24 (1.11-1.39) and 1.94 (1.74-2.16)for patients with high and very high blood pressure respectively.

Survival after first MI paradoxically worse with fewer CHD risk factors: As the number of traditional CHD risk factors increased, the likelihood of in-hospital death after a first MI decreased, in a large, observational study published in the last issue of JAMA. The study, was based on data from over 500 000 patients listed in the 1994-2006 National Registry of Myocardial Infarction (NRMI). Hypertension was the most common risk factor (52.3% of patients), followed by smoking (31.3%), dyslipidemia (28.0%), family history of CHD (28.0%), and diabetes (22.4%). Only 14.4% of the patients had no CHD risk factors. Almost all patients (85.6%) had at least one of the five risk factors—hypertension, smoking, dyslipidemia, diabetes, or an immediate relative diagnosed with CHD before age 60. Compared with patients who had all five risk factors, patients with no risk factors were 54% more likely to have a fatal first MI (odds ratio 1.54; 95% CI 1.23-1.94), after adjustment for age, weight, sex, race/ethnicity, payer status, systolic blood pressure, prehospital delay, Killip class, hospital characteristics, region, type of MI, and calendar year.

European Medicines Agency updates on safety of Pradaxa: The European Medicines Agency announced that despite the number of deaths from serious bleeding seen with Boehringer Ingelheim’s Pradaxa (dabigatran), it believes that changes to the product's label recommended last month can "adequately manage the risk." The regulator added that the efficacy of the anticoagulant "demonstrated in clinical trials remains unchanged." The drug, which has been approved in Europe since 2008 for the prevention of venous thromboembolic events in adults who have had certain surgeries, and more recently for the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation, has been linked to 256 reports of serious bleeding resulting in death as of November 6. The EMA noted that 21 of these deaths have occurred within the EU. According to the agency, the number of reports should be viewed in "context of the rapidly increasing use of Pradaxa worldwide," due in part to recent authorisation in several markets for the prevention of stroke, as well as increased awareness of the drug, which "is known to lead to higher than usual reporting of side effects." Last month, the EMA recommended that the label of Pradaxa be updated to include advice that renal function is assessed in all patients before starting treatment with the drug. The EMA also reiterated that the anticoagulant should be "used with caution and at lower doses" in elderly patients and those with moderate kidney impairment. The agency said it "will continue to closely monitor this issue and the overall safety profile" of Pradaxa, including determining whether the frequency of fatal bleeding events has increased.

November 14, 2011

ATLAS ACS 2 TIMI 51: Low dose of rivaroxaban has a good benefit/risk balance in patients with acute coronary syndromes: The lower of the two doses of the new oral anticoagulant rivaroxaban (Xarelto, Bayer/Johnson & Johnson) tested in the ATLAS ACS 2 TIMI 51 trial has shown promising results, with a reduction in overall and cardiovascular mortality vs placebo, despite an increased risk of bleeding and intracranial hemorrhage (ICH). The trial, presented at the American Heart Association (AHA) 2011 Scientific Sessions and published online in NEJM, compared two doses of rivaroxaban with placebo in ACS patients. All patients were taking low-dose (75-100 mg) aspirin and 93% were also on clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis). Study treatment was started an average of 4.6 days after the ACS event. Patients with a previous stroke or transient ischemic attack (TIA) were excluded, as this group has been shown to have a particularly high risk of ICH in previous trials of other antithrombotic agents. The population was high risk, with half having had a STEMI. Both rivaroxaban doses reduced the primary end point of cardiovascular death/MI/stroke, at the cost of increased bleeding rates. The 2.5-mg twice-daily dose had the better benefit/risk balance, due to a lower bleeding risk than the 5-mg twice-daily dose.

New-onset AF in sepsis increases stroke and death rates: New-onset atrial fibrillation (AF) in patients with severe sepsis is associated with a significant increase in in-hospital stroke and death compared with both sepsis patients who don't develop AF and those with preexisting AF, according to new research presented at the American Heart Association 2011 Scientific Sessions and published simultaneously online in JAMA. In this retrospective study were participated 3. 144. 787 hospitalized adults, whereas 49.082 of them suffered from severe sepsis. New-onset AF was defined as AF that occurred during hospital admission, excluding patients who had AF at admission. Outcome measures were in-hospital stroke or death. New-onset AF was significantly more common in patients with severe sepsis than in hospitalized patients without severe sepsis. Severe sepsis was present in 14% of all new cases of AF among hospitalized adults

NHBLI-appointed expert panel recommends universal cholesterol screening for kids: An expert panel is recommending that all children, regardless of family history, undergo universal screening for elevated cholesterol levels. The panel recommends that adolescents undergo lipid screening for nonfasting non-HDL-cholesterol levels or a fasting lipid panel between the ages of 9 and 11 years followed by another full lipid screening test between 18 and 21 years of age. The guidelines, from the Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents, appointed by the National Health, Lung, and Blood Institute (NHLBI) and endorsed by the American Academy of Pediatrics (AAP), also recommend measuring fasting glucose levels to test for diabetes in children 10 years of age (or at the onset of puberty) who are overweight with other risk factors, including a family history, for type 2 diabetes mellitus.

ISAR-REACT 4: Bivalirudin preferable to combination abciximab/heparin in NSTEMI: The ISAR-REACT-4 trial has shown that bivalirudin is preferable to abciximab plus heparin in NSTEMI patients undergoing PCI. In the trial, presented at the American Heart Association 2011 Scientific Sessions and simultaneously published online in the New England Journal of Medicine, the primary end point was not significantly different between the two groups, but bivalirudin was associated with less bleeding. In the study were participated 1721 NSTEMI patients who were randomized to receive abciximab plus unfractionated heparin or bivalirudin immediately before PCI. Results showed that abciximab and unfractionated heparin failed to reduce the rate of the primary end point and increased the risk of bleeding.

TRACER: Varopaxar failed to improve the prognosis of patients with acute coronary syndromes and increased the risk of major bleedings: A novel oral antithrombotic agent, given to high-risk patients with non-ST-elevation ACS who were mostly already on dual-agent antiplatelet therapy, failed to hit that coveted treatment sweet-spot—reduced ischemic risk without more bleeding—in an huge international trial reported here today at the American Heart Association (AHA) 2011 Scientific Sessions and published online in NEJM. In the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) trial with >12 000 patients, adding the investigational vorapaxar (a PAR1 antagonist) to standard therapy significantly raised the risk of major bleeding complications, including intracranial hemorrhage (ICH), over two years.

November 7, 2011

NICE recommended Dabigatran etexilate as a cost effective option for the prevention of stroke in patients with atrial fibrillation: The National Institute for Health and Clinical Excellence (NICE) has reviewed the numbers and is now recommending use of dabigatran etexilate (Pradaxa, Boehringer Ingelheim) as a treatment option for the prevention of stroke and systemic embolism in individuals with nonvalvular atrial fibrillation. In August, the agency had requested a cost-effectiveness analysis of patients 80 years of age and younger who begin treatment with dabigatran 150 mg twice daily and patients 80 years of age and older who switch to dabigatran 110 mg twice daily from warfarin. In its final appraisal, NICE has concluded that the "most plausible" incremental cost-effectiveness ratios for all patients eligible for dabigatran are within the range considered cost-effective for use in the UK National Health Service (NHS), that being less than £20 000 per quality-adjusted life-year (QALY) gained. Based on the review, the NICE committee recommends treatment with the novel anticoagulant "after an informed discussion between the clinician and the person about the risks and benefits of dabigatran compared with warfarin."

Rivaroxaban Approved by FDA to prevent stroke in patients with AF: The FDA has approved rivaroxaban (Xarelto, Johnson & Johnson) for stroke reduction in people with non-valvular atrial fibrillation. The label will include a boxed warning that people should not discontinue taking the drug without talking with a healthcare professional. The FDA will also require that patients getting the drug receive a Medication Guide describing the risks and adverse reactions associated with the drug.

FDA approved first artificial aortic heart valve placed without open-heart surgery (Sapien) for patients with inoperable aortic valve disease: The US Food and Drug Administration has approved the first-ever transcatheter valve for the treatment of inoperable aortic-stenosis disease, the Sapien (Edwards Lifesciences). The FDA’s approval of the Sapien THV is based on PARTNER cohort B study with 365 patients who were not eligible for open-heart surgery. Half of the patients received the Sapien valve. The other study patients received another treatment that did not require open-heart surgery. One alternative procedure involved enlarging the aortic valve opening by stretching it with a balloon (balloon valvuloplasty). Patients receiving the Sapien valve experienced two and a half times more strokes and eight times as many vascular and bleeding complications than patients who did not receive the implant; however, they were more likely to survive one year after surgery. After a year, 69 percent of the Sapien patients were alive compared with 50 percent of those who received an alternative treatment.

ACC/AHA updates secondary-prevention guidelines: The American Heart Association and American College of Cardiology Foundation have issued new guidelines for secondary prevention and risk reduction in patients with atherosclerotic vascular disease, even though it is still waiting for the new Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8) guidelines and new Adult Treatment Panel 4 (ATP 4) guidance on lipid management [1]. The new guidelines, published online in Circulation, update the 2006 guidelines on secondary prevention and change the title to include risk-factor reduction, "because important evidence from clinical trials has emerged that further supports and broadens the merits of intensive risk-reduction therapies for patients with established coronary and other atherosclerotic vascular disease," including peripheral artery disease, the writing committee explains.

October 31, 2011

Esomeprazole, but not rosuvastatin, affects clopidogrel post-PCI SPICE study: The proton-pump inhibitor (PPI) esomeprazole (Nexium, AstraZeneca) is "at least as bad" as omeprazole in reducing the antiplatelet effects of clopidogrel (Plavix, Sanofi-Aventis/Bristol-Myers Squibb), a new randomized trial (SPICE) shows. In a secondary analysis, investigators for the Statins and Proton-Pump Inhibitors on Clopidogrel Antiplatelet Effects (SPICE) trial found no differences in clopidogrel effects of rosuvastatin (Crestor, AstraZeneca) and atorvastatin (Lipitor, Pfizer). The SPICE results presented during the late-breaking clinical-trials session at the Canadian Cardiovascular Congress 2011. SPICE enrolled 350 post-PCI patients discharged on clopidogrel and excluded patients who were intolerant to the study drugs or who had an absolute need for a PPI. In the initial randomization, post-PCI patients were prescribed either rosuvastatin 20 mg or atorvastatin 80 mg, their CYP2C19*2 status was measured, and they were given clopidogrel but not a PPI. At 30 days, platelet-function tests were performed using both light transmittance aggregometry to test maximal platelet aggregation (MPA) and vasodilator stimulated phosphoprotein (VASP) testing to measure platelet-reactivity index (PRI). At the 30-day mark, the 302 patients who'd remained in the study were further randomized to one of four gastroprotection agents: esomeprazole, pantoprazole, omeprazole, or ranitidine. Platelet-function testing was then repeated at 60 days, although only 277 remained in the study at the 60-day mark. For the statin analysis, there were no differences in the effects of rosuvastatin and atorvastatin on antiplatelet effects at 30 days. For the PPI analysis, there was no difference in mean change in platelet reactivity with pantoprazole as compared with ranitidine—an H2 antagonist. Esomeprazole, however, had the largest effect on platelet reactivity as measured by both MPA and PRI, with more than 35% of patients taking esomeprazole demonstrating a greater than 10% change in platelet activity by MPA, a proportion that rose to more than 50% by PRI. Omeprazole, by comparison, showed increases in mean change in platelet reactivity by PRI only, with nonsignificant increases seen on MPA.

