Researcher said results show that cutting balloons are still relevant in the drug-eluting stent era.
Cutting-balloon angioplasty prior to stenting is a feasible and safe strategy for the treatment of coronary lesions and can lead to a significant reduction in restenosis. ¡°Cutting-balloon stenting could still have an impact on PCI practice even in the era of drug-eluting stents¡±, Takahiko Suzuki, MD, of the Toyohashi heart Center in Japan, said during a presentation of REDUCE-III results here yesterday. REDUCE-III is a prospective, randomized, multicenter trial conducted at 38 Japanese centers investigating the efficacy of using cutting balloons prior to stenting for reucing chronic in-stent restenosis. The procedure was compared to conventilnal balloon angioplasty with stenting.
The trial included 521 patients who were randomly assigned to cutting balloon with stenting (n=260) or conventional balloon angioplasty with stenting (n=261). Patients were followed for six months. Patients were included if they were 25 to 80 years old and had a de novo lesion or first restenotic lesion that could be treated by conventional balloon angioplasty or a cutting balloon. The lesions had to be less than 20 mm. Excluded patients were those who had an AMI within the previous two weeks, a left ventricular ejection fraction ¡Ì 30%, acute or chronic renal failure, or had participated in a previous study. There was no difference in baseline clinical characteristics, coronary risk factors or lesion characteristics. Mean age of participants was 65, 76% were men, 32% had prior MI, 27% to 34% were diabetic, 41% were smokers, 56% to 60% had hypertension and 44% had hyperlipidemia.

Most procedures were performed in the left anterior descending artery (43%). There was 100% angiographic success in both treatment groups. In the cutting-balloon group, procedural success was 98.2% compared to 100% in the traditional balloon angioplasty with stenting group. There were no significant differences in vessel perforation, distal embolization, thrombus or dissection. ¡°The high percentage of procedural success proved that cutting-balloon angioplasty prior to stenting is a feasible and safe strategy¡±, Dr. Suzuki said. Major adverse cardiovascular events were similar between the two groups at 11.5% in the cutting-balloon group and 16.1% in the traditional balloon group (P=1.19). Need for target lesion revascularization was also not significantly different between the two groups at 10.4% in the cutting-balloon group and 14.9% in the traditional balloon group (P=.117). Restenosis was reduced by 38.2% in the cutting-balloon group. The cutting-balloon group had less restenosis (11.8%) than the traditional-balloon group (19.1%)(P=.032).

There was a significant difference in maximum dilatation pressure at 7.47 atm in the cutting-balloon group and 8.8 atm in the traditional balloon group (P=.001). Percent diameter stenosis was higher immediately after the procedure in the traditional balloon group (16% vs. 14% in the cutting-balloon group).