Abstract
A prospective, open label, single-arm, multicenter, post-approval registry study was performed from 2015 to 2019. A total of 632 patients at 43 sites considered at high risk of complications from carotid endarterectomy (CEA; anatomic factors, 44%; physiologic factors, 32%; both, 24%) with symptomatic stenosis ≥50% or asymptomatic stenosis ≥80% underwent transcarotid revascularization (TCAR). Of the operators, 81% were TCAR naive before study initiation. Approximately one quarter of the patients were symptomatic. The technical success rate was 99.7% for all cases and 98% for the per-protocol patients. The composite 30-day stroke/death rate was 2.3% and the stroke/death/myocardial infarction rate was 3.2%. In the per-protocol population, the composite 30-day stroke/death rate was 0.8% and the stroke/death/myocardial infarction rate was 1.7%. TCAR results in excellent early outcomes with high technical success and low rates of postprocedure stroke and death. These results were achieved by most operators new to this technology at the start of the trial. Adherence to the study protocol and periprocedural antiplatelet therapy optimized the outcomes.
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