Results from the PROFI study indicate that the use of a proximal balloon occlusion in carotid artery stenting led to fewer cerebral ischaemic lesions than with the use of a filter. Trial results were presented at the TCT symposium in San Francisco.
Previous randomised trials have revealed a higher rate of stroke following carotid artery stenting when compared to surgical removal of plaque from the carotid artery. One of the reasons for this may be that the use of filters in carotid artery stenting allows plaque particles to travel to the brain. PROFI is the first randomised trial comparing proximal balloon occlusion with filter protection in patients undergoing carotid artery stenting.
In the PROFI (Prevention of cerebral embolization by proximal balloon occlusion compared to filter protection during carotid artery stenting) trial, 62 patients undergoing carotid artery stenting with cerebral embolic protection for a ≥60 % symptomatic or ≥80% asymptomatic internal carotid artery stenosis were randomly assigned to proximal balloon occlusion or filter protection. The primary endpoint was the incidence of new cerebral ischaemic lesions as assessed by diffusion weighted magnetic resonance imaging (DW-MRI). Secondary endpoints were the number and volume of new ischaemic lesions and major adverse cardiovascular and cerebral events (MACCE).
The incidence rate of new cerebral ischaemic lesions was 87.1% in the filter group, and 45.2% in the balloon group. The mean number of new cerebral ischaemic lesions was 3.5 in the filter group and 1.0 in the balloon group. There were no significant differences in MACCE at 30 days between the two groups.
“In this single centre, randomised trial in patients undergoing carotid artery stenting, the incidence, number, and volume of new cerebral ischaemic lesions were significantly lower under proximal balloon protection than under filter protection,” said Joachim Schofer, professor of Medicine, at the Medical Care Center, Professor Mathey, Professor Schofer, Hamburg University Cardiovascular Center. “A larger randomised trial with clinical endpoints is needed to investigate whether this benefit translates into a reduced periprocedural stroke rate,” said Schofer.