Obesity- and alcohol-related cardiomyopathies are common causes of nonischaemic sudden cardiac death: A study of a Finish population, published online in Heart Rhythm, indicates that cardiomyopathy associated with obesity, alcoholic cardiomyopathy, and fibrotic cardiomyopathy are common causes of nonischaemic sudden cardiac death. In the study reviewed post-mortem data from 2,661 consecutive victims of sudden cardiac death from the province of Oulu in Finland who died between 1998 and 2007. The vast majority of deaths were due to coronary artery disease (78.2%). Of those who died of a nonischaemic cause (21.8%), the most common cause of death was cardiomyopathy related to obesity. Alcoholic cardiomyopathy was the second most common cause of nonischaemic sudden cardiac death, and accounted for 25.8% of deaths in people aged 40 and 59 years.

NICE in its final guidance recommended Brilique plus aspirin for Acute Coronary Syndrome: NICE in its final guidance to the NHS in England and Wales recommended Brilique plus aspirin and for up to 12 months, as an option to treat adults with Acute Coronary Syndromes (ACS). The NICE guidance recommends the use of Brilique plus aspirin, as a treatment option in people with ST-segment-elevation myocardial infarction who are to undergo percutaneous coronary intervention and in people with Non-ST-segment-elevation myocardial infarction. It is also recommended as a treatment option for people admitted to hospital with unstable angina, which is defined as changes on electrocardiogram suggestive of ischaemia, and who have one characteristic associated with cardiovascular disease.

October 24, 2011

No risk in stopping dual antiplatelet therapy (DAPT) at six months : An analysis of 2032 patients treated with the zotarolimus-eluting stent (Endeavor) published in the Journal of the American College of Cardiology Interventions suggests there is no increased risk of death, myocardial infarction, stroke, or stent thrombosis when stopping dual antiplatelet therapy (DAPT) with aspirin and thienopyridine therapy at six months. After three years of follow-up, the adjusted risk of individual ischemic events—death, myocardial infarction, stroke, and stent thrombosis—did not significantly differ between patients treated with DAPT for six months, more than 12 months, or more than two years. In addition, the composite risk of ischemic events did not statistically differ between treatment durations. Treatment with DAPT for six months was not associated with a higher risk of thrombotic events compared with patients treated for longer durations. Bleeding risks were similar across treatment durations and considered negligible.

European Medicines Agency starts new review of cardiovascular risks of non-selective NSAIDs: The European Medicines Agency is reviewing the latest available data on the cardiovascular safety of non-selective NSAIDs (non-steroidal anti-inflammatory drugs). NSAIDS have been the subject of several European reviews in relation to gastrointestinal and cardiovascular safety and the occurrence of serious skin reactions. At the outcome of the last review on the cardiovascular safety of non-selective NSAIDs, in 2006, the Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the overall benefit-risk balance remained positive, but the possibility of a small increased risk of thrombotic events such as heart attacks or stroke with non-selective NSAIDs could not be excluded.

Statin use in hospital linked to improved post-stroke survival: Treating ischemic stroke patients with statins at the beginning of hospitalization and avoiding interruptions in statin use for stroke patients who already were taking statins may be a prudent course of care, based on results of a study published online Oct. 20 in Stroke. The observational study found a strong association between early statin use in ischemic stroke patients and improved survival as well as an association between statin withdrawal and worsened survival.

EMA Review Concludes: No Cancer Risk With ARBs: The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has reviewed the possible link between the use of angiotensin II receptor antagonists (ARBs) and the occurrence of new cancers and concluded that the evidence does not support any increased risk of cancer in patients using these medicines. Angiotensin II receptor antagonists have been authorised in the European Union since the mid-1990s for the treatment of hypertension (high blood pressure). They are also used in the treatment of conditions such as heart failure and kidney disease in type 2 diabetes and for the prevention of strokes and heart disease. The review was formally requested by the Italian Medicines Agency following the publication of a meta-analysis which showed a small increased risk of new cancers (particularly lung cancer) with ARBs compared with placebo and other heart medicines (7.2% versus 6%).

October 17, 2011

FDA Panel Recommends First DES For peripheral artery disease (PAD): The Zilver® PTX® Drug-Eluting Stent, the first device of its kind developed to treat peripheral artery disease (PAD) in the superficial femoral artery (SFA), has received a unanimous recommendation from the Food and Drug Administration's (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee, Cook Medical announced today. The panel convened today in the Washington, DC area and all 11 of its members voted to recommend approval of the device on the basis of its safety, efficacy and acceptable risk profile.

Better Rate Control Does Not Improve Quality of life (QOL) in Atrial Fibrillation: Better heart rate control did not translate to improved quality of life (QOL) for patients with atrial fibrillation in a recent Dutch study published in JACC. The findings are from a predefined substudy of RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation: A Comparison Between Lenient and Strict Rate Control II), in which 437 patients filled out validated surveys that asked about general health, AF severity, and fatigue. Symptoms of AF (dyspnea, fatigue, and palpitations) did not differ at baseline or at the end of the study between the lenient and strict control subjects in the current study. At baseline, quality of life was similar in the lenient and strict control groups, and also in patients with high vs normal heart rates, as assessed by patient responses to the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). A year later, and at the end of the study (median, 3 years), QOL was still similar in the lenient and strict control groups on all of the SF-36 subscales. At those points the two groups also had similar scores on the Multidimensional Fatigue Inventory-20 (MFI-20) and the University of Toronto AF Severity Scale.

ACE Inhibitors seems to have No Benefit After CABG: More evidence that low-risk patients who have undergone elective coronary artery bypass (CABG) surgery do not benefit from treatment with an ACE inhibitor has come from a new cohort study published online in American Heart Journal. The study included 3718 patients 65 years and older who underwent CABG between 1996 and 2005. Subsequent clinical events were determined from Canadian hospitalization databases and vital statistics for mortality. The primary outcome was all-cause mortality or hospital readmission for cardiac events or procedures. After risk adjustment for potential confounding variables, there was a trend toward a higher rate of such events among patients treated with an ACE inhibitor after CABG, although this was not statistically significant. Statins were associated with a significant 35% reduction in the primary end point and beta blockers with a 17% reduction.

SORIN's SonR CRT device gets CE mark: Sorin Group announced at the Venice Arrhythmias 2011 Congress, CE mark approval and the European commercial launch of its SonR cardiac resincronisation therapy optimisation system. The SonR system includes the SonR haemodynamic sensor embedded in the SonRtip atrial pacing lead and the Paradym RF SonR CRT-D device. SonR is the first and only system to provide weekly automatic optimisation during patient's real life activities as an alternative to in-clinic manual echocardiography-based device optimisation for improved CRT response.

According to the company, promising early clinical results suggest that SonR increases responder rates and reduces heart failure hospitalisations compared with standard medical practice over a one year follow-up

October 10, 2011

A new Brochure with information about the HCRS is now available for downloading.

Statins improve outcomes for MI patients with low LDL levels: Statin therapy reduced the risk of cardiac death and coronary revascularization in patients with acute MI who had baseline low-density lipoprotein cholesterol (LDL-C) levels below 70 mg/dl, according to a study published in the last issue of the Journal of the American College of Cardiology. In the study were included 1,054 patients with AMI who had enrolled in the Korean Acute Myocardial Infarction Registry between November 2005 and December 2007. They were divided into two groups: a statin group in which 607 patients were administered statins for at least one month after discharge and a non-statin group, in which 447 patients did not receive statins. The primary end point was the composite of major adverse cardiac events at one year. During the 12-month follow-up t statin therapy significantly reduced the risk of the composite primary endpoint. Cardiac death occurred in 4 percent of the statin group compared with 7.5 percent of the non-statin group; 6.8 percent of the statin group experienced coronary revascularization compared with 10 percent of the non-statin group. There were no differences in the risk of the composite of all-cause death, recurrent MI and repeated percutaneous coronary intervention.

Dabigatran proves safe, effective post-AF ablation: According to a study published online in the Journal of Cardiovascular Electrophysiology dabigatran may be safe and well tolerated in atrial fibrillation (AF) patients after ablation. Dabigatran also was safe in terms of bleeding complications and thromboembolic events, leaving the authors to conclude that the drug may be a good alternative to warfarin. In the study, were evaluated 123 patients who were administered dabigatran post-AF ablation to better assess whether dabigatran would be an alternative to warfarin post-ablation procedure. Patients enrolled in the study were administered a 0.5 mg/kg dose of enoxaparin at the end of the procedure, which was repeated 12 hours later and then discontinued. Dabigatran was administered 22 hours post-ablation procedure.The study's primary endpoints were thromboembolic events, bleeding complications and side effects over a 30-day period. The authors reported that there were no preprocedural or intraprocedural episodes of bleeding or thromboembolic events. No post-ablation strokes, transient ischemic attacks or system thromboemboli were reported. Only three patients discontinued dabigatran and switched to warfarin due to side effects.

FDA approves combination therapy in one pill for diabetes and cholesterol: The FDA has given a nod of approval for the combination drug Juvisync (sitagliptin and simvastatin, Merck), which is indicated for patients with type 2 diabetes and high cholesterol.

The fixed-dose combination (FDC) drug is approved for use in patients who need both sitagliptin and simvastatin. According to the FDA, 20 million people in the U.S. are diagnosed with type 2 diabetes; many of these patients also have high cholesterol levels.

Sitagliptin is a dipeptidyl peptidase 4 inhibitor that works to lower blood sugar. The drug is approved for use in combination with diet and exercise to improve glycemic control in type 2 diabetics. Simvastatin is also approved for use with diet and exercise to reduce low-density lipoprotein cholesterol.

September 26, 2011

EMA advisory board recommend rivaroxaban for the prevention of pulmonary embolism in patients after orthopedic surgery and stroke in patients with atrial fibrilation: Advisors for the European Medicines Agency (EMA) have paved the way for two new indications for rivaroxaban (Xarelto, Bayer) in Europe. The EMA's Committee for Medicinal Products for Human Use (CHMP) issued two "positive opinions" for the oral factor Xa inhibitor yesterday: one in the setting of the prevention of stroke and systemic embolism in in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age = 75 years, diabetes mellitus, prior stroke or transient ischaemic attack, and two, for the treatment of venous thromboembolism (VTE), deep vein thrombosis (DVT), and pulmonary embolism (PE). A 10-mg dose of rivaroxaban was already approved in the EU for the prevention of VTE in adults undergoing hip and knee replacement surgery. The latest CHMP recommendation is for two new indications for the 15-mg and 20-mg tablets:

Prevention of stroke and systemic embolism in adults with nonvalvular AF with one or more risk factors, such as congestive heart failure, hypertension, aged >75 years, diabetes mellitus, prior stroke, or transient ischemic attack.
Treatment of VTE, DVT, and PE, which includes acute treatment and extended therapy of these conditions

Survey: Only half of AFib patients think they are at risk for stroke: Despite the fact that one in four atrial fibrillation (AF) patients named stroke as a major health concern, only 50 percent this patient population understand that their disease burden, AF, them at a heightened risk for stroke, according to a survey put forth by the American Heart Association (AHA). The online survey, fielded July 18 to 26, included data from 502 respondents and aimed to outline what AF patients perceive to be their biggest health risk. Additionally, the survey looked at respondents' knowledge of stroke, warning signs of stroke and stroke prevention strategies. Of those diagnosed with AF, 42 percent said that they were most concerned about the potential of heart disease or MI, while 10 percent said that they were most concerned about becoming diabetic. Only 8 percent of respondents said that they believed stroke was their greatest health concern.

