Carotid artery revascularization with distal protection in high-surgical-risk patients in routine clinical practice: rationale and design of the CABANA safety surveillance program.

Background: Continuous improvement in carotid artery stenting (CAS) outcomes, especially for periprocedural death and stroke in high-surgical-risk patients, have been seen in recent randomized trials of CAS versus carotid endarterectomy and CAS registries. However, these studies use stringent inclusion/exclusion criteria for patient, institution, and physician selection. The Carotid Stenting Boston Scientific Surveillance Program (CABANA) study was initiated to evaluate periprocedural outcomes with modern versions of the Carotid Wallstent and FilterWire EZ System for operators with a wide range of clinical specialties, CAS experience and training levels, in patients with a broad range of high-surgical-risk conditions and lesion types.

Methods: This prospective, single-arm study enrolled 1,097 subjects with 1,098 carotid artery lesions at 99 study centers. Investigators were grouped into one of three tiers according to whether they had a high, medium, or low level of previous CAS experience and were also categorized by their CAS-credential-based training requirements for the CABANA study. Follow-up at 30 days includes clinical evaluation and independent neurological and NIH stroke scale assessments. The primary endpoint rate of 30-day composite stroke, death, and MI, as well as the rates of these individual events, will be evaluated across the overall study, by physician experience tier, and by physician training tier.

Discussion: The evaluation of periprocedural CAS safety in a real-world environment with modern devices in high-surgical-risk patients treated by physicians with a broad range of training and experience will better inform treatment decisions in the future.