Heart failure & cardiomyopathiesRandomised controlled trial
Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure
- Randomised controlled trial
- double-blind
- placebo-controlled
- non-inferiority
- international
- multicentre (51 centres, 9 countries)
Enrolment July 2020 to September 2022; median follow-up 14 months
Authors' conclusion
In patients with advanced heart failure treated with a fully magnetically levitated LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes VKA, is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events.
Study context
- Population
- Patients with advanced HF implanted with a fully magnetically levitated LVAD589 analysed
- Participants
- 628 patients
- Comparison
- Placebo vs aspirin with VKA therapy
- Placebon = 314
- Aspirinn = 314reference
- Primary endpoint
- Survival free of major nonsurgical (>14 days after implant) hemocompatibility-related adverse events (stroke, pump thrombosis, major bleeding or arterial peripheral thromboembolism); non-inferiority of placebo, −10% margin
- Follow-up
- 12 months
Primary result
Alive and free of hemocompatibility events
Absolute between-group difference
6.0%
97.5% one-sided CI −1.6%
P < 0.001
By group
As reported in the abstract
Safety
| Outcome | RR (95% CI) | P value | |
|---|---|---|---|
| Nonsurgical bleeding events (principal secondary end point) | 0.66 (0.51–0.85) | P = 0.002 | |
| 0.512Relative risk (log scale) |
Stroke or other thromboembolic events
- No increase with aspirin avoidance
Original publication
Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure. JAMA. Published 12 December 2023. doi:10.1001/jama.2023.23204
Summarised from the published abstract; every number is checked against it