ISAR-LEFT-MAIN-2 Results Published

August 21, 2013—Principal Investigator Julinda Mehilli, MD, of the Intracoronary Stenting and Antithrombosis Research (ISAR) Center at the German Heart Center Munich, et al published 1-year results from the ISAR-LEFT-MAIN-2 study online ahead of print in the Journal of the American College of Cardiology (JACC).

ISAR-LEFT-MAIN-2 was designed to compare the safety and efficacy of the two second-generation zotarolimus-eluting and everolimus-eluting stents (ZES and EES) for treatment of unprotected coronary left main (uLMCA) disease.

Prof. Mehilli first presented the data on October 24, 2012, at the Cardiovascular Research Foundation's TCT 2012: Transcatheter Cardiovascular Therapeutics conference in Miami, Florida. Adnan Kastrati, MD, of the German Heart Center Munich, is Study Chair of LEFT-MAIN-2.

The LEFT-MAIN-2 investigators concluded that within the statistical limitations of the present study, the ZES and the EES for treatment of uLMCA lesions provide comparable clinical and angiographic outcomes out to 1-year follow-up.

The background of the LEFT-MAIN-2 study is that both devices have been shown to reduce the risk of restenosis in large patient cohorts; however, their comparative performance in uLMCA lesions is not known.

As summarized in JACC, in the LEFT-MAIN-2 study, patients with symptomatic coronary artery disease undergoing percutaneous coronary intervention for uLMCA lesions were randomly assigned to receive either ZES (n = 324) or 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 the LMCA area analysis at follow-up angiography.

The LEFT-MAIN-2 investigators found that 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 [RR]: 1.26; 95% confidence interval [CI], 0.85 to 1.85; P = .25). Three patients in the ZES group (0.9%) and two patients in the EES group (0.6%) experienced definite/probable stent thrombosis (P > .99). All-cause mortality at 1 year was equal in the two groups at 5.6% (RR, 1.00; 95% CI, 0.52 to 1.93; P = .98). Angiographic restenosis was 21.5% with ZES and 16.8% with EES (RR, 1.28; 95% CI, 0.86 to 1.92; P = .24), reported the investigators in JACC.