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 [protocol].

Fischer, Urs; Kaesmacher, Johannes; Plattner, Patricia S.; Bütikofer, Lukas; Mordasini, Pasquale; Deppeler, Sandro; Cognard, Christophe; Pereira, Vitor; Siddiqui, Adnan; Froehler, Michael T; Furlan, Anthony; Chapot, Rene; Strbian, Daniel; Wiesmann, Martin; Bressan, Jenny; Lerch, Stefanie; Saver, Jeffrey L; Gralla, Jan (2022). 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 [protocol]. International journal of stroke, 17(6), pp. 698-705. SAGE 10.1177/17474930211048768

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AbstractRationale: Whether treatment with intravenous alteplase prior to mechanical thrombectomy (MT) in acute ischaemic stroke (AIS) patients with large vessel occlusion is beneficial remains unclear.

AIM

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.

SAMPLE SIZE

To randomize 404 patients 1:1 to direct MT or combined IVT+MT.

METHODS AND DESIGN

A multicentre, prospective, randomized, open-label, blinded-endpoint (PROBE) trial utilizing an adaptive statistical design.

OUTCOMES

The primary efficacy endpoint is functional independence (modified Rankin Scale 0â2) at 90 days. Secondary clinical efficacy outcomes include change in NIHSS 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 haemorrhage, and mortality up to 90 days.

DISCUSSION

SWIFT DIRECT will inform physicians whether direct MT in AIS patients with large vessel occlusion is equally or more efficacious than combined treatment with intravenous alteplase and MT.

Item Type:

Journal Article (Further Contribution)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology
04 Faculty of Medicine > Pre-clinic Human Medicine > Department of Clinical Research (DCR)
04 Faculty of Medicine > Department of Radiology, Neuroradiology and Nuclear Medicine (DRNN) > Institute of Diagnostic and Interventional Neuroradiology

UniBE Contributor:

Fischer, Urs Martin, Kaesmacher, Johannes, Plattner, Patricia, Bütikofer, Lukas (B), Mordasini, Pasquale Ranato, Deppeler, Sandro, Bressan, Jenny Fabienne, Gralla, Jan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1747-4949

Publisher:

SAGE

Language:

English

Submitter:

Andrea Flükiger-Flückiger

Date Deposited:

08 Oct 2021 12:23

Last Modified:

20 Feb 2024 14:16

Publisher DOI:

10.1177/17474930211048768

PubMed ID:

34569878

Uncontrolled Keywords:

Ischaemic stroke Large vessel occlusion alteplase bridging therapy endovascular treatment intravenous thrombolysis stent retriever

BORIS DOI:

10.48350/159875

URI:

https://boris.unibe.ch/id/eprint/159875

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