Effect of nifedipine on recurrent stenosis after percutaneous transluminal coronary angioplasty.

This double-blind, randomized study evaluated the effect of nifedipine on restenosis after coronary angioplasty. Two hundred forty-one patients with dilation of 271 coronary sites were randomized at the time of hospital discharge to receive nifedipine, 10 mg (123 patients), or placebo (118 patients) four times daily for 6 months. No patient was known to have coronary artery spasm. The mean duration of therapy was 4.4 +/- 2 (mean +/- SD) months for nifedipine and 4.3 +/- 2 months for placebo. A restudy angiogram was available in 100 patients (81%) in the nifedipine group and 98 patients (83%) in the placebo group. A recurrent coronary stenosis was noted in 28% of patients in the nifedipine group and in 29.5% of those in the placebo group (p = NS). The mean diameter stenosis was 36.4 +/- 23% for the nifedipine group and 36.7 +/- 23% for the placebo group (p = NS). By pill count, 78% of patients receiving nifedipine and 82% of those receiving placebo complied with the study drug regimen. Coronary stenosis recurred in 33% of patients in the placebo group and in 29% of patients in the nifedipine group who complied with the regimen and had angiograms (p = NS). In conclusion, the study did not demonstrate a significant beneficial effect of nifedipine on the incidence of recurrent stenosis after successful percutaneous transluminal coronary angioplasty.

RCT Entities:   Population Interventions Outcomes