Randomized trial of cutting balloon compared with high-pressure angioplasty for the treatment of resistant pulmonary artery stenosis

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

Research output: Contribution to journalArticle

26 Citations (Scopus)

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. Methods and 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. Conclusion-CB therapy for pulmonary artery stenosis not responsive to low-pressure balloon is more effective than HPB therapy and has an equivalent safety profile.

Original languageEnglish (US)
Pages (from-to)2388-2396
Number of pages9
JournalCirculation
Volume124
Issue number22
DOIs
StatePublished - Nov 29 2011

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Angioplasty
Pressure
Therapeutics
Pulmonary Artery Stenosis
Dilatation
Safety
Clinical Trials Data Monitoring Committees

Keywords

  • angioplasty
  • balloon dilation
  • congenital abnormalities
  • pulmonary artery
  • randomized controlled trial

ASJC Scopus subject areas

  • Physiology (medical)
  • Cardiology and Cardiovascular Medicine

Cite this

Randomized trial of cutting balloon compared with high-pressure angioplasty for the treatment of resistant pulmonary artery stenosis. / Bergersen, Lisa; Gauvreau, Kimberlee; Justino, Henri; Nugent, Alan; Rome, Jonathon; Kreutzer, Jacqueline; Rhodes, John; Nykanen, David; Zahn, Evan; Latson, Larry; Moore, Phillip; Lock, James; Jenkins, Kathy.

In: Circulation, Vol. 124, No. 22, 29.11.2011, p. 2388-2396.

Research output: Contribution to journalArticle

Bergersen, L, Gauvreau, K, Justino, H, Nugent, A, Rome, J, Kreutzer, J, Rhodes, J, Nykanen, D, Zahn, E, Latson, L, Moore, P, Lock, J & Jenkins, K 2011, 'Randomized trial of cutting balloon compared with high-pressure angioplasty for the treatment of resistant pulmonary artery stenosis', Circulation, vol. 124, no. 22, pp. 2388-2396. https://doi.org/10.1161/CIRCULATIONAHA.111.018200
Bergersen, Lisa ; Gauvreau, Kimberlee ; Justino, Henri ; Nugent, Alan ; Rome, Jonathon ; Kreutzer, Jacqueline ; Rhodes, John ; Nykanen, David ; Zahn, Evan ; Latson, Larry ; Moore, Phillip ; Lock, James ; Jenkins, Kathy. / Randomized trial of cutting balloon compared with high-pressure angioplasty for the treatment of resistant pulmonary artery stenosis. In: Circulation. 2011 ; Vol. 124, No. 22. pp. 2388-2396.
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AU - Rome, Jonathon

AU - Kreutzer, Jacqueline

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AU - Nykanen, David

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AU - Latson, Larry

AU - Moore, Phillip

AU - Lock, James

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AB - 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. Methods and 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. Conclusion-CB therapy for pulmonary artery stenosis not responsive to low-pressure balloon is more effective than HPB therapy and has an equivalent safety profile.

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