The Carotid Occlusion Surgery Study.
The St. Louis Carotid Occlusion Study demonstrated that ipsilateral increased O2 extraction fraction (OEF) (Stage II hemodynamic failure) measured by positron emission tomography (PET) is a powerful independent risk factor for subsequent stroke in patients with symptomatic complete carotid artery (CA) occlusion. The ipsilateral ischemic stroke rate at 2 years has been shown to be 5.3% in 42 patients with normal OEF and 26.5% in 39 patients with increased OEF (p = 0.004). In patients in whom hemispheric symptoms developed within 120 days, the 2-year ipsilateral stroke rates were 12% in 27 patients with normal OEF and 50% in 18 patients with increased OEF. Previous PET studies have demonstrated that anastomosis of the superficial temporal artery (STA) to a middle cerebral artery (MCA) cortical branch can restore OEF to normal. The authors discuss the undertaking of a study that will test the hypothesis that STA-MCA anastomosis, when combined with the best medical therapy, can reduce ipsilateral ischemic stroke by 40% at 2 years in patients with symptomatic internal CA occlusion and Stage II hemodynamic failure occurring within 120 days after surgery. Only patients with increased OEF distal to a symptomatic occluded CA will be randomized to surgery or medical treatment. The primary endpoint will be all strokes and death occurring between randomization and the 30-day postoperative cut off (with an equivalent period in the nonsurgical group), as well as subsequent ipsilateral ischemic stroke developing within 2 years. It is estimated that 186 patients will be required in each group. Assuming that 40% of PET scans will demonstrate increased OEF, this will require enrolling 930 clinically eligible individuals.
Grubb
Robert L
RL
Department of Neurological Surgery, Washington University School of Medicine, Washington University Medical Center, St. Louis, Missouri 63110-1093, USA. GrubbR@nsurg.wustl.edu
Powers
William J
WJ
Derdeyn
Colin P
CP
Adams
Harold P
HP
Clarke
William R
WR
D000925:Anticoagulants / Q000627:therapeutic use; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000601:surgery*; D002545:Brain Ischemia / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D002340:Carotid Artery Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000601:surgery*; D002343:Carotid Artery, Internal / Q000000981:diagnostic imaging / Q000601:surgery; D016893:Carotid Stenosis / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000601:surgery; D002548:Cerebral Revascularization; D003131:Combined Modality Therapy; D005500:Follow-Up Studies; D006439:Hemodynamics; D006801:Humans; D015993:Life Tables; D017063:Outcome Assessment, Health Care; D018579:Patient Selection; D049268:Positron-Emission Tomography; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D012307:Risk Factors
D000925:Anticoagulants