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

作者：von Birgelen Clemens^*; Basalus Mounir W Z; Tandjung Kenneth; van Houwelingen K Gert; Stoel Martin G; Louwerenburg J W; Linssen Gerard C M; Said Salah A M; Kleijne Miep A W J; Sen Hanim; Lowik Marije M; van der Palen Job; Verhorst Patrick M J; de Man Frits H A F

来源：Journal of the American College of Cardiology, 2012, 59(15): 1350-1361.

DOI：10.1016/j.jacc.2012.01.008

• coronary artery disease
• drug-eluting stent
• percutaneous coronary intervention
• randomized controlled trial

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. %26lt;br%26gt;Background Only 1 randomized trial previously compared these stents. %26lt;br%26gt;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. %26lt;br%26gt;Results Acute coronary syndromes were present in 52% and %26quot;off-label%26quot; 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: -2.8% 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. %26lt;br%26gt;Conclusions Resolute ZES were noninferior to Xience V EES in treating %26quot;real-world%26quot; patients with a vast majority of complex lesions and %26quot;off-label%26quot; 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

• 出版日期2012-4-10