Early Outcomes in the ROADSTER 2 Clinical Trial of Transcarotid Artery Revascularization in Patients with Significant Carotid Artery Disease

Abstract

Introduction: Transcarotid artery revascularization (TCAR) involves carotid artery stenting with cerebral protection via reversal of carotid arterial flow. The aim of the present study was to evaluate the real world safety and efficacy of TCAR using the ENROUTE Transcarotid Neuroprotection System (NPS) Methods: The ROADSTER 2 trial is a prospective, open label, single arm, multicenter post-approval registry for patients undergoing TCAR. Patients considered at high risk for complications from carotid endarterectomy (CEA) with symptomatic stenosis ≥50% or asymptomatic stenosis ≥80% were included. The primary endpoint was procedural success, which encompassed technical success plus the absence of stroke, myocardial infarction, or death within the 30 day postoperative period. Secondary endpoints were acute device success (delivery of device, establishment of flow reversal, and retrieval), technical success (acute device success plus introduction of interventional tools), stroke, death, and the composite of stroke, death, or myocardial infarction (S/D/MI). Results: This study enrolled 623 patients who underwent TCAR at 41 sites with 599 having completed 30 day follow up. The cohort included 67.0% (417/623) male patients, 42% over the age of 75, and 26.8% (167/623) with symptoms. Overall, 425 (68.2%) patients had anatomic-related high risk factors, 352 (56.5%) had physiologic high risk factors, and 154 (24.7%) had both. The majority (81.2%) of operators in this study were new to TCAR and did not participate in the ROADSTER 1 trial. The early postoperative outcomes included five patients (0.8%) suffering a stroke, one patient (0.2%) dying from a ruptured AAA two weeks post-procedure, and six (1.0%) having an MI. The composite stroke/death/MI rate was 1.9%. Acute device success and technical success occurred in 99.7% of cases. Conclusion: Transcarotid artery revascularization results in excellent early outcomes with a combined stroke/death rate of 1.0%. These results were achieved despite the majority of operators were new to this technology. Longer follow up data is needed to confirm these early outcomes. Disclosure: Stents and neuroprotection devices were provided by SILKROAD within the trial.