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Spotlight on fondaparinux sodium in acute coronary syndromes
Stephanie K A Blick1, Jennifer S Orman, Antona J Wagstaff
1Wolters Kluwer Health | Adis, Auckland, New Zealand, an editorial office of Wolters Kluwer Health, Conshohocken, Pennsylvania, USA. demail@adis.co.nz
Insights
Fondaparinux sodium is a synthetic anticoagulant that effectively prevents thrombus formation in acute coronary syndromes (ACS). It shows favorable benefit-risk profiles compared to enoxaparin and usual care, with reduced bleeding risk.
Area of Science:
- Cardiology
- Pharmacology
- Thrombosis
Background:
- Acute coronary syndromes (ACS) are a spectrum of conditions including unstable angina, non-ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI).
- Effective anticoagulation is crucial in managing ACS to prevent thrombus formation and reduce ischemic events.
- Fondaparinux sodium is a synthetic pentasaccharide, a selective factor Xa inhibitor.
Purpose of the Study:
- To review the efficacy and safety of fondaparinux sodium in patients with acute coronary syndromes (ACS).
- To compare fondaparinux with enoxaparin and usual care in ACS management.
Main Methods:
- Review of data from large clinical trials, including OASIS-5 (n=20,078) and OASIS-6 (n>12,000).
- Evaluation of fondaparinux 2.5 mg/day subcutaneously versus enoxaparin and usual care in ACS patients.
- Assessment of outcomes including death, ischemic events, and major bleeding.
Main Results:
- Fondaparinux was noninferior to enoxaparin in reducing death or ischemic events in unstable angina/NSTEMI patients, with significantly less major bleeding.
- Fondaparinux demonstrated superior efficacy over usual care in STEMI patients regarding death or reinfarction at 30 days, with similar bleeding rates.
- Fondaparinux offers once-daily dosing, 100% bioavailability, and does not require monitoring of activated clotting time.
Conclusions:
- Fondaparinux sodium presents a favorable benefit-risk profile for ACS management, particularly due to its reduced bleeding risk.
- Clinical evidence supports fondaparinux's valuable role in treating patients with unstable angina, NSTEMI, and STEMI.
- Fondaparinux offers advantages in administration and monitoring compared to other anticoagulants.
Abstract:
Fondaparinux sodium (Arixtra) is a synthetic, sulfated pentasaccharide, selective factor Xa inhibitor that is indicated in Europe for preventing thrombus formation in patients with acute coronary syndromes (ACS; the focus of this review), including those with ST-segment elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), or unstable angina. The large (n = 20,078), well designed OASIS-5 trial showed that subcutaneous fondaparinux 2.5 mg/day for < or =8 days was noninferior to subcutaneous enoxaparin 1 mg/kg twice daily (once daily in those with renal dysfunction) in reducing death or ischemic events at 9 days and the efficacy was maintained for up to 6 months (study end) in patients with unstable angina or NSTEMI. During this time, major bleeding occurred in fewer fondaparinux than enoxaparin recipients, resulting in a benefit : risk balance favoring fondaparinux. The incidence of death or reinfarction at 30 days was significantly lower in recipients of subcutaneous fondaparinux 2.5 mg/day than in those who received usual care (including unfractionated heparin treatment as indicated) in patients with STEMI in the large (n > 12,000) OASIS-6 trial. There were no differences in the incidence of major bleeding between these groups, resulting in a benefit : risk balance favoring fondaparinux. The specificity and selectivity of fondaparinux, combined with its long half-life and 100% bioavailability, allows once-daily anticoagulation without the need for monitoring activated clotting time. Subcutaneous fondaparinux was noninferior to enoxaparin treatment in patients with unstable angina or NSTEMI, and was more effective than usual care in those with STEMI. Fondaparinux has a favorable tolerability profile, particularly with regard to the risk of major bleeding, and limited data suggest that it is more cost effective than enoxaparin in the short term. Thus, overall, clinical evidence suggests that fondaparinux has a valuable place in the treatment of patients with ACS.
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