Does bypass surgery plus medical therapy reduce the risk of stroke or death in adults with atherosclerotic occlusion of the internal carotid artery or middle cerebral artery versus medical therapy alone?
This study found no additional benefit of bypass surgery plus medical therapy over medical therapy alone after 2 years of follow-up in reducing the risk of stroke or death in adults with atherosclerotic occlusion of the ICA or the MCA.
Plan de l'etude:
Randomized controlled trial (single-blinded)
Inpatient (any location) with outpatient follow-up
These investigators identified symptomatic adults, aged 18 to 65 years, with an angiographic diagnosis of unilateral internal carotid artery (ICA) or middle cerebral artery (MCA) occlusion or hemodynamic insufficiency in the MCA territory. Eligible symptoms included a transient ischemic attack or ischemic stroke in the territory of the occluded ICA or MCA within the past 12 months, with the most recent event occurring more than 3 weeks previously and with any neurologic deficit remaining stable for more than 1 month. Patients with more than 50% stenosis of any other vessels were excluded. Consenting patients (n = 330) randomly received assignment to either bypass surgery plus optimal medical therapy or to medical therapy alone. Individuals masked to treatment group assignment assessed all outcomes. Complete follow-up occurred for 95.5% of participants at 2 years.
Using both intention-to-treat and per-protocol analyses, no significant difference occurred for the surgical group versus medical group for the primary composite outcome of any stroke or death within 30 days after randomization, or ipsilateral ischemic stroke beyond 30 days, through 2 years. Similarly, no significant group differences occurred for multiple other secondary outcomes.
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Professor of Family Medicine, UNC Chapel Hill