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.
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: firstname.lastname@example.org