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)
Bibliographical noteFunding Information:
This study was supported by a grant from the Clinical Research Center for Ischemic Heart Disease , Seoul, Republic of Korea ( 0412-CR02-0704-0001 ), and 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. The authors also received unrestricted grants from Abbott Vascular Korea and Boston Scientific Korea . The funding source of the study had no role in study design, data collection, monitoring, analysis, interpretation, or writing of the manuscript. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
All Science Journal Classification (ASJC) codes
- Cardiology and Cardiovascular Medicine