June 12, 2019
Favorable Outcomes for TCAR Versus CEA Presented at Vascular Annual Meeting
June 13, 2019—Silk Road Medical, Inc. announced real-world data from the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project evaluating the treatment of patients with carotid artery disease at risk for stroke. Mahmoud B. Malas, MD, Principal Investigator of the TCAR Surveillance Project, presented, “Outcomes of Transcarotid Revascularization with Dynamic Flow Reversal Versus Carotid Endarterectomy in the Transcarotid Revascularization Surveillance Project,” at the Society for Vascular Surgery's (SVS) Vascular Annual Meeting held June 12–15 in National Harbor, Maryland.
The study's text and tables by Malas et al are available online in SVS's Journal of Vascular Surgery (2019;69:e95–e96).
The TCAR Surveillance Project, a key initiative of the SVS's Vascular Quality Initiative (VQI), is an open-ended registry intended to compare real-world patient outcomes between TCAR and carotid endarterectomy (CEA).
TCAR, which combines surgical principles of neuroprotection with endovascular techniques to treat blockages in the carotid artery while avoiding passing through the aortic arch, is performed with Silk Road Medical's Enroute transcarotid stent in conjunction with the Enroute transcarotid neuroprotection system (NPS). The 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 stent.
According to the company, the study evaluated patients between 2015 and 2018, with 5,716 patients receiving TCAR compared to 44,442 patients receiving CEA, with 5,160 patients in each group analyzed using propensity score matching.
Dr. Malas reported that there were no statistical differences noted between TCAR and CEA for in-hospital stroke (odds ratio [OR], 0.8; P = .19) or in-hospital stroke and death (OR, 0.77; P = .09).
Other key findings for TCAR compared to CEA include:
- 59% lower odds of in-hospital myocardial infarction (OR, 0.41; P < .001)
- 87% lower odds of in-hospital cranial nerve injury (OR, 0.13; P < .001)
- 35% lower odds of in-hospital stroke, death, and myocardial infarction (OR, 0.65; P < .01)
- 26% lower odds of hospital stay longer than 1 day (OR, 0.74; P < .001)
- 25% lower odds of nonhome discharge (OR, 0.75; P < .001)
In the company's announcement, Dr. Malas commented, “The results of the TCAR Surveillance Project are overwhelmingly positive on a large data set of patients, showing, for the first time, significantly lower odds of composite in-hospital stroke, death, and myocardial infarction compared to CEA. TCAR had statistically equivalent in-hospital stroke and death rates as CEA, with significantly lower odds of myocardial infarction and cranial nerve injury. Additionally, there was a significant reduction in mortality at 30 days and 1 year, likely attributable to the reduction in myocardial infarction. Patients clearly benefit from TCAR’s less invasive approach, and with these data and future studies with similar results, I believe TCAR may become the standard of care.”
In a separate risk-adjusted analysis looking at 30-day and 1-year follow-up, the results for TCAR compared to CEA were as follows:
- 34% lower odds of 30-day death (OR, 0.66; P = .03)
- 46% lower odds of 30-day stroke and death (OR, 0.54; P = .02)
- 53% lower odds of 30-day stroke, death, and myocardial infarction (OR, 0.47; P < .01)
- 23% lower odds of 1-year mortality (OR, 0.77; P = .02)
Previously, data from the VQI's TCAR Surveillance Project showed that TCAR compared to CEA resulted in similar rates of in-hospital stroke and death with shorter operating room time and fewer cranial nerve injuries. Marc Schermerhorn, MD, presented these findings at the 45th annual VEITHsymposium held November 13–17, 2018, in New York, New York.