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September 21, 2020

Outcomes Reported From TCAR Surveillance Project Studying TCAR Versus CEA

September 21, 2020—Silk Road Medical, Inc. announced that positive results from the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project comparing TCAR with carotid endarterectomy (CEA) were published online ahead of print in Annals of Surgery by Mahmoud B. Malas, MD, et al.

The TCAR Surveillance Project is an open-ended registry designed to obtain and compare data about real-world patient outcomes of TCAR with other alternatives, as performed by centers participating in the Society for Vascular Surgery’s Vascular Quality Initiative.

According to Silk Road Medical, TCAR combines the surgical principles of neuroprotection with endovascular techniques to treat carotid artery blockages at risk of causing stroke. The company’s Enroute transcarotid neuroprotection system 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.

The study evaluated patients in the United States and Canada who underwent TCAR or CEA for carotid artery stenosis from 2016 and 2019. Propensity scores were calculated and used to match patients in the two groups, which each contained 6,384 patients. The primary endpoint was a combined outcome of perioperative stroke and/or death.

Comparing TCAR with CEA, the investigators found the following:

  • TCAR was associated with lower rates of in-hospital myocardial infarction (0.5% vs 0.9%; P = .005) and cranial nerve injury (0.4% vs 2.7%; P < .001).
  • No statistical differences were noted between TCAR and CEA for in-hospital stroke/death (1.6% vs 1.6%; P = .945), stroke (1.4% vs 1.4%; P = 0.881), and death (0.4% vs 0.3%; P = .662).
  • Patients who underwent TCAR were less likely to stay in the hospital for > 1 day (26.4% vs 30.1%; P < .001).
  • TCAR and CEA had a similar incidence of ipsilateral stroke or death at 1 year (hazard ratio, 1.09; 95% CI, 0.87-1.36; P = .44).

“The publication of these data in the Annals of Surgery further validates the effectiveness of TCAR as a treatment option for patients with carotid artery disease, while highlighting the consistency of these data,” commented Erica Rogers, Silk Road Medical CEO. “We are confident that the updated results from the TCAR Surveillance Project, taken together with the recent publication of ROADSTER 2 data in Stroke, will continue to drive adoption of TCAR towards the standard of care.”

Another TCAR Surveillance Project analysis, comparing TCAR and transfemoral carotid artery stenting, was published by Marc L. Schermerhorn, MD, et al in Journal of the American Medical Association (2019;322:2313-2322) last year.

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