Gender-specific outcome after paclitaxel-eluting stent implantation in japanese patients with coronary artery disease: Sub-analysis of the Japan taxus express2 post-marketing survey

摘要

Background: Although previous randomized and non-randomized studies have demonstrated the safety and efficacy of paclitaxel-eluting stents (PES), a higher revascularization rate has been reported in women than in men. A sub-analysis of the TAXUS Japan Post-market Surveillance Study (TAXUS-PMS) was done to assess the influence of gender on clinical outcome. Methods and Results: A total of 2,132 PES-treated Japanese patients (women, n=551) from this registry were analyzed. Subjects were stratified by gender to compare 1-year clinical outcome. PES-treated women were older and more likely to have insulin-treated diabetes and hypertension. In contrast, PES-treated men were more likely to be smokers, have a previous history of myocardial infarction, and lower ejection fraction. While cardiac death, myo-cardial infarction and stent thrombosis were similar between men and women, major cardiac events tended to be lower in women than in men (6.4% vs. 8.8%, P=0.08). Although women had significantly smaller reference vessel size (2.46±0.53 mm vs. 2.59±0.60 mm, P<0.0001), the restenosis rate tended to be lower in women than in men (11.5% vs. 14.8%, P=0.11). Subsequently, the target lesion revascularization rate was significantly lower in women than in men (4.2% vs. 6.5%, P<0.05). Conclusions: Despite a higher risk profile, Japanese women treated with PES did not have a higher rate of repeat revascularization or major adverse clinical outcome than PES-treated men at 1 year.