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Drug trial results refine treatment during angioplasty operations
Date:8/31/2010

nt the results of the FUTURA-OASIS 8 (Fondaparinux with UnfracTionated heparin dUring Revascularisation in Acute coronary syndromes) trial at the annual European Society of Cardiology Congress in Stockholm, Sweden on August 31. The study was also published simultaneously in the Journal of the American Medical Association (JAMA).

FUTURA-OASIS 8 is a Phase III, multicentre, multinational, randomized, parallel-group trial of 2,026 patients undergoing angioplasty within 72 hours of arriving in a hospital with unstable angina or a heart attack. As soon as possible after their arrival, patients were enrolled and received fondaparinux 2.5 mg daily. Patients who required angioplasty were then randomized to low fixed dose heparin or standard dose heparin with activated clotting time (ACT) guidance during angioplasty. The low fixed dose UFH regimen consisted of a dose of 50 U/kg irrespective of use of GP IIb/IIIa inhibitors (another group of drugs used to prevent clots at time of angioplasty). The standard dose UFH regimen consisted of a dose of 85 U/kg or 60 U/kg when GP IIb/IIIa inhibitor used, adjusted by blinded ACT.

The low dose regimen did not reduce the risk of major or minor bleeding or vascular access complications compared to standard dose regimen. The low dose regimen did not lower the risk of major bleeding but did lower minor bleeding by 60 per cent. There was a trend, however, for higher risk of death, myocardial infarction or target vessel revascularization with low dose vs. standard dose UFH. The rates of catheter thrombosis were very low (0.5 per cent and 0.1 per cent in the low and standard dose UFH groups). In the standard dose arm, only about one in five patients required an additional UFH bolus to reach target ACT.

"There has been a widely believed hypothesis that lowering heparin dose lowers bleeding with similar efficacy during angioplasty but randomized trial data has been lacking," remarked Professor Gabriel Steg, int
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Contact: Laura Thompson
lthomp@mcmaster.ca
905-525-9140
McMaster University
Source:Eurekalert

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