Personnel at the clinical coordinating center, including the principal investigator and project manager, were blinded to treatment assignment and to outcome, but persons who paid local sites or processed postoperative PET scans knew treatment assignment. The COSS was a parallel-group, 1:1 randomized, open-label, blinded-adjudication treatment trial conducted at 49 clinical centers and 18 PET centers in the United States and Canada. 3, 9 - 11 We conducted the Carotid Occlusion Surgery Study (COSS) to determine whether EC-IC bypass surgery, added to best medical therapy, reduces subsequent ipsilateral ischemic stroke at 2 years in patients with recently symptomatic AICAO and hemodynamic cerebral ischemia identified by positron emission tomography (PET) measurements of oxygen extraction fraction (OEF). Subsequent advances in neuroimaging have made it possible to identify those with hemodynamic cerebral ischemia who are at high risk for subsequent stroke when treated medically. 5 This trial was criticized for failing to identify the subgroup of patients with hemodynamic cerebral ischemia due to poor collateral circulation for whom surgical revascularization might be of greatest benefit. 4 In 1985, a randomized trial demonstrated no benefit of this surgery in 808 patients with symptomatic carotid artery occlusion. 1 - 3 Extracranial-intracranial (EC-IC) arterial bypass surgery was developed to prevent subsequent stroke by improving hemodynamics distal to the occluded artery. 1, 2 The 2-year risk of subsequent ipsilateral ischemic stroke while a patient receives medical therapy is 10% to 15%. Trial Registration Identifier: NCT00029146Ītherosclerotic internal carotid artery occlusion (AICAO) causes approximately 10% of transient ischemic attacks (TIAs) and 15% to 25% of ischemic strokes in the carotid territory. #JAIKOZ TRIAL BYPASS PLUS#Thirty-day rates for ipsilateral ischemic stroke were 14.4% (14/97) in the surgical group and 2.0% (2/98) in the nonsurgical group, a difference of 12.4% (95% CI, 4.9% to 19.9%).Ĭonclusion Among participants with recently symptomatic AICAO and hemodynamic cerebral ischemia, EC-IC bypass surgery plus medical therapy compared with medical therapy alone did not reduce the risk of recurrent ipsilateral ischemic stroke at 2 years. Results The trial was terminated early for futility. For the nonsurgical group and participants assigned to surgery who did not receive surgery, the combination of (1) all stroke and death from randomization to randomization plus 30 days and (2) ipsilateral ischemic stroke within 2 years of randomization. Main Outcome Measure For all participants who were assigned to surgery and received surgery, the combination of (1) all stroke and death from surgery through 30 days after surgery and (2) ipsilateral ischemic stroke within 2 years of randomization. Antithrombotic therapy and risk factor intervention were recommended for all participants. Interventions Anastomosis of superficial temporal artery branch to a middle cerebral artery cortical branch for the surgical group. No participant withdrew because of adverse events. Follow-up for the primary end point until occurrence, 2 years, or termination of trial was 99% complete. Of 195 patients who were randomized, 97 were randomized to receive surgery and 98 to no surgery. Participants Patients with arteriographically confirmed AICAO causing hemispheric symptoms within 120 days and hemodynamic cerebral ischemia identified by ipsilateral increased oxygen extraction fraction measured by PET. The majority were academic medical centers. Setting Forty-nine clinical centers and 18 positron emission tomography (PET) centers in the United States and Canada. Objective To test the hypothesis that extracranial-intracranial (EC-IC) bypass surgery, added to best medical therapy, reduces subsequent ipsilateral ischemic stroke in patients with recently symptomatic AICAO and hemodynamic cerebral ischemia.ĭesign Parallel-group, randomized, open-label, blinded-adjudication clinical treatment trial conducted from 2002 to 2010. Shared Decision Making and CommunicationĬontext Patients with symptomatic atherosclerotic internal carotid artery occlusion (AICAO) and hemodynamic cerebral ischemia are at high risk for subsequent stroke when treated medically.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |