Impact of patient sex and dual antiplatelet therapy duration on 10-year mortality following percutaneous coronary intervention with drug-eluting stents: A post-hoc analysis of the ISAR-SAFE trial

Background Women are underrepresented in cardiovascular clinical trials and evidence regarding sex-specific long-term outcomes after percutaneous coronary intervention (PCI) remains limited. Objectives To investigate the association between patient sex and duration of dual antiplatelet therapy (DAPT) with the 10-year prognosis of patients enrolled in the randomized, double-blind, placebo-controlled ISAR-SAFE trial. Methods This post-hoc analysis included 1871 patients from centers that participated in the ISAR-SAFE trial and agreed to collect 10-year follow-up data. In the ISAR-SAFE trial, a 6-month DAPT duration was compared with a 12-month DAPT regimen in patients treated with drug-eluting stents (DES). The primary endpoint of the present study was all-cause death at 10 years. Results Compared to men, women were older (69.0 ± 9.7 vs. 64.8 ± 10.4 years, P < 0.001), had lower body weight (72.1 ± 14.2 vs. 84.8 ± 13.5 Kg, P < 0.001) and a higher prevalence of arterial hypertension (93.2% vs. 89.3%, P = 0.031) and dyslipidemia (85.1% vs. 77.9%, P = 0.003). The 10-year mortality was 11.9% in women and 9.3% in men (hazard ratio [HR] 1.28 [95% confidence interval 0.91–1.81], P = 0.156). The 10-year mortality was 10.1% in the 6-month DAPT arm and 9.6% in the 12-month DAPT arm (HR 1.06 [0.79–1.42], P = 0.685). There was no significant interaction between sex and DAPT duration with respect to mortality. Age was the only independent predictor of mortality (adjusted HR per 1 year increase 1.08 [1.06–1.09]; P < 0.001). Conclusions Among patients undergoing PCI with DES implantation, neither patient sex nor duration of DAPT regimen were independently associated with 10-year all-cause mortality after adjustment for relevant clinical covariates.