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Welcome to the APRIL 2012 issue of HEART VESSELS and BRAIN Thrombosis & Antithrombosis

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May 15, 2012

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Ablation superior to antiarrhythmic drugs as first-line therapy for AF (HRS Congress): Pulmonary vein isolation (PVI) with radiofrequency ablation is safe for patients with symptomatic atrial fibrillation (AF) and significantly superior to the current first-line therapy approach of antiarrhythmic drugs (AAD), according to trial results presented at the 33rd annual scientific sessions of the Heart Rhythm Society. The primary efficacy outcome was time to first recurrence of AF as documented by electrocardiography. The higher percentage of patients that reached AF, the less favorable the outcome. The trial followed a total of 127 patients at 16 healthcare centers in five countries. Sixty-six were randomized to receive ablation and 61 were randomized to treatment with AAD. Mean age of patients was 55 years, and 76 % were male. Nearly half had a history of paroxysmal/persistent AF, and mean follow-up was more than 25 months. Results showed that among the AAD group of patients, 72 % reached AF. This compares to 55 % of patients in the PVI ablation group who reached the primary efficacy outcome.

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ICD therapy shows benefit at long-term follow-up : Results from the long term follow-up to the Sudden Cardiac Death Heart Failure Trail (SCD-HeFT) have shown that ICD therapy in patients with moderate heart failure significantly reduces mortality for at least 11 years from the time of implantation, according to a study presentation at the 33rd annual scientific sessions of the Heart Rhythm Society (HRS).

SCD-HeFT, which began in 1997, remains the only placebo-controlled ICD trial and initial findings showed that ICD therapy provided a 23 percent survival advantage when compared with amiodarone treatment or placebo. While the initial results were based on a median follow-up of 45.5 months, the long term follow-up results were based on a median follow-up of 11 years. Patients from SCD-HeFT were randomized to receive amiodarone, a placebo or a single lead shock-only ICD therapy. Patients were grouped based on whether the heart failure was ischemic or non-ischemic, and also by whether the heart failure was Class II or Class III according to New York Heart Association (NYHA) classifications. Mortality data for the long term follow-up were available on 2,291 (91 %) of the original patients enrolled in SCD-HeFT, though data were limited on long term use of amiodarone and new ICD implantations. ICD therapy provided an absolute risk reduction of 5 % compared with placebo. When looking at the individual patient subgroups, NYHA Class II patients randomized to ICD therapy demonstrated benefit over placebo, with a hazard ratio of 0.76. There was no significant reduction in mortality for NYHA Class III patients.

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Older female AF patients have higher stroke risk: Atrial fibrillation (AF) patients have a five-fold increase in the risk of stroke; however, older women diagnosed with AF may fare worse than men, despite warfarin use, according to a study published in the Journal of the American Medical Association (JAMA). In this population-based study were included AF patients age 65 years or older who were recently diagnosed with AF between 1998 and 2007. The authors used risk of stroke as the study's primary endpoint. The study enrolled 39.398 men and 44.115 women. Of this cohort, 74.2 % of women were over the age of 75 compared with 61.4 % of men.

The women had higher CHADS2 scores, an older age, prior stroke and transient ischemic attack when compared with men. However, men had a greater prevalence of heart failure and diabetes when compared with women.

Thirty days after hospital discharge 58.2 % of men and 60.6% of women filled warfarin prescriptions. While women were more likely than men to fill prescriptions for the drug, the researchers reported adherence to warfarin to be good in both sexes. Stroke incidence rates were reported to be 2.02 per 100 person-years in women and 1.61 per 100 person years in men (p<0.001). Crude stroke rates were also reportedly higher in women when compared with men, 5.8% vs. 4.3%, respectively. The authors said that these differences in males and females were mainly in the population of patients who were 75 years or older.

A subgroup analysis of patients without a history of stroke, which is a known powerful risk factor for stroke, found that women still had a higher risk of stroke compared with men (HR 1.17).

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Obesity Drug Lorcaserin Gets Positive Vote From FDA Panel: Lorcaserin, an investigational obesity drug, was given a positive recommendation by the Endocrinologic and Metabolic Drugs Advisory Committee, which advises the Food and Drug Administration (FDA). The Committee voted 18 to 4 in favor, with one abstention, in advising the FDA whether to approve the medication for obese or overweight individuals. The majority of the members of the Committee found that available evidence shows that lorcaserin's potential risks are outweighed by its possible benefits. Lorcaserin is intended for obese and overweight patients for weight management, including weight loss and then maintaining a healthy body weight. The FDA is expected to complete its review of lorcaserin by June 27th, 2012.

