Key result
Female gender was associated with a lower rate of major adverse cardiac events at 5 years compared to male gender (4.7% vs. 8.4%, P=0.004) after sirolimus-eluting stenting.
Why the study?
Does gender affect the 5-year rate of MACE in patients receiving biodegradable polymer-coated sirolimus-eluting stents?
Cohort (n=2,077)
Yes
Does gender affect the 5-year rate of MACE in patients receiving biodegradable polymer-coated sirolimus-eluting stents?
Absolute Event Rate: 4.7% vs 8.4%
p-value: p=0.004
Women had a lower rate of MACE and cardiac death than men at 5 years after biodegradable polymer-coated sirolimus-eluting stenting, despite having more baseline clinical risk factors.
May indicate gender differences in long-term stent outcomes; leaves open prospective validation for biodegradable polymer sirolimus-eluting stents.
BACKGROUND: The gender difference on long-term outcome in unselected patients after percutaneous coronary intervention (PCI) has not yet been fully investigated. This study aimed to evaluate the gender difference on five-year outcomes following EXCEL biodegradable polymer-coated sirolimus-eluting stenting in patients with coronary disease. METHODS: A total of 2077 "all comers", consisting of 1528 (73.6%) men and 549 (26.4%) women, who were exclusively treated with EXCEL coronary stents were enrolled in the prospective CREATE study at 59 centers from four countries. After propensity score matching, the baseline characteristics of the two groups were well matched. Recommended antiplatelet regimen was clopidogrel and aspirin for six months followed by chronic aspirin therapy. The primary outcome that was the rate of major adverse cardiac events (MACE), defined as a composite of cardiac mortality, non-fatal myocardial infarction (MI) and target lesion revascularization (TLR), and stent thrombosis (ST) at five years were compared between the two gender groups. RESULTS: In the two groups, women had higher proportions of clinical risk factors, such as being elderly, diabetes mellitus, hypertension and hyperlipidemia, compared to men. Besides, the mean target vessel number per patient was higher and the mean reference vessel diameter smaller for women. Men had higher risks of cardiac death (3.7% vs. 1.6%, P = 0.021) and MACE (8.4% vs. 4.7%, P = 0.004) at five years compared with women. However, the cumulative hazards of non-fatal MI and TLR were similar between men and women. The incidence of Academic Research Consortium (ARC) definite or probable stent thrombosis was similar between the two groups (1.3% vs. 1.0%, P = 0.639). Prolonged clopidogrel therapy (>6 months) did not reduce the cumulative hazards of ST from six months to five years in both men (χ(2) = 0.098, log rank P = 0.754) and women (χ(2) = 2.043, log rank P = 0.153) patients. CONCLUSIONS: Women had a lower MACE and cardiac death rate than men after biodegradable polymer-coated sirolimus-eluting stenting in long term follow-up. Effects of prolonged dual antiplatelet therapy (DAPT) in preventing stent thrombosis was similar with six-month DAPT after EXCEL stent implantation in both men and women groups.
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Zhang et al. (2013) conducted a cohort in Coronary disease (n=2,077). Female gender vs. Male gender was evaluated on Major adverse cardiac events (MACE), defined as a composite of cardiac mortality, non-fatal myocardial infarction (MI) and target lesion revascularization (TLR) (p=0.004). Female gender was associated with a lower rate of major adverse cardiac events at 5 years compared to male gender (4.7% vs. 8.4%, P=0.004) after sirolimus-eluting stenting.
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