Study Finds Similar DES Outcomes in Women and Men

March 20, 2012—Giulio G. Stefanini, MD, et al published findings from a study that sought to investigate sex-based differences in long-term clinical and angiographic outcomes after coronary revascularization with drug-eluting stents (DES) in the Journal of the American College of Cardiology: Cardiovascular Interventions (2012;5:301–310). The investigators concluded that the unrestricted use of DES is associated with similar long-term safety and efficacy among women and men with coronary artery disease.

The study investigators pooled individual patient data from three all-comers randomized DES trials (SIRTAX, LEADERS, RESOLUTE AC). Of 5,011 patients, 4,885 (97.5%) completed 2-year follow-up (1,164 women, 3,721 men). Protocol-mandated angiographic follow-up was available for 1,561 lesions (351 among women, 1,210 among men). The primary endpoint was the composite of cardiac death and myocardial infarction (MI) at 2 years.

As detailed in the Journal of the American College of Cardiology: Cardiovascular Interventions, at baseline, women, as compared with men, were older, more frequently had diabetes, obesity, and hypertension, less frequently had smoking habits, previous MI, and previous surgical revascularization, and had a smaller reference diameter of the target vessel, as well as a lower SYNTAX score.

After adjustment for baseline differences, women and men had a similar risk of cardiac death or MI (odds ratio [OR]: 1.13, 95% confidence interval [CI]: 0.82–1.56; P = .44), cardiac death (OR: 1.04, 95% CI: 0.61–1.8; P = .87), and MI (OR: 1.07, 95% CI: 0.75–1.53; P = .71) at 2 years. Similarly, risks of target lesion revascularization (OR: 1.09, 95% CI: 0.77–1.54; P = .62), target vessel revascularization (OR: 0.88, 95% CI: 0.63–1.22; P = .43), and definite or probable stent thrombosis (OR: 0.73, 95% CI: 0.38–1.38; P = .33) were comparable for women and men. Follow-up angiography showed no differences in terms of in-stent late loss (0.18 ± 0.54 mm vs 0.2 ± 0.99 mm; P = .76) and in-segment binary restenosis (8.5% vs 8.5%; P = .76), reported the investigators.