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 tra nsluminal coronary angioplasty (PTCA), we compared the complication ra tes observed with low compliant plastomer (PM 300), intermediately com pliant polyethylene (PE 600), and highly compliant polyolefin copolyme r (POC) balloons. In a total of 1,650 procedures, one of these balloon materials was used to dilate 2,040 lesions. The dissection rate tende d to be slightly lower with the use of more compliant balloon material . The total clinical complication rate (death, emergency coronary surg ery, myocardial infarction, need for bail-out stenting or for prolonge d 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 co ncerns, the use of compliant balloon material seems st least as safe a s the use of less compliant material. (C) 1994 Wiley-Liss, Inc.