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FUTURA/OASIS 8: Post-PCI bleeding rates comparable in patients given low, high dose of unfractionated heparin

Issue: April 2011

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Cardiovascular Research Technologies 2011

Patients who underwent percutaneous coronary intervention and were given a low fixed dose of unfractionated heparin during PCI had no significant difference in major and minor bleeding or vascular complications as those given a standard dose of unfractionated heparin, according to study findings.

The FUTURA/OASIS 8 trial featured patients (n=2,026) who were treated with either standard dose unfractionated heparin (n=1,024; mean age, 65.3 years) or standard activated clotting time guided unfractionated heparin (n=1,002; mean age, 65.5 years) during PCI to determine whether low-dose or standard heparin reduced the composite of peri-PCI (within 48 of procedure) major and minor bleeding, as well as vascular site complications in ACS patients treated with fondaparinux (Arixtra, GlaxoSmithKline). As a secondary objective, researchers also compared major bleeding rates in FUTURA/OASIS 8 with those found in the OASIS 5 trial in which patients were given fondaparinux alone.

At 48 hours, major and minor bleeds as well as vascular access complications were similar between arms (standard dose, 5.8% vs. low dose, 4.7%; P=.27). Individually, for the low dose arm, major bleeding rates were slightly higher (1.4% vs. 1.2%), but minor bleeding (0.7% vs. 1.7%) and vascular access complication rates (3.2% vs. 4.3%) were lower.

When compared with OASIS 5 findings showing major bleeding rates at 1.5% for those treated with fondaparinux alone and 3.6% in those treated with enoxaparin (Lovenox, Sanofi-Aventis), Sanjit S. Jolly, MD, trial investigator with McMaster University, Hamilton, Ontario, Canada, said in his presentation that data from FUTURA/OASIS 8 indicated that unfractionated heparin plus fondaparinux does not appear to increase peri-PCI bleeding rates and in fact lowered them.

These results, Sanjit later added, solve an important question. “ACS patients treated with fondaparinux can undergo PCI safely with unfractionated heparin. There is no evidence to depart from guideline recommended standard dosing regimen of unfractionated heparin during PCI,” he said. “Adding unfracitonated heparin during PCI to fondaparinux appears to preserve the benefits and safety of fondaparinux (i.e. very low rates of reduced bleeding) and minimizes this important issue of catheter thrombus.”

Initial Cardiology Today coverage of FUTURA/OASIS 8 can be viewed here. – by Brian Ellis

For more information:

• Jolly S. Presented at: Cardiovascular Research Technologies 2011. Feb. 27-March 1, 2011; Washington, D.C.

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