Influence of balloon size on initial success, acute complications, and restenosis after percutaneous transluminal coronary angioplasty. A prospective randomized study.

Abstract

Restenosis after percutaneous transluminal coronary angioplasty (PTCA) is strongly associated with incomplete initial dilatation. To determine if oversized PTCA balloons would reduce the restenosis rate without increasing the risk of arterial dissection and acute complications, we prospectively randomized 336 patients to receive either smaller or larger balloons. Thirty-four percent of patients had multivessel disease and 18% had multisite dilatation. One hundred sixty-nine patients were randomized to PTCA with a larger balloon and 167 to PTCA with a smaller balloon. Balloon:artery diameter ratios were 1.13 +/- 0.14 in the larger group and 0.93 +/- 0.12 in the smaller group (p less than 0.001). The trial was halted as clinically important differences in acute complications emerged. Emergency bypass graft surgery, usually for the treatment of arterial dissection, was required in 7.1% of patients in the larger balloon group and 3.6% of patients in the smaller balloon group (p = 0.15). Myocardial infarction ...