Abstract 18594: Efficacy of Dabigatran versus Warfarin in Patients With Acute Venous Thromboembolism and Thrombophilia: A Pooled Analysis of RE-COVER™ and RE-COVER™ II
Bibliographic record
Abstract
Objectives: In the RE-COVER™ and RE-COVER™ II trials, dabigatran etexilate (DE) compared with warfarin in patients with acute venous thromboembolism (VTE) resulted in similar rates of recurrent VTE/VTE-related death with fewer bleeding events. From the pooled RE-COVER™ and RE-COVER™ II trial data, we assessed the hypothesis that the efficacy of DE versus warfarin would be similar in the subgroup of patients with thrombophilia, a known risk factor for VTE recurrence. Methods: In both studies, patients with symptomatic proximal deep vein thrombosis or pulmonary embolism (PE) were randomized to warfarin or warfarin-placebo plus parenteral anticoagulation for ≥ 5 days until the international normalized ratio (INR) was ≥ 2 at two consecutive measurements. Parenteral therapy was then discontinued and patients continued warfarin (target INR range 2.0-3.0) or received DE 150 mg twice-daily for 6 months (double-dummy, oral-only treatment period). The primary efficacy outcome was recurrent, symptomatic, objectively confirmed VTE/VTE-related death from randomization up to the end of the prespecified post-treatment follow-up (6 months + 30 days). Outcomes were centrally adjudicated. Results: Overall, 209/2553 (8.2%) patients randomized to DE and 199/2554 (7.8%) randomized to warfarin had thrombophilia identified at baseline; Factor V Leiden thrombophilia was the most common type (Table). The frequency of VTE/VTE-related deaths or of PE was lower with DE versus warfarin in patients with thrombophilia, but was not statistically different (Table). The treatment efficacy was not significantly affected by the presence of thrombophilia. Conclusions: In patients with acute VTE and thrombophilia, there was a lower frequency of VTE/VTE-related deaths or of PE with DE versus warfarin, but the difference was not statistically significant. The treatment efficacy was not significantly affected by the presence of thrombophilia.
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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 | 0.014 | 0.014 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.009 | 0.019 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| 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".