(Stroke. 1996;27:2216-2224.)
© 1996 American Heart Association, Inc.
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the Albert B. Chandler Medical Center, Lexington, Ky (B.Y., R.J.D.); Department of Surgery, University of California at Los Angeles Medical Center (W.S.M.); Department of Neurosurgery, University of Tennessee, Memphis (J.T.R.); Wake Forest University/Bowman-Gray School of Medicine Medical Center, Winston-Salem, NC (J.F.T.); Department of Vascular Surgery, Henry Ford Hospital, Detroit, Mich (C.B.E.); Neurology Service, West Los Angeles (Calif) VA Medical Center (S.N.C.); University of Cincinnati (Ohio) College of Medicine (J.P.B.); University of North Carolina, Chapel Hill (J.D.H.); for the ACAS Investigators.
Background and Purpose Our aim was to determine the perioperative morbidity and mortality rates of patients in the surgical arm of the multi-institutional, prospective, randomized Asymptomatic Carotid Atherosclerosis Study (ACAS).
Methods Of 828 patients with carotid stenosis of 60% or more randomized to the surgical arm of ACAS, 721 underwent carotid endarterectomy (CEA). To qualify for participation, surgeons were required to have performed at least 12 CEAs per year with a combined neurological morbidity and mortality rate no greater than 3% for asymptomatic patients and 5% for symptomatic patients. Clinical centers had to demonstrate arteriographic morbidity less than 1% and mortality less than 0.1% per year. Primary events were stroke and death in the period between randomization and 30 days after surgery; secondary events were transient ischemic attack and myocardial infarction occurring in the same period.
Results Of the 721 patients who underwent CEA, 1 died and 10 others had strokes within 30 days (1.5%). Of the 415 who underwent arteriography after randomization but before CEA, 5 (1.2%) suffered transient ischemic attack or stroke caused by arteriography. Thus, a nearly equal risk of stroke was associated with both CEA and carotid arteriography. In addition, 6 transient ischemic attacks and 3 myocardial infarctions could be directly linked to CEA, for a total CEA event rate of 2.6%.
Conclusions Patients with asymptomatic internal carotid artery stenosis exceeding 60% reduction in diameter who are acceptable candidates for elective operation may be considered for CEA if the combined arteriographic and surgical complication rates are 3% or less.
Key Words: carotid endarterectomy carotid stenosis clinical trials complications
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