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December 18, 2019

Results Published From TCAR Surveillance Project

December 18, 2019—Silk Road Medical, Inc. announced that positive results from the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project comparing TCAR and transfemoral carotid artery stenting (TF-CAS) have been published by Marc L. Schermerhorn, MD, et al in Journal of the American Medical Association (JAMA) (2019;322:2313–2322).

The TCAR Surveillance Project, which is part of the Society for Vascular Surgery’s Vascular Quality Initiative, is an open-ended registry intended to compare real-world patient outcomes between TCAR and other alternatives.

The company noted that TCAR combines surgical principles of neuroprotection with endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. In the TCAR procedure, Silk Road Medical’s Enroute transcarotid stent is intended to be used in conjunction with the Enroute transcarotid neuroprotection system (NPS). 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.

The study, which evaluated patients who underwent carotid procedures between 2016 and 2019, was composed of 5,251 patients receiving TCAR compared with 6,640 patients receiving TF-CAS, with 3,286 patients in each group analyzed using propensity score matching.

As summarized by Silk Road Medical, TCAR compared with TF-CAS was associated with significantly lower rates of in-hospital stroke or death (1.6% vs 3.1%; P < .001); as well as the individual rates of stroke (1.3% vs 2.4%; P = .001) and death (0.4% vs 1%; P = .008). Additionally, there were no statistical differences noted between TCAR and TF-CAS for in-hospital myocardial infarction (0.2% vs 0.3%; P = .47).

Additionally, TCAR procedures compared with TF-CAS were associated with less radiation (median fluoroscopy time, 5 vs 16 min; P < .001) and contrast use (30 vs 80 mL; P < .001). Patients who underwent TCAR were significantly less likely to fail the CMS-recommended discharge criteria (16.4% vs 22.7%; P < .001), including length of stay > 2 days (13.9% vs 19%; P < .001) and failed discharge home (7.3% vs 12.7%; P < .001).

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 compared with TF-CAS (5.1% vs 9.6%; P < .001), reported the company.

Dr. Schermerhorn commented in Silk Road Medical’s announcement, “These results showed a significantly lower risk of stroke or death for TCAR versus TF-CAS and further contribute to the groundswell of clinical evidence showing the benefits of TCAR. I am confident that the growing evidence base coupled with the publication of these data in JAMA, a peer-reviewed journal, will incrementally drive TCAR toward standard of care.”

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