Silk Road Medical Announces Presentation of TCAR Data
June 29, 2018—Silk Road Medical, Inc. announced the presentation of real-world data from the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project, an initiative of the Society for Vascular Surgery’s (SVS) Vascular Quality Initiative. Marc Schermerhorn, MD, presented the TCAR results on the treatment of patients with carotid artery disease at risk for stroke at the SVS Vascular Annual Meeting held June 20–23 in Boston, Massachusetts.
According to the company, the study evaluated patients over a 2-year period, with 1,182 patients undergoing TCAR compared to 10,797 patients undergoing carotid endarterectomy (CEA). The company noted that the TCAR Surveillance Project is the largest single body of evidence reported since the launch of TCAR in 2016. TCAR combines surgical principles of neuroprotection with endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke.
Silk Road Medical's Enroute transcarotid stent is intended to be used in conjunction with the Enroute transcarotid neuroprotection system (NPS) during the TCAR procedure. The Enroute transcarotid NPS is used to directly access the common carotid artery and initiate high-rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the Enroute transcarotid stent.
In the company's announcement, Dr. Schermerhorn commented, “Our overall findings showed that while patients receiving TCAR were sicker and more likely to be symptomatic with a higher degree of stenosis, the stroke and death rate compared to CEA was the same. With TCAR, there were significantly lower cranial nerve injuries, less time spent in the operating room, and fewer patients with a prolonged length of stay. I believe that clinicians should more widely adopt the TCAR technology as it has demonstrated both safety and efficacy and is an excellent alternative to CEA.”
According to Silk Road Medical, findings from the study showed that TCAR versus CEA had comparable rates of in-hospital stroke or death (1.6% vs 1.4%; P = .33), lower rates of acute cranial nerve injury (0.6% vs 1.8%; P < .001), shorter operative times (78 min vs 111 min; P < .001), and shorter hospital stays, despite patients being older and sicker (percent of hospital stays longer than 1 night, 27% vs 30%; P = .046).
Additional TCAR presentations highlighted at the the SVS Vascular Annual Meeting included an interim update on the ROADSTER 2 per-protocol data set. The ROADSTER 2 trial is a postmarket study intended to enroll a minimum of 600 patients with at least 70% of enrollment procedures completed by newly trained operators. The study’s Coprincipal Investigator, Peter Schneider, MD, presented interim results on 470 patients, highlighting a 30-day stroke rate of 0.6% and a stroke/death rate of 0.9%, consistent with the outcomes seen in the pivotal ROADSTER trial.
Alex King, MD, presented findings from a study that compared outcomes of TCAR to CEA across four institutions. The results showed that patients undergoing TCAR (n = 292) had similar 30-day stroke rates (1% vs 1.1%; P = 1.00) compared with patients undergoing CEA (n = 371), despite being more likely to have significant comorbidities. Acute (0.3% vs 4.1%; P < .01) and 6-month (0% vs 1.9%; P = .02) cranial nerve injury rates were shown to be lower with TCAR versus CEA.