Ximelagatran in Major Orthopedic Surgery: A Systematic Review and Meta-Analysis of Efficacy and Safety.
Bibliographic record
Abstract
Abstract Background. Venous thromboembolism (VTE) is a frequent complication of total hip (THR) and knee replacement (TKR). Current recommendations are to administer prophylaxis for at least 10 days with either low molecular weight heparin (LMWH), warfarin (warf) or fondaparinux. Ximelagatran (xim) might represent a convenient alternative not needing laboratory monitoring. Methods. We conducted a protocolized systematic review of randomized control trials evaluating the use of xim (7>d) for VTE prophylaxis in patients (pts) undergoing THR and TKR, screening MEDLINE, EMBASE, The Cochrane Library, and grey literature after 1980. Two reviewers assessed methodological quality using Jadad score and extracted data on outcomes (major VTE [proximal DVT, PE and death by PE], total VTE [assessed by venography], major bleeding and hepatic toxicity [ALT>3x upper normal limit at venography]). Results were pooled using a random effects model. Subgroup and sensitivity analyses were done for type of surgery, xim dose, comparator, initial use of SC melagatran (mel) and methodological quality. Results. Of 187 potentially relevant reports retrieved, 9 fulfilled the inclusion criteria. In total 13,756 pts were randomized to either xim (24>mg bid x 7–12 d; 6,379 pts in 4 trials received initial SC mel) or a comparator (8,472 pts LMWH, 5,284 warf). Pooled effect estimates of VTE and major bleeding in trials evaluating ximelagatran in orthopedic surgery Total Hip Replacement Total Knee Replacement OR(95% CI) p OR(95% CI) p NE Not evaluable. An OR < 1 favours xim; an OR > 1 favours comparator. All Studies Major VTE 0.76(0.29, 1.98) .58 0.68(0.53, 0.89) <0.001 Total VTE 0.88(0.50, 1.55) 0.65 0.71(0.63, 0.80) <0.001 Major Bleeding 1.70(0.78, 3.70) 0.18 1.38(0.86, 2.22) 0.19 Studies using SC melagatran Major VTE 1.49(1.20, 1.19) 0.12 0.53(0.33, 0.84) 0.008 Total VTE 0.70(0.36, 1.80) 0.31 0.77(0.61, 0.97) 0.03 Major Bleeding 2.05(0.81, 5.16) 0.13 1.12(0.55, 2.27) 0.76 Studies not using SC melagatran Major VTE NE NE 0.77(0.56, 1.06) 0.10 Total VTE NE NE 0.68(0.59, 0.78) <0.001 Major Bleeding NE NE 1.63(0.86, 3.10) 0.13 In THR pts there were no differences in the odds of major or total VTE or major bleeding between the xim and LMWH groups. In TKR pts xim seemed to be superior to the comparator for preventing total VTE, however subgroup analysis showed that this might be true only for pts receiving initial SC mel or else, xim 36 mg. bid compared to warf (OR 0.64; 95%CI 0.55, 0.75; p<0.001). In TKR pts xim was superior to LMWH for preventing major VTE only in the group receiving SC mel. Xim induced less cases of ALT elevation than LMWH and there were no differences when compared to warf Pooled effect estimates of short-term liver toxicity in trials evaluating ximelagatran in orthopedic surgery OR(95% CI) p An OR <1 favours xim; an OR >1 favours comparator. Xim vs LMWH 0.36(0.25, 0.52) <0.0001 Xim vs warf 0.81(0.30, 2.21) 0.69 Conclusion. Our results suggest that xim is not inferior to LMWH or warf for preventing VTE in patients undergoing THR or TKR and that in the latter it might even be superior to LMWH if initial SC mel is administered. Short-term liver toxicity seems to be less frequent in xim than in LMWH and no different from warf.
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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 | 0.013 | 0.027 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.018 | 0.029 |
| Bibliometrics | 0.006 | 0.007 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 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".