Naim N Khoury1, Tim E Darsaut2, Jimmy Ghostine3, Yan Deschaintre4, Nicole Daneault5, André Durocher6, Sylvain Lanthier7, Alexandre Y Poppe8, Céline Odier9, Louise-Hélène Lebrun10, François Guilbert11, Jean-Christophe Gentric12, André Batista13, Alain Weill14, Daniel Roy15, Serge Bracard16, Jean Raymond17. 1. Centre hospitalier universitaire de Montréal, Notre-Dame hospital, department of radiology, 1560, Sherbrooke east, Pavilion Simard, suite Z12909, H2L 4M1 Montreal, Quebec, Canada. Electronic address: naim.khoury@umontreal.ca. 2. Department of surgery, division of neurosurgery, university of Alberta hospital, Mackenzie health sciences centre, Edmonton, Alberta, Canada (TED). Electronic address: tdarsaut@ualberta.ca. 3. Centre hospitalier universitaire de Montréal, Notre-Dame hospital, department of radiology, 1560, Sherbrooke east, Pavilion Simard, suite Z12909, H2L 4M1 Montreal, Quebec, Canada. Electronic address: jimmy.ghostine@gmail.com. 4. Centre hospitalier universitaire de Montréal, Notre-Dame hospital, department of medicine, division of neurology, 1560, Sherbrooke east, H2L 4M1 Montreal, Quebec, Canada. Electronic address: yan.deschaintre.chum@ssss.gouv.qc.ca. 5. Centre hospitalier universitaire de Montréal, Notre-Dame hospital, department of medicine, division of neurology, 1560, Sherbrooke east, H2L 4M1 Montreal, Quebec, Canada. Electronic address: nicole.daneault.chum@ssss.gouv.qc.ca. 6. Centre hospitalier universitaire de Montréal, Notre-Dame hospital, department of medicine, division of neurology, 1560, Sherbrooke east, H2L 4M1 Montreal, Quebec, Canada. Electronic address: andre.p.durocher.chum@ssss.gouv.qc.ca. 7. Centre hospitalier universitaire de Montréal, Notre-Dame hospital, department of medicine, division of neurology, 1560, Sherbrooke east, H2L 4M1 Montreal, Quebec, Canada. Electronic address: sylanthier@gmail.com. 8. Centre hospitalier universitaire de Montréal, Notre-Dame hospital, department of medicine, division of neurology, 1560, Sherbrooke east, H2L 4M1 Montreal, Quebec, Canada. Electronic address: aypoppe@yahoo.ca. 9. Centre hospitalier universitaire de Montréal, Notre-Dame hospital, department of medicine, division of neurology, 1560, Sherbrooke east, H2L 4M1 Montreal, Quebec, Canada. Electronic address: c_odier@hotmail.com. 10. Centre hospitalier universitaire de Montréal, Notre-Dame hospital, department of medicine, division of neurology, 1560, Sherbrooke east, H2L 4M1 Montreal, Quebec, Canada. Electronic address: louise-helene.lebrun.chum@ssss.gouv.qc.ca. 11. Centre hospitalier universitaire de Montréal, Notre-Dame hospital, department of radiology, 1560, Sherbrooke east, Pavilion Simard, suite Z12909, H2L 4M1 Montreal, Quebec, Canada. Electronic address: francois.guilbert.chum@ssss.gouv.qc.ca. 12. Centre hospitalier universitaire de Montréal, Notre-Dame hospital, department of radiology, 1560, Sherbrooke east, Pavilion Simard, suite Z12909, H2L 4M1 Montreal, Quebec, Canada; Groupe d'étude de la thrombose en Bretagne Occidentale (GETBO, EA 3878), 29609 Brest cedex, France. Electronic address: jcgentric@gmail.com. 13. Centre hospitalier universitaire de Montréal, Notre-Dame hospital, department of radiology, 1560, Sherbrooke east, Pavilion Simard, suite Z12909, H2L 4M1 Montreal, Quebec, Canada. Electronic address: batista.nchir@gmail.com. 14. Centre hospitalier universitaire de Montréal, Notre-Dame hospital, department of radiology, 1560, Sherbrooke east, Pavilion Simard, suite Z12909, H2L 4M1 Montreal, Quebec, Canada. Electronic address: alain.weill.chum@ssss.gouv.qc.ca. 15. Centre hospitalier universitaire de Montréal, Notre-Dame hospital, department of radiology, 1560, Sherbrooke east, Pavilion Simard, suite Z12909, H2L 4M1 Montreal, Quebec, Canada. Electronic address: daniel.roy.chum@ssss.gouv.qc.ca. 16. Service de neuroradiologie diagnostique et thérapeutique, hôpital Central, CHU de Nancy, 54000 Nancy, France. Electronic address: s.bracard@gmail.com. 17. Centre hospitalier universitaire de Montréal, Notre-Dame hospital, department of radiology, 1560, Sherbrooke east, Pavilion Simard, suite Z12909, H2L 4M1 Montreal, Quebec, Canada. Electronic address: jean.raymond@umontreal.ca.
Abstract
BACKGROUND: Until recently, the benefits of endovascular treatment in stroke were not proven. Care trials have been designed to simultaneously offer yet-to-be validated interventions and verify treatment outcomes. Our aim was to implement a care trial for patients with 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 and suspected or demonstrated proximal large vessel occlusion. Exclusion criteria were few: established infarction or hemorrhagic transformation of the target symptomatic territory and poor 3-month prognosis. The primary outcome was mRS≤2 at 3 months. Patients were randomly allocated to standard care or standard care plus endovascular treatment. ClinicalTrials.gov: Identifier NCT02157532. RESULTS: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 3 months, 20 of 40 patients (50.0%; 95% CI: 35%-65%) in the intervention group had reached the primary outcome, compared to 14 of 37 patients (37.8%; 95% CI: 24%-54%) in the control group (P=0.36). Eleven patients in the intervention group died within 3 months compared to 9 patients in the standard care group. CONCLUSION: A care trial was implemented to offer verifiable care to acute stroke patients. This approach offers a promising means to manage clinical dilemmas and guide uncertain practices.
RCT Entities:
BACKGROUND: Until recently, the benefits of endovascular treatment in stroke were not proven. Care trials have been designed to simultaneously offer yet-to-be validated interventions and verify treatment outcomes. Our aim was to implement a care trial for patients with 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 and suspected or demonstrated proximal large vessel occlusion. Exclusion criteria were few: established infarction or hemorrhagic transformation of the target symptomatic territory and poor 3-month prognosis. The primary outcome was mRS≤2 at 3 months. Patients were randomly allocated to standard care or standard care plus endovascular treatment. ClinicalTrials.gov: Identifier NCT02157532. RESULTS: 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 3 months, 20 of 40 patients (50.0%; 95% CI: 35%-65%) in the intervention group had reached the primary outcome, compared to 14 of 37 patients (37.8%; 95% CI: 24%-54%) in the control group (P=0.36). Eleven patients in the intervention group died within 3 months compared to 9patients in the standard care group. CONCLUSION: A care trial was implemented to offer verifiable care to acute strokepatients. This approach offers a promising means to manage clinical dilemmas and guide uncertain practices.
Authors: Robert Fahed; Stefanos Finitsis; Naim Khoury; Yan Deschaintre; Nicole Daneault; Laura Gioia; Gregory Jacquin; Céline Odier; Alexande Y Poppe; Alain Weill; Daniel Roy; Tim E Darsaut; Thanh N Nguyen; Jean Raymond Journal: Trials Date: 2018-09-19 Impact factor: 2.279