Credentialing and Training for CREST Physicians Studied

February 26, 2010—At the International Stroke Conference 2010, the CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) investigators presented data on the rigorous two-step credentialing and training for the trial's stent operators, which aimed to minimize learning-curve effects upon outcomes. They stated that previous randomized control trials comparing carotid artery stenting (CAS) and carotid endarterectomy have been criticized for suboptimal credentialing and training of stent operators. They concluded that the CREST credentialing and training process is the most rigorous reported to date and may serve as a model for future trials.

First, candidates submit procedural data on their latest 10 to 30 consecutive CAS cases, which a multidisciplinary Interventional Management Committee (IMC) evaluates for technical ability and outcome. If approved for the lead-in credentialing phase, operators must undergo animal training and/or didactic and hands-on training with the study devices. Second, they must perform up to 20 CAS lead-in cases for review by the IMC for technique, data completeness, and outcome. Only those meeting IMC criteria are approved to enroll patients in the randomized phase. Operators demonstrating sufficient experience with the use of the study devices in other trials may be exempted from the lead-in phase by the IMC.

Of 429 stent operators who applied, 225 (52%) were approved for randomization. Initially, 117 applicants did not meet criteria to advance; the number of cases evaluated ranged from one to 56, median 12. The IMC judged that 70 operators of the 429 had sufficient experience, and sufficient experience with the study devices (range: 7–81), to be exempt from the lead-in. A total of 242 applicants met the criteria for the lead-in phase; the number of cases submitted by this group ranged from three to 63, median 29. Forty-four did not meet the regulatory and training requirements, moved to another institution or were from an institution that was not CREST-approved. The remaining 198 were approved by the IMC to enroll in the lead-in phase and are board certified (or the Canadian equivalent) in cardiology (40%), vascular surgery (21%), neuroradiology (15%), interventional radiology (15%), neurosurgery (8%), and neurology (2%). Of these 198 operators, 160, completing an average of nine (range: 1–35) cases, were approved for randomization; the remaining 38 did not do the required number of cases before trial enrollment ended. Of the 70 lead-in exempt, IMC-approved experienced operators, four were unable to meet the regulatory or training requirements, and one was from an unapproved site. A total of 225 operators at 122 sites were therefore qualified in the Interventional/CAS arm of CREST, the investigators reported.