Use of the REG1 anticoagulation system in patients with acute coronary syndromes undergoing percutaneous coronary intervention: results from the phase II RADAR-PCI study

EuroIntervention. 2014 Aug;10(4):431-8. doi: 10.4244/EIJY14M06_01.

Abstract

Aims: 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.

Methods and 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.

Clinical trials registration: ClinicalTrials.gov NCT00932100.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Coronary Syndrome / drug therapy*
  • Aged
  • Anticoagulants / therapeutic use*
  • Aptamers, Nucleotide / administration & dosage
  • Aptamers, Nucleotide / therapeutic use*
  • Female
  • Hemorrhage / chemically induced*
  • Heparin / therapeutic use
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction / drug therapy*
  • Percutaneous Coronary Intervention* / methods
  • Treatment Outcome

Substances

  • Anticoagulants
  • Aptamers, Nucleotide
  • RB 006
  • Heparin

Associated data

  • ClinicalTrials.gov/NCT00932100