Safety and efficacy of second-generation everolimus-eluting Xience v Stents versus zotarolimus-eluting resolute stents in real-world practice: Patient-related and stent-related outcomes from the multicenter prospective EXCELLENT and RESOLUTE-Korea registries

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

Research output: Contribution to journalArticlepeer-review

34 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)536-544
Number of pages9
JournalJournal of the American College of Cardiology
Volume61
Issue number5
DOIs
Publication statusPublished - 2013 Feb 5

Keywords

  • Resolute zotarolimus-eluting stent
  • clinical outcome
  • everolimus-eluting stent
  • patient-oriented composite outcome
  • stent thrombosis
  • target lesion failure

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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