Patients facing respiratory failure may benefit from levosimendan: Treatment with the calcium-sensitizing drug levosimendan may be effective in improving muscle function in patients with respiratory muscle weakness, which often accompanies chronic diseases such as chronic obstructive pulmonary disease (COPD) and congestive heart failure, according to researchers in the Netherlands, who studied the effects of the drug on healthy volunteers. The drug, which is normally prescribed in patients with acute heart failure, increases the sensitivity of muscle tissue to calcium, improving the muscle's ability to contract. The findings were published online ahead of the print edition of the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine.

International Consortium Identifies 5 New Genes Affecting The Risk Of Coronary Artery Disease: An international consortium of scientists reports the discovery of five new genes that affect the risk of developing coronary artery disease (CAD) and heart attacks in a study published in the open-access journal PLoS Genetics.
Coronary artery disease is the most common cause of premature death and disability in the world and has a strong but incompletely characterised genetic contribution. The identification of the roles of various genes in the onset of heart disease could help in the development of new treatments and improve prediction of CAD. The study also demonstrated that some associations between genes and CAD, suggested by other, smaller studies, are spurious, according to Dr Adam Butterworth, who co-ordinated the analysis. The consortium examined 49,094 genetic variants in ~2,100 genes of cardiovascular relevance in 15,596 CAD cases and 34,992 controls (11,202 cases and 30,733 controls of European descent, and 4,394 cases and 4,259 controls of South Asian origin) and replicated their principal findings in an additional 17,121 CAD cases and 40,473 controls.

September 19, 2011

Possible rivaroxaban antidote identified: Results of a small study published online in Circulation show that prothrombin complex concentrate (PCC) appears to be an effective antidote for rivaroxaban that could be used to stop or prevent serious bleeding in patients taking this new anticoagulant. However, the same study showed that PCC has no influence on dabigatran. The researchers randomized 12 healthy male volunteers to either 20 mg of rivaroxaban twice a day or 150 mg of dabigatran twice a day for two and a half days, followed by either a single 50-IU/kg dose of PCC or a similar dose of saline. After 11 days, the patients repeated this procedure with the other anticoagulant treatment. Rivaroxaban induced a significant prolongation of the prothrombin time (15.8 vs 12.3 seconds at baseline; p<0.001) that was immediately and completely reversed by the PCC to an average of 12.8 seconds (p>0.001). The endogenous thrombin potential, a measure of blood coagulability, was inhibited by rivaroxaban (51% vs 92% at baseline, p<0.002) and normalized with PCC (114%, p<0.001), while the saline had no effect.

Xanthelasmata seems to be an independent cardiovascular risk factor: The occurrence of xanthelasmata (yellowish, flat lipid plaques on the upper or lower eyelid) predicts increased risk of MI, ischemic heart disease, and death, independent of well-known cardiovascular risk factors, including plasma cholesterol and triglycerides according to a new study published online in BMJ. In this analysis, researchers followed 12.745 people aged 20-93 years free of ischemic vascular disease at baseline from 1976-1978 until May 2009 as part of the Copenhagen City Heart Study. Results showed that 563 (4.4%) of participants had xanthelasmata, and these patients had an increased risk of MI, ischemic heart disease, severe atherosclerosis, and death compared with individuals without xanthelasmata over the 33-year follow-up period.

Ondansetron (Zofron) Linked to Arrhythmias, FDA Warns: Clinicians should avoid using the antinausea drug ondansetron (Zofran, GlaxoSmithKline) in patients with congenital long QT syndrome because they run a particular risk for an abnormal and potentially fatal heart rhythm (torsades de pointes), the US Food and Drug Administration (FDA) announced .The agency is revising the drug's label to feature this warning. The label also will include recommendations for electrocardiogram monitoring for patients with electrolyte abnormalities, congestive heart failure, and bradyarrhythmias, and for the use of the drug with patients taking other medications that can trigger QT prolongations. Ondansetron, a 5-HT3 receptor antagonist, is prescribed to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Today's announcement comes in the wake of an ongoing safety review of the drug. The FDA is requiring GlaxoSmithKline to conduct a QT study to determine the degree to which ondansetron may prolong the QT interval.

Postprandial Glucose Predicts CV Risk in Type 2 Diabetes: Postprandial blood glucose levels, but not fasting blood glucose, predict cardiovascular events and all-cause mortality in people with type 2 diabetes, according to 14 years of follow-up in the San Luigi Gonzaga Diabetes Study which presented at the European Association for the Study of Diabetes (EASD) 2011 Meeting.. HbA1c was also a predictor of both outcomes over the long term. The study included 505 patients with type 2 diabetes reporting for regular follow-up at the diabetes clinic. Patients underwent blood glucose tests at four time points: fasting, two hours after breakfast, two hours after lunch, and before dinner. Three separate Cox regression models were applied to confirm the results, with one of the models adjusting for age, sex, known diabetes duration, smoking, body-mass index (BMI), systolic and diastolic blood pressure, cholesterol levels, triglycerides, creatinine, and albumin excretion rate. Over the 14 years of follow-up, 147 patients died and 172 cardiovascular events occurred. Across all of the analyses conducted, HbA1c and blood glucose levels after lunch predicted both future cardiovascular events and all-cause deaths. Further analyses suggested that the information provided by postprandial blood glucose added to the predictive power of HbA1c alone for both cardiovascular events and all-cause mortality. For all-cause mortality, the predictive ability of postprandial test was similar to that of HbA1c.

September 13, 2011

In accordance with the statute of the Hellenic Cardiovascular Research Society a new Board was formally elected by the General Assembly on 12 September 2011. The new Board, which will serve a three-year term, is as follows:

President: Panos Vardas
Vice President: Christodoulos Stefanadis
Secretary: George Andrikopoulos
Treasurer: Stavros Konstantinides

Counsellors (in alphabetical order):

Gerasimos Filippatos
George Kochiadakis
Fragiskos Parthenakis
Emmanuel Simantirakis
Charalambos Vlachopoulos

September 13, 2011

FDA Approved Rivaroxaban for Stroke Prevention in AF: The Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee voted 9 to 2, with one abstention, in favor of recommending the approval of rivaroxaban (Xarelto, Bayer/Johnson & Johnson), an oral factor Xa inhibitor, for the prevention of stroke in patients with atrial fibrillation.

Cisplatin increase the risk of thromboembolic events: The incidence of thromboembolic events in patients receiving cisplatin-based chemotherapy is unacceptably high, according to research published in the last issue of the Journal of Clinical Oncology.
In this retrospective analysis of 932 patients treated with cisplatin-based chemotherapy for any type of malignancy and were examined all thromboembolic events occurred between the start of treatment and 4 weeks after the last dose of cisplatin. Overall, 169 patients (18.1%) developed a thromboembolic event either during treatment or within 4 weeks of their last cisplatin dose. Almost half of the thromboembolic events were deep vein thrombosis (DVT) alone, which occurred in 84 patients (49.7%). Pulmonary embolus (PE) alone occurred in 43 patients (25.4%), DVT plus PE occurred in 23 patients (13.6%), arterial thrombosis alone occurred in 14 patients (8.3%), and DVT plus arterial thrombosis occurred in 5 patients (3.0%).

Platelet Reactivity Correlates With Adverse Events: Latest results from the GRAVITAS trial have confirmed that platelet reactivity on clopidogrel correlates with event rates in PCI patients and that achievement of an on-treatment reactivity of below 208 platelet reactivity units (PRU) as measured by the VerifyNow (Accumetrics) test is associated with a lower rate of cardiovascular death, MI, or stent thrombosis. The results were presented in the last ESC Congress and published in the last issue of Circulation.

Stenting Worse Than Medical Therapy for Intracranial Stenosis: In the SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) trial, which has now been published online in the New England Journal of Medicine, 451 patients with a recent TIA or stroke attributed to a 70-99% stenosis of a major intracranial artery were randomized to either aggressive medical therapy (consisting of aspirin, clopidogrel, and management of primary risk factors) or the same medical therapy plus stenting with the Wingspan stent system. The trial was terminated early due to a much higher rate of stroke or death in the stenting group during the 11.9 months of follow up. The rate of stroke or death at 30 days was 14.7% in the stent group versus 5.8% in the medical group (p=0.002) and at 1 year was 20% versus 12.2% (p:0.009).

September 5, 2011

News from ESC Congress

ARISTOTLE STUDY: In this randomized, double-blind trial apixaban, a new anticoagulant drug, was found superior to the standard drug warfarin for preventing stroke and systemic embolism in patients with atrial fibrillation. Moreover, apixaban results in substantially less bleeding, and also results in lower mortality. The benefits of apixaban are consistent irrespective of how well warfarin is used at different centers, as measured by "time in therapeutic range." In the trial were included 18,201 patients and the study was published online by the New England Journal of Medicine.

CORP TRIAL: Colchicine, when given in addition to conventional therapy, was more effective than placebo in reducing the incidence of recurrence and the persistence of symptoms of pericarditis as it was found in the randomised controlled trial CORP . This is the first time that the efficacy of colchicine in preventing recurrent episodes of pericarditis has been demonstrated in a double-blind multicentre randomised trial.

EMPHASIS HF TRIAL: A sub-analysis of the EMPHASIS-HF study showed significant reductions in death and hospitalization for five pre-defined high-risk patient sub-groups with chronic heart failure (CHF) and mild symptoms treated with eplerenone in addition to standard therapy versus those treated with placebo and standard therapy. These subgroups were: Age > 75 years, Diabetes Mellitus (DM), estimated glomerular filtration rate (eGFR) < 60 ml/min /1.73 m2, Left ventricular ejection fraction (LVEF) < 30 %, and Systolic blood pressure ( SBP) < median of 123 mm Hg.

PRODIGY TRIAL: In this randomised multicentre open-label study with more than 2000 patients was evaluated the efficacy and safety of prolonged antiplatelet therapy in patients with coronary disease and was found that 24 months' duration of dual therapy (DAPT) is no better than six months DAPT in preventing adverse cardiac events.

EXAMINATION STUDY: The second generation drug-eluting stent Xience V performs well in patients having primary PCI for ST elevation myocardial infarction, and has a better safety profile than that of bare metal stents, according to results of the EXAMINATION (Evaluation of Xience-V stent in Acute Myocardial INfArcTION) trial. The study was an investigator-initiated, multicentre, multinational trial involving 1498 STEMI patients randomised to either a Xience V stent (everolimus-eluting) or cobalt chromium bare metal stent. The primary endpoint was a composite of all-cause death, any recurrent myocardial infarction and any repeat revascularisation at one-year follow-up.

RUBI 1 TRIAL: RUBY-1 was a multicentre, double-blind phase II dose-finding study in 1279 patients with recent high-risk non-ST-segment elevation and ST-segment elevation ACS. The results showed that the new oral Factor Xa inhibitor darexaban was associated with a two to four-fold increase in bleeding when added to dual antiplatelet therapy in patients following an acute coronary syndrome. The primary outcome of the study (major or clinically relevant non-major bleeding events) was numerically higher in all darexaban arms than in the placebo group (pooled HR 2.275, 95% CI 1.13-4.60, p=0.022). Using placebo as reference (with a bleeding rate of 3.1%), there was a dose-response relationship (p=0.009) for increased bleeding rates with increasing darexaban dose (6.2, 6.5 and 9.3% for 10, 30 and 60 mg daily, respectively). This increase was statistically significant for the 30 mg bid dose (p=0.002).

