| Outcome | Domains Pertaining to SOE | Effect Estimate (95% CI) | SOE | |||
|---|---|---|---|---|---|---|
| Number of Studies (Subjects) | Study Design/Quality | Consistency Directness | Precision Publication Bias | |||
| FXa vs. LMWHa | ||||||
| Mortality (up to 10 weeks) | 11 (22,838) | RCT/Good | Consistent Direct | Precise None detected | OR=0.95 (0.55 to 1.63) RD=0 (2 fewer to 1 more) deaths/1000 patients | High |
| Symptomatic DVT (up to 5 weeks) | 18 (22,877) | RCT/Good | Consistent Direct | Precise None detected | OR=0.46 (0.30 to 0.70) RD=4 fewer (3 to 6 fewer) events/1000 patients | High |
| Nonfatal PE (up to 5 weeks) | 20 (26,998) | RCT/Good | Consistent Direct | Precise None detected | OR=1.07 (0.65 to 1.73) RD=0 (1 fewer to 2 more) events/1000 patients | High |
| Major bleeding (up to 5 weeks) | 21 (31,424) | RCT/Good | Inconsistent Direct | Precise None detected | OR=1.27 (0.98 to 1.65) RD=2 more (0 to 4 more) events/1000 patients | Moderate |
| LMWH vs. DTIb | ||||||
| Mortality (up to 13 weeks) | 4 (10,080) | RCT/Good | Inconsistent Direct | Imprecise None detected | TKR RR=1.06 (0.36 to 3.12) RD=0 (2 fewer to 6 more) events/1000 patients THR RR=1.17 (0.04 to 36.52) RD=0 (3 fewer to 107 more) events/1000 patients | Low |
| Symptomatic DVT (up to 5 weeks) | 4 (10,264) | RCT/Good | Consistent Direct | Imprecise None detected | RR=0.82 (0.17 to 3.99) RD=2 fewer (7 fewer to 27 more) events/1000 patients | Low |
| Symptomatic PE (up to 5 weeks) | 4 (10,264) | RCT/Good | Consistent Direct | Imprecise None detected | OR=0.69 (0.31 to 1.54) RD=1 fewer (2 fewer to 2 more) events/1000 patients | Low |
| Major bleeding (up to 5 weeks) | 4 (10,264) | RCT/Good | Consistent Direct | Imprecise None detected | RR=0.94 (0.58 to 1.52) RD=0 (3 fewer to 3 more) events/1000 patients | Moderate |
| FXa or DTI vs. other antithrombotics | ||||||
| All outcomes | 0 | NA | NA | NA | Not estimable | Insufficient |
Data from Neumann, 2012.
Notes: Outcomes are short-term; there may be some differences for hip versus knee replacement (different baseline risk and different duration of anticoagulation in existing studies); there is some evidence that FXa inhibitors at higher doses increase risk of bleeding.
Abbreviations: CI=confidence interval; DVT=deep vein thrombosis; DTI=direct thrombin inhibitor; FXa=factor X inhibitor; LMWH=low molecular weight heparin; NA=not applicable; OR=odds ratio; PE=pulmonary embolism; RCT=randomized controlled trial; RD=risk difference; RR=risk ratio; SOE=strength of evidence; THR=total hip replacement; TKR=total knee replacement
From: SUMMARY AND DISCUSSION
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