Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated With Percutaneous Coronary Intervention
Authors: Okkels Jensen Lisette , Thayssen Per , Hansen Henrik Steen , Christiansen Evald Høj , Tilsted Hans Henrik , Krusell Lars Romer , Villadsen Anton Boel , Junker Anders , Nørregaard Hansen Knud , Kaltoft Anne , Maeng Michael , Pedersen Knud Erik , Kristensen Steen Dalby , Bøtker Hans Erik , Ravkilde Jan , Sanchez Richardo , Aarøe Jens , Madsen Morten , Sørensen Henrik Toft , Thuesen Leif , Lassen Jens Flensted ,   for the Scandinavian Organization for Randomized Trials With Clinical Outcome IV (SORT OUT IV) Investigators,   Principal Investigator:, Thayssen Per ,   Principal Coinvestigator:, Jensen Lisette Okkels ,   Coordinating Center:,   The Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT),   Critical Events Committee:, Thygesen Kristian , Terkelsen Christian Juhl , Norgaard Bjarne Linde ,   Data and Monitoring Center:, Madsen Morten , Pedersen Lars , Sørensen Henrik Toft ,   Steering Committee:, Thayssen Per , Jensen Lisette Okkels , Tilsted Hans Henrik , Ravkilde Jan , Lassen Jens Flensted , Thuesen Leif 
Published: February 2012

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.

Clinical Trial Registration—

URL:
http://www.clinicaltrials.gov
. Unique identifier: NCT00552877.