Safety and efficacy of bivalirudin in female acute coronary syndrome patients undergoing percutaneous coronary intervention
Randomized controlled study published in 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.
Summary
Randomized study of 100 Bangladeshi women with acute coronary syndrome undergoing PCI: bivalirudin versus heparin-based control lowered 30-day net adverse clinical events (5.7% vs 27.6%) and bleeding (2.8% vs 16.9%), with comparable MACCE and stent thrombosis rates.
Why This Matters for Hirudotherapy
This randomized controlled study evaluated bivalirudin versus heparin (with or without eptifibatide) in 100 female ACS patients undergoing PCI in a Bangladeshi population, reporting significantly lower 30-day net adverse clinical events (5.7% vs 27.6%, p=0.009) and bleeding (2.8% vs 16.9%, p=0.03) with bivalirudin, with comparable MACCEs. The sample is modest and single-center. Bivalirudin (formerly Hirulog) is a synthetic peptide anticoagulant designed partly on the C-terminal sequence of hirudin, the anticoagulant of the medicinal leech (Maraganore et al., 1990); this paper studies the drug, not leech therapy.
Citation
Reference (Vancouver style)
Mostofa ABM, Karmoker KK, Afrin R, Hossain A, Alam A, Dutta B, et al. Safety and efficacy of bivalirudin in female acute coronary syndrome patients undergoing percutaneous coronary intervention. Mymensingh Med J. 2025;34(2):545-553. PMID: 40160076
Bibliographic details (authors, volume, pages, DOI) are taken from the PubMed record.
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