A clinical and angiographic study of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease. Study design and rationale of the EXECUTIVE trial.
BACKGROUND
Myocardial revascularization with drug-eluting stents (DESs) is emerging as an alternative to conventional coronary artery bypass surgery in patients with multivessel coronary artery disease (MV-CAD). First-generation DESs have yielded equivalent safety results at mid-term compared with surgery, but inferior efficacy in preventing the recurrence of ischemic symptoms. The outcome of percutaneous coronary intervention with a second-generation everolimus DES as compared with a paclitaxel DES in patients with MV-CAD has not been established.


OBJECTIVE
The aim of the study is the assessment of the efficacy and performance of the XIENCE V everolimus-eluting stent in the treatment of de-novo coronary artery lesions in patients with MV-CAD.


METHODS
The study is composed of two parts: a prospective, double arm, randomized multicenter trial to assess the angiographic efficacy of the XIENCE V everolimus-eluting coronary stent system (EECSS) compared with the Taxus Liberté Paclitaxel Eluting Coronary Stent System (Taxus Liberté Stent) and a prospective, open-label, single arm, controlled registry to analyze the clinical efficacy and safety of XIENCE V EECSS at mid-term and long-term follow-up in patients treated for MV-CAD.


METHODS
For the EXECUTIVE randomized trial, the primary endpoint is in-stent late lumen loss at 9 months. For the EXECUTIVE registry, the primary endpoint is a composite of all death, myocardial infarction (Q-wave and non-Q-wave), and ischemia-driven target vessel revascularization at 12 months. The study will be conducted at 30 study centers in Italy and 600 patients will be enrolled in total: 200 patients will be enrolled (1: 1) in the randomized trial and 400 patients will enter the registry.


METHODS
It was calculated that, assuming a mean in-stent late lumen loss of 0.20 +/- 0.41 mm in the XIENCE V EECSS arm and 0.30 +/- 0.53 mm in the Taxus Liberté stent arm, and a noninferiority margin delta of 0.12 (according to the SPIRIT III results), the analysis of 81 lesions per arm would provide over 90% power. Therefore, 200 patients will be enrolled to account for dropouts.


CONCLUSIONS
The present study is expected to provide as yet unavailable information about the performance of second-generation stents in the specific setting of patients with MV-CAD.
Ribichini
Flavio
F
Dipartimento di Scienze Biomediche e Chirurgiche, Università di Verona, Verona, Italy. flavio.ribichini@univr.it
Ansalone
Gerardo
G
Bartorelli
Antonio
A
Beqaraj
Federico
F
Berni
Andrea
A
Colangelo
Salvatore
S
D'Amico
Maurizio
M
Della Rovere
Francesco
F
Fiscella
Antonio
A
Gabrielli
Gabriele
G
Indolfi
Ciro
C
La Vecchia
Luigi
L
Loschiavo
Paolo
P
Marinoni
Giampietro
G
Marzocchi
Antonio
A
Milazzo
Diego
D
Romano
Michele
M
Sangiorgio
Pietro
P
Sheiban
Imad
I
Tamburino
Corrado
C
Tuccillo
Bernardino
B
Villani
Rosvaldo
R
Cappi
Barbara
B
Quijada
Maria Josè Lopera
MJ
Vassanelli
Corrado
C
D000792:Angiography; D019917:Blood Vessel Prosthesis Implantation; D002985:Clinical Protocols; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000601:surgery*; D003362:Cost-Benefit Analysis; D054855:Drug-Eluting Stents; D000068338:Everolimus; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D009204:Myocardial Revascularization; D011446:Prospective Studies; D012107:Research Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*
D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus