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

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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)299-309
Number of pages11
JournalJournal of Cardiovascular Medicine
Volume11
Issue number4
DOIs
Publication statusPublished - Apr 2010

Keywords

  • Coronary artery disease
  • Drug-eluting stent
  • Multivessel disease
  • Randomized clinical trial

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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