- 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.
- 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).
- 60.0% (95% CI, 45.9%-73.0%) with dabigatran.
- 67.3% (95% CI, 52.9%-79.7%) with warfarin.
- 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.
- Insufficient power for differences in recurrences.
- Sample size precluded assessment of statistical noninferiority, superiority.
- Lack of blinding of patients, treating physicians.
- Unknown generalizability.