Balloon Occlusion Bests Filter in Cerebral Protection After Carotid Stenting

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SAN FRANCISCO, CA—In patients undergoing carotid artery stenting (CAS), proximal balloon occlusion is associated with fewer new cerebral ischemic lesions than filter protection, according to data presented November 11, 2011, at the annual Transcatheter Cardiovascular Therapeutics scientific symposium.

For the prospective, single-center PROFI trial, Klaudija Bijuklic, MD, of Hamburg University Cardiovascular Center (Hamburg, Germany), and colleagues randomized 62 patients with symptomatic (≥ 60%) or asymptomatic (≥ 80%) internal carotid artery stenosis undergoing CAS to cerebral protection with either a filter (n = 31) or proximal balloon occlusion (n = 31). Using diffusion weighted MRI, researchers compared the incidence, number, and volume of new cerebral ischemic lesions.

More Lesions Seen with Filters

At 30 days, the incidence of new cerebral ischemic lesions was significantly higher in the filter group (87.1% vs. 45.2%; P = 0.001). These differences were maintained in the subgroups of symptomatic (P = 0.04) and asymptomatic (P = 0.02) patients. In patients older than 80 years, there was a trend toward a higher rate of new lesions in the filter group, but the difference was not significant.

Patients receiving filter protection also had a higher mean volume (0.59 cm3 vs. 0.16 cm3; P = 0.0001) and number (3.5 vs. 1.0; P = 0.0001) of new ischemic lesions.

The incidence of MACCE at 30 days was minimal, with only 1 minor stroke in the filter arm.

Despite the results, “whether this translates into a reduced periprocedural stroke rate has to be shown in a larger randomized trial with clinical endpoints,” Dr. Bijuklic cautioned.

In an e-mail communication, L. Nelson Hopkins, MD, of University at Buffalo Neurosurgery (Buffalo, NY), told TCTMD that though the definition of new cerebral ischemic lesion should be further clarified, this study’s “87% [diffusion weighted imaging] hits after filter are higher than any other study to date.”

Further, Hopkins said that PROFI’s findings add to the mounting evidence suggesting that proximal balloon occlusion is better if the anatomy easily permits access. “Access takes longer, but not with worse results in selected patients,” he concluded.

Study Details

Baseline characteristics between the 2 groups were similar except for a longer mean procedure duration in the balloon arm (30 ± 8 min. vs. 22 ± 7 min.; P = 0.003). Both groups consisted of approximately three-quarters men with an average age of 72 years.

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Source:
Bijuklic K. PROFI: A prospective, randomized trial of proximal balloon occlusion vs. filter embolic protection in patients undergoing carotid stenting. Presented at: Transcatheter Cardiovascular Therapeutics 2011; November 11, 2011; San Francisco, CA

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