American Society of Hirudotherapy

Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction

Systematic review published in Cardiovasc Revasc Med (2024)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Randomized controlled trialDrug DevelopmentClinical TrialsOmerovic et al. · Cardiovascular revascularization medicine, 2024

Abstract

BACKGROUND: The registry-based randomized VALIDATE-SWEDEHEART trial (NCT02311231) compared bivalirudin vs. heparin in patients undergoing percutaneous coronary intervention (PCI) for myocardial infarction (MI). It showed no difference in the composite primary endpoint of death, MI, or major bleeding at 180 days. Here, we report outcomes at two years. METHODS: Analysis of primary and secondary endpoints at two years of follow-up was prespecified in the study protocol. We report the study results for the extended follow-up time here. RESULTS: In total, 6006 patients were enrolled, 3005 with ST-segment elevation MI (STEMI) and 3001 with Non-STEMI (NSTEMI), representing 70 % of all eligible patients with these diagnoses during the study. The primary endpoint occurred in 14.0 % (421 of 3004) in the bivalirudin group compared with 14.3 % (429 of 3002) in the heparin group (hazard ratio [HR] 0.97; 95 % confidence interval [CI], 0.85-1.11; P = 0.70) at one year and in 16.7 % (503 of 3004) compared with 17.1 % (514 of 3002), (HR 0.97; 95 % CI, 0.96-1.10; P = 0.66) at two years. The results were consistent in patients with STEMI and NSTEMI and across major subgroups. CONCLUSIONS: Until the two-year follow-up, there were no differences in endpoints between patients with MI undergoing PCI and allocated to bivalirudin compared with those allocated to heparin. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02311231.

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

Publication typeJournal ArticleComparative StudyMulticenter StudyRandomized Controlled TrialResearch Support, Non-U.S. Gov't
Indexed MeSH termsHumansHirudinsHeparinPeptide FragmentsST Elevation Myocardial InfarctionPercutaneous Coronary InterventionRecombinant ProteinsMaleTreatment OutcomeFemaleTime FactorsAged

Summary

Bivalirudin (leech-derived) versus heparin systematic review across STEMI and NSTEMI populations.

Why This Matters for Hirudotherapy

This registry-based randomized controlled trial (VALIDATE-SWEDEHEART) compared bivalirudin versus heparin in 6,006 patients undergoing percutaneous coronary intervention for myocardial infarction, reporting outcomes at two years of follow-up. The study found no significant differences between the bivalirudin and heparin groups in the composite endpoint of death, myocardial infarction, or major bleeding at two years, with consistent results across STEMI and NSTEMI subgroups. The abstract does not describe bivalirudin's origin, structure, or any relationship to hirudin, leeches, or the leech secretome. The abstract makes no mention of leeches or hirudotherapy, so this study has no defensible relevance to ASH's domain.

Citation

Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction.

Omerovic et al. · Cardiovascular revascularization medicine, 2024

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

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