• J. Am. Coll. Cardiol. · Jun 2013

    Randomized Controlled Trial

    Clinical outcome following stringent discontinuation of dual antiplatelet therapy after 12 months in real-world patients treated with second-generation zotarolimus-eluting resolute and everolimus-eluting Xience V stents: 2-year follow-up of the randomized TWENTE trial.

    • Kenneth Tandjung, Hanim Sen, Ming Kai Lam, Basalus Mounir W Z MWZ Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands., Louwerenburg J Hans W JHW Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands., Martin G Stoel, K Gert van Houwelingen, de Man Frits H A F FHAF Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands., Linssen Gerard C M GCM Department of Cardiology, Ziekenhuisgroep Twente, Almelo, the Netherlands., Saïd Salah A M SAM Department of Cardiology, Ziekenhuisgroep Twente, Hengelo, the Netherlands., Mark B Nienhuis, Marije M Löwik, Verhorst Patrick M J PMJ Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands., Job van der Palen, and Clemens von Birgelen.
    • Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
    • J. Am. Coll. Cardiol. 2013 Jun 18; 61 (24): 2406-2416.

    ObjectivesThe aim of this study was to assess the safety and efficacy of the implantation of Resolute zotarolimus-eluting stents (ZES) (Medtronic Inc., Santa Rosa, California) and Xience V everolimus-eluting stents (EES) (Abbott Vascular, Santa Clara, California) following strict discontinuation of dual antiplatelet therapy (DAPT) after 12 months.BackgroundOnly limited long-term follow-up data are available from head-to-head comparisons of second-generation drug-eluting stents.MethodsThe randomized TWENTE (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente) trial is an investigator-initiated study performed in a population with many complex patients and lesions and only limited exclusion criteria. Patients were randomly assigned 1:1 to ZES (n = 697) or EES (n = 694).ResultsTwo-year follow-up information was available on all patients. The rate of continuation of DAPT beyond 12 months was very low (5.4%). The primary endpoint of target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization, did not differ between ZES and EES (10.8% vs. 11.6, p = 0.65), despite fewer target lesion revascularizations in patients with EES (2.6% vs. 4.9%, p = 0.03). The patient-oriented composite endpoint was similar (16.4% vs. 17.1%, p = 0.75). Two-year rates of definite or probable stent thrombosis were 1.2% and 1.4%, respectively (p = 0.63). Very late definite or probable stent thrombosis occurred only in 2 patients in each study arm (0.3% vs. 0.3%, p = 1.00).ConclusionsAfter 2 years of follow-up and stringent discontinuation of DAPT beyond 12 months, Resolute ZES and Xience V EES showed similar results in terms of safety and efficacy for treating patients with a majority of complex lesions and off-label indications for drug-eluting stents. (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente [TWENTE]; NCT01066650).Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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