Urs Fischer1, Johannes Kaesmacher2, Patricia S Plattner2, Lukas Bütikofer3, Pasquale Mordasini2, Sandro Deppeler2, Christoph Cognard4, Vitor M Pereira5, Adnan H Siddiqui6, Michael T Froehler7, Anthony J Furlan8, René Chapot9, Daniel Strbian10, Martin Wiesmann11, Jenny Bressan1, Stefanie Lerch1, David S Liebeskind12, Jeffery L Saver13, Jan Gralla2. 1. Department of Neurology, University Hospital and University of Bern, Bern, Switzerland. 2. Institute of Diagnostic and Interventional Neuroradiology, University Hospital and University of Bern, Bern, Switzerland. 3. CTU Bern, University of Bern, Bern, Switzerland. 4. Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Toulouse, Toulouse, France. 5. Division of Neuroradiology and Division of Neurosurgery, Departments of Medical Imaging and Surgery, 26625Toronto Western Hospital, University Health Network, University of Toronto, Toronto, Canada. 6. Department of Neurosurgery and Toshiba Stroke and Vascular Research Center, State University of New York at Buffalo, Buffalo, USA. 7. Vanderbilt Cerebrovascular Program, Vanderbilt University Medical Center, Nashville, USA. 8. School of Medicine, 2546Case Western Reserve University, Cleveland, OH, USA. 9. Department of Intracranial Endovascular Therapy, Alfried Krupp Krankenhaus Essen, Essen, Germany. 10. Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland. 11. Department of Neuroradiology, University Hospital RWTH Aachen, Aachen, Germany. 12. Department of Neurology and UCLA Stroke Center, Los Angeles, California, USA. 13. Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine, University of California, Los Angeles, USA.
Abstract
RATIONALE: Whether treatment with intravenous alteplase prior to mechanical thrombectomy (MT) in acute ischemic stroke patients with large vessel occlusion is beneficial remains unclear. AIM: To determine whether patients experiencing acute ischemic stroke 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 center 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. SAMPLE SIZE: To randomize 404 patients 1:1 to direct MT or combined IVT+MT. METHODS AND DESIGN: A multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial utilizing an adaptive statistical design. OUTCOMES: The primary efficacy endpoint is functional independence (modified Rankin Scale 0-2) at 90 days. Secondary clinical efficacy outcomes include change in National Institutes of Health Stroke Scale score from baseline to day 1 and health-related quality of life at 90 days. Secondary technical efficacy outcomes include successful reperfusion prior to start of MT and time from randomization to successful reperfusion. Safety outcomes include all serious adverse events, symptomatic intracranial hemorrhage, and mortality up to 90 days. DISCUSSION: SWIFT DIRECT will inform physicians whether direct MT in acute ischemic stroke patients with large vessel occlusion is equally or more efficacious than combined treatment with intravenous alteplase and MT. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03192332.
RATIONALE: Whether treatment with intravenous alteplase prior to mechanical thrombectomy (MT) in acute ischemic stroke patients with large vessel occlusion is beneficial remains unclear. AIM: To determine whether patients experiencing acute ischemic stroke 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 center 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. SAMPLE SIZE: To randomize 404 patients 1:1 to direct MT or combined IVT+MT. METHODS AND DESIGN: A multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial utilizing an adaptive statistical design. OUTCOMES: The primary efficacy endpoint is functional independence (modified Rankin Scale 0-2) at 90 days. Secondary clinical efficacy outcomes include change in National Institutes of Health Stroke Scale score from baseline to day 1 and health-related quality of life at 90 days. Secondary technical efficacy outcomes include successful reperfusion prior to start of MT and time from randomization to successful reperfusion. Safety outcomes include all serious adverse events, symptomatic intracranial hemorrhage, and mortality up to 90 days. DISCUSSION: SWIFT DIRECT will inform physicians whether direct MT in acute ischemic stroke patients with large vessel occlusion is equally or more efficacious than combined treatment with intravenous alteplase and MT. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03192332.
Entities:
Keywords:
Ischemic stroke; alteplase; large vessel occlusion; stent retriever
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