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Sex Differences in 10-Year Outcomes After DES PCI
Quick Takes
- After statistical adjustment for differences in age, female and male patients appear to have comparable 10-year cardiovascular mortality after DES PCI.
- Implications of the findings of increased risk of early MI (within the first 30 days after the index procedure) and a reduced incidence of repeat revascularization over follow-up remain unclear and will need further study.
Study Questions:
Are there sex-related differences in long-term outcomes after drug-eluting stent (DES) percutaneous coronary intervention (PCI)?
Methods:
Individual data of patients treated with DES in five randomized controlled trials with 10-year follow-up were pooled. Patients were divided into two groups by sex. The analysis of individual participant data was performed using a one-stage approach by entering a clustering effect by parent study in all univariable and multivariable models focusing on sex. The main outcomes of interest for this analysis included cardiovascular death, myocardial infarction (MI), repeat revascularization, and definite stent thrombosis to 10 years after PCI. Survival was analyzed by the Kaplan-Meier method to estimate the time to first event, and differences between the two groups were tested with the log-rank test. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated with a Cox proportional hazards model. Conventional multivariable analyses with adjustment for relevant variables were performed.
Results:
Among 9,700 patients undergoing PCI with DES implantation included in the present analysis, 2,296 were women and 7,404 were men. Through to 10 years, cardiovascular death occurred in 407 of the 2,296 female patients and 1,012 of the 7,404 male patients (adjusted HR [aHR], 0.94; 95% confidence interval [CI], 0.80–1.11). Female sex was associated with a lower risk of repeat revascularization of the target lesion (aHR, 0.80; 95% CI, 0.74–0.87), target vessel (aHR, 0.81; 95% CI, 0.76–0.87), and nontarget vessels (aHR, 0.69; 95% CI, 0.62–0.77). Compared with male patients, female patients displayed an increased risk of MI in the first 30 days after PCI with DES (aHR, 1.65; 95% CI, 1.24–2.19) but a comparable risk of MI thereafter. The risk of definite stent thrombosis was not significantly different between female and male patients (aHR, 1.14; 95% CI, 0.89–1.47).
Conclusions:
Through to 10-year follow-up after PCI with DES, female patients are at increased risk of early MI, receive fewer repeat revascularizations, and have no difference in cardiovascular mortality compared with male patients.
Perspective:
The authors present a post hoc analysis of individual patient data from randomized trials evaluating clinical outcomes (cardiovascular death, MI, repeat revascularization, and definite stent thrombosis) at 10 years. After statistical adjustment for differences in age, female and male patients appear to have comparable 10-year cardiovascular mortality after DES PCI. Implications of the findings of increased risk of early MI (within the first 30 days after the index procedure) and a reduced incidence of repeat revascularization over follow-up remain unclear and will need further study.
Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery
Keywords: Drug-Eluting Stents, Myocardial Infarction, Myocardial Revascularization, Outcome Assessment, Health Care, Percutaneous Coronary Intervention, Sex Characteristics, Stents, Thrombosis
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