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Safety and Efficacy of Drug-Eluting Stents in Women: A Patient-Level Pooled Analysis of Randomised Trials
Study Questions:
How does the safety and efficacy of drug-eluting stents (DES) in the treatment of coronary artery disease compare to bare-metal stents among women?
Methods:
The study population compared women who were enrolled in randomized controlled trials identified through the Gender Data Forum. Data from 26 randomized trials of DES were pooled. Outcomes were analyzed by stent type (bare-metal stents, early-generation DES, and newer-generation DES). The primary safety endpoint was a composite of death or myocardial infarction. The secondary safety endpoint was definite or probable stent thrombosis. The primary efficacy endpoint was target lesion revascularization. Analysis was by intention to treat.
Results:
A total of 43,904 patients were included in the 26 trials of DES used for the present analysis. Of this cohort, 11,557 (26.3%) were women (mean age 67.1 years; standard deviation [SD] 10.6): 1,108 (9.6%) women received bare-metal stents, 4,171 (36.1%) early-generation DES, and 6,278 (54.3%) newer-generation DES. Mean follow-up was 2.9 years (SD 1.4) for the overall cohort, and 3.3 years (SD 1.5) in the bare-metal stent group, 3.2 years (SD 1.4) in the early-generation DES group, and 2.6 years (SD 1.4) in the newer-generation DES. At 3 years, estimated cumulative incidence of the composite of death or myocardial infarction occurred in 132 (12.8%) women in the bare-metal stent group, 421 (10.9%) in the early-generation DES group, and 496 (9.2%) in the newer-generation DES group (p = 0.001). Definite or probable stent thrombosis occurred in 13 (1.3%), 79 (2.1%), and 66 (1.1%) women in the bare-metal stent, early-generation DES, and newer-generation DES groups, respectively (p = 0.01). The use of DES was associated with a significant reduction in the 3-year rates of target lesion revascularization (197 [18.6%] women in the bare-metal stent group, 294 [7.8%] in the early-generation DES group, and 330 [6.3%] in the newer-generation DES group, p < 0.0001). These results did not change after adjustment for baseline characteristics in the multivariable analysis.
Conclusions:
The investigators concluded that the use of DES in women is more effective and safe than is use of bare-metal stents during long-term follow-up. Newer-generation DES are associated with an improved safety profile compared with early-generation DES, and should therefore be thought of as the standard of care for percutaneous coronary revascularization in women.
Perspective:
Data on gender-related safety and efficacy outcomes are needed to understand management of heart disease in women. This large-scale pooled analysis suggests that DES are safe and effective in women.
Keywords: Coronary Restenosis, Health Resources, Drug-Eluting Stents, Sirolimus, Stents
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