A Clinical and Angiographic Study of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With Multivessel Coronary Artery Disease The EXECUTIVE Trial (EXecutive RCT: Evaluating XIENCE V in a Multi Vessel Disease)

作者：Ribichini Flavio^*; Romano Michele; Rosiello Renato; La Vecchia Luigi; Cabianca Ester; Caramanno Giuseppe; Milazzo Diego; Loschiavo Paolo; Rigattieri Stefano; Musaro Salvatore; Pironi Bruno; Fiscella Antonio; Amico Francesco; Indolfi Ciro; Spaccarotella Carmen; Bartorelli Antonio; Trabattoni Daniela; Della Rovere Francesco; Rolandi Andrea; Beqaraj Federico; Belli Riccardo; Sangiorgio Pietro; Villani Rosvaldo; Berni Andrea; Sheiban Imad; Quijada Maria Jose Lopera

来源：JACC: Cardiovascular Interventions , 2013, 6(10): 1012-1022.

DOI：10.1016/j.jcin.2013.05.016

• coronary artery disease
• drug-eluting stent(s)
• multivessel disease
• randomized clinical trial

Objectives This study sought to investigate the efficacy and performance of the XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in the treatment of de novo coronary lesions in patients with 2- to 3-vessel multivessel coronary artery disease (MV-CAD). %26lt;br%26gt;Background 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. %26lt;br%26gt;Methods Prospective, randomized (1:1), multicenter feasibility trial was designed to assess angiographic efficacy of EES compared with the TAXUS paclitaxel-eluting stent (PES) in 200 patients, and 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. %26lt;br%26gt;Results 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 = 0.001). Similar results were observed when analyzing all lesions (0.05 +/- 0.51 mm vs. 0.24 +/- 0.50 mm, p %26lt; 0.001). 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 = 0.30). %26lt;br%26gt;Conclusions The EXECUTIVE trial was a randomized pilot trial dedicated to the comparison of the efficacy of 2 different DES among patients with 2- to 3-vessel MV-CAD. The study shows lower in-stent late loss at 9 months with the EES XIENCE V compared with the PES TAXUS Liberte, and a low major adverse cardiac event rate at 1 year in patients with 2- to 3-vessel MV-CAD.

• 出版日期2013-10