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Abstract
Multiple challenges confront procedural trials, including slow enrollment, lack of equipoise among patients and physicians, and failure to achieve adequate masking. Nonetheless, randomized clinical trials provide the best evidence of efficacy. The evolution of technology, techniques, and standards of care during the conduct of procedural trials challenges external validity. In this study, we review how a multicenter trial of revascularization of asymptomatic carotid arteries for stroke prevention has managed changes in treating carotid stenosis and medical management of atherothrombotic disease.
Trial Registration Information ClinicalTrials.gov number: NCT02089217.
Glossary
- AHA=
- American Heart Association;
- CAS=
- carotid revascularization by stenting;
- CEA=
- carotid revascularization by endarterectomy;
- cIRB=
- central Institutional Review Board;
- CREST-2=
- Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis;
- DSMB=
- Data and Safety Monitoring Board;
- the US FDA=
- the US Food and Drug administration;
- IDE=
- investigational device exemption;
- IMM=
- intensive medical management;
- LDL=
- low-density lipoprotein;
- NIHSS=
- NIH Stroke Scale;
- NINDS=
- National Institute for Neurological Disorders and Stroke;
- PCSK9=
- proprotein convertase subtilisin/kexin type 9;
- RCT=
- randomized clinical trial;
- SBP=
- systolic blood pressure;
- TCAR=
- transcarotid artery revascularization
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Submitted and externally peer reviewed. The handling editor was Editor-in-Chief José Merino, MD, MPhil, FAAN.
- Received September 27, 2022.
- Accepted in final form January 4, 2023.
- Written work prepared by employees of the Federal Government as part of their official duties is, under the U.S. Copyright Act, a “work of the United States Government” for which copyright protection under Title 17 of the United States Code is not available. As such, copyright does not extend to the contributions of employees of the Federal Government.
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