Sex-based influence on clinical outcomes after drug-eluting stent implantation in real-world patients: insight from the FOCUS registry.

OBJECTIVES: To investigate the impact of sex on clinical outcomes after drug-eluting stent (DES) implantation in real-world patients.

METHODS AND RESULTS: A total number of 4720 patients (3365 males and 1355 females) undergoing the second-generation cobalt-chromium sirolimus-eluting stent (CoCr-SES) implantation from the FOCUS registry were included in this analysis. The cumulative incidences of major adverse cardiovascular event (MACE) (1.5% vs. 2.4%; p = .03), cardiovascular death (0.5% vs. 1.0%; p = .02) and target vessel revascularization (TVR) (0.3% vs. 0.8%; p = .01) within six months were significantly higher in females and the risks of MACE (adjusted hazard ratio [HR] 0.5 (0.3-0.9); p = .01) and TVR (adjusted HR 0.1(0.0-0.5); p = .001) remained significant in multivariate analysis. Reversely, the cumulative incidences of MACE (5.4% vs. 4.8%; p = .04) and any revascularization (5.1% vs. 3.3%; p = .01) were significantly higher in males beyond six months and the risks of all-cause death (adjusted HR 1.6 (1.1-2.5); p = .03) and cardiovascular death (adjusted HR 1.9 (1.1-3.6); p = .03) turned out to be significant in multivariate analysis. Notes: All cumulative incidences were presented as male vs. female; all HRs were calculated as male relative to female.

CONCLUSIONS: Females were associated with higher risk of early adverse events, while, males were associated with higher risk of late adverse events. Key messages Females undergoing PCI are typically older, have more cardiovascular risk factors, while, males in need of PCI are more frequently associated with complex lesions. The overall three-year cumulative incidences of adverse events are not significantly different between males and females but numerically higher in males. Females are associated with significantly higher risks of MACE and TVR within six months, while, males are associated with significantly higher risk of all-cause mortality and cardiac mortality beyond 6 months.