ANGIOTENSIN-CONVERTING ENZYME-INHIBITION WITH FOSINOPRIL SODIUM IN THE PREVENTION OF RESTENOSIS AFTER CORONARY ANGIOPLASTY

Background Several angiotensin-converting enzyme inhibitors have antip roliferative effects in a rat model after carotid artery balloon injur y. Methods and Results We conducted a randomized, double-blind, placeb o-controlled trial to assess the effect of fosinopril, a novel angiote nsin-converting enzyme inhibitor, in restenosis prevention after percu taneous transluminal coronary angioplasty (PTCA). Patients received fo sinopril or matched pra cebo 10 mg at least 18 hours before PTCA, 20 m g at least 4 hours before PTCA, and 40 mg daily for 6 months. In addit ion, all patients received aspirin. Coronary angiograms before PTCA an d immediately after PTCA as well as at 6-month follow-up were quantita tively analyzed. A total of 509 patients were recruited. The final per -protocol population consisted of 153 fosinopril-treated and 151 place bo-treated patients. Restenosis rates according to the National Heart, Lung, and Blood Institute criterion 4 (loss of greater than or equal to 50% of the initial gain [primary end point]) were 45.7% and 40.7% i n the fosinopril and control groups, respectively (not significant). T he respective mean differences in minimal coronary luminal diameter be tween post-PTCA and follow-up angiograms were -0.59+/-0.71 mm and -0.5 1+/-0.67 mm (not significant). Clinical events during the 6-month foll ow-up period, analyzed on an on-treatment basis, were ranked according to the most serious event. The respective numbers in the fosinopril a nd the control groups were for death, 0 and 0; myocardial infarction, 0 and 0; coronary artery bypass graft surgery, 1 and 3; repeat PTCA, 3 5 and 35; recurrent signs of ischemia necessitating early repeat coron ary angiography and managed medically, 6 and 7; and none of the above, 111 and 106. Ah these differences were insignificant. Conclusions Adm inistration of fosinopril in a dose of 40 mg daily during 6 months aft er PTCA does not prevent restenosis and has no effect on overall clini cal outcome.