Objectives: This study sought to compare the safety and efficacy of the zotarolimus-eluting stent (ZES) and the everolimus-eluting stent (EES) for treatment of unprotected left main coronary artery (uLMCA) disease.
Background: The second-generation ZES and EES have reduced the risk of restenosis in large patient cohorts. However, their comparative performance in uLMCA lesions is not known.
Methods: In this study, patients with symptomatic coronary artery disease undergoing percutaneous coronary intervention for uLMCA lesions were randomly assigned to receive either a ZES (n = 324) or an EES (n = 326). The primary endpoint was the combined incidence of death, myocardial infarction, and target lesion revascularization at 1 year. Secondary endpoints were definite or probable stent thrombosis at 1 year and angiographic restenosis based on analysis of the left main coronary artery area at follow-up angiography.
Results: At 1 year, the cumulative incidence of the primary endpoint was 17.5% in the ZES group and 14.3% in the EES group (relative risk: 1.26; 95% confidence interval [CI]: 0.85 to 1.85; p = 0.25). Three patients in the ZES group (0.9%) and 2 patients in the EES group (0.6%) experienced definite or probable stent thrombosis (p > 0.99). All-cause mortality at 1 year was equal in the 2 groups (5.6%; relative risk: 1.00; 95% CI: 0.52 to 1.93; p = 0.98). Angiographic restenosis occurred in 21.5% of patients in the ZES group and 16.8% in the EES group (relative risk: 1.28; 95% CI: 0.86 to 1.92; p = 0.24).
Conclusions: Within the statistical limitations of the present study, treatment of uLMCA lesions with a ZES or an EES provided comparable clinical and angiographic outcomes at 1-year follow-up.
Trial registration: ClinicalTrials.gov NCT00598637.
Keywords: CABG; CI; DES; EES; LMCA; MI; PCI; RR; TLR; ZES; aortocoronary artery bypass graft; confidence interval; coronary artery disease; drug-eluting stent(s); everolimus; everolimus-eluting stent(s); left main coronary artery; myocardial infarction; percutaneous coronary intervention; relative risk; restenosis; target lesion revascularization; uLMCA; unprotected left main coronary artery; zotarolimus; zotarolimus-eluting stent(s).
Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.