BACKGROUND AND PURPOSE: The Asymptomatic Carotid Atherosclerosis Study is a prospective, multicenter, randomized clinical trial of carotid endarterectomy for the treatment of asymptomatic hemodynamically significant stenosis. This report describes the selection process for participating surgeons in the trial. METHODS: The Surgical Management Committee established guidelines for minimal annual experience and maximum neurological morbidity and mortality for surgeons to qualify to participate in the study. For approval, a surgeon must perform at least 12 carotid endarterectomies per year. Based on a review of the surgeon's last 50 consecutive endarterectomies, the combined neurological morbidity and mortality rate must be no greater than 5% for all indications and no greater than 3% for endarterectomies performed on asymptomatic patients. RESULTS:One hundred sixty-four surgeons from 48 centers applied for approval: 117 were approved, 17 were rejected, and 30 were not reviewed. The 117 approved surgeons submitted a total of 5,641 endarterectomies with a combined mortality and neurological morbidity rate of 2.3% for the variety of indications for operation. CONCLUSIONS: This overall experience with carotid endarterectomy is one of the largest series reported to date. The data from approved surgeons are well within the range of acceptable neurological morbidity and mortality rates recommended by the Stroke Council of the American Heart Association, which attests to the overall quality of the surgeons participating in the study.
RCT Entities:
BACKGROUND AND PURPOSE: The Asymptomatic Carotid Atherosclerosis Study is a prospective, multicenter, randomized clinical trial of carotid endarterectomy for the treatment of asymptomatic hemodynamically significant stenosis. This report describes the selection process for participating surgeons in the trial. METHODS: The Surgical Management Committee established guidelines for minimal annual experience and maximum neurological morbidity and mortality for surgeons to qualify to participate in the study. For approval, a surgeon must perform at least 12 carotid endarterectomies per year. Based on a review of the surgeon's last 50 consecutive endarterectomies, the combined neurological morbidity and mortality rate must be no greater than 5% for all indications and no greater than 3% for endarterectomies performed on asymptomatic patients. RESULTS: One hundred sixty-four surgeons from 48 centers applied for approval: 117 were approved, 17 were rejected, and 30 were not reviewed. The 117 approved surgeons submitted a total of 5,641 endarterectomies with a combined mortality and neurological morbidity rate of 2.3% for the variety of indications for operation. CONCLUSIONS: This overall experience with carotid endarterectomy is one of the largest series reported to date. The data from approved surgeons are well within the range of acceptable neurological morbidity and mortality rates recommended by the Stroke Council of the American Heart Association, which attests to the overall quality of the surgeons participating in the study.
Authors: Thomas G Brott; Robert W Hobson; George Howard; Gary S Roubin; Wayne M Clark; William Brooks; Ariane Mackey; Michael D Hill; Pierre P Leimgruber; Alice J Sheffet; Virginia J Howard; Wesley S Moore; Jenifer H Voeks; L Nelson Hopkins; Donald E Cutlip; David J Cohen; Jeffrey J Popma; Robert D Ferguson; Stanley N Cohen; Joseph L Blackshear; Frank L Silver; J P Mohr; Brajesh K Lal; James F Meschia Journal: N Engl J Med Date: 2010-05-26 Impact factor: 91.245
Authors: Nicole R Gonzales; Bart M Demaerschalk; Jenifer H Voeks; MeeLee Tom; George Howard; Alice J Sheffet; Lawrence Garcia; Daniel G Clair; John Barr; Steven Orlow; Thomas G Brott Journal: Stroke Date: 2014-09-25 Impact factor: 7.914
Authors: L Nelson Hopkins; Gary S Roubin; Elie Y Chakhtoura; William A Gray; Robert D Ferguson; Barry T Katzen; Kenneth Rosenfield; Jonathan Goldstein; Donald E Cutlip; William Morrish; Brajesh K Lal; Alice J Sheffet; MeeLee Tom; Susan Hughes; Jenifer Voeks; Krishna Kathir; James F Meschia; Robert W Hobson; Thomas G Brott Journal: J Stroke Cerebrovasc Dis Date: 2010-03 Impact factor: 2.136
Authors: Thomas G Brott; George Howard; Gary S Roubin; James F Meschia; Ariane Mackey; William Brooks; Wesley S Moore; Michael D Hill; Vito A Mantese; Wayne M Clark; Carlos H Timaran; Donald Heck; Pierre P Leimgruber; Alice J Sheffet; Virginia J Howard; Seemant Chaturvedi; Brajesh K Lal; Jenifer H Voeks; Robert W Hobson Journal: N Engl J Med Date: 2016-02-18 Impact factor: 91.245
Authors: A J Sheffet; G Roubin; G Howard; V Howard; W Moore; J F Meschia; R W Hobson; T G Brott Journal: Int J Stroke Date: 2010-02 Impact factor: 5.266