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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).

Original publication




Journal article


JACC Cardiovasc Interv

Publication Date





301 - 310


Aged, Angioplasty, Balloon, Coronary, Cardiovascular Diseases, Coronary Angiography, Coronary Restenosis, Coronary Stenosis, Drug-Eluting Stents, Europe, Evidence-Based Medicine, Female, Humans, Logistic Models, Male, Middle Aged, Myocardial Infarction, Odds Ratio, Predictive Value of Tests, Prosthesis Design, Randomized Controlled Trials as Topic, Risk Assessment, Risk Factors, Sex Factors, Thrombosis, Time Factors, Treatment Outcome