Conference coverage: Late Breaking Trials
From the American College of Cardiology Meeting, March 6-9, 2005.
Seven trials comparing drug eluting stents to each other or bare metal stents were presented. In general, they showed that drug eluting stents were superior to bare metal stents, but among the drug eluting stents, the data favored sirolimus eluting stents.
ISAR-Diabetes
Dr. Adnan Kastrati from Munich, Germany, presented this study comparing the Cypher (Johnson and Johnson) sirolimus eluting stent to the Taxus (Boston Scientific) paclitaxel eluting stent in 250 diabetic patients. The primary end point of lumen loss was .43mm with the sirolimus stent (Cypher) and .67mm with the paclitaxel stent (Taxus). The angiographic restenosis rate was 6.9% Cypher and 16.5% Taxus. Mortality at 9 months was 3.2% Cypher vs 4.8% Taxus. The investigators concluded that drug eluting stents are more effective than bare metal stents for preventing restenosis, but the sirolimus eluting stent was more effective than the paclitaxel eluting stent in preventing restenosis in diabetic patients.
REALITY
Dr. Marie-Claude Morice from Paris, France, reported on this study, which compared the Cypher stent to the Taxus stent in 1386 patients, of whom 28% were diabetics and had 1 or 2 de novo lesions in 1 artery, 2.25 to 3mm in diameter. Both stents were safe and effective, since there was no difference in major adverse cardiovascular events (MACE) or restenosis at 8 months (11 vs 10%%). However, all angiographic parameters favored the Cypher. Also, 30-day in-stent thrombosis was 0.4% with the Cypher and 1.8% with Taxus, P = .02.
Dr. Morice concluded that the observed safety difference between the 2 stents will require further study.
SIRTAX Trial
Dr. Stephan Windecker presented the results of this study, which compared the safety and efficacy of the Cypher and the Taxus stents in 1012 patients; 49% chronic stable angina, 51% unstable angina, and 22% acute myocardial infarction. The primary end point of 9-month MACE was 6.2% Cypher vs 10.8% Taxus, P = .009. The secondary end point of target lesion revascularization (TLR) was 4.8% Cypher and 8.3% Taxus, P < .025, and angiographic restenosis was 3.2% Cypher and 7.6% Taxus, P = .013. The investigators concluded that angiographic and clinical end points were superior with the Cypher stent.
TAXUS 5
Dr. Gregg Stone from Colombia University in New York, NY, reported the results of this study comparing the Taxus stent to a bare metal stent (BMS) in 1156 patients with mainly single vessel lesions of 10-46mm length in arteries 2.25-4mm wide; one third had long lesions requiring overlapping stents, and 30% were diabetic. MACE at 30 days were equal in both groups, and there were no deaths. The primary end point of TLR was 8.6% Taxus vs 15.7% BMS. Stent thrombosis occurred in 4 patients in each group, but in-stent restenosis was reduced from 32% to 16% by the drug eluting stent. Thirty-day MACE was not different, but at 9 months, MACE was lower with the Taxus stent. However, in the subgroup of 379 patients with multivessel disease, 326 of whom had overlapping stents, 30-day MACE was 8.3% with Taxus and only 3.3% with BMS, P < .05. The difference was driven by double the rate of nonST elevation myocardial infarctions due to side vessel occlusions with Taxus vs BMS. The investigators concluded that in these complex patients, the Taxus stent is safe and effective, but the restenosis rate is higher than expected. Also, in small vessels with overlapping stents, there are more adverse events.
ARTS 2
Earlier trials compared plain old balloon angioplasty (POBA) to coronary artery bypass surgery (CABG), and showed that surgery was somewhat better, especially in diabetics. ARTS 1 compared CABG to BMS, and showed equivalent results. ARTS 2 compares CABG to the Taxus stent. The primary end point of 6-month MACE plus stroke (MACCE) was 93.6% with Taxus, 91% with ARTS 1 CABG, and 84.7% with ARTS 1 POBA, P < .05. Dr. Patrick Serruys concluded that despite the fact that ARTS 2 patients were older, had more cardiovascular comorbidity, and had more 3 vessel disease with longer more complex lesions, that the Taxus stent was not inferior to CABG. Dr. Valentin Fuster, who discussed the trial, commented that this was not a randomized trial, and one third of ARTS 2 patients got platelet glycoprotein IIb/IIIa agents, whereas, none got them in ARTS 1.
SCANDSTENT
Dr. Henning Kelbaek presented the results of this comparison of Cypher vs BMS in complex coronary artery lesions. The primary end point of angiographic restenosis at 6 months was 2% for Cypher vs 32% for BMS. Target lesion revascularization was only 4% Cypher vs 47% BMS, P < .0001. In-stent thrombosis was 0.6 Cypher vs 3.1% BMS. MACE at 12 months was not significantly different, but event-free survival was 96% for Cypher and 72% for BMS. The investigators concluded that compared to BMS, Cypher reduced restenosis and clinical events without increasing the risk of in-stent thrombosis in complex coronary lesions.
ENDEAVOR 2
Dr. William Wijns presented this European trial of a new limus molecule ABT578 coated stent (ABT) vs a Driver BMS in 1200 patients with mainly complex lesions. The primary end point of MACE at 9 months was 7.4% ABT vs 14.7% BMS. Six-month angiographic measures were all better with ABT. The investigators concluded that the antiproliferative effect of this new compound is proven, since the primary end point was reduced 47%, compared to BMS.
Seven trials comparing drug eluting stents to each other or bare metal stents were presented. In general, they showed that drug eluting stents were superior to bare metal stents, but among the drug eluting stents, the data favored sirolimus eluting stents.
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