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February 9, 2010
Everolimus Versus Paclitaxel DES Studied in COMPARE
January 16, 2010—Elvin Kedhi, MD, et al have published findings from the COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) trial in The Lancet (2010;375:201–209). The investigators found that the everolimus-eluting stent is better than the second-generation paclitaxel-eluting stent in unselected patients in terms of safety and efficacy. On the basis of these results, the investigators suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice.
The background of the study is that everolimus-eluting and paclitaxel-eluting stents, compared with bare-metal stents, reduced the risk of restenosis in clinical trials with strict inclusion and exclusion criteria. The investigators compared the safety and efficacy of the second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice.
As detailed in The Lancet, the investigators randomly assigned 1,800 consecutive patients (aged 18–85 years) undergoing percutaneous coronary intervention at one center for treatment with everolimus-eluting or paclitaxeleluting stents. The primary endpoint was a composite of safety and efficacy (all-cause mortality, myocardial infarction, and target vessel revascularization) within 12 months. Patients were not told which stent they had received. Analysis was done by intention to treat.
The investigators reported that follow-up was completed in 1,797 patients. The primary endpoint occurred in 56 (6%) of 897 patients in the everolimus-eluting stent group versus 82 (9%) of 903 in the paclitaxel-eluting stent group (relative risk [RR], 0.69; 95% confidence interval [CI], 0.5–0.95; P value for superiority = .02). The difference was attributable to a lower rate of stent thrombosis (6 [<1%] vs 23 [3%]; RR, 0.26; 95% CI, 0.11– 0.64; P = .002), myocardial infarction (25 [3%] vs 48 [5%]; RR, 0.52; 95% CI, 0.33–0.84]; P = .007), and target vessel revascularization (21 [2%] vs 54 [6%]; RR, 0.39; 95% CI, 0.24–0.64]; P = .0001). Cardiac death, nonfatal myocardial infarction, or target lesion revascularization occurred in 44 (5%) patients in the everolimus-eluting stent group versus 74 (8%) patients in the paclitaxel-eluting stent group (P value for superiority = .005), the investigators found.
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