JAMA：外科手术不能降低小中风后续风险

Extracranial-Intracranial Bypass Surgery for Stroke Prevention in Hemodynamic Cerebral Ischemia

Powers, William J.; Clarke, William R.; Grubb, Robert L.; Videen, Tom O.; Adams, Harold P.; Derdeyn, Colin P.

Context Patients with symptomatic atherosclerotic internal carotid artery occlusion (AICAO) and hemodynamic cerebral ischemia areat high risk for subsequent stroke when treated medically.Objective To test the hypothesis that extracranial-intracranial (EC-IC) bypass surgery, added to best medical therapy, reduces subsequentipsilateral ischemic stroke in patients with recently symptomatic AICAO and hemodynamic cerebral ischemia.Design Parallel-group, randomized, open-label, blinded-adjudication clinical treatment trial conducted from 2002 to 2010.Setting Forty-nine clinical centers and 18 positron emission tomography (PET) centers in the United States and Canada. The majoritywere academic medical centers.Participants Patients with arteriographically confirmed AICAO causing hemispheric symptoms within 120 days and hemodynamic cerebral ischemiaidentified by ipsilateral increased oxygen extraction fraction measured by PET. Of 195 patients who were randomized, 97 wererandomized to receive surgery and 98 to no surgery. Follow-up for the primary end point until occurrence, 2 years, or terminationof trial was 99% complete. No participant withdrew because of adverse events.Interventions Anastomosis of superficial temporal artery branch to a middle cerebral artery cortical branch for the surgical group. Antithrombotictherapy and risk factor intervention were recommended for all participants.Main Outcome Measure For all participants who were assigned to surgery and received surgery, the combination of (1) all stroke and death fromsurgery through 30 days after surgery and (2) ipsilateral ischemic stroke within 2 years of randomization. For the nonsurgicalgroup and participants assigned to surgery who did not receive surgery, the combination of (1) all stroke and death from randomizationto randomization plus 30 days and (2) ipsilateral ischemic stroke within 2 years of randomization.Results The trial was terminated early for futility. Two-year rates for the primary end point were 21.0% (95% CI, 12.8% to 29.2%;20 events) for the surgical group and 22.7% (95% CI, 13.9% to 31.6%; 20 events) for the nonsurgical group (P = .78, Z test), a difference of 1.7% (95% CI, ?10.4% to 13.8%). 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%).Conclusion Among participants with recently symptomatic AICAO and hemodynamic cerebral ischemia, EC-IC bypass surgery plus medical therapycompared with medical therapy alone did not reduce the risk of recurrent ipsilateral ischemic stroke at 2 years.Trial Registration clinicaltrials.gov Identifier: NCT00029146