Dal VESSEL STUDY: Results of the phase IIb dal-VESSEL study show that dalcetrapib, an investigational molecule which acts on cholesteryl ester transfer protein (CETP), did not impair endothelial function (as indicated by flow-mediated dilatation) or increase blood pressure, and was generally well tolerated in patients with or at risk of coronary heart disease. Dal-VESSEL was an exploratory phase IIb randomised, double-blind, placebo-controlled trial in patients with coronary heart disease (CHD), or CHD risk equivalents, in which 476 patients with HDL-C levels <50 mg/dL were recruited. They received dalcetrapib 600 mg/day or placebo in addition to their existing treatments. Results showed that dalcetrapib reduced CETP activity by almost 50% and increased high-density lipoprotein cholesterol (HDL-C) levels by 31% without changing nitric-oxide-dependent endothelial function or markers of inflammation and oxidative stress. No safety signals were observed during the whole study, and 23 pre-specified positively adjucated events occurred with an even distribution in both treatement arms (11 with dalcetrapib and 12 with placebo).

September 2, 2011

Revised guidelines for stroke centers from Brain Attack Coalition: Revised recommendations on the essential elements necessary to properly care for patients with acute stroke in primary stroke centers (PSCs) have been released by the Brain Attack Coalition (BAC), representing numerous professional stroke societies and government agencies. Their recommendations were published as a special report in the September 2011 issue of Stroke.

ESC published the revised guidelines for patients with acute coronary syndromes: The European task force for the management of ACS patients presenting with non-STEMI has released new guidelines at the European Society of Cardiology 2011 Congress. The guidelines update a previous version issued in 2007 and contain a number of important new recommendations. the guidelines recommend the use of high-sensitivity (hs) troponin assays: a rapid rule-out protocol (within zero to three hours of symptoms) using hs-troponin is given a class Ib recommendation in the new guidelines. They also, for the first time, support a role for coronary CT angiography (CTA) as an alternative to invasive angiography to exclude ACS in patients with a low to intermediate likelihood of CAD, when both troponin tests and an ECG are inconclusive (class IIa, level of recommendation). Moreover, clopidogrel is now recommended only for patients who cannot take ticagrelor or prasugrel (class Ia).

New Resuscitation Strategies Fail To Improve Outcomes After Cardiac Arrest: Two trials from the Resuscitation Outcomes Consortium (ROC) investigators were unable to demonstrate meaningful improvements to resuscitation strategies after cardiac arrest. The two trials, one testing an impedance threshold device and the other a strategy comparing early and late rhythm analysis, have been published in the New England Journal of Medicine.
In the first trial, 8718 patients were randomized to treatment with an active or sham impedance threshold device (ITD) intended to improve venous return and cardiac output during CPR. There was no significant difference between the groups in the percentage of subjects who survived to hospital discharge with satisfactory function:
•6.0% (260 patients) in the sham-ITD group versus 5.8% (254 patients) in the active-ITD group
In the second trial, which utilized a cluster-randomized design, 9933 patients with out-of-hospital cardiac arrest received either CPR for 30-60 seconds or CPR for 180 seconds prior to ECG analysis. Once again, no difference in the primary outcome of survival to hospital discharge with satisfactory function status was observed:
•5.9% (273 patients) in the later-analysis group versus5.9% (310 patients) in the early-analysis group.
There were no significant differences in any of the secondary outcomes or among subgroups in either of the trials.

August 24, 2011

New hypertension guidelines from NICE : Patients suspected of having hypertension should be sent home and told to wear a monitor for 24 hours, rather than having their blood pressure checked in the clinic according the new Hypertension guidelines published from NICE. This is the most important change from the previous guidelines. Moreover, the updated guidelines recommend for the first time that patients over the age of 80 must be treated for hypertension and the use of calcium-channel blockers rather than diuretics is now recommended for patients over 55 or patients of African or Caribbean family origin of any age, following the emergence of new evidence.

LV diastolic dysfunction linked to heart failure, even in healthy people. : Signs of left ventricular diastolic dysfunction that may eventually lead to heart failure can be detected even in healthy patients, new data from the Olmsted County Heart Function Study show. In the study were examined 2042 patients 45 years or older with echocardiography and clinical examination between 1997 and 2000 and graded their diastolic left ventricular function, from normal to severely dysfunctional, by validated Doppler techniques. The researchers reexamined study participants four years later, and they were then followed through 2010 for ascertainment of new-onset heart failure. A total of 1402 of the 1960 surviving patients came in for the second evaluation. Between the first exam and the four-year follow-up exam, the prevalence of diastolic dysfunction in the study group increased from 23.8% to 39.2% (p<0.001). Worsened diastolic dysfunction was associated with age 65 years or older (odds ratio 2.85), and after a mean of 6.3 years of additional follow-up, 12.2% of patients whose LV diastolic dysfunction was moderate to severe developed heart failure. By contrast, during the follow-up period, only 2.6% of people with normal diastolic dysfunction showed heart failure, and 7.8% of participants with mild diastolic dysfunction developed heart failure (p<.001). The study also showed that diastolic dysfunction was associated with incident heart failure after adjustment for age, hypertension, diabetes, and coronary artery disease (hazard ratio 1.81).

Heart-healthy foods lower LDL-C better than low-saturated-fat diet : A diet rich in foods with proven heart-healthy benefits is significantly better than a diet low in saturated fat for reducing LDL-cholesterol levels in patients with hyperlipidemia, according to the results of a new study published in JAMA. The "dietary portfolio" of cholesterol-lowering foods reduced LDL-cholesterol levels by 26 mg/dL, nearly as large a reduction as was observed in some of the earliest statin trials. In this the 24-week, parallel-design study included 351 patients with hyperlipidemia. Patients were randomized to one of two dietary interventions: a standard diet low in saturated fat; and the portfolio diet consisting of plant sterols, soy protein, viscous fibers, and nuts. In addition to the portfolio diet, the patients eating the heart-healthy foods received dietary advice for six months, with intensive-treatment patients receiving seven 40-minute counseling sessions and the routine-treatment portfolio patients receiving two counseling sessions. Intensive therapy with the portfolio diet reduced LDL-cholesterol levels 13.8% from baseline, a reduction of 26 mg/dL (p<0.001). Similarly, patients treated with the portfolio diet who received just two counseling sessions also had significant reductions in LDL cholesterol, which was reduced 13.1% from baseline, or down 24 mg/dL. The reductions in LDL cholesterol were not statistically different in the two dietary-portfolio treatment arms.

August 17, 2011

Genous stent fails to match drug-eluting stent performance in TRIAS HR trial : The Genous endothelial progenitor cell capture stent (ECS) has failed again to live up to the hopes for it created by smaller trials, as one-year data from the TRI-Stent Adjudication Study—High Risk of Restenosis (TRIAS HR) show it performing much worse than a drug-eluting stent (DES) . The one-year results of TRIAS HR published in the August 2011 issue of the Journal of the American College of Cardiology: Cardiovascular Interventions.TRIAS HR was designed to randomize 1300 patients with stable coronary disease and a high risk of restenosis to PCI with either the ECS or a DES at 26 centers. A variety of commercially available DES were used in the trial. The ECS patients got one month of dual-antiplatelet therapy, while the DES patients received at least six months of dual-antiplatelet therapy. The ECS technology is designed to provide fast endothelialization. Impairment of long-term endothelialization by DES increases the risk of late stent thrombosis and necessitates prolonged dual antiplatelet therapy. But TRIAS HR was stopped early after about half the patients were enrolled, because one-year follow-up on 304 patients receiving ECS and 318 receiving DES showed 17.4% target lesion failure in the ECS group and 7% in the DES group (p=0.98 for noninferiority).

Landmark pan-European atrial fibrillation trial (EAST) recruits first patient : The largest pan-European study to determine whether an early comprehensive rhythm control strategy will be beneficial in patients with atrial fibrillation has recruited its first patient. Investigators for the early comprehensive atrial fibrillation stroke prevention trial (EAST) have recruited the first of what they hope will be more than 3000 patients, from 200 centres in 11 European countries. The aim of the pan-European study is to investigate whether an early standardised, rhythm control therapy can help to prevent patients with atrial fibrillation from having adverse cardiovascular outcomes, such as stroke. The primary outcome, therefore, is a composite of cardiovascular death, stroke, heart failure, or acute coronary syndrome (hospitalisation).

Cigarette smoking doubles the risk of atrial fibrillation : A large study, published in the August edition of HeartRhythm, is the first to show that cigarette smoking doubles the risk of atrial fibrillation. In the Atherosclerosis Risk in Communities Study (ARIC), participants were asked whether they had ever smoked and if they had, they were asked about the age they started smoking, the number of years they smoked, the amount of cigarettes they smoked, and if they were currently smokers (and if they were not, when they gave up). Compared with "never smokers", current smokers had a two-fold increased risk of developing atrial fibrillation while former smokers had a 1.32 increased risk. After excluding participants who had prevalent chronic heart disease or heart failure at baseline from the results and censoring for incident chronic heart disease or heart failure during follow-up, the risk attenuated but still remained. The heaviest smokers (>675 cigarette years) had a hazard ratio of 2.10 compared with never smokers (1.94 after adjusting for prevalent chronic heart disease and heart failure at baseline).

ROCKET AF published. Rivaroxaban non inferior to warfarin in patients with atrial fibrillation : The results of ROCKET-AF, which showed that the direct Factor Xa inhibitor rivaroxaban (Xarelto, Bayer Healthcare) was non-inferior to the prevention of stroke or systemic embolism in patients with atrial fibrillation, have now been published online in The New England Journal of Medicine. In an intention-to-treat superiority analysis, rivaroxaban was not shown to be superior to warfarin, but it fared better when investigators analyzed only patients treated with the drug in an on-treatment superiority comparison. In the on-treatment superiority analysis, rivaroxaban reduced the risk of stroke and non-CNS embolization 21% compared with warfarin, a statistically significant difference.

August 05, 2011

EMA approvd dabigatran for AF indication : Dabigatran etexilate (Pradaxa, Boehringer Ingelheim) has been officially approved in the EU for prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). The decision by the European Commission represents a label extension for the new oral anticoagulant, which is already available in the EU for prevention of venous thromboembolism (VTE) in the setting of hip- and knee-replacement surgery. The approval follows the "positive opinion" handed down for the dabigatran AF indication in April by the European Medicines Agency (EMA), which is normally a prerequisite to pan-EU approval of a product within 67 days. Boehringer Ingelheim will market the drug in Europe in the 110-mg and 150-mg strengths, as it does in Canada, with both dosages given twice daily as studied in the RE-LY trial, as covered extensively by heartwire. The 110-mg twice-daily dosage is intended for patients aged 80 years or older and anyone with an increased risk of bleeding.

July 26, 2011

New defibrillation technique reduces energy and prolonged the battery lifetime : A new defibrillation technique that delivers five sequential low-energy pulses to a fibrillating heart reduces energy use by an average of 84 percent compared to standard defibrillation, according to study findings published in Nature. This new technique called Low-Energy Anti-fibrillation Pacing (LEAP) technique, initiates a completely different process than standard defibrillation. The current standard defibrillation technique uses a strong electrical pulse—delivering a shock of up to 4,000 volts, known to be capable of damaging tissue—to force the heart back to its regular beating. The new method uses a cardiac catheter to create a sequence of weak electrical signals in the heart. Although at first glance the new method appears similar to the old way, the process is completely different, according to the researchers.

