COMPARISON OF CLINICAL COMPLICATIONS, ANGIOGRAPHIC RESULTS, AND DEVICE USAGE OF CORONARY ANGIOPLASTY USING LOW-COMPLIANCE AND HIGH-COMPLIANCE BALLOONS

We randomized 800 patients in a prospective study comparing the angiog raphic results, device usage and in-hospital outcome of balloon angiop lasty of primary stenoses of native coronary vessels with low-complian t and highly compliant balloons. The cumulative incidence of prespecif ied clinical endpoints was 8.0% in both treatment groups. The primary angiographic success rates were 83.9% and 78.9% in the high- and low-c ompliance group, respectively (P = 0.05), For the lesions dilated with one study balloon only, the quantitative angiographic findings were v irtually identical in the two treatment groups, The total number of di ssections was slightly but not significantly higher in the lesions tre ated with a highly compliant balloon. The global usage of angioplasty balloons was similar in both treatment groups. We conclude that, in ge neral, there is no objective reason to prefer one balloon material to another on the basis of its compliance characteristics. (C) 1997 Wiley -Liss, Inc.