Prevention of Cerebral Embolization by PROximal Balloon Occlusion Compared to FIlter Protection During Carotid Artery Stenting - PROFI

Jan 25, 2012
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Presented:
01/01/2011
Date Published:
01/01/2012
Date Updated:
01/25/2012
Original Posted Date:
01/25/2012
References

Description:

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.

Hypothesis:

Proximal balloon occlusion will reduce the frequency of new cerebral ischemic lesions.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • 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

Exclusions:

  • 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

Primary Endpoints:

  • Incidence of cerebral ischemic lesions by DW-MRI 12-24 hours after stenting

Secondary Endpoints:

  • Number of new ischemic lesions
  • Volume of new ischemic lesions
  • MACCE

Drug/Procedures Used:

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.

Principal Findings:

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.

Interpretation:

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.

References:

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.

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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