CREST‐2 Commitment to Rigorous Assessment of Carotid Stenting for Primary Prevention of Stroke

Abstract

BACKGROUND Rather than considering carotid stenting and endarterectomy to be rival procedures, they ought to be seen as complementary, with some patients more suited to one procedure over another. The respective patient populations best suited for optimal outcomes with stenting and endarterectomy differ substantially. Hence, the CREST‐2 (Carotid Revascularization, Endarterectomy Versus Stent Trial‐2) ( study was designed as 2 separate 2‐arm randomized trials run in parallel. One trial compares intensive medical management with and without stenting; the other, intensive medical management with and without endarterectomy. Each trial has a recruitment target of 1240 patients with ≥70% asymptomatic carotid stenosis, randomized 1:1 in each arm. To ensure patient safety and give stenting the best possible chance of demonstrating net benefits in stroke prevention, CREST‐2 adopted a rigorous procedure for evaluating, monitoring, and approving operators to enroll in the trial. The CREST‐2 Registry was established to allow for recent experience for applicant stent operators. METHODS The CREST‐2 Registry is a prospective, multicenter, short‐term observational study of carotid stenting allowing use of multiple devices. RESULTS The registry enrolled its first patient in September 2014, and as of October 2, 2023, a total of 9830 patients have been treated by 207 different stent operators from 103 different clinical centers. In this mixed cohort of asymptomatic (61.1% of the cohort) and symptomatic (38.9%) patients, the 30‐day stroke rate is 1.8% and the combined 30‐day stroke or death rate is 2.6%. At its peak in March 2016, the registry achieved an enrollment rate of 142 cases/month. As of October 20, 2023, a total of 104 patients remain to be enrolled in the CREST‐2 stenting trial. CONCLUSION The registry has facilitated assembly of a high‐performing team of stent operators for the CREST‐2 trial. With continued support of the many operators, we anticipate completing enrollment by the summer of 2024.