Key result
Highly compliant balloon material was associated with a lower clinical complication rate (4.2%) compared to intermediately (7.4%) and low compliant (8.1%) balloons (P=0.03).
Why the study?
Does the use of more compliant balloon material reduce clinical complications in patients undergoing percutaneous transluminal coronary angioplasty?
Observational (n=1,650)
Does the use of more compliant balloon material reduce clinical complications in patients undergoing percutaneous transluminal coronary angioplasty?
Absolute Event Rate: 4.2% vs 8.1%
p-value: p=0.03
The use of more compliant balloon material during coronary angioplasty is associated with a lower rate of clinical complications compared to less compliant materials, although lesion complexity is a stronger predictor of adverse events.
Should not yet alter balloon choice in angioplasty; leaves open whether randomized trials confirm lower complications.
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.
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Raymenants et al. (1994) conducted an observational in coronary angioplasty (n=1,650). Highly compliant polyolefin copolymer (POC) balloons vs. Low compliant plastomer (PM 300) and intermediately compliant polyethylene (PE 600) balloons was evaluated on 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) (p=0.03). Highly compliant balloon material was associated with a lower clinical complication rate (4.2%) compared to intermediately (7.4%) and low compliant (8.1%) balloons (P=0.03).
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