The Barath Cutting Balloon versus conventional angioplasty. A randomized study comparing acute success rate and frequency of late restenosis.
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.
Mølstad
P
P
Feiring Heart Clinic, Norway.
Myreng
Y
Y
Golf
S
S
Sirnes
P A
PA
Kassis
E
E
Abilgaard
U
U
Andersen
P E
PE
Thuesen
L
L
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006406:Hematoma / Q000209:etiology; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009204:Myocardial Revascularization / Q000009:adverse effects*; D012008:Recurrence; D015607:Stents