The quality of evidence is downgraded by imprecise results (few outcome events).
A Cochrane review [Abstract] 1 included 10 studies with a total of 13 073 subjects with pulmonary embolism (PE). Two studies tested oral direct thrombin inhibitors (DTIs) (dabigatran) and 8 studies tested oral factor Xa inhibitors (3 rivaroxaban, 3 apixaban, and 2 edoxaban).
There was no difference in the effectiveness of oral DTIs and conventional anticoagulation in preventing recurrent PE, recurrent venous thromboembolism, deep vein thrombosis (DVT) and major bleeding (table T1).
Outcome | Relative effect (95% CI) | Assumed risk - conventional anticoagulation | Corresponding risk - oral DTI (95% CI) | Participants (studies) |
---|---|---|---|---|
Recurrent pulmonary embolism | OR 1.02(0.50 to 2.04) | 20 per 1000 | 20 per 1000(10 to 40) | 1 602 (1 study) |
Recurrent venous thromboembolism | OR 0.93(0.52 to 1.66) | 31 per 1000 | 29 per 1000(16 to 50) | 1 602 (1 study) |
Deep vein thrombosis | OR 0.79(0.29 to 2.13) | 11 per 1000 | 9 per 1000(3 to 23) | 1 602 (1 study) |
Major bleeding | OR 0.50(0.15 to 1.68) | 10 per 1000 | 5 per 1000(2 to 17) | 1 527 (1 study) |
For oral factor Xa inhibitors, there was no clear difference in the rate of recurrent PE, venous thromboembolism, DVT, all-cause mortality or major bleeding (table T2).
Outcome | Relative effect (95% CI) | Assumed risk - conventional anticoagulation | Corresponding risk - oral factor Xa (95% CI) | Participants (studies) |
---|---|---|---|---|
Recurrent pulmonary embolism | OR 0.92(0.66 to 1.29) | 18 per 1000 | 16 per 1000(12 to 23) | 8 186(3 studies) |
Recurrent venous thromboembolism | OR 0.83(0.66 to 1.03) | 32 per 1000 | 26 per 1000(21 to 33) | 11 416(8 studies) |
Deep vein thrombosis | OR 0.77(0.48 to 1.25) | 10 per 1000 | 7 per 1000(5 to 12) | 8 151(2 studies) |
All-cause mortality | OR 1.16(0.79 to 1.70) | 21 per 1000 | 24 per 1000(16 to 35) | 4 817 (1 study) |
Major bleeding | OR 0.71(0.36 to 1.41)¹ | 23 per 1000 | 16 per 1000(8 to 32) | 11 447 (8 studies) |
¹statistical heterogeneity, I2 = 79% | ||||
Clinical comments
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