Methods
Between 2015-2019, 692 high surgical risk patients (Intent to Treat population, ITT) were enrolled in 43 sites. The FDA-approved protocol was adhered to in 632 patients (Per Protocol population, PP). The primary endpoint was procedural success, which encompassed technical success plus the absence of stroke, myocardial infarction, or death within the 30-day postoperative period. Secondary endpoints included technical success and individual/composite rates of stroke, death, and/or myocardial infarction (MI).
Findings
Among the PP population, procedural success rate was 97.6%, the stroke rate was 0.6%, the death rate was 0.2% (ruptured pre-existing abdominal aortic aneurysm), the stroke/death rate was 0.8%, and stroke/death/MI rate was 1.7%. For the ITT population, procedural success rate was 96.5%, the stroke rate was 1.9%, the death rate was 0.4%, the stroke/death rate was 2.3%, and the stroke/death/MI rate was 3.2%. The cranial nerve injury (CNI) rate was 1.3% for the PP group and 1.4% for the ITT group; CNI resolved in all patients that consented to followup at 90 days (6 out of 10).
Conclusions
TCAR results in excellent early outcomes with high technical success combined with low rates of post-procedure stroke and death. These results were achieved by a majority of operators new to this technology at the start of the trial. Adherence to the study protocol and periprocedural antiplatelet therapy optimizes outcomes.
