SWIFT DIRECT investigators
Whether pre-treatment with intravenous alteplase prior to mechanical thrombectomy (MT) in patients with large vessel occlusion is beneficial remains a matter of debate. Two Asian trials (DIRECT MT, DEVT) showed that direct MT is non-inferior to intravenous alteplase plus MT, whereas a European and Asian trial (MR CLEAN noIV, SKIP) failed to prove non-inferiority. SWIFT DIRECT aims to assess, whether direct MT in patients with proximal vessel occlusion in the anterior circulation is non-inferior to intravenous alteplase plus MT.
We conducted a trial at 44 academic tertiary care centers in Europe and North America to evaluate MT with or without intravenous alteplase in patients with acute ischaemic stroke. Patients with an occlusion of the internal carotid artery or the M1 segment of the middle cerebral artery and immediate access to MT were randomly assigned in a 1:1 ratio to undergo direct MT with a Solitaire device or intravenous alteplase plus MT, at a dose of 0.9 mg per kilogram of body weight, administered within 4.5 hours after symptom onset. Primary efficacy, defined as functional independence (mRS 0-2) at 90 days, was assessed for non-inferiority of the experimental arm to the standard arm using a one-sided type 1-error rate of 5% with a pre-specified non-inferiority margin of 12%.
A total of 404 patients were randomly assigned either to the direct MT group (xy patients) or to the intravenous alteplase plus MT group (xy patients).
Current trial status (April 12, 2021): 373 / 404 patients randomised
To be determined
ClinicalTrials.gov Identifier: NCT03192332