August 31st, 2010

No Benefits for Low-Dose Heparin Over Standard Heparin in FUTURA/OASIS-8

FUTURA (Fondaparinux Trial With Unfractionated Heparin During Revascularization in Acute Coronary Syndromes)/OASIS-8 is the first trial to compare low-dose unfractionated heparin with conventional heparin dosing in PCI patients receiving fondaparinux. Sanjit Jolly and colleagues randomized 2026 non-STEMI high-risk patients undergoing PCI within 72 hours to either low-dose unfractionated heparin or a standard dose of heparin adjusted by activated clotting time (ACT), in addition to fondaparinux. The results were presented at the ESC in Stockholm and published simultaneously in  JAMA.

The primary endpoint — a composite of major bleeding, minor bleeding, or major vascular access-site complications in the 48 hours after PCI — occurred in 4.7% of patients in the low-dose group compared with 5.8% of the conventional-dose group. This difference did not achieve statistical significance. The researchers also observed a nonsignificant increase in the low-dose group in the composite secondary endpoint of periprocedural major bleeding or 30-day death, MI, or target vessel revascularization.

The authors conclude: “The finding that adding ACT-guided unfractionated heparin to fondaparinux while treating patients with acute coronary syndromes does not increase major bleeding is important in the context of modern PCI practice…. These findings support using the currently recommended standard ACT-guided dose of unfractionated heparin when performing PCI in patients with non-ST segment elevation acute coronary syndromes who are treated with fondaparinux.”

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