A Clinical and Angiographic Study of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With Multivessel Coronary Artery Disease The EXECUTIVE Trial (EXecutive RCT: Evaluating XIENCE V in a Multi Vessel Disease)

被引：21

作者：

Ribichini, Flavio ^{[1
]}

Romano, Michele ^{[2
]}

Rosiello, Renato ^{[2
]}

La Vecchia, Luigi ^{[3
]}

Cabianca, Ester ^{[3
]}

Caramanno, Giuseppe ^{[4
]}

Milazzo, Diego ^{[4
]}

Loschiavo, Paolo ^{[5
]}

Rigattieri, Stefano ^{[5
]}

Musaro, Salvatore ^{[6
]}

Pironi, Bruno ^{[6
]}

Fiscella, Antonio ^{[7
]}

Amico, Francesco ^{[7
]}

Indolfi, Ciro ^{[8
,9
]}

Spaccarotella, Carmen ^{[8
]}

Bartorelli, Antonio ^{[9
]}

Trabattoni, Daniela ^{[9
]}

Della Rovere, Francesco ^{[10
]}

Rolandi, Andrea ^{[10
]}

Beqaraj, Federico ^{[11
]}

Belli, Riccardo ^{[11
]}

Sangiorgio, Pietro ^{[12
]}

Villani, Rosvaldo ^{[13
]}

Berni, Andrea ^{[14
]}

Sheiban, Imad ^{[15
]}

Quijada, Maria Jose Lopera ^{[16
]}

Cappi, Barbara ^{[16
]}

Ribaldi, Licia ^{[16
]}

Vassanelli, Corrado ^{[1
]}

机构：

[1] Univ Verona, Dept Med, I-37126 Verona, Italy

[2] Azienda Osped Carlo Poma, Mantua, Italy

[3] Osped San Bortolo, Vicenza, Italy

[4] Azienda Osped San Giovanni di Dio, Agrigento, Italy

[5] Osped Sandro Pertini, Rome, Italy

[6] Osped Gen Madre Vannini, Rome, Italy

[7] Azienda Osped Cannizzaro, Catania, Italy

[8] Magna Graecia Univ Catanzaro, Azienda Osped Mater Domini, Catanzaro, Italy

[9] IRCCS Ctr Cardiol Monzino, Milan, Italy

[10] Ente Osped Osped Galliera, Genoa, Italy

[11] Osped Maria Vittoria, Turin, Italy

[12] Osped Maggiore Bologna, Bologna, Italy

[13] Osped Vigevano, Azienda Osped Pavia & Prov, Vigevano, Italy

[14] Azienda Osped S Andrea, Rome, Italy

[15] Azienda Osped Univ Molinette San Giovanni Battist, Turin, Italy

[16] Abbott Vasc Knoll Ravizza SpA, Milan, Italy

来源：

JACC-CARDIOVASCULAR INTERVENTIONS | 2013年 / 6卷 / 10期

关键词：

coronary artery disease; drug-eluting stent(s); multivessel disease; randomized clinical trial; BYPASS-SURGERY; FOLLOW-UP; LEFT MAIN; 3-VESSEL DISEASE; TASK-FORCE; SPIRIT III; ERACI-II; INTERVENTION; REVASCULARIZATION; LESIONS;

D O I：

10.1016/j.jcin.2013.05.016

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 Liberte, 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) (J Am Coll Cardiol Intv 2013;6:1012-22) (C) 2013 by the American College of Cardiology Foundation

引用

页码：1012 / 1022

页数：11

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