A Randomized Trial of Dabigatran Versus Warfarin in the Treatment of Acute Venous Thromboembolism (RE-COVER II)
Bibliographic record
Abstract
Abstract Abstract 205 Background: Dabigatran has been compared with warfarin for treatment of acute venous thromboembolism in one previous trial (RE-COVER). Based on the low rate of the primary outcome as the RE-COVER study was running, we undertook this replica study to confirm the results of RE-COVER, and to allow for more rigorous sub-group analyses. Methods: In a randomized, double-blind, double-dummy trial of 2568 patients with acute VTE, treated with low molecular weight or unfractionated heparin for 5 to 11 days, we compared dabigatran, 150 mg twice daily, with warfarin, dose-adjusted to an International Normalized Ratio of 2.0 and 3.0, each given for 6 months. Primary outcome was recurrent symptomatic, objectively confirmed venous thromboembolism and deaths related to venous thromboembolism during 6 months. Safety endpoints included bleeding events, acute coronary syndrome, elevated liver function tests, and adverse events. Results: Of 1279 patients randomized to dabigatran, 30 (2.4%) had recurrent VTE compared with 28 (2.2%) of 1289 patients randomized to warfarin; risk difference 0.2% (95% confidence interval [CI], −1.0 to 1.5); p<0.0001 for the pre-specified non-inferiority margin. The hazard ratio for dabigatran was 1.08 (95% CI, 0.64 to 1.80). Major bleeding occurred in 15 patients treated with dabigatran and 22 patients treated with warfarin (hazard ratio 0.69; 95% CI, 0.36 to 1.32) and any bleeding occurred in 200 versus 285 patients, respectively (hazard ratio 0.67, 95% CI, 0.56 to 0.81). The frequency of reported ACS events was less than 1% in the trial, with more cases in the dabigatran treatment group than those treated with warfarin. There were 25 deaths during each treatment, and serious adverse events were similar in the two groups. Analysis of outcomes based on demographic characteristics showed consistency of effects for both safety and efficacy. This included the analysis based on Asian race, which had been limited in RE-COVER. There were 537 Asian patients in RE-COVER II compared to only 65 in RE-COVER. The event rates of recurrent VTE and of any bleeding were similar in Asians and non-Asians. Conclusion: The study confirms that the efficacy of dabigatran is non-inferior to warfarin in the treatment of acute VTE and with a lower risk for bleeding. The safety of dabigatran is similar in the Asian population compared with non-Asians. Disclosures: Off Label Use: dabigatran for treatment of venous thromboembolism. Christiansen:Boehringer Ingelheim: Employment. Schnee:Boehringer Ingelheim: Employment.
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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 | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| 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".