A Cochrane review [Abstract] 1 included 21 studies with a total of 30 895 subjects. Three studies compared oral direct thrombin inhibitors (DTIs; 2 dabigatran and 1 ximelagatran) with conventional anticoagulation (LMWH/vitamin K antagonists), 17 studies tested oral factor Xa inhibitors (8 rivaroxaban, 5 apixaban and 4 edoxaban), and one three-arm study investigated both a DTI (dabigatran) and factor Xa inhibitor (rivaroxaban).
There was no difference in the rate of recurrent venous thromboembolism (VTE), recurrent deep vein thrombosis (DVT), fatal pulmonary embolism (PE), non-fatal PE, or all-cause mortality between oral DTIs and conventional anticoagulation groups (table T1). Oral DTIs were associated with reduced bleeding. The rate of recurrent VTE, recurrent DVT, fatal PE, non-fatal PE, and all-cause mortality remained similar when the study testing ximelagatran was removed from the meta-analyses, but result for major bleeding was no longer significant (OR 0.62, 95% CI 0.35 to 1.08) due to insufficient statistical power.Ximelagatran was withdrawn from the market in 2006 due to safety issues.
Outcome | OR (95% CI) | Participants (studies) |
---|---|---|
Recurrent venous thromboembolism | 1.17 (0.83 to 1.65) | 5 994 (3 studies) |
Recurrent deep vein thrombosis | 1.11 (0.74 to 1.66) | 5 994 (3 studies) |
Fatal pulmonary embolism | 1.32 (0.29 to 6.02) | 5 994 (3 studies) |
Non-fatal pulmonary embolism | 1.29 (0.64 to 2.59) | 5 994 (3 studies) |
All-cause mortality | 0.66 (0.41 to 1.08) | 2 489 (1 study) |
Major bleeding | 0.58 (0.38 to 0.89) | 5 994 (3 studies) |
There was no clear difference in the rate of recurrent VTE, recurrent DVT, fatal PE, non-fatal PE and all-cause mortality between oral factor Xa inhibitors and conventional anticoagulation. Oral factor Xa inhibitors were also associated with reduced bleeding (table T2).
Outcome | OR (95% CI) | Participants (studies) |
---|---|---|
Recurrent venous thromboembolism | 0.85 (0.71 to 1.01) | 17 505 (13 studies) |
Recurrent deep vein thrombosis | 0.70 (0.49 to 1.01) | 16 439 (9 studies) |
Fatal pulmonary embolism | 1.18 (0.69 to 2.02) | 15 082 (6 studies) |
Non-fatal pulmonary embolism | 0.93 (0.68 to 1.27) | 15 166 (7 studies) |
All-cause mortality | 0.87 (0.67 to 1.14) | 10 770 (9 studies) |
Major bleeding | 0.63 (0.45 to 0.89) | 18 066 (17 studies) |
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