CRT significantly improves LV dyssynchrony and contractile function in mild heart failure : New data, published in the current issue of European Heart Journal, from the MADIT-CRT study shows that cardiac resynchronisation therapy with a defibrillator (CRT-D) significantly improves both left ventricular dyssynchrony and contractile function compared with an implantable cardiac defibrillator (ICD) in patients with New York Heart Association (NYHA) class I or II heart failure. The greater improvements, seen with CRT-D, in left ventricular dyssynchrony and contractile function were associated with lower rates of the study's primary outcome of death or heart failure (at one year). The authors reported that the results suggested that improvements in both synchrony and contractile function may account for a considerable portion of the benefit of CRT.

APPRAISE 2 trial published. Apixaban failed to improve the outcome in acute coronary syndromes and increased the major bleeding events : The results of the APPRAISE-2 trial in ACS patients, which was terminated early last November was published online in the New England Journal of Medicine. APPRAISE-2 (Apixaban for Prevention of Acute Ischemic Events – 2) was a phase 3 trial comparing apixaban to placebo in patients with acute coronary syndrome (ACS) already receiving standard antiplatelet therapy and who had at least 2 additional risk factors for recurrent ischemic events. The trial was stopped early after 7,392 patients had been enrolled (the original plan had been to enroll 10,800 patients) due to an increase in major bleeding events in patients treated with apixaban. The main results of the trial, after a median followup of 241 days were : Primary endpoint (combined rate of cardiovascular death, MI, or ischemic stroke): 7.5% in the apixaban group versus 7.9% in the placebo group HR with apixaban (0.95, CI 0.80-1.11, p=0.51), major bleeding: 1.3% in the apixaban group versus 0.5% in the placebo group (HR with apixaban: 2.59, CI 1.50-4.46, p=0.001)

The addition of HbA1c measurements Improves CV Risk Prediction in Diabetics : In a new report from the Women's Health Study and the Physician's Health Study II which published online in Archives of Internal Medicine suggested that adding HbA1c measurements can improve risk prediction and lead to downward classification of some diabetics. The study include data from 24,674 women and 11,280 men. From these 685 women and 563 men were diabetic at baseline. CV events occurred in 125 diabetic women and 170 diabetic men. In women, including HbA1c levels improved the C statistic by 0.177 (p<0.001) and improved the risk category assignment. The results were less dramatic in men, but the C statistic was improved by 0.039 (p<0.02) as well as the risk category assignment.

July 18, 2011

Chronic NSAID use doubles risk for CV deaths in elderly : Older patients with hypertension and coronary artery disease who use nonsteroidal anti-inflammatory drugs (NSAIDs) chronically for pain are at significantly increased risk of cardiovascular events, according to a new post hoc analysis from the International Verapamil-Trandolapril Study (INVEST) published online in American Journal of Medicine.
Within the large cohort of more than 22 000 patients in INVEST, were identified 882 patients who reported taking NSAIDs at every follow-up visit and termed them chronic users . They compared the chronic NSAID users with those who only intermittently (n=7286) or never (n=14 408) used NSAIDs over an average of 2.7 years and adjusted the findings for potential confounders. The primary outcome—a composite of all-cause death, nonfatal MI, or nonfatal stroke—occurred at a rate of 4.4 events per 100 patient-years in the chronic-NSAID group vs 3.7 events per 100 patient-years in the nonchronic group (adjusted hazard ratio 1.47; p=0.0003). The end point was primarily driven by a more than doubling in the risk of death from CV causes in the chronic-NSAID group compared with never or infrequent users (adjusted HR 2.26; p<0.0001).

Obstructive sleep apnea (OSA) characterized by endothelial dysfunction : Obstructive sleep apnea (OSA) appears to be characterized by endothelial dysfunction and impaired myocardial perfusion and these abnormalities can be reversed by continuous positive airway pressure (CPAP) treatment according to a study published online in Hypertension Journal. Using myocardial contrast echocardiography, the researchers assessed the myocardial perfusion of 36 otherwise healthy sleep-apnea patients and compared the findings with those from 36 hypertensive subjects and 36 healthy individuals. They also measured endothelial function using a variety of techniques. Those with OSA and hypertension had abnormal myocardial perfusion (p<0.001 for both comparisons), attenuated brachial artery reactivity (p<0.001), and cutaneous perfusion responses (p<0.001) compared with the healthy subjects, but they showed significant improvements in all of these parameters after 26 weeks of CPAP therapy.

More Risk Than Benefit With Combined Anti-Clotting Therapy in Atrial Fibrillation : In patients with atrial fibrillation (AF), combining an anticoagulant and a platelet inhibitor will raise the risk for bleeding without lowering the risk for stroke, according to a post hoc analysis of AMADEUS trial published in the last issue of CHEST. In this study 4,576 patients with AF were included (2,283 who received idraparinux and 2,293 who received warfarin or acenocoumarol). In addition, 848 patients also received antiplatelet therapy. In the current analysis, the researchers detected a total of 572 clinically relevant bleeding episodes (15.3% per year) and 103 major bleeding episodes (2.6% per year). Patients receiving combination antithrombotic therapy had a 2.3-fold increased risk for clinically relevant bleeding and a 2.5-fold increased risk for major bleeding, compared with those who received anticoagulants only. Moreover, combination therapy didn't reduce patients' risk for ischemic stroke.

July 11, 2011

Dronedarone trial (PALLAS) suspended due to CV events in permanent atrial fibrillation : Sanofi announced today that the company has discontinued the PALLAS Phase IIIb trial in patients with permanent Atrial Fibrillation (AF). The decision follows recommendations from the study's Operations Committee and the Data Monitoring Committee (DMC) which observed a significant increase in cardiovascular events in the dronedarone arm. The company also has asked all PALLAS clinical investigators to inform their patients included in the trial to stop taking the study medication and consult their clinical trial center.

Falsely elevated point-of-care INR values in dabigatran-treated patients : New case reports are highlighting inaccuracies in the point-of-care international normalized ratios (INRs) in patients treated with dabigatran etexilate (Pradaxa, Boehringer Ingelheim) . In these instances, the point-of-care INR in patients taking dabigatran was falsely elevated, thereby raising concerns that such inaccuracies might affect patient care. In the first case, a 59-year-old woman with paroxysmal atrial fibrillation admitted to the hospital with rapid atrial fibrillation. Therapy with warfarin 10 mg was started and administered for three days. After discharge, the primary-care physician stopped warfarin and prescribed dabigatran 150 mg twice daily. Later referred to the anticoagulation clinic for assessment of the INR, her point-of-care INR was 7.2, a concentration that would likely never be achieved in clinical practice with appropriate dosing of dabigatran. In light of this elevated finding, a laboratory INR test was performed, revealing an INR of 1.7. A second patient, a 52-year-old man referred to the anticoagulation clinic for restarting warfarin was prescribed off-label use of dabigatran after an ablation procedure as a bridge to warfarin. After 16 hours, which is beyond the usual trough of 12 hours, his point-of-care INR was 1.6, which is close to the upper range of the INR seen with dabigatran 150 mg.

July 08, 2011

Nonsteroidal anti-inflammatory drugs use increase the risk of atrial fibrillation or flutter : Nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) and selective COX-2 inhibitors are associated with an increased risk of atrial fibrillation or flutter, according to the results of a new population-based, case-control study published in the British Medical Journal. In this study were included 32.602 patients diagnosed with atrial fibrillation or flutter in Northern Denmark between 1999-2008 and 325.918 age- and gender-matched controls selected from the source population. Compared with controls who were not treated with the drugs, current use of nonselective NSAIDs was associated with an adjusted 17% increased risk of developing atrial fibrillation or flutter. Current use of COX-2 inhibitors was associated with a 27% higher risk of atrial fibrillation or flutter.

FDA readies for rivaroxaban stroke/AF review : The FDA has announced that its Cardiovascular and Renal Drugs Advisory Committee will meet September 8, 2011 to review the new drug application (NDA) for rivaroxaban for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). The meeting date was announced in the FDA's Advance Publication Display. The news comes just days after the announcement last Friday that rivaroxaban had been approved for the prevention of deep vein thrombosis (DVT) in the setting of knee- or hip-replacement surgery.

FDA warns Abiomed over Impella marketing practices : The FDA sent a warning letter to Abiomed, dated June 10, concerning marketing practices of its Impella Recover LP 2.5 percutaneous cardiac support system, which the agency said is in violation of the Federal Food, Drug and Cosmetic Act. The Danvers, Mass.-based Abiomed, according to the FDA, obtained the following clearance for the device: for "partial circulatory support using an extracorporeal bypass control unit, for periods up to six hours. It is also intended to be used to provide partial circulatory support (for periods up to six hours) during procedures not requiring cardiopulmonary bypass. The Impella Recover LP 2.5 also provides pressure measurements which are useful in determining intravascular pressure." However, the Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed an advertisement, labeling pieces and Abiomed's website. The FDA review suggested that Abiomed is making claims that were "inappropriate," and the claims represent a "major modification to both the intended use and the indications for use of the device."

Adherence to a healthy lifestyle lower the risk of sudden cardiac death among women : A new study published in JAMA shows that up to 80% of sudden cardiac death (SCD) could be attributable to unhealthy lifestyle practices, at least among women . The research illustrates that those who adhered to four healthy lifestyle practices—not smoking, body mass index (BMI) <25 kg/m2, exercising 30 min/day or longer, and eating a Mediterranean diet—had a 92% lower risk of SCD than women who did not.

July 01, 2011

Ticagrelor has better efficacy with low-dose aspirin : The antiplatelet ticagrelor seems to work better at preventing clinical events in patients with ACS when it's accompanied by low-dose as opposed to high-dose aspirin, suggests a new analysis of the PLATO trial. Low-dose aspirin was defined as <300 mg/day, high-dose aspirin as doses above that threshold. Such an interaction between aspirin dosage and ticagrelor effects could possibly explain the trial's so-called "North American anomaly," in which outcomes were superior with the new drug vs clopidogrel across the entire international trial but not in North America, where the aspirin doses were generally higher. Those divergent outcomes are thought to be the reason why US regulators have postponed decisions on whether to approve ticagrelor, while the drug has already been approved for the PLATO indication in Canada, Europe, and other parts of the world. An FDA decision on ticagrelor is expected by July 20.

Higher vitamin D linked to lower diabetes risk : Higher levels of vitamin D in the blood appear to be associated with a reduced risk of incident diabetes among people with high risk for the disease, according to a new report presented at the American Diabetes Association (ADA) 2011 Scientific Sessions. Vitamin D may have a role in diabetes via improvements in insulin secretion and insulin sensitivity. To determine the relationship between vitamin-D status and risk of incident diabetes, the researchers analyzed data from the Diabetes Prevention Program (DPP), a three-arm trial comparing intensive lifestyle modification or metformin vs placebo for prevention of diabetes in patients with prediabetes. The mean follow-up of the cohort of 2039 participants was 3.2 years. Plasma vitamin-D levels were measured at yearly intervals, and subjects were assessed for incident diabetes. Participants in the highest tertile of vitamin-D levels, with a median concentration of 30.1 ng/mL, had a hazard ratio of 0.74 (95% CI 0.59-0.93) for developing diabetes compared with participants in the lowest tertile (median vitamin D level of 12.8 ng/mL).

