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 language | English (US) |
|---|---|
| Pages (from-to) | 431-438 |
| Number of pages | 8 |
| Journal | EuroIntervention |
| Volume | 10 |
| Issue number | 4 |
| DOIs | |
| State | Published - Aug 1 2014 |
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Keywords
- Acute coronary syndrome
- Anticoagulation
- Factor IXa
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
Cite this
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.
In: EuroIntervention, Vol. 10, No. 4, 01.08.2014, p. 431-438.Research output: Contribution to journal › Article
}
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
UR - http://www.scopus.com/inward/record.url?scp=84922335735&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84922335735&partnerID=8YFLogxK
U2 - 10.4244/EIJY14M06-01
DO - 10.4244/EIJY14M06-01
M3 - Article
C2 - 24929350
AN - SCOPUS:84922335735
VL - 10
SP - 431
EP - 438
JO - EuroIntervention
JF - EuroIntervention
SN - 1774-024X
IS - 4
ER -