TLorcaserin is an experimental medication aimed at helping overweight/obese people manage their body weight. It is a new chemical entity; scientists believe it functions as a selective serotonin 2C receptor agonist. The hypothalamus is a brain area believed to be in control of metabolism and appetite - the serotonin 2C receptor is expressed in the brain, including the hypothalamus.

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May 8, 2012

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No advantage for warfarin in heart failure patients in sinus rhythm (WARCEF study): According to the results of a large randomized trial (WARCEF) which published online in NEJM in heart-failure patients in sinus rhythm, there was no overall difference in the risk of a composite of ischemic stroke, intracerebral hemorrhage, or death from any cause with treatment with warfarin vs aspirin. WARCEF enrolled 2305 patients from 176 sites in 11 countries with an LVEF of less than 35% in sinus rhythm. This double-blind trial studied the results of warfarin treatment with a target INR of 2 to 3.5 vs aspirin given in a dose of 325 mg daily. Mean follow-up in the trial was 3.5 years, with a range of one to six years. Only 3% of patients were lost to follow-up. The primary outcome was a composite of ischemic stroke, intracerebral hemorrhage, or death from any cause. As compared with aspirin, warfarin did not significantly reduce the rate of the primary outcome (7.47 events per 100 patient-years in the warfarin arm and 7.93 in the aspirin arm). The hazard ratio (HR) with warfarin was 0.93 (95% CI 0.79-1.10; p=0.40). Throughout the study, warfarin, as compared with aspirin, was associated with a significant reduction in the rate of ischemic stroke (0.72 events vs 1.36 events per 100 patient-years; HR 0.52, 95% CI 0.33-0.82; p=0.005). However, the benefit of warfarin in reducing the rate of ischemic stroke was offset by a significant increase in the rate of major bleeding (1.78 events per 100 patient-years vs 0.87 in the aspirin group; p<0.001). The rates of intracerebral and intracranial hemorrhage did not differ significantly between the warfarin and aspirin groups (0.27 and 0.22 events per 100 patient-years, respectively; p=0.82).

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AATS: Study questions insulin protocols for CABG patients : Cardiothoracic surgeons and endocrinologists from Boston Medical Center (BMC) have found that among patients undergoing CABG surgery, achieving Surgical Care Improvement Project (SCIP) benchmarks for glycemic control may be irrelevant when perioperative continuous insulin infusion protocols are implemented. These findings were presented May 1 at the annual meeting of the American Association for Thoracic Surgery (AATS) in San Francisco. Between January 2006 and April 2011, were enrolled 833 patients who underwent CABG surgery at a single center and received continuous insulin infusions to maintain serum blood glucose of less than 180 mg/dl. They divided the patients into two groups: patients compliant with SCIP and those who were outliers, that is, those who fell outside of the SCIP guidelines. The researchers found the incidence of SCIP outliers to be 6.6 percent. These patients were more likely to suffer from insulin-dependent diabetes (76 percent vs. 33 percent); have a higher hemoglobin A1c level, which is indicative of poor glucose control in the months preceding surgery (8.7 vs. 7.59); higher body mass index (31.1 vs. 29.2), and lower ejection fraction (49 vs. 53).

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Use of angiotensin receptor blockers (ARBs) was not associated with an increased risk of cancer: Another study about the potential increased risk of cancer in patients receiving ARBs was published in BMJ and the results are that there is no evidence about an increase of cancer risk in these patients. In this study 377.649 new users of angiotensin receptor blockers or ACE inhibitors with at least one year of initial treatment were followed up a median of 4.6 years after the start of treatment. A total of 20.203 cancers were observed. There was no evidence of any increase in overall risk of cancer among those ever exposed to angiotensin receptor blockers (adjusted hazard ratio 1.03, 95% confidence interval 0.99 to 1.06, P=0.10). For specific cancers, there was some evidence of an increased risk of breast and prostate cancer (1.11, 1.01 to 1.21, P=0.02; and 1.10, 1.00 to 1.20, P=0.04; respectively), which in absolute terms corresponded to an estimated 0.5 and 1.1 extra cases, respectively, per 1000 person years of follow-up among those with the highest baseline risk. Longer duration of treatment did not seem to be associated with higher risk (P>0.15 in each case). There was a decreased risk of lung cancer (0.84, 0.75 to 0.94), but no effect on colon cancer (1.02, 0.91 to 1.16).

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May 2, 2012

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CHA2DS2-VASc score gives best prediction of stroke risk in patients with atrial fibrillation (AF): Another study has suggested that the newer CHA2DS2-VASc score may be more suitable than the CHADS2 score for assessing risk of stroke and thromboembolic events in AF patients, particularly in those at lower risk.

