Original Article
The Carotid Revascularization Endarterectomy versus Stenting Trial: Credentialing of Interventionalists and Final Results of Lead-in Phase

https://doi.org/10.1016/j.jstrokecerebrovasdis.2010.01.001Get rights and content

The success of carotid artery stenting in preventing stroke requires a low risk of periprocedural stroke and death. A comprehensive training and credentialing process was prerequisite to the randomized Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) to assemble a competent team of interventionalists with low periprocedural event rates. Interventionalists submitted cases to a multidisciplinary Interventional Management Committee. This committee evaluated 427 applicants. Of these, 238 (56%) were selected to participate in the training program and the lead-in phase, 73 (17%) who had clinical registry experience and satisfactory results with the devices used in CREST were exempt from training and were approved for the randomized phase, and 116 (27%) did not qualify for training. At 30 days in the lead-in study, stroke, myocardial infarction, or death occurred in 6.1% of symptomatic subjects and 4.8% of asymptomatic subjects. Stroke or death occurred in 5.8% of symptomatic subjects and 3.8% of asymptomatic subjects. Outcomes were better for younger subjects and varied by operator training. Based on experience, training, and lead-in results, the Interventional Management Committee selected 224 interventionalists to participate in the randomized phase of CREST. We believe that the credentialing and training of interventionalists participating in CREST have been the most rigorous reported to date for any randomized trial evaluating endovascular treatments. The study identified competent operators, which ensured that the randomized trial results fairly contrasted outcomes between endarterectomy and stenting.

Section snippets

Credentialing of CAS Operators in the CREST Lead-in Study

The first step in the credentialing process was selecting interventionalists for the lead-in phase of CREST. To document their experience and technical skills, candidates had to submit records of their CAS cases, including admission notes, indications for CAS, procedure reports, and discharge summaries, to a multidisciplinary Interventional Management Committee (IMC). The number of cases before the lead-in reflected cases over the preceding months to several years. A physician-reviewer on the

Credentialing Process

CREST sent invitations to 140 candidate sites, requesting data from potential interventionalists and surgeons.12 During 137 teleconferences, the IMC reviewed 10,164 CAS cases from 427 applicants (Fig 1). Of the 427 stent operators who applied for the trial, 224 (52.4%) were ultimately approved for the randomization phase.

The IMC did not approve 116 applicants for participation in the lead-in study. The primary reason that approval was not granted was insufficient experience; applicants either

Discussion

This article describes the most extensive credentialing process for carotid interventionalists yet reported. The process involved assessment of the clinical and technical acceptability to enter a credentialing registry by a multidisciplinary IMC, rigorous per-protocol assessment of outcomes in a lead-in registry, and approval for CREST by the IMC, largely on the basis of data from the registry.

The CREST lead-in phase is the largest federally funded study of its type, with 414 symptomatic

Conclusions

Large multicenter randomized trials that compare technical procedures ideally include rigorous training and credentialing protocols. Careful selection, training, and lead-in registry analysis of operators prerandomization are expected to ensure that the results of a randomized trial are applicable to the quality standards expected in the medical community. In the CREST lead-in study, which included both conventional-risk and higher-risk symptomatic and asymptomatic patients, outcomes achieved

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  • Cited by (0)

    Supported by National Institutes of Health, National Institute of Neurological Disorders of Stroke Grant RO1-NS38384. Industry support was provided by Abbott Vascular Solutions (formerly Guidant Endovascular Solutions).

    The authors report no conflicts of interest.

    Clinical trials registration identifier: NCT00004732.

    ∗∗∗

    Deceased.

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