Silk Road Medical Inc. has announced the presentation of real-world data from two studies into the treatment of patients with carotid artery disease at risk for stroke at the Society for Vascular Surgery 2019 Vascular Annual Meeting (VAM).
Background
Silk Road Medical is a company focused on reducing the risk of stroke and its devastating impact. Its TCAR (TransCarotid Artery Revascularization) system 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.
TCAR Surveillance Project
The VAM saw updates from two studies both of which yielded compelling supportive data for the TCAR approach.
In a headline presentation at the VAM, Dr. Mahmoud Malas of the University of California, San Diego School of Medicine shared updated results for the TransCarotid Artery Revascularization (TCAR) Surveillance Project. A key initiative of the Society for Vascular Surgery’s Vascular Quality Initiative (VQI), the project is an open-ended registry intended to compare real-world patient outcomes between TCAR and CEA.
The presentation 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 1 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 1 year follow up, the results were as follows:
· 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)
Investigator comments
“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. 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,” Dr. Malas said. “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.”
ROADSTER-2
The Roadster-2 study, also presented at VAM is a post-marketing study evaluating real world use of the ENROUTE® Neuroprotection and Stent Systems in TransCarotid Artery Revascularization (TCAR) procedures.
In the late-breaking session , Dr. Vikram Kashyap, Chief of Vascular Surgery and Endovascular Therapy at University Hospitals Case Medical Center (Cleveland, OH) and National Co-Principal Investigator of ROADSTER-2, reported that the study demonstrated compelling patient outcomes with low stroke and combined stroke and death rates of 0.6% and 0.8%, respectively, in 632 high surgical risk patients enrolled across 42 sites. Seventy percent (70%) of patients enrolled in the study were from physicians new to TCAR.
Investigator comments
“The results of ROADSTER-2 continue to demonstrate the safety, effectiveness and clinical advantages of TCAR, especially given that a majority of the TCAR procedures were performed by a broad group of physicians with no previous TCAR experience,” Dr. Kashyap said.
“The study results highlight the short learning curve of the TCAR procedure and its remarkable consistency and reproducibility, and, I believe, will further encourage physicians to broadly adopt the TCAR procedure.”
Company comments
“The updated data from the TCAR Surveillance Project mark a major milestone in our journey to build the clinical evidence base,” said Erica Rogers, Chief Executive Officer. “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 data from ROADSTER-2, taken together with recent updated results from the TCAR Surveillance Project, supports the case for TCAR as the standard of care in high surgical risk patients,”
Source: Globe Newswire
