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

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, Flavioa; Ansalone, Gerardob; Bartorelli, Antonioc; Beqaraj, Federicod; Berni, Andreae; Colangelo, Salvatoref; D'Amico, Mauriziog; Rovere, Francesco Dellah; Fiscella, Antonioi; Gabrielli, Gabrielej; Indolfi, Cirok; La Vecchia, Luigil; Loschiavo, Paolom; Marinoni, Giampietron; Marzocchi, Antonioo; Milazzo, Diegop; Romano, Micheleq; Sangiorgio, Pietror; Sheiban, Imads; Tamburino, Corradot; Tuccillo, Bernardinou; Villani, Rosvaldov; Cappi, Barbaraw; Quijada, Maria Josè Loperaw; Vassanelli, Corradoa; on behalf of the EXECUTIVE Trial Investigators

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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.

© 2010 Italian Federation of Cardiology

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