title: Use of the REG1 anticoagulation system in patients with acute coronary syndromes undergoing percutaneous coronary intervention: results from the phase II RADAR-PCI study.
abstract: OBJECTIVE
  We sought to determine the feasibility of conducting percutaneous coronary intervention (PCI) in high-risk acute coronary syndrome (ACS) patients utilising the REG1 system consisting of pegnivacogin, an aptameric factor IXa inhibitor, and its controlling agent anivamersen.
  
  
  RESULTS
  In RADAR, ACS patients were randomised to pegnivacogin 1 mg/kg with 25%, 50%, 75%, or 100% anivamersen reversal or unfractionated heparin. Of the 640 patients randomised, 388 (61%) underwent PCI. Major modified ACUITY 30-day bleeding rates were 18% (25% reversal), 12% (50% reversal), 9% (75% reversal), and 7% (100% reversal), compared with 11% with heparin. The corresponding total bleeding rates were 68%, 39%, 35%, 34%, and 38% (heparin). Ischaemic events were less frequent in those receiving pegnivacogin versus heparin (4.4% vs. 7.3%, p=0.3). Thirty-day urgent TVR (1.1% vs. 0.9%, p=1.0), myocardial infarction (4.0% vs. 6.4%, p=0.3), and angiographic complication (11.2% and 10.8%, p=0.9) rates were similar with pegnivacogin and heparin. There were no incidences of clot formation on guidewires or catheters.
  
  
  CONCLUSIONS
  High-level factor IXa inhibition in ACS patients undergoing PCI, with at least 50% reversal, has a favourable bleeding profile and appears effective at suppressing ischaemic events and thrombotic complications. Larger phase trials in PCI are warranted.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00932100.
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Povsic
authors.forename: John P
authors.initials: JP
authors.lastname: Vavalle
authors.forename: John H
authors.initials: JH
authors.lastname: Alexander
authors.forename: Laura H
authors.initials: LH
authors.lastname: Aberle
authors.forename: Steven L
authors.initials: SL
authors.lastname: Zelenkofske
authors.forename: Richard C
authors.initials: RC
authors.lastname: Becker
authors.forename: Christopher E
authors.initials: CE
authors.lastname: Buller
authors.forename: Mauricio G
authors.initials: MG
authors.lastname: Cohen
authors.forename: Jan H
authors.initials: JH
authors.lastname: Cornel
authors.forename: Jaroslaw D
authors.initials: JD
authors.lastname: Kasprzak
authors.forename: Gilles
authors.initials: G
authors.lastname: Montalescot
authors.forename: Peter S
authors.initials: PS
authors.lastname: Fail
authors.forename: Ian J
authors.initials: IJ
authors.lastname: Sarembock
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy*; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D052157:Aptamers, Nucleotide / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced*; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy*; D062645:Percutaneous Coronary Intervention / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D052157:Aptamers, Nucleotide; C515724:RB 006; D006493:Heparin