Safety Profile and Bleeding Complications of Fondaparinux Versus Enoxaparin in Non‐ST Elevation Acute Coronary Syndrome

TL;DR

This study compares fondaparinux and enoxaparin in treating heart patients and finds fondaparinux safer and more effective in reducing bleeding and heart issues.

Contribution

The study provides new evidence on fondaparinux's superiority over enoxaparin in NSTE-ACS patients in a Bangladeshi context.

Findings

Fondaparinux significantly reduced bleeding and ischemic events compared to enoxaparin.

Fondaparinux lowered the risk of heart attacks and hospitalization for heart failure.

Fondaparinux was an independent protective factor against composite adverse outcomes.

Abstract

Background

Non-ST-elevation acute coronary syndrome (NSTE-ACS) remains a major contributor to morbidity and mortality worldwide. Optimal anticoagulation is critical for preventing complications, but the choice between fondaparinux and enoxaparin remains debated, particularly regarding bleeding and ischemic outcomes. The objective of this study was to compare the safety profile, bleeding complications, ischemic outcomes, mortality, and composite adverse events between fondaparinux and enoxaparin in NSTE-ACS patients in Bangladesh.

Methods

This prospective observational study enrolled 177 NSTE-ACS patients from Noakhali Medical College and Hospital, Bangladesh, between January and December 2022. Patients received either fondaparinux (n=87) or enoxaparin (n=90). Bleeding and ischemic events, mortality, and composite outcomes were assessed at baseline, 3-month, and 6-month follow-ups. Multivariable logistic regression was performed to evaluate predictors of composite outcomes.

Results

Total bleeding incidence was significantly lower in fondaparinux-treated patients (6.90% vs. 23.33%, p=0.002), notably during index hospitalization (4.60% vs. 17.78%, p=0.006). Fondaparinux significantly reduced myocardial infarction (3.45% vs. 14.44%, p=0.016), recurrent ischemia (11.49% vs. 24.44%, p=0.025), and hospitalization due to heart failure (4.60% vs. 14.44%, p=0.026). Mortality was lower with fondaparinux but not statistically significant (13.79% vs. 25.56%, p=0.050). The composite endpoint of mortality and ischemic events was significantly lower in fondaparinux-treated patients (20.69% vs. 40.00%, p=0.005). Multivariable analysis revealed fondaparinux as an independent protective factor against composite outcomes (OR=0.336, 95% CI: 0.166-0.683, p=0.003), with no significant predictive value found for age, sex, hypertension, diabetes, smoking, or time to intervention.

Conclusions

Fondaparinux demonstrates superior safety and effectiveness over enoxaparin in reducing bleeding complications and ischemic events among NSTE-ACS patients. These findings support its preferential use in resource-constrained clinical settings.