Abstract
RationaleEarly reperfusion in patients experiencing acute ischemic stroke is critical, especially for patients with large vessel occlusion who have poor prognosis without revascularization. Solitaire™ stent retriever devices have been shown to immediately restore vascular perfusion safely, rapidly, and effectively in acute ischemic stroke patients with large vessel occlusions.AimThe aim of the study was to demonstrate that, among patients with large vessel, anterior circulation occlusion who have received intravenous tissue plasminogen activator, treatment with Solitaire revascularization devices reduces degree of disability 3 months post stroke.DesignThe study is a global multicenter, two-arm, prospective, randomized, open, blinded end-point trial comparing functional outcomes in acute ischemic stroke patients who are treated with either intravenous tissue plasminogen activator alone or intravenous tissue plasminogen activator in combination with the Solitaire device. Up to 833 patients will be enrolled.ProceduresPatients who have received intravenous tissue plasminogen activator are randomized to either continue with intravenous tissue plasminogen activator alone or additionally proceed to neurothrombectomy using the Solitaire device within six-hours of symptom onset.Study OutcomesThe primary end-point is 90-day global disability, assessed with the modified Rankin Scale (mRS). Secondary outcomes include mortality at 90 days, functional independence (mRS ≤ 2) at 90 days, change in National Institutes of Health Stroke Scale at 27 h, reperfusion at 27 h, and thrombolysis in cerebral infarction 2b/3 flow at the end of the procedure.AnalysisStatistical analysis will be conducted using simultaneous success criteria on the overall distribution of modified Rankin Scale (Rankin shift) and proportions of subjects achieving functional independence (mRS 0–2).
Highlights
Stroke is the second leading cause of death and a leading cause of disability worldwide (1)
The SWIFT PRIME trial will provide definitive information on the efficacy and safety of the Solitaire revascularization devices when added to IV tissue plasminogen activator (tPA), in comparison with therapy with IV tPA alone
SWIFT PRIME ensures that all enrolled patients have appropriate target occlusions by mandating CT angiography (CTA) or MR angiography (MRA) imaging at entry
Summary
Stroke is the second leading cause of death and a leading cause of disability worldwide (1). The only specific therapy of demonstrated benefit for acute ischemic stroke (AIS) is intravenous (IV) fibrinolysis with tissue plasminogen activator (tPA) up to 4·5 hours after onset. The SolitaireTM Flow Restoration (FR) device is a self-expanding stent retriever that restores blood flow in patients experiencing ischemic stroke because of large intracranial vessel occlusion. Head-to-head device trial, compared with first-generation, coil retriever devices, use of the SolitaireTM FR was associated with superior recanalization rates, faster achievement of reperfusion, reduced intracranial haemorrhage complications, and improved final disability outcome (9). The SolitaireTM with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) trial is being undertaken to establish the safety and efficacy of neurothrombectomy with Solitaire in conjunction with IV tPA vs IV tPA alone, among AIS patients treatable within six-hours of symptom onset
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