Dabigatran Etexilate: Pivotal Trials for Venous Thromboembolism Prophylaxis After Hip or Knee Arthroplasty
Bibliographic record
Abstract
Dabigatran etexilate, an oral direct thrombin inhibitor, was investigated in 3 large phase III trials for the prevention of venous thromboembolism (VTE) after total hip arthroplasty (RE-NOVATE, N = 3494) or total knee arthroplasty (RE-MODEL, N = 2076 and RE-MOBILIZE, N = 2615). RE-NOVATE and RE-MODEL were conducted mainly in Europe, and RE-MOBILIZE was conducted predominantly in the United States and Canada. This review discusses the results of these trials. In all 3 trials, 2 doses, 220 mg and 150 mg once daily, were compared with enoxaparin. Both RE-MODEL and RE-NOVATE demonstrated noninferiority for the primary outcome (a composite of total VTE events and all-cause mortality), P = .0003 and P < .0001, respectively, for these trials. In 2008, these data formed the basis for European and Canadian approval. While RE-MOBILIZE did not demonstrate noninferiority for the primary outcome (25.3% for enoxaparin vs 31.1% for 220 mg, risk difference +5.8%, 95% CI, 0.8-10.8; P = .02 and 33.7% for 150 mg, risk difference +8.4%, 95% CI, 3.4-13.3; P = .0009), both treatments were similar for the secondary composite outcome (major VTE plus VTErelated mortality; 3.4% with 220 mg, 3.0% with 150 mg, and 2.2% with enoxaparin) and symptomatic deep vein thrombosis (0.8%, 0.7%, and 0.6%). There were no differences in the bleeding rates, hepatic enzyme elevations, or acute coronary syndrome events between the 2 treatments. With the practical advantages of once-daily oral dosing, dabigatran etexilate can be considered an attractive alternative to conventional thromboprophylaxis regimens in patients undergoing elective total hip and knee arthroplasty.
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 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 | 0.004 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.018 | 0.004 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.001 | 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; both teacher heads agree on what is shown here.
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".