Summary of findings 2. Oral factor Xa inhibitors versus standard anticoagulation for the treatment of pulmonary embolism.
| Oral factor Xa inhibitors versus standard anticoagulation for the treatment of pulmonary embolism | ||||||
| Patient or population: patients with a pulmonary embolism, confirmed by standard imaging techniques Setting: hospital Intervention: oral factor Xa inhibitors Comparison: standard anticoagulation | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with standard anticoagulation | Risk with oral factor Xa | |||||
| Recurrent pulmonary embolism1 | Study population | OR 1.08 (0.46 to 2.56) | 4509 (2 RCTs) | ⊕⊕⊕⊝ MODERATE 2 3 4 | ‐ | |
| 22 per 1000 | 24 per 1000 (10 to 55) | |||||
| Recurrent venous thromboembolism5 | Study population | OR 0.85 (0.63 to 1.15) | 6295 (3 RCTs) | ⊕⊕⊕⊕ HIGH 2 4 | ‐ | |
| 24 per 1000 | 20 per 1000 (15 to 27) | |||||
| Deep vein thrombosis6 | Study population | OR 0.72 (0.39 to 1.32) | 4509 (2 RCTs) | ⊕⊕⊕⊕ HIGH 4 | ‐ | |
| 11 per 1000 | 8 per 1000 (4 to 15) | |||||
| All‐cause mortality | Study population | OR 1.16 (0.79 to 1.70) | 4817 (1 RCT) | ⊕⊕⊕⊝ MODERATE 2 4 7 | ‐ | |
| 16 per 1000 | 19 per 1000 (13 to 27) | |||||
| Major bleeding8 | Study population | OR 0.97 (0.59 to 1.62) | 4507 (2 RCTs) | ⊕⊕⊕⊕ HIGH 2 4 | ‐ | |
| 14 per 1000 | 13 per 1000 (8 to 22) | |||||
| Health‐related quality of life | See comment | See comment | See comment | ‐ | The studies did not measure health‐related quality of life | |
| *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; 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 | ||||||
1Confirmed by ventilation–perfusion lung scanning, angiography or spiral computed tomography of pulmonary arteries. 2Risk of bias was 'unclear' for random sequence generation but we did not consider it sufficient to downgrade the quality of evidence. 3Statistical heterogeneity was found for this outcome and could not be explained. 4The possibility of publication bias is not excluded but we did not consider it sufficient to downgrade the quality of evidence as only two studies were included in this comparison. 5Clinically overt DVT, confirmed by standard imaging techniques including proximal leg vein ultrasound scan or D‐dimer test, or both; or clinically overt pulmonary embolism, confirmed by ventilation–perfusion lung scanning, angiography or spiral computed tomography of pulmonary arteries. 6Clinically overt DVT confirmed by standard imaging techniques (proximal leg vein ultrasound scan, venography) or D‐dimer test, or both. 7Quality of evidence downgraded to moderate as only one study was included. 8As defined by the International Society on Thrombosis and Haemostasis (ISTH); Schulman 2005). Fatal bleeding; symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra‐articular or pericardial, or intramuscular with compartment syndrome; bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells; any combination of points 1 to 3.