title: A double-blind randomised study to evaluate the efficacy and safety of bindarit in preventing coronary stent restenosis.
abstract: OBJECTIVE
  Bindarit (BND) is a selective inhibitor of monocyte chemotactic protein-1 (MCP-1/CCL2), which plays an important role in generating intimal hyperplasia. Our aim was to explore the efficacy and safety of bindarit in preventing restenosis following percutaneous coronary intervention.
  
  
  RESULTS
  A phase II, double-blind, multicentre randomised trial included 148 patients randomised into three arms (BND 600 mg, n=48; BND 1,200 mg, n=49; PLB, n=51). Bindarit was given following PCI and continued for 180 days. Monthly clinical follow-up and six-month coronary angiography were conducted. The primary endpoint was in-segment late loss; the main secondary endpoints were in-stent late loss and major adverse cardiovascular events. Efficacy analysis was carried out on two populations, ITT and PP. There were no significant differences in the baseline characteristics among the three treatment groups. In-segment and in-stent late loss at six months in BND 600, BND 1,200 and PLB were: (ITT 0.54 vs. 0.52 vs. 0.72; p=0.21), (PP 0.46 vs. 0.53 vs. 0.72; p=0.12) and (ITT 0.74 vs. 0.74 vs. 1.05; p=0.01), (PP 0.66 vs. 0.73 vs. 1.06; p=0.003), respectively. The MACE rates at nine months among treatment groups were 20.8% vs. 28.6% vs. 25.5% (p=0.54), respectively.
  
  
  CONCLUSIONS
  This was a negative study with the primary endpoint not being met. However, significant reduction in the in-stent late loss suggests that bindarit probably exerts a favourable action on the vessel wall following angioplasty. Bindarit was well tolerated with a compliance rate of over 90%. A larger study utilising a loading dose and targeting a specific patient cohort may demonstrate more significant results.
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.forename: Sandeep
authors.initials: S
authors.lastname: Basavarajaiah
authors.forename: Ugo
authors.initials: U
authors.lastname: Limbruno
authors.forename: Andrea
authors.initials: A
authors.lastname: Picchi
authors.forename: Corrado
authors.initials: C
authors.lastname: Lettieri
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.forename: Alessandro
authors.initials: A
authors.lastname: Sciahbasi
authors.forename: Francesco
authors.initials: F
authors.lastname: Prati
authors.forename: Marco
authors.initials: M
authors.lastname: Calabresi
authors.forename: Daniela
authors.initials: D
authors.lastname: Pierucci
authors.forename: Angelo
authors.initials: A
authors.lastname: Guglielmotti
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D017023:Coronary Angiography / Q000379:methods; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D006801:Humans; D007191:Indazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods; D011422:Propionates / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007191:Indazoles; D011422:Propionates; C079489:bindarit