Meinel, Thomas R; Kaesmacher, Johannes; Buetikofer, Lukas; Strbian, Daniel; Eker, Omer Faruk; Cognard, Christophe; Mordasini, Pasquale; Deppeler, Sandro; Mendes Pereira, Vitor; Albucher, Jean François; Darcourt, Jean; Bourcier, Romain; Guillon, Benoit; Papagiannaki, Chrysanthi; Costentin, Guillaume; Sibolt, Gerli; Räty, Silja; Gory, Benjamin; Richard, Sébastien; Liman, Jan; ... (2023). Time to treatment with bridging intravenous alteplase before endovascular treatment:subanalysis of the randomized controlled SWIFT-DIRECT trial. Journal of neurointerventional surgery, 15(e1), e102-e110. BMJ Publishing Group 10.1136/jnis-2022-019207
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BACKGROUND
We hypothesized that treatment delays might be an effect modifier regarding risks and benefits of intravenous thrombolysis (IVT) before mechanical thrombectomy (MT).
METHODS
We used the dataset of the SWIFT-DIRECT trial, which randomized 408 patients to IVT+MT or MT alone. Potential interactions between assignment to IVT+MT and expected time from onset-to-needle (OTN) as well as expected time from door-to-needle (DTN) were included in regression models. The primary outcome was functional independence (modified Rankin Scale (mRS) 0-2) at 3 months. Secondary outcomes included mRS shift, mortality, recanalization rates, and (symptomatic) intracranial hemorrhage at 24 hours.
RESULTS
We included 408 patients (IVT+MT 207, MT 201, median age 72 years (IQR 64-81), 209 (51.2%) female). The expected median OTN and DTN were 142 min and 54 min in the IVT+MT group and 129 min and 51 min in the MT alone group. Overall, there was no significant interaction between OTN and bridging IVT assignment regarding either the functional (adjusted OR (aOR) 0.76, 95% CI 0.45 to 1.30) and safety outcomes or the recanalization rates. Analysis of in-hospital delays showed no significant interaction between DTN and bridging IVT assignment regarding the dichotomized functional outcome (aOR 0.48, 95% CI 0.14 to 1.62), but the shift and mortality analyses suggested a greater benefit of IVT when in-hospital delays were short.
CONCLUSIONS
We found no evidence that the effect of bridging IVT on functional independence is modified by overall or in-hospital treatment delays. Considering its low power, this subgroup analysis could have missed a clinically important effect, and exploratory analysis of secondary clinical outcomes indicated a potentially favorable effect of IVT with shorter in-hospital delays. Heterogeneity of the IVT effect size before MT should be further analyzed in individual patient meta-analysis of comparable trials.
TRIAL REGISTRATION NUMBER
URL: https://www.
CLINICALTRIALS
gov ; Unique identifier: NCT03192332.
Item Type: |
Journal Article (Original Article) |
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Division/Institute: |
04 Faculty of Medicine > Department of Radiology, Neuroradiology and Nuclear Medicine (DRNN) > Institute of Diagnostic and Interventional Neuroradiology 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) |
UniBE Contributor: |
Meinel, Thomas Raphael, Kaesmacher, Johannes, Bütikofer, Lukas (B), Mordasini, Pasquale Ranato, Arnold, Marcel, Bassetti, Claudio L.A., Fischer, Urs Martin, Gralla, Jan |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
1759-8486 |
Publisher: |
BMJ Publishing Group |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
02 Aug 2022 09:57 |
Last Modified: |
20 Feb 2024 14:15 |
Publisher DOI: |
10.1136/jnis-2022-019207 |
PubMed ID: |
35902234 |
Uncontrolled Keywords: |
Thrombectomy Thrombolysis |
BORIS DOI: |
10.48350/171657 |
URI: |
https://boris.unibe.ch/id/eprint/171657 |