Prevention of Cerebral Embolization by PROximal Balloon Occlusion Compared to FIlter Protection During Carotid Artery Stenting - PROFI
The goal of the trial was to compare proximal balloon occlusion versus distal embolic protection among patients with severe carotid artery stenosis undergoing carotid artery stenting.
Proximal balloon occlusion will reduce the frequency of new cerebral ischemic lesions.
- Patients at least 18 years of age with severe internal carotid artery stenosis (≥60% if symptomatic or ≥80% if asymptomatic) undergoing carotid artery stenting
- No occlusion of the ipsilateral external carotid artery
- Complete circle of Willis assessed by MR angiography
- Patent contralateral internal carotid artery
- Passage of the lesion with the filter without pre-dilatation
- Sufficient landing zone for the filter
Number of patients screened: 84
Number of enrollees: 62
Duration of follow-up: 30 days
- Ischemic stroke within the last 48 hours or previous major stroke
- Occlusion of the target vessel
- Contraindication for MRI
- Contraindication for antiplatelet and/or anticoagulation therapy
- In-stent restenosis
- Coagulation disorder
- Gastrointestinal bleeding in the last 30 days
- Untreated hyperthyroidism
- Allergy to contrast agent, aspirin, or clopidogrel
- Incidence of cerebral ischemic lesions by DW-MRI 12-24 hours after stenting
- Number of new ischemic lesions
- Volume of new ischemic lesions
Patients with severe carotid artery stenosis undergoing carotid artery stenting were randomized to proximal balloon occlusion (n = 31) versus distal filter embolic protection (n = 31).
Patients received aspirin/clopidogrel before the procedure and clopidogrel 4 weeks after the procedure.
Overall, 62 patients were randomized. The mean age was 72 years, 23% were women, 32% had diabetes, and the mean internal carotid artery stenosis was 90%. The mean duration of the procedure was 30 minutes in the balloon occlusion group versus 22 minutes in the distal embolic protection group (p = 0.003), and the mean time of protection was 6 versus 5 minutes (p = NS), respectively. One patient in each group crossed over to the other group.
The primary outcome, new ischemic lesions by diffusion weighed-magnetic resonance imaging (DW-MRI) occurred in 45.2% of the proximal balloon occlusion group versus 87.1% of the distal embolic protection group (p = 0.001).
Mean number of ischemic lesions: 1.0 versus 3.2 (p = 0.0001) and volume of ischemic lesions: 0.16 cm3 versus 0.59 cm3 (p = 0.0001), respectively.
Major adverse cardiac and cerebrovascular events (MACCE) were 0 versus 3.2%, respectively.
Among patients undergoing carotid artery stenting, the use of proximal balloon occlusion is feasible. This device was associated with a reduced frequency of new ischemic lesions compared with distal embolic protection; however, the rate was still quite high in both groups. This was a single-center and single-operator study; therefore, it is unclear how the device would perform among less experienced operators. Additionally, appropriately powered studies are needed to determine if this device can reduce clinically evident periprocedural strokes.
Bijuklic K, Wandler A, Hazizi F, Schofer J. The PROFI Study (Prevention of Cerebral Embolization by Proximal Balloon Occlusion Compared to Filter Protection During Carotid Artery Stenting): A Prospective Randomized Trial. J Am Coll Cardiol 2012;Jan 25:[Epub ahead of print].
Presented by Dr. Joachim Schofer at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2011), San Francisco, CA, November 11, 2011.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Vascular Medicine, Interventions and Imaging, Interventions and Vascular Medicine, Magnetic Resonance Imaging
Keywords: Stroke, Follow-Up Studies, Dilatation, Ticlopidine, Magnetic Resonance Imaging, Carotid Artery, Internal, Stents, Embolic Protection Devices, Balloon Occlusion, Carotid Stenosis, Carotid Artery, External, Diabetes Mellitus, Circle of Willis
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