Impact of sex on clinical and angiographic outcomes among patients undergoing revascularization with drug-eluting stents.
Stefanini GG., Kalesan B., Pilgrim T., Räber L., Onuma Y., Silber S., Serruys PW., Meier B., Jüni P., Windecker S.
OBJECTIVES: The goal of this study was to investigate sex-based differences in long-term clinical and angiographic outcomes after coronary revascularization with drug-eluting stents (DES). BACKGROUND: The impact of sex on clinical and angiographic outcomes following revascularization with DES is not well established. METHODS: Individual patient data from 3 all-comers randomized DES trials (SIRTAX, LEADERS, RESOLUTE All-Comers) were pooled. 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. RESULTS: 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 to 1.56, p = 0.44), cardiac death (OR: 1.04, 95% CI: 0.61 to 1.80, p = 0.87), and MI (OR: 1.07, 95% CI: 0.75 to 1.53, p = 0.71) at 2 years. Similarly, risks of target lesion revascularization (OR: 1.09, 95% CI: 0.77 to 1.54, p = 0.62), target vessel revascularization (OR: 0.88, 95% CI: 0.63 to 1.22, p = 0.43), and definite or probable stent thrombosis (OR: 0.73, 95% CI: 0.38 to 1.38, p = 0.33) 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. 0.20 ± 0.99 mm, p = 0.76) and in-segment binary restenosis (8.5% vs. 8.5%, p = 0.76). CONCLUSIONS: The unrestricted use of DES is associated with similar long-term safety and efficacy among women and men with coronary artery disease. (Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization [SIRTAX]; NCT00297661, LEADERS Trial Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS]; NCT00389220, RESOLUTE-III All-comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention [RESOLUTE All-Comers]; NCT00617084).