Abstract
Background
Intravenous thrombolysis (IVT)-ineligible patients undergoing direct thrombectomy tended to have poorer functional outcome as compared with IVT-eligible patients undergoing bridging therapy. We aimed to assess radiological and functional outcomes in large vessel occlusion-related stroke patients receiving direct thrombectomy in the presence of absolute exclusion criteria for IVT vs relative exclusion criteria for IVT and vs non-exclusion criteria for IVT.
Methods
A cohort study on prospectively collected data from 2282 patients enrolled in the Italian Registry of Endovascular Treatment in Acute Stroke cohort for treatment with direct thrombectomy (n = 486, absolute exclusion criteria for IVT alone; n = 384, absolute in combination with relative exclusion criteria for IVT; n = 777, relative exclusion criteria for IVT alone; n = 635, non-exclusion criteria for IVT).
Results
After adjustment for unbalanced variables (model 1), ORs for 3-month death was higher in the presence of absolute exclusion criteria for IVT alone (vs relative exclusion criteria for IVT alone) (1.595, 95% CI 1.042–2.440) and in the presence of absolute exclusion criteria for IVT alone (vs non-exclusion criteria for IVT) (1.235, 95% CI 1.014–1.504). After adjustment for predefined variables (model 2: age, sex, pre-stroke mRS ≤ 1, NIHSS, occlusion in the anterior circulation, onset-to-groin time, and procedure time), ORs for 3-month death was higher in the presence of absolute exclusion criteria for IVT alone (vs relative exclusion criteria for IVT alone) (1.235, 95% CI 1.014–1.504) and in the presence of absolute exclusion criteria for IVT alone (vs non-exclusion criteria for IVT) (1.246, 95% CI 1.039–1.495). No significant difference was found between the groups as regards any type of intracerebral hemorrhage and parenchymal hematoma within 24 h, successful and complete recanalization after procedure, and modified Rankin Scale score 0–2 at 3 months. After adjustment for predefined variables of model 2, ORs for death were higher in the presence of recent administration of IV heparin (OR: 2.077), platelet count < 100,000/mm3 (OR: 4.798), bacterial endocarditis (OR: 15.069), neoplasm with increased hemorrhagic risk (OR: 6.046), and severe liver disease (OR: 6.124).
Conclusions
Radiological outcomes were similar after direct thrombectomy in patients with absolute, relative, and non- exclusion criteria for IVT, while an increase of fatal outcome was observed in the presence of some absolute exclusion criterion for IVT.
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Funding
The project “Registro Nazionale Trattamento Ictus Acuto’’ (RFPS-2006-1-336562) was funded by grants from the Italian Ministry of Health within the framework of 2006 Finalized Research Programmes (D.Lgs.n.502/1992). The corresponding authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.
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MC: design and conceptualization of the study, acquisition of data, analysis and interpretation of the data, and drafting the manuscript for intellectual content. All authors: acquisition of data and revising the manuscript for intellectual content
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Manuel Cappellari received consulting fees from Boehringer-Ingelheim and Pfizer-BMS. Patrizia Nencini received consulting fees from Amicus. Domenico Inzitari declared to have speaker honoraria and research grants relationship with Shire Italia. Andrea Zini received consulting fees from Boehringer-Ingelheim, Medtronic, Cerenovus and declared to have advisory board relationship with Daiichi Sankyo and Boehringer-Ingelheim and Stryker. Mauro Bergui received consulting fees from Stryker Italia and Penumbra Inc. Nicola Cavasin received consulting fees from Microvention Europe and Acandis GmbH. Nunzio Paolo Nuzzi received consulting fees from Penumbra and Acandis. Danilo Toni declared to have speaker honoraria and advisory board relationship with Abbott, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Medtronic, and Pfizer. Salvatore Mangiafico received consulting fees from Cerenovus. The other authors report no disclosures.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Informed consent was obtained from all individual participants included in the study.
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Cappellari, M., Pracucci, G., Forlivesi, S. et al. Direct thrombectomy for stroke in the presence of absolute exclusion criteria for thrombolysis. J Neurol 267, 3731–3740 (2020). https://doi.org/10.1007/s00415-020-10098-w
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DOI: https://doi.org/10.1007/s00415-020-10098-w