Summary of findings 3. DOAC compared to placebo for prevention of venous thromboembolism following total hip or knee replacement or hip fracture repair.
| DOAC compared to placebo for prevention of venous thromboembolism following total hip or knee replacement or hip fracture repair | ||||||
| Patient or population: people requiring prevention of venous thromboembolism following total hip or knee replacement or hip fracture repair Setting: hospital and outpatient setting Intervention: DOAC Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with DOAC | |||||
| Symptomatic VTE (DVT and PE) Treatment duration 28 ‐ 42 days | Study population | OR 0.20 (0.06 to 0.68) | 2419 (1 RCT) | ⊕⊕⊕⊝ MODERATE 1 | — | |
| 12 per 1000 | 3 per 1000 (1 to 8) | |||||
| Symptomatic DVT (proximal or distal) Treatment duration 28 ‐ 42 days | Study population | OR 0.18 (0.04 to 0.81) | 2459 (2 RCTs) | ⊕⊕⊕⊕ HIGH | — | |
| 9 per 1000 | 2 per 1000 (0 to 7) | |||||
| Symptomatic PE Treatment duration 28 ‐ 42 days | Study population | OR 0.25 (0.03 to 2.25) | 1733 (1 RCT) | ⊕⊕⊝⊝ LOW 1 2 | — | |
| 5 per 1000 | 1 per 1000 (0 to 10) | |||||
| Bleeding ‐ major Treatment duration 28 ‐ 42 days | Study population | OR 1.00 (0.06 to 16.02) | 2457 (1 RCT) | ⊕⊕⊝⊝ LOW 1 2 | — | |
| 1 per 1000 | 1 per 1000 (0 to 13) | |||||
| Bleeding‐ clinically relevant non‐major Treatment duration 28 ‐ 42 days | Study population | OR 1.22 (0.76 to 1.95) | 2457 (1 RCT) | ⊕⊕⊕⊝ MODERATE 1 | — | |
| 27 per 1000 | 33 per 1000 (21 to 51) | |||||
| Bleeding ‐ minor Treatment duration 28 ‐ 42 days | Study population | OR 1.18 (0.74 to 1.88) | 2457 (1 RCT) | ⊕⊕⊕⊝ MODERATE 1 | — | |
| 28 per 1000 | 32 per 1000 (21 to 51) | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; DOAC: direct oral anticoagulant; DVT: deep vein thrombosis; OR: odds ratio; PE: pulmonary embolism; RCT: randomised controlled trial; VTE: venous thromboembolism | ||||||
| GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Downgraded by one level, results from a single study so heterogeneity cannot be assessed 2 Downgraded by one level, low number of events leading to wide CI and imprecision of results