May 25 to 28, 2010

Compiled by D. Sakellariou and S. Pastromas

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SOURCE Registry

Mortality rates among patients treated with the Sapien transcatheter valve seem to be edging downward as compared with previous series, according to data announced in the congress. In fact, patients enrolled in cohort 1 of the SOURCE registry who underwent a transapical (TA) transcatheter valve implantation had one-year survival rates similar to the transfemoral (TF) results seen in a pooled analysis of earlier studies. The 12 months survival was 72.1% for patients treated with a TA approach and 81.1% for patients treated via a TF approach, yielding an overall survival rate of 76.1% for the entire 1038-patient cohort. Patients treated transapically had more renal dysfunction, a higher logistic EuroSCORE (32.5% vs. 25.5%), and more peripheral, carotid, and coronary artery disease, as well as more prior CABG, porcelain aorta, and mitral-valve disease. The one-year survival rates for both TA and TF patients were related to baseline EuroSCORE; while those with the highest EuroSCOREs (>40) had the lowest rates of survival, patients at lower surgical risk (EuroSCORE <20 and 20-40) had much higher survival rates.Indeed, in patients at the lowest surgical risk (EuroSCORE <20), one-year survival was actually very similar between the two groups: 78.4% for TA patients and 80.9% for TF patients.

RES-I study

During the congress, the 12-month results of the RES-I trial were announced. The superiority reported at six months of the novel micro-reservoir sirolimus-eluting Nevo-Res I stent over the paclitaxel-eluting Taxus stent was still apparent. The 400-patient head-to-head trial, which evenly randomised patients with de novo lesions to the Nevo-Res stent or to Taxus, demonstrated a significantly lower in-stent late loss at six months favouring Nevo-Res (0.13 mm vs. 0.36 mm, p<0.001), which was the primary endpoint of the trial, and the 12-month results confirmed numerically but not significantly lower rates of death, myocardial infarction, and revascularisation. The absolute difference in major adverse cardiac events was 3.9% at six months and 4.3% at 12 months (p=0.107). A subset analysis of results in patients with diabetes revealed a similar pattern (an 8.3% event rate in the Nevo-Res arm versus 12.8% in the Taxus arm p: NS).

RESOLUTE trial

In this 2,292-patient randomised trial, the Resolute zotarolimus-eluting stent was found to be as safe and effective as the Xience everolimus-eluting stent. At one year, the Resolute DES was shown to be as effective as the Xience DES in reducing the need for repeat procedures, and both second-generation stents were associated with low and similar rates of death from cardiac causes and heart attacks attributed to the treated vessel. The primary endpoint of the study was target lesion failure (TLF)—a composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularisation. The Resolute DES posted TLF rates of 8.2 percent versus 8.3 percent for the Xience DES (non-inferiority p<0.001).

TALENT trial

This single-centre study randomised 1540 patients over the course of a year to either a left or right radial approach. A total of 1467 were randomised for their diagnostic cath, and 688 patients were randomised for their PCI cath, with some patients randomised twice for both procedures. The investigators included elective, unstable-angina, and non-STEMI patients but excluded STEMI patients, patients with prior CABG, haemodynamically unstable patients, and patients with a radial or ulnar artery deemed unsuitable by the Allen test. The primary endpoints of fluoroscopy time (168 vs. 149 s, p: 0.0025) and dose/area of irradiated tissue (dose area product) during fluoroscopy (12.1 Gy/cm² vs. 10.7 Gy/cm², p: 0.004) were significantly reduced among patients treated via the left radial artery vs. the right during diagnostic procedures. The stroke rates and crossovers to femoral access were very low for both radial routes—only 1% of patients crossed over to a femoral procedure in both groups, and only one stroke occurred in the entire series.

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