Randomized Trial of Cutting Balloon Compared With High-Pressure Angioplasty for the Treatment of Resistant Pulmonary Artery Stenosis

• DOI: 10.1161/circulationaha.111.018200
• Publication Date: 2011-11-01T04:22:04Z
• Authors: Lisa Bergersen; Kimberlee Gauvreau; Henri Justino; Alan Nugent; Jonathon Rome; Jacqueline Kreutzer; John Rhodes; David Nykanen; Evan Zahn; Larry Latson; Phillip Moore; James Lock; Kathy Jenkins
• Keywords: Cutting balloon

Background— We sought to determine the safety and efficacy of Cutting Balloon therapy (CB) compared with conventional high-pressure balloon (HPB) for treatment pulmonary artery stenosis. Methods Results— This prospective, randomized, multicenter, investigational device exemption trial CB HPB. Patient eligibility was determined at precatheterization assessment; vessel catheterization. In all vessels, low-pressure dilation 8 atm performed, if it not successful, randomized or The primary outcome percent change in minimum lumen diameter. A core laboratory performed measurements angiographic assessment damage. any serious adverse event attributable as assessed by Data Safety Monitoring Board. Seventy-three patients from institutions were enrolled between 2004 2008. these patients, 72 vessels responded dilation. Of 173 that met criteria, 107 66 associated greater increase diameter (85% versus 52%; P =0.004). After crossover introduced, 26 47 treated HPB underwent experienced an additional 48% diameter; final after 99% than initial There no events related a study vessel. Conclusion— stenosis responsive is more effective has equivalent profile.