Long-term follow-up for recurrent stenosis: A prospective randomized study of expanded polytetrafluoroethylene patch angioplasty versus primary closure after carotid endarterectomy

Background and Purpose-Although several studies have compared the results of carotid endarterectomy (CEA) with primary closure (PC) versus patch closure, none have compared the outcome of bilateral CEAs with patch versus PC performed on the same patient. This prospective randomized study compares the clinical outcome and incidence of recurrent stenosis (Ն80%) for CEA with PC versus patch closure in patients with bilateral CEAs. Methods-This study includes 74 patients with bilateral CEAs with PC on one side and patching on the other. Patients were randomized to sequential operative treatment of either patching/PC or PC/patching. Postoperative duplex ultrasounds and clinical follow-up were done at 1, 6, and 12 months and every year thereafter. A Kaplan-Meier analysis was used to estimate the risk of significant restenosis (Ն80%). Results-Demographic characteristics and the mean operative diameter of the internal carotid artery were similar for both PC and patching. The mean follow-up was 29 months (range, 6 to 65 months). The incidence of ipsilateral stroke was 4% for PC versus 0% for patching. PC had a significantly higher incidence of neurological complications (transient ischemic attacks and stroke combined) than patching (12% versus 1%; Pϭ0.02). Operative mortality was 0%. PC had a higher incidence of recurrent stenosis (22% versus 1%; PϽ0.003) and total internal carotid artery occlusion (8% versus 0%; Pϭ0.04) than patching. Restenoses necessitating a repeated CEA were also higher for PC (14%) than for patching (1%; Pϭ0.01). The Kaplan-Meier analysis showed that patching had a significantly better cumulative patency rate than PC (PϽ0.01). This analysis also showed that freedom from recurrent stenosis at 24 months was 75% for PC and 98% for patching. Conclusions-Patch closure is less likely than PC to cause ipsilateral stroke, transient ischemic attacks, and recurrent carotid stenosis. The higher rate of unilateral recurrent stenosis may suggest that local factors play a more significant role than systemic factors in the etiology of recurrent carotid stenosis.

Section: Discussionmentioning

confidence: 99%

Prospective Randomized Trial of Bilateral Carotid Endarterectomies

AbuRahma

Robinson

Saiedy

et al. 1999

“…The rationale for patching the internal carotid artery during CEA is that the additional luminal diameter provided by the patch limits restenosis, but there are no convincing data on the effectiveness of the technique. 26,27 Although we did not measure postoperative carotid stenosis, our nonrandomized analysis provides no evidence to support the use of patching in the prevention of late postoperative stroke.…”

Section: Risk Factors For Ipsilateral Stroke After Ceamentioning

confidence: 93%

Long-Term Durability of Carotid Endarterectomy for Symptomatic Stenosis and Risk Factors for Late Postoperative Stroke

