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Evaluation of stroke thrombectomy including patients where IV thrombolysis is contraindicated or has failed: A randomized trial of two novel thrombectomy devices

Lookup NU author(s): Professor Phil White, Dr Barbara Gregson, Dr Adela Cora, Dr Anand Dixit, Dr Rachel Lakey, Dr Ahmed Maiter, Professor Gary Ford

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This is the authors' accepted manuscript of an article that has been published in its final definitive form by BMJ Publishing Group, 2021.

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Abstract

© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ. Background: Study was a PROBE design phase II randomized controlled trial (RCT). We assessed trial feasibility and technical efficacy and safety of two novel thrombectomy devices - ERIC (a retriever device) and SOFIA (a distal access catheter) - used alone or in combination depending on operator preference. Methods: Four UK neuroscience centers enrolled adults with proximal large artery occlusion (LAO) stroke on imaging where arterial puncture was achievable within 5.5 hours (8.5 hours for posterior circulation) of symptom onset; National Institutes of Health Stroke Scale (NIHSS) ≥6 with limited ischemic change on CT imaging. Randomization was 2:1 into intervention arm (ERIC and/or SOFIA). Patients and core lab were blinded to allocation. Primary outcome was independent core lab adjudication of reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) scale). Secondary outcomes were modified Rankin score (mRS) at 90 and 365 days (independence and shift analysis), 30-day mortality, symptomatic intracranial hemorrhage (sICH), procedural complications and NIHSS change. Results: Sixty-six patients were enrolled. TICI 2B/3 reperfusion was achieved in 72% in intervention compared with 90% in control arm on intention to treat (ITT) analysis (P=0.2) and 78% compared with 86% on per protocol analysis (P=0.7). Functional independence at 90 days was 40% (intervention) compared with 43% (control) on ITT analysis (P=1.0). sICH rates were low at 0% and 5%, respectively (P=0.3). The 30-day mortality was 9% intervention compared with 14% control (P=0.7). Conclusions: Study indicated feasibility of a phase II RCT trial approach for assessing new thrombectomy devices. In a broad LAO stroke population ERIC and SOFIA were not statistically different from control devices. Larger trials are needed.

Publication metadata

Author(s): White PM, Gregson B, Cora EA, Dixit A, Subramanian G, Joshi Y, Simister R, Lakey R, Maiter A, Ford GA

Publication type: Article

Publication status: Published

Journal: Journal of NeuroInterventional Surgery

Year: 2021

Volume: 13

Issue: 4

Pages: 311-318

Print publication date: 01/04/2021

Online publication date: 14/07/2020

Acceptance date: 17/06/2020

Date deposited: 18/08/2020

ISSN (print): 1759-8478

ISSN (electronic): 1759-8486

Publisher: BMJ Publishing Group

URL: https://doi.org/10.1136/neurintsurg-2020-016038

DOI: 10.1136/neurintsurg-2020-016038

PubMed id: 32665431

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