EFFECT OF CILAZAPRIL ON VASCULAR RESTENOSIS AFTER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY

Background: In experimental studies using cilazapril, the strongest inhibition of neointima formation was obtained when treatment was initiated 6 days before injury. The MERCATOR trial showed no reduction in restenosis with cilazapril given after percutaneous transluminal coronary angioplasty (PTCA). The purpose of this study is to determine whether previous administration of cilazapril could prevent restenosis. Methods: A total of 167 patients were randomly and prospectively assigned to the cilazapril group or the control group. In the cilazapril group, 78 patients received a 2 mg dose of cilazapril daily, starting 7 days before PTCA and continuing for 6 months. Only 128 patients (cilazapril 56, control 72) completed the study because 39 dropped out. Coronary angiograms were evaluated by the quantitative coronary angiogram (QCA) system. Results: There were no differences between the two groups of patients with regard to baseline clinical and angiographic characteristics. QCA analysis (cilazapril 66 lesions, control 101 lesions): the loss at follow-up in minimal lumen diameter was 0.36 +/- 0.57 mm in the cilazapril group and 0.57 +/- 0.75 mm in the control group (P < 0.05). Restenosis rate: in the cilazapril group, 16 of 56 patients (28.6%) had restenosis in contrast to 36 of 72 patients (50.0%) in the control group (P < 0.02). When vessel restenosis was evaluated, 16 of 63 vessels (25.4%) demonstrated restenosis in the cilazapril group, in contrast to 41 of 82 vessels (50.0%) in the control group (P < 0.01). Conclusions: Treatment using cilazapril 7 days before PTCA significantly reduced the rate of restenosis. These data suggest that previous administration of cilazapril might be important for preventing restenosis.