New consensus statement on high triglycerides, low HDL cholesterol from European Atherosclerosis Society (EAS) : An expert consensus panel from the European Atherosclerosis Society (EAS) has issued new recommendations for the management of patients with elevated triglycerides and low HDL-cholesterol levels. The new EAS recommendations, were presented at the European Atherosclerosis Society 2011 Congress. For patients with high triglycerides or low HDL-cholesterol levels, the first task is lifestyle modification, but barring that, fibrates, niacin, or even the intensification of statin therapy is recommended. The new consensus statement state that the focus of treatment should be patients at high risk for cardiovascular disease who have triglyceride levels >150 mg/dL and/or HDL-cholesterol levels <40 mg/dL. In the review, the panel assesses the evidence supporting the link between triglyceride-rich lipoproteins, HDL cholesterol, and cardiovascular disease, recommending that after insufficient improvement following intensive lifestyle management, physicians should consider adding niacin or a fibrate or even intensifying LDL therapy for further reductions.

Another meta-analysis supports 130mmHg as systolic blood pressure goal in diabetics : A new meta-analysis examining intensive blood-pressure lowering in diabetics has found a clear reduction in stroke as BP falls and a trend toward benefit for MI, a reassuring finding since there had been concerns this approach could up the risk of coronary events . The authors conclude that intensive BP control, at least to the target that is currently recommended among diabetics—130/80 mm Hg—is a safe therapeutic approach. The new analysis—which included 31 intervention trials involving almost 73.913 patients, among which were five trials specifically targeted to tighter vs less tight BP control in diabetics—was presented at the European Meeting on Hypertension 2011 and is also published in the July 2011 issue of the Journal of Hypertension. The five trials of intensive vs less intensive control of BP that they included were ABCD-H, ABCD-N, ACCORD, UKPDS 38, and HOT-DM.

June 20, 2011

New-onset AF rife in ONTARGET/TRANSCEND patients : New-onset atrial fibrillation (AF) is common in high-risk vascular patients, and the rate observed is considerably higher than that found in the general population, according to a post hoc analysis of the ONTARGET and TRANSCEND studies reported at the European Society of Hypertension (ESH) European Meeting on Hypertension 2011. The new analysis also identifies a previously unknown determinant of AF, hip circumference.

FDA: Varenicline may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease : The U.S. Food and Drug Administration (FDA) after reviewing a randomized clinical trial of 700 smokers with cardiovascular disease, is notifying the public that the smoking cessation aid Varenicline may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section of the Chantix physician labeling. The patient Medication Guide will also be revised to inform patients about this possible risk.

Cordis exits DES market : Cordis, a subsidiary of Johnson & Johnson, will discontinue manufacturing drug-eluting stents (DES), including Cypher and Cypher Select sirolimus-eluting stents, and also will stop development of its Nevo DES line to focus on other cardiovascular therapies.

Melatonin Improves Hypertensive-Induced Sleep Disruption : Melatonin supplementation can significantly improve sleep disturbances in hypertensive men treated with ß-blockers, according to a randomized, double-blind, placebo-controlled trial presented here at SLEEP 2011, the 25th anniversary meeting of the Associated Professional Sleep Societies. The results may have implications for other populations treated with ß-blockers, as well as people with decreased melatonin production for other reasons, such as spinal cord injury.

June 06, 2011

FDA Drug Safety Committee: No increase in risk of cancer with Angiotensin Receptor Blockers (ARBs): The U.S. Food and Drug Administration (FDA) has completed a review of the potential risk of cancer associated with the class of medications known as angiotensin receptor blockers (ARBs). FDA has concluded that treatment with an ARB medication does not increase a patient's risk of developing cancer.

FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone: The U.S. Food and Drug Administration (FDA) is informing the public about new information1,2 that is being assessed as part of FDA's ongoing safety review of birth control pills that contain drospirenone. This review will further evaluate the risk of blood clots in women who use these products. Drospirenone is a type of female sex hormone called a progestin. Most birth control pills contain two types of hormones--estrogen and progestin. Birth control pills work by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus to prevent pregnancy.

New study shows remarkably high survival rates of sudden cardiac arrest at traditional and alternative exercise facilities: New research conducted in USA found that sudden cardiac arrest is associated with a high rate of survival at both traditional and alternative exercise facilities. The study included data from 960 sudden cardiac arrest cases revealing the most common activities performed at time of sudden cardiac arrest and overall outcomes in individuals. Furthermore, the study also showed that this heart anomaly occurred frequently at alternative exercise facilities, including dance studios and bowling alleys. The study was presented at Heart Rhythm 2011, the Heart Rhythm Society's 32nd Annual Scientific Sessions.

Phase 3 SAVE-ONCO trial of semuloparin showed a 64 % risk reduction in Venous Thromboembolism: Sanofi announced results from a pivotal randomized Phase 3 SAVE-ONCO trial which showed that, in cancer patients initiating a chemotherapy regimen, semuloparin significantly reduced the risk of the composite of symptomatic-Deep Vein Thromboembolism, non-fatal Pulmonary Embolism or Venous Thromboembolism related death by 64%, meeting the trial primary endpoint (respectively 1.2% and 3.4% for semuloparin and placebo HR=0.36 95%; p< 0.0001). The SAVE-ONCO trial results were presented at the 47th Annual Meeting of the American Society of Clinical Oncology.

May 27, 2011

Abbott's received FDA approval for smaller Xience DES: Abbott has received FDA approval for its Xience nano everolimus-eluting coronary stent system for the treatment of coronary artery disease (CAD) in small vessels based on results from the SPIRIT Small Vessel trial. This Xience nano, which is based on the same platform as the Xience V everolimus-eluting coronary stent system, allows U.S. physicians to treat patients with CAD in vessels as small as 2.25 mm in diameter.

Aldosterone antagonist in HF cuts risk of new atrial fib: EMPHASIS-HF: Aldosterone antagonist therapy in the EMPHASIS-HF trial, previously reported to significantly cut the risk of clinical events in patients with mild systolic heart failure, apparently also suppressed development of new atrial fibrillation (AF) or atrial flutter (AFL) in many patients. In the trial's two-year average follow-up, the rate of new AF/AFL was 42% lower (p=0.034) among patients who received eplerenone (Inspra, Pfizer), compared with placebo, on top of standard HF medications.

Omega-3 PUFAs don't protect against new AF in heart failure: GISSI-HF analysis: With some evidence suggesting that intake of omega-3 polyunsaturated fatty acids (PUFAs) may protect against atrial fibrillation (AF) and even more evidence pointing to an effect against heart failure—although the benefits have generally been mild—it seems a natural that they might prevent AF in patients with heart failure. But they don't, according to a post hoc analysis of the GISSI Heart-Failure (GISSI-HF) trial, presented here at the Heart Failure Congress 2011 sessions of the European Society of Cardiology (ESC) Heart Failure Association. In a look at 5835 patients in the study who were free of AF at baseline ECG and had been randomized to receive 1 g/day omega-3 PUFA or placebo, PUFA therapy didn't reduce the risk of incident AF over the trial's mean follow-up of about four years.

Early onset AF linked with death for women: Healthy women with a new-onset of atrial fibrillation (AF) saw a heightened risk of mortality and cardiovascular (CV) events, Swedish researchers found in a study published in the May 25 issue of the Journal of American Medical Association. However, the risk was linked to the occurrence of nonfatal CV events prior to death, which led the researchers to conclude that it may be possible to improve the outcomes of these patients through prevention and management strategies.

Terutroban has shown no advantage over aspirin for the secondary prevention of ischemic stroke or transient ischemic attack: A large randomized trial of a novel antiplatelet agent, terutroban , has shown no advantage in terms of efficacy or safety over aspirin for the secondary prevention of ischemic stroke or transient ischemic attack (TIA). In fact, the study was stopped early due to its futility and Servier has decided to stop development of the drug. In the Prevention of Cerebrovascular and Cardiovascular Events of Ischemic Origin with Terutroban in Patients with a History of Ischemic Stroke or Transient Ischemic Attack (PERFORM) trial which announced at the 2011 European Stroke Conference and was published simultaneously online in the Lancet., terutroban was not superior to aspirin and also failed to meet criteria for noninferiority to aspirin.

May 20, 2011

No clinical benefit from the use of aspirin or statin in pulmonary hypertension: There is no clinical benefit from the use of simvastatin or aspirin in patients with pulmonary hypertension according to the ASA-STAT study which published online in Circulation. In this study, 92 patients with PAH were randomized to aspirin 81 mg or matching placebo and simvastatin 40 mg or matching placebo. The primary outcome was six-minute-walk distance at six months. The trial was stopped early after 65 patients had been enrolled because of futility in reaching the primary end point for simvastatin. Results showed no difference in the six-minute-walk distance at six months between aspirin and placebo or between simvastatin and placebo. The simvastatin group actually showed a trend toward a worse six-minute-walk distance and more dyspnea.

FDA committee to review fenofibrate after the results of ACCORD LIPID: FDA's Endocrinologic & Metabolic Drugs Advisory Committee is going to discuss whether previous indications for fenofibrate should be reduced after results of the ACCORD-Lipid trial showed that the addition to a statin to fenofibrate did not significantly reduce major adverse cardiac event rates in diabetic patients. In 2008, the FDA approved fenofibrate and has indicated the drug to be used in combination with a statin and to reduce elevated LDL-cholesterol, total cholesterol, triglycerides and apolipoprotein B. In addition, the drug is indicated to help increase HDL-cholesterol levels in patients with lipid problems. The drug is also approved as a monotherapy to reduce triglycerides (TG) in severe hypertriglyceridemia patients.

New study finds link between diabetes and cancer: Researchers from the Centers for Disease Control and Prevention (CDC) have found a link between diabetes and cancer, according to research published ahead of print in Diabetes Care. Of the almost 400,000 adults surveyed, diabetic men had a higher prevalence of prostate, colon and pancreas cancer while diabetic women had higher prevalence for breast cancer compared with nondiabetic patients.

Rosiglitazone risk-management strategy released by FDA: The FDA has come through with a risk evaluation and mitigation strategy (REMS) for the use of rosiglitazon, the controversial diabetes drug that some of the agency's expert advisors wanted to banish and others preferred to keep but with tight restrictions on its use. There is abundant evidence that rosiglitazone can up the risk of heart failure, MI, or death in some patients who take it for glucose control, compared with its cousin pioglitazone. But some patients can take it successfully, and for others it may be the last best bet among antidiabetic agents, some argue.

May 12, 2011

New AHA statement for pediatric cardiac catheterization: The American Heart Association (AHA) has issued a scientific statement containing recommendations for diagnostic and therapeutic cardiac catheterization in pediatric heart disease. According to the new statement, cardiac catheterization is no longer recommended as a diagnostic tool for routine presurgical evaluation of most congenital defects ( ventricular septal and atrial septal defects, atrioventricular canal, tetralogy of Fallot, double-outlet right ventricle, coarctation of the aorta, hypoplastic left heart syndrome)

MitraClip recalled due to problems with delivery system: Abbott Vascular is voluntarily recalling 500 units of its MitraClip mitral valve repair system (Evalve), used to reduce mitral regurgitation and is an alternative to open-heart surgery, after the company found problems with its delivery catheter system.The recall focuses on three reported cases involving the delivery catheter system used to deploy the MitraClip system. In those cases, the radiopaque ring housed at the tip of the delivery catheter detached after the MitraClip was implanted.

