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Clinical outcomes after TAVR with heparin or bivalirudin as periprocedural anticoagulation in patients with and without peripheral arterial disease: results from the BRAVO-3 randomized trial

Randomized trial subanalysis published in Catheterization and Cardiovascular Interventions (2019)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Observational studyClinical TrialsDrug DevelopmentZilberszac R et al. · Catheterization and cardiovascular interventions, 2019

Abstract

OBJECTIVES: This study sought to investigate the clinical outcomes of patients with and without peripheral artery disease (PAD) in the BRAVO-3 trial with respect to the effect of bivalirudin versus unfractionated heparin (UFH). BACKGROUND: PAD is found frequently in patients undergoing transcatheter aortic valve replacement (TAVR) and is reported to confer an increased risk of adverse events. It is unknown whether patients with and without PAD may demonstrate a differential response to bivalirudin versus UFH. METHODS: BRAVO-3 was a randomized multicenter trial comparing transfemoral TAVR with bivalirudin versus UFH (31 centers, n = 802). Major adverse cardiovascular events (MACE) were a composite of 30-day death, myocardial infarction, or cerebrovascular accidents (CVA). Net adverse cardiovascular events (NACE) were a composite of major bleeding or MACE. RESULTS: The total cohort included 119 patients with PAD. Vascular complications occurred significantly more frequently in patients with PAD both in-hospital (25.2 vs. 16.7%; OR 1.68) and at 30 days (29.4 vs. 17.3%; OR 1.99). No significant differences were observed regarding mortality, NACE, MACE, major bleeding or CVA with bivalirudin versus UFH among patients with or without PAD. In patients with PAD, bivalirudin was associated with an increased risk of minor vascular complications at 30 days. CONCLUSIONS: Patients with PAD undergoing transfemoral TAVR did not exhibit an increased risk of any major adverse events, according to the procedural anticoagulant randomization. However, patients treated with Bivalirudin had significantly higher rates of minor vascular complications.

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

Publication typeComparative StudyJournal ArticleMulticenter Study
Indexed MeSH termsAgedAged, 80 and overAnticoagulantsAntithrombinsAortic Valve StenosisCatheterization, PeripheralCerebrovascular DisordersEuropeFemaleFemoral ArteryHemorrhageHeparin

Summary

BRAVO-3 subanalysis comparing bivalirudin vs UFH for TAVR anticoagulation in patients with vs without peripheral arterial disease. PAD patients have more vascular complications regardless of anticoagulation choice.

Why This Matters for Hirudotherapy

This randomized multicenter trial (BRAVO-3, n=802) compared bivalirudin versus unfractionated heparin as periprocedural anticoagulation during transfemoral transcatheter aortic valve replacement, analyzing outcomes in patients with and without peripheral artery disease. The abstract reports no significant differences in mortality, major adverse cardiovascular events, major bleeding, or cerebrovascular accidents between bivalirudin and heparin among patients with or without PAD, though bivalirudin was associated with higher rates of minor vascular complications in PAD patients. The abstract does not mention leeches, hirudin, leech saliva, or any leech-derived origin for bivalirudin, and does not describe the study as a secondary analysis. No defensible hirudotherapy relevance can be drawn from the abstract.

Citation

Clinical outcomes after TAVR with heparin or bivalirudin as periprocedural anticoagulation in patients with and without peripheral arterial disease: results from the BRAVO-3 randomized trial.

Zilberszac R et al. · Catheterization and cardiovascular interventions, 2019

DOI

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

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