CAROTID OCCLUSION SURGERY STUDY (COSS)

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The St. Louis Carotid Occlusion Study has demonstrated that ipsilateral increased oxygen extraction fraction (OEF) measured by PET is a powerful independent risk factor for subsequent stroke in patients with symptomatic carotid occlusion. After adjustment for 17 baseline patient characteristics and interval medical treatment, the relative risk conferred by Stage II hemodynamic failure was 7.3 (95% CI 1.6 - 33.4) for ipsilateral ischemic stroke corresponding to two year rates for ipsilateral stroke of 5.3% in 42 patients with normal OEF and 26.5% in 39 patients with increased OEF (p=.004). In those patients with hemispheric symptoms within 120 days, the two 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 surgical anastomosis of the superficial temporal artery to the middle cerebral artery (STA-MCA) can restore OEF to normal. We will test the hypothesis that STA-MCA surgical anastomosis when added to best medical therapy can reduce by 40%, despite perioperative stroke and death, subsequent ipsilateral ischemic stroke (fatal and non-fatal) at two years in patients with recently (120 days) symptomatic internal carotid artery occlusion and Stage II hemodynamic failure. Clinically eligible patients with unilateral carotid artery occlusion demonstrated by vascular imaging will be asked to consent to PET and treatment randomization if PET shows increased OEF. Those who agree and meet criteria will be randomized 1:1 to undergo STA-MCA bypass surgery followed by medical management or medical management alone. All randomized patients will be followed at three month intervals. The primary endpoint will be all stroke and death from randomization until 30 days post-operatively (an equivalent period in the non-surgical group) plus subsequent ipsilateral ischemic stroke within two years.