Abstract 17291: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis: CREST-2 update

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
James Meschia ◽  
Brajesh K Lal ◽  
George Howard ◽  
Gary Roubin ◽  
Robert D Brown ◽  
...  
Keyword(s):  
Carotid Stenosis ◽  
Medical Therapy ◽  
Primary Outcome ◽  
Randomized Clinical Trials ◽  
Carotid Stenting ◽  
Current Treatment ◽  
Asymptomatic Carotid Stenosis ◽  
Asymptomatic Carotid ◽  
Carotid Revascularization ◽  
Asymptomatic Patients

Purpose: The safety of revascularization for asymptomatic carotid stenosis, and the efficacy of medical therapy for stroke prevention have improved. Therefore, results of prior randomized trials may not apply to current treatment decisions. The NINDS-funded CREST-2 will compare carotid endarterectomy and intensive medical therapy (IMT) versus IMT alone (n=1240), and carotid stenting and IMT versus IMT alone (n=1240) in asymptomatic patients with≥70% stenosis. Materials & Methods: CREST-2 consists of two parallel randomized clinical trials to be conducted at a target of ≈120 centers, including within NINDS StrokeNet. The composite primary outcome is stroke or death during the peri-procedural period or ipsilateral ischemic stroke thereafter up to 4 years. Blinded assessment of cognition will be done periodically. Centrally directed IMT includes tight control of blood pressure (systolic target <140 mm Hg) and cholesterol (LDL target <70 mg/dl) as well as lifestyle coaching. Results: As of June 12, 2015, 94 centers have been approved by the Site Selection Committee. Credentialing is ongoing, with 198 approved surgeons and 64 approved interventionists; 124 additional conditionally approved interventionists will be able to submit additional cases for review under the CREST-2 Registry. The Centers for Medicare and Medicaid will offer CAS reimbursement for Registry enrollees. As of June 12, 2015, there are 39 actively enrolling centers, and 37 patients have been randomized. Conclusion: CREST-2 is designed to identify the best approach for asymptomatic carotid stenosis. The first patient was randomized in December, 2014. An update will be provided regarding the numbers of patients randomized, centers certified, as well as surgeons and interventionists fully approved. Registration: ClinicalTrials.gov Identifier: NCT02089217

Abstract 2956: Carotid Revascularization in Elderly Asymptomatic Patients: Are the Results Optimal?

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Rahul H Damani ◽  
Mahmoud Rayes ◽  
Pratik Bhattacharya ◽  
Seemant Chaturvedi
Keyword(s):  
Elderly Patients ◽  
Carotid Stenosis ◽  
Medical Therapy ◽  
Beta Blockers ◽  
Asymptomatic Carotid Stenosis ◽  
Asymptomatic Carotid ◽  
Carotid Revascularization ◽  
Asymptomatic Patients ◽  
Operative Complications ◽  
Best Medical Therapy

Objectives: Assess the hypothesis that patients with asymptomatic carotid stenosis older than 75 years are not on “best medical therapy” and their operative complication exceeds the AHA/ASA 3% threshold. Background: According to the Asymptomatic Carotid Atherosclerosis Study (ACAS), the Asymptomatic Carotid Surgery Trial (ACST) and recent AHA/ASA guidelines; benefits of carotid revascularization in asymptomatic patient >75 years would be offset if the operative complications rate exceed 3% and it would be more prudent to manage such patients on “best medical therapy”. How often these guidelines are being followed remains unclear. Methods: A retrospective chart review (2009-2011) at three urban, one suburban hospital within 30 miles was performed. Information of carotid revascularization (CEA & CAS) in asymptomatic elderly patients, in-hospital outcomes of stroke/death and/or MI and pre-procedural medications were evaluated. Statistical analysis with chi square testing was used. Results: A total of 114 patients met our inclusion criteria. Their features are described below.At four hospitals, the proportion of carotid revascularization done was 62% (114/185). More then quarter and one-third of patients undergoing carotid revascularization were not on statin and beta-blockers, respectively. Further, the rate of in hospital stroke was 4.4%. Conclusions: The majority of elderly patients with asymptomatic carotid stenosis patients are still undergoing carotid revascularization with operative complications that exceeded the AHA/ASA 3% threshold. More then quarter of patients in this subgroup are not on “best medical therapy”. These results reinforce the need for a new clinical trial comparing aggressive medical therapy alone vs. aggressive medical therapy and revascularization.

