Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial)
Michael Maeng, Evald Høj Christiansen, Bent Raungaard, Johnny Kahlert, Christian Juhl Terkelsen, Steen Dalby Kristensen, Steen Carstensen, Jens Aarøe, Svend Eggert Jensen, Anton Boel Villadsen, Jens Flensted Lassen, Troels Thim, Ashkan Eftekhari, Karsten Tange Veien, Knud Nørregaard Hansen, Anders Junker, Hans Erik Bøtker, Lisette Okkels Jensen, SORT OUT VIII Investigators, Michael Maeng, Hans Erik Bøtker, Evald Høj Christiansen, Bent Raungaard, Svend Eggert Jensen, Henrik Steen Hansen, Lisette Okkels Jensen, Helle Bargsteen, Helle Pedersen, Lars P Jørgensen, Pia Ottosen, Karin M Pedersen, Kristian Thygesen, Jacob Thorsted Sørensen, Henning Rud Andersen, Johnny Kahlert, Michael Maeng, Evald Høj Christiansen, Bent Raungaard, Johnny Kahlert, Christian Juhl Terkelsen, Steen Dalby Kristensen, Steen Carstensen, Jens Aarøe, Svend Eggert Jensen, Anton Boel Villadsen, Jens Flensted Lassen, Troels Thim, Ashkan Eftekhari, Karsten Tange Veien, Knud Nørregaard Hansen, Anders Junker, Hans Erik Bøtker, Lisette Okkels Jensen, SORT OUT VIII Investigators, Michael Maeng, Hans Erik Bøtker, Evald Høj Christiansen, Bent Raungaard, Svend Eggert Jensen, Henrik Steen Hansen, Lisette Okkels Jensen, Helle Bargsteen, Helle Pedersen, Lars P Jørgensen, Pia Ottosen, Karin M Pedersen, Kristian Thygesen, Jacob Thorsted Sørensen, Henning Rud Andersen, Johnny Kahlert
Abstract
Objectives: The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES).
Background: Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation.
Methods: This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%.
Results: A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001).
Conclusions: At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent-SORT-OUT VIII; NCT02093845).
Keywords: biodegradable polymer; biolimus; drug-eluting stent(s); everolimus; percutaneous coronary intervention; randomized clinical trial.
Copyright © 2019. Published by Elsevier Inc.
Source: PubMed