title: Randomized trial of cutting balloon compared with high-pressure angioplasty for the treatment of resistant pulmonary artery stenosis.
abstract: BACKGROUND
  We sought to determine the safety and efficacy of Cutting Balloon therapy (CB) compared with conventional high-pressure balloon therapy (HPB) for the treatment of pulmonary artery stenosis.
  
  
  RESULTS
  This prospective, randomized, multicenter, investigational device exemption trial compared CB with HPB. Patient eligibility was determined at the precatheterization assessment; vessel eligibility was determined at catheterization. In all vessels, low-pressure balloon dilation to 8 atm was performed, and if it was not successful, the vessel was randomized to CB or HPB. The primary efficacy outcome was percent change in minimum lumen diameter. A core laboratory performed all vessel measurements and angiographic assessment of vessel damage. The primary safety outcome was any serious adverse event attributable to vessel dilation as assessed by the Data and Safety Monitoring Board. Seventy-three patients from 8 institutions were enrolled between 2004 and 2008. In these patients, 72 vessels responded to low-pressure balloon dilation. Of the 173 vessels that met eligibility criteria, 107 were randomized to CB and 66 to HPB. In randomized vessels, CB therapy was associated with greater percent increase in lumen diameter (85% versus 52%; P=0.004). After crossover was introduced, 26 of 47 vessels treated with HPB underwent CB therapy and experienced an additional 48% increase in lumen diameter; the final diameter after CB was 99% greater than the initial diameter. There were no serious adverse events related to treatment in a study vessel.
  
  
  CONCLUSIONS
  CB therapy for pulmonary artery stenosis not responsive to low-pressure balloon is more effective than HPB therapy and has an equivalent safety profile.
authors: MPH, Department of Cardiology, The Children's Hospital, 300 Longwood Ave, Boston, MA 02115, USA. Lisa.Bergersen@cardio.CHBoston.org
authors: Lisa
authors: L
authors: Bergersen
authors: Kimberlee
authors: K
authors: Gauvreau
authors: Henri
authors: H
authors: Justino
authors: Alan
authors: A
authors: Nugent
authors: Jonathon
authors: J
authors: Rome
authors: Jacqueline
authors: J
authors: Kreutzer
authors: John
authors: J
authors: Rhodes
authors: David
authors: D
authors: Nykanen
authors: Evan
authors: E
authors: Zahn
authors: Larry
authors: L
authors: Latson
authors: Phillip
authors: P
authors: Moore
authors: James
authors: J
authors: Lock
authors: Kathy
authors: K
authors: Jenkins
mesh_terms: D000293:Adolescent; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D002404:Catheterization / Q000379:methods; D002648:Child; D002675:Child, Preschool; D003251:Constriction, Pathologic / Q000503:physiopathology / Q000628:therapy; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D011446:Prospective Studies; D011651:Pulmonary Artery / Q000503:physiopathology*; D016896:Treatment Outcome; D014652:Vascular Diseases / Q000503:physiopathology / Q000628:therapy*; D055815:Young Adult