Effect of an anti-PDGF-beta-receptor-blocking antibody on restenosis in patients undergoing elective stent placement.
OBJECTIVE
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%.


CONCLUSIONS
A single intravenous administration of monoclonal antibody against PDGF-beta receptor failed to reduce the amount of neointimal hyperplasia after stent implantation.
Serruys
Patrick W
PW
Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands. p.w.j.c.serruys@erasmusmc.nl
Heyndrickx
Guy R
GR
Patel
Jatin
J
Cummins
Paul A
PA
Kleijne
Jeroen A
JA
Clowes
Alexander W
AW
D000787:Angina Pectoris / Q000628:therapy*; D000911:Antibodies, Monoclonal; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D017479:Receptors, Platelet-Derived Growth Factor / Q000276:immunology*; D015607:Stents; D013997:Time Factors; D018084:Ultrasonography, Interventional
D000911:Antibodies, Monoclonal; D017479:Receptors, Platelet-Derived Growth Factor