Abstract 213: Effect of Idarucizumab on Intracranial Bleeding in Dabigatran-treated Patients: Initial Results From RE-VERSE AD
Bibliographic record
Abstract
Introduction: Dabigatran is a non-vitamin K antagonist oral anticoagulant (NOAC) licensed for stroke prevention in nonvalvular atrial fibrillation. In the RE-LY trial, both doses of dabigatran (110 mg and 150 mg bid) were associated with a significantly lower annualized rate of intracranial hemorrhage (ICH) than warfarin (0.23%, 0.32% and 0.76%, respectively). Nonetheless, the mortality rate with ICH in the context of any anticoagulation remains high, probably reflecting the effects of hematoma expansion. Whether a specific reversal agent for dabigatran will improve clinical outcomes in dabigatran-treated patients with ICH is unknown. RE-VERSE AD is an ongoing, open-label, phase 3, cohort study evaluating the extent to which idarucizumab, a humanized Fab fragment directed against dabigatran, reverses the latter’s anticoagulant effects in patients with serious bleeding or in those requiring urgent interventions. This study focuses on the results in patients with ICH. Hypothesis: Compared with historical controls, idarucizumab improves clinical outcomes in dabigatran-treated patients with ICH. Methods: Patients presenting with ICH were given intravenous idarucizumab 5 g as two 2.5 g bolus infusions administered no more than 15 minutes apart. The primary endpoint was the maximum reversal of the anticoagulant effect of dabigatran, based on central laboratory determination of the dilute thrombin time or ecarin clotting time. Results: In an interim analysis at 90 patients, 18 with ICH had been enrolled in RE-VERSE AD. Updated results on the effects of idarucizumab on coagulation parameters, imaging studies, and clinical outcomes in this patient subgroup will be presented. Conclusions: Currently, there are no specific reversal agents for the NOACs. We present the first data on the clinical outcomes for idarucizumab in dabigatran-treated patients who present with ICH.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".