Gender-specific outcomes after sirolimus-eluting stent implantation.
OBJECTIVE
We examined the impact of gender on outcomes of patients undergoing percutaneous coronary intervention using sirolimus-eluting stents (SES).


BACKGROUND
Although gender-specific differences in outcome after implantation of bare-metal stents (BMS) have been described, there are no data assessing outcomes of women treated with SES.


METHODS
We performed a patient-level pooled analysis from 4 randomized SES versus BMS trials (RAVEL [Randomized Comparison of a Sirolimus-Eluting Stent with a Standard Stent for Coronary Revascularization], SIRIUS [SIRolImUS-coated Bx Velocity balloon expandable stent in the treatment of patients with de novo coronary artery lesions], E-SIRIUS [Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries], and C-SIRIUS [Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries]) and analyzed outcomes as a function of gender.


RESULTS
Of 1,748 patients, 1,251 were men and 497 were women. A total of 878 patients were randomized to SES (629 men and 249 women), and 870 patients were randomized to BMS (622 men and 248 women). Compared with men, women were older and more frequently had diabetes mellitus, hypertension, and congestive heart failure. Although overall clinical outcomes were similar in both genders, treatment with SES was associated with significant (p < 0.0001) reductions in rates of in-segment binary restenosis both in women (6.3% vs. 43.8%) and in men (6.4% vs. 35.6%), resulting in a significant reduction in 1-year major adverse cardiac events, driven by a lower incidence of target lesion revascularization/target vessel revascularization in both genders. By multivariable analysis, female gender was not an independent predictor of in-segment binary restenosis or clinical outcomes regardless of stent type.


CONCLUSIONS
In this analysis, despite less favorable baseline clinical and angiographic features in women compared with men, the angiographic and clinical benefits of SES were independent of gender.
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York, USA.
Emilia
E
Solinas
Eugenia
E
Nikolsky
Alexandra J
AJ
Lansky
Ajay J
AJ
Kirtane
Marie-Claude
MC
Morice
Jeffrey J
JJ
Popma
Joachim
J
Schofer
Erick
E
Schampaert
Tereza
T
Pucelikova
Jiro
J
Aoki
Martin
M
Fahy
George D
GD
Dangas
Jeffrey W
JW
Moses
Donald E
DE
Cutlip
Martin B
MB
Leon
Roxana
R
Mehran
D000368:Aged; D000789:Angina, Unstable / Q000628:therapy; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D012737:Sex Factors; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D020123:Sirolimus