What question did this study set out to answer?

The study aims to compare the safety and effectiveness of fondaparinux versus enoxaparin in patients with non-ST elevation acute coronary syndrome.

January 10, 2026Cureus0 citationsOpen Access

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

Q: What does this research mean for the field?

Fondaparinux reduces total bleeding incidence to 6.90% and ischemic events compared to enoxaparin's 23.33% and 14.44%, respectively, in NSTE-ACS patients. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

MRMd. Mahfuzur RahmanChittagong Medical College FAFarid Uddin AhmedJamia Millia Islamia MCMohammad Ibrahim ChowdhuryChittagong Medical College

Key Result

Fondaparinux reduced total bleeding incidence to 6.90% and ischemic events compared to enoxaparin's 23.33% and 14.44%, respectively, in NSTE-ACS patients.

Key Points

The study aims to compare the safety and effectiveness of fondaparinux versus enoxaparin in patients with non-ST elevation acute coronary syndrome.
Conducted a prospective observational study with 177 NSTE-ACS patients in Bangladesh.
Patients received either fondaparinux or enoxaparin and were followed up at baseline, 3-month, and 6-months.
Assessments included bleeding events, ischemic outcomes, mortality, and composite adverse events.
Fondaparinux had lower total bleeding incidence (6.90%) compared to enoxaparin (23.33%).
Significantly fewer myocardial infarctions occurred in the fondaparinux group (3.45% vs. 14.44%).
Lower rates of recurrent ischemia (11.49% vs. 24.44%) and heart failure hospitalization (4.60% vs. 14.44%) were observed with fondaparinux.
Fondaparinux showed a lower but not significant mortality rate (13.79% vs. 25.56%).
The composite endpoint of mortality and ischemic events was lower in fondaparinux patients (20.69% vs. 40.00%).

Structured PICO

Does fondaparinux reduce composite ischemic events and bleeding complications compared to enoxaparin in patients with NSTE-ACS?

Population

177 patients with non-ST-elevation acute coronary syndrome (NSTE-ACS), including unstable angina and NSTEMI, from a single center in Bangladesh. Mean age ~60 years, predominantly male. Key exclusions: contraindications to LMWH, recent hemorrhagic stroke, other indications for long-term anticoagulation, serum creatinine ≥3.0 mg/dL, pregnancy, STEMI, or life-limiting comorbidities.

Intervention

Fondaparinux 2.5 mg once daily via subcutaneous injection for an average duration of 6 days or until hospital discharge.

Comparator

Enoxaparin 1 mg/kg subcutaneously twice daily (adjusted to 1 mg/kg once daily if creatinine clearance <30 mL/min) for a minimum of 2 days and up to 8 days or until clinical stabilization.

Outcome

Primary efficacy outcome: Composite of death, myocardial infarction, recurrent ischemia, stroke, heart failure, and hospitalization due to heart failure within a six-month follow-up period. Primary safety outcome: Incidence of bleeding classified according to BARC criteria.composite

In a real-world, resource-constrained setting, fondaparinux demonstrated superior safety and effectiveness over enoxaparin by significantly reducing bleeding complications and composite ischemic events in NSTE-ACS patients.

Main Result

Absolute Event Rate: 0% vs 0%

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.

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