Fondaparinux advocated for ACS patients

16 March 2006

Fondaparinux is as effective as enoxaparin at reducing ischemic events in patients with acute coronary syndrome (ACS), with significantly reduced risk of bleeding events and long-term mortality, the results of an international trial suggest.

The Fifth Organization to Assess Strategies in Acute Ischemic Syndromes (OASIS-5) was a double-blind trial that compared enoxaparin and fondaparinux therapy in 20,078 patients with unstable angina or non-ST-segment elevation myocardial infarction (MI).

"The combined use of anticoagulants, antiplatelet agents, and invasive coronary procedures reduces ischemic coronary events but also increases bleeding in patients with ACS," note Salim Yusif (Hamilton General Hospital, Ontario, Canada) and colleagues in the New England Journal of Medicine.

For the OASIS-5 trial, patients from 576 centers in 41 countries were randomly assigned to receive either the factor Xa inhibitor fondaparinux or enoxaparin for 6 days, within 24 hours of the onset of ACS symptoms.

Patients were followed-up for a minimum of 6 months.

Yusif et al report that the 9-day incidence of MI or refractory ischemia was the same in the fondaparinux and enoxaparin patient groups, at 5.8% and 5.7%, respectively.

However, major bleeding events were significantly less likely in the fondaparinux group compared with the enoxaparin group, occurring in 2.2% and 4.1% of patients, respectively.

Compared with enoxaparin use, fondaparinux use was also associated with a significantly reduced number of deaths at 30 and 180 days, at 295 versus 352 and 574 versus 638, respectively.

The authors conclude: "Fondaparinux is similar to enoxaparin in reducing the risk of ischemic events at 9 days, but it substantially reduces major bleeding and improves long term mortality and morbidity."

N Engl J Med 2006; Early online edition