November 29, 2017
Updated TCAR Data Presented From Silk Road Medical's ROADSTER 1 and 2 Studies
November 29, 2017—Silk Road Medical, Inc. announced data from the ROADSTER 1 and 2 trials demonstrating the safety and efficacy of the company’s Enroute transcarotid neuroprotection and Enroute transcarotid stent system, which are specifically designed and indicated for transcarotid artery revascularization (TCAR). The data were first presented at the 2017 VEITHsymposium, held November 14–18 in New York, New York.
Peter Schneider, MD, National Coprincipal Investigator of the ROADSTER 2 postmarket study of the Enroute system, commented in the company's announcement, “TCAR is the next step. Carotid endarterectomy has been perfected over 50 years, but no matter how good it gets, it has certain inherent challenges that aren’t ever going to go away. My attitude now has really flip-flopped from that of tried-and-true surgery to what I think is the future of carotid artery repair.”
Silk Road stated that at the VEITHsymposium, “Recent Modifications of the TCAR System and Status of the ROADSTER 2 Trial to Evaluate Real-World Usage and Value of the US Food and Drug Administration–Approved Device For TCAR” was presented by Vikram Kashyap, MD, who is also National Coprincipal Investigator of the ROADSTER 2 postmarket study. The data evaluated real-world use of the Enroute systems in a broader group of operators with little or no TCAR experience.
Dr. Kashyap reported that the procedural success rate (defined as acute device and technical success in the absence of stroke, death, or myocardial infarction at 30 days) was 98.6% (n = 365) and the stroke and death rate was 1.1% for patients with 30-day follow-up (n = 362). More than 70% of the enrollment was from new TCAR operators.
“The Silk Road System for TransCarotid Access With Reversal of Flow to Perform TCAR: Results of the ROADSTER Trial Demonstrate Safety and Efficacy of the Enroute Version of the System: Lessons Learned” was presented by Dr. Schneider on behalf of Christopher Kwolek, MD, National Coprincipal Investigator for the ROADSTER 1 pivotal study.
Highlighting the use of TCAR in patient populations at an increased risk for stroke during transfemoral carotid artery stenting, Dr. Schneider shared subgroup analyses of TCAR on elderly, symptomatic, and female patients that demonstrated stroke and cardiovascular/neurological death rates of 1.1%, 0%, and 0%, respectively.
In “Technical Tips for Safe, Effective TCAR With the Enroute System: When Is the Procedure Contraindicated,” Mahmoud Malas, MD, expanded on the technical aspects of TCAR published earlier this year in Journal of Vascular Surgery. Dr. Malas is National Coprincipal Investigator for the ROADSTER 1 long-term follow-up study.
Dr. Malas concluded that TCAR is safe and effective in patients with high surgical risk factors, that use of the right tools for access is the key to achieving successful outcomes, and that there are very few absolute contraindications to the use of TCAR.