2-year patient-related versus stent-related outcomes: the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) Trial
Lisette Okkels Jensen, Per Thayssen, Evald Høj Christiansen, Hans Henrik Tilsted, Michael Maeng, Knud Nørregaard Hansen, Anne Kaltoft, Henrik Steen Hansen, Hans Erik Bøtker, Lars Romer Krusell, Jan Ravkilde, Morten Madsen, Leif Thuesen, Jens Flensted Lassen, SORT OUT IV Investigators, Lisette Okkels Jensen, Per Thayssen, Evald Høj Christiansen, Hans Henrik Tilsted, Michael Maeng, Knud Nørregaard Hansen, Anne Kaltoft, Henrik Steen Hansen, Hans Erik Bøtker, Lars Romer Krusell, Jan Ravkilde, Morten Madsen, Leif Thuesen, Jens Flensted Lassen, SORT OUT IV Investigators
Abstract
Objectives: There are limited head-to-head randomized data on patient-related versus stent-related outcomes for everolimus-eluting stents (EES) and sirolimus-eluting stents (SES).
Background: In the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) trial, comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months.
Methods: The primary endpoint was a composite: cardiac death, myocardial infarction (MI), definite stent thrombosis, or target vessel revascularization. Safety and efficacy outcomes at 2 years were further assessed with specific focus on patient-related composite (all death, all MI, or any revascularization) and stent-related composite outcomes (cardiac death, target vessel MI, or symptom-driven target lesion revascularization). A total of 1,390 patients were assigned to receive the EES, and 1,384 patients were assigned to receive the SES.
Results: At 2 years, the composite primary endpoint occurred in 8.3% in the EES group and in 8.7% in the SES group (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.73 to 1.22). The patient-related outcome: 15.0% in the EES group versus 15.6% in the SES group, (HR: 0.95, 95% CI: 0.78 to 1.15), and the stent-related outcome: 5.2% in the EES group versus 5.3% in the SES group (HR: 0.97, 95% CI: 0.70 to 1.35) did not differ between groups. Rate of definite stent thrombosis was lower in the EES group (0.2% vs. 0.9%, (HR: 0.23, 95% CI: 0.07 to 0.80).
Conclusions: At 2-year follow-up, the EES was found to be noninferior to the SES with regard to both patient-related and stent-related clinical outcomes.
Trial registration: ClinicalTrials.gov NCT00552877.
Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed