Zotarolimus- Versus Everolimus-Eluting Stents for Unprotected Left Main Coronary Artery Disease

doi:10.1016/j.jacc.2013.07.044

Journal of the American College of Cardiology

Volume 62, Issue 22, 3 December 2013, Pages 2075-2082

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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. (Intracoronary Stenting and Angiographic Results: Drug-Eluting Stents for Unprotected Coronary Left Main Lesions [ISAR-LEFT MAIN-2]; NCT00598637)

Key Words

coronary artery disease

drug-eluting stent(s)

everolimus

left main coronary artery

restenosis

zotarolimus

Abbreviations and Acronyms

CABG

aortocoronary artery bypass graft

confidence interval

DES

drug-eluting stent(s)

EES

everolimus-eluting stent(s)

LMCA

left main coronary artery

myocardial infarction

PCI

percutaneous coronary intervention

relative risk

TLR

target lesion revascularization

uLMCA

unprotected left main coronary artery

ZES

zotarolimus-eluting stent(s)

Cited by (0)

: ISAR-LEFT-MAIN 2 was supported in part by the German Centre for Cardiovascular Research (DZHK) and by the German Ministry of Education and Research (BMBF). Dr. Mehilli has received lecture fees from Abbott Vascular, Biotronik, Cordis, Lilly/Daiichi Sankyo, Terumo, and The Medicines Company. Dr. Valgimigli has served as a speaker and consultant for The Medicines Company, Abbott, Terumo, CID Vascular, Iroko Cardio, and AstraZeneca; and as a consultant for Medtronic, St. Jude, and Eli Lilly. Dr. Abdel-Wahab has received an institutional research grant from Medtronic. Dr. Hausleiter has received a research grant from Siemens Medical Solutions; and speaker honoraria from Abbott Vascular. Dr. Seyfarth has received lecture fees from Bristol-Myers Squibb, Lilly, and Sanofi-Aventis. Dr. Kastrati has received lecture fees from Abbott, AstraZeneca, Biosensors, Biotronik, Bristol-Myers Squibb, Cordis, GlaxoSmithKline, Lilly/Daiichi Sankyo, Medtronic, Merck Sharp & Dohme, The Medicines Company, Novartis, Sanofi-Aventis, and St. Jude Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.