Aspirin Dosing for Secondary Prevention of Atherosclerotic Cardiovascular Disease in Male and Female Patients: A Secondary Analysis of the ADAPTABLE Randomized Clinical Trial
Authors' conclusion
In this secondary analysis of the ADAPTABLE trial, there were no significant sex-specific differences in the effectiveness and safety of 2 aspirin doses for secondary prevention of ASCVD events.
Study context
- Population
- Adults with chronic, stable established atherosclerotic cardiovascular disease (ASCVD)4,724 female
- Participants
- 15,076 adults
- Comparison
- Aspirin 81 mg vs 325 mg daily, by sex
- Primary endpoint
- All-cause death and hospitalisation for myocardial infarction (MI) or stroke; safety: hospitalisation for major bleeding requiring transfusion
Methodological detailsopen-label, pragmatic, 40 medical centres and 1 health plan, Median follow-up 26.2 (19.0-34.9) months
- Open-label
- Pragmatic
- 40 medical centres and 1 health plan
- Median follow-up 26.2 (19.0-34.9) months
Primary result
As reported in the abstract
- Primary effectiveness outcome in female participants
- 379 (8.1%)
- Primary effectiveness outcome in male participants
- 780 (7.1%)
- Female: aHR between the 2 aspirin doses
- 1.01 (95% CI 0.82-1.26)
- Male: aHR between the 2 aspirin doses
- 1.06 (95% CI 0.91-1.23)
- No significant interaction by sex
- P interaction term for sex = .74
Further findings
| Outcome | aHR (95% CI) | P value | |
|---|---|---|---|
| Revascularisation, femalevs male237 [5.0%] vs 680 [6.6%] | 0.79 (0.68–0.92) | P = 0.002 | |
| Hospitalisation for stroke, femalevs male | 1.72 (1.27–2.33) | P < 0.001 | |
| 0.512Adjusted hazard ratio (log scale) |
Aspirin dose adherence by sex
- No significant differences between female and male participants
Safety
| Outcome | 81 mg | 325 mg | aHR (95% CI) | |
|---|---|---|---|---|
| Bleeding, female participants | 0.83% | 0.52% | 2.21 (1.04–4.70) | |
| 0.20.5125Adjusted hazard ratio (log scale) |
- Bleeding, female participants: interaction P = .07
Original publication
Aspirin Dosing for Secondary Prevention of Atherosclerotic Cardiovascular Disease in Male and Female Patients: A Secondary Analysis of the ADAPTABLE Randomized Clinical Trial. JAMA Cardiol. Published 1 September 2024. doi:10.
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