A CHADS2 score of 0 included CHA2DS2-VASc scores of 0 to 3 and that a CHADS2 score of 1 included CHA2DS2-VASc scores of 1 to 4. To look further at whether use of the CHA2DS2-VASc score improved risk stratification of AF patients with a CHADS2 score of 0 to 1, a new study published online in Thrombosis and Haemostasis Journal in which included 47.576 AF patients with a CHADS2 score of 0 to 1 and not with treated anticoagulants or heparin. Patients were classified by both CHADS2 and CHA2DS2-VASc risk scores, and the actual rates of stroke/thromboembolism were determined, also from national databases. The results showed that CHA2DS2-VASc score gave a much more accurate prediction of risks than the CHADS2 score, with risk increasing with each point on the CHA2DS2-VASc scale.

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Drug-Eluting vs Bare-Metal Stents in Primary Angioplasty: It was published the results of the first meta-analysis reporting on long-term clinical outcomes, out to three years, with drug-eluting stents (DES) compared with bare-metal stents in the setting of primary angioplasty for ST-elevation MI (STEMI). The aim of the study—the Drug-Eluting Stents in Primary Angioplasty (DESERT) Cooperation—was to perform a pooled patient-level meta-analysis of randomized trials to evaluate the risks and benefits of DES compared with bare-metal stents in those undergoing primary PCI for STEMI. They included trials from the literature—including BASKET-AMI, HORIZONS-AMI, and SESAMI—and presentations from scientific meetings, from January 2000 to June 2011. Individual patient data were obtained in a total of 6298 patients, 63.2% of whom were randomized to DES, the remainder to bare-metal stents. The primary end point for the study was mortality; secondary end points included reinfarction, TVR, and stent thrombosis (definite or probable according to Academic Research Consortium definitions) at long-term follow-up. At a mean of 3.3 years of follow-up, DES implantation reduced the occurrence of TVR by 43% (12.7% vs 20.1% with bare-metal stents; HR 0.57; p<0.001) without any significant difference in terms of cumulative mortality (HR 0.85), reinfarction (HR 1.12), or stent thrombosis (HR 1.13). The researchers do acknowledge, however, an increase in very late (more than one year) infarction—6.6% with DES vs 3.0% with bare-metal stents (HR 1.57; 95% CI 1.08-2.27) and stent thrombosis (3.1% with DES vs 1.4% with bare-metal stents; HR 1.89, 95% CI 1.13-3.15).

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Survival rates similar for off-hours, office-hours PCIs: STEMI patients who undergo PCI during evenings and weekends in a high volume center have similar outcomes as a their counterparts who are treated during regular weekday office hours, according to a study published in the April issue of European Heart Journal: Acute Cardiovascular Care. The study group included patients 18 years old or older who presented within 12 hours of STEMI symptom onset who then underwent primary PCI at the Thoraxcenter between January 2000, and December 2009. Of those patients, 4,352 underwent 4,541 primary PCIs. The primary endpoints were all-cause mortality within 30 days of the index event and all-cause mortality at one-year and four-year follow-up. The secondary endpoints included repeat PCI, CABG or recurrent MI, and the composite endpoint of recurrent MI, revascularization and all-cause mortality at 30-day, one-year and four-year follow-up.

The researchers found that 63.4 percent of the patients were treated during off-hours. There were no significant differences between the groups, with the exception of smoking, diabetes mellitus, use of glycoprotein IIb/IIIa antagonists and calcium antagonists rates being higher in the off-hours group. Mortality at 30-day and four-year follow-up was the same in patients treated during off-hours and those treated during regular hours, at 7.7 percent and 17.3 percent, respectively. There was no statistical difference in all-cause mortality at one-year follow-up as well.

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April 23, 2012

Dabigatran causes fewer fatal and traumatic intracranial hemorrhages (RELY substudy): During the World Congress of Cardiology in Dubai was announced the results of a substudy of RE-LY according which the fatal and traumatic hemorrhages was fewer with both doses of dabigatran than with warfarin.

Specifically, during a mean of 2.0 years of follow-up, 154 intracranial hemorrhages occurred in 153 participants: The rates of intracranial hemorrhage were 0.76%, 0.31%, and 0.23% per year among those assigned to warfarin, dabigatran 150 mg and dabigatran 110 mg, respectively (p<0.001 for either dabigatran dose versus warfarin). Fewer fatal intracranial hemorrhages occurred among those assigned dabigatran 150 mg and 110 mg (n=13 and n=11, respectively) versus warfarin (n=32; P<0.01 for both). The results was also published online in Stroke Journal.

