Improved two-year outcomes after drug-eluting versus bare-metal stent implantation in women and men with large coronary arteries: Importance of vessel size

Objectives: To investigate the importance of vessel size on outcome differences by comparing the effects of drug-eluting stents (DES) versus bare-metal stents (BMS) in women and men with large coronary vessels. Methods: All 2314 BASKET-PROVE patients randomized to DES versus BMS were followed for 2 years with a primary endpoint of major adverse cardiac events (MACE: cardiac death, non-fatal myocardial infarction, target-vessel revascularization). Cox proportional hazard models were used to evaluate the relative risk for women and men, respectively. All comparisons were adjusted for vessel size. Results: Age, risk factors and complexity of coronary artery disease differed between women and men. DES reduced MACE rates at 2 years compared to BMS - in women: 4% vs. 15%, p < 0.0001 with a hazard ratio (HR) of 0.27 (0.15-0.51), and men: 6% vs. 10%, p = 0.003 (HR = 0.60 (0.43-0.84)), respectively. The association persisted in both women (HR = 0.25 (0.13-0.46)) and men (HR = 0.60 (0.42-0.84)) following multivariable adjustments. A significant gender-treatment interaction was present (p = 0.02). The reduced risk of MACE following DES vs. BMS implantation was present until 6 months in both women (HR = 0.15 (0.06-0.36)) and men (HR = 0.32 (0.17-0.59)) and remained significant until 2 years in women (HR = 0.36 (0.15-0.87)), but not in men (HR = 0.87 (0.49-1.55)). Conclusions: In women and men with similarly sized large coronary arteries, DES reduced 2-year MACE rates compared to BMS, but the significant gender-treatment interaction indicated a greater benefit of DES in women. Thus, factors other than vessel size seem to determine this gender difference. (C) 2013 Elsevier Ireland Ltd. All rights reserved.