Bridging Thrombolysis Versus Direct Mechanical Thrombectomy in Acute Ischemic Stroke
Summary
Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA) has been the only proven therapy for acute ischemic stroke (AIS) for almost 20 years. Whether IV t-PA prior to endovascular clot retrieval is beneficial for AIS patients with a proximal vessel occlusion in the anterior circulation has currently become a matter of debate and is a relevant unanswered question in clinical practice. The main objective is to determine whether subjects experiencing an AIS due to large intracranial vessel occlusion in the anterior circulation will have non-inferior functional outcome at 90 days when treated with direct mechanical thrombectomy (MT) compared to subjects treated with combined IV t-PA and MT. The secondary objectives are to study causes of mortality, dependency and quality of life in these AIS patients.
Timeline
- Start
- 2017-11-29
- Primary completion
- 2021-05-14
- Completion
- 2021-08-11
Publications
- Fladt J, Kaesmacher J, Meinel TR, Butikofer L, Strbian D, Eker OF, Albucher JF, Desal H, Marnat G, Papagiannaki C, Richard S, Requena M, Lapergue B, Pagano P, Ernst M, Wiesmann M, Boulanger M, Liebeskind DS, Gralla J, Fischer U. MRI vs CT for Baseline Imaging Evaluation in Acute Large Artery Ischemic Stroke: A Subanalysis of the SWIFT-DIRECT Trial. Neurology. 2024 Jan 23;102(2):e207922. doi: 10.1212/WNL.0000000000207922. Epub 2023 Dec 14.
- Mujanovic A, Eker O, Marnat G, Strbian D, Ijas P, Preterre C, Triquenot A, Albucher JF, Gauberti M, Weisenburger-Lile D, Ernst M, Nikoubashman O, Mpotsaris A, Gory B, Tuan Hua V, Ribo M, Liebeskind DS, Dobrocky T, Meinel TR, Buetikofer L, Gralla J, Fischer U, Kaesmacher J; SWIFT DIRECT investigators. Association of intravenous thrombolysis and pre-interventional reperfusion: a post hoc analysis of the SWIFT DIRECT trial. J Neurointerv Surg. 2023 Nov;15(e2):e232-e239. doi: 10.1136/jnis-2022-019585. Epub 2022 Nov 17.
- Meinel TR, Kaesmacher J, Buetikofer L, Strbian D, Eker OF, Cognard C, Mordasini P, Deppeler S, Mendes Pereira V, Albucher JF, Darcourt J, Bourcier R, Guillon B, Papagiannaki C, Costentin G, Sibolt G, Raty S, Gory B, Richard S, Liman J, Ernst M, Boulanger M, Barbier C, Mechtouff L, Zhang L, Marnat G, Sibon I, Nikoubashman O, Reich A, Consoli A, Weisenburger D, Requena M, Garcia-Tornel A, Saleme S, Moulin S, Pagano P, Saliou G, Carrera E, Janot K, Boix M, Pop R, Della Schiava L, Luft A, Piotin M, Gentric JC, Pikula A, Pfeilschifter W, Arnold M, Siddiqui A, Froehler MT, Furlan AJ, Chapot R, Wiesmann M, Machi P, Diener HC, Kulcsar Z, Bonati L, Bassetti C, Escalard S, Liebeskind D, Saver JL, Fischer U, Gralla J; SWIFT-DIRECT investigators. Time to treatment with bridging intravenous alteplase before endovascular treatment:subanalysis of the randomized controlled SWIFT-DIRECT trial. J Neurointerv Surg. 2023 Sep;15(e1):e102-e110. doi: 10.1136/jnis-2022-019207. Epub 2022 Jul 28.
- Fischer U, Kaesmacher J, Strbian D, Eker O, Cognard C, Plattner PS, Butikofer L, Mordasini P, Deppeler S, Pereira VM, Albucher JF, Darcourt J, Bourcier R, Benoit G, Papagiannaki C, Ozkul-Wermester O, Sibolt G, Tiainen M, Gory B, Richard S, Liman J, Ernst MS, Boulanger M, Barbier C, Mechtouff L, Zhang L, Marnat G, Sibon I, Nikoubashman O, Reich A, Consoli A, Lapergue B, Ribo M, Tomasello A, Saleme S, Macian F, Moulin S, Pagano P, Saliou G, Carrera E, Janot K, Hernandez-Perez M, Pop R, Schiava LD, Luft AR, Piotin M, Gentric JC, Pikula A, Pfeilschifter W, Arnold M, Siddiqui AH, Froehler MT, Furlan AJ, Chapot R, Wiesmann M, Machi P, Diener HC, Kulcsar Z, Bonati LH, Bassetti CL, Mazighi M, Liebeskind DS, Saver JL, Gralla J; SWIFT DIRECT Collaborators. Thrombectomy alone versus intravenous alteplase plus thrombectomy in patients with stroke: an open-label, blinded-outcome, randomised non-inferiority trial. Lancet. 2022 Jul 9;400(10346):104-115. doi: 10.1016/S0140-6736(22)00537-2.
- Fischer U, Kaesmacher J, S Plattner P, Butikofer L, Mordasini P, Deppeler S, Cognard C, Pereira VM, Siddiqui AH, Froehler MT, Furlan AJ, Chapot R, Strbian D, Wiesmann M, Bressan J, Lerch S, Liebeskind DS, Saver JL, Gralla J; SWIFT DIRECT study investigators. 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. Int J Stroke. 2022 Jul;17(6):698-705. doi: 10.1177/17474930211048768. Epub 2021 Oct 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alteplase | Protein / enzyme biologic | 0.9 mg/kg | Intravenous |