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Evidence summaries

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 reduce the rate of major bleeding compared to conventional anticoagulation, and appear to be equivalent in terms of efficacy for the treatment of deep vein thrombosis. Level of evidence: "A"

Summary

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was no longer significant (OR 0.62, 95% CI 0.35 to 1.08) due to insufficient statistical power.Ximelagatran was withdrawn from the market in 2006 due to safety issues.

Oral direct thrombin inhibitor (DTI) versus conventional anticoagulation

OutcomeOR (95% CI)Participants (studies)
Recurrent venous thromboembolism1.17 (0.83 to 1.65)5 994 (3 studies)
Recurrent deep vein thrombosis1.11 (0.74 to 1.66)5 994 (3 studies)
Fatal pulmonary embolism1.32 (0.29 to 6.02)5 994 (3 studies)
Non-fatal pulmonary embolism1.29 (0.64 to 2.59)5 994 (3 studies)
All-cause mortality0.66 (0.41 to 1.08)2 489 (1 study)
Major bleeding0.58 (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).

Oral factor Xa inhibitor versus conventional anticoagulation

OutcomeOR (95% CI)Participants (studies)
Recurrent venous thromboembolism0.85 (0.71 to 1.01)17 505 (13 studies)
Recurrent deep vein thrombosis0.70 (0.49 to 1.01)16 439 (9 studies)
Fatal pulmonary embolism1.18 (0.69 to 2.02)15 082 (6 studies)
Non-fatal pulmonary embolism0.93 (0.68 to 1.27)15 166 (7 studies)
All-cause mortality0.87 (0.67 to 1.14)10 770 (9 studies)
Major bleeding0.63 (0.45 to 0.89)18 066 (17 studies)

Clinical comments

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References

  • Wang X, Ma Y, Hui X, et al. Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of deep vein thrombosis. Cochrane Database Syst Rev 2023;4(4):CD010956 [PubMed]

Primary/Secondary Keywords