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)
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.
Zusammenfassung
Acute kidney injury (AKI) is not uncommon in patients undergoing transcatheter aortic valve replacement (TAVR).
Warum dies für die Hirudotherapie relevant ist
Diese Analyse der randomisierten BRAVO-3-Studie (802 Patienten, die sich einer transfemoralen TAVR unterzogen und bivalirudin gegenüber unfraktioniertem heparin zugeteilt wurden) untersuchte die akute Nierenschädigung und berichtete über eine AKI bei 17,0% nach 30 Tagen und bei 10,7% nach 7 Tagen, über eine starke Assoziation zwischen AKI und 30-Tage-Sterblichkeit (z. B. OR 5,84, 95% CI 2,62–12,99) sowie über Prädiktoren einschließlich Ausgangshämoglobin, Körpergewicht und vorbestehender koronarer Erkrankung; bemerkenswert war, dass die 48-Stunden-AKI unter bivalirudin höher war als unter heparin in der Intention-to-treat-Kohorte (10,9% gegenüber 6,5%, p=0,03), jedoch nicht in der Per-Protocol-Kohorte (10,7% gegenüber 7,1%, p=0,08). Für ASH trägt dies zum klinischen Sicherheitsprofil von bivalirudin bei, einem synthetischen hirudin-Analogon und somit Teil der Geschichte der von der Medizinegel abgeleiteten direkten Thrombininhibitoren. Vorbehalt: Dies ist eine sekundäre (Substudien-)Analyse einer einzigen randomisierten Studie in einer älteren TAVR-Population mit einem renalen und nicht primären Wirksamkeitsendpunkt, und das bivalirudin-AKI-Signal war nur in der Intention-to-treat-Analyse statistisch signifikant, sodass es als eine weiterer Untersuchung bedürftige Assoziation und nicht als Beweis für einen Schaden zu lesen ist.
Zitation
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
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