Abstract TP29: Endovascular Thrombectomy and Medical Therapy Versus Medical Therapy Alone in Acute Stroke (EASI): a Randomized Care Trial
Background: Until recently, clinical benefits of endovascular stroke treatment remained unproven. Care trials can be used to simultaneously offer yet-to-be validated interventions and verify treatment outcomes. Our aim was to implement care trial methodology for patients with severe acute ischemic stroke.
Methods: The study was offered to all patients considered for endovascular management of acute ischemic stroke in one Canadian hospital. Inclusion criteria were broad: onset of symptoms ≤ 5h or at any time in the presence of clinical-imaging mismatch; suspected anterior or posterior circulation large vessel occlusion; patients eligible or ineligible for intravenous thrombolysis. Exclusion criteria were few: established infarction or hemorrhagic transformation of the target symptomatic territory; poor 3-month prognosis from comorbidities. The primary outcome was mRS ≤ 2 at three months. Patients were randomly allocated to standard care (control) or standard care plus endovascular treatment (intervention group). Analyses were by intention-to-treat. (Identifier NCT02157532)
Findings: Seventy-seven patients were recruited in 19 months (March 2013 - October 2014) at a single center. Randomized allocation was interrupted when other trials showed the benefits of endovascular therapy. At three months, 20 of 40 patients (50·0 %; 95% C.I.: 35%-65%) in the intervention group had reached the primary outcome, compared to 14 of 37 patients (37·8%; 95% C.I.: 24%-54%) in the control group arm (P=0·36). Eleven patients in the intervention arm died within 3 months compared to 9 patients in the standard care arm.
Interpretation: EASI met all the characteristics of a care trial: inclusion of all eligible patients, no extra risk, no extra test, no extra cost, simple case report forms filled by care personnel, normal follow-up, involvement of all regular practitioners, and flexible care. The trial was prematurely interrupted, but this approach offers a promising means to manage clinical dilemmas and guide uncertain practices in the care of patients.
Funding: There was no funding source for this study.
Author Disclosures: N.N. Khoury: None. T.E. Darsaut: None. J. Ghostine: None. Y. Deschaintre: None. N. Daneault: None. A. Durocher: None. S. Lanthier: None. A. Poppe: None. C. Odier: None. L. Lebrun: None. F. Guilbert: None. J. Gentric: None. A. Batista: None. A. Weill: None. D. Roy: None. S. Bracard: None.
- © 2016 by American Heart Association, Inc.