Abstract W P380: Asymptomatic Carotid Stenosis is Not a Walking Time Bomb

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Catherine Yang ◽  
Chrysi Bogiatzi ◽  
J David Spence
Keyword(s):  
Carotid Stenosis ◽  
Carotid Stenting ◽  
Contralateral Side ◽  
Carotid Occlusion ◽  
Asymptomatic Carotid Stenosis ◽  
Asymptomatic Carotid ◽  
Kaplan Meier ◽  
Asymptomatic Patients ◽  
Walking Time ◽  
Prevention Clinic

Background & Objective: Patients with asymptomatic carotid stenosis are often persuaded to have carotid stenting or endarterectomy on the grounds that they are “walking time bombs”, headed for disaster if the artery occludes. However, this approach ignores the protection afforded by the Circle of Willis. We therefore sought to determine the risk of stroke at the time of carotid occlusion, among patients being followed in a vascular prevention clinic. Methods: Complete data were available in 386 asymptomatic patients who had a new carotid occlusion while being followed with annual carotid ultrasound examinations in our clinic. Mean followup after the occlusion was 3.42 ± 4.07 years. Percent stenosis was ≥ 80% in 60% and ≥ 90% in 53% of cases. Prior asymptomatic occlusion on the contralateral side was present in 11 cases. Mean age was 66.5 ± 10.7 years; 71.8% were male, 21% diabetic, and 24.4% still smoking prior to the occlusion. Results: Only 1 patient (0.3%) had an ipsilateral stroke at the time of the new carotid occlusion. Percent stenosis did not predict a higher risk of any stroke/TIA/death during followup in Kaplan-Meier survival analysis ( Log rank p=0.60), nor did prior contralateral occlusion at the time of the index occlusion (p=1.0). Conclusions: The risk of ipsilateral stroke at the time of carotid occlusion is well below the risk of either carotid stenting or carotid endarterectomy. Preventing carotid occlusion is not a valid indication for intervention, and percent stenosis or contralateral occlusion do not identify patients who would benefit from intervention. Patients with ACS should be treated with intensive medical therapy unless they have characteristics such as microemboli on transcranial Doppler, or other features of vulnerable plaque that identify them as high-risk.

scholarly journals Asymptomatic carotid stenosis

Neurology ◽  
2017 ◽  
Vol 88 (21) ◽  
pp. 2061-2065 ◽  
Author(s):  
Donald V. Heck ◽  
Gary S. Roubin ◽  
Kenneth G. Rosenfield ◽  
William A. Gray ◽  
Christopher J. White ◽  
...  
Keyword(s):  
Carotid Stenosis ◽  
Medical Therapy ◽  
Medical Management ◽  
Randomized Trials ◽  
Asymptomatic Carotid Stenosis ◽  
Asymptomatic Carotid ◽  
Carotid Revascularization ◽  
Average Patient ◽  
Asymptomatic Carotid Artery Stenosis ◽  
Revascularization Procedures

Two positive randomized trials established carotid endarterectomy (CEA) as a superior treatment to medical management alone for the treatment of asymptomatic carotid artery stenosis. However, advances in medical therapy have led to an active and spirited debate about the best treatment for asymptomatic carotid stenosis. The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis (CREST 2) trial aims to better define the best treatment for the average patient with severe asymptomatic carotid stenosis. Enrollment in the trial may be hampered by strong opinions on either side of the debate. It is important to realize that equipoise exists and that neither the old data on CEA nor the new data on optimal medical therapy provide a rigorous answer. The assumption that medical therapy has already been proven superior to revascularization procedures may hinder both enrollment in the trial and technical advancements in revascularization procedures.