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FDA announces new warning and contraindication for blood pressure medicines containing aliskiren: The U.S. Food and Drug Administration (FDA) is warning of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. These drug combinations should not be used (are contraindicated) in patients with diabetes. In addition, a new warning is being added to avoid use of these drug combinations in patients with kidney impairment. The labels for the aliskiren drugs are being updated based on preliminary data from the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE), which evaluated aliskiren in combination with ACE inhibitors and ARBs. A higher risk of renal impairment, hypotension, and hyperkalemia along with an apparent lack of efficacy caused the sponsor company to halt the trial in December 2011.The following recommendations are being added to the drug labels for aliskiren-containing products:

• A new contraindication against the use of aliskiren with ARBs or ACEIs in patients with diabetes because of the risk of renal impairment, hypotension, and hyperkalemia.
• A warning to avoid use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment (i.e., where glomerular filtration rate [GFR] < 60 mL/min).

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European and American Diabetes Associations issue new hyperglycemia management guidelines: The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) have issued a joint position statement emphasizing patient-specific treatment of hyperglycemia in those with type 2 diabetes . The new guidelines are reported online in Diabetes Care and Diabetologia. Key recommendations in the new ADA/EASD statement include the following:

• Glycemic targets and treatments to lower glucose must be individualized according to specific patient characteristics.
• The mainstay of any type 2 diabetes treatment program is still diet, exercise, and education.
• Metformin is the preferred first-line drug, in the absence of contraindications.
• Data are limited regarding use of agents other than metformin. A reasonable approach is combination therapy with one to two additional oral or injectable agents, with the goal of minimizing side effects to the extent possible.
• To maintain glycemic control, many patients will ultimately need insulin monotherapy or in combination with other medications.
• Whenever possible, the patient should participate in all treatment decisions, focusing on their preferences, needs, and values.
• A major treatment goal must be comprehensive cardiovascular risk reduction.

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A group of experts from ESC issues position paper on new anticoagulants: In a "position paper" on the new oral anticoagulants, a group of experts from the European Society of Cardiology Working Group on Thrombosis which published in JACC are enthusiastic about the new agents in AF, but not so impressed with their use in ACS.

In this statement the authors welcome all three new drugs as attractive alternatives to warfarin. According to the authors apixaban is currently the best-documented alternative to both warfarin and aspirin for stroke prevention in a broad population with AF as it has been shown to be superior compared with warfarin concerning the reduction of stroke and mortality in combination with a reduction in major bleeding.

Dabigatran 150 mg is also a well-documented alternative to warfarin based on its reduction of hemorrhagic stroke as well as of ischemic stroke and systemic embolism, with a similar risk of major bleeding and a reduced risk of intracranial bleeding. They note, however, that dabigatran is associated with some specific side effects, such as an increased rate of dyspepsia and gastrointestinal bleeding, a trend toward an increased risk of myocardial infarction, and a dependence on normal or only moderately impaired renal function for its elimination. But they add that lower doses allow for tailoring of treatment in older patients and/or those with poor renal function.

The rivaroxaban is a third alternative to warfarin in AF, having been documented to be noninferior concerning stroke prevention and major bleeding, with a lower risk of intracranial but a higher rate of gastrointestinal bleeding in this population. Rivaroxaban has the advantage of a convenient once-daily regimen, which may improve adherence.

The authors are not so enthusiastic about use of the new anticoagulants in ACS patients. Apixaban failed to significantly reduce ischemic events in APPRAISE-2, while a low dose of rivaroxaban succeeded in ATLAS-2. But it adds that a three- to fourfold excess in major and intracranial bleeding events was seen in both trials when the new anticoagulants were added to current antiplatelet treatment, which it says is a major concern.

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The Hellenic Cardiovascular Research Society has published the first issue of the new journal “Heart Vessels & Brain- thrombosis & antithrombosis” in the beginning of April. The journal circulates in greek language, every three months, in printed and electronic form, in subscribers only and includes review articles, innovations in imaging and developments in pharmaceutical and medical technology. It is targeted primarily to cardiologists, as well as neurologists, doctors of internal medicine and general practioners. Reviews of distinguished authors, as professor GY Lip has been included in the first issue.

April 17, 2012

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No mortality risk for losartan vs candesartan seen in heart failure: All-cause mortality is not greater in patients with heart failure taking losartan than in those treated with candesartan, concluded a prospective analysis of patients in a national registry–based cohort study from Denmark published in the last issue of JAMA.
Patients aged 45 years and older with first-time hospitalization for heart failure in 1998-2008 were identified from the Danish National Patient Registry. New users of losartan and candesartan were selected for inclusion in the study cohort. Among 4397 users of losartan, 1212 deaths occurred during the follow-up period (unadjusted incidence rate [IR]/100 person-years, 10.7; 95% CI, 10.1-11.3) compared with 330 deaths among 2082 users of candesartan (unadjusted IR/100 person-years, 9.0; 95% CI, 8.1-10.0). Compared with candesartan, losartan was not associated with increased all-cause mortality (adjusted hazard ratio [HR], 1.10; 95% CI, 0.96-1.25) or cardiovascular mortality (adjusted HR, 1.14; 95% CI, 0.96-1.36). Compared with high doses of candesartan (16-32 mg), low-dose (12.5 mg) and medium-dose losartan (50 mg) were associated with increased mortality (HR, 2.79; 95% CI, 2.19-3.55 and HR, 1.39; 95% CI, 1.11-1.73, respectively); use of high-dose losartan (100 mg) was similar in risk (HR, 0.71; 95% CI, 0.50-1.00).
The authors concluded that among patients with heart failure, overall use of losartan compared with candesartan was not associated with an increased mortality risk although low doses of losartan were associated with increased mortality.

