scholarly journals Faculty Opinions recommendation of Carotid revascularization and medical management for asymptomatic carotid stenosis - Hemodynamics (CREST-H): Study design and rationale.

2020 ◽  
Author(s):  
Seemant Chaturvedi
Keyword(s):  
Carotid Stenosis ◽  
Study Design ◽  
Medical Management ◽  
Asymptomatic Carotid Stenosis ◽  
Asymptomatic Carotid ◽  
Carotid Revascularization

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

scholarly journals The CREST-2 experience with the evolving challenges of COVID-19

Neurology ◽  
2020 ◽  
Vol 95 (1) ◽  
pp. 29-36 ◽  
Author(s):  
James F. Meschia ◽  
Kevin M. Barrett ◽  
Robert D. Brown ◽  
Tanya N. Turan ◽  
Virginia J. Howard ◽  
...  
Keyword(s):  
Carotid Stenosis ◽  
Medical Management ◽  
Neurological Disorders ◽  
Stroke Prevention ◽  
Prevention Trial ◽  
Asymptomatic Carotid Stenosis ◽  
Asymptomatic Carotid ◽  
Ethical Obligation ◽  
Carotid Revascularization

The coronavirus disease 2019 pandemic has disrupted the lives of whole communities and nations. The multinational multicenter National Institute of Neurological Disorders and Stroke Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial stroke prevention trial rapidly experienced the effects of the pandemic and had to temporarily suspend new enrollments and shift patient follow-up activities from in-person clinic visits to telephone contacts. There is an ethical obligation to the patients to protect their health while taking every feasible step to ensure that the goals of the trial are successfully met. Here, we describe the effects of the pandemic on the trial and steps that are being taken to mitigate the effects of the pandemic so that trial objectives can be met.

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.

scholarly journals Carotid revascularization and medical management for asymptomatic carotid stenosis: Protocol of the CREST-2 clinical trials

2017 ◽  
Vol 12 (7) ◽  
pp. 770-778 ◽  
Author(s):  
Virginia J Howard ◽  
James F Meschia ◽  
Brajesh K Lal ◽  
Tanya N Turan ◽  
Gary S Roubin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Carotid Stenosis ◽  
Medical Management ◽  
Asymptomatic Carotid Stenosis ◽  
Asymptomatic Carotid ◽  
Carotid Revascularization

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 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

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