Abstract 155: Comparative Effectiveness of Carotid Endarterectomy Compared to Medical Therapy Among Patients With Asymptomatic Carotid Stenosis

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Salomeh Keyhani ◽  
Eric Cheng ◽  
Katherine Hoggatt ◽  
Peter Austin ◽  
Paul Hebert ◽  
...  
Keyword(s):  
Carotid Endarterectomy ◽  
Carotid Stenosis ◽  
Medical Therapy ◽  
Community Sample ◽  
Asymptomatic Carotid Stenosis ◽  
Asymptomatic Carotid ◽  
Immortal Time Bias ◽  
Asymptomatic Patients ◽  
Stroke Death

Background: Carotid endarterectomy (CEA) reduces stroke risk compared to medical therapy alone among patients with asymptomatic carotid stenosis. CEA involves a tradeoff between higher perioperative short-term risks in exchange for a lower long-term risk of stroke. However, overall declines in stroke rates raise concerns that CEA may no longer be a preferred treatment. We examined the effectiveness of CEA compared to medical therapy (MT) among asymptomatic patients in preventing stroke and stroke-death within 5 years of follow-up. Methods: We identified Veterans ≥65 years old with carotid stenosis (n=2712 CEA and n=2509 MT patients) who did not have a history of stroke or transient ischemic attack. We propensity score-matched MT patients to CEA patients to control for baseline confounding and used methods to mimic analyses from the Asymptomatic Carotid Stenosis Trial, the last published trial to compare CEA to MT. We accounted for “immortal time” bias by randomizing patients to CEA and MT groups and censoring patients if their actual treatment became inconsistent with the arm in which they were randomized (e.g., patient received CEA, but was randomized to MT). We accounted for the informative censoring by estimating time-dependent inverse probability of censoring weights using measured covariates (demographics and 72 time-varying comorbidities). We computed weighted Kaplan-Meier (KM) curves and estimated the risk of stroke/stroke-death in each group over 5 years of follow-up. Results: The observed stroke or death rate (perioperative complications) within 30 days in the CEA arm was 3%. The 5-year risk were similar among patients randomized to CEA 5.5% (95% CI, 4.3%-6.7%) versus MT 7.6% (95% CI,5.9%-9.2%) (risk difference, -2.1%, 95% CI -4%- 0%) with little difference in the KM curves (logrank p=0.2). Conclusion: CEA was not superior to MT in a community sample of Veterans after 5 years of follow-up, suggesting that CEA may no longer be the preferred treatment strategy.

scholarly journals Trends and controversies in carotid artery stenosis treatment

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 940
Author(s):  
Rakhee Lalla ◽  
Prashant Raghavan ◽  
Seemant Chaturvedi
Keyword(s):  
Carotid Stenosis ◽  
Imaging Techniques ◽  
Current Treatment ◽  
Resonance Imaging ◽  
Asymptomatic Carotid Stenosis ◽  
Asymptomatic Carotid ◽  
Carotid Revascularization ◽  
Symptomatic Stenosis ◽  
Key Questions

Despite the completion of several multi-center trials, the management of carotid stenosis remains in flux. Key questions include the role of intensive medical management in the treatment of asymptomatic carotid stenosis. In addition, identification of patients with symptomatic stenosis who will most benefit from carotid revascularization remains a priority. The role of newer imaging techniques such as carotid plaque analysis with magnetic resonance imaging is also challenging current treatment paradigms. These topics are explored in this topical update.

scholarly journals Carotid artery stenosis – Current evidence and treatment recommendations

2021 ◽  
Vol 5 (1) ◽  
pp. 2514183X2110016
Author(s):  
Mandy D Müller ◽  
Leo H Bonati
Keyword(s):  
Carotid Artery ◽  
Carotid Stenosis ◽  
Carotid Artery Stenosis ◽  
Artery Stenosis ◽  
Current Evidence ◽  
Asymptomatic Carotid Stenosis ◽  
Asymptomatic Carotid ◽  
Risk Of Death ◽  
Asymptomatic Patients

Background: Carotid artery stenosis is an important cause for stroke. Carotid endarterectomy (CEA) reduces the risk of stroke in patients with symptomatic carotid stenosis and to some extent in patients with asymptomatic carotid stenosis. More than 20 years ago, carotid artery stenting (CAS) emerged as an endovascular treatment alternative to CEA. Objective and Methods: This review summarises the available evidence from randomised clinical trials in patients with symptomatic as well as in patients with asymptomatic carotid stenosis. Results: CAS is associated with a higher risk of death or any stroke between randomisation and 30 days after treatment than CEA (odds ratio (OR) = 1.74, 95% CI 1.3 to 2.33, p < 0.0001). In a pre-defined subgroup analysis, the OR for stroke or death within 30 days after treatment was 1.11 (95% CI 0.74 to 1.64) in patients <70 years old and 2.23 (95% CI 1.61 to 3.08) in patients ≥70 years old, resulting in a significant interaction between patient age and treatment modality (interaction p = 0.007). The combination of death or any stroke up to 30 days after treatment or ipsilateral stroke during follow-up also favoured CEA (OR = 1.51, 95% CI 1.24 to 1.85, p < 0.0001). In asymptomatic patients, there is a non-significant increase in death or stroke occurring within 30 days of treatment with CAS compared to CEA (OR = 1.72, 95% CI 1.00 to 2.97, p = 0.05). The risk of peri-procedural death or stroke or ipsilateral stroke during follow-up did not differ significantly between treatments (OR = 1.27, 95% CI 0.87 to 1.84, p = 0.22). Discussion and Conclusion: In symptomatic patients, randomised evidence has consistently shown CAS to be associated with a higher risk of stroke or death within 30 days of treatment than CEA. This extra risk is mostly attributed to an increase in strokes occurring on the day of the procedure in patients ≥70 years. In asymptomatic patients, there may be a small increase in the risk of stroke or death within 30 days of treatment with CAS compared to CEA, but the currently available evidence is insufficient and further data from ongoing randomised trials are needed.

scholarly journals Comparative Effectiveness of Carotid Endarterectomy vs Initial Medical Therapy in Patients With Asymptomatic Carotid Stenosis

2020 ◽  
Vol 77 (9) ◽  
pp. 1110
Author(s):  
Salomeh Keyhani ◽  
Eric M. Cheng ◽  
Katherine J. Hoggatt ◽  
Peter C. Austin ◽  
Erin Madden ◽  
...  
Keyword(s):  
Carotid Endarterectomy ◽  
Carotid Stenosis ◽  
Medical Therapy ◽  
Comparative Effectiveness ◽  
Asymptomatic Carotid Stenosis ◽  
Asymptomatic Carotid

scholarly journals Carotid revascularization and medical management for asymptomatic carotid stenosis – Hemodynamics (CREST-H): Study design and rationale

2018 ◽  
Vol 13 (9) ◽  
pp. 985-991 ◽  
Author(s):  
Randolph S Marshall ◽  
Ronald M Lazar ◽  
David S Liebeskind ◽  
E Sander Connolly ◽  
George Howard ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
White Matter ◽  
Carotid Stenosis ◽  
Medical Management ◽  
Cerebral Microbleeds ◽  
White Matter Hyperintensity ◽  
Asymptomatic Carotid Stenosis ◽  
Asymptomatic Carotid ◽  
Carotid Revascularization ◽  
One Year

Rationale For patients with asymptomatic high-grade carotid stenosis, clinical investigations have focused on preventing cerebral infarction, yet stenosis that reduces cerebral blood flow may independently impair cognition. Whether revascularization of a hemodynamically significant carotid stenosis can alter the course of cognitive decline has never been investigated in the context of a randomized clinical trial. Hypothesis Among patients randomized in the Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis (CREST-2) trials, the magnitude of treatment differences (revascularization versus medical management alone) with regard to cognition will differ between those with flow impairment compared to those without flow impairment. Sample size We will enroll approximately 500 patients from CREST-2, of which we anticipate 100 will have hemodynamic impairment. We estimate 93% power to detect a clinically meaningful treatment difference of 0.5 SD. Methods and design We will use perfusion-weighted magnetic resonance imaging to stratify by hemodynamic status. Linear regression will compare treatment differences, controlling for baseline cognitive status, age, depression, prior cerebral infarcts, silent infarction, white matter hyperintensity volume, and cerebral microbleeds. Study outcomes The primary outcome is change in cognition at one year. Secondary outcomes include silent infarction, change in white matter hyperintensity volume, number of cerebral microbleeds, and cortical thickness over one year. Discussion If cognitive impairment can be shown to be reversible by revascularization, then we can redefine “symptomatic carotid stenosis” to include cognitive impairment and identify a new population of patients likely to benefit from revascularization. Trial Registration US National Institutes of Health (NIH) clinicaltrials.gov NCT03121209

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