Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.
Objective: Transcarotid artery revascularization (TCAR) with flow reversal offers a less invasive option for carotid revascularization in high-risk patients and has the lowest reported overall stroke rate for any prospective trial of carotid artery stenting. However, outcome comparisons between TCAR and carotid endarterectomy (CEA) are needed to confirm the safety of TCAR outside of highly selected patients and providers.Methods: We compared in-hospital outcomes of patients undergoing TCAR and CEA from January 2016 to March 2018 using the Society for Vascular Surgery Vascular Quality Initiative TCAR Surveillance Project registry and the Society for Vascular Surgery Vascular Quality Initiative CEA database, respectively. The primary outcome was a composite of in-hospital stroke and death.Results: A total of 1182 patients underwent TCAR compared with 10,797 patients who underwent CEA. Patients undergoing TCAR were older (median age, 74 vs 71 years; P < .001) and more likely to be symptomatic (32% vs 27%; P < .001); they also had more medical comorbidities, including coronary artery disease (55% vs 28%; P < .001), chronic heart failure (20% vs 11%; P < .001), chronic obstructive pulmonary disease (29% vs 23%; P < .001), and chronic kidney disease (39% vs 34%; P ¼ .001). On unadjusted analysis, TCAR had similar rates of in-hospital stroke/death (1.6% vs 1.4%; P ¼ .33) and stroke/death/myocardial infarction (MI; 2.5% vs 1.9%; P ¼ .16) compared with CEA. There was no difference in rates of stroke (1.4% vs 1.2%; P ¼ .68), in-hospital death (0.3% vs 0.3%; P ¼ .88), 30-day death (0.9% vs 0.4%; P ¼ .06), or MI (1.1% vs 0.6%; P ¼ .11). However, on average, TCAR procedures were 33 minutes shorter than CEA (78 6 33 minutes vs 111 6 43 minutes; P < .001). Patients undergoing TCAR were also less likely to incur cranial nerve injuries (0.6% vs 1.8%; P < .001) and less likely to have a postoperative length of stay >1 day (27% vs 30%; P ¼ .046). On adjusted analysis, there was no difference in terms of stroke/death (odds ratio, 1.3; 95% confidence interval, 0.8-2.2; P ¼ .28), stroke/death/MI (odds ratio, 1.4; 95% confidence interval, 0.9-2.1, P ¼ .18), or the individual outcomes.Conclusions: Despite a substantially higher medical risk in patients undergoing TCAR, in-hospital stroke/death rates were similar between TCAR and CEA. Further comparative studies with larger samples sizes and longer follow-up will be needed to establish the role of TCAR in extracranial carotid disease management. (J Vasc Surg 2020;71:87-95.)
Objective: To compare the outcomes of TCAR with flow reversal to the gold standard CEA using data from the Society for Vascular Surgery Vascular Quality Initiative TCAR Surveillance Project. Summary of Background Data: TCAR is a novel minimally invasive procedure for carotid revascularization in high-risk patients that is associated with significantly lower stroke rates compared with carotid artery stenting via the transfemoral approach. Methods: Patients in the United States and Canada who underwent TCAR and CEA for carotid artery stenosis (2016-2019) were included. Propensity scores were calculated based on baseline clinical variables and used to match patients in the 2 treatment groups (n = 6384 each). The primary endpoint was the combined outcome of perioperative stroke and/or death.Results: No significant differences were observed between TCAR and CEA in terms of in-hospital stroke/death [TCAR, 1.6% vs CEA, 1.6%, RR (95% CI): 1.01 (0.77-1.33), P = 0.945], stroke [1.4% vs 1.4%, RR (95% CI): 1.02 (0.76-1.37), P = 0.881], or death [0.4% vs 0.3%, RR (95% CI): 1.14 (0.64-2.02), P = 0.662]. Compared to CEA, TCAR was associated with lower rates of in-hospital myocardial infarction [0.5% vs 0.9%, RR (95% CI): 0.53 (0.35-0.83), P = 0.005], cranial nerve injury [0.4% vs 2.7%, RR (95% CI): 0.14 (0.08-0.23), P < 0.001], and postprocedural hypertension [13% vs 18.8%, RR (95% CI): 0.69 (0.63-0.76), P < 0.001]. They were also less likely to stay in the hospital for more than 1 day [26.4% vs 30.1%, RR (95% CI): 0.88 (0.82-0.94), P < 0.001]. No significant interaction was observed between procedure and symptomatic status in predicting postoperative outcomes. At 1 year, the incidence of ipsilateral stroke or death was similar between the 2 groups [HR (95% CI): 1.09 (0.87-1.36), P = 0.44]. Conclusions: This propensity-score matched analysis demonstrated significant reduction in the risk of postoperative myocardial infarction and cranial nerve injury after TCAR compared to CEA, with no differences in the rates of stroke/death.
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