Effect of Endovascular Treatment With Medical Management vs Standard Care on Severe Cerebral Venous Thrombosis TO-ACT Trial
- Does endovascular treatment (EVT) plus standard medical care improve outcome (mRS) for patients with severe cerebral venous thrombosis (CVT) in comparison to standard medical care (SMC)?
- Prospective open-label RCT with blinded endpoint, sample size 67 patients (33 EVT, 34 control).
- Inclusion: patients (aged ≥18 years) with RAD confirmed CVT, GCS <9, ICH, or deep cerebral vein(s) thrombosis.
- Exclusion: CVT > 10 days, pregnancy, thrombocytopenia, or recent major surgery.
- EVT: thrombolysis, mechanical thrombectomy, or both, followed by heparin drip then warfarin for 3 mos.
- SMC: Heparin UF or LMW followed by warfarin for 3 mos.
- 1º endpoint: % of patients with MRS <2 at 12 months.
- 2º endpoints: recanalization rate, need for surgery in EVT group, and others.
- Trial was terminated after 1st interim analysis as it passed the futility threshold.
- After 12 months, 67% EVT patients had an mRS <2 vs 68% SMC patients (RR ratio,0.99).
- Mortality rate at 12months, 12% EVT vs 3% SMC; P = .20.
- Sinus/vein perforation during EVT was 9%.
- Seizure rate, 3% in EVT vs 30% in SMC; P = .006.
- For all other 2º endpoints, no significant differences were found.
- EVT plus SMC was not superior to SMC alone in patients with a severe CVT.