Three-year outcomes after revascularization with everolimus- and sirolimus-eluting stents from the SORT OUT IV trial
Lisette Okkels Jensen, Per Thayssen, Michael Maeng, Evald Høj Christiansen, Jan Ravkilde, Knud Nørregaard Hansen, Anne Kaltoft, Hans Henrik Tilsted, Morten Madsen, Jens Flensted Lassen, Scandinavian Organization for Randomized Trials With Clinical Outcome SORT OUT IV Investigators, Lisette Okkels Jensen, Per Thayssen, Michael Maeng, Evald Høj Christiansen, Jan Ravkilde, Knud Nørregaard Hansen, Anne Kaltoft, Hans Henrik Tilsted, Morten Madsen, Jens Flensted Lassen, Scandinavian Organization for Randomized Trials With Clinical Outcome SORT OUT IV Investigators
Abstract
Objectives: The study sought to compare the risk of late outcome with a focus on very late definite stent thrombosis of the everolimus-eluting stent (EES) with that of the sirolimus-eluting stent (SES) at 3-year follow-up.
Background: In the SORT OUT IV (SORT OUT IV Trial), comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. The SORT OUT IV trial provides long-term head-to-head randomized comparison of the EES with the SES.
Methods: We prospectively randomized 2,774 patients in the SORT OUT IV trial. Follow-up through 3 years was complete in 2,771 patients (99.9%). The 3-year pre-specified endpoints were composites of safety and efficacy (major adverse cardiac events [MACE]: cardiac death, myocardial infarction, target vessel revascularization, and definite stent thrombosis).
Results: At 3 years, the composite endpoint MACE occurred in 9.8% of the EES group and in 11.1% of the SES group (hazard ratio [HR]: 0.89, 95% confidence interval [CI]: 0.70 to 1.12). Overall rate of definite stent thrombosis was lower in the EES group (0.2% vs. 1.4%; HR: 0.15, 95% CI: 0.04 to 0.50), which was largely attributable to a lower risk of very late definite stent thrombosis: 0.1% versus 0.8% (HR: 0.09, 95% CI: 0.01 to 0.70).
Conclusions: At 3-year follow-up, the MACE rate did not differ significantly between EES- and SES-treated patients. A significant reduction of overall and very late definite stent thrombosis was found in the EES group. (The SORT OUT IV TRIAL [SORT OUT IV]; NCT00552877).
Keywords: drug-eluting stent; percutaneous coronary intervention; very late definite stent thrombosis.
Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed