Vascular Annual Meeting

Early Outcomes To Be Presented From ROADSTER 2


 

Vikram S. Kashyap, MD, of the University Hospitals Cleveland Medical Center, will present results from ROADSTER 2, a prospective, multicenter, postapproval registry for patients undergoing transcarotid artery revascularization (TCAR). This technique involves carotid artery stenting with cerebral protection via reversal of carotid arterial flow. The aim of the study was to evaluate the real- world safety and efficacy of TCAR.

Dr. Kashyap and his colleagues enrolled 623 patients who were considered at high risk for complications from carotid endarterectomy (CEA) and who had symptomatic stenosis equal to or greater than 50% or asymptomatic stenosis equal to or greater than 80%. 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), according to Dr. Kashyap.

A total of 599 of the patients completed 30-day follow-up. The cohort included 67.0% men, 42% older than 75 years, and 26.8% with symptoms Overall, 68.2% of the patients had anatomic-related high-risk factors, 56.5% had physiologic high-risk factors, and 24.7% had both. The majority (81.2%) of the 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%.

“TCAR results in excellent early outcomes with a combined stroke/death rate of 1.0%. Broader, longer- term, comparative studies are needed in this area. But if these results can be confirmed, I believe TCAR may become a favorable alternative to transfemoral carotid artery stenting, and even rival carotid endarterectomy,” Dr. Kashyap concluded.

Saturday, June 15
1:30-2:30 p.m.
Gaylord National, Potomac 4-6
S10: Scientific Session 10/Late-Breaking: LB2

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