Abbreviated or Standard Dual Antiplatelet Therapy by Sex in Patients at High Bleeding Risk: A Prespecified Secondary Analysis of a Randomized Clinical Trial
Authors' conclusion
These findings suggest that women with HBR did not experience higher rates of ischemic or bleeding events compared with men and may derive particular benefit from abbreviated compared with standard DAPT owing to these numerically lower rates of events.
Study context
- Population
- Patients at high bleeding risk randomised 1 month after percutaneous coronary intervention (PCI)1,408 women · 3,171 men
- Participants
- 4,579 patients
- Comparison
- Abbreviated vs standard DAPT, by sex
- Primary endpoint
- NACE (death, MI, stroke or major bleeding), MACCE (death, MI or stroke) and major or clinically relevant nonmajor bleeding (MCB)
- Follow-up
- 1 year
Methodological detailsmulticentre, open-label, 140 sites in 30 countries
- Multicentre
- Open-label
- 140 sites in 30 countries
Primary result
As reported in the abstract
NACE by sex
Abbreviated DAPT vs Standard DAPTHazard ratio (95% CI)
Men
0.97(0.75–1.24)
Women
0.87(0.60–1.26)
Further findings
MACCE by sex (subgroup) · 1 year
- Women: trend toward benefit with abbreviated vs standard DAPT, HR
- 0.68 (95% CI 0.44-1.05)
- Men: no benefit with abbreviated vs standard DAPT, HR
- 1.17 (95% CI 0.88-1.55)
- Heterogeneity of treatment effect by sex
- P = .04 for interaction
NACE, MACCE and MCB in patients with ACS and/or complex PCI
- Results remained consistent
Safety
| Outcome | HR (95% CI) | |
|---|---|---|
| MCB by sex · 1 year — Abbreviated DAPT vs Standard DAPT · men | 0.65 (0.50–0.84) | |
| MCB by sex · 1 year — Abbreviated DAPT vs Standard DAPT · women | 0.77 (0.53–1.12) | |
| 0.512Hazard ratio (log scale) |
- MCB by sex: P = .46 for interaction
Original publication
Abbreviated or Standard Dual Antiplatelet Therapy by Sex in Patients at High Bleeding Risk: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. Published 1 January 2024. doi:10.
Summarised from the published abstract; every number is checked against it