Safety and Efficacy of Second-Generation Everolimus-Eluting Xience V Stents Versus Zotarolimus-Eluting Resolute Stents in Real-World Practice

• Published in: Journal of the American College of Cardiology Vol. 61; no. 5; pp. 536 - 544
• Main Authors: Park, Kyung Woo, MD, PhD, Lee, Joo Myung, MD, Kang, Si-Hyuck, MD, Ahn, Hyo-Suk, MD, Yang, Han-Mo, MD, PhD, Lee, Hae-Young, MD, PhD, Kang, Hyun-Jae, MD, PhD, Koo, Bon-Kwon, MD, PhD, Cho, Janghyun, MD, PhD, Gwon, Hyeon-Cheol, MD, PhD, Lee, Sung Yoon, MD, PhD, Chae, In-Ho, MD, PhD, Youn, Tae-Jin, MD, PhD, Chae, Jei Keon, MD, PhD, Han, Kyoo-Rok, MD, PhD, Yu, Cheol Woong, MD, PhD, Kim, Hyo-Soo, MD, PhD
• Format: Journal Article
• Language: English
• Published: New York Elsevier Inc 05-02-2013; Elsevier Limited
• Subjects: Cardiology; Cardiovascular; clinical outcome; Clinical outcomes; Drug therapy; everolimus-eluting stent; Heart attacks; Internal Medicine; patient-oriented composite outcome; Resolute zotarolimus-eluting stent; stent thrombosis; Stents; target lesion failure; United States > US; California; everolimus-eluting stent(s); RCT; everolimus-eluting stent; myocardial infarction; patient-oriented composite outcome; POCO; drug-eluting stent(s); TLF; percutaneous coronary intervention; stent thrombosis; ZES-R; Resolute zotarolimus-eluting stent; TLR; MI; ST; target lesion revascularization; CI; cobalt-chromium everolimus-eluting stent(s); randomized controlled trial; CoCr-EES; EES; DES; clinical outcome; Resolute zotarolimus-eluting stent(s); PCI; confidence interval; target lesion failure
• DOI: 10.1016/j.jacc.2012.11.015
• EISSN: 1558-3597
• ISSN: 0735-1097

Objectives This study sought to compare the safety and efficacy of the Xience V/Promus everolimus-eluting stent (EES) (Abbott Vascular, Temecula, California) with the Endeavor Resolute zotarolimus-eluting stent (ZES-R) (Medtronic Cardiovascular, Santa Rosa, California) in “all-comer” cohorts. Background Only 2 randomized controlled trials have compared these stents. Methods The EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with the EES and 1,998 patients treated with the ZES-R, respectively, without exclusions. Stent-related composite outcomes (target lesion failure [TLF]) and patient-related composite outcomes were compared in crude and propensity score-matched analyses. Results Of 5,054 patients, 3,830 (75.8%) had off-label indication (2,217 treated with EES and 1,613 treated with ZES-R). The stent-related outcome (82 [2.7%] vs. 58 [2.9%], p = 0.662) and the patient-related outcome (225 [7.4%] vs. 153 [7.7%], p = 0.702) did not differ between EES and ZES-R, respectively, at 1 year, which was corroborated by similar results from the propensity score-matched cohort. The rate of definite or probable stent thrombosis (18 [0.6%] vs. 7 [0.4%], p = 0.306) also was similar. In multivariate analysis, off-label indication was the strongest predictor of TLF (adjusted hazard ratio: 2.882; 95% confidence interval: 1.226 to 6.779; p = 0.015). Conclusions In this robust real-world registry with unrestricted use of EES and ZES-R, both stents showed comparable safety and efficacy at 1-year follow-up. Overall incidences of TLF and definite stent thrombosis were low, even in the patients with off-label indication, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents.