A multi-institutional analysis of transcarotid artery revascularization compared to carotid endarterectomy.

OBJECTIVE: Transcarotid artery revascularization (TCAR) is a novel approach to carotid intervention that uses a direct carotid cut-down approach coupled with cerebral blood flow reversal to minimize embolic potential. The initial positive data with TCAR indicates that it may be an attractive alternative to trans-femoral carotid artery stenting and possibly carotid endarterectomy (CEA) for high-risk patients. The purpose of this study was to present 30-day and 1-year outcomes after treatment by TCAR and to compare these outcomes against a matched control group undergoing CEA at the same institutions.
METHODS: A retrospective review of all patients who underwent TCAR at four institutions between 2013 and 2017 was performed to evaluate the use of the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical, Inc, Sunnyvale, Calif). TCAR patients had high-risk factors and were either enrolled in prospective trials or treated with a commercially available TCAR device after US Food and Drug Administration approval. Contemporaneous patients undergoing CEA at each institution were also reviewed. Patients were propensity matched in a 1:1 (CEA:TCAR) fashion with respect to preoperative comorbidities. Data were analyzed using statistical models with a P value of less than .05 considered significant. Individual and composite stroke, myocardial infarction, and death at 30 days and 1 year postoperatively were assessed.
RESULTS: Consecutive patients undergoing TCAR or CEA were identified (n = 663) and compared. Patients undergoing the TCAR procedure (n = 292) had higher rates of diabetes (P = .01), hyperlipidemia (P = .02), coronary artery disease (P < .01), and renal insufficiency (P < .01) compared with unmatched CEA patients (n = 371). Stroke rates were similar at 30 days (1.0% TCAR vs 1.1% CEA) and 1 year (2.8% TCAR vs 3.0% CEA) in the unmatched groups. After propensity matching by baseline characteristics including gender, age, symptom status (36.3%, 35.3%) and diabetes, 292 TCAR patients were compared with 292 CEA patients. TCAR patients were more likely to be treated preoperative and postoperatively with clopidogrel (preoperatively, 82.2% vs 39.4% [P < .01]; postoperatively, 98.3% vs 36.0% [P < .01]) and statins (preoperatively, 88.0% vs 75.0% [P < .01]; postoperatively, 97.8% vs 78.8% [P < .01]). Stroke (1.0% TCAR vs 0.3% CEA; P = .62) and death (0.3% TCAR vs 0.7% CEA; P = NS) rates were similar at 30 days and comparable at 1 year (stroke, 2.8% vs 2.2% [P = .79]; death 1.8% vs 4.5% [P = .09]). The composite end point of stroke/death/myocardial infarction at 1 month postoperatively was 2.1% vs 1.7% (P = NS). TCAR was associated with a decreased rate of cranial nerve injury (0.3% vs 3.8%; P = .01).
CONCLUSIONS: These early data suggest that patients undergoing TCAR, even those with high-risk comorbidities, achieve broadly similar outcomes compared with patients undergoing CEA while mitigating cranial nerve injury. Further comparative studies are warranted.