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

RADAR Investigators

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15 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)431-438
Number of pages8
JournalEuroIntervention
Volume10
Issue number4
DOIs
StatePublished - Aug 1 2014

Fingerprint

Percutaneous Coronary Intervention
Acute Coronary Syndrome
Heparin
Factor IXa
Hemorrhage
Catheters
Myocardial Infarction
Clinical Trials
RB 006
Incidence
RB 007

Keywords

  • Acute coronary syndrome
  • Anticoagulation
  • Factor IXa

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

@article{b118cdfc1d214a3384a16d93c93272dc,
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 = "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.",
keywords = "Acute coronary syndrome, Anticoagulation, Factor IXa",
author = "{RADAR Investigators} and Povsic, {Thomas J.} and Vavalle, {John P.} and Alexander, {John H.} and Aberle, {Laura H.} and Zelenkofske, {Steven L.} and Becker, {Richard C.} and Buller, {Christopher E.} and Cohen, {Mauricio G} and Cornel, {Jan H.} and Kasprzak, {Jaroslaw D.} and Gilles Montalescot and Fail, {Peter S.} and Sarembock, {Ian J.} and Roxana Mehran",
year = "2014",
month = "8",
day = "1",
doi = "10.4244/EIJY14M06-01",
language = "English (US)",
volume = "10",
pages = "431--438",
journal = "EuroIntervention",
issn = "1774-024X",
publisher = "EuroPCR",
number = "4",

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TY - JOUR

T1 - Use of the REG1 anticoagulation system in patients with acute coronary syndromes undergoing percutaneous coronary intervention

T2 - Results from the phase II RADAR-PCI study

AU - RADAR Investigators

AU - Povsic, Thomas J.

AU - Vavalle, John P.

AU - Alexander, John H.

AU - Aberle, Laura H.

AU - Zelenkofske, Steven L.

AU - Becker, Richard C.

AU - Buller, Christopher E.

AU - Cohen, Mauricio G

AU - Cornel, Jan H.

AU - Kasprzak, Jaroslaw D.

AU - Montalescot, Gilles

AU - Fail, Peter S.

AU - Sarembock, Ian J.

AU - Mehran, Roxana

PY - 2014/8/1

Y1 - 2014/8/1

N2 - 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.

AB - 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.

KW - Acute coronary syndrome

KW - Anticoagulation

KW - Factor IXa

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