Coronary disease & ACSSecondary analysis
Effectiveness and Safety of Enteric-Coated vs Uncoated Aspirin in Patients With Cardiovascular Disease
- Secondary analysis of the ADAPTABLE randomised trial
- post hoc
- pragmatic
- intention-to-treat
Authors' conclusion
In this post hoc secondary analysis of the ADAPTABLE randomized clinical trial, enteric-coated aspirin was not associated with significantly higher risk of myocardial infarction, stroke, or death or with lower bleeding risk compared with uncoated aspirin, regardless of dose, although a reduction in bleeding with enteric-coated aspirin cannot be excluded.
Study context
- Population
- Patients with atherosclerotic CVD in ADAPTABLE (randomised to aspirin 325 mg vs 81 mg daily) who reported aspirin formulation at baselineof 15,076 in ADAPTABLE
- Participants
- 10,678 patients
- Comparison
- Enteric-coated vs uncoated aspirin
- Enteric-coated aspirinn = 7,366
- Uncoated aspirinn = 3,312reference
- Primary endpoint
- Effectiveness: composite of MI, stroke or all-cause death; safety: major bleeding (hospitalization for bleeding with blood product use or intracranial hemorrhage)
- Follow-up
- Median 26.2 months
Primary result
As reported in the abstract
Adjusted hazard ratio
0.94
95% CI 0.80–1.09
P = 0.40
Enteric-coated aspirin vs Uncoated aspirin
AHR 0.94 (95% CI 0.80–1.09); P = 0.40
Further findings
| Outcome | AHR (95% CI) | |
|---|---|---|
| Effectiveness, aspirin dose within formulation (subgroup) — Enteric-coated aspirin vs Uncoated aspirin · dose effect within enteric-coated | 1.13 (0.88–1.45) | |
| Effectiveness, aspirin dose within formulation (subgroup) — Uncoated aspirin vs Uncoated aspirin · dose effect within uncoated | 0.99 (0.83–1.18) | |
| 0.512Adjusted hazard ratio (log scale) |
- Effectiveness, aspirin dose within formulation (subgroup): interaction P = .41
Safety
| Outcome | AHR (95% CI) | P value | |
|---|---|---|---|
| Major bleeding (primary safety end point) | 0.82 (0.49–1.37) | P = 0.46 | |
| Major bleeding, aspirin dose within formulation (subgroup) — Enteric-coated aspirin vs Uncoated aspirin · dose effect within enteric-coated | 2.37 (1.02–5.50) | ||
| Major bleeding, aspirin dose within formulation (subgroup) — Uncoated aspirin vs Uncoated aspirin · dose effect within uncoated | 0.89 (0.49–1.64) | ||
| 0.20.5125Adjusted hazard ratio (log scale) |
- Major bleeding, aspirin dose within formulation (subgroup): interaction P = .07
Original publication
Effectiveness and Safety of Enteric-Coated vs Uncoated Aspirin in Patients With Cardiovascular Disease. JAMA Cardiol. Published 1 November 2023. doi:10.1001/jamacardio.2023.3364
Summarised from the published abstract; every number is checked against it