1. Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated With Percutaneous Coronary Intervention: The Scandinavian Organization for Randomized Trials With Clinical Outcome IV (SORT OUT IV).
- Author
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Jensen, Lisette Okkels, Thayssen, Per, Hansen, Henrik Steen, Christiansen, Evald Høj, Tilsted, Hans Henrik, Krusell, Lars Romer, Villadsen, Anton Boel, Junker, Anders, Hansen, Knud Nørregaard, Kaltoft, Anne, Maeng, Michael, Pedersen, Knud Erik, Kristensen, Steen Dalby, B&slash;otker, Hans Erik, Ravkilde, Jan, Sanchez, Richardo, Aar&oalash;e, Jens, Madsen, Morten, Sørensen, Henrik Toft, and Thuesen, Leif
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RAPAMYCIN , *RANDOMIZED controlled trials , *SURGICAL stents , *HEALTH outcome assessment , *DRUG-eluting stents , *CONFIDENCE intervals - Abstract
Background--Among drug-eluting stents released to date, the sirolimus-eluting stent has demonstrated the least amount of late lumen loss, but its efficacy and safety have not been compared head-to-head with the next-generation everolimus-eluting stent. Methods and Results--The Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV) trial was a randomized multicenter, single-blind, all-comer, 2-arm, noninferiority trial comparing the everolimus-eluting stent with the sirolimus-eluting stent in patients with coronary artery disease. The primary end point was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization) parameters. The noninferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9- and 18-month follow-ups. A total of 1390 patients were assigned to receive the everolimus-eluting stent and 1384 patients to the sirolimus-eluting stent. At the 9-month follow-up, 68 patients (4.9%) treated with the everolimus-eluting stent compared with 72 patients (5.2%) treated with the sirolimus-eluting stent experienced the primary end point (hazard ratio, 0.94; 95% confidence interval, 0.67-1.31; P for noninferiority=0.01). At the 18-month follow-up, this differential remained: 99 patients (7.2%) treated with the everolimus-eluting stent versus 105 (7.6%) treated with the sirolimus-eluting stent (hazard ratio, 0.94; 95% confidence interval, 0.71-1.23). At the 9-month follow-up, the rate of definite stent thrombosis was higher in the sirolimus-eluting group (2 patients [0.1%] versus 9 patients [0.7%]; hazard ratio, 0.22; 95% confidence interval, 0.05-1.02). At the 18-month follow-up, this difference was sustained (3 patients [0.2%] versus 12 patients [0.9%]; hazard ratio, 0.25; 95% confidence interval, 0.07-0.88). Conclusion--The everolimus-eluting stent was found to be noninferior to the sirolimus-eluting stent. [ABSTRACT FROM AUTHOR]
- Published
- 2012
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