Clinically significant occlusive disease in the coronary and carotid circulation coexist in a significant number of patients. Proper management of coexistent disease remains a perplexing problem for clinicians. From 5-12 percent of patients who present for Coronary Artery Bypass Grafting (CABG) will have significant stenosis at the carotid bifurcation. Conversely, a number of patients who present for surgical treatment of carotid stenosis, if screened, will have significant coronary artery disease. When patients have surgical lesions in both carotid and coronary circulation, management alternatives include performing either the carotid endarterectomy (CEA) or the CABG first, followed later by a second operation, or performing both operations under the same anesthetic. Delaying carotid endarterectomy is associated with increased incidence of stroke while delaying CABG increases the rate of myocardial infarction. While it is likely that different strategies will apply in different clinical situations, minimal prospective data (Level I evidence) is available in this area despite increasing numbers of operations performed. We propose to develop a prospective randomized trial to test the efficacy of these different strategies in the management of patients with combined disease. It is likely that a large multicentered trial will eventually be needed to answer this question. As a first step we propose a pilot study in select centers to assess the ability to recruit patients to each treatment strategy, determine the effect of preoperative patient characteristics on THE ABILITY TO RANDOMIZE PATIENTS and to develop and refine protocols to be used in the main trial. We plan to involve 5 centers and recruit 300 patients over a period of 3 years for this effort. Patients will be randomized on the basis of their neurologic status. Patients with neurologic symptoms referable to a carotid stenosis greater than 50 percent will be randomized to CEA first or CEA/CABG combined under the same anesthetic. Patients with asymptomatic carotid stenosis (greater than 80 percent unilateral, greater than 70 percent with contralateral occlusion) will be randomized to combined CEA/CABG and delayed CEA. Endpoints will be death, stroke and q wave MI at 4 months. Secondary endpoints will be Quality of Life at 4 months, and perioperative neurologic events, stroke and death associated with each procedure.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project (R01)
Project #
1R01NS039336-01
Application #
6027721
Study Section
National Institute of Neurological Disorders and Stroke Initial Review Group (NSD)
Program Officer
Marler, John R
Project Start
2000-04-20
Project End
2003-03-31
Budget Start
2000-04-20
Budget End
2001-03-31
Support Year
1
Fiscal Year
2000
Total Cost
$453,844
Indirect Cost
Name
State University New York Stony Brook
Department
Surgery
Type
Schools of Medicine
DUNS #
804878247
City
Stony Brook
State
NY
Country
United States
Zip Code
11794
Ricotta, John J; Wall, L Philipp; Blackstone, Eugene (2005) The influence of concurrent carotid endarterectomy on coronary bypass: a case-controlled study. J Vasc Surg 41:397-401; discussion 401-2
Ricotta, John J; Char, Daniel J; Cuadra, Salvador A et al. (2003) Modeling stroke risk after coronary artery bypass and combined coronary artery bypass and carotid endarterectomy. Stroke 34:1212-7