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-beta 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-beta receptor failed to reduce the amount of neointimal hyperplasia after stent implantation.
RCT Entities:
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-beta 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-beta receptor failed to reduce the amount of neointimal hyperplasia after stent implantation.
Authors: Dong Hoon Kang; Mina Choi; Soyoung Chang; Min Young Lee; Doo Jae Lee; Kyungsun Choi; Junseong Park; Eun Chun Han; Daehee Hwang; Kihwan Kwon; Hanjoong Jo; Chulhee Choi; Sang Won Kang Journal: PLoS One Date: 2015-08-25 Impact factor: 3.240