One-Year Results of the ROADSTER Multicenter Trial of Transcarotid Stenting With Dynamic Flow Reversal

Abstract

The aim of this study was to report the 1-year outcomes of the transcarotid artery stenting (TCAR) with cerebral blood flow reversal (ROADSTER) multicenter trial and to evaluate the durability of TCAR. This trial introduced a novel transcarotid neuroprotection system (ENROUTE Transcarotid NPS; Silk Road Medical Inc, Sunnyvale, Calif). Overall 30-day stroke rate was 1.4%, which was the lowest reported in any clinical trial for carotid artery stenting. This study is a prospective, single-arm clinical trial. Enrollment occurred in 14 centers. Primary end points were incidence rates of ipsilateral stroke and death at 1 year after TCAR. Occurrence of stroke was ascertained by an independent clinical event committee. Overall, 219 patients were enrolled (pivotal phase, 141; extended access, 78 patients). Of those, 164 patients were included in the 1-year follow-up (16 had postoperative events, 3 died, 10 declined to participate, and 26 were lost to follow-up). Mean age was 73.9 years (range, 42.1-91.3 years). Patients aged 75 years and older were 43.3% of the cohort; 34.8% of patients were female, 92.7% were white, and 5.5% were African American. Most patients were asymptomatic (79.9%). Patients with anatomic risk factors were distributed as follows: contralateral carotid artery occlusion, 11.0%; tandem stenosis of >70%, 1.8%; high cervical carotid artery stenosis, 25.0%; restenosis after CEA, 25.6%; and bilateral stenosis requiring treatment, 4.3%. Hostile neck was the indication for TCAR in 14.6% of cases. Physiologic high-risk factors including two-vessel coronary artery disease were reported in 14.0% of the participants, and severe left ventricular dysfunction (left ventricular ejection fraction <30%) was reported in three (1.8%) patients. Overall, anatomic and physiologic high-risk factors were reported in 43.3% and 29.9% of patients, respectively. Both subsets of factors were present in 26.8% of the entire cohort. At 1-year follow-up, ipsilateral stroke incidence rate was 0.6%, and overall mortality rate was 3.7%. The 1-year risk of stroke found in this study is the lowest to date to be reported in any Food and Drug Administration-approved carotid stent (Fig). Transcarotid artery revascularization with dynamic flow reversal had previously shown favorable 30-day perioperative outcomes. This excellent performance seems to extend to 1 year after TCAR as illustrated in this analysis. The promising results from the ROADSTER trial might stem from the novel cerebral protection provided through the ENROUTE Transcarotid NPS in comparison to distal protection devices. The transcervical approach circumvents aortic arch manipulation that takes place through the transfemoral approach. TCAR offers a potentially safe alternative option for patients who are deemed to be at high risk for CEA.