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).
OBJECTIVE
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).
Department of Medicine, Università di Verona, Verona, Italy. Electronic address: flavio.ribichini@univr.it.
Flavio
F
Ribichini
Michele
M
Romano
Renato
R
Rosiello
Luigi
L
La Vecchia
Ester
E
Cabianca
Giuseppe
G
Caramanno
Diego
D
Milazzo
Paolo
P
Loschiavo
Stefano
S
Rigattieri
Salvatore
S
Musarò
Bruno
B
Pironi
Antonio
A
Fiscella
Francesco
F
Amico
Ciro
C
Indolfi
Carmen
C
Spaccarotella
Antonio
A
Bartorelli
Daniela
D
Trabattoni
Francesco
F
Della Rovere
Andrea
A
Rolandi
Federico
F
Beqaraj
Riccardo
R
Belli
Pietro
P
Sangiorgio
Rosvaldo
R
Villani
Andrea
A
Berni
Imad
I
Sheiban
Maria Josè
MJ
Lopera Quijada
Barbara
B
Cappi
Licia
L
Ribaldi
Corrado
C
Vassanelli
D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000503:physiopathology; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D017239:Paclitaxel / Q000008:administration & dosage; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus
CAD; CI; DES; EES; MACE; MLD; MV; PCI; PES; QCA; TVR; confidence interval; coronary artery disease; drug-eluting stent(s); everolimus-eluting stent(s); major adverse cardiac event(s); minimal lumen diameter; multivessel; multivessel disease; paclitaxel-eluting stent(s); percutaneous coronary intervention; quantitative coronary angiography; randomized clinical trial; target vessel revascularization