Objectives:
Drug-eluting stents (DES) are associated with lower rates of target vessel revascularization (TVR) compared with bare-metal stents (BMS), possibly with a particular benefit in women. Inferences on efficacy and safety of DES compared to BMS have been difficult to study in female subgroups as clinical trials often enroll a low proportion of women. Therefore we investigated the safety and efficacy of DES vs. BMS in women and men in a pooled analysis of two randomized stent trials.
Methods:
BASKET PROVE and BASKET PROVE II were all-comers trials including patients with coronary artery disease requiring at least one stent ≥ 3.0 mm. 4605 patients were randomized to DES vs. BMS and followed for 2 years with a primary endpoint of major adverse cardiac events (MACE: cardiac death, non-fatal myocardial infarction, TVR). The safety (cardiac death and myocardial infarction) and efficacy (non-myocardial infarction TVR) of DES vs. BMS in men and women with large coronary vessels were examined with adjusted Cox proportional hazard models.
Results:
At baseline, women presented with higher age and more hypertension and heart failure than did men. Risk factors such as smoking, prior myocardial infarction or revascularization were more frequent in men. DES reduced MACE rates at 2 years compared to BMS in both women (6.8 vs. 14.9 %, hazard ratio (HR) 0.40 (0.27-0.60)) and men (7.8 vs. 12.3 %, HR 0.61 (0.49-0.76)), although the reduction in MACE rates was more pronounced in women (p-value for interaction, 0.05). DES significantly reduced the overall rates of non-fatal myocardial infarction and cardiac death compared to BMS in women (HR 0.52 (0.28-0.99)) but not in men (HR 0.75 (0.53-1.05)). The stent-dependent difference in MACE was mainly driven by a difference in non-myocardial infarction TVR in women (2.7 vs. 8.9 %, HR 0.25 (0.14-0.44)) and men (3.8 vs. 7.6 %, HR 0.48 (0.36-0.65)).
Conclusions:
In patients requiring stenting of large coronary arteries we found that DES, as compared to BMS, were associated with improved safety in women, but not in men. Although, DES demonstrated superior efficacy over BMS in both genders, women benefited more than men. Our findings suggest that DES should always be the stent of choice in women - even in patients at low risk of restenosis.
Drug-eluting stents versus bare-metal stents for acute coronary syndrome
