2013年4月23日星期二

Clinical Outcome Following Stringent Discontinuation of Dual Anti-Platelet Therapy After 12 Months in Real-World Patients Treated With Second-Generation Zotarolimus-Eluting Resolute and Everolimus-Eluting Xience V Stents: Two-Year Follow-up of the Randomized TWENTE Trial.

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Clinical Outcome Following Stringent Discontinuation of Dual Anti-Platelet Therapy After 12 Months in Real-World Patients Treated With Second-Generation Zotarolimus-Eluting Resolute and Everolimus-Eluting Xience V Stents: Two-Year Follow-up of the Randomized TWENTE Trial.

J Am Coll Cardiol. 2013 Apr 16;

Authors: Tandjung K, Sen H, Kai Lam M, Basalus MW, Louwerenburg JH, Stoel MG, van Houwelingen KG, de Man FH, Linssen GC, Sa�d SA, Nienhuis MB, L�wik MM, Verhorst PM, van der Palen J, von Birgelen C

Abstract
OBJECTIVES: The aim of this study was to assess safety and efficacy of the implantation of Resolute zotarolimus-eluting stents (ZES) and Xience V everolimus-eluting stents (EES) following strict discontinuation of dual anti-platelet 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 (DES). METHODS: The randomized TWENTE (the real-world endeavor Resolute versus Xience V drug-eluting stent study in Twente) is an investigator-initiated study performed in a population with many complex patients and lesions, and only limited exclusion criteria. Patients were 1:1 randomly assigned to ZES (n=697) or EES (n=694). RESULTS: Two-year follow-up information on all patients were available. The rate of DAPT continuation beyond 12 months was very low (5.4%). The primary endpoint target-vessel failure (TVF), 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 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 definite-or-probable stent thrombosis rates were 1.2% and 1.4% (p=0.63), respectively. Very late definite-or-probable stent thrombosis occurred only in 2 patients of each study arm (0.3% vs. 0.3%, p=1.00). CONCLUSION: 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 DES. http://www.clinicaltrials.gov. Unique identifier: NCT01066650.

PMID: 23602769 [PubMed - as supplied by publisher]

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