CVT: dabigatran, dose-adjusted warfarin effectively prevent VTE recurrence

  • Ferro JM & al.
  • JAMA Neurol
  • 03.09.2019

  • von Susan London
  • Clinical Essentials
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Takeaway

  • 6 months of therapy with either dabigatran (Pradaxa) or dose-adjusted warfarin was safe and highly efficacious for preventing recurrent venous thrombotic events (VTEs) in patients with cerebral venous thrombosis (CVT).

Why this matters

  • Lack of randomized controlled trials of non-vitamin K oral anticoagulants (NOACs) in this population.

 Key results

  • None of the patients in either the dabigatran group or the warfarin group experienced recurrent VTEs.
  • Major bleeding events:
    • 1.7% (95% CI, 0.0%-8.9%) with dabigatran (intestinal).
    • 3.3% (95% CI, 0.4%-11.5%) with warfarin (intracranial).
  • Clinically relevant nonmajor bleeding events:
    • 0.0% (95% CI, 0.0%-0.6%) with dabigatran.
    • 1.7% (95% CI, 0.0%-8.9%) with warfarin (genitourinary).
  • Recanalization:
    • 60.0% (95% CI, 45.9%-73.0%) with dabigatran.
    • 67.3% (95% CI, 52.9%-79.7%) with warfarin.

Study design

  • Multinational exploratory randomized controlled trial among 120 patients with CVT stable after 5-15 days of parenteral heparin (RE-SPECT CVT trial).
  • Randomization: open-label dabigatran (150 mg twice daily) vs dose-adjusted warfarin for 24 weeks.
  • Main outcome: composite of new VTEs (recurrent CVT, deep vein thrombosis of any limb, pulmonary embolism, splanchnic vein thrombosis) or major bleeding.
  • Funding: Boehringer Ingelheim.

Limitations

  • Insufficient power for differences in recurrences.
  • Sample size precluded assessment of statistical noninferiority, superiority.
  • Lack of blinding of patients, treating physicians.
  • Unknown generalizability.