Clinical Data Presented for Silk Road's Enroute Neuroprotection and Stent System
December 19, 2016—Silk Road Medical, Inc. announced that the company's Enroute transcarotid neuroprotection and stent system was featured in several presentations at the 44th annual VEITHsymposium held November 15–19 in New York, New York. The Enroute system is designed and indicated for transcarotid artery revascularization (TCAR). One-year data on the pivotal cohort from ROADSTER 1 trial and the first interim analysis of the 30-day data from the ROADSTER 2 postapproval study were presented at the conference.
Mahmoud Malas, MD, National Coprincipal Investigator for the ROADSTER 1 long-term follow-up study, presented the study's midterm results for the Enroute device in the treatment of high-risk patients with carotid stenosis. Dr. Malas is Director of Endovascular Surgery at Johns Hopkins Bayview Medical Center in Baltimore, Maryland.
According to the company, the objective of the ROADSTER 1 long-term follow-up study is to evaluate the incidence of ipsilateral stroke through 1 year for patients treated during the pivotal and continued access phases of the trial.
In this ongoing retrospective review of the 141 patients treated in the pivotal phase, Dr. Malas reported outcomes for 87 patients with long-term follow-up (median, 1.3 years; range, 0.5–2.9 years). One patient presented with an ipsilateral stroke after the periprocedural period for an overall 1-year ipsilateral stroke rate of 1.1%.
Dr. Malas concluded that long-term outcomes with TCAR are comparable to carotid endarterectomy (CEA) in the population at standard surgical risk. Data collection continues in this cohort and will be published upon completion, advised Silk Road Medical.
Vikram Kashyap, MD, National Coprincipal Investigator of the ROADSTER 2 postmarket registry, presented early results from the study of the Enroute TCAR device in high-risk patients with carotid stenosis. Dr. Kashyap is from University Hospitals Case Medical Center in Cleveland, Ohio.
The ROADSTER 2 postmarket study is evaluating the real-world use of the Enroute neuroprotection and stent system in a broader group of operators with little or no TCAR experience. In this interim analysis of patients at high surgical risk treated per US Food and Drug Administration–approved protocol (n = 195), Dr. Kashyap reported that the procedural success rate in ROADSTER 2 (defined as acute device and technical success in the absence of stroke, death, or myocardial infarction at 30 days) is 97.5%.
Additionally, Dr. Kashyap noted that the stroke and death rates in patients with 30-day follow-up (n = 159) are 1.3% and 1%, respectively, for all patients enrolled thus far. With more than 50% of the enrollment coming from new TCAR operators, the outcomes are on par with the low stroke rates seen in ROADSTER, noted Silk Road Medical.
Also at the VEITHsymposium, Christopher Kwolek, MD, National Coprincipal Investigator for the ROADSTER 1 trial, presented on the technical improvements of the next-generation Enroute neuroprotection system released earlier in 2016, as well as the procedural advantages of the device for TCAR. Dr. Kwolek is Director of the Vascular and Endovascular training program at Massachusetts General Hospital, Chief of Vascular Surgery at Newton Wellesley Hospital in Newton, Massachusetts. Dr. Kwolek noted that new TCAR operators can achieve CEA-like outcomes with a short learning curve, reported Silk Road Medical.