A randomized trial of carotid artery stenting with and without cerebral protection
Joel E Barbato1, Ellen Dillavou, Michael B Horowitz
1Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA 15213, USA.
Insights
Cerebral protection filters during carotid artery stenting did not reduce embolic lesions. Routine filter use requires critical reassessment before widespread adoption for stroke prevention.
Area of Science:
- Cardiovascular Medicine
- Neurosurgery
- Interventional Radiology
Background:
- Carotid artery stenting (CAS) commonly employs distal filter cerebral protection devices.
- Evidence supporting the efficacy of these filters in preventing embolic lesions is limited.
- This study investigated embolic phenomenon incidence during CAS with and without filter use.
Purpose of the Study:
- To evaluate the effectiveness of distal filter cerebral protection devices in reducing embolic lesions during CAS.
- To compare the incidence of new embolic lesions after CAS in patients with and without cerebral protection filters.
Main Methods:
- Prospective, randomized, single-center study of 36 CAS procedures in 35 patients.
- Patients were randomized 1:1 to CAS with or without a distal cerebral protection filter.
- Diffusion-weighted magnetic resonance imaging (DW MRI) assessed new embolic lesions 24 hours post-procedure.
Main Results:
- New MRI lesions were observed in 72% of the cerebral protection group versus 44% in the no-filter group (P = .09).
- Average lesion number and volume were similar between groups (6.1 vs 6.2 lesions; 16.63 mm³ vs 15.61 mm³).
- Four strokes occurred (11%), two in each group, with one major stroke in the no-filter group.
Conclusions:
- Distal filter use during CAS did not demonstrate a reduction in microemboli.
- Routine adoption of cerebral protection filters warrants critical evaluation.
- Findings suggest reconsidering mandatory universal adoption of filters in CAS procedures.
Background:
The use of a distal filter cerebral protection device with carotid artery stenting is commonplace. There is little evidence, however, that filters are effective in preventing embolic lesions. This study examined the incidence of embolic phenomenon during carotid artery stenting with and without filter use.
Methods:
This was a prospective, randomized, single-center study of carotid artery stenting with or without a distal cerebral protection filter. A 1:1 scheme was used to randomize 36 carotid artery stenting procedures in 35 patients. Diffusion-weighted magnetic resonance imaging (DW MRI) 24 hours after stenting was used to assess the occurrence of new embolic lesions. Blinded observers calculated lesion number and volume.
Results:
The mean age was 78.6 +/- 7.0 in the cerebral protection group compared with 74.1 +/- 8.7 in the no cerebral protection group (P = .92). Despite similar average age, the percentage of octogenarians was higher in the cerebral protection group (61.1% vs 22.2%; P = .04). Two procedures in the cerebral protection group were not successful. One was completed without protection because of inability to track the filter, and the second was aborted because of severe tortuosity with a later carotid endarterectomy. New MRI lesions were noted in 72% of the cerebral protection group compared with 44% in the no cerebral protection group (P = .09). The average number of lesions in these patients was 6.1 and 6.2, respectively, with mean DW MRI lesion size of 16.63 mm(3) vs 15.61 mm(3) (P = .79 and .49, respectively). Four strokes occurred (11%), two in each group, in patients aged 75, 80, 82, and 84 years. The only major stroke occurred in the no cerebral protection group.
Conclusions:
The use of filters during carotid artery stenting provided no demonstrable reduction of microemboli, as expected. Routine use of cerebral protection filters should undergo a more critical assessment before mandatory universal adoption.
