Clinical Health Updates

Less bleeding with fondaparinux vs enoxaparin for ACS with PCI

Clinical Question:
In patients with acute coronary syndromes who are managed with percutaneous coronary intervention, is fondaparinux as safe and effective as enoxaparin?

Bottom Line:
For patients with acute coronary syndromes (ACS) who undergo percutaneous coronary intervention (PCI), fondaparinux is equally as effective as enoxaparin and results in less major bleeding.

Reference:
Mehta SR, Granger CB, Eikelboom JW, et al. Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes undergoing percutaneous coronary intervention. J Amer Coll Cardiol 2007;50(18):1742-1751.

Study Design:
Randomized controlled trial (double-blinded)

Synopsis:
This study was a preplanned analysis of patients from the OASIS-5 trial (Fifth Organization to Assess Strategies in Ischemic Syndromes), which evaluated the efficacy and safety of subcutaneous fondaparinux (2.5 mg daily) versus enoxaparin (1 mg/kg twice daily) in patients with unstable angina or non-ST-segment elevation myocardial infarction. Primary end points were rates of major bleeding and the composite of death, myocardial infarction, or stroke at days 9, 30, and 180. Results were analyzed by intention to treat. Patients were matched for baseline characteristics. PCI was done in 6238 patients of the 12,715 enrolled in the main trial who underwent cardiac catheterization during the period of study drug administration. Fondaparinux and enoxaparin were given for a mean of 2.4 days and 2.6 days, respectively, before PCI. More than 90% of patients received a thienopyridine, and approximately 40% were treated with glycoprotein (GP) IIb/IIIa inhibitors. At 30 days and 6 months, there was no difference in the rate of the composite primary end point or in the rates of the individual events. Major bleeding at day 9 was significantly lower among patients receiving fondaparinux [2.4% vs 5.1%; number needed to treat = 40; 95% CI, 25 – 86]. This difference persisted at 180 days. The reduction in bleeding with fondaparinux was seen both in patients who did and did not receive treatment with a GP IIb/IIIa inhibitor.