COMPLIANT VS NONCOMPLIANT BALLOONS - A PROSPECTIVE RANDOMIZED STUDY

In this prospective randomized trial we explored the possibility of di fferent procedural outcomes with regard to compliant (polyolefin copol ymer (POC)), and non-compliant (polyethylene terapthelate (PET)) ballo on materials commonly used during percutaneous transluminal coronary a ngioplasty (PTCA). For this purpose, 51 female and 149 male (total 200 ) patients were randomized to 100 compliant and 100 non-compliant ball oons. Only single lesions were included in the study and patients who had PTCA for more than one lesion in different segments at different s essions were each entered seperately (there were actually 49 female an d 143 male patients). PTCA procedures were performed in conjuction wit h quantitative coronary angiographic techniques and the films were rev iewed 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 di fferences 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 an d percent stenosis of the index lesion. Similarly, minimal residual di ameter, percent residual stenosis, net gain, densitometric net area ga in, and maximum pressure (2.2 +/- 5 mm vs 2.1 +/- 0.6 mm, 18 +/- 17% v s 23 +/- 15%, 0.8 +/- 0.5 mm vs 0.8 +/- 0.6 mm, 48 +/- 25% vs 48 +/- 2 6%, 7.3 +/- 2 atm. vs 6.8 +/- 3 atm., respectively) values were not st atistically different between compliant and non-compliant ballon group s. Major in-hospital complications, dissections caused by the study ba lloon (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 comp liant and non-compliant balloon groups. Study balloon success rate (de fined as < 50% residuel stenosis or > 20% net gain in the absence of m ajor in-hospital complications, crossovers and bail-outs) and overall procedural success rate (80% vs 74%, 90% vs 85%) were not statisticall y different for compliant and non-compliant balloons. In conclusion, w e did not observe any statistically significant difference between com pliant and non-compliant balloons in terms of immediate procedural res ults.