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.