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A clinical and angiographic study of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease. Study design and rationale of the EXECUTIVE trial

Ribichini, Flavio; Ansalone, Gerardo; Bartorelli, Antonio; Beqaraj, Federico; Berni, Andrea; Colangelo, Salvatore; D'Amico, Maurizio; Rovere, Francesco Della; Fiscella, Antonio; Gabrielli, Gabriele; Indolfi, Ciro; La Vecchia, Luigi; Loschiavo, Paolo; Marinoni, Giampietro; Marzocchi, Antonio; Milazzo, Diego; Romano, Michele; Sangiorgio, Pietro; Sheiban, Imad; Tamburino, Corrado; Tuccillo, Bernardino; Villani, Rosvaldo; Cappi, Barbara; Quijada, Maria Josè Lopera; Vassanelli, Corrado; on behalf of the EXECUTIVE Trial Investigators

Journal of Cardiovascular Medicine:
doi: 10.2459/JCM.0b013e3283331e69
Research trial protocols
Abstract

Background: Myocardial revascularization with drug-eluting stents (DESs) is emerging as an alternative to conventional coronary artery bypass surgery in patients with multivessel coronary artery disease (MV-CAD). First-generation DESs have yielded equivalent safety results at mid-term compared with surgery, but inferior efficacy in preventing the recurrence of ischemic symptoms. The outcome of percutaneous coronary intervention with a second-generation everolimus DES as compared with a paclitaxel DES in patients with MV-CAD has not been established.

Aim of the study: The aim of the study is the assessment of the efficacy and performance of the XIENCE V everolimus-eluting stent in the treatment of de-novo coronary artery lesions in patients with MV-CAD.

Study design: The study is composed of two parts: a prospective, double arm, randomized multicenter trial to assess the angiographic efficacy of the XIENCE V everolimus-eluting coronary stent system (EECSS) compared with the Taxus Liberté Paclitaxel Eluting Coronary Stent System (Taxus Liberté Stent) and a prospective, open-label, single arm, controlled registry to analyze the clinical efficacy and safety of XIENCE V EECSS at mid-term and long-term follow-up in patients treated for MV-CAD.

Endpoints: For the EXECUTIVE randomized trial, the primary endpoint is in-stent late lumen loss at 9 months. For the EXECUTIVE registry, the primary endpoint is a composite of all death, myocardial infarction (Q-wave and non-Q-wave), and ischemia-driven target vessel revascularization at 12 months. The study will be conducted at 30 study centers in Italy and 600 patients will be enrolled in total: 200 patients will be enrolled (1: 1) in the randomized trial and 400 patients will enter the registry.

Sample size: It was calculated that, assuming a mean in-stent late lumen loss of 0.20 ± 0.41 mm in the XIENCE V EECSS arm and 0.30 ± 0.53 mm in the Taxus Liberté stent arm, and a noninferiority margin delta of 0.12 (according to the SPIRIT III results), the analysis of 81 lesions per arm would provide over 90% power. Therefore, 200 patients will be enrolled to account for dropouts.

Conclusion: The present study is expected to provide as yet unavailable information about the performance of second-generation stents in the specific setting of patients with MV-CAD.

Author Information

aDipartimento di Scienze Biomediche e Chirurgiche, Università di Verona, Verona, Italy

bOspedale Generale Madre Vannini, Rome, Italy

cIRCCS Centro Cardiologico Monzino, Milan, Italy

dOspedale Maria Vittoria, Torino, Italy

eAzienda Ospedaliera S. Andrea, Rome, Italy

fOspedale S. Giovanni Bosco, Italy

gAzienda Ospedaliera Molinette San Giovanni Battista, Torino, Italy

hEnte Ospedaliero Ospedali Galliera, Genova, Italy

iAzienda Ospedaliera Cannizzaro, Catania, Italy

jAzienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi, Ancona, Italy

kAzienda Ospedaliera Mater Domini Università degli Studi Magna Graecia, Catanzaro, Italy

lOspedale di Vicenza, Vicenza, Italy

mOspedale Sandro Pertini, Rome, Italy

nA.O. della Provincia di Pavia Ospedale di Voghera, Voghera, Italy

oPoliclinico S. Orsola Malpighi, Bologna, Italy

pAzienda Ospedaliera San Giovanni di Dio, Agrigento, Italy

qAzienda Ospedaliera Carlo Poma, Mantova, Italy

rOspedale Maggiore, Bologna, Italy

sAzienda Ospedaliera Universitaria Molinette San Giovanni Battista, Torino, Italy

tAzienda Ospedaliera Universitaria Vittorio Emanuele Ferrarotto S. Bambino, Catania, Italy

uOspedale S. Maria Loreto Mare, Napoli, Italy

vA.O. della Provincia di Pavia Ospedale di Vigevano, Vigevano, Italy

wAbbott Vascular Knoll Ravizza S.p.A., Milan, Italy

Received 18 May, 2009

Revised 16 September, 2009

Accepted 17 September, 2009

Correspondence to Professor Flavio Ribichini, MD, Director, Laboratory of Interventional Cardiology, Università di Verona, Ospedale Civile Maggiore, Piazzale A. Stefani 1, 37126 Verona, Italy Tel: +39 045 812 2039; fax: +39 045 8027307; e-mail: flavio.ribichini@univr.it

© 2010 Italian Federation of Cardiology. All rights reserved.