Carotid stenting may be less safe in women: According to a substudy published online in Lancet Neurology, peri-procedural risk of events seems to be higher in women who have carotid artery stenting than those who have carotid endarterectomy whereas there is little difference in men. Specifically, rates of the primary endpoint (the composite of stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke within 4 years) for carotid artery stenting compared with carotid endarterectomy were 6,2% versus 6,8% in men (hazard ratio [HR] 0•99, 95% CI 0•66—1•46) and 8,9% versus 6,7% in women (1,35, 0,82—2,23).

Sorin Group Receives CE Mark Approval for PARADYM™ RF ICDS And CRT-D: Sorin Group announced, at Heart Rhythm 2011, the CE mark approval for the Paradym RF family of implantable cardiac defibrillators and cardiac resynchronisation therapy devices. With their proprietary algorithms, SafeR and Parad+, Paradym RF remote monitoring-enabled implantable cardiac defibrillators and cardiac resynchronisation therapy devices automatically adjust to provide individualised, appropriate therapy in a thin, powerful, long-lasting device.

Use of erythropoietin in anemia may be harmful in patients with STEMI (REVEAL study): The REVEAL trial, which published in last issue of the Journal of the American Medical Association, showing no benefit and likely harm of erythropoietin in MI patients. , The trial was investigating whether erythropoietin could reduce infarct size after successful PCI in STEMI patients, but not only did it fail to achieve this, it was also associated with an increased rate of cardiovascular events

May 05, 2011

FDA approves Linagliptin for the treatment for Type 2 diabetes: The U.S. Food and Drug Administration approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes. Tradjenta was demonstrated to be safe and effective in eight double-blind, placebo-controlled clinical studies involving about 3,800 patients with Type 2 diabetes. The studies showed improvement in blood glucose control compared with placebo.

CABG rates decline in U.S and PCI remains steady: In the last issue of JAMA published a study from the University of Pennsylvania School of Medicine in Philadelphia which found a substantial decrease (15%) in CABG surgery utilization rates, but PCI utilization rates remained unchanged in U.S. hospitals between 2001 and 2008.

Fatty acids seems to interfere with platelet inhibition by aspirin: Fatty acids in the bloodstream appear to interfere with aspirin's ability to inhibit platelet aggregation, according to a new study presented in the American Heart Association Arteriosclerosis, Thrombosis and Vascular Biology 2011 Scientific Sessions. In this study blood samples from healthy volunteers were used and determined platelet inhibition by aspirin with and without various fatty acids in platelet-rich plasma. They found that several free fatty acids partially prevented the inhibition of platelet aggregation and thromboxane synthesis by aspirin. Among saturated fatty acids, chain length was the critical determination of their interaction with aspirin, with decanoic acid showing the most effect.

FDA announced that more than 65.000 Defibtech AEDs recalled: Defibtech, LLC is initiating a worldwide voluntary recall of certain DDU-100 series semi-automatic external defibrillators (AEDs) sold under the Lifeline AED and ReviveR AED brand names, including 65,885 AEDs distributed in the United States. This recall affects only DDU-100 Series AEDs shipped with 2.004 software or earlier. This corrective action addresses two possible conditions, which in rare cases may cause an affected AED to cancel shock during the charging process and not provide therapy which may result in failure to resuscitate the patient. Both conditions are not detectable by the periodic self test.

U.S. costs for AF soars to $26B per year: The cost of medical care in the US is about $8700 per year higher for a patient with atrial fibrillation (AF) than one without AF, for a national annual cost of about $26 billion, suggests a study published online in Circulation: Cardiovascular Quality and Outcomes. Total annual direct medical costs were 73% higher for the study's 89 066 patients with AF compared with an equal number of propensity-matched patients without the arrhythmia, in the study. Consistent with their higher cost, those with AF were hospitalized at several times the rate of patients without AF.

March 28, 2011

FDA Approved two new Medtronic's (CRT-P) Systems: Medtronic, Inc. (NYSE: MDT) today announced that the U.S Food & Drug Administration (FDA) has approved its Consulta® and Syncra™ cardiac resynchronization therapy-pacemaker (CRT-P) systems. Consulta is the first CRT-P that includes Medtronic's exclusive OptiVol® Fluid Status Monitoring, which identifies patients at risk for worsening heart failure before symptoms develop. Additionally, both Consulta and Syncra are the first CRT-Ps that include Leadless ECG Waveform, which offer the possibility of remote follow-up in heart failure patients implanted with these devices.

Pioglitazone prevents progression to diabetes in people with impaired glucose tolerance (ACT NOW study): Pioglitazone prevents progression to diabetes in people with impaired glucose tolerance according the results of ACT NOW study which published in the last issue of NEJM. In this study 602 patients with impaired glucose tolerance randomized to pioglitazone or placebo. During a median followup of 2.4 years diabetes developed in 16.7% of the placebo group versus 5% in the pioglitazone group followup (HR for pioglitazone 0.28, CI 0.16-0.49, p<0.001). The investigators calculated that 18 people needed to be treated for one year to prevent one case of diabetes.

Portola Pharmaceuticals to Regain Global Rights for Investigational Medicine Betrixaban from Merck: Portola Pharmaceuticals and Merck announced that Merck plans to return to Portola all rights for betrixaban, an investigational oral Factor Xa inhibitor anticoagulant being evaluated for the prevention of stroke in patients with atrial fibrillation (SPAF). This decision was made following a review of Merck's investigational portfolio.

The risk for myocardial infraction doubled after a transient ischemic attack: The average incidence of MI among patients who have already had a transient ischemic attack (TIA) but who have no known coronary artery disease (CAD) is approximately double that of the general population, at about 1% per year. The relative risk increase is especially high in patients younger than 60 years old (relative risk:15.1)

A New 2 hour Protocol Identifies Low Risk Chest Pain Patients (ASPECT study): A new protocol for rapid identification of patients admitted with chest pain who are at low risk of having a serious cardiac event is published in the last issue of Lancet. This observational study was undertaken in 14 emergency departments in nine countries and 3582 consecutive patients were recruited and completed 30-day follow-up. The new protocol classified 352 (9.8%) patients as low risk and potentially suitable for early discharge. A major adverse cardiac event subsequently occurred in three (0.9%) of these patients, making the new protocol 99% accurate. Thus these patients could potentially be discharged earlier, reducing costs and freeing the emergency department for other emergency patients.

March 22, 2011

TRIGGER-PCI halted: Low events stymie platelet reactivity trial with prasugrel, clopidogrel: Sponsors of the TRIGGER-PCI trial announced today that they are halting the trial after a preliminary, blinded analysis of patients enrolled to date made it clear that the trial was not going to see enough primary end point events to deliver any meaningful results. TRIGGER-PCI, was comparing clopidogrel and prasugrel based on platelet reactivity testing in stable coronary artery disease patients post-stenting, excluded patients with ACS.

Meta-Analysis of Observational Studies Finds Worse Outcomes For Rosiglitazone Compared To Pioglitazone: A new meta-analysis of 16 observational studies with more than 800,000 patients published in BMJ has provided more evidence that the diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) is associated with a higher risk of heart failure, MI, and death than a similar agent, pioglitazone.

European Medicines Agency approved apixaban for the prevention of venous thromboembolic events: The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), approved apixaban (Xa inhibitor) for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.

Double-dose clopidogrel ineffective for high on-treatment platelet reactivity (GRAVITAS study): The GRAVITAS trial, showing no benefit of double-dose clopidogrel (150 mg) in patients with high on-treatment platelet reactivity after PCI, has been published in the last issue of JAMA. Specifically, among patients with high on-treatment reactivity after PCI with drug-eluting stents, the use of high-dose clopidogrel compared with standard-dose clopidogrel did not reduce the incidence of death from cardiovascular causes, nonfatal myocardial infarction, or stent thrombosis.

March 15, 2011

Updated Blood Conservation Clinical Practice Guidelines were published: The 2011 update to the Society of Thoracic Surgeons (STS) and the Society of Cardiovascular Anesthesiologists (SCA) blood conservation clinical practice guidelines, published in the last issue of the Annals of Thoracic Surgery, include significant changes to the societies' first set of blood conservation recommendations in 2007. The new guidelines continuing to emphasize in the importance of preoperative risk assessment.

SAPPHIRE cost analysis published: Stenting is cost-effective in high-risk surgical patients: In the last issue of Catheterization and Cardiovascular Interventions Journal published a cost analysis of the SAPPHIRE study in which was shown that while there are higher costs associated with carotid stenting, the procedure is economically feasible.

Both types of obesity ("apple" and "pears") are equally dangerous for cardiovascular diseases: According to a new study of more than 220.000 participants published online in the last issue of Lancet, central adiposity (apple shape) is not associated with a greater risk of cardiovascular disease than other types of obesity and any kind of obesity are equally associated with heart disease.

March 9, 2011

Still no support For Intensive Glucose Lowering after 5 Year Followup of ACCORD: Long-term followup of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial has once again failed to support routine intensive glucose lowering in high risk type 2 diabetics. In the study published in the New England Journal of Medicine reported the 5 year results of the trial, after 3.7 years of intensive glucose lowering treatment and up to 17 months of additional followup. Mortality at 5 years was 19% higher at 5 years in the intensive control group (7.6% in the intensive therapy group versus 6.4% in the standard therapy group).

FDA removed liver injury warning from ambrisentan: The U.S. Food and Drug Administration (FDA) is removing the warning related to liver injury from the boxed warning of the Letairis (ambrisentan) tablet label. Further evaluation of the clinical trial data and post-marketing safety information has led the FDA to conclude that the risk of liver injury in patients treated with this drug is low. FDA has also concluded that routine monthly serum liver enzyme testing for patients taking Letairis is not necessary. Healthcare professionals should still continue to order liver enzyme tests when they consider it clinically necessary.

AF stroke survivors may have greater chance of developing dementia: Stroke survivors who have atrial fibrillation (AF) may be at higher risk of developing dementia than stroke survivors who do not have the heart condition, according to a meta-analysis of 15 studies in which included 46,637 participants with an average age of 71.7 years published in last issue of Neurology.

Meta-Analysis Finds Mediterranean Diet Helps Fight Metabolic Syndrome: Mediterranean die is associated with a lower prevalence and slower progression of metabolic syndrome, according to the results of a new meta-analysis from Greece published in the last issue of JACC. In the metaanalysis were included 534.946 participants from 35 clinical trials, two prospective studies, and 13 cross-sectional studies.

High levels of HDL may protect from colon cancer: High levels of "good" (high density lipoprotein) HDL cholesterol seem to cut the risk of bowel cancer, suggests research published online in the Journal Gut. The association is independent of other potentially cancer-inducing markers of inflammation in the blood. The researchers base their findings on participants in the European Prospective Investigation into Cancer and Nutrition (EPIC) study. This is tracking the long term impact of diet on the development of cancer in more than half a million people in 10 European countries. Each rise of 16.6 mg/dl in HDL and of 32 mg/dl in apoA reduced the risk of bowel cancer by 22% and 18%, respectively, after taking account of diet, lifestyle, and weight.

March 3, 2011

FDA announced that antiretroviral treatment (Abacavir) does not raise MI risk: The US Food and Drug Administration (FDA) announced that abacavir (Ziagen, GlaxoSmithKline) does not increase the risk for MI . This announcement based in a meta-analysis of 26 clinical trials. The FDA looked for MI outcomes in 9868 subjects. Roughly half received an antiretroviral regimen containing abacavir; the other half received a regimen that lacked the agent. The rates of MI in the two groups were roughly equal.