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Mobile stroke unit improve the time to treatment: Using a mobile stroke unit (MSU) equipped with a CT scanner, laboratory, and telemedicine connection cuts "door-to-needle" time in half, according to a study published online in Lancet Neurology. For the study, all emergency calls to the central emergency medical service (EMS) coordinating office from a region of up to 30 km around Saarland University Hospital were assessed for reporting of stroke symptoms. Patients aged 18 to 80 years who had at least one stroke symptom that had started within the previous two to five hours were considered for the study. The MSU team included a paramedic, a stroke physician, and a neuroradiologist. The team undertook a neurological examination, CT scan, and laboratory examination in their specially equipped ambulance and, if the patient was eligible, gave thrombolysis directly at the emergency site. Patients in the control group received optimized conventional stroke management that included point-of-care laboratory testing instead of testing by the centralized hospital lab. Thrombolysis was given in accordance with criteria for the approval of alteplase.
The study was stopped early after enrollment 100 of 200 planned patients (53 in the MSU and 47 in the control groups) when the predefined interim analysis showed the prespecified superiority (p=0.0015) in the primary end point, time from alarm to therapy decision.
Median times from alarm to arrival at the scene were 12 minutes for the MSU group and eight minutes in the control group. However, the MSU approach roughly halved the time from alarm to therapy decision compared with the control group, with a median of 35 minutes vs 76 minutes.

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Atrial fibrillation patients admitted to the hospital on weekends have worse outcomes: Atrial-fibrillation patients admitted on the weekend tend to stay in the hospital longer, are less likely to undergo cardioversion, and are more likely to die in the hospital than similar patients admitted during the week, according to a new study published online in the American Journal of Cardiology.
In this study were examined records of 86 497 discharges with a primary diagnosis of AF in the Nationwide Inpatient Sample (NIS) 2008 database and compared outcomes of patients admitted to the hospital on the weekend vs those admitted during the week. Cardioversion procedures were about half as frequent for AF patients admitted on the weekend as for patients admitted on a weekday (7.9% vs 16.2% of patients; p<0.0001). After adjustment for patient and hospital characteristics and disease severity, the adjusted in-hospital mortality odds were 23% greater (p<0.0001) and the length of hospital stay was significantly longer for weekend admissions.
The study also showed that hospitals in major urban areas had lower AF mortality rates than the 1044 hospitals in the study overall, but the size of the hospital had no effect on in-hospital mortality.

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The first fully bioabsorbable stent (Igaki-Tamai) is safe out to 10 years: Long-term data of 50 patients treated with the Igaki-Tamai stent, the first fully bioabsorbable stent implanted in the coronary arteries, shows the stent to be safe out to 10 years and associated with major adverse cardiovascular event (MACE) rates similar to those of bare-metal stents. After 10 years, just one patient (2%) died from cardiac-related causes, six patients (12%) died from noncardiac causes, and one patient (2%) had a lesion-related MI. The cumulative rate of target lesion revascularization (TLR) and target vessel revascularization (TVR) was 28% and 38%, respectively. The device disappeared from the coronary artery within three years of implantation. In total, 63 lesions were treated with 84 Igaki-Tamai stents. The study published online in Circulation. In follow-up of the Igaki-Tamai-treated patients, just one individual (2%) developed very late stent thrombosis. The researchers report that MACE-free survival continued to decline during follow-up (50% at 10 years), and this was the result of increases in TLR and TVR rates. The Igaki-Tamai stent is not available for the treatment of coronary artery disease but does have CE Mark approval in Europe for the treatment of peripheral artery disease.

