SWIFT DIRECT: Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke: Methodology of a randomized, controlled, multicentre study

International Journal of Stroke, vol. 17, pp. 698–705

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.

Authors 19

1. Urs Fischer

   University of Bern · University Hospital of Bern

   Affiliation as printed

   Department of Neurology, University Hospital and University of Bern, Bern, Switzerland

2. Johannes Kaesmacher

   University of Bern · University Hospital of Bern

   Affiliation as printed

   Institute of Diagnostic and Interventional Neuroradiology, University Hospital and University of Bern, Bern, Switzerland

3. Patricia S Plattner

   University of Bern · University Hospital of Bern

   Affiliation as printed

   Institute of Diagnostic and Interventional Neuroradiology, University Hospital and University of Bern, Bern, Switzerland

4. Lukas Bütikofer

   University of Bern

   Affiliation as printed

   CTU Bern, University of Bern, Bern, Switzerland

5. Pasquale Mordasini

   University of Bern · University Hospital of Bern

   Affiliation as printed

   Institute of Diagnostic and Interventional Neuroradiology, University Hospital and University of Bern, Bern, Switzerland

6. Sandro Deppeler

   University of Bern · University Hospital of Bern

   Affiliation as printed

   Institute of Diagnostic and Interventional Neuroradiology, University Hospital and University of Bern, Bern, Switzerland

7. Christophe Cognard

   Centre Hospitalier Universitaire de Toulouse

   Affiliation as printed

   Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Toulouse, Toulouse, France

8. Vítor Mendes Pereira

   University Health Network · University of Toronto · Toronto Western Hospital

   Affiliation as printed

   Division of Neuroradiology and Division of Neurosurgery, Departments of Medical Imaging and Surgery, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, Canada

9. Adnan Hussain Siddiqui

   University at Buffalo, State University of New York

   Affiliation as printed

   Department of Neurosurgery and Toshiba Stroke and Vascular Research Center, State University of New York at Buffalo, Buffalo, USA

10. Michael T. Froehler

    Vanderbilt University Medical Center

    Affiliation as printed

    Vanderbilt Cerebrovascular Program, Vanderbilt University Medical Center, Nashville, USA

11. Anthony J. Furlan

    Case Western Reserve University

    Affiliation as printed

    School of Medicine, Case Western Reserve University, Cleveland, OH, USA

12. René Chapot

    Alfried Krupp Hospital

    Affiliation as printed

    Department of Intracranial Endovascular Therapy, Alfried Krupp Krankenhaus Essen, Essen, Germany

13. Daniel Strbian

    University of Helsinki · Helsinki University Hospital

    Affiliation as printed

    Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland

14. Martin Wiesmann Aachen Department of Neuroradiology

    Universitätsklinikum Aachen · RWTH Aachen University

    Affiliation as printed

    Department of Neuroradiology, University Hospital RWTH Aachen, Aachen, Germany

15. Jenny Bressan

    University of Bern · University Hospital of Bern

    Affiliation as printed

    Department of Neurology, University Hospital and University of Bern, Bern, Switzerland

16. Stefanie Lerch

    University of Bern · University Hospital of Bern

    Affiliation as printed

    Department of Neurology, University Hospital and University of Bern, Bern, Switzerland

17. David S. Liebeskind

    University of California, Los Angeles

    Affiliation as printed

    Department of Neurology and UCLA Stroke Center, Los Angeles, California, USA

18. Jeffrey L. Saver

    University of California, Los Angeles

    Affiliation as printed

    Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine, University of California, Los Angeles, USA

19. Jan Gralla

    University of Bern · University Hospital of Bern

    Affiliation as printed

    Institute of Diagnostic and Interventional Neuroradiology, University Hospital and University of Bern, Bern, Switzerland