American Society of Hirudotherapy

Incidence, predictors, and outcomes associated with acute kidney injury in patients undergoing transcatheter aortic valve replacement: from the BRAVO-3 randomized trial

Randomized controlled trial published in Clinical research in cardiology : official journal of the German Cardiac Society (2021)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Randomized controlled trialClinical TrialsDrug DevelopmentSalivary PharmacologyChandrasekhar J et al. · Clinical research in cardiology : official journal of the German Cardiac Society, 2021

Abstract

BACKGROUND: Acute kidney injury (AKI) is not uncommon in patients undergoing transcatheter aortic valve replacement (TAVR). OBJECTIVE: We examined the incidence, predictors, and outcomes of AKI from the BRAVO 3 randomized trial. METHODS: The BRAVO-3 trial included 802 patients undergoing transfemoral TAVR randomized to bivalirudin vs. unfractionated heparin (UFH). The primary endpoint of the trial was Bleeding Academic Research Consortium (BARC) type ≥ 3b bleeding at 48 h. Total follow-up was to 30 days. AKI was adjudicated using the modified RIFLE (Valve Academic Research Consortium, VARC 1) criteria through 30-day follow-up, and in a sensitivity analysis AKI was assessed at 7 days (modified VARC-2 criteria). We examined the incidence, predictors, and 30-day outcomes associated with diagnosis of AKI. We also examined the effect of procedural anticoagulant (bivalirudin or unfractionated heparin, UFH) on AKI within 48 h after TAVR. RESULTS: The trial population had a mean age of 82.3 ± 6.5 years including 48.8% women with mean EuroScore I 17.05 ± 10.3%. AKI occurred in 17.0% during 30-day follow-up and was associated with greater adjusted risk of 30-day death (13.0% vs. 3.5%, OR 5.84, 95% CI 2.62-12.99) and a trend for more BARC ≥ 3b bleeding (15.1% vs. 8.6%, OR 1.80, 95% CI 0.99-3.25). Predictors of 30-day AKI were baseline hemoglobin, body weight, and pre-existing coronary disease. AKI occurred in 10.7% at 7 days and was associated with significantly greater risk of 30-day death (OR 6.99, 95% CI 2.85-17.15). Independent predictors of AKI within 7 days included pre-existing coronary or cerebrovascular disease, chronic kidney disease (CKD), and transfusion which increased risk, whereas post-dilation was protective. The incidence of 48-h AKI was higher with bivalirudin compared to UFH in the intention to treat cohort (10.9% vs. 6.5%, p = 0.03), but not in the per-protocol assessment (10.7% vs. 7.1%, p = 0.08). CONCLUSION: In the BRAVO 3 trial, AKI occurred in 17% at 30 days and in 10.7% at 7 days. AKI was associated with a significantly greater adjusted risk for 30-day death. Multivariate predictors of AKI at 30 days included baseline hemoglobin, body weight, and prior coronary artery disease, and predictors at 7 days included pre-existing vascular disease, CKD, transfusion, and valve post-dilation. Bivalirudin was associated with greater AKI within 48 h in the intention to treat but not in the per-protocol analysis.

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

Publication typeJournal ArticleRandomized Controlled Trial
Indexed MeSH termsAcute Kidney InjuryAgedAged, 80 and overAnticoagulantsAntithrombinsFemaleFollow-Up StudiesHemorrhageHeparinHirudinsHumansIncidence

Summary

Acute kidney injury (AKI) is not uncommon in patients undergoing transcatheter aortic valve replacement (TAVR).

Why This Matters for Hirudotherapy

This analysis from the randomized BRAVO-3 trial (802 patients undergoing transfemoral TAVR assigned to bivalirudin versus unfractionated heparin) examined acute kidney injury, reporting AKI in 17.0% by 30 days and 10.7% by 7 days, a strong association between AKI and 30-day death (e.g., OR 5.84, 95% CI 2.62-12.99), and predictors including baseline hemoglobin, body weight, and pre-existing coronary disease; notably, 48-hour AKI was higher with bivalirudin than heparin in the intention-to-treat cohort (10.9% vs 6.5%, p=0.03) but not per-protocol (10.7% vs 7.1%, p=0.08). For ASH this contributes to the clinical safety profile of bivalirudin, a synthetic hirudin analog and thus part of the medicinal-leech-derived direct thrombin inhibitor story. Caveat: this is a secondary (substudy) analysis of one randomized trial in an elderly TAVR population with a renal rather than primary efficacy endpoint, and the bivalirudin-AKI signal was statistically significant only in intention-to-treat, so it should be read as an association warranting further study, not proof of harm.

Citation

Incidence, predictors, and outcomes associated with acute kidney injury in patients undergoing transcatheter aortic valve replacement: from the BRAVO-3 randomized trial

Chandrasekhar J et al. · Clinical research in cardiology : official journal of the German Cardiac Society, 2021

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

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