Author + information
- Received August 2, 2012
- Revision received May 15, 2013
- Accepted May 24, 2013
- Published online October 1, 2013.
- Flavio Ribichini, MD∗∗ (, )
- Michele Romano, MD†,
- Renato Rosiello, MD†,
- Luigi La Vecchia, MD‡,
- Ester Cabianca, MD‡,
- Giuseppe Caramanno, MD§,
- Diego Milazzo, MD§,
- Paolo Loschiavo, MD‖,
- Stefano Rigattieri, MD‖,
- Salvatore Musarò, MD¶,
- Bruno Pironi, MD¶,
- Antonio Fiscella, MD#,
- Francesco Amico, MD#,
- Ciro Indolfi, MD∗∗,††,
- Carmen Spaccarotella, MD∗∗,
- Antonio Bartorelli, MD††,
- Daniela Trabattoni, MD††,
- Francesco Della Rovere, MD‡‡,
- Andrea Rolandi, MD‡‡,
- Federico Beqaraj, MD§§,
- Riccardo Belli, MD§§,
- Pietro Sangiorgio, MD‖‖,
- Rosvaldo Villani, MD¶¶,
- Andrea Berni, MD##,
- Imad Sheiban, MD∗∗∗,
- Maria Josè Lopera Quijada, MSC†††,
- Barbara Cappi, MSC†††,
- Licia Ribaldi, BS†††,
- Corrado Vassanelli, MD∗,
- EXECUTIVE Trial Investigators
- ∗Department of Medicine, Università di Verona, Verona, Italy
- †Azienda Ospedaliera Carlo Poma, Mantova, Italy
- ‡Ospedale san Bortolo, Vicenza, Italy
- §Azienda Ospedaliera San Giovanni di Dio, Agrigento, Italy
- ‖Ospedale Sandro Pertini, Roma, Italy
- ¶Ospedale Generale Madre Vannini, Roma, Italy
- #Azienda Ospedaliera Cannizzaro, Catania, Italy
- ∗∗Azienda Ospedaliera Mater Domini Università degli Studi Magna Graecia, Catanzaro, Italy
- ††IRCCS Centro Cardiologico Monzino, Milano, Italy
- ‡‡Ente Ospedaliero Ospedali Galliera, Genova, Italy
- §§Ospedale Maria Vittoria, Torino, Italy
- ‖‖Ospedale Maggiore, Bologna, Italy
- ¶¶Azienda Ospedaliera di Pavia e provincia, Ospedale di Vigevano, Vigevano, Italy
- ##Azienda Ospedaliera S. Andrea, Roma, Italy
- ∗∗∗Azienda Ospedaliera Universitaria Molinette San Giovanni Battista, Torino, Italy
- †††Abbott Vascular Knoll-Ravizza S.p.A., Milano, Italy
- ↵∗Reprint requests and correspondence:
Dr. Flavio Ribichini, University of Verona, Piazzale A. Stefani 1, 37126 Verona, Italy.
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)
This study was sponsored by Abbott Vascular Knoll-Ravizza S.p.A., Italy. Dr. Ribichini has received a fee from Abbott Vascular Knoll-Ravizza S.p.A. to design the study, develop the statistical analysis, and write the manuscript. Dr. Bartorelli is on the advisory board of Abbott Vascular. Drs. Lopera Quijada, Cappi, and Ribaldi are employees of Abbott Vascular Knoll-Ravizza S.p.A. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- coronary artery disease
- confidence interval
- drug-eluting stent(s)
- everolimus-eluting stent(s)
- major adverse cardiac event(s)
- minimal lumen diameter
- percutaneous coronary intervention
- paclitaxel-eluting stent(s)
- quantitative coronary angiography
- target vessel revascularization
- Received August 2, 2012.
- Revision received May 15, 2013.
- Accepted May 24, 2013.
- American College of Cardiology Foundation