Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention
In: JACC: Cardiovascular Interventions, Jg. 12 (2019-04-01), S. 624-633
Online
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Zugriff:
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 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)
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Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention
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Autor/in / Beteiligte Person: | Maeng, Michael ; Evald Høj Christiansen ; Raungaard, Bent ; Kahlert, Johnny ; Christian Juhl Terkelsen ; Steen Dalby Kristensen ; Carstensen, Steen ; Aarøe, Jens ; Svend Eggert Jensen ; Anton Boel Villadsen ; Jens Flensted Lassen ; Thim, Troels ; Eftekhari, Ashkan ; Karsten Tange Veien ; Knud Nørregaard Hansen ; Junker, Anders ; Hans Erik Bøtker ; Lisette Okkels Jensen ; Henrik Steen Hansen ; Bargsteen, Helle ; Pedersen, Helle ; Jørgensen, Lars P. ; Ottosen, Pia ; Pedersen, Karin M. ; Thygesen, Kristian ; Jacob Thorsted Sørensen ; Henning Rud Andersen |
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Zeitschrift: | JACC: Cardiovascular Interventions, Jg. 12 (2019-04-01), S. 624-633 |
Veröffentlichung: | Elsevier BV, 2019 |
Medientyp: | unknown |
ISSN: | 1936-8798 (print) |
DOI: | 10.1016/j.jcin.2018.12.036 |
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