The results of the ROADSTER trial demonstrate that the use of the ENROUTE Transcarotid NPS is safe and effective at preventing stroke during CAS. The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multicenter clinical trial of CAS.
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 ¼ 663) and compared. Patients undergoing the TCAR procedure (n ¼ 292) had higher rates of diabetes (P ¼ .01), hyperlipidemia (P ¼ .02), coronary artery disease (P < .01), and renal insufficiency (P < .01) compared with unmatched CEA patients (n ¼ 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 ¼ .62) and death (0.3% TCAR vs 0.7% CEA; P ¼ NS) rates were similar at 30 days and comparable at 1 year (stroke, 2.8% vs 2.2% [P ¼ .79]; death 1.8% vs 4.5% [P ¼ .09]). The composite end point of stroke/death/myocardial infarction at 1 month postoperatively was 2.1% vs 1.7% (P ¼ NS). TCAR was associated with a decreased rate of cranial nerve injury (0.3% vs 3.8%; P ¼ .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.
Background and Purpose: Transcarotid artery revascularization (TCAR) is comprised of carotid artery stent placement with cerebral protection via proximal carotid artery clamping and reversal of cerebral arterial flow. The aim of the present study was to evaluate the safety and efficacy of TCAR performed by a broad group of physicians with variable TCAR experience. Methods: The ROADSTER 2 study is a prospective, open label, single arm, multicenter, postapproval registry for patients undergoing TCAR. Patients considered at high risk for complications from carotid endarterectomy with symptomatic stenosis ≥50% or asymptomatic stenosis ≥80% were included. The primary end point was procedural success, which encompassed technical success plus the absence of stroke, myocardial infarction, or death within the 30-day postoperative period. Secondary end points included technical success and individual/composite rates of stroke, death, and myocardial infarction (MI). All patients underwent independent neurological assessments before the procedure, within 24 hours, and at 30 days after TCAR. An independent clinical events committee adjudicated all major adverse events. Results: Between 2015 and 2019, 692 patients (Intent to Treat Population) were enrolled at 43 sites. Sixty cases had major protocol violations, leaving 632 patients adhering to the Food and Drug Administration-approved protocol (per-protocol population). The majority (81.2%) of operators were TCAR naïve before study initiation. Patients underwent TCAR for neurological symptoms in 26% of cases, and all patients had high-risk factors for carotid endarterectomy (anatomic-related 44%; physiological 32%; both 24%). Technical success occurred in 99.7% of all cases. The primary end point of procedural success rate in the Intent to Treat population was 96.5% (per-protocol 97.9%). The early postoperative outcomes in the Intent to Treat population included stroke in 13 patients (1.9%), death in 3 patients (0.4%), and MI in 6 patients (0.9%). The composite 30-day stroke/death rate was 2.3%, and stroke/death/MI rate was 3.2%. In the per-protocol population, there were strokes in 4 patients (0.6%), death in one patient (0.2%), and MI in 6 patients (0.9%) leading to a composite 30-day stroke/death rate of 0.8% and stroke/death/MI rate of 1.7%. Conclusions: TCAR results in excellent early outcomes with high technical success combined with low rates of postprocedure 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 peri-procedural antiplatelet therapy optimizes outcomes. Longer-term follow-up data are needed to confirm these early outcomes. REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02536378.
Study design: A prospective, open label, single-arm, multicenter, postapproval registry study was performed from 2015 to 2019. Key findings: 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%. Conclusion: 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. Commentary: I mentioned in a review of an article in last month's JVS Vantage Point November 2020 issue that I believe TCAR will replace CEA for most patients in the near future. However, as with CEA, patients must be carefully selected for TCAR. It was good for the authors' that our group was not included in this study or the technical success rate would not have been as high. Although we are very experienced endovascular interventionalists, including for transfemoral carotid artery stenting, two different members of our group could not advance wires through severely stenotic, calcified internal carotid lesions in two different patients on the same day; thus, conversion to good old CEA proved necessary in both cases. Granted, the patients might not have been "per protocol" patients. A factor that might be associated with a greater incidence of stroke, hematoma, local nerve injury, and, especially, dissection when performing TCARs is the use of TCAR for patients with thick, short necks. Advancing wires, catheters, and sheaths through the common carotid artery via a small lower neck incision in patients with a deep common carotid artery can be much more challenging than doing so percutaneously via the femoral artery. Although I applaud the authors' efforts to show the safety of a relatively new technique, the novice should be careful to be sure to use TCARs "per protocol"dand avoid thick necks.
An initial wire-catheter approach to cross a peripheral artery CTO is most frequently adopted. The use of dedicated CTO crossing devices provides significantly higher technical success and lower reintervention and amputation rates, at a net cost of $423.80 per procedure at 12 months.
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