Low-dose Fondaparinux Not Safer for Non-STEMI Patients

A comparison of low-dose fondaparinux to standard dose in non-STEMI patients during percutaneous coronary intervention (PCI) did not result in any significant reductions in bleeding rates or complications, according to a report published in the Journal of the American Medical Association.

Researchers from the FUTURA/OASIS-8 Study Group conducted double-blind, randomized, parallel-group trials 2,026 patients undergoing PCI in 179 hospitals spread out among 18 countries. The patients were selected from a cohort of 3,235 high-risk patients with non—ST-segment elevation acute coronary syndromes initially treated with fondaparinux.

Patients received intravenously either low-dose unfractionated heparin (50 U/kg) or standard-dose unfractionated heparin (85 U/kg). The primary outcome was a composite of bleeding, minor bleeding, or major vascular access-site complications up to 48 hours after PCI, while key secondary outcomes included a composite of major bleeding at 48 hours with death, myocardial infarction, or target vessel revascularization within 30 days.

The investigators found that the primary outcome occurred in 4.7% of patients in the low-dose group vs. 5.8% in the standard-dose group. Although the rates of major bleeding did not differ, rates of minor bleeding were lower, with 0.7% in the low-dose group compared with 1.7% in the standard-dose group. For the key secondary outcome, the rates for low-dose group were 5.8% vs 3.9% in the standard-dose group; for death, myocardial infarction, or target vessel revascularization, the rates were 4.5% for the low-dose group compared with 2.9% for the standard-dose group.

It was concluded that “low-dose compared with standard-dose unfractionated heparin did not reduce major peri-PCI bleeding and vascular access-site complications.”

For more information:

• New Medication Reduces Leukotriene Production Following Acute Coronary Syndrome
• American Journal of Managed Care: Outpatient Medication Use and Health Outcomes in Post-Acute Coronary Syndrome Patients
• Annals of Internal Medicine: Patients’ and Cardiologists’ Perceptions of the Benefits of Percutaneous Coronary Intervention for Stable Coronary Disease