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)

Flavio Ribichini, Michele Romano, Renato Rosiello, Luigi La Vecchia, Ester Cabianca, Giuseppe Caramanno, Diego Milazzo, Paolo Loschiavo, Stefano Rigattieri, Salvatore Musarò, Bruno Pironi, Antonio Fiscella, Francesco Amico, Ciro Indolfi, Carmen Spaccarotella, Antonio Bartorelli, Daniela Trabattoni, Francesco Della Rovere, Andrea Rolandi, Federico Beqaraj & 9 others Riccardo Belli, Pietro Sangiorgio, Rosvaldo Villani, Andrea Berni, Imad Sheiban, Maria Josè Lopera Quijada, Barbara Cappi, Licia Ribaldi, Corrado Vassanelli

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

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 Libertè, 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)

Original languageEnglish
Pages (from-to)1012-1022
Number of pages11
JournalJACC: Cardiovascular Interventions
Volume6
Issue number10
DOIs
Publication statusPublished - Oct 2013

Fingerprint

Stents
Coronary Artery Disease
Paclitaxel
Drug-Eluting Stents
Therapeutics
Registries
Everolimus
Clinical Studies
Coronary Artery Bypass
Multicenter Studies
Myocardial Ischemia
Blood Vessels
Cause of Death
Myocardial Infarction
Safety

Keywords

  • coronary artery disease
  • drug-eluting stent(s)
  • multivessel disease
  • randomized clinical trial

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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). / Ribichini, Flavio; Romano, Michele; Rosiello, Renato; La Vecchia, Luigi; Cabianca, Ester; Caramanno, Giuseppe; Milazzo, Diego; Loschiavo, Paolo; Rigattieri, Stefano; Musarò, Salvatore; Pironi, Bruno; Fiscella, Antonio; Amico, Francesco; Indolfi, Ciro; Spaccarotella, Carmen; Bartorelli, Antonio; Trabattoni, Daniela; Della Rovere, Francesco; Rolandi, Andrea; Beqaraj, Federico; Belli, Riccardo; Sangiorgio, Pietro; Villani, Rosvaldo; Berni, Andrea; Sheiban, Imad; Lopera Quijada, Maria Josè; Cappi, Barbara; Ribaldi, Licia; Vassanelli, Corrado.

In: JACC: Cardiovascular Interventions, Vol. 6, No. 10, 10.2013, p. 1012-1022.

Research output: Contribution to journalArticle

Ribichini, F, Romano, M, Rosiello, R, La Vecchia, L, Cabianca, E, Caramanno, G, Milazzo, D, Loschiavo, P, Rigattieri, S, Musarò, S, Pironi, B, Fiscella, A, Amico, F, Indolfi, C, Spaccarotella, C, Bartorelli, A, Trabattoni, D, Della Rovere, F, Rolandi, A, Beqaraj, F, Belli, R, Sangiorgio, P, Villani, R, Berni, A, Sheiban, I, Lopera Quijada, MJ, Cappi, B, Ribaldi, L & Vassanelli, C 2013, '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)', JACC: Cardiovascular Interventions, vol. 6, no. 10, pp. 1012-1022. https://doi.org/10.1016/j.jcin.2013.05.016
Ribichini, Flavio ; Romano, Michele ; Rosiello, Renato ; La Vecchia, Luigi ; Cabianca, Ester ; Caramanno, Giuseppe ; Milazzo, Diego ; Loschiavo, Paolo ; Rigattieri, Stefano ; Musarò, Salvatore ; Pironi, Bruno ; Fiscella, Antonio ; Amico, Francesco ; Indolfi, Ciro ; Spaccarotella, Carmen ; Bartorelli, Antonio ; Trabattoni, Daniela ; Della Rovere, Francesco ; Rolandi, Andrea ; Beqaraj, Federico ; Belli, Riccardo ; Sangiorgio, Pietro ; Villani, Rosvaldo ; Berni, Andrea ; Sheiban, Imad ; Lopera Quijada, Maria Josè ; Cappi, Barbara ; Ribaldi, Licia ; Vassanelli, Corrado. / 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). In: JACC: Cardiovascular Interventions. 2013 ; Vol. 6, No. 10. pp. 1012-1022.
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abstract = "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 Libert{\`e}, 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)",
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author = "Flavio Ribichini and Michele Romano and Renato Rosiello and {La Vecchia}, Luigi and Ester Cabianca and Giuseppe Caramanno and Diego Milazzo and Paolo Loschiavo and Stefano Rigattieri and Salvatore Musar{\`o} and Bruno Pironi and Antonio Fiscella and Francesco Amico and Ciro Indolfi and Carmen Spaccarotella and Antonio Bartorelli and Daniela Trabattoni and {Della Rovere}, Francesco and Andrea Rolandi and Federico Beqaraj and Riccardo Belli and Pietro Sangiorgio and Rosvaldo Villani and Andrea Berni and Imad Sheiban and {Lopera Quijada}, {Maria Jos{\`e}} and Barbara Cappi and Licia Ribaldi and Corrado Vassanelli",
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TY - JOUR

T1 - A clinical and angiographic study of the XIENCE v everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease

T2 - The executive trial (executive RCT: Evaluating XIENCE v in a multi vessel disease)

AU - Ribichini, Flavio

AU - Romano, Michele

AU - Rosiello, Renato

AU - La Vecchia, Luigi

AU - Cabianca, Ester

AU - Caramanno, Giuseppe

AU - Milazzo, Diego

AU - Loschiavo, Paolo

AU - Rigattieri, Stefano

AU - Musarò, Salvatore

AU - Pironi, Bruno

AU - Fiscella, Antonio

AU - Amico, Francesco

AU - Indolfi, Ciro

AU - Spaccarotella, Carmen

AU - Bartorelli, Antonio

AU - Trabattoni, Daniela

AU - Della Rovere, Francesco

AU - Rolandi, Andrea

AU - Beqaraj, Federico

AU - Belli, Riccardo

AU - Sangiorgio, Pietro

AU - Villani, Rosvaldo

AU - Berni, Andrea

AU - Sheiban, Imad

AU - Lopera Quijada, Maria Josè

AU - Cappi, Barbara

AU - Ribaldi, Licia

AU - Vassanelli, Corrado

PY - 2013/10

Y1 - 2013/10

N2 - 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 Libertè, 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)

AB - 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 Libertè, 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)

KW - coronary artery disease

KW - drug-eluting stent(s)

KW - multivessel disease

KW - randomized clinical trial

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