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 Rando

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• 作者：Kenneth Tandjung ; MD^&lowast ; ; Hanim Sen ; MD^&lowast ; ; Ming Kai Lam ; MD^&lowast ; ; Mounir W.Z. Basalus ; MD^&lowast ; ; J. (Hans) W. Louwerenburg ; MD^&lowast ; ; Martin G. Stoel ; MD^&lowast ; ; K. Gert van Houwelingen ; MD^&lowast ; ; Frits H.A.F. de Man ; MD ; PhD^&lowast ; ; Gerard C.M. Linssen ; MD ; PhD^&dagger ; ; Salah A.M. Saï ; d ; MD ; PhD^&Dagger ; ; Mark B. Nienhuis ; MD ; PhD^§ ; ; Marije M. Lö ; wik ; PhD^&lowast ; ; Patrick M.J. Verhorst ; MD ; PhD^&lowast ; ; Job van der Palen ; PhD^? ; ^¶ ; ; Clemens von Birgelen ; MD ; PhD^&lowast ; ; ^# ; ^{c.vonbirgelen@mst.nl}
• 关键词：drug-eluting stent(s) ; everolimus-eluting stent(s) ; percutaneous coronary intervention ; revascularization ; zotarolimus-eluting stent(s)
• 刊名：Journal of the American College of Cardiology
• 出版年：2013
• 出版时间：18 June, 2013
• 年：2013
• 卷：61
• 期：24
• 页码：2406-2416
• 全文大小：1268 K

文摘

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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 [TWENTE]; )