TY - JOUR
T1 - Safety and efficacy of second-generation everolimus-eluting Xience v Stents versus zotarolimus-eluting resolute stents in real-world practice
T2 - Patient-related and stent-related outcomes from the multicenter prospective EXCELLENT and RESOLUTE-Korea registries
AU - Park, Kyung Woo
AU - Lee, Joo Myung
AU - Kang, Si Hyuck
AU - Ahn, Hyo Suk
AU - Yang, Han Mo
AU - Lee, Hae Young
AU - Kang, Hyun Jae
AU - Koo, Bon Kwon
AU - Cho, Janghyun
AU - Gwon, Hyeon Cheol
AU - Lee, Sung Yoon
AU - Chae, In Ho
AU - Youn, Tae Jin
AU - Chae, Jei Keon
AU - Han, Kyoo Rok
AU - Yu, Cheol Woong
AU - Kim, Hyo Soo
N1 - Funding Information:
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. Dr. Kyung Woo Park and Dr. Joo Myung Lee contributed equally to this study.
PY - 2013/2/5
Y1 - 2013/2/5
N2 - 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.
AB - 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.
KW - Resolute zotarolimus-eluting stent
KW - clinical outcome
KW - everolimus-eluting stent
KW - patient-oriented composite outcome
KW - stent thrombosis
KW - target lesion failure
UR - http://www.scopus.com/inward/record.url?scp=84873100211&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2012.11.015
DO - 10.1016/j.jacc.2012.11.015
M3 - Article
C2 - 23273394
AN - SCOPUS:84873100211
SN - 0735-1097
VL - 61
SP - 536
EP - 544
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 5
ER -