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April 9, 2012

Cancer diagnosis ups risk of cardiovascular death: Receiving a diagnosis of cancer can trigger cardiovascular events that result in death, as well as spur people to take their own lives, according to a new study published online in the New England Journal of Medicine.
In this study was conducted a historical cohort study of 6 073 240 Swedes and compared the risk of cardiovascular death or suicide among newly diagnosed cancer patients with individuals who did not have cancer during the time period (1991 through 2006), controlling for age, sex, socioeconomic status, and education level.
During follow-up, the rate of cardiovascular death was 7.53 per 1000 person-years in people with no cancer diagnosis, compared with 23.10 per 1000 person-years in people diagnosed with cancer.
In the first week after diagnosis, the CV death rate was more than five-times higher than that in cancer-free subjects, but CV deaths fell sharply over time. In the first four weeks, the CV death rate in newly diagnosed cancer patients was three-times higher than in cancer-free subjects. That translates into a CV death rate in the cancer group of 116.8 per 1000 person-years within the first week, falling to 65.81 per 1000 person-years over four weeks.
Cancer-free individuals experienced a suicide rate of 0.18 per 1000 person-years, compared with 0.36 per 1000 person-years in those diagnosed with cancer. During the first 12 weeks post-diagnosis, cancer patients were five-times more likely to commit suicide than cancer-free individuals, a rate that fell to three-times higher over 12 months.

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Mitral regurgitation and aortic stenosis: Results from TAVI: Moderate-to-severe mitral regurgitation (MR) is relatively common in patients undergoing transcatheter aortic valve implantation and is associated with a doubling in risk of 30-day death, a new series suggests. Beyond this initial period, however, survival among MR patients is just as good as among patients with no MR, and MR itself is likely to improve over time. These are the results of a study published online in JACC.
In this study, 478 patients treated over a five-year period at two centers in Canada. Devices used over this period were the Edwards-Cribier valve, Edwards Sapien, and Sapien XT. Although the bulk of patients had mild or no MR, 89 had moderate MR, and 43 had severe MR.
At 30 days, mortality among patients with moderate or severe MR was twice as high as among those with mild or less MR (hazard ratio [HR] 2.10, p=0.02); after 30 days and up to two years, however, mortality rates were no different between these groups (HR 0.82, p=0.42).
Of note, among survivors, MR had improved in 55% of subjects, remained the same in another 16%, and had worsened in just 1%. Among those with moderate or severe MR at baseline, 61% of patients experienced some improvement post-TAVI.

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Incomplete revascularization makes for worse outcomes out to one year: A new scoring scheme to quantify untreated coronary artery disease following PCI shows that incomplete revascularization is associated with adverse 30-day and one-year clinical outcomes. The residual SYNTAX score was a strong predictor of mortality, myocardial infarction, and ischemic target lesion revascularization (TLR), according to the study published online in JACC. The new score—calculated following coronary revascularization—is derived from the SYNTAX score and is used to assess coronary anatomic severity and complexity of the unrevascularized lesions.
Using data from the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) study, baseline SYNTAX score was calculated using 2686 angiograms of patients with moderate- and high-risk acute coronary syndrome undergoing PCI. The average baseline SYNTAX score was 12.8 and, after PCI, the average residual SYNTAX score was 5.6. Just over 40% of patients had complete revascularization following PCI, while 19.5% of patients had a residual SYNTAX score of 0 to <2, 21.8% had a score >2 and <8, and 18.7% had a score >8.
The 30-day and one-year rates of all ischemic events were significantly increased in patients with incomplete revascularization when compared with patients who were completely revascularized. The risk of ischemic events increased across the residual SYNTAX score tertiles, with the highest risk of ischemic events observed in patients with a residual SYNTAX score >8. Each one-point increase in the SYNTAX score was associated with a significant 5% increase in risk of all-cause mortality, a 6% increase in risk of cardiac death, a 2% increase in risk of myocardial infarction, and a 4% increase in risk of ischemic-driven revascularization.

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April 4, 2012

Non-HDL-C levels linked to risk of cardiovascular events: Levels of non-HDL-C among users of statins are linked to the risk of developing a major cardiovascular event more strongly than levels of LDL-C and apolipoprotein B (apoB) according to a meta-analysis is published in the Journal of the American Medical Association.
The meta-analysis looked at individual patient data from eight randomized data comprising a total of 62 154 patients published between 1994 and 2008. All study participants had conventional lipids and apolipoprotein levels assessed at baseline and at one-year follow-up.
Among the 38 153 patients who were randomized to statin therapy, 158 (0.4%) had a fatal MI and 1678 (4.4%) had a nonfatal MI during follow-up. Death due to other types of coronary artery disease occurred in 615 (1.6%) of the study participants, and fatal or nonfatal stroke occurred in 1029 (2.7%) study participants. In addition, 2806 (7.4%) were hospitalized for unstable angina, and 6286 major cardiovascular events (MACE) occurred in 5387 participants, for an event rate of 14.1%.
The analysis showed that all of the lipid and apolipoprotein parameters that were studied were associated with the risk of MACE and that these associations were statistically significant.
Further analysis showed that the difference between LDL-C and non-HDL-C in predicting the risk of MACE for each one-standard-deviation increase was statistically significant (p=0.002). The difference between non-HDL-C and apoB was also statistically significant (p=0.02), but the difference between LDL-C and apoB was not (p=0.21).

