American Society of Hirudotherapy

Efficacy and safety of bivalirudin for percutaneous coronary intervention in acute coronary syndromes: a meta-analysis of randomized-controlled trials

Review published in Clinical research in cardiology : official journal of the German Cardiac Society (2018)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Meta-analysisClinical TrialsDrug DevelopmentSafety & Infection ControlSalivary PharmacologyNhrenberg TG et al. · Clinical research in cardiology : official journal of the German Cardiac Society, 2018

Abstract

AIMS: The efficacy and safety of bivalirudin in patients undergoing percutaneous coronary intervention (PCI) for treatment of acute coronary syndromes (ACS) remains controversial despite recent evidence from large randomized-controlled trials (RCTs). Thus, this systematic review and meta-analysis sought to investigate the efficacy and safety of bivalirudin as compared to heparin in patients with ACS undergoing PCI. METHODS AND RESULTS: Medline/PubMed, Cochrane Central Register of Controlled Trials, and Clinical Trials.gov databases were searched for RCTs. Primary endpoint was MACE consisting of all-cause death, myocardial infarction, and stroke within 30 days. Secondary endpoints were components of the primary endpoint and stent thrombosis. The primary safety endpoint was major bleeding. We identified 12 RCTs comprising 33,844 patients. Between bivalirudin and heparin, there were no significant differences for MACE (OR 1.06; 95% CI 0.96-1.17; p = 0.24), death, myocardial infarction, and stent thrombosis. Similar results were seen following stratification by use of glycoprotein inhibitors (GPI). Major bleeding trended to be less frequent in patients treated with bivalirudin. However, no safety benefit for bivalirudin was seen when use of GPI was balanced between groups (OR 0.88; 95% CI 0.67-1.16; p = 0.35; p for heterogeneity < 0.01). CONCLUSIONS: Compared with heparin, bivalirudin was associated with a similar incidence of ischemic events following PCI for ACS. An association of bivalirudin with decreased bleeding was not seen with balanced use of GPI.

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

Publication typeJournal ArticleMeta-AnalysisSystematic Review
Indexed MeSH termsAcute Coronary SyndromeAntithrombinsGlobal HealthHirudinsHumansIncidencePeptide FragmentsPercutaneous Coronary InterventionRecombinant ProteinsThrombosisTreatment Outcome

Summary

The efficacy and safety of bivalirudin in patients undergoing percutaneous coronary intervention (PCI) for treatment of acute coronary syndromes (ACS) remains controversial despite recent evidence from large randomized-controlled trials (RCTs).

Why This Matters for Hirudotherapy

This systematic review and meta-analysis of 12 randomized-controlled trials (33,844 patients) compared bivalirudin to heparin in patients with acute coronary syndromes undergoing percutaneous coronary intervention, finding no significant difference in major adverse cardiovascular events (OR 1.06; 95% CI 0.96-1.17) and suggesting that bivalirudin's apparent bleeding advantage was not observed when glycoprotein inhibitor use was balanced between groups. Bivalirudin is a synthetic direct thrombin inhibitor structurally modeled on hirudin, the anticoagulant from medicinal leech saliva, so this study is relevant to understanding how a leech-secretome-inspired anticoagulant performs in contemporary interventional cardiology. However, this is an evaluation of a specific pharmaceutical product in PCI rather than a study of leech therapy itself, and its findings cannot be directly extrapolated to hirudotherapy or the broader leech secretome.

Citation

Efficacy and safety of bivalirudin for percutaneous coronary intervention in acute coronary syndromes: a meta-analysis of randomized-controlled trials

Nhrenberg TG et al. · Clinical research in cardiology : official journal of the German Cardiac Society, 2018

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

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