Influence of sex on long-term outcomes after percutaneous coronary intervention with the paclitaxel-eluting coronary stent: Results of the "tAXUS Woman" analysis

Objectives: We conducted the "TAXUS Woman" analysis to assess the influence of sex on long-term outcomes after percutaneous coronary intervention using paclitaxel-eluting stents (PES) in a broad spectrum of patients. Background Previous studies indicate that the sex gap suggesting worse outcomes in women has narrowed. However, limited data are available on long-term sex-based outcomes with drug-eluting stents despite their extensive use in current practice. Methods We analyzed 2,271 PES-treated patients (women = 665), from 5 randomized trials and 7,492 PES-treated patients (women = 2,449) from 2 "real-world" registries. The trial and registry datasets were stratified by sex to compare long-term outcomes. Additionally, the outcomes in PES-treated women were compared with bare-metal stenttreated women (n = 395) in the randomized trials. Results In the randomized trials, PES-treated women had a lower target lesion revascularization (TLR) rate (11.5% vs. 22.6%, p <0.001) than bare-metal stenttreated women, with no significant sex-based differences in death, myocardial infarction, stent thrombosis, or TLR through 5 years. In both the trials and the registries, although women had more adverse baseline characteristics including advanced age, hypertension, and diabetes, they had similar outcomes to men. In expanded-use patients, however, women showed significantly higher rates of death and TLR, although only the higher TLR rate was confirmed by multivariate analysis. Conclusions This study of nearly 10,000 patients including more than 3,000 women demonstrates that despite their higher-risk profile, women have comparable benefits to men from percutaneous coronary intervention with PES except for a slightly higher revascularization rate in the high-risk cohort.