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  • 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.

    Source

    JAMA Neurology

     

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