SAN FRANCISCO—Using a proximal balloon protection device significantly decreased cerebral embolization during carotid artery stenting (CAS) procedures compared with filter protection devices, according to the results of the PROFI trial presented Nov. 11 at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) conference.

“Stroke is the third leading cause of death and the major cause of functional impairment,” Joachim Schofer, MD, of the center for cardiology and vascular intervention in Hamburg, Germany, offered during a press conference. While carotid artery stenosis remains an important cause of stroke, carotid endarterectomy and the less invasive alternative carotid artery stenting (CAS) are now options that have emerged for the treatment of stroke.

“Both harbor the risk of periprocedural stroke, but randomized trials revealed a higher stroke rate after CAS compared to carotid endarterectomy," Schofer noted.

The help prevent periprocedural strokes during CAS, filters were used. However, Schofer noted that these filters have several disadvantages including the fact that they must cross the lesion before the protection device is installed, and the fact that they allow small particles to pass through or along the filter, often creating brain injury.

“Proximal balloon occlusion is an alternative that may be more effective because it is installed before crossing the lesion and it induces reversed flow from the brain back to the arteries by occluding the external and the common carotid artery,” Shofer noted.

The prospective, randomized PROFI trial compared the outcomes of proximal balloon occlusion devices vs. distal filter embolic protection in patients undergoing carotid stenting. The researchers aimed to compare the incidence rate (number and volume) of new cerebral ischemic lesions assessed by DW-MRI post-CAS. Sixty-two patients were enrolled and randomized to receive either a filter device 31 patients) or a proximal balloon occlusion device (31 patients).

The primary endpoint of incidence of cerebral ischemic lesions occurred in 87.1 percent of the filter arm and 45.2 percent of the proximal balloon occlusion arm. Meanwhile, the secondary endpoint (number of ischemic lesions) occurred in 3.5 percent of the filter group and 1 percent of the proximal balloon occlusion arm.

“Thus, in conclusion of this single-center randomized trial in patients undergoing carotid artery stenting, cerebral embolization was significantly reduced under proximal balloon protection compared to filter protection,” Schofer concluded. “Whether this translates into a reduced periprocedural stroke rate has to be shown in a larger randomized trial with clinical endpoints.“

Shofer noted that in his facility, clinicians use a proximal protection device in 85 percent of cases. “If you interrupt the flow to the brain not all patients can tolerate this,” he offered. “You have to look carefully whether patients have a sufficient circulation in the brain, which can be assessed by MRI.”

Additionally, he said that patients with a contralateral occlusion of the carotid artery were excluded from the trial.

Panelist Ron Wakesman, MD, of the Washington Hospital Center in Washington, D.C., said that while it is “almost criminal not to use it [protection device] in U.S., outlooks are different in Europe."

The varied use of these devices could be due to a hesitation to use them by other members of the interventional team, including radiologists or other specialists involved in CAS procedures, he said.