Hospital Availability of TCAR Is Associated With Improved Outcomes for Carotid Revascularization

February 25, 2021—Silk Road Medical, Inc. announced positive results from a comparative effectiveness study showing that the availability of transcarotid artery revascularization (TCAR) at a hospital was associated with a significant decrease in the likelihood of major adverse cardiovascular events (MACE), a composite of in-hospital stroke, myocardial infarction, or death at 30 days after carotid revascularization, whether TCAR or carotid endarterectomy (CEA).

The company noted that TCAR combines surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke.

Jesse Columbo, MD, et al published the findings of the study online in Journal of the American Medical Association’s JAMA Network Open.

According to Silk Road Medical, the analysis studied 86,027 patients who underwent carotid procedures between 2015 and 2019 using retrospective data from the Vascular Quality Initiative (VQI) registry, a consortium of > 400 centers in North America. In total, 7,664 patients (8.9%) underwent TCAR and 78,363 patients (91.1%) underwent CEA.

The analysis cited increased use of TCAR, with 15 centers performing both TCAR and CEA at the beginning of the analysis period (2015) and 247 centers at the end of the analysis period (2019), representing a > 16-fold increase in centers performing TCAR.

Silk Road Medical noted that the analysis found that the use of TCAR as a percentage of total carotid revascularization procedures also increased, from 90 of 12,276 procedures (0.7%) in 2015 to 2,718 of 15,956 procedures (17.0%) in 2019, representing a 24-fold increase over 5 years.

The analysis also revealed that centers that adopted TCAR had a 10% reduction in the likelihood of MACE at 12 months compared to those that continued to perform CEA alone (odds ratio, 0.90; 95% CI, 0.81-0.99; P = .04).

“Our results demonstrate that VQI centers who offer TCAR achieve lower rates of adverse events after carotid surgery when compared to centers who do not offer the new procedure,” said Jesse Columbo, MD. “We believe this indicates that centers that offer TCAR are able to better align patients with the best procedure for their individual clinical and anatomic characteristics.”

Silk Road Medical’s Enroute transcarotid stent is intended to be used in conjunction with the Enroute transcarotid neuroprotection system (NPS) during TCAR. The Enroute 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, stated the company.