Silk Road Medical has announced positive results from an independent analysis of standard surgical risk patients undergoing carotid endarterectomy (CEA) and transcarotid artery revascularization (TCAR) for atherosclerotic carotid disease. The data were presented at the Society for Vascular Surgery (SVS) 2021 Vascular Annual Meeting (VAM) in San Diego on Wednesday during Plenary Session 2.
Over 20,000 standard surgical risk patients were included in the analysis (15,198 CEA and 5,066 TCAR) from the Vascular Quality Initiative (VQI) CEA and carotid artery stent (CAS) registries over four years (August 2016 to September 2020). The results for symptomatic and asymptomatic standard surgical risk patients undergoing CEA and TCAR for atherosclerotic carotid disease showed that TCAR had statistically equivalent stroke and death outcomes to CEA, while showing a nine-fold reduction in cranial nerve injury (2.7% vs. 0.3%, p=<0.001). The data were delivered in a presentation delivered by Patric Liang, MD, a vascular surgery fellow at Beth Israel Deaconess Medical Center in Boston.
“The promise of safely preventing stroke while delivering benefits from a less-invasive approach is critically important as we consider an expanded patient population. This first ever large-scale, standard surgical risk analysis demonstrates that TCAR delivers on that promise,” said Erica Rogers, president and chief executive officer of Silk Road Medical.
“These results reinforce the effectiveness of TCAR as an important treatment option for patients with carotid artery disease and standard surgical risk factors,” said Marc L. Schermerhorn, chief in the division of vascular and endovascular surgery at Beth Israel Deaconess Medical Center. “TCAR again shows equivalent risk to CEA of perioperative stroke, death, or myocardial infarction and ipsilateral stroke at one year in patients undergoing carotid revascularization with improved secondary outcomes such as cranial nerve injury.”