A study that will appear in the September 22 issue of
JAMA says that patients with acute coronary syndromes initially treated with the anticoagulant fondaparinux who underwent a coronary procedure and received a lower dose of the anticoagulant heparin during the procedure did not have a reduced rate of major bleeding and vascular access site complications.
The study is being released early online to coincide with its presentation at the European Society of Cardiology meeting in Stockholm.
Previous study results suggested the use of unfractionated heparin as supplemental therapy at the time of percutaneous coronary intervention (PCI; procedures such as balloon angioplasty or stent placement used to open narrowed coronary arteries) for patients with non-ST segment elevation (a certain pattern on an electrocardiogram) acute coronary syndromes (such as heart attack or unstable angina) who were treated with fondaparinux and undergoing PCI. But there is disagreement on the appropriate range of dosing of heparin during PCI for these patients, according to background information in the article. "The optimal dosing of unfractionated heparin should maintain the safety profile of fondaparinux but achieve adequate antithrombin effect to prevent catheter thrombus [blood clots]," the authors write.
Sanjit S. Jolly, M.D., of Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada, and colleagues with the Fondaparinux Trial With Unfractionated Heparin During Revascularization in Acute Coronary Syndromes (FUTURA)/OASIS-8 trial evaluated the safety of two dose regimens of adjunctive intravenous unfractionated heparin during PCI in high-risk patients. The randomized trial included 179 hospitals in 18 countries and involved 2,026 patients undergoing PCI within 72 hours, who were from a group of 3,235 high-risk patients with non-ST segment elevation acute coronary syndromes initially treated with fondaparinux, enrolled from February 2009 to March 2010. Patients received intravenously either low-dose unfractionated heparin (50 U/kg, regardless of use of glycoprotein IIb-IIIa [GpIIb-IIIa] inhibitors) or standard-dose unfractionated heparin (85 U/kg [60 U/kg with GpIIb-IIIa inhibitors]), adjusted by activated clotting time (ACT).