A Randomized Controlled Trial in Second-Generation Zotarolimus-Eluting Resolute Stents Versus Everolimus-Eluting Xience V Stents in Real-World Patients: The TWENTE Trial

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• 作者：Clemens von Birgelen ; MD ; PhD^?/sup> ; ^&dagger ; ; ^{c.vonbirgelen@mst.nl} ; Mounir W.Z. Basalus ; MD^?/sup> ; Kenneth Tandjung ; MD^?/sup> ; K. Gert van Houwelingen ; MD^?/sup> ; Martin G. Stoel ; MD^?/sup> ; J.(Hans) W. Louwerenburg ; MD^?/sup> ; Gerard C.M. Linssen ; MD ; PhD^&Dagger ; ; Salah A.M. Saï ; d ; MD ; PhD^§ ; ; Miep A.W.J. Kleijne ; MD^?/sup> ; Hanim Sen ; MD^?/sup> ; Marije M. Lö ; wik ; PhD^?/sup> ; Job van der Palen ; PhD^¶ ; ; ^# ; Patrick M.J. Verhorst ; MD ; PhD^?/sup> ; Frits H.A.F. de Man ; MD ; PhD^?/sup>
• 关键词：coronary artery disease ; drug-eluting stent ; percutaneous coronary intervention ; randomized controlled trial
• 刊名：Journal of the American College of Cardiology
• 出版年：2012
• 出版时间：10 April, 2012
• 年：2012
• 卷：59
• 期：15
• 页码：1350-1361
• 全文大小：1948 K

文摘

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Objectives

The aim of this study was to compare the safety and efficacy of Resolute zotarolimus-eluting stents (ZES) (Medtronic Cardiovascular, Santa Rosa, California) with Xience V everolimus-eluting stents (EES) (Abbott Vascular Devices, Santa Clara, California) at 1-year follow-up.

Background

Only 1 randomized trial previously compared these stents.

Methods

This investigator-initiated, patient-blinded, randomized noninferiority study had limited exclusion criteria (acute ST-segment elevation myocardial infarctions not eligible). Patients (n = 1,391; 81.4 % of eligible population) were randomly assigned to ZES (n = 697) or EES (n = 694). Liberal use of stent post-dilation was encouraged. Cardiac biomarkers were systematically assessed. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, myocardial infarction not clearly attributable to non-target vessels, and clinically indicated target-vessel revascularization. An external independent research organization performed clinical event adjudication (100 % follow-up data available). Analysis was by intention-to-treat.

Results

Acute coronary syndromes were present in 52 % and ¡°off-label?feature in 77 % of patients. Of the lesions, 70 % were type B2/C; the post-dilation rate was very high (82 % ). In ZES and EES, TVF occurred in 8.2 % and 8.1 % , respectively (absolute risk-difference 0.1 % ; 95 % confidence interval: ?.8 % to 3.0 % , p_{noninferiority} = 0.001). There was no significant between-group difference in TVF components. The definite-or-probable stent thrombosis rates were relatively low and similar for ZES and EES (0.9 % and 1.2 % , respectively, p = 0.59). Definite stent thrombosis rates were also low (0.58 % and 0 % , respectively, p = 0.12). In EES, probable stent thrombosis beyond day 8 was observed only in patients not adhering to dual antiplatelet therapy.

Conclusions

Resolute ZES were noninferior to Xience V EES in treating ¡°real-world?patients with a vast majority of complex lesions and ¡°off-label?indications for drug-eluting stents, which were implanted with liberal use of post-dilation. (The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario; )