title: The PROFI study (Prevention of Cerebral Embolization by Proximal Balloon Occlusion Compared to Filter Protection During Carotid Artery Stenting): a prospective randomized trial.
abstract: OBJECTIVE
  The objective of this study was to compare the cerebral embolic load of filter-protected versus proximal balloon-protected carotid artery stenting (CAS).
  
  
  BACKGROUND
  Randomized trials comparing filter-protected CAS with carotid endarterectomy revealed a higher periprocedural stroke rate after CAS. Proximal balloon occlusion may be more effective in preventing cerebral embolization during CAS than filters.
  
  
  METHODS
  Patients undergoing CAS with cerebral embolic protection for internal carotid artery stenosis were randomly assigned to proximal balloon occlusion or filter protection. The primary endpoint was the incidence of new cerebral ischemic lesions assessed by diffusion-weighted magnetic resonance imaging. Secondary endpoints were the number and volume of new ischemic lesions and major adverse cardiovascular and cerebral events (MACCE).
  
  
  RESULTS
  Sixty-two consecutive patients (mean age: 71.7 years, 76.4% male) were randomized. Compared with filter protection (n = 31), proximal balloon occlusion (n = 31) resulted in a significant reduction in the incidence of new cerebral ischemic lesions (45.2% vs. 87.1%, p = 0.001). The number (median [range]: 2 [0 to 13] vs. 0 [0 to 4], p = 0.0001) and the volume (0.47 [0 to 2.4] cm(3) vs. 0 [0 to 0.84] cm(3), p = 0.0001) of new cerebral ischemic lesions were significantly reduced by proximal balloon occlusion. Lesions in the contralateral hemisphere were found in 29.0% and 6.5% of patients (filter vs. balloon occlusion, respectively, p = 0.047). The 30-day MACCE rate was 3.2% and 0% for filter versus balloon occlusion, respectively (p = NS).
  
  
  CONCLUSIONS
  In this randomized trial of patients undergoing CAS, proximal balloon occlusion as compared with filter protection significantly reduced the embolic load to the brain.
authors.affiliation: Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg University Cardiovascular Center, Hamburg, Germany.
authors.forename: Klaudija
authors.initials: K
authors.lastname: Bijuklic
authors.forename: Andreas
authors.initials: A
authors.lastname: Wandler
authors.forename: Fadia
authors.initials: F
authors.lastname: Hazizi
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D021721:Balloon Occlusion / Q000379:methods*; D016893:Carotid Stenosis / Q000150:complications / Q000175:diagnosis / Q000601:surgery*; D038524:Diffusion Magnetic Resonance Imaging; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D020766:Intracranial Embolism / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D007430:Intraoperative Care / Q000379:methods*; D007431:Intraoperative Complications; D008297:Male; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome