Transfemoral carotid-artery stenting (TFCAS) carries a higher risk of iatrogenic emboli than does CEA. By circumventing aortic-arch manipulation, TCAR with flow reversal protects against shed of emboli throughout the procedure.
An earlier study of more than 3,000 matched pairs of patients found a 50% reduction in in-hospital stroke or death after TCAR (1.6%) compared with TFCAS (3.1%).
In the current study, Dr. Mahmoud B. Malas of the University of California, San Diego, and colleagues used data from 8,104 TCAR procedures and more than 53,000 CEA procedures to compare perioperative outcomes.
After matching 6,384 pairs of patients who underwent TCAR or CEA, the rates of in-hospital stroke or death were 1.6% in each group, including 1.4% of patients in each group who had in-hospital stroke and similar proportions of patients who died (0.4% and 0.3%, respectively).
Similarly, there were no significant differences between the groups in the risk of stroke or death at 30 days or one year after the procedures, the researchers report in Annals of Surgery.
TCAR was associated with significantly lower rates of in-hospital myocardial infarction (0.5% vs. 0.9% for CEA), cranial-nerve injury (0.4% vs. 2.7%), post-procedural hypertension (13.6% vs. 19.6%) and mean operative times (72.5 minutes vs. 121.4 minutes).
When protamine was used for heparin reversal, TCAR was associated with a significant 39% reduced risk of bleeding compared with CEA, but the risk of bleeding was not significantly different when no protamine was used.
Patients in the TCAR group were significantly less likely than patients in the CEA group to remain in the hospital beyond one day after the procedure (29.8% vs. 34.1%).
"These favorable outcomes might be attributable to the minimally invasive nature of TCAR which eliminates the need for complete surgical dissection of the carotid artery bifurcation compared to CEA," the authors note.
"These promising outcomes will likely increase the role of TCAR in the management of carotid artery stenosis," they conclude. "Larger studies with longer follow-up, especially in symptomatic patients, are needed to further explore the benefits of TCAR in the treatment of carotid artery stenosis and stroke prevention."
Dr. Kosmas I. Paraskevas of Southmead Hospital, in Bristol, U.K., who has studies carotid-artery stenosis, told Reuters Health by email, "In my opinion, it is too early to declare with certainty that TCAR should become the standard of care."
"We need to have Level I Evidence in the form of at least one randomized controlled trial comparing TCAR vs. CEA in symptomatic patients," he said.
"We also need to make sure that TCAR can be offered routinely in all institutes and by all physicians with the same excellent results, and that the results reported in this study do not reflect the results of TCAR experts from Centers of TCAR Excellency," said Dr. Paraskevas, who was not involved in the research. "In other words, before supporting that TCAR should become the standard of care for treating carotid-artery stenosis, we must make sure that the excellent outcomes are reproducible and generalizable to all patients, irrespective of age, sex, and symptomatic status."
He added, "Certain limitations should be kept in mind. First of all, a significant limitation is its higher cost compared with CEA. Another limitation for TCAR is that it can only be offered in specific Centers of TCAR Excellence. As CEA has been the standard of care for the last 60 years, it can be offered in virtually any institute and in any country in the world. In contrast, TCAR requires not only specific equipment, but also physician expertise."
Dr. Malas did not respond to a request for comments.
By Will Boggs MD
SOURCE: https://bit.ly/3mHK70V Annals of Surgery, online September 15, 2020.
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