Abstract

Fifty-four patients presenting with stenotic lesions in a major coronary artery visually estimated by diagnostic angiography to be > 90% but < 100% were randomized to one of two angioplasty regimens, predilation (group 1) or no predilation (group 2). In group 1, the artery was initially dilated with a 2 mm balloon followed by a balloon that was considered by the operator to be the definitive size to fully dilate the target vessel. In group 2, the artery was dilated with a balloon deemed the definitive size to complete the angioplasty procedure. There were no statistical differences between groups with respect to age, sex, history of unstable angina, or prior acute myocardial infarction. There were also no significant differences in the angiographic characteristics of the coronary lesions including artery location, lesion length, concentric or eccentric morphology, tubular versus discrete stenosis, calcium in lesions, or lesions on a bend. Following angioplasty, luminal filling defects were present in 5% of the predilated group and in 9% of the nonpredilated group ( p = NS). The incidence of luminal border haziness at the dilatation site did not differ between groups, seven (35%) in group 1 versus eight (24%) in group 2. Angiographic evidence of a linear dissection at the angioplasty site was also similar between groups, one (5%) in group 1 versus five (15%) in group 2. Occlusive complications were witnessed in 10% of the predilated group and 12% of the nonpredilated group ( p = NS). Dissection accompanied by a dye stain and dissection beyond the angioplasty site accompanied by a stain each occurred in one patient in the predilated group but not in the nonpredilated group ( p = NS). No patients required emergency coronary artery bypass surgery and there were no deaths. In conclusion, there is no evidence to support the routine predilatation of coronary stenoses in an effort to decrease the acute complication rate as a consequence of major artery injury.

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