The role of intravenous thrombolysis before mechanical Thrombectomy : A subgroup analysis of the RESILIENT trial
Copyright © 2023. Published by Elsevier B.V..
BACKGROUND: Randomized trials have recently evaluated the non-inferiority of direct thrombectomy versus intravenous thrombolysis (IVT) followed by endovascular therapy in anterior circulation large vessel occlusion (LVO) stroke in patients eligible for IVT within 4.5 h from stroke onset with controversial results. We aimed to assess the effect of IVT on the clinical outcome of mechanical thrombectomy (MT) in the RESILIENT trial.
METHODS: RESILIENT was a randomized, prospective, multicenter, controlled trial assessing the safety and efficacy of thrombectomy versus medical treatment alone. A total of 221 patients were enrolled. The trial showed a substantial benefit of MT when added to medical management. All eligible patients received intravenous tPA within the 4.5-h-window. Ordinal logistic and binary regression analyses using intravenous tPA as an interaction term were performed with adjustments for potential confounders, including age, baseline NIHSS score, occlusion site, and ASPECTS. A p-value <0.05 was considered statistically significant.
RESULTS: Among 221 randomized patients (median NIHSS, 18 IQR [14-21]), 155 (70%) were treated with IVT. There was no difference in the mRS ordinal shift and frequency of functional independence between patients who received or not IV tPA; the odds ratio for the ordinal mRS shift was 2.63 [1.48-4.69] for the IVT group and 1.54 [0.63-3.74] for the no IVT group, with a p-value of 0.42. IVT also did not affect the frequency of good recanalization (TICI 2b or higher) and hemorrhagic transformation.
CONCLUSIONS: The large effect size of MT on LVO outcomes was not significantly affected by IVT.
TRIAL REGISTRATION: RESILIENT ClinicalTrials.gov number, NCT02216643.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:457 |
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| Enthalten in: |
Journal of the neurological sciences - 457(2024) vom: 15. Feb., Seite 122853 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Silva, Gisele Sampaio [VerfasserIn] |
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| Links: |
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| Themen: |
Fibrinolytic Agents |
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| Anmerkungen: |
Date Completed 19.02.2024 Date Revised 19.02.2024 published: Print-Electronic ClinicalTrials.gov: NCT02216643 Citation Status MEDLINE |
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| doi: |
10.1016/j.jns.2023.122853 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM366730746 |
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| 100 | 1 | |a Silva, Gisele Sampaio |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a The role of intravenous thrombolysis before mechanical Thrombectomy |b A subgroup analysis of the RESILIENT trial |
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| 500 | |a ClinicalTrials.gov: NCT02216643 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023. Published by Elsevier B.V. | ||
| 520 | |a BACKGROUND: Randomized trials have recently evaluated the non-inferiority of direct thrombectomy versus intravenous thrombolysis (IVT) followed by endovascular therapy in anterior circulation large vessel occlusion (LVO) stroke in patients eligible for IVT within 4.5 h from stroke onset with controversial results. We aimed to assess the effect of IVT on the clinical outcome of mechanical thrombectomy (MT) in the RESILIENT trial | ||
| 520 | |a METHODS: RESILIENT was a randomized, prospective, multicenter, controlled trial assessing the safety and efficacy of thrombectomy versus medical treatment alone. A total of 221 patients were enrolled. The trial showed a substantial benefit of MT when added to medical management. All eligible patients received intravenous tPA within the 4.5-h-window. Ordinal logistic and binary regression analyses using intravenous tPA as an interaction term were performed with adjustments for potential confounders, including age, baseline NIHSS score, occlusion site, and ASPECTS. A p-value <0.05 was considered statistically significant | ||
| 520 | |a RESULTS: Among 221 randomized patients (median NIHSS, 18 IQR [14-21]), 155 (70%) were treated with IVT. There was no difference in the mRS ordinal shift and frequency of functional independence between patients who received or not IV tPA; the odds ratio for the ordinal mRS shift was 2.63 [1.48-4.69] for the IVT group and 1.54 [0.63-3.74] for the no IVT group, with a p-value of 0.42. IVT also did not affect the frequency of good recanalization (TICI 2b or higher) and hemorrhagic transformation | ||
| 520 | |a CONCLUSIONS: The large effect size of MT on LVO outcomes was not significantly affected by IVT | ||
| 520 | |a TRIAL REGISTRATION: RESILIENT ClinicalTrials.gov number, NCT02216643 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
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| 700 | 1 | |a Barros, Felipe Chaves Duarte |e verfasserin |4 aut | |
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| 700 | 1 | |a Pontes-Neto, Octavio Marques |e verfasserin |4 aut | |
| 700 | 1 | |a Mont'Alverne, Francisco Jose |e verfasserin |4 aut | |
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| 700 | 1 | |a Liebeskind, David |e verfasserin |4 aut | |
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| 700 | 1 | |a Martins, Sheila Ouriques |e verfasserin |4 aut | |
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