Effect of an anti‐PDGF‐β‐receptor‐blocking antibody on restenosis in patients undergoing elective stent placement

AIM: The aim of the study was to determine whether a single intravenous infusion of 25 mg/kg CDP860, a humanized di‐Fab′ fragment against PDGF‐β receptor, leads to a reduction of in‐stent restenosis. METHODS: In this phase II, double‐blind, placebo‐controlled, multicentre study 145 patients presenting with stable or unstable angina were randomized to a single infusion of placebo or active drug (CDP860) before undergoing stenting. Quantitative angiography and 3D intravascular ultrasound (IVUS) were obtained at baseline and follow‐up. Primary endpoint was the IVUS assessment of percentage in‐stent volume obstruction. RESULTS: At six‐month follow‐up, the placebo group and CDP860 group did not differ significantly regarding minimal luminal diameter (1.75 ± 0.68 versus 1.82 ±­0.66 mm), restenosis rate (16.2 versus 14.1%), minimal lumen area (4.71 ± 1.85 versus 4.41 ± 1.77 mm 2 ), in‐stent neointimal volume (30 ± 23 versus 31 ± 31 mm 3 ) and in‐stent obstruction volume (23.8 ± 14.4 versus 22.1 ± 15.3%). Major adverse cardiac events at 210 days were similar in both groups: death 1.5 versus 1.4%, myocardial infarction 5.9 versus 8.1% and target vessel revascularization 16.4 versus 17.6%. CONCLUSION: A single intravenous administration of monoclonal antibody against PDGF‐β receptor failed to reduce the amount of neointimal hyperplasia after stent implantation. (Int J Cardiovasc Intervent 2003; 5: 214–222)