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)
Flavio Ribichini, Michele Romano, Renato Rosiello, Luigi La Vecchia, Ester Cabianca, Giuseppe Caramanno, Diego Milazzo, Paolo Loschiavo, Stefano Rigattieri, Salvatore Musarò, Bruno Pironi, Antonio Fiscella, Francesco Amico, Ciro Indolfi, Carmen Spaccarotella, Antonio Bartorelli, Daniela Trabattoni, Francesco Della Rovere, Andrea Rolandi, Federico Beqaraj, Riccardo Belli, Pietro Sangiorgio, Rosvaldo Villani, Andrea Berni, Imad Sheiban, Maria Josè Lopera Quijada, Barbara Cappi, Licia Ribaldi, Corrado Vassanelli, EXECUTIVE Trial Investigators, Corrado Vassanelli, Flavio Ribichini, Maria Jose' Lopera Quijada, Francesco Bedogni, Ciro Indolfi, Antonio Marzocchi, Corrado Tamburino, V Ferrero, G Molinari, G Pesarini, G Menegatti, L Farraguto, G Miccichè, D Milazzo, G Caramanno, G Gabrielli, T Piva, A Pangrazi, M G Pallotti, P Sangiorgio, F Saia, N Taglieri, A Marzocchi, V Argentino, S Azzarelli, M Giacoppo, F Amico, A Fiscella, A La Manna, C Tamburino, C Spaccarotella, C Indolfi, A Rolandi, F Della Rovere, N Baccaglioni, F Buffoli, C Lettieri, R Rosiello, M Romano, F Fabbiocchi, S Galli, P Montorsi, G Teruzzi, D Trabattoni, A Bartorelli, A O Modena, C Cappelli, P Magnavacchi, S Tondi, F Punzo, B Tuccillo, C Di Russo, S Fedele, S Rigattieri, P Lo Schiavo, F Giovannelli, C Nannini, B A Pace, D M Zardi, A Berni, S Musarò, B Pironi, G Ansalone, M Giammaria, F Beqaraj, R Belli, F Conrotto, P Scacciatela, M D'amico, C Moretti, P Omedé, F Sciuto, I Sheiban, S Colangelo, M Minelli, E Cabianca, A Fontanelli, M Morato, L La Vecchia, G Giacomarra, M Romanò, R Villani, R Osti, G Marinoni, Nicoletta De Cesare, Fabrizio Tomai, Marco Valgimigli, Flavio Ribichini, Michele Romano, Renato Rosiello, Luigi La Vecchia, Ester Cabianca, Giuseppe Caramanno, Diego Milazzo, Paolo Loschiavo, Stefano Rigattieri, Salvatore Musarò, Bruno Pironi, Antonio Fiscella, Francesco Amico, Ciro Indolfi, Carmen Spaccarotella, Antonio Bartorelli, Daniela Trabattoni, Francesco Della Rovere, Andrea Rolandi, Federico Beqaraj, Riccardo Belli, Pietro Sangiorgio, Rosvaldo Villani, Andrea Berni, Imad Sheiban, Maria Josè Lopera Quijada, Barbara Cappi, Licia Ribaldi, Corrado Vassanelli, EXECUTIVE Trial Investigators, Corrado Vassanelli, Flavio Ribichini, Maria Jose' Lopera Quijada, Francesco Bedogni, Ciro Indolfi, Antonio Marzocchi, Corrado Tamburino, V Ferrero, G Molinari, G Pesarini, G Menegatti, L Farraguto, G Miccichè, D Milazzo, G Caramanno, G Gabrielli, T Piva, A Pangrazi, M G Pallotti, P Sangiorgio, F Saia, N Taglieri, A Marzocchi, V Argentino, S Azzarelli, M Giacoppo, F Amico, A Fiscella, A La Manna, C Tamburino, C Spaccarotella, C Indolfi, A Rolandi, F Della Rovere, N Baccaglioni, F Buffoli, C Lettieri, R Rosiello, M Romano, F Fabbiocchi, S Galli, P Montorsi, G Teruzzi, D Trabattoni, A Bartorelli, A O Modena, C Cappelli, P Magnavacchi, S Tondi, F Punzo, B Tuccillo, C Di Russo, S Fedele, S Rigattieri, P Lo Schiavo, F Giovannelli, C Nannini, B A Pace, D M Zardi, A Berni, S Musarò, B Pironi, G Ansalone, M Giammaria, F Beqaraj, R Belli, F Conrotto, P Scacciatela, M D'amico, C Moretti, P Omedé, F Sciuto, I Sheiban, S Colangelo, M Minelli, E Cabianca, A Fontanelli, M Morato, L La Vecchia, G Giacomarra, M Romanò, R Villani, R Osti, G Marinoni, Nicoletta De Cesare, Fabrizio Tomai, Marco Valgimigli
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 < 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).
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 Libertè, 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).
Keywords: CAD; CI; DES; EES; MACE; MLD; MV; PCI; PES; QCA; TVR; confidence interval; coronary artery disease; drug-eluting stent(s); everolimus-eluting stent(s); major adverse cardiac event(s); minimal lumen diameter; multivessel; multivessel disease; paclitaxel-eluting stent(s); percutaneous coronary intervention; quantitative coronary angiography; randomized clinical trial; target vessel revascularization.
Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed