LONG-TERM EFFECTS OF ANGIOPEPTIN TREATMENT IN CORONARY ANGIOPLASTY - REDUCTION OF CLINICAL EVENTS BUT NOT ANGIOGRAPHIC RESTENOSIS

Background Angiopeptin is a cyclic octapeptide analogue of somatostati n that has been shown to limit myointimal thickening of arteries in ba lloon injury models and to restore the vasodilating response to acetyl choline. A randomized, double-blind placebo controlled trial was condu cted to assess the effect of angiopeptin in restenosis prevention afte r percutaneous transluminal coronary angioplasty (PTCA). Methods and R esults Patients received a continuous infusion of either placebo or an giopeptin subcutaneously 6 to 24 hours before PTCA and for 4 days afte r PTCA (3 mg per 24 hours before PTCA followed by 6 mg per 24 hours af ter PTCA and for the remaining period). A 1.5-mg bolus dose of placebo or angiopeptin was given at PTCA. Aspirin (acetylsalicylic acid, 150 mg/d) was administered throughout the study period. Coronary angiogram s obtained before and after PTCA and at 6-month follow-up were subject ed to computerized quantification. Clinical follow-up was performed af ter 12 months. Primary clinical end points were death, myocardial infa rction, coronary artery bypass surgery, or repeat PTCA. In total, 553 patients with 742 lesions were randomized. Clinical follow-up was avai lable for all 553 patients. Angiopeptin decreased the clinical events during 12 months of follow-up from 36.4% in the placebo-treated group to 28.4% in the angiopeptin-treated patients (P=.046). Quantitative an giography after PTCA and at follow-up was available in 423 of 455 pati ents who underwent successful PTCA. The minimal lumen diameter at foll ow-up was 1.52+/-0.64 mm in the angiopeptin-treated group compared wit h 1.52+/-0.64 mm in the placebo-treated patients (P=.96). The late los ses were 0.31+/-0.59 and 0.30+/-0.62 mm (P=.81) and the restenosis rat es (>50% diameter stenosis at follow-up) were 36% and 37% (P=.85) in t he angiopeptin- and placebo-treated groups, respectively. Conclusions In this study, angiopeptin significantly decreased the incidence of cl inical events, principally the rate of revascularization procedures. I n contrast, no significant effect was seen on angiographic variables.