Why the study?
Does the Barath Cutting Balloon improve initial success rate and reduce late restenosis compared to conventional angioplasty in patients with type A or B lesions in native coronary arteries?
Does the Barath Cutting Balloon improve initial success rate and reduce late restenosis compared to conventional angioplasty in patients with type A or B lesions in native coronary arteries?
The Barath Cutting Balloon did not significantly reduce late restenosis compared to conventional angioplasty, though a potential benefit in stented patients requires further study.
Cutting balloon angioplasty yields no restenosis reduction versus conventional; leaves open possible benefit in stented patients.
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.
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Yngvar Myreng Per Mølstad (1998) studied this question.
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