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Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: the EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) randomized trial

Authors
 Kyung Woo Park  ;  In-Ho Chae  ;  Do-Sun Lim  ;  Kyoo-Rok Han  ;  Han-Mo Yang  ;  Hae-Young Lee  ;  Hyun-Jae Kang  ;  Bon-Kwon Koo  ;  Taehoon Ahn  ;  Jung-Han Yoon  ;  Myung-Ho Jeong  ;  Taek-Jong Hong  ;  Woo-Young Chung  ;  Sang-Ho Jo  ;  Young-Jin Choi  ;  Seung-Ho Hur  ;  Hyuck-Moon Kwon  ;  Dong-Woon Jeon  ;  Byung-Ok Kim  ;  Si-Hoon Park  ;  Nam-Ho Lee  ;  Hui-Kyung Jeon  ;  Hyeon-Cheol Gwon  ;  Yang-Soo Jang  ;  Hyo-Soo Kim 
Citation
 JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, Vol.58(18) : 1844-1854, 2011 
Journal Title
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
ISSN
 0735-1097 
Issue Date
2011
MeSH
Aged ; Angioplasty, Balloon, Coronary* ; Coronary Angiography ; Coronary Disease/therapy ; Coronary Restenosis/epidemiology ; Drug-Eluting Stents* ; Everolimus ; Humans ; Immunosuppressive Agents/administration & dosage* ; Male ; Middle Aged ; Prospective Studies ; Prosthesis Failure ; Sirolimus/administration & dosage* ; Sirolimus/analogs & derivatives*
Keywords
everolimus ; percutaneous coronary intervention ; sirolimus ; stents
Abstract
OBJECTIVES: The goal of this study was to compare the angiographic outcomes of everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in a head-to-head manner.

BACKGROUND: EES have been shown to be superior to paclitaxel-eluting stents in inhibiting late loss (LL) and clinical outcome. Whether EES may provide similar angiographic and clinical outcomes compared with SES is undetermined.

METHODS: This was a prospective, randomized, open-label, multicenter trial to demonstrate the noninferiority of EES compared with SES in preventing LL at 9 months. A total of 1,443 patients undergoing percutaneous coronary intervention were randomized 3:1 to receive EES or SES. Routine follow-up angiography was recommended at 9 months. The primary endpoint was in-segment LL at 9 months, and major secondary endpoints included in-stent LL at 9 months, target lesion failure, cardiac death, nonfatal myocardial infarction, target lesion revascularization, and stent thrombosis at 12 months. Data were managed by an independent management center, and clinical events were adjudicated by an independent adjudication committee.

RESULTS: Clinical follow-up was available in 1,428 patients and angiographic follow-up in 924 patients (1,215 lesions). The primary endpoint of the study (in-segment LL at 9 months) was 0.11 ± 0.38 mm and 0.06 ± 0.36 mm for EES and SES, respectively (p for noninferiority = 0.0382). The in-stent LL was also noninferior (EES 0.19 ± 0.35 mm; SES 0.15 ± 0.34 mm; p for noninferiority = 0.0121). The incidence of clinical endpoints was not statistically different between the 2 groups, including target lesion failure (3.75% vs. 3.05%; p = 0.53) and stent thrombosis (0.37% vs. 0.83%; p = 0.38).

CONCLUSIONS: EES were noninferior to SES in inhibition of LL after stenting, which was corroborated by similar rates of clinical outcomes. (Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting [EXCELLENT]; NCT00698607).
Full Text
http://www.sciencedirect.com/science/article/pii/S0735109711028993
DOI
10.1016/j.jacc.2011.07.031
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kwon, Hyuck Moon(권혁문) ORCID logo https://orcid.org/0000-0001-9901-5015
Jang, Yang Soo(장양수) ORCID logo https://orcid.org/0000-0002-2169-3112
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/94645
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