American Society of Hirudotherapy

Bivalirudin Versus Heparin Monotherapy in Elderly Patients With Myocardial Infarction: A Prespecified Subgroup Analysis of the VALIDATE-SWEDEHEART Trial

Prespecified subgroup analysis of a randomized controlled trial published in Circ Cardiovasc Interv (2020)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Randomized controlled trialDrug DevelopmentClinical LiteratureWester A et al. · Circ Cardiovasc Interv, 2020

Abstract

BACKGROUND: Elderly patients with acute myocardial infarction undergoing percutaneous coronary intervention are at increased risk of both ischemic and bleeding complications. The optimal anticoagulation strategy in these patients is uncertain. Therefore, we compared bivalirudin to heparin monotherapy in a contemporary cohort of such patients. METHODS: A prespecified subgroup analysis of elderly patients with myocardial infarction (≥75 years) from the VALIDATE-SWEDEHEART trial (Bivalirudin Versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry Trial) was performed. In the trial, patients were randomized to either bivalirudin or heparin monotherapy during percutaneous coronary intervention, with mandatory potent P2Y12 inhibition, routine radial artery access, and only bail-out glycoprotein IIb/IIIa inhibition. Kaplan-Meier event rates were assessed for the primary end point, consisting of a composite of all-cause death, myocardial reinfarction, or major bleeding, within 180 days. RESULTS: The elderly (n=1592) had more than twice the risk of all events compared with younger patients (n=4406). Baseline and periprocedural characteristics were equal between bivalirudin (n=799) and heparin (n=793) treated patients ≥75 years. No differences were found in the elderly between bivalirudin and heparin monotherapy regarding the primary end point (180-day all-cause death, myocardial reinfarction, or major bleeding), the individual components of the primary end point, definite stent thrombosis, or stroke. CONCLUSIONS: In this prespecified subgroup analysis of the VALIDATE-SWEDEHEART trial, elderly patients with myocardial infarction had a highly increased risk of all events. However, no difference in outcomes could be observed with an anticoagulation strategy with either bivalirudin or heparin as monotherapy in this patient group.

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

Publication typeComparative StudyJournal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov't
Indexed MeSH termsAge FactorsAgedAged, 80 and overAnticoagulantsAntithrombinsCoronary ThrombosisFemaleHemorrhageHeparinHirudinsHumansMaleNon-ST Elevated Myocardial InfarctionPeptide FragmentsPercutaneous Coronary InterventionPlatelet Aggregation InhibitorsPurinergic P2Y Receptor AntagonistsRecombinant ProteinsRecurrenceRegistriesRisk AssessmentRisk FactorsST Elevation Myocardial InfarctionStrokeSwedenTime FactorsTreatment Outcome

Summary

In a prespecified VALIDATE-SWEDEHEART subgroup analysis of elderly myocardial infarction patients (n=1592, age ≥75), who had more than twice the event risk of younger patients, bivalirudin and heparin monotherapy showed no differences in 180-day all-cause death, reinfarction, or major bleeding.

Why This Matters for Hirudotherapy

This prespecified subgroup analysis of the VALIDATE-SWEDEHEART trial compared bivalirudin to heparin monotherapy in 1,592 elderly (≥75 years) myocardial infarction patients undergoing percutaneous coronary intervention, finding no differences in the composite primary endpoint of all-cause death, myocardial reinfarction, or major bleeding at 180 days, nor in any individual components including definite stent thrombosis or stroke. The elderly had more than twice the risk of all events compared with younger patients, but no difference in outcomes was observed between the two anticoagulation strategies. This is a cardiology trial comparing anticoagulant monotherapies. 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)

Wester A, Attar R, Mohammad MA, Isma N, James S, Omerovic E, et al. Bivalirudin Versus Heparin Monotherapy in Elderly Patients With Myocardial Infarction: A Prespecified Subgroup Analysis of the VALIDATE-SWEDEHEART Trial. Circ Cardiovasc Interv. 2020;13(4):e008671. doi:10.1161/CIRCINTERVENTIONS.119.008671. PMID: 32216471

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

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.