Circulation, Vol 78, 557-565, Copyright © 1988 by American Heart Association
GS Roubin, JS Douglas Jr, SB King 3d, SF Lin, N Hutchison, RG Thomas and AR Gruentzig
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 (Q wave and non- Q wave) complicated 7.7% of procedures in which
large balloons were assigned and 3.0% of procedures in which small balloons
were assigned (p = 0.056). There were no deaths in either group. The
incidence of bypass surgery was 1.7% when the balloon:artery ratio was less
than 0.9, 3.1% when the ratio was 0.9-1.1, and 7.8% when it was greater
than 1.1. Stepwise logistic regression analysis demonstrated that larger
balloon assignment, multiple lesion dilatation, and multivessel coronary
artery disease were independent predictors of emergency surgery.
Angiographic restudy rates were 50% in the larger group and 60% in the
smaller group (p = NS).(ABSTRACT TRUNCATED AT 250 WORDS)
ARTICLES
Influence of balloon size on initial success, acute complications, and restenosis after percutaneous transluminal coronary angioplasty. A prospective randomized study
Andreas Gruentzig Cardiovascular Center, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.
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