TCAR Achieves Favorable Outcomes vs. Carotid Endarterectomy in Patients with Carotid Artery Disease 

Updated Results of TCAR Surveillance Project Presented at Society for Vascular Surgery Vascular Annual Meeting

NATIONAL HARBOR, Md., June 13, 2019 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (SILK), a company focused on reducing the risk of stroke and its devastating impact, 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 2019 Vascular Annual Meeting (VAM). In a headline presentation, Dr. Mahmoud Malas of the University of California, San Diego School of Medicine shared updated results for the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project.

“The results of the TCAR Surveillance Project are overwhelmingly positive on a large dataset of patients, showing, for the first time, significantly lower odds of composite in-hospital stroke, death and myocardial infarction compared  to CEA. TCAR had statistically equivalent in-hospital stroke and death rates as CEA, with significantly lower odds of myocardial infarction and cranial nerve injury. Additionally, there was a significant reduction in mortality at 30 days and 1 year, likely attributable to the reduction in myocardial infarction,” Dr. Malas said. “Patients clearly benefit from TCAR’s less-invasive approach and with these data and future studies with similar results, I believe TCAR may become the standard of care.”

The presentation, “Outcomes of Transcarotid Revascularization with Dynamic Flow Reversal Versus Carotid Endarterectomy in the Transcarotid Revascularization Surveillance Project,” evaluated patients between 2015 and 2018, with 5,716 patients receiving TCAR compared to 44,442 patients receiving carotid endarterectomy (CEA), with 5,160 patients in each group analyzed using propensity score matching. There were no statistical differences noted between TCAR and CEA for in-hospital stroke (odds ratio (OR) 0.80, p=0.19) or in-hospital stroke and death (OR: 0.77, p=0.09).  Other key findings for TCAR compared to CEA include:
·        59% lower odds of in-hospital myocardial infarction (OR: 0.41, p<.001)
·        87% lower odds of in-hospital cranial nerve injury (OR: 0.13, p<0.001)
·        35% lower odds of in-hospital stroke, death and myocardial infarction (OR: 0.65, p<.01)
·        26% lower odds of hospital stay longer than 1 day (OR: 0.74, p<0.001)
·        25% lower odds of non-home discharge (OR: 0.75, p<0.001)

In a separate risk adjusted analysis looking at 30-day and 1 year follow up, the results were as follows:
·        34% lower odds of 30-day death (OR: 0.66, p=0.03)
·        46% lower odds of 30-day stroke and death (OR: 0.54, p=0.02)
·        53% lower odds of 30-day stroke, death and MI (OR: 0.47, p<0.01)
·        23% lower odds of 1-year mortality (OR: 0.77, p=0.02)

“These updated data from the TCAR Surveillance Project mark a major milestone in our journey to build the clinical evidence base,” said Erica Rogers, Chief Executive Officer. “As these results are proven on ever larger numbers of patients, we are seeing the continued impact of our relentless focus on patient outcomes which we believe is key to driving durable and growing adoption of TCAR in the long run.”

The TCAR Surveillance Project, a key initiative of the Society for Vascular Surgery’s Vascular Quality Initiative (VQI), is an open-ended registry intended to compare real-world patient outcomes between TCAR and CEA. 

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 medical device company located in Sunnyvale, California, that is focused on reducing the risk of stroke and its devastating impact. The company has pioneered a new approach for the treatment of carotid artery disease called TransCarotid Artery Revascularization (TCAR). 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.