One-year Results of the (ROADSTER) Multicenter Trial of Transcarotid Stenting with Dynamic Flow Reversal
Mahmoud Malas1, Besma J Nejim1, Christopher J Kwolek2, Jose Ignacio Leal Lorenzo3, Tod Hanover4, Manish Mehta5, Vikram S. Kashyap6, Richard Cambria2
1Johns Hopkins University, Baltimore, MD;2Massachusetts General Hospital, Boston, MA;3Complejo Hospitalario de Toledo, Toledo, Spain4Greenville Hospital System, Greenville, SC;5Albany Vascular Group, The Institute for Vascular Health and Disease, Albany, NY;6University Hospitals Case Medical Center, Cleveland, OH
BACKGROUND: The aim of this study is to report the one-year outcomes of the Transcarotid artery stenting (TCAR) with cerebral blood flow reversal (ROADSTER) multicenter trial. 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. The aim of this study is to report the one-year outcomes and to evaluate the durability of TCAR.
METHODS: 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 one-year following (TCAR). Occurrence of stroke was ascertained by an independent clinical event committee.
RESULTS: Overall, 219 patients were enrolled (pivotal phase: 141 and extended access: 78 patients). Of those, 164 patients were included in the one-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: 42.1-91.3years). 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 risk factors were distributed as follows: contralateral carotid artery occlusion (11.0%), tandem stenosis of greater than 70% (1.8%), high cervical carotid artery stenosis (25.0%), restenosis after CEA (25.6%), bilateral stenosis requiring treatment (4.3%) and hostile neck was the indication of TCAR in 14.6% of cases. Physiological high-risk factors including 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. Overall, anatomical and physiological 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 one-year follow-up, ipsilateral stroke incidence rate was 0.6% and 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)
CONCLUSIONS: 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 through the ENROUTE Transcarotid NPS in comparison to distal protection devices. The trans-cervical approach circumvents aortic arch manipulation that takes place through the trans-femoral approach. TCAR offers a potentially safe alternative option for patients who are deemed to be high-risk for CEA.
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