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Clinical Summary

Rivaroxaban vs warfarin after thrombolysis of iliofemoral deep vein thrombosis

Takeaway

  • Rivaroxaban was equally effective as warfarin in preventing deep vein thrombosis (DVT) recurrence after catheter-directed thrombolysis (CDT) because of iliofeomral DVT (IFDVT).

Why this matters

  • The current guidelines recommend that the standard course of conventional anticoagulation should be considered in patients managed with CDT after the procedure without specific recommendations made on the type of oral anticoagulants.
  • Findings suggest that rivaroxaban can be safely replaced with vitamin K antagonist (VKA) after successful thrombolysis for acute IFDVT.

Study design

  • In the intention-to-treat analysis, 67 patients with IFDVT were randomly assigned to receive standard anticoagulation (enoxaparin and warfarin; n=32) or rivaroxaban (n=35) after successful thrombolysis or mechanical thrombectomy.
  • Primary efficacy outcome: recurrence of any venous thromboembolism (VTE) within 6 months.
  • Secondary safety outcomes: major bleeding (MB), clinically relevant non-MB (CRNMB), other adverse event and all-cause mortality.
  • Funding: Bayer Korea.

Key results

  • At 6 months, no significant difference was observed in the rate of recurrent VTE between rivaroxaban vs standard therapy group (11.4% vs 12.5%; HR, 0.95; 95% CI, 0.24-3.79; P=.94).
  • The rate of CRNMB did not differ between rivaroxaban vs standard therapy group (2.9% vs 9.4%; HR, 0.31; 95% CI, 0.03-2.96; P=.31).
  • No significant difference was observed between rivaroxaban vs standard therapy group in:
    • any bleeding (8.6% vs 9.4%; HR, 0.94; 95% CI, 0.19-4.68; P=.94) and
    • adverse event (45.7% vs 43.7%; HR, 1.03; 95% CI, 0.50-2.12; P=.93).

Limitations

  • Small sample size.

References


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