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The Carotid Revascularization Endarterectomy vs. Stenting Trial completes randomization: lessons learned and anticipated results.
J Vasc Surg. 2009 Nov; 50(5):1224-31.JV

Abstract

The Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) completed randomization on July 18, 2008. Sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), the trial has enrolled 2,522 participants across North America and is the largest randomized clinical trial (RCT) comparing the efficacy of carotid artery stenting (CAS) to carotid endarterectomy (CEA). It is also the largest RCT to assess carotid revascularization in both symptomatic and asymptomatic patients with carotid artery stenosis. Conventional-risk patients with symptomatic carotid stenosis (> or =50% by angiography, > or =70% by ultrasound) or asymptomatic carotid stenosis (> or =60% by angiography, > or =70% by ultrasound) were randomized to both treatment arms in a 1:1 ratio. Eligibility criteria for CREST were similar to those of the previous NINDS-sponsored CEA RCTs. The investigational devices used in the CAS arm of the study are the RX Acculink stent and the RX Accunet embolic protection system, (Abbott Vascular, Santa Clara, Calif). The primary aim is to contrast the efficacy of CAS versus CEA in preventing stroke, myocardial infarction, and all-cause mortality during a 30-day peri-procedural period, and ipsilateral stroke over the follow-up period (extending up to four years). The secondary aims are to contrast the efficacy of CAS and CEA in men and women, the restenosis rates of the two procedures, health-related quality of life, and cost effectiveness of CAS and CEA. The conclusion of enrollment in CREST marks the end of a long recruitment period from 117 community and academic hospital centers across the United States and Canada. Each surgeon and interventionalist underwent a rigorous credentialing process that included performance-assessment of prior CEA and CAS procedures. Credentialing of interventionalists also included a review of additional CAS procedures enrolled into a CREST lead-in phase prior to entering patients into the randomized trial; 1564 patients were enrolled in the lead-in, the final pathway for the largest credentialing effort to date for any clinical trial. CREST will provide long-term follow-up after carotid revascularization based on systematic ultrasonographic and neurologic surveillance, and on quality of life and cost-effectiveness comparisons between CAS and CEA in the setting of a RCT. We present a brief description of the CREST protocol, impediments that were overcome during the trial, salient results from the lead-in phase of the trial, a summary of enrollment activities and characteristics of the final cohort, and a timeline for anticipated results from the randomized phase.

Authors+Show Affiliations

Division of Vascular Surgery, University of Maryland Medical Center, USA.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19878793

Citation

Lal, Brajesh K., and Thomas G. Brott. "The Carotid Revascularization Endarterectomy Vs. Stenting Trial Completes Randomization: Lessons Learned and Anticipated Results." Journal of Vascular Surgery, vol. 50, no. 5, 2009, pp. 1224-31.
Lal BK, Brott TG. The Carotid Revascularization Endarterectomy vs. Stenting Trial completes randomization: lessons learned and anticipated results. J Vasc Surg. 2009;50(5):1224-31.
Lal, B. K., & Brott, T. G. (2009). The Carotid Revascularization Endarterectomy vs. Stenting Trial completes randomization: lessons learned and anticipated results. Journal of Vascular Surgery, 50(5), 1224-31. https://doi.org/10.1016/j.jvs.2009.09.003
Lal BK, Brott TG. The Carotid Revascularization Endarterectomy Vs. Stenting Trial Completes Randomization: Lessons Learned and Anticipated Results. J Vasc Surg. 2009;50(5):1224-31. PubMed PMID: 19878793.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Carotid Revascularization Endarterectomy vs. Stenting Trial completes randomization: lessons learned and anticipated results. AU - Lal,Brajesh K, AU - Brott,Thomas G, PY - 2009/09/01/received PY - 2009/09/01/revised PY - 2009/09/02/accepted PY - 2009/11/3/entrez PY - 2009/11/3/pubmed PY - 2009/11/13/medline SP - 1224 EP - 31 JF - Journal of vascular surgery JO - J. Vasc. Surg. VL - 50 IS - 5 N2 - The Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) completed randomization on July 18, 2008. Sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), the trial has enrolled 2,522 participants across North America and is the largest randomized clinical trial (RCT) comparing the efficacy of carotid artery stenting (CAS) to carotid endarterectomy (CEA). It is also the largest RCT to assess carotid revascularization in both symptomatic and asymptomatic patients with carotid artery stenosis. Conventional-risk patients with symptomatic carotid stenosis (> or =50% by angiography, > or =70% by ultrasound) or asymptomatic carotid stenosis (> or =60% by angiography, > or =70% by ultrasound) were randomized to both treatment arms in a 1:1 ratio. Eligibility criteria for CREST were similar to those of the previous NINDS-sponsored CEA RCTs. The investigational devices used in the CAS arm of the study are the RX Acculink stent and the RX Accunet embolic protection system, (Abbott Vascular, Santa Clara, Calif). The primary aim is to contrast the efficacy of CAS versus CEA in preventing stroke, myocardial infarction, and all-cause mortality during a 30-day peri-procedural period, and ipsilateral stroke over the follow-up period (extending up to four years). The secondary aims are to contrast the efficacy of CAS and CEA in men and women, the restenosis rates of the two procedures, health-related quality of life, and cost effectiveness of CAS and CEA. The conclusion of enrollment in CREST marks the end of a long recruitment period from 117 community and academic hospital centers across the United States and Canada. Each surgeon and interventionalist underwent a rigorous credentialing process that included performance-assessment of prior CEA and CAS procedures. Credentialing of interventionalists also included a review of additional CAS procedures enrolled into a CREST lead-in phase prior to entering patients into the randomized trial; 1564 patients were enrolled in the lead-in, the final pathway for the largest credentialing effort to date for any clinical trial. CREST will provide long-term follow-up after carotid revascularization based on systematic ultrasonographic and neurologic surveillance, and on quality of life and cost-effectiveness comparisons between CAS and CEA in the setting of a RCT. We present a brief description of the CREST protocol, impediments that were overcome during the trial, salient results from the lead-in phase of the trial, a summary of enrollment activities and characteristics of the final cohort, and a timeline for anticipated results from the randomized phase. SN - 1097-6809 UR - https://www.unboundmedicine.com/medline/citation/19878793/The_Carotid_Revascularization_Endarterectomy_vs__Stenting_Trial_completes_randomization:_lessons_learned_and_anticipated_results_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0741-5214(09)01833-3 DB - PRIME DP - Unbound Medicine ER -