Association between the use of Fondaparinux vs. Low Molecular Weight Heparin and clinical outcomes in patients with Non- ST-Segment Elevation Myocardial Infarction

Hiral Patel, PharmD Candidate 2015 Mercer University College of Pharmacy

In patients with Non- ST-segment elevation myocardial infarction, fondaparinux was non-inferior to low molecular weight heparin in reducing ischemic outcomes. However, the use of fondaparinux reduced severe in-hospital bleeding events, which translated into both short- and long-term reduction in mortality.1

Title: Association between the use of Fondaparinux vs. Low Molecular Weight Heparin and clinical outcomes in patients with Non- ST-Segment Elevation Myocardial Infarction 2
Design Prospective, multicenter, cohort study
Objective To look at the association between the use of fondaparinux and low molecular weight heparin (LMWH) on outcomes in patients with Non-ST-segment-Elevation-Myocardial-Infarction (NSTEMI)
Study groups Fondaparinux vs. LMWH
Methods Prospective study looking at 40616 patients with NSTEMI who were either treated with fondaparinux or LMWH
Duration September 1, 2006 – December 31, 2010
Primary Outcome Measure Major bleeding at 30 and 180 days, stroke, and recurrent myocardial infarction (MI)
Baseline Characteristics The median age was 73 years, 37.2% were women, 30.1% had a previous MI, 11.3% had previous ischemic stroke, while 1.4% had a previous hemorrhagic stroke
Results The rate of severe bleeding while in the hospital or causing readmission both at 30 days was 1.4% (fondaparinux) vs. 2.1% (LMWH) and at 180 days was: 1.9% (fondaparinux) vs. 2.8% (LMWH). Patients in the fondaparinux group had lower adjusted odds of having either a severe bleed or death event in the hospital (OR, 0.68; 95% CI, 0.58-0.79), at 30 days (OR, 0.74; 95% CI, 0.65-0.84), and at 180 days (OR, 0.72; 95% CI, 0.65- 0.80) than patients in the LMWH group. The rate of recurrent MI in the fondaparinux group was 9.0% vs. 9.5% in the LMWH group at 30 days and was 14.2% (fondaparinux) vs. 15.8% (LMWH) at 180 days. The rate of stroke did not differ in ORs after adjustments at 30 days (OR, 1.11; 95% CI, 0.74-1.65) and at 180 days (OR, 0.98; 95% CI, 0.79-1.22).
Adverse Events Common Adverse Events: Not provided
Serious Adverse Events: Severe in hospital bleeding leading to mortality occurred in 1.5% of the fondaparinux patients vs. 11.7% of the LMWH patients.
Percentage that Discontinued due to Adverse Events: Not provided
Study Author Conclusions In routine clinical care of patients with NSTEMI, fondaparinux compared with LMWH was associated with lower odds of major bleeding events and death both in-hospital and up to 180 days after.

Due to the mounting evidence of safety for fondaparinux, the use of it has increased rapidly for patients with NSTEMI. This study was not a randomized controlled trial, so there could be residual confounding. Also there is no mention of dosing and duration of either medication in the study, making it even harder to draw a complete conclusion. Overall, the study showed the benefits of fondaparinux over LMWH for the treatment of NSTEMI.

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