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The role of intravenous thrombolysis before mechanical Thrombectomy: A subgroup analysis of the RESILIENT trial.

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العنوان: The role of intravenous thrombolysis before mechanical Thrombectomy: A subgroup analysis of the RESILIENT trial.
المؤلفون: Silva GS; Universidade Federal de São Paulo, São Paulo, Brazil; Hospital Israelita Albert Einstein, São Paulo, SP, Brazil. Electronic address: giselesampaio@hotmail.com., Alves MM; Universidade Federal de São Paulo, São Paulo, Brazil., Barros FCD; Universidade Federal de São Paulo, São Paulo, Brazil., Frudit ME; Universidade Federal de São Paulo, São Paulo, Brazil., Pontes-Neto OM; Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brazil., Mont'Alverne FJ; Hospital Geral de Fortaleza, Fortaleza, Brazil., Rebello LC; Hospital de Base, Brasília, Brazil., Carbonera LA; Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil., Abud DG; Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brazil., Lima F; Universidade de Campinas, Campinas, Brazil., de Souza AC; Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil., Liebeskind D; Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA., Mosmann G; Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil., Bezerra D; Hospital Pro Cardíaco, Rio de Janeiro, Brazil., Saver J; Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA., Cardoso F; Universidade de Campinas, Campinas, Brazil., Nogueira RG; Emory University, Atlanta, GA, USA., Martins SO; Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
المصدر: Journal of the neurological sciences [J Neurol Sci] 2024 Feb 15; Vol. 457, pp. 122853. Date of Electronic Publication: 2023 Dec 20.
نوع المنشور: Randomized Controlled Trial; Multicenter Study; Letter
اللغة: English
بيانات الدورية: Publisher: Elsevier Country of Publication: Netherlands NLM ID: 0375403 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1878-5883 (Electronic) Linking ISSN: 0022510X NLM ISO Abbreviation: J Neurol Sci Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Amsterdam : Elsevier, <19 ->
مواضيع طبية MeSH: Stroke*/drug therapy , Stroke*/etiology , Arterial Occlusive Diseases*/drug therapy , Ischemic Stroke*/drug therapy , Ischemic Stroke*/surgery , Brain Ischemia*/drug therapy , Brain Ischemia*/surgery , Mechanical Thrombolysis*/methods, Humans ; Fibrinolytic Agents/therapeutic use ; Thrombolytic Therapy/methods ; Prospective Studies ; Treatment Outcome ; Thrombectomy/methods
مستخلص: 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.
Competing Interests: Declaration of Competing Interest Gisele Sampaio Silva reports receiving consulting fees from Boehringer Ingelheim and lecture fees from Pfizer, Michel Eli Frudt receiving consulting fees from Balt USA and Medtronic, Octavio Marques Pontes-Neto receiving lecture fees from Boehringer Ingelheim, Medtronic, and Pfizer, Francisco Jose Montalverne receiving consulting fees from Balt USA, Medtronic, MicroVention, Leonardo Augusto Carbonera receiving consulting fees from Allm, lecture fees from Boehringer Ingelheim, and travel support from iSchemaView, Daniel Abud receiving consulting fees from Medtronic and Stryker, Fabrício Lima receiving lecture fees from Boehringer Ingelheim, Ana Cláudia de Souza receiving lecture fees from Boehringer Ingelheim, Jeffrey Saver receiving consulting fees and travel support from Boehringer Ingelheim, BrainsGate, Johnson and Johnson Health Care Systems, Medtronic USA, and Stryker and receiving consulting fees and travel support from and owning stock options in Rapid Medical, Raul Nogueira receiving consulting fees from Anaconda Biomed, Genentech, Imperative Care, Phenox, Prolong Pharmaceuticals, and Stryker, receiving advisory board fees from Biogen and Cerenovus, receiving consulting fees from and owning stock options in Brainomix, Corindus, Perfuze, and Viz.ai, and receiving advisory board fees from and owning stock options in Ceretrieve and Vesalio, Sheila Martins reports receiving lecture fees from Bayer, Medtronic, and Pfizer and advisory board fees and lecture fees from Boehringer Ingelheim. No other potential conflict of interest relevant to this article was reported.
(Copyright © 2023. Published by Elsevier B.V.)
فهرسة مساهمة: Keywords: Stroke; Thrombectomy; Thrombolysis
سلسلة جزيئية: ClinicalTrials.gov NCT02216643
المشرفين على المادة: 0 (Fibrinolytic Agents)
تواريخ الأحداث: Date Created: 20240105 Date Completed: 20240219 Latest Revision: 20240219
رمز التحديث: 20240219
DOI: 10.1016/j.jns.2023.122853
PMID: 38182456
قاعدة البيانات: MEDLINE
الوصف
تدمد:1878-5883
DOI:10.1016/j.jns.2023.122853