A new study shows that transcarotid artery revascularization (TCAR) procedures significantly lowered the odds of composite in-hospital stroke, death and heart attack compared to surgical removal of plaque from the carotid artery, according to Silk Road Medical (NSDQ:SILK).
The company is developing a neuroprotection and stent system called Enroute as an aid to TCAR procedures. The real-world data from the TransCarotid Artery Revascularization Surveillance Project were announced this week at the Society for Vascular Surgery 2019 vascular annual meeting in Fort Washington, Md.
The retrospective study evaluated patients between 2015 and 2018, with 5,716 patients receiving TCAR compared to 44,442 patients receiving carotid endarterectomy (CEA), with 5,160 patients in each group analyzed using propensity score matching. There were no statistical differences noted between TCAR and CEA for in-hospital stroke (odds ratio (OR) 0.80, p=0.19) or in-hospital stroke and death (OR: 0.77, p=0.09). 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<0.001).
- 35% lower odds of in-hospital stroke, death and myocardial infarction (OR: 0.65, p<.01).
- 26% lower odds of hospital stay longer than one day (OR: 0.74, p<0.001).
- 25% lower odds of non-home discharge (OR: 0.75, p<0.001).
In a separate risk-adjusted analysis looking at 30-day and one-year follow up, the results were:
- 34% lower odds of 30-day death (OR: 0.66, p=0.03).
- 46% lower odds of 30-day stroke and death (OR: 0.54, p=0.02).
- 53% lower odds of 30-day stroke, death and MI (OR: 0.47, p<0.01).
- 23% lower odds of 1-year mortality (OR: 0.77, p=0.02).
“The results of the TCAR Surveillance Project are overwhelmingly positive on a large dataset of patients, showing, for the first time, significantly lower odds of composite in-hospital stroke, death and myocardial infarction compared to CEA,” study presenter Dr. Mahmoud Malas of the University of California, San Diego School of Medicine said in a news release. “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.”
“These updated data from the TCAR Surveillance Project mark a major milestone in our journey to build the clinical evidence base,” said Erica Rogers, CEO of Sunnyvale, Calif.-based Silk Road Medical. “As these results are proven on ever-larger numbers of patients, we are seeing the continued impact of our relentless focus on patient outcomes, which we believe is key to driving durable and growing adoption of TCAR in the long run.”
The TCAR Surveillance Project is an open-ended registry intended to compare real-world patient outcomes between TCAR and CEA.
Silk Road cleared just more than $109 million in its initial public offering in April, including a fully subscribed underwriters option.