Heart failure & cardiomyopathies
Withdrawal of aspirin in patients with left ventricular assist device treated with vitamin K antagonists: impact of anticoagulation quality in the randomized ARIES-HM3 trial
Authors' conclusion
The quality of VKA management as measured by TTR correlates with the occurrence of non-surgical bleeding in patients with the HM3 LVAD, with a lower TTR associated with an increased bleeding risk.
Study context
- Population
- Patients with de-novo HeartMate 3 LVAD on vitamin K antagonists (VKA), randomised to aspirin (100 mg/day) or placebo
- Participants
- 554 patients
- Comparison
- High time in therapeutic range (TTR) vs low TTR in patients with HM3 LVAD
- Primary endpoint
- Primary endpoint success, stratified by TTR group
Methodological detailspre-specified analysis, international, double-blind, placebo-controlled
- Pre-specified analysis
- International
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Primary endpoint success
P = 0.01
Secondary outcomes
Predictors of low TTR
| OR (95% CI) | ||
|---|---|---|
| Female sex | 1.70 (1.12–2.57) | |
| Black race | 1.62 (1.11–2.35) | |
| 0.20.5125Odds ratio (log scale) |
TTR interaction with assigned treatment (aspirin vs placebo)
- No interaction between assigned treatment group and TTR
Safety
Bleeding, by TTR (higher vs lower) · 12 months
- Higher TTR vs lower TTR: bleeding rate
- 26.4 vs 49.2 events per 100 participant-years
- Bleeding rate ratio
- 1.84 (1.37-2.53) (95% CI)
- No interaction between assigned treatment and TTR
Stroke, by TTR (higher vs lower)
- Higher TTR vs lower TTR: stroke rate
- 3.2 vs 2.8 events per 100 participant-years
- Stroke rate ratio
- 0.88 (0.30-2.53) (95% CI)
- No stroke increase with higher TTR
Original publication
Withdrawal of aspirin in patients with left ventricular assist device treated with vitamin K antagonists: impact of anticoagulation quality in the randomized ARIES-HM3 trial. Eur Heart J. Published 7 November 2025. doi:10.
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