American Society of Hirudotherapy

Bivalirudin versus heparin for percutaneous coronary intervention: an updated meta-analysis of randomized controlled trials

Meta-analysis published in Cardiovascular revascularization medicine : including molecular interventions (2014)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Meta-analysisDrug DevelopmentLipinski MJ et al. · Cardiovascular revascularization medicine : including molecular interventions, 2014

Abstract

AIMS: Given controversy over anticoagulation regimens for percutaneous coronary intervention (PCI), we performed an updated meta-analysis of randomized controlled trials (RCTs) to compare bivalirudin versus heparin. METHODS AND RESULTS: Medline/Pubmed and Cochrane CENTRAL were searched for all RCTs comparing bivalirudin with provisional glycoprotein IIb/IIIa inhibitor (GPI) use versus heparin with provisional or routine GPI use for PCI. Pooled estimates of 30day outcomes, presented as risk ratios (RR) [95% confidence intervals], were generated with random-effect models. Our analysis included 14 studies with 30,446 patients that were randomized to bivalirudin with provisional GPI use (n=14,869) versus heparin with provisional (n=6451) or routine GPI use (n=9126). There was no significant difference between anticoagulation with bivalirudin compared with heparin for death (RR 0.95 [0.78-1.14]) or myocardial infarction (RR 1.10 [0.97-1.25]). Early stent thrombosis was significantly greater with bivalirudin compared with heparin (RR 1.61 [1.18-2.20], p=0.003), especially in patients undergoing primary PCI (2.15 [1.15-4.03], p=0.02). However, bivalirudin reduced the risk of major bleeding (RR 0.59 [0.51-0.70], p<0.0001) and TIMI major bleeding (RR 0.59 [0.48-0.72], p<0.0001) compared with heparin. Meta-regression analysis demonstrated that bleeding risk with use of heparin significantly increases with increasing GPI use (p=0.02). CONCLUSION: Meta-analysis of 14 RCTs with 30,446 patients demonstrated that bivalirudin is associated with higher risk of stent thrombosis but lower risk of major bleeding compared with heparin.

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

Publication typeComparative StudyJournal ArticleMeta-Analysis
Indexed MeSH termsAngioplasty, Balloon, CoronaryAnticoagulantsAntithrombinsHemorrhageHeparinHirudinsHumansMyocardial InfarctionOdds RatioPeptide FragmentsPercutaneous Coronary InterventionPlatelet Aggregation InhibitorsPlatelet Glycoprotein GPIIb-IIIa ComplexRandomized Controlled Trials as TopicRecombinant ProteinsTreatment Outcome

Summary

In a meta-analysis of 14 randomized trials (30,446 patients), bivalirudin versus heparin for PCI showed no difference in death or myocardial infarction, higher early stent thrombosis risk, and reduced major bleeding.

Why This Matters for Hirudotherapy

This meta-analysis of 14 randomized controlled trials (30,446 patients) compared bivalirudin with provisional glycoprotein IIb/IIIa inhibitor use versus heparin with provisional or routine GPI use for percutaneous coronary intervention. Pooled 30-day outcomes showed no significant difference in death or myocardial infarction between groups, but bivalirudin was associated with higher early stent thrombosis (especially in primary PCI) and lower major and TIMI major bleeding compared with heparin. 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)

Lipinski MJ, Lhermusier T, Escarcega RO, Baker NC, Magalhães MA, Torguson R, et al. Bivalirudin versus heparin for percutaneous coronary intervention: an updated meta-analysis of randomized controlled trials. Cardiovasc Revasc Med. 2014;15(6-7):315-322. doi:10.1016/j.carrev.2014.08.010. PMID: 25440505

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

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