1. Three-year outcomes after revascularization with everolimus- and sirolimus-eluting stents from the SORT OUT IV trial.
- Author
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Jensen LO, Thayssen P, Maeng M, Christiansen EH, Ravkilde J, Hansen KN, Kaltoft A, Tilsted HH, Madsen M, and Lassen JF
- Subjects
- Aged, Coronary Artery Disease diagnosis, Coronary Artery Disease mortality, Coronary Thrombosis etiology, Coronary Thrombosis mortality, Coronary Thrombosis prevention & control, Female, Humans, Male, Middle Aged, Myocardial Infarction etiology, Myocardial Infarction mortality, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Proportional Hazards Models, Prospective Studies, Prosthesis Design, Registries, Risk Factors, Scandinavian and Nordic Countries, Single-Blind Method, Time Factors, Treatment Outcome, Cardiovascular Agents administration & dosage, Coronary Artery Disease therapy, Drug-Eluting Stents, Everolimus administration & dosage, Percutaneous Coronary Intervention instrumentation
- 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)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2014
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