Key result
Drug-eluting stents reduced MACE compared to bare-metal stents in women (6.1% vs 14.7%; HR 0.36, 95% CI 0.24-0.54) and men (7.7% vs 12.1%; HR 0.62, 95% CI 0.50-0.77) (P=0.02 for interaction).
Why the study?
Inference regarding DES superiority over BMS in women has been limited by low enrolment rates of women in clinical trials.
Do drug-eluting stents reduce major adverse cardiac events compared with bare-metal stents in women and men requiring stenting of large coronary arteries?
Meta-Analysis (n=4,605)
randomised
Yes
Do drug-eluting stents reduce major adverse cardiac events compared with bare-metal stents in women and men requiring stenting of large coronary arteries?
Hazard Ratio: 0.36 (95% CI 0.24–0.54)
Absolute Event Rate: 6.1% vs 14.7%
p-value: p=0.02 for sex-stent interaction
In patients requiring stenting of large coronary arteries, drug-eluting stents significantly reduced major adverse cardiac events compared to bare-metal stents in both sexes, with a more pronounced benefit observed in women.
Background: Drug-eluting stents (DES) have proven superior to bare-metal stents (BMS) in terms of safety and efficacy. However, inference to the female subgroup has been limited by low enrolment rates of women in clinical trials. The objective of this study was to investigate the safety and efficacy of DES versus BMS in women and men. Methods: In a pooled analysis of two all-comers randomised trials (Basel Stent Kosten-Effektivitäts Trial-Prospective Validation Examination (BASKET-PROVE) and BASKET-PROVE II) (n=4605), we examined safety and efficacy of DES versus BMS according to sex. Patients were followed 2 years for a composite endpoint of cardiac death, non-fatal myocardial infarction (MI) and clinically driven target-vessel revascularisation not related to MI. Results: Among the 1076 women and 3529 men included in the analysis, 65.6% of the women and 67.2% of the men were randomised to receive DES. At baseline, men had more complex coronary artery disease than women. After 2 years, DES reduced rates of major adverse cardiac events (MACE) compared with BMS in both women (cumulative incidence, 6.1% vs 14.7%; adjusted HR 0.36 (95% CI 0.24 to 0.54)) and men (7.7 vs 12.1%, HR 0.62 (0.50 to 0.77)), although the reduction in MACE rates was more pronounced in women (adjusted p=0.02 for sex-stent interaction). Event rates were lower in DES for both safety and efficacy outcomes, with the largest effect seen for non-MI TVR, in both women (2.3 vs 9.2%, adjusted HR 0.24 (0.13 to 0.44)) and men (4.0 vs 7.8%, adjusted HR 0.48 (0.36 to 0.64)) (adjusted p=0.049 for sex-stent interaction). Conclusions: In patients requiring stenting of large coronary arteries, DES were associated with improved safety in women and superior efficacy in both sexes as compared with BMS.
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Bjerking et al. (2019) conducted a meta-analysis in Coronary artery disease requiring stenting of large vessels (n=4,605). Drug-eluting stents (DES) vs. Bare-metal stents (BMS) was evaluated on Composite of cardiac death, non-fatal myocardial infarction (MI) and clinically driven target-vessel revascularisation not related to MI (MACE) in women (adjusted HR 0.36, 95% CI 0.24 to 0.54, p=0.02 for sex-stent interaction). Drug-eluting stents reduced MACE compared to bare-metal stents in women (6.1% vs 14.7%; HR 0.36, 95% CI 0.24-0.54) and men (7.7% vs 12.1%; HR 0.62, 95% CI 0.50-0.77) (P=0.02 for interaction).
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