Silk Road Medical, Inc. today announced the presentation of real-world data for the treatment of patients with carotid artery disease at risk for stroke at the VEITHsymposium. 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 contemporaneously comparing TCAR to the surgical standard of care, carotid endarterectomy (CEA).
“Our updated dataset 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 and cranial nerve injury. Additionally, TCAR patients experience shorter length of hospital stay and are discharged home more often,” said Dr. Malas. “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.”
“The TCAR Surveillance Project is validating the consistency and reproducibility of these results as we continue to train and support physicians, many who are performing TCAR for the first time or are early in their experience curve,” said Erica Rogers, Chief Executive Officer. “We are confident that these outcomes coupled with the procedure’s short learning curve and ease of use are establishing TCAR as a reliable, safe front-line approach for preventing stroke.”
The updated data from the TCAR Surveillance Project evaluated patients between 2016 and 2019, with 8,104 patients receiving TCAR compared to 53,869 patients receiving carotid endarterectomy (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 (TCAR, 1.4%; CEA, 1.2%, p=0.54) or in-hospital stroke and death (TCAR, 1.6%; CEA, 1.4%, p=0.57). Other key findings for TCAR compared to CEA include:
- 59% lower odds of in-hospital myocardial infarction (TCAR, 0.4%; CEA, 1.1%, p<0.001)
- 86% lower odds of in-hospital cranial nerve injury (TCAR, 0.4%; CEA, 2.5%, p<0.001)
- 18% lower odds of in-hospital stroke, death and myocardial infarction (TCAR, 1.9%; CEA, 2.4%, p=0.10)
- 14% lower odds of hospital stay longer than 1 day (TCAR, 29.9%; CEA, 34.7%, p<0.001)
- 21% lower odds of non-home discharge in asymptomatic patients (TCAR, 4.0%; CEA, 5.0%, p=0.01)
In a separate risk adjusted analysis looking at patients with one year follow up, ipsilateral stroke or death at one year was lower in TCAR vs CEA (TCAR, 2.0%; CEA, 3.5%, p=.03).
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.