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
Bibliographic record
Abstract
BACKGROUND AND AIMS: Left ventricular assist devices (LVADs), including the HeartMate 3 (HM3), have improved outcomes in patients with advanced heart failure. Use of vitamin K antagonists (VKA) is mandated to reduce the risk of thrombotic events, but there is heterogeneity in management. Time in therapeutic range (TTR) is a crucial metric for assessing the quality of VKA management. The ARIES-HM3 trial demonstrated that aspirin can be safely omitted from the antithrombotic regimen, resulting in reduced bleeding without increased thrombosis. This pre-specified trial analysis explores the relationship of quality of VKA management assessed by TTR with haemocompatibility-related outcomes. METHODS: ARIES-HM3 was an international, randomized, double-blind, placebo-controlled study of aspirin (100 mg/day) or placebo (1:1) with VKA therapy in patients with de-novo HM3 placement. Participants were stratified into low TTR or high TTR groups based on median levels (n = 554). Primary endpoint success and secondary endpoint rates were stratified based on TTR groups. Bleeding rates at 12 months were estimated using an Andersen-Gill model with TTR as a single continuous variable, and multivariable regression analysis was performed. RESULTS: The percentage of patients with a TTR above or below the median of 56 was similar between the aspirin and placebo groups. More participants achieved primary endpoint success with TTR ≥56% (77% vs 66.9%, P = .01). Higher TTR was associated with lower bleeding rates at 12 months (26.4 vs 49.2 events per 100 participant-years; rate ratio 1.84, 95% confidence interval [CI] 1.37-2.53) without stroke increase (3.2 vs 2.8 events per 100 participant-years; rate ratio 0.88 [95% CI: 0.30-2.53]). No interaction was observed between the assigned treatment group and TTR. Modelling demonstrated a constant decrease in bleeding as a function of increasing TTR. Female sex and Black race were independent predictors of low TTR (odds ratio: 1.70 [95% CI: 1.12-2.57]; 1.62 [95% CI: 1.11-2.35], respectively), with more frequent INRs below the therapeutic range. Multivariable modelling identified age ≥65 years, aspirin use, TTR <56%, and blood urea nitrogen ≥30 mg/dL as predictors of non-surgical bleeding. CONCLUSIONS: 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. These data provide new clinical direction to define a benchmark TTR to achieve further mitigation of residual risk of bleeding and enhance haemocompatibility with the HM3 LVAD.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".