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

2012; Elsevier BV; Volume: 61; Issue: 5 Linguagem: Inglês

10.1016/j.jacc.2012.11.015

1558-3597

Kyung Woo Park, Joo Myung Lee, Si‐Hyuck Kang, Hyo–Suk Ahn, Han‐Mo Yang, Hae‐Young Lee, Hyun‐Jae Kang, Bon‐Kwon Koo, Janghyun Cho, Hyeon‐Cheol Gwon, Sung Yoon Lee, In‐Ho Chae, Tae‐Jin Youn, Jei Keon Chae, Kyoo-Rok Han, Cheol Woong Yu, Hyo-Soo Kim,

Cardiac Valve Diseases and Treatments

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. Only 2 randomized controlled trials have compared these stents. 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. 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). 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.