한빛사논문
Abstract
Patient-Related and Stent-Related Outcomes from the Multicenter Prospective EXCELLENT and RESOLUTE-Korea Registries
Kyung Woo Park, MD, PhD; Joo Myung Lee, MD; Si-Hyuck Kang, MD; Hyo-Suk Ahn, MD; Han-Mo Yang, MD, PhD; Hae-Young Lee, MD, PhD; Hyun-Jae Kang, MD, PhD; Bon-Kwon Koo, MD, PhD; Janghyun Cho, MD, PhD; Hyeon-Cheol Gwon, MD, PhD; Sung Yoon Lee, MD, PhD; In-Ho Chae, MD, PhD; Tae-Jin Youn, MD, PhD; Jei Keon Chae, MD, PhD; Kyoo-Rok Han, MD, PhD; Cheol Woong Yu, MD, PhD; Hyo-Soo Kim, MD, PhD
This study was supported by a grant from the Innovative Research Institute for Cell Therapy, Seoul National University Hospital (A062260), sponsored by the Ministry of Health, Welfare & Family, Republic of Korea. Dr. Kim received research grants, lecture fees, and honoraria from Medtronic, Abbot Vascular, and Boston Scientific. All other authors have reported they have no relationships relevant to the contents of this paper to disclose. The funding source of the study had no role in study design, data collection, monitoring, analysis, interpretation, or writing of this paper. Dr. Kim has received research grants, lecture fees, and honoraria from Medtronic, Abbott Vascular, and Boston Scientific. All other authors have reported they have no relationships relevant to the contents of this paper to disclose. Dr. Kyung Woo Park and Dr. Joo Myung Lee contributed equally to this study.
Reprint requests and correspondence: Dr. Hyo-Soo Kim, Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, 101 Daehakro, Jongro Gu, Seoul 110-744, Republic of Korea
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.
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