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, Mounir W.Z. Basalus, J. (Hans) W. Louwerenburg, Martin G. Stoel, K. Gert van Houwelingen, Frits H.A.F. de Man, Gerard C.M. Linssen, Salah A.M. Saïd, Mark B. Nienhuis, Marije M. Löwik, Patrick M.J. Verhorst, Job van der Palen, Clemens von Birgelen

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Abstract

Objectives: The 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.

Background: Only limited long-term follow-up data are available from head-to-head comparisons of second-generation drug-eluting stents.

Methods: The 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).

Results: Two-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).

Conclusions: After 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
Original languageEnglish
Pages (from-to)2406-2416
JournalJournal of the American College of Cardiology
Volume61
Issue number24
DOIs
Publication statusPublished - 2013

Keywords

  • IR-86695
  • METIS-296952

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