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SOLITAIRE™ WITH THE INTENTION FOR THROMBECTOMY PLUS INTRAVENOUS T-PA VERSUS DIRECT SOLITAIRE™ STENT-RETRIEVER THROMBECTOMY IN ACUTE ANTERIOR CIRCULATION STROKE (SWIFT DIRECT)
Abstract
Background and Aims
Whether treatment with intravenous alteplase prior to mechanical thrombectomy (MT) in acute ischaemic stroke (AIS) patients with large vessel occlusion is beneficial remains a matter of debate. We aimed to determine whether patients experiencing AIS due to occlusion of the intracranial internal carotid artery or the M1 segment of the middle cerebral artery who are referred to an endovascular stroke centre and who are candidates for intravenous alteplase will have non-inferior functional outcome at 90 days when treated with MT alone (direct MT) with stent retrievers compared to patients treated with combined intravenous thrombolysis (IVT) with alteplase plus MT (IVT+MT) with stent retrievers.
Methods
We conducted prospective, randomized (1:1), open-label, blinded-endpoint (PROBE) trial at 44 academic tertiary care centers in Europe and North America, utilizing an adaptive statistical design. 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%. Secondary objectives were to study causes of mortality, dependency and quality of life.
Results
A total of 410 patients were randomly assigned either to the direct MT group (xy patients) or to the intravenous alteplase plus MT group (xy patients). Direct MT was …..
Conclusions
Among patients with ischaemic stroke due to proximal anterior vessel occlusion within 4.5 hours from onset, direct mechanical thrombectomy compared with intravenous alteplase plus mechanical thrombectomy was…..