EXECUTIVE Trial Supports Abbott Vascular's Xience V EES in Treatment of Multivessel CAD

September 18, 2013—Flavio Ribichini, MD, et al have published results from the EXECUTIVE trial, a clinical and angiographic study of the Xience V everolimus-eluting coronary stent system (Abbott Vascular, Santa Clara, CA) in the treatment of patients with multivessel coronary artery disease. The study is available online ahead of print in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

The EXECUTIVE study sought to investigate the efficacy and performance of the Xience V everolimus-eluting stent (EES) in the treatment of de novo coronary lesions in patients with two- to three-vessel multivessel coronary artery disease (MV-CAD). Drug-eluting stents (DES) have emerged as an alternative to conventional coronary artery bypass surgery in patients with MV-CAD, although first-generation DES yielded inferior efficacy and safety compared with surgery, noted the investigators in the background to the study.

As summarized in JACC: Cardiovascular Interventions, EXECUTIVE is a prospective, randomized (1:1), multicenter feasibility trial. It was designed to assess angiographic efficacy of the Xience V EES compared with a paclitaxel-eluting stent (PES), the Taxus Libertè (Boston Scientific Corporation, Natick, MA), in 200 patients. A prospective, open-label, single-arm, controlled registry was designed to analyze the clinical outcome of EES at 1-year follow-up in 400 MV-CAD patients. For the randomized trial, the primary endpoint was in-stent late loss at 9 months. For the registry, the primary endpoint was a composite of all-cause death, myocardial infarction, and ischemia-driven target vessel revascularization at 12 months.

The investigators found that the primary endpoint per single lesion was significantly lower in the EES group compared with the PES group (−0.03 ± 0.49 mm vs 0.23 ± 0.51 mm; P = .001). Similar results were observed when analyzing all lesions (0.05 ± 0.51 mm vs 0.24 ± 0.50 mm; P < .001). Clinical outcome at 1 year yielded a composite of major adverse cardiac events of 9.2% in the single-arm registry and 11.1% and 16.5% in the EES and PES randomized groups, respectively (P = .30).

This randomized pilot trial dedicated to the comparison of the efficacy of two different DES among patients with two- to three-vessel MV-CAD showed lower in-stent late loss at 9 months with the Xience V EES compared with the Taxus Libertè PES, and a low major adverse cardiac event rate at 1 year in patients with two- to three-vessel MV-CAD, concluded the EXECUTIVE investigators in JACC: Cardiovascular Interventions.