Oral direct thrombin inhibitors or oral factor Xa inhibitors for the treatment of deep vein thrombosis

Oral direct thrombin inhibitors and oral factor Xa inhibitors appear to be as effective as vitamin K antagonists (VKA) for the treatment of deep vein thrombosis. They are associated with reduced risk of major bleeding compared with VKA treatment.

The quality of evidence is downgraded by possible publication bias (all included studies were funded by the pharmaceutical company that developed the particular drug being tested).

Summary

A Cochrane review included 11 studies with a total of 27 945 subjects. Three studies compared oral direct thrombin inhibitors (DTIs; 2 dabigatran and 1 ximelagatran) with standard anticoagulation (LMWH/vitamin K antagonists), and 8 studies tested oral factor Xa inhibitors (4 rivaroxaban, 2 apixaban and 2 edoxaban). Duration of treatment varied between 12 weeks and 12 months. None of the included studies measured post-thrombotic syndrome or health-related quality of life.

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 standard anticoagulation groups (table ). 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 0.76, 95% CI 0.49 to 1.18; 2 studies, n=5 107). Ximelagatran was withdrawn from the market in 2006 due to safety issues.

There was a similar rate of recurrent VTE, fatal PE, non-fatal PE and all-cause mortality between oral factor Xa inhibitors and standard anticoagulation. Oral factor Xa inhibitors were associated with a lower rate of recurrent DVT, but this was a weak association, heavily dependent on one study. Oral factor Xa inhibitors were also associated with reduced bleeding (table ).

Clinical comments

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Ədəbiyyat

1. Robertson L, Kesteven P, McCaslin JE. Oral direct thrombin inhibitors or oral factor Xa inhibitors for the treatment of deep vein thrombosis. Cochrane Database Syst Rev 2015;(6):CD010956.