American Society of Hirudotherapy

The efficacy and safety of bivalirudin and heparin in patients with acute coronary syndrome: a systematic review and meta-analysis

Systematic review with meta-analysis published in Systematic Reviews (2025)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Meta-analysisClinical LiteratureDrug DevelopmentZhai Y et al. · Systematic reviews, 2025

Abstract

BACKGROUND: Patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) are at high risk of thrombosis. However, bleeding-related complications during antithrombotic therapy remain a major barrier to effective treatment and can often lead to adverse outcomes. This meta-analysis aimed to determine the efficacy and safety of bivalirudin and heparin in patients with ACS after PCI. METHODS: Randomized controlled trials (RCTs) on the efficacy and safety of bivalirudin versus heparin in patients with ACS after PCI were identified from the PubMed, Embase, Cochrane Library, CBM, CNKI, WanFang, and VIP database until August 2024. The outcomes included all-cause mortality, major adverse cardiovascular events (MACEs), incidence of recurrent myocardial infarction, stent thrombosis, short-term bleeding, revascularization, and retransfusion. Meta-analysis was performed using RevMan 5.3 and Stata 12.0 softwares. The included studies were assessed for risk of bias using the Cochrane risk-of-bias assessment tool. RESULTS: A total of 70,199 patients from 27 randomized controlled trials (RCTs) were analyzed in this review. There were no significant differences between the bivalirudin and heparin groups in terms of all-cause mortality, major adverse cardiovascular events (MACEs), recurrent myocardial infarction, stent thrombosis within 30 days, or subacute stent thrombosis. Specifically, the incidence of short-term bleeding (P = 0.001) and retransfusion (P = 0.001) was significantly lower in the bivalirudin group compared to the heparin group. Conversely, the incidence of acute stent thrombosis (P < 0.0001) and revascularization (P = 0.009) was significantly higher in the bivalirudin group. CONCLUSIONS: Compared with heparin, bivalirudin has definite anticoagulant effect in patients with acute myocardial infarction after PCI, and the risk of bleeding and the incidence of retransfusion were lower in the bivalirudin group. This review helps doctors in PCI management choose bivalirudin or heparin more precisely based on patients' conditions for better treatment and fewer adverse events.

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

Publication typeJournal ArticleMeta-AnalysisSystematic ReviewResearch Support, Non-U.S. Gov't
Indexed MeSH termsHumansHirudinsAcute Coronary SyndromePeptide FragmentsHeparinRecombinant ProteinsPercutaneous Coronary InterventionAntithrombinsAnticoagulantsRandomized Controlled Trials as TopicHemorrhageThrombosis

Summary

Across 27 randomized trials (70,199 ACS patients after PCI), bivalirudin versus heparin showed no differences in mortality, MACE or recurrent myocardial infarction, with less short-term bleeding but more acute stent thrombosis and revascularization.

Why This Matters for Hirudotherapy

This systematic review and meta-analysis of 27 randomized controlled trials (70,199 patients) compared the efficacy and safety of bivalirudin versus heparin in acute coronary syndrome patients undergoing percutaneous coronary intervention. No significant differences were found in all-cause mortality, MACEs, recurrent MI, or 30-day stent thrombosis, but bivalirudin was associated with significantly lower short-term bleeding (P=0.001) and retransfusion rates (P=0.001), alongside higher acute stent thrombosis (P<0.0001) and revascularization rates (P=0.009). The authors conclude bivalirudin has a definite anticoagulant effect in post-PCI acute MI patients with lower bleeding and retransfusion risk. 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)

Zhai Y, Shang H, Li Y, Zhang N, Zhang J, Wu S. The efficacy and safety of bivalirudin and heparin in patients with acute coronary syndrome: a systematic review and meta-analysis. Syst Rev. 2025;14(1):39. doi:10.1186/s13643-025-02782-7. PMID: 39930484

Bibliographic details (authors, volume, pages, DOI) are taken from the PubMed record.

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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.