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

• Published in: Journal of the American College of Cardiology Vol. 59; no. 15; pp. 1350 - 1361
• Main Authors: von Birgelen, Clemens, MD, PhD, Basalus, Mounir W.Z., MD, Tandjung, Kenneth, MD, van Houwelingen, K. Gert, MD, Stoel, Martin G., MD, Louwerenburg, J.(Hans) W., MD, Linssen, Gerard C.M., MD, PhD, Saïd, Salah A.M., MD, PhD, Kleijne, Miep A.W.J., MD, Sen, Hanim, MD, Löwik, Marije M., PhD, van der Palen, Job, PhD, Verhorst, Patrick M.J., MD, PhD, de Man, Frits H.A.F., MD, PhD
• Format: Journal Article
• Language: English
• Published: New York Elsevier Inc 10-04-2012; Elsevier Limited
• Subjects: Acids; Acute coronary syndromes; Cardiology; Cardiovascular; Cardiovascular disease; Confidence intervals; coronary artery disease; drug-eluting stent; Heart attacks; Internal Medicine; Mortality; percutaneous coronary intervention; randomized controlled trial; Stents; Studies; Success; Thrombosis; United States > US; California; coronary artery disease; everolimus-eluting stent(s); target vessel failure; drug-eluting stent; target lesion revascularization; zotarolimus-eluting stent; TVF; CI; myocardial infarction; ZES; randomized controlled trial; drug-eluting stent(s); TVR; percutaneous coronary intervention; EES; DES; PCI; STEMI; target vessel revascularization; confidence interval; ST-segment elevation myocardial infarction; TLR; MI
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2012.01.008

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: −2.8% to 3.0%, pnoninferiority = 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; NCT01066650 )