Compliant vs non-compliant balloons. A prospective randomized study.

In this prospective randomized trial we explored the possibility of different procedural outcomes with regard to compliant (polyolefin copolymer (POC)), and non-compliant (polyethylene terapthelate (PET)) balloon materials commonly used during percutaneous transluminal coronary angioplasty (PTCA). For this purpose, 51 female and 149 male (total 200) patients were randomized to 100 compliant and 100 non-compliant balloons. Only single lesions were included in the study and patients who had PTCA for more than one lesion in different segments at different sessions were each entered separately (there were actually 49 female and 143 male patients). PTCA procedures were performed in conjunction with quantitative coronary angiographic techniques and the films were reviewed by two investigators in a blinded fashion. Statistical analysis for various procedural end-points were performed by non-paired Student t test with statistical significance being p < 0.05. There were no differences in demographic and clinical characteristics between groups. Lesion characteristics of both groups were exactly matching for vessel size, balloon size, balloon vessel ratio, minimal luminal diameter and percent stenosis of the index lesion. Similarly, minimal residual diameter, percent residual stenosis, net gain, densitometric net area gain, and maximum pressure (2.2 +/- 5 mm vs 2.1 +/- 0.6 mm, 18 +/- 17% vs 23 +/- 15%, 0.8 +/- 0.5 mm vs 0.8 +/- 0.6 mm, 48 +/- 25% vs 48 +/- 26%, 7.3 +/- 2 atm. vs 6.8 +/- 3 atm., respectively) values were not statistically different between compliant and non-compliant balloon groups. Major in-hospital complications, dissections caused by the study balloon (mostly type A and B), crossover and bail-out procedures (5 vs 3, 34 vs 32, 4 vs 3, 13 vs 14, respectively) were similar for both compliant and non-compliant balloon groups. Study balloon success rate (defined as < 50% residual stenosis or > 20% net gain in the absence of major in-hospital complications, crossovers and bail-outs) and overall procedural success rate (80% vs 74%, 90% vs 85%) were not statistically different for compliant and non-compliant balloons. In conclusion, we did not observe any statistically significant difference between compliant and non-compliant balloons in terms of immediate procedural results.

RCT Entities:   Population Interventions Outcomes