TCT-47 Two-Year Clinical Outcome of the TWENTE Trial, a Randomized Controlled Trial Comparing Second-Generation Zotarolimus-Eluting Resolute Stents Versus Everolimus-Eluting Xience V Stents in Real-World Patients

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

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background: In the prospective, randomized TWENTE trial, the zotarolimus-eluting Resolute stent was at 1 year follow-up non-inferior to the everolimus-eluting Xience V stent for the primary endpoint target vessel failure. This composite endpoint consisted of cardiac death, clinically indicated target vessel revascularization, or target vessel-related myocardial infarction (MI). So far, few long-term data of prospective head-to-head comparisons between both DES have been reported.

Methods: Patients requiring percutaneous coronary interventions (PCI) with DES implantation at Thoraxcentrum Twente in Enschede were randomization between Resolute (Medtronic Vascular, Santa Rosa, CA, USA) and Xience V (Abbott Vascular, Santa Clara, CA, USA) in a 1:1 fashion. Inclusion of all coronary or bypass graft lesions and all clinical settings was permitted except for primary PCI (i.e. acute ST-elevation myocardial infarction (STEMI) was an exclusion criterion). Both external monitoring and clinical event adjudication were performed by an independent external contract research organization (Cardialysis, Rotterdam, the Netherlands). Two year clinical follow-up was performed as indicated in the study protocol.

Results: A total of 1,391 patients were enrolled in the TWENTE trial between June 2008 and August 2010. The study population comprised 21.6% diabetics with a vast majority of complex lesions and “off-label” indications for drug-eluting stents (77.4%). Patients presented with either stable angina (48.5%) or unstable angina/Non-STEMI (51.5%). Demographics, baseline angiographic and procedural data, and 2-year clinical follow-up data will be presented. This includes the primary endpoint of the study: Target vessel failure (TVF) at 2 year follow-up. Secondary endpoints include the individual components of the primary endpoint and the incidence of very late stent thrombosis. In addition, results of subgroup analyses will be reported.

Conclusions: Results of pre-specified analyses of 2-year clinical outcome of the TWENTE trial will be presented at TCT 2012.
Original languageEnglish
Pages (from-to)B15-B15
JournalJournal of the American College of Cardiology
Volume60
Issue number17, Suppl.
DOIs
Publication statusPublished - 23 Oct 2012
Event24th Annual Scientific Symposium of Transcatheter Cardiovascular Therapeutics, TCT 2012 - Miami Beach Convention Center, Miami, United States
Duration: 22 Oct 201226 Oct 2012
Conference number: 24

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