Clinical Research
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)

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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)

Key Words

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

Abbreviations and Acronyms

CAD
coronary artery disease
CI
confidence interval
DES
drug-eluting stent(s)
EES
everolimus-eluting stent(s)
MACE
major adverse cardiac event(s)
MLD
minimal lumen diameter
MV
multivessel
PCI
percutaneous coronary intervention
PES
paclitaxel-eluting stent(s)
QCA
quantitative coronary angiography
TVR
target vessel revascularization

Cited by (0)

This study was sponsored by Abbott Vascular Knoll-Ravizza S.p.A., Italy. Dr. Ribichini has received a fee from Abbott Vascular Knoll-Ravizza S.p.A. to design the study, develop the statistical analysis, and write the manuscript. Dr. Bartorelli is on the advisory board of Abbott Vascular. Drs. Lopera Quijada, Cappi, and Ribaldi are employees of Abbott Vascular Knoll-Ravizza S.p.A. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.