Head-to-head comparison of sirolimus- and paclitaxel-eluting stent in the same diabetic patient with multiple coronary artery lesions: a prospective, randomized, multicenter study.
OBJECTIVE
It is still controversial whether sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) are equally effective in patients with diabetes. In these patients, multiple individual variables may be responsible for neointimal hyperplasia, thus making difficult the comparison of the two drug-eluting stents (DES).


METHODS
We designed a prospective, randomized study to compare the efficacy in prevention of restenosis of SES and PES, both implanted in the same diabetic patient with multiple de novo coronary artery lesions undergoing elective percutaneous coronary intervention. We enrolled 60 patients with diabetes with at least two significant de novo angiographic stenoses in different coronary segments. The primary end point was in-stent late luminal loss (LLL) at 8-month angiographic follow-up.


RESULTS
A total of 120 lesions were successfully treated with the randomly assigned DES (SES, n = 60; PES, n = 60). In-stent LLL was lower in the SES than in the PES group (0.26 +/- 0.4 vs. 0.50 +/- 0.6 mm; P = 0.01). Coronary lesions treated with SES presented a reduced in-stent LLL in 40 (68%) patients, while PES resulted in a lower in-stent LLL in 19 (32%) patients (P = 0.0002). At multivariable analysis, the type of DES implanted was the only independent predictor of in-stent LLL (odds ratio 2.3 [95% CI 1.1-5.0]; P = 0.03).


CONCLUSIONS
SES directly compared with PES in the same diabetic patient is associated with a decrease in the extent of in-stent LLL at 8 months, suggesting a reduced risk of restenosis.
Tomai
Fabrizio
F
Division of Cardiology, Department of Cardiovascular Sciences, European Hospital, Via Portuense 700, 00149 Rome, Italy. f.tomai@tiscali.it
Reimers
Bernhard
B
De Luca
Leonardo
L
Galassi
Alfredo R
AR
Gaspardone
Achille
A
Ghini
Anna S
AS
Ferrero
Valeria
V
Favero
Luca
L
Gioffrè
Gaetano
G
Prati
Francesco
F
Tamburino
Corrado
C
Ribichini
Flavio
F
D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D017023:Coronary Angiography; D003327:Coronary Disease / Q000188:drug therapy / Q000601:surgery*; D023903:Coronary Restenosis / Q000517:prevention & control*; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003925:Diabetic Angiopathies / Q000188:drug therapy / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000627:therapeutic use*
D000900:Anti-Bacterial Agents; D000970:Antineoplastic Agents; D017239:Paclitaxel; D020123:Sirolimus