Cunningham

Bond²,

Mehta³

et al. 2002

Background and Purpose-Carotid endarterectomy (CEA) reduces the risk of stroke ipsilateral to recently symptomatic severe carotid stenosis. Other techniques such as percutaneous transluminal angioplasty with stenting are currently being compared with CEA. Thus far, case series and several small, randomized, controlled trials of CEA versus percutaneous transluminal angioplasty (with and without stenting) have focused primarily on the 30-day procedural risks of stroke and death. However, long-term durability is also important. To determine the long-term risk of stroke after CEA and to identify risk factors, we studied patients in the European Carotid Study Trial (ECST), the largest published cohort with long-term follow-up by physicians after CEA. Methods-Risks of ipsilateral carotid territory ischemic stroke were calculated by Kaplan-Meier analysis starting on the 30th day after CEA in 1728 patients who underwent trial surgery. Risk factors were determined by Cox regression. For comparison, we also determined the "background" risk of stroke on medical treatment in the ECST in the territory of 558 previously asymptomatic contralateral carotid arteries with Ͻ30% angiographic stenosis (ECST method) at randomization. Results-The risks of disabling ipsilateral ischemic stroke and any ipsilateral ischemic stroke were constant after CEA, reaching 4.4% [95% confidence interval (CI), 3.0 to 5.8] and 9.7% (95% CI, 7.6 to 11.7), respectively, by 10 years. The equivalent ischemic stroke risks distal to contralateral Ͻ30% asymptomatic carotid stenoses were 1.9% (95% CI, 0.8 to 3.2) and 4.5% (95% CI, 1.5 to 7.4). Presentation with cerebral symptoms, diabetes, elevated systolic blood pressure, smoking, male sex, increasing age, and a lesser severity of preoperative stenosis were associated with an increased risk of late stroke after CEA, but plaque morphology and patch grafting were not. Conclusions-Although the risk of late ipsilateral ischemic stroke after CEA for symptomatic stenosis is approximately double the background risk in the territory of Ͻ30% asymptomatic stenosis, it is still only Ϸ1% per year and remains low for at least 10 years after CEA. This is the standard against which alternative treatments should be judged. Several risk factors may be useful in identifying patients at particularly high risk of late postoperative stroke.

“…(5) Of the patients who developed recurrent carotid stenosis, how many required reoperation for either symptoms or continued progression to a high-grade lesion? (6) In both unifactorial and multifactorial analyses comparing patients with and without recurrent stenosis, were there any correlations with the following parameters: age, sex, hyperlipidemia, continued cigarette smoking, diabetes mellitus, hypertension, peripheral vascular disease, contralateral carotid stenosis, or operation? In addition, were there any correlations with the following technical features: patch closure, distal endarterectomy tacking sutures, or shunt versus no shunt?…”

Section: Methodsmentioning

confidence: 99%

“…The incidence of recurrence has been quite variable, ranging from Ͻ2.0% to as much as 30%. [5][6][7][8][9][10][11][12] However, most reports have been retrospective analyses. The Asymptomatic Carotid Atherosclerosis Study (ACAS) had as one of its primary objectives to define the true incidence and consequence of recurrent carotid stenosis after CEA.…”

mentioning

confidence: 99%

Recurrent Carotid Stenosis

Moore

Kempczinski

Nelson

et al. 1998

146

for the ACAS InvestigatorsBackground and Purpose-We sought to determine the incidence of recurrent carotid stenosis in patients in the Asymptomatic Carotid Atherosclerosis Study (ACAS) who had undergone carotid endarterectomy and were prospectively followed with Doppler ultrasound for up to 5 years. Methods-The ACAS database was interrogated to determine the rate of recurrent carotid stenosis (Ն60%) based up angiogram-validated Doppler data, with a 90% and a 95% positive predictive value, as well as information concerning the technologists' interpretation of percent stenosis. These 3 parameters are reported for each of 3 time intervals: within 3 months of operation (residual disease), between 3 and 18 months (early restenoses), and between 18 and 60 months (late restenosis). Results-Of the 825 patients randomized to the surgical arm of the study, 720 actually underwent carotid endarterectomy, and 645 had complete ultrasound data. The aggregate incidence of residual and recurrent carotid stenosis for all time intervals ranged from 12.7% to 20.4%, depending on the positive predictive value confidence level desired. Residual disease occurred in 4.1% to 6.5%; true, early restenosis was found in 7.6% to 11.4%; and late restenosis occurred in 1.9% to 4.9%. None of the traditional risk factors showed a statistically significant effect on recurrent stenosis. The use of patch angioplasty closure reduced overall risk of restenosis from 21.2% to 7.1%, from 16.7% to 4.6%, and from 27.4% to 8.2%, depending on the PPV confidence level desired (PϽ0.001). Of the 136 patients judged to have recurrent stenosis, only 8 (5.9%) underwent reoperation (only 1 for symptoms). There was no correlation between late stroke and recurrent stenosis. Conclusions-Carotid endarterectomy is a durable procedure with a low rate of true restenosis, particularly when patch angioplasty is used to close the arteriotomy.