William A. Gray
HOLLYWOOD, Fla. — New carotid artery stenting technologies have reduced risk for stroke during and after the procedure to much lower levels than historically seen, a speaker said at the International Symposium on Endovascular Therapy.
Some technologies have data that show improvement in clinical and surrogate marker results compared with historical CAS data, and other technologies in development have potential to make further advances, William A. Gray, MD, system chief of the division of cardiovascular disease at Main Line Health and president of the Lankenau Heart Institute in Wynnewood, Pennsylvania, said during a presentation.
While the CREST and ACT I trials found similar outcomes between CAS and carotid endarterectomy, the data identified opportunities for improvement, as minor strokes were higher in the CAS group in both studies, Gray said.
In addition, CAS studies with filter embolic protection have showed a much higher rate of new lesions identified after the procedure by diffusion-weighted MRI compared with the 17% traditionally associated with endarterectomy, he said.
One technology developed in response was the Neurogard (Contego Medical), Gray said. In the PALADIN study, the rate of new MRI lesions in patients treated with the device was 21.2%, comparable to the 17% associated with endarterectomy, and the mean lesion volume was very low (0.005 cm3).
“[Neuroguard] is a device developed with a balloon and filter attached,” Gray said. “It’s meant to be used in the post-dilatation phase of carotid artery stenting. Its pore size is 40 microns, compared with 130 microns or more for traditional filters. It can be smaller because it is only up for the very short duration of the balloon inflation.”
Transcarotid artery revascularization was also developed to address these issues, he said. Regarding the Enroute system (Silk Road Medical), the only TCAR system currently approved by the FDA, the ROADSTER pivotal trial showed it was associated with very low rates of stroke and death, which was also confirmed by very low rates of stroke as well as new MRI lesions comparable to endarterectomy.
The SCAFFOLD trial of the Scaffold carotid stent (W.L. Gore and Associates) also found a new-generation CAS was associated with low rates of stroke and death, Gray said, noting that in the per-protocol population, the 1-year stroke rate was just 1.1%.
Scaffold is one of several new mesh designs — others include CGuard (InspireMD) and Roadsaver (Terumo) — designed to address a prolapse phenomenon that may contribute to late stroke, Gray said.
“Over the last 15 years, we have made great progress in reducing stroke and death,” he said. “The third-wave devices are poised to further improve outcomes.” – by Erik Swain
Gray WA. Update on carotid therapy: Carotid stenting vs. CEA vs. TCAR vs. medical management. Presented at: the International Symposium on Endovascular Therapy (ISET); Jan. 27-30, 2019; Hollywood, Fla.
Disclosure: Gray reports he has financial ties with Abbott Vascular, Biocardia, Boston Scientific, Contego Medical, Cook Medical, Intact Vascular, Medtronic, Shockwave Medical, Silk Road Medical and W.L. Gore and Associates.