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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Gender-Specific Outcomes After Sirolimus-Eluting Stent Implantation

Emilia Solinas, MD, PhD^_*, Eugenia Nikolsky, MD, PhD, FACC^_*, Alexandra J. Lansky, MD, FACC^_*, Ajay J. Kirtane, MD, SM^_*, Marie-Claude Morice, MD, FACC, Jeffrey J. Popma, MD, FACC, Joachim Schofer, MD, Erick Schampaert, MD^||, Tereza Pucelikova, MD^_*, Jiro Aoki, MD^_*, Martin Fahy, MSc^_*, George D. Dangas, MD, PhD, FACC^_*, Jeffrey W. Moses, MD, FACC^_*, Donald E. Cutlip, MD, FACC^¶, Martin B. Leon, MD, FACC^_* and Roxana Mehran, MD, FACC^_*,_*

^_* Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
Institut Cardiovasculaire Paris Sud, Massy, France
Brigham and Women’s Hospital, Boston, Massachusetts
Centre for Cardiology and Vascular Intervention, Hamburg, Germany
^|| Hopital Sacre-Coeur de Montreal, Montreal, PQ, Canada
^¶ Harvard Clinical Research Institute, Boston, Massachusetts.

Manuscript received April 5, 2007; revised manuscript received June 4, 2007, accepted June 5, 2007.

^_* Reprint requests and correspondence: Dr. Roxana Mehran, 55 East 59th Street, 6th Floor, New York, New York 10022. (Email: rmehran{at}crf.org).

Objectives: 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.

Abbreviations and Acronyms   BMS = bare metal stent(s)   CI = confidence interval   DS = diameter stenosis   HR = hazard ratio   MACE = major adverse cardiac events   MI = myocardial infarction   MLD = minimal luminal diameter   PCI = percutaneous coronary intervention   RVD = reference vessel diameter   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization   TVR = target vessel revascularization

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