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Bedside gene test identifies CYP2C19*2 carriers: According to a Canadian study published in Lancet it is possible to identify carriers of the CYP2C19*2 allele before undergoing PCI. In the RAPID GENE study, patients randomized to undergo bedside testing and who were identified as carriers of the allele were then treated with prasugrel (Effient, Lilly/Daiichi) instead of clopidogrel post-PCI. Seven days postprocedure, those singled out by testing (and treated differently as a result) were significantly less likely to have high on-treatment platelet reactivity than patients who did not undergo point-of-care testing but who were also carriers of the CYP2C19*2 allele.
For the study, were randomized 200 patients to bedside testing or standard treatment. Carriers identified in the bedside-testing group received 10-mg prasugrel daily following PCI, while noncarriers as well as patients randomized to standard treatment received 75-mg clopidogrel daily. Prasugrel, like another novel P2Y12 inhibitor, ticagrelor , is unaffected by the CYP2C19*2 allele.
At follow-up, 23 patients in each group were found to carry at least one CYP2C19*2 allele. But while none of the carriers in the genotyping group (who'd been switched to prasugrel) had high platelet reactivity (P2Y12 reactivity unit [PRU] value of more than 234), seven of those in the standard-therapy group had PRUs >234 by day seven.

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Antipsychotics linked to MI risk in dementia patients: Antipsychotic medications used to treat behavioral symptoms in elderly patients with dementia are associated with an increased risk for MI, especially during the first month of use according to a new study published in Archives of Internal Medicines. According to this retrospective cohort study of more than 20 000 patients over the age of 64 years treated with cholinesterase inhibitors (ChIs) , those who also started using antipsychotics had a significantly higher risk of developing incident MI within the next year than those who did not use antipsychotics. However, the hazard risk ratios (RRs) were highest within the first 30 days after treatment initiation (RR 2.19) and dropped continuously at each subsequent assessment point.
The investigators evaluated randomly selected data on 37 138 older patients with dementia who were treated with ChIs between January 2000 and December 2009. The participants were then divided into subcohorts made up of incident users of any antipsychotics (n=10 969; 66% women) and a random sample of nonusers (n=10 969; 65.7% women).
Of the treated group, 97.8% received atypical antipsychotics (64.5% took risperidone, 21.6% took quetiapine fumarate and 11.7% took olanzapine . Of the remaining 2.2% who received conventional antipsychotics, 1.9% took prochlorperazine maleate and 0.3% took chlorpromazine hydrochloride.
All patients were followed for up to one year after treatment initiation. Results showed that 1.3% of the participants who started treatment with antipsychotics had an incident MI within a year. The hazard RRs of MI were 2.19 during the first 30 days after treatment initiation, 1.62 within the first 60 days, 1.36 within the first 90 days, and 1.15 within the first 365 days.
Other significant risk factors for MI for patients who took antipsychotics included having diabetes (p=0.002) or being male and over the age of 84 years (p=0.006). The investigators also conducted a self-controlled case series study that assessed only the new users of antipsychotics who experienced incident cases of MI (n=804) within the entire nine-year study period (2000-2009; median follow-up time 47 months). The incidence rate ratios for these patients were 1.78 for the first 30-day period after start of treatment, 1.67 for the 31- to 60-day period, 1.37 for the 61- to 90-day period, and 1.18 for the remaining exposure period.

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March 26, 2012

C-PORT E nine-month results: Elective PCI no on-site cardiac surgery is safe: Nine-month clinical outcomes from a randomized trial comparing elective PCI at centers without vs with on-site cardiac surgery suggest, like the previously reported six-week mortality results, that patients fare about the same regardless of whether PCI has the surgical safety net. The composite rates of death from any cause, Q-wave MI (QMI), and target-vessel revascularization (TVR) at nine months were 12.1% without on-site surgery and 11.2% with backup surgery in the noninferiority trial, called Cardiovascular Patient Outcomes Research Team Non-Primary PCI (C-PORT E). Previously reported six-week mortality had been 0.9% and 1.0% respectively, which also met the trial's criterion for noninferiority.The C-PORT-E trial with its six-week and nine-month outcomes, which were co-primary end points, was published online in the New England Journal of Medicine today to coincide with presentation of the nine-month results here at the American College of Cardiology 2012 Scientific Sessions.

