The phase II RADAR-PCI study has determined 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.
In RADAR, patients with acute coronary syndrome 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.
In conclusion, 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. ( Xagena )
Povsic TJ et al, EuroIntervention 2014; Epub ahead of print