A randomized trial of corticosteroids for the prevention of restenosis in 102 patients undergoing repeat coronary angioplasty

To examine the effect of corticosteroid therapy on the development of restenosis following successful percutaneous transluminal coronary angioplasty (PTCA), we randomized 102 patients with restenosis following prior PTCA to receive high-dose steroids (n = 52) or no steroids (n = 50). The steroid regimen consisted of 125 mg methylprednisolone I.M. the night before and morning of the PTCA, and prednisone 60 mg p.o. Q.D. for 1 week. post-PTCA. Angiographic follow-up at 6 months was available in 27 steroid-treated patients (52%) and 27 controls (54%). The per lesion incidence of restenosis was similar in the two groups (36% vs. 40%, respectively, P = NS). Clinical follow-up was available in the remaining patients at a mean interval of 1.2 years. The clinical correlates of restenosis (incidence and severity of angina, positive treadmill exercise test, nonfatal infarction or death) were similar in the steroid treated and control groups (24% vs. 39%, respectively, P = .56). At late follow-up, 30 steroid-treated patients (58%) and 26 control patients (52%) had no clinical or angiographic evidence of restenosis (P = NS). In conclusion, a short course of high-dose corticosteroid therapy does not significantly reduce the frequency of restenosis following PTCA.