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 language | English |
|---|---|
| Pages (from-to) | 1012-1022 |
| Number of pages | 11 |
| Journal | JACC: Cardiovascular Interventions |
| Volume | 6 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - Oct 2013 |
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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 journal › Article
}
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
UR - http://www.scopus.com/inward/record.url?scp=84886402054&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84886402054&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2013.05.016
DO - 10.1016/j.jcin.2013.05.016
M3 - Article
VL - 6
SP - 1012
EP - 1022
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
SN - 1936-8798
IS - 10
ER -