The Barath Cutting Balloon versus conventional angioplasty. A randomized study comparing acute success rate and frequency of late restenosis

Scand Cardiovasc J. 1998;32(2):79-85. doi: 10.1080/14017439850140229.

Abstract

In a randomized multicenter study initial success rate and 6 months' follow-up were compared between coronary angioplasty performed with the Barath Cutting Balloon (group A, n = 32) and conventional balloons (group B, n = 32) in patients with type A or B lesions in native coronary arteries. The culprit lesion was not reached in one patient in group A. Initial success rates were similar with and without additional stenting (8 in group A and 10 in group B). Angiographic follow-up data (in 95%) revealed a non-significant improvement in minimal lumen diameter, diameter stenosis in group A. Restenosis developed in 16.7% of group A vs 25.8% of group B, (p = 0.57). A separate analysis of stented patients showed no restenosis in group A and restenosis in 4 out of 10 patients in group B (p = 0.10). A possible beneficial effect of the Cutting Balloon with respect to in-stent restenosis requires further studies.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / methods
  • Coronary Angiography
  • Coronary Disease / diagnostic imaging
  • Coronary Disease / therapy*
  • Equipment Design
  • Female
  • Follow-Up Studies
  • Hematoma / etiology
  • Humans
  • Logistic Models
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Myocardial Revascularization / adverse effects*
  • Recurrence
  • Stents