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 VersusBiolimus-Eluting Biomatrix NeoFlex Stent-SORT-OUT VIII; NCT02093845).
RCT Entities:
OBJECTIVES: The aim of this study was to compare the thin-strut biodegradable-polymereverolimus-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).
Authors: Lars Jakobsen; Evald H Christiansen; Phillip Freeman; Johnny Kahlert; Karsten Veien; Michael Maeng; Bent Raungaard; Julia Ellert; Steen D Kristensen; Martin K Christensen; Christian J Terkelsen; Troels Thim; Ashkan Eftekhari; Rebekka V Jensen; Nicolaj B Støttrup; Anders Junker; Henrik S Hansen; Lisette O Jensen Journal: Catheter Cardiovasc Interv Date: 2022-04-06 Impact factor: 2.585
Authors: Ian B A Menown; Mamas A Mamas; James M Cotton; David Hildick-Smith; Franz R Eberli; Gregor Leibundgut; Damras Tresukosol; Carlos Macaya; Samuel Copt; Sara Sadozai Slama; Hans-Peter Stoll Journal: Int J Cardiol Heart Vasc Date: 2020-01-27