The impact of balloon material and lesion characteristics on the incidence of angiographic and clinical complications of coronary angioplasty.

To assess the importance of balloon material used for percutaneous transluminal coronary angioplasty (PTCA), we compared the complication rates observed with low complaint plastomer (PM 300), intermediately compliant polyethylene (PE 600), and highly compliant polyolefin copolymer (POC) balloons. In a total of 1,650 procedures, one of these balloon materials was used to dilate 2,040 lesions. The dissection rate tended to be slightly lower with the use of more compliant balloon material. The total clinical complication rate (death, emergency coronary surgery, myocardial infarction, need for bail-out stenting or for prolonged heparin treatment, abrupt out-of-laboratory vessel closure) was 8.1%, 7.4%, and 4.2% in the procedures exclusively performed with PM 300 (N = 653), PE 600 (N = 543) and POC (N = 454) balloons, respectively (P = 0.03). In multivariate analysis, the use of less compliant balloon material emerged as an independent correlate of clinical complications (P = 0.007). However, the predictive power of the lesion complexity (B2, C versus A, B1) was four times stronger. In contrast to current concerns, the use of compliant balloon material seems at least as safe as the use of less compliant material.