Malas M, et al. - Researchers in this study reported the 1-year outcomes of the transcarotid artery stenting (TCAR) with cerebral blood flow reversal (ROADSTER) multicenter trial and evaluated the durability of TCAR. Previous reports suggested favorable 30-day perioperative outcomes with transcarotid artery revascularization with dynamic flow reversal. This analysis revealed extension of this excellent performance to 1 year after TCAR. In comparison to distal protection devices, the promising results from the ROADSTER trial could be related to the novel cerebral protection provided through the ENROUTE Transcarotid NPS (a novel transcarotid neuroprotection system). The transcervical approach circumvented aortic arch manipulation that took place through the transfemoral approach. For patients who were found to be at high risk for CEA, TCAR seemed to be a potentially safe alternative option.

Methods

• Researchers performed a prospective, single-arm clinical trial.
• In 14 centers, enrollment occurred.
• Incidence rates of ipsilateral stroke and death at 1 year after TCAR were assessed as the primary end points.
• An independent clinical event committee ascertained occurrence of stroke.

Results

• Researchers enrolled 219 patients (pivotal phase, 141; extended access, 78 patients) for this study.
• Of those, inclusion of 164 patients was performed in the 1-year follow-up (16 had postoperative events, 3 died, 10 declined to participate, and 26 were lost to follow-up).
• Data revealed mean age of 73.9 years (range, 42.1-91.3 years).
• The cohort was comprised of 43.3% patients aged 75 years and older, 34.8% female, 92.7% white, and 5.5% African American.
• Majority of the patients were asymptomatic (79.9%).
• Following distribution of patients with anatomic risk factors was noticed: 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%.
• In 14.6% of cases, hostile neck was identified as the indication for TCAR.
• Observations revealed physiologic high-risk factors including two-vessel coronary artery disease in 14.0% of the participants, and severe left ventricular dysfunction (left ventricular ejection fraction <30%) in 3 (1.8%) patients.
• Overall, anatomic high-risk factors were reported in 43.3% of patients and physiologic high-risk factors were reported in 29.9% of patients.
• Data revealed that 26.8% of the entire cohort had both subsets of factors.
• Ipsilateral stroke incidence rate was 0.6%, and overall mortality rate was 3.7% at 1-year follow-up.
• In this study, the 1-year risk of stroke identified was the lowest to date to be reported in any Food and Drug Administration-approved carotid stent (Fig).