P1732Extended duration betrixaban in acutely ill medical patients is associated with reduction in fatal or irreversible ischemic or bleeding events compared with standard dose enoxaparin: an APEX substudy
Bibliographic record
Abstract
Background: Among acutely ill medical patients, extended duration betrixaban showed a significant reduction in venous thromboembolism in the extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients (APEX) trial. Given the variable clinical impact of some efficacy and safety events, one approach to assess net clinical outcomes is to include only events that are either fatal or cause irreversible harm. Methods: This was a post-hoc analysis of the APEX trial, a multicenter, randomized, double-blind, placebo-controlled trial that randomized 7,513 hospitalized acutely ill medical patients to extended duration betrixaban vs. standard of care enoxaparin. Net clinical outcomes were evaluated as a composite of all fatal or irreversible safety and efficacy events in a time-to-first event analysis. Safety events included fatal bleeding or intracranial hemorrhage, and efficacy events included cardiopulmonary death (venous thromboembolism and cardiac), myocardial infarction, pulmonary embolism, and ischemic stroke. Findings: In D-Dimer + patients, betrixaban reduced fatal or irreversible events at 35–42 days (4.80% vs 3.54%, HR=0.73, ARR 1.26%, NNT 79, p=0.033) and at study end at 77 days (6.27% vs 4.36%, HR=0.70, ARR 1.91%, NNT52, p=0.005) vs enoxaparin. In all patients, betrixaban was associated with a significant reduction in fatal or irreversible events at 35–42 days (4.08% vs 2.90%, HR = 0.71, ARR 1.18%, NNT=86, p=0.006) as well as through the end of the study follow-up (5.17% vs 3.64%, HR=0.70, ARR 1.53%, NNT 65, p=0.002) (Figure).
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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 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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 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".