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FUTURA/OASIS-8: No reduction in PCI bleeding complications with low-dose heparin in patients treated with fondaparinux
Steg P. JAMA. 2010;doi:10.1001/jama.2010.1320.
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A low dose of unfractionated heparin did not reduce major periprocedural bleeding complications when compared with a standard dose in patients undergoing percutaneous coronary intervention for acute coronary syndromes treated initially with fondaparinux, results from the FUTURA/OASIS-8 study suggested.
Researchers for the prospective study selected a cohort of 2,026 patients undergoing PCI within 72 hours after the onset of ACS from a larger cohort of 3,235 high-risk patients with non-ST segment elevation ACS who were initially treated with fondaparinux (Arixtra, GlaxoSmithKline) between February 2009 and March 2010. Patients were randomly assigned to either IV low-dose unfractionated heparin (50 U/kg, n=1,024), regardless of the use of glycoprotein IIb/IIIa inhibitors, or to a standard dose of unfractionated heparin (85 U/kg, n=1,002). The standard dose was reduced to 60 U/kg in patients treated with planned glycoprotein IIb/IIIa inhibitors and was adjusted by activated clotting time. The primary outcome measure was a composite of major bleeding, minor bleeding or major vascular access-site complications up to 48 hours after PCI, with a composite secondary endpoint of major bleeding at 48 hours with death, MI or target vessel revascularization within 30 days.
According to the results, the primary endpoint occurred in 4.7% of patients in the low-dose group and in 5.8% of patients in the standard dose group (OR=0.80; 95% CI, 0.54-1.19). A slight increase in the secondary endpoint was reported in the low-dose group vs. the standard-dose group (5.8% vs. 3.9%), but the increase did not reach statistical significance. No difference in peri-PCI major bleeding between the low-dose and standard-dose groups was reported (1.4% vs. 1.2%; OR=1.14; 95% CI, 0.53-2.49), and major bleeding events up to 30 days were also similar between the low-dose and standard-dose groups (2.2% vs. 1.8%; OR=1.20; 95% CI, 0.64-2.25).
“Low-dose compared with [activated clotting time]-guided standard-dose heparin did not reduce peri-PCI bleeding and vascular access site complications,” the researchers concluded. “Catheter thromboses are rare when using unfractionated heparin for PCI in patients with non-ST segment ACS treated with fondaparinux. Therefore, patients with ACS treated with fondaparinux and undergoing PCI should receive the guideline-recommended [activated clotting time]-guided standard dose of unfractionated heparin.”
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