Summary of findings 6. DOAC compared to heparin for people requiring prevention of venous thromboembolism following total hip or knee replacement or hip fracture repair.
DOAC compared to heparin for people requiring 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: heparin | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Risk with heparin | Risk with DOAC | |||||
Symptomatic VTE (DVT and PE) Treatment duration 28 ‐ 42 days | Study population | OR 0.70 (0.28 to 1.70) | 15977 (5 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | — | |
4 per 1000 | 3 per 1000 (1 to 8) | |||||
Symptomatic DVT (proximal or distal) Treatment duration 28 ‐ 42 days |
Study population | OR 0.60 (0.11 to 3.27) | 15977 (5 RCTs) | ⊕⊕⊝⊝ LOW 2 3 | — | |
3 per 1000 | 2 per 1000 (0 to 9) | |||||
Symptomatic PE Treatment duration 28 ‐ 42 days | Study population | OR 0.91 (0.43 to 1.94) | 14731 (5 RCTs) | ⊕⊕⊕⊝ MODERATE 2 | — | |
2 per 1000 | 2 per 1000 (1 to 4) | |||||
Bleeding ‐ major Treatment duration 28 ‐ 42 days |
Study population | OR 1.11 (0.79 to 1.54) | 16199 (5 RCTs) | ⊕⊕⊕⊕ HIGH | — | |
8 per 1000 | 9 per 1000 (7 to 13) | |||||
Bleeding ‐ clinically relevant, non‐major Treatment duration 28 ‐ 42 days | Study population | OR 1.08 (0.90 to 1.28) | 15241 (4 RCTs) | ⊕⊕⊕⊕ HIGH | — | |
33 per 1000 | 36 per 1000 (30 to 42) | |||||
Bleeding ‐ minor Treatment duration 28 ‐ 42 days |
Study population | OR 0.95 (0.82 to 1.10) | 11766 (4 RCTs) | ⊕⊕⊕⊕ HIGH | — | |
66 per 1000 | 63 per 1000 (55 to 72) | |||||
*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 for inconsistency (heterogeneity, I2 = 55%) 2 Downgraded by one level for imprecision due to low number of events leading to wide CI 3 Downgraded by one level for inconsistency (heterogeneity, I2 = 65%)