Solitaire™ with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) Trial: Protocol for a Randomized, Controlled, Multicenter Study Comparing the Solitaire Revascularization Device with IV tPA with IV tPA Alone in Acute Ischemic Stroke

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).

Mechanical Thrombectomy for Isolated M2 Occlusions: A Post Hoc Analysis of the STAR, SWIFT, and SWIFT PRIME Studies

“…The design of these studies has been reported previously. 3,[7][8][9] Briefly, the SWIFT trial was a randomized clinical trial that ran from 2010 to 2011, in which patients with acute ischemic stroke and an angiographically confirmed occlusion of a the proximal cerebral artery were allocated to treatment with a stent retriever (Solitaire; Covidien, Irvine, California) or the Merci device (Concentric Medical, Mountain View, California). SWIFT had a roll-in phase during which all patients were treated with a stent retriever, and these patients were included in the current study.…”

“…[7][8][9] The aim was to achieve successful recanalization of the territory of the occluded vessel. The use of a balloon-guide catheter was mandatory in STAR and SWIFT and optional in SWIFT PRIME.…”

Iatrogenic Vessel Dissection in Endovascular Treatment of Acute Ischemic Stroke

“…Over the past decade endovascular management of AIS has rapidly improved and several catheter-based treatment systems have been developed. To date, 5 randomized controlled trials have shown that endovascular clot retrieval in addition to best medical treatment with or without intravenous recombinant tissue plasminogen activator (rtPA) improves outcome in patients with stroke occurring in the anterior circulation with proximal vessel occlusion [5][6][7][8][9]; however, despite minimally invasive device systems, endovascular procedures still carry a risk of iatrogenic complications, poten-tially worsening the outcome. Manipulation of the catheter, guidewire or thrombectomy devices could cause vessel wall injury.…”

TICI and Age: What's the Score?

“…7,[9][10][11][12][13] Recent clinical studies demonstrating the value of mechanical thrombectomy for acute ischemic stroke (AIS) did not include a significant number of elderly patients. [14][15][16][17] We performed a post hoc analysis of 2 prospective core lab-reviewed studies assessing mechanical thrombectomy by using new-generation devices (stent retrievers) for AIS to determine whether the benefit of reperfusion was constant across age groups, including the older population.…”