Silk Road Medical Announces Presentation of TCAR Data Demonstrating Favorable Outcomes in Patients with Carotid Artery Disease
First Large Body of Real World Clinical Evidence Showing Benefits of TCAR vs Surgery
Presented at SVS 2018 Annual Meeting
SUNNYVALE, Calif., June 29, 2018 /PRNewswire/ — Silk Road Medical, Inc., a company dedicated to preventing the devastating burden of stroke through surgical innovation, today announced the presentation of real-world data for the treatment of patients with carotid artery disease at risk for stroke at the Society for Vascular Surgery 2018 Vascular Annual Meeting (VAM). In a headline presentation, Dr. Marc Schermerhorn of Beth Israel Deaconess Medical Center (Boston) shared, for the first time, results from the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project, a key initiative of the Society for Vascular Surgery’s Vascular Quality Initiative (VQI).
“In-hospital Outcomes of TransCarotid Artery Revascularization and Carotid Endarterectomy in the SVS Vascular Quality Initiative” evaluated patients over a two-year period, with 1,182 patients receiving TCAR compared to 10,797 patients receiving carotid endarterectomy (CEA).
“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,” said Dr. Schermerhorn. “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.”
Significant findings from the study showed TCAR to have:
- Comparable rates of in-hospital stroke or death to CEA (TCAR, 1.6%; CEA, 1.4%, p=.33)
- Lower rates of acute cranial nerve injury (TCAR, 0.6%; CEA, 1.8%, p<.001)
- Shorter operative times (TCAR, 78 min; CEA, 111 min, p<.001)
- Shorter hospital stays, despite patients being older and sicker (percent of hospitals stays longer than one night – TCAR, 27%; CEA, 30%, p=0.046)
TCAR is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. This is the largest single body of evidence reported since the launch of TCAR in 2016. Additional TCAR presentations highlighted at SVS VAM 2018 demonstrated similar results:
“Vascular Live: Latest Stroke Prevention Data Signals Standard of Care Potential in Carotid Revascularization” provided an interim update on the ROADSTER 2 Per Protocol data set. The ROADSTER 2 trial is a post-market study intended to enroll a minimum of 600 patients and with at least 70% enrollment completed by newly trained operators. Dr. Peter Schneider of Kaiser Permanente (Honolulu) and co-principal investigator for the ROADSTER 2 trial 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 compelling outcomes seen in the pivotal ROADSTER trial.
“A Multi-Institutional Analysis of Contemporary Outcomes after TransCarotid Artery Revascularization versus Carotid Endarterectomy” compared outcomes of TCAR to CEA across four institutions. Dr. Alex King of University Hospitals Cleveland Medical Center presented results showing that patients undergoing TCAR (n=292), had similar 30-day stroke rates (TCAR, 1.0%; CEA, 1.1%, p=1.00) compared with patients undergoing CEA (n=371), despite being more likely to have significant comorbidities. Acute (TCAR, 0.3%; CEA, 4.1%, p<.01) and 6-month cranial nerve injury rates (TCAR, 0.0%; CEA: 1.9%, p=0.02) were shown to be lower with TCAR vs CEA.
“The large body of real-world data presented at VAM18 demonstrates that TCAR can achieve neuroprotection similar to CEA despite being performed in sicker, more frail and “at-risk” patients. These results reiterate the compelling data previously published in the ROADSTER pivotal trial,” said Erica Rogers, president and chief executive officer of Silk Road Medical. “Carotid endarterectomy has been the gold standard for 65 years, but with the growing body of evidence for TCAR the medical community is showing that TCAR is fulfilling the promise of a less invasive, more efficient, and more patient friendly procedure.”
About TCAR with the ENROUTE Transcarotid Neuroprotection and Stent System
TCAR (TransCarotid Artery Revascularization) is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. The 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 a first in class device 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.
About Silk Road Medical
Silk Road Medical, Inc. is a private company located in Sunnyvale, California, that develops and manufactures less-invasive medical devices intended to improve the treatment of vascular disease through proprietary transcarotid therapies. The company’s TCAR procedure addresses the concerns of millions of people with carotid artery disease who are at an increased risk of stroke. Detailed information can be found at www.silkroadmed.com.
ENROUTE is a registered trademark of Silk Road Medical, Inc.