GP IIb/IIIa blockers are still here: GP IIb/IIIa blockers still provide clinical benefit in the current era of elective PCI performed with stents and thienopyridines, a new meta-analysis published in the last issue of JACC shows . The authors explain that GP IIb/IIIa blockers have been shown beneficial during PCI, but most of the studies were conducted before the routine use of coronary stents and thienopyridines.

Optimistic heart-disease patients have better outcomes: Patients with coronary heart disease who expect they will do well despite their diagnosis live longer than their pessimistic counterparts, according to a new study published online in the Archives of Internal Medicine.

Patients with cardiovascular diseases benefit from antihypertensive tretament even in absence of hypertension: According to a new meta-analysis of 25 clinical trials with approximately 65.000 patients published in the last issue of JAMA antihypertensive treatment patients with CV disease who do not have hypertension may nevertheless benefit from antihypertensive therapy. Specifically, it reduced the mortality rate from stroke, CHF, composite CVD events, and all-cause mortality.

February 25, 2011

AF Guidelines Updated to Incorporate Dabigatran.: Less than two months after the publication of the 2010 updated atrial fibrillation (AF) guidelines, the AHA, the ACC, and the HRS have released a new focused update incorporating recommendations and a discussion concerning the direct thrombin inhibitor dabigatran, which gains a Class I recommendation.

February 21, 2011

Sanofi Aventis Buys Genzyme for Over $20 Billion. Ending a nine-month standoff, French drugmaker Sanofi-Aventis has agreed to pay $20.1 billion for Genzyme, the U.S. biopharmaceutical pioneer. Sanofi will pay $74.00 per share in cash. The company has also agreed to contingent value right (CVR) payments of up to $14.00 per share based mostly on the success of Genzyme's Lemtrada, a multiple sclerosis drug in Phase III clinical trials.

Quarter of U.S. Adults 45 and Older Taking Statins: One-quarter of U.S. adults age 45 and older are taking statins, and one-half of men ages 65 to 74 are taking these drugs, according to the CDC's annual report on trends in health statistics. From 1988 to 1994, only 2% of adults age 45 and older were taking statins. High cholesterol levels have been declining, according to the CDC, but hypertension, diabetes, and obesity have all increased. The overall prevalence of heart disease has remained stable in all groups except for an increased rate in men age 75 and older.

Aspirin cost-effectiveness in primary prevention in middle-aged men: Treatment with aspirin for primary prevention of heart disease is cost-effective in middle-aged men across a wide range of CHD and GI bleeding risk levels, a new study published at the last issue of Annals of Internal Medicine suggests. The study also found that adding a proton-pump inhibitor (PPI) is not cost-effective for men with average GI bleeding risk but may be cost-effective for selected men at increased risk for GI bleeding.

February 14, 2011

SCAST Trial Provides No Support for Blood Pressure Lowering in Acute Stroke: According to SCAST trial which published online February 11, 2011 in the Lancet there is no benefit and a hint of possible harm associated with antihypertensive treatment with candesartan in the acute phase of stroke. In this study were randomized 2029 patients with acute stroke and systolic blood pressure to receive candesartan or placebo for 7 days and concluded that there is no indication that lowering blood pressure with candesartan is beneficial, and that the evidence suggested a harmful effect. However, in 6 months of follow-up, no difference emerged between the two groups in the risk of death from any cause, heart attack or stroke.

AVERROES published: Apixaban Better Than Aspirin for Stroke Prevention in AF Patients Unable to Take Warfarin: A new trial presented at the American Stroke Association's International Stroke Conference and published online in the New England Journal of Medicine demonstrates that the novel factor Xa inhibitor apixaban is better than aspirin for the prevention of stroke in AF patients who don't take warfarin.

Pressure-sensor implant guides HF treatment, cuts hospitalizations (CHAMPION study): Heart-failure patients managed with a wireless implantable hemodynamic monitoring system had a significant and large reduction in hospitalizations compared with standard management, according to the results of CHAMPION study which published online in the Lancet. The study suggests that the use of an implanted device to remotely monitor pressures within the pulmonary arteries could reduce hospitalisation by 39%.

High dietary salt intake seen to worsen risk of ischemic strokes: People who consumed more than 4000 mg per day of sodium had more than double the risk of stroke compared with those who consumed less than 1500 mg according the results of Northern Manhattan Study in which participated 2657 people as it was announced in International Stroke Conference 2011which organised by the American Stroke Association (ASA).

FDA approves first "MRI-safe" pacemaker: The FDA approved the first pacemaker specifically designed to be safe with magnetic resonance imaging scans. The approval is based primarily on the company's 484-patient trial that randomized patients with the device to undergo or not undergo an MRI. None of the 211 patients who underwent a magnetic resonance imaging exam during the clinical trial of Revo MRI SureScan pacing system experienced an MRI-related complication . The study measured changes in the pacemaker's pacing capture threshold (PCT) as the indicator of myocardial damage associated with lead heating during an MRI.

February 7, 2011

FDA Drug Safety Communication: Avandia (rosiglitazone) labels now contain updated information about cardiovascular risks and use in certain patients:The U.S. Food and Drug Administration (FDA) is notifying the public that information on the cardiovascular risks (including heart attack) of the diabetes drug rosiglitazone has been added to the physician labeling and patient Medication Guide. Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. Rosiglitazone is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride). In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:
• In patients already being treated with these medicines
• In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines

July date set for ticagrelor FDA decisionAstraZeneca announced today that the US Food and Drug Administration (FDA) has acknowledged receipt of the company's reply to the Complete Response Letter (CRL) for the ticagrelor New Drug Application (NDA). Accordingly, the agency has accepted AstraZeneca's resubmission of the ticagrelor NDA, categorised it as a Class 2 resubmission to the CRL, and set a new PDUFA date of 20 July 2011.

New Guidelines for the Primary Prevention of Stroke The American Heart Association/American Stroke Association has unveiled its first scientific statement on cerebral venous thrombosis. The recommendations which published in the last issue of Stroke will help clinicians identify this uncommon cause of stroke that mostly affects young people.

NT5E gene mutations found involved in arterial calcification. According to a new study published in the last issue of NEJM NT5E gene mutations have been discovered that are thought to be responsible for a rare disease causing extensive calcification of lower-extremity arteries and hand and foot joint capsules. NT5E gene, codes for the CD73 protein, which converts AMP to adenosine on the surface of various types of cells. According to the authors CD73 deficiency causes a reduction in extracellular adenosine, which enhances TNAP activity, which in turn reduces pyrophosphate levels, leading to calcification. They add that the selective involvement of lower-extremity arteries may be related to the distribution of particular adenosine receptors in these tissues.

January 27, 2011

FAST-MI Registry Analysis: No effect of PPIs on clopidogrel effectiveness: The findings from 3670 participants in the French Registry of Acute ST-Elevation and Non ST-Elevation Myocardial Infarction (FAST-MI) which published online in Circulation support a large body of observational, largely retrospective data—but also at least one prospective clinical trial—suggesting that PPIs can be safely given with clopidogrel in patients at increased gastric bleeding risk. Specifically, no significant sign of excess cardiovascular events, including death, MI, or stroke in-hospital or at one year, were seen in patients who received proton-pump inhibitors (PPIs), especially omeprazole along with clopidogrel.

Hydrochlorothiazide (HCTZ) is less effective in reducing blood pressure. According to a meta-analysis of 19 studies which published in the last issue of JACC the antihypertensive efficacy of HCTZ in its daily dose of 12.5 to 25 mg as measured in head-to-head studies by ambulatory BP measurement is consistently inferior to that of all other drug classes. The authors concluded that HCTZ is an inappropriate first-line drug for the treatment of hypertension.because outcome data at this dose are lacking.

Carotid Stenting Benefits Outweigh Risks Among Standard-Risk Surgical Patients, FDA Advisors Say. The Food and Drug Administration Circulatory System Devices Panel voted 7 to 3 in favor of an expanded indication for the RX Acculink Carotid Stent System (Abbott, Abbott Park, IL), stating the benefits of carotid stenting in patients at standard risk for adverse events from endarterectomy outweigh the risks.

Prasugrel is associated with greater platelet inhibition and better response profiles than clopidogrel in diabetic patients. According to (OPTIMUS)-3 study published online in European Heart Journal prasugrel resulted in greater platelet inhibition than double-dose clopidogrelfrom four hours' post-loading dose through the seven days. In addition, prasugrel resulted in fewer poor responders at all time points irrespective of definition used.

January 17, 2011

Severe liver injury associated with the use of dronedarone: The U.S. Food and Drug Administration (FDA) with a safety announcement is alerting healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication dronedarone (Multaq).

ACCELERATE study: Combination therapy is better as an initial antihypertension treatment. According to the ACCELERATE study which published online in Lancet patients with hypertension given combined two-drug therapy (aliskiren and amlodipine) from the start of treatment respond better than patients initially given monotherapy. Moreover, those who later switched from monotherapy to combination therapy improved their response, but not to the same level as those who began with combination therapy.

January 12, 2011

First bioabsorbable stent get CE mark aproval:Abbott announced today that it had received CE Mark approval for Absorb, its everolimus eluted bioresorbable vascular scaffold (BVS) device. The device props a narrowed coronary artery open but then dissolves within 2 years, leaving the patient without a permanent implant.

Stroke risk at AF cardioversion similar on dabigatran or warfarin:According to a post hoc analysis of RELY trial published online on Circulation the 30-day risk of stroke or systemic embolism in the setting of cardioversion for nonvalvular atrial fibrillation (AF) is similarly low whether the accompanying anticoagulation is with warfarin or with dabigatran. Rates of major bleeding after cardioversion, achieved in 1270 patients, were also low and not significantly different in the dabigatran 150-mg-twice-daily and warfarin groups.

Hysterectomy in women under 50 years associated with raised CV risk:Women under 50 years old undergoing hysterectomy, with or without oophorectomy, are at an increased risk of heart disease according to a new study published online in the European Heart Journal. Specifically , 184.441 patients who undergone hysterectomy were compared with control women who had not. The main outcome measure was the first hospitalization or death due to incident cardiovascular disease (coronary heart disease, stroke, or heart failure). The women under 50 years old had 18% increased risk for cardiovascular disease and 25% if they had oophorectomy at study entry but the women >50 years old hadn't increased risk.

Vernakalant is more effective than amiodarone for new onset AF conversion (AVRO trial):Vernakalant , a novel intravenous pharmacologic agent that blocks early-activating K+ channels and frequency-dependent Na+ channels, is more effective than amiodarone for the rapid conversion of atrial fibrillation to sinus rhythm according the AVRO trial which published in the lasdt issue of JACC. In addition, patients treated with vernakalant had significantly greater symptom relief at 90 minutes and a greater perceived feeling of well-being at two hours, report investigators. The AVRO investigators enrolled 254 adult patients with recent-onset AF (duration of three hours to 48 hours) eligible for cardioversion. Regarding the primary end point, the conversion to normal sinus rhythm, 51.7% of patients were converted from AF to sinus rhythm in the vernakalant arm, compared with just 5.2% of those in the amiodarone arm (p<0.0001). At 90 minutes, significantly more patients treated with vernakalant were without AF symptoms when compared with those treated with amiodarone (53% vs 33%, p=0.0012).

PTA scoring balloon catheters were recalled by FDA :AngioSculpt percutaneous transluminal angioplasty (PTA) scoring balloon catheters, manufactured by AngioScore, are subject to a class I US Food and Drug Administration (FDA) recall. The device was recalled because of a design defect causing unintended fracture and peeling, and has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. Use of affected devices may lead to retained device fragments or significant arterial injury which may lead to death, or need for additional surgical intervention.

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