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Abciximab reduces myocardial infarct size (INFUSE –AMI trial): The intracoronary administration of abciximab delivered to the infarct lesion site resulted in a significant, albeit modest, reduction in infarct size in patients presenting with a large anterior ST-segment elevation MI (STEMI), whereas the use of aspiration thrombectomy failed to have any demonstrable effect on myocardial infarct size. At 30 days, neither intracoronary abciximab nor thrombectomy improved myocardial reperfusion, ST-segment resolution, or 30-day clinical event rates. The study, known as INFUSE-AMI, was presented at the American College of Cardiology 2012 Scientific Sessions and published online in the Journal of the American Medical Association.
The INFUSE-AMI study is a 2x2 factorial, randomized, multicenter, single-blind study of a single 0.25-mg/kg bolus of intracoronary abciximab administered at the site of the infarct lesion vs no abciximab and manual aspiration thrombectomy vs no thrombectomy. Over a two-year period, 452 patients from 37 sites in six countries presenting within four hours of STEMI due to a proximal or mid-left anterior descending artery occlusion were included in the study. All patients underwent PCI and received procedural anticoagulation with bivalirudin Cardiac magnetic resonance imaging (cMRI) was used to assess wall motion and infarct size. The primary and secondary efficacy end point was infarct size at 30 days in patients assigned to intracoronary abciximab and manual aspiration thrombectomy, respectively.
Patients randomized to intracoronary abciximab had a significant reduction in the primary end point compared with patients who did not receive abciximab. Infarct size measured as a percentage of total left ventricular mass was 15.2% in the abciximab-treated patients compared with 17.5% in those who did not receive abciximab, a significant 2.3% absolute difference in infarct size (p=0.03). Comparatively, there was no difference in infarct size between patients undergoing manual aspiration thrombectomy and those who didn't receive thrombectomy. In both arms, there was no difference in the abnormal wall-motion scores among those who received treatment and those who did not.

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Varopaxar benefits post MI patients (TRA 2°P-TIMI 50 trial): Full results of the TRA 2°P TIMI-50 study suggest that the novel antiplatelet agent vorapaxar appears to have a net clinical benefit in selected secondary-prevention patients. Patients who did best on the drug were those with a prior MI without a history of stroke or transient ischemic attack (TIA) and who weighed over 60 kg. But many observers expressed concerns about the bleeding risk with the drug, with suggestions that it may not be suitable for general availability. The top-line results of the trial, announced earlier this year, reported that vorapaxar, which blocks the protease-activated receptor 1 (PAR-1) on the platelet, was successful in reducing the primary ischemic end point of the study, but at the cost of increased bleeding, including intracranial hemorrhage (ICH).
The detailed results were presented today at the American College of Cardiology (ACC) 2012 Scientific and it was also published online simultaneously in the New England Journal of Medicine. TRA 2°P TIMI 50 was conducted to investigate whether vorapaxar could reduce thrombotic events in stable patients with atherosclerosis treated for one year or more in addition to standard therapy.
The trial included three types of patients: those who had had an MI within the past year (67% of patients); those who had an ischemic stroke or TIA within the past year (19%); and those with peripheral arterial disease (PAD) (14%).
In total, 26 449 were randomized to vorapaxar 2.5 mg per day or placebo. In January 2011, the data safety and monitoring board (DSMB) recommended that patients with a history of stroke should stop taking vorapaxar after an increase in ICH was seen in this group. The trial continued in the other patient groups.
After a median follow-up of 2.5 years, there was a significant 13% relative reduction in the primary efficacy end point (CV death/MI/stroke) for the whole patient population. The reduction was slightly larger in the patients without a history of stroke.

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New Canadian AF guidelines encourage the use of new oral anticoagulants: The Canadian Cardiovascular Society has updated its guidelines on atrial fibrillation to reflect some major new findings that have been reported during the past year or so. The new update, published in the March 2012 issue of the Canadian Journal of Cardiology, adds to the most recent version of the Canadian AF guidelines published in 2010. Notable in the new update is support for the oral anticoagulant drugs, which are said to be "preferable" to warfarin for most patients.
The update also advises on dose reductions in the elderly: "Among patients over 75 years and certainly those over 80 years, dose reduction of the new oral anticoagulants, especially dabigatran, should be considered."
Similarly, for patients with reduced renal function, the guidelines suggest that while patients with mild to moderate kidney dysfunction—glomerular filtration rate (GFR) of 30 to 50 mL/min—can be treated with normal doses of the new oral anticoagulants, they need more frequent measures of kidney function and may need dose reductions with conditions that may transiently reduce GFR. This is especially true in the elderly (age older than 75 years), as bleeding risk increases with age.
For patients with more severe renal dysfunction (GFR 15-30 mL/min), the guidelines suggest warfarin would be the preferred agent. For patients with a GFR <15 who would be on dialysis, the guidelines do not recommend any routine antithrombotic therapy.

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