Zotarolimus- versus everolimus-eluting stents for unprotected left main coronary artery disease.

Abstract

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.

• Authors: Julinda Mehilli, Gert Richardt, Marco Valgimigli, Stefanie Schulz, Ambika Singh, Mohamed Abdel-Wahab, Klaus Tiroch, Jürgen Pache, Jörg Hausleiter, Robert A Byrne, Ilka Ott, Tareq Ibrahim, Massimiliano Fusaro, Melchior Seyfarth, Karl-Ludwig Laugwitz, Steffen Massberg, Adnan Kastrati, ISAR-LEFT-MAIN 2 Study Investigators
• Journal: Journal of the American College of Cardiology (J Am Coll Cardiol) Vol. 62 Issue 22 Pg. 2075-82 (Dec 03 2013) ISSN: 1558-3597 [Electronic] United States
• PMID: 23973699 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Immunosuppressive Agents
• Everolimus
• zotarolimus
• Sirolimus

Topics

• Aged
• Aged, 80 and over
• Coronary Angiography
• Coronary Artery Disease (drug therapy, mortality)
• Coronary Restenosis (diagnostic imaging)
• Drug-Eluting Stents
• Everolimus
• Humans
• Immunosuppressive Agents (administration & dosage, therapeutic use)
• Middle Aged
• Myocardial Infarction (epidemiology)
• Sirolimus (administration & dosage, analogs & derivatives, therapeutic use)