The Carotid Revascularization Endarterectomy versus Stenting Trial: credentialing of interventionalists and final results of lead-in phase

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00004732.

Figure 1

Credentialing process used to identify stent operators approved for the lead-in (n=238) and randomized (n=224) phases of CREST.

Figure 2

Kaplan-Meier analyses showing the composite outcome of death, stroke, and myocardial infarction for asymptomatic (n=1,151) and symptomatic (n=414) patients. At 12 months, the event rates were 5.4% vs 7.2%, respectively (P=.22). Difference in event rates between symptomatic and asymptomatic patients and between age strata was tested assuming normality of the estimated even rates for both groups using a standard linear contrast.

Figure 3

Kaplan-Meier analyses showing the composite outcome of death, stroke, and myocardial infarction for patients aged 75 years or younger (n=1,133) and older than 75 years (n=432). At 12 months, the event rates were 4.3% vs 10.0%, respectively (P=.001). Difference in event rates between symptomatic and asymptomatic patients and between age strata was tested assuming normality of the estimated even rates for both groups using a standard linear contrast.

Figure 4

The 30-day event rates compared by operator training background specialty. Odds ratios for the composite event of death, stroke, or myocardial infarction are shown constructed using multivariate logistic regression with the event rates for the largest group of operators, interventional cardiology, shown as unity. The most parsimonious multivariate model contains age (hazard ratio, 2.62 [95% confidence interval, 1.59–4.33]) in addition to specialty.