Major adverse cardiovascular event (MACE) rates -- counting in-hospital stroke, MI, and death at 30 days -- were similar between patients undergoing TCAR and those getting surgical carotid endarterectomy (CEA; 2.3% vs 2.4%, P=0.91), reported a group led by Jesse Columbo, MD, MS, of Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.
Despite such similar results, VQI centers had 10% less MACE in their overall carotid revascularization programs in the year after adopting TCAR than if they had stuck with the surgical option alone (OR 0.90, 95% CI 0.81-0.99), according to a difference-in-difference analysis by Columbo's group, published online in JAMA Open Network.
"This finding suggests that this new technology may have allowed proceduralists to select patients for whom TCAR may be superior to CEA, while still performing CEA on patients for whom that procedure was appropriate," researchers say.
"Overall, while observational in nature, these data imply that both TCAR and CEA may be reasonable treatment choices for patients undergoing carotid revascularization and providers may be able to choose the modality they feel best aligns with the patient's clinical presentation and anatomy," they concluded.
In contrast, device sales records indicate that the registry captures more than 95% of TCAR procedures.
TCAR was introduced to the U.S. market with the 2015 FDA approval of the Enroute stent system from Silk Road Medical.
The carotid procedure is designed to be a lower-risk alternative to surgery for patients at high risk due to anatomic or medical challenges. It is also designed with no need to traverse the aortic arch and carotid lesion prior to embolic protection, unlike transfemoral carotid stenting.
Whether TCAR is truly non inferior to CEA has not been proven in a randomized controlled trial. Transfemoral carotid stenting has been linked to more periprocedural events but no difference in outcomes at 10 years compared with surgery.