1. A Clinical and Angiographic Study of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With Multivessel Coronary Artery Disease
- Author
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Ciro Indolfi, Corrado Vassanelli, Andrea Berni, Luigi La Vecchia, Pietro Sangiorgio, Diego Milazzo, Andrea Rolandi, Giuseppe Caramanno, Federico Beqaraj, Michele Romano, Renato Rosiello, Flavio Ribichini, Ester Cabianca, Carmen Spaccarotella, Daniela Trabattoni, Stefano Rigattieri, Francesco Della Rovere, Riccardo Belli, Antonio Fiscella, Bruno Pironi, Salvatore Musarò, Maria Josè Lopera Quijada, Barbara Cappi, Licia Ribaldi, Imad Sheiban, Paolo Loschiavo, Antonio L. Bartorelli, Francesco Amico, and Rosvaldo Villani
- Subjects
medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Percutaneous coronary intervention ,Stent ,medicine.disease ,Surgery ,law.invention ,Coronary artery disease ,Coronary artery bypass surgery ,Randomized controlled trial ,law ,Internal medicine ,Coronary stent ,medicine ,Cardiology ,Clinical endpoint ,Myocardial infarction ,business ,Cardiology and Cardiovascular Medicine - Abstract
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). 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. 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. 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 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. (EXECUTIVE [EXecutive RCT: Evaluating XIENCE V in a Multi Vessel Disease]; NCT00531011 )
- Published
- 2013
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