American Society of Hirudotherapy

Safety and efficacy of bivalirudin in female acute coronary syndrome patients undergoing percutaneous coronary intervention

Comparative study published in Mymensingh Medical Journal (2025)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Randomized controlled trialClinical TrialsDrug DevelopmentMostofa ABM et al. · Mymensingh medical journal, 2025

Abstract

Being women is an independent predictor of adverse events during percutaneous coronary intervention (PCI). Whether newer anticoagulant bivalirudin is safe and effective in female acute coronary syndrome (ACS) patients undergoing PCI, as compared with conventional heparin, is less well defined in Bangladeshi population. Our aim was to evaluate safety and efficacy of Bivalirudin in female ACS patients undergoing PCI. One hundred (100) female ACS patients were enrolled in this randomized controlled study, which underwent PCI from May to November, 2019 at BSMMU. Among them 35 patients were randomly assigned to receive bivalirudin and 65 patients were in control group to receive heparin with or without eptifibatide (GPI, glycoprotein IIb/IIIa inhibitor). The outcome measures were incidence of 30-day hemorrhagic complications, stent thrombosis and major adverse cardiac and cerebral events (MACCEs). Bivalirudin treatment was associated with significantly lower incidences of 30-day net adverse clinical events (NACEs) (5.7% vs. 27.6%, p=0.009) and bleeding (2.8% vs. 16.9%, p=0.03) compared with the control regimen. The incidence of MACCEs (2.8% vs. 15.4%, p=0.05) and stent thrombosis (0.0% vs. 3.1%, p=0.295) were comparable between the two groups. Multivariate analysis showed that bivalirudin (OR: 0.264, 95% CI: 0.071-0.977, p=0.04), trans-radial access (OR: 0.056, 95% CI: 0.003-0.967, p=0.04) and statin (OR: 0.009, 95% CI: 0.0005-0.168, p=0.001) were independent protective factors for 30-day NACEs. Bivalirudin is safe and effective in female ACS patients undergoing PCI as it reduces hemorrhagic complications without increase ischemic events (MACCEs) as compared with conventional heparin.

Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.

Publication typeJournal ArticleRandomized Controlled Trial
Indexed MeSH termsHumansFemaleHirudinsPercutaneous Coronary InterventionAcute Coronary SyndromePeptide FragmentsRecombinant ProteinsMiddle AgedAntithrombinsAgedTreatment OutcomeHeparin

Summary

Bangladeshi cohort study of bivalirudin in female ACS patients undergoing PCI. Reports favorable safety and effectiveness profile with low bleeding rates.

Why This Matters for Hirudotherapy

Female-specific bivalirudin PCI data from South Asia — important regional drug-development context.

Citation

Safety and efficacy of bivalirudin in female acute coronary syndrome patients undergoing percutaneous coronary intervention.

Mostofa ABM et al. · Mymensingh medical journal, 2025

Added to ASH library: May 27, 2026 · Site last updated: June 18, 2026

This website provides educational information and does not constitute medical advice, diagnosis, or treatment recommendations. Medicinal leech therapy carries clinically meaningful risks and should be performed only by qualified clinicians under institutionally approved protocols. FDA 510(k) clearance for medicinal leeches is limited to specific indications; investigational and off-label discussions are labeled accordingly. For patient-specific guidance, consult a qualified healthcare provider.