Silk Road Medical has announced positive results from a comparative-effectiveness study have been published in JAMA Network Open.
The study found the availability of TCAR at a hospital was associated with a significant decrease in the likelihood of major adverse cardiovascular events (MACE), a composite of in-hospital stroke, myocardial infarction, or death at 30 days after carotid revascularisation, whether TCAR or carotid endarterectomy (CEA).
“Our results demonstrate that VQI [Vascular Quality Initiative] centres who offer TCAR achieve lower rates of adverse events after carotid surgery when compared to centres who do not offer the new procedure,” said lead author Jesse Columbo (Dartmouth-Hitchcock Medical Center, Lebanon, USA). “We believe this indicates that centres that offer TCAR are able to better align patients with the best procedure for their individual clinical and anatomic characteristics.”
The analysis studied 86,027 patients who underwent carotid procedures between 2015 and 2019 using retrospective data from the VQI registry, a consortium of more than 400 centres in North America. In total, 7,664 patients (8.9%) underwent TCAR and 78,363 patients (91.1%) underwent CEA. The analysis cited increased use of TCAR, with 15 centres performing both TCAR and CEA at the beginning of the analysis period (2015), increasing to 247 centres at the end of the analysis period (2019), which represents a more than 16-fold increase in centres performing TCAR. The use of TCAR as a percentage of total carotid revascularisation procedures also increased, from 90 of 12,276 procedures (0.7%) in 2015 to 2,718 of 15,956 procedures (17.0%) in 2019, which represents a 24-fold increase over five years.
Importantly, the analysis also revealed centres that adopted TCAR had a 10% reduction in the likelihood of MACE at 12 months compared to those centres that continued to perform CEA alone (odds ratio, 0.90; 95% confidence interval [CI], 0.81–0.99; p=0.04).
“The publication of these findings in JAMA is another powerful reminder that TCAR gives the vascular specialist more options when treating carotid artery disease to the benefit of all carotid patients,” said Erica Rogers, Silk Road Medical CEO. “We are confident that as more and more practices adopt TCAR, providers will recognise the overall benefits of a less invasive approach and will further drive TCAR toward standard of care.”
To read the published study and the invited commentary, visit: http://jamanetwork.com/article.aspx?doi=10.1001/jamanetworkopen.2020.37885