Mid-term Outcomes of the (Roadster) Multi-center Trial of Transcarotid Stenting With Dynamic Flow Reversal

Abstract

Introduction - The Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial has introduced a novel transcarotid neuroprotection system (ENROUTE Transcarotid NPS; Silk Road Medical Inc, Sunnyvale, Calif). Perioperative results demonstrated that the use of EROUTE Transcarotid NPS was safe and effective. Overall 30-day stroke rate was 1.4% which was the lowest reported in any clinical trial for carotid artery stenting. We now present the mid-term results to evaluate the durability of transcarotid carotid artery revascularization (TCAR). Methods - This study is a prospective, single-arm clinical trial. Current enrollment occurs in 14 centers. Primary endpoints were incidence rates of ipsilateral stroke and death at one-year following (TCAR). The occurrence of stroke was ascertained by an independent clinical event committee. Results - Overall, 286 patients were enrolled (lead-in phase: 67, pivotal phase: 141 and extended access: 78 patients). Of those, 164 were included in the long-term follow-up (112 patients from the pivotal phase and 52 from the extended access). Mean age was 73.9 years (range: 42.1-91.3years). Patients of age 75 years and older were 43.3% of the cohort. 34.8% of patients were females, 92.7% were Caucasians and 5.5% were African-American. Most patients were asymptomatic (79.9%). Patients with anatomical high-risk factors for carotid artery endarterectomy (CEA) were eligible for ROADSTER trial. Those anatomical risk factors were distributed as follows: contralateral carotid artery occlusion was reported in 11.0% of patients, tandem stenosis of greater than 70% was found in 1.8% of patients, high cervical carotid artery stenosis contributed to 25.0% of TCAR indications, restenosis after CEA was found in 25.6%, while bilateral stenosis requiring treatment occurred in 4.3% and hostile neck was the indication of TCAR in 14.6% of cases. two-vessel coronary artery disease was reported in 14.0% of the participants and severe left ventricular dysfunction (LEVF<30%) was reported in 3 (1.8%) patients. In general, anatomical high-risk factors took place in 43.3% while clinical high-risk factors were 29.9%. Both subsets of factors were present in 26.8%. At one-year follow-up, ipsilateral stroke incidence rate was 0.6% and the overall mortality rate was 3.7%. The one-year risk of stroke found in this study is the lowest to date to be reported in any FDA approved carotid stents (Figure). Conclusion - Transcarotid carotid artery revascularization with dynamic flow reversal had previously shown favorable 30-day perioperative outcomes. This excellent performance seems to extend to one year following TCAR as illustrated in this analysis. The promising results from the ROADSTER trial might stem from the novel cerebral protection provided by the ENROUTE Transcarotid NPS in comparison to distal protection devices. The trans-cervical approach circumvents aortic arch manipulation that takes place through the transfemoral approach. TCAR offers a potentially safe option for patients who are deemed to be high-risk for CEA.