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November 22, 2019

Data From the TCAR Surveillance Project Support Silk Road Medical's Enroute Devices

November 22, 2019—Silk Road Medical, Inc. announced the presentation of real-world data from the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project at the VEITHsymposium held November 19–23 in New York, New York.

The TCAR Surveillance Project, a key initiative of the Society for Vascular Surgery’s (SVS) Vascular Quality Initiative (VQI), is an open-ended registry intended to compare real-world patient outcomes between TCAR and carotid endarterectomy (CEA). The data were presented by Mahmoud Malas, MD.

Dr. Malas commented in the company’s announcement, “Our updated data set now includes 6,526 matched patients. TCAR continues to show a low stroke and death rate equivalent to CEA with lower rates of myocardial infarction (MI) and cranial nerve injury. Additionally, TCAR patients experience shorter length of hospital stay, and are discharged home more often.

"I am confident that as this compelling clinical evidence continues to mount, TCAR will continue to challenge CEA as the standard of care for treating carotid artery disease in high-surgical-risk patients.”

According to the company, the updated data from the TCAR Surveillance Project evaluated patients between 2016 and 2019, with 8,104 patients receiving TCAR compared with 53,869 patients receiving CEA, with 6,526 patients in each group analyzed using propensity score matching.

There were no statistical differences noted between TCAR and CEA for in-hospital stroke (1.4% vs 1.2%; P = .54) or in-hospital stroke and death (1.6% vs 1.4%; P = .57). Other key findings for TCAR compared to CEA include:

  • 59% lower odds of in-hospital MI (0.4% vs 1.1%; P < .001)
  • 86% lower odds of in-hospital cranial nerve injury (0.4% vs 2.5%; P < .001)
  • 18% lower odds of in-hospital stroke, death, and MI (1.9% vs 2.4%; P = .1)
  • 14% lower odds of hospital stay longer than 1 day (29.9% vs 34.7%; P < .001)
  • 21% lower odds of non-home discharge in asymptomatic patients (4% vs 5%; P = .01)

In a separate risk-adjusted analysis looking at patients with 1-year follow-up, ipsilateral stroke or death at 1 year was lower in TCAR versus CEA (2% vs 3.5%; P = .03).

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, combining the 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 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 June, Silk Road announced that Dr. Malas et al presented data from the TCAR Surveillance Project at the SVS's Vascular Annual Meeting held June 12–15 in National Harbor, Maryland. The study's text and tables by Dr. Malas et al were simultaneously published in Journal of Vascular Surgery (2019;69:e95–e96).

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