Impact of anemia on short-term outcomes after TAVR: A subgroup analysis from the BRAVO-3 randomized trial
Razuk, Victor; Camaj, Anton; Cao, Davide; Nicolas, Johny; Hengstenberg, Christian; Sartori, Samantha; Zhang, Zhongjie; Power, David; Beerkens, Frans; Chiarito, Mauro; Meneveau, Nicolas; Tron, Christophe; Dumonteil, Nicolas; Widder, Julian D.; Ferrari, Markus; Violini, Roberto; Stella, Pieter R.; Jeger, Raban; Anthopoulos, Prodromos; Mehran, Roxana; Dangas, George D.
(2021) Catheterization and Cardiovascular Interventions, volume 98, issue 6, pp. E870 - E880
(Article)
Abstract
OBJECTIVES: To determine the prognostic impact of anemia in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR). BACKGROUND: Whether the periprocedural use of bivalirudin as compared with UFH in anemic patients undergoing TAVR has an impact on outcomes remains unknown. METHODS: The BRAVO-3 trial
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compared the use of bivalirudin versus UFH in 802 high risk patients undergoing transfemoral TAVR for severe symptomatic aortic stenosis. Patients were stratified according to the presence (defined as hemoglobin levels <13 g/dl in men and <12 g/dl in women) or absence of anemia. The primary outcomes were net adverse cardiac events (NACE; a composite of all-cause mortality, myocardial infarction, stroke, or bleeding) and major bleeding (Bleeding Academic Research Consortium ≥3b) at 30 days. RESULTS: Among 798 patients with available baseline hemoglobin levels, 427 (54%) were anemic of whom 221 (52%) received bivalirudin. There were no significant differences in NACE and major bleeding at 30 days between patients with and without anemia, irrespective of the type of anticoagulant used (p interaction = 0.71 for NACE, p interaction = 1.0 for major bleeding). However, anemic patients had a higher risk of major vascular complications (adjusted OR 2.43, 95% CI 1.42-4.16, p = 0.001), and acute kidney injury (adjusted OR 1.74, 95% CI 1.16-2.59, p = 0.007) compared to non-anemic patients at 30 days. CONCLUSIONS: Anemia was not associated with a higher risk of NACE or major bleeding at 30 days after TAVR without modification of the treatment effects of periprocedural anticoagulation with bivalirudin versus UFH.
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Keywords: anemia, bivalirudin, heparin, TAVI, TAVR, Radiology Nuclear Medicine and imaging, Cardiology and Cardiovascular Medicine, Journal Article
ISSN: 1522-1946
Publisher: Wiley-Liss Inc.
Note: Funding Information: George D. Dangas has received consulting fees from GE HealthCare, Janssen Pharmaceuticals, Inc. and Medtronic, Inc.; has <1% equity with Claret Medical and Elixir Medical; has delivered industry sponsored lectures for The Medicines Company; and is on the scientific advisory board for AstraZeneca. Roxana Mehran has received institutional research funding from AstraZeneca, Bayer, Beth Israel Deaconess, Bristol‐Myers Squibb/Sanofi, CSL Behring, Eli Lilly/Daiichi Sankyo, Medtronic, Novartis and OrbusNeich; is a consultant to Boston Scientific, Abbott Vascular, Medscape, Siemens Medical Solutions, Regeneron Pharmaceuticals Inc. (no fees), Roivant Sciences Inc, and Sanofi; is an institution consultant (payment to institution) with Abbott Vascular and Spectranetics/Phillips/Volcano Corporation; is on executive committee for Janssen Pharmaceuticals and BMS; receives institutional (payment to institution) advisory board funding from Bristol Myers Squibb and Novartis; has received DSMB membership funding (payment to institution) from Watermark Research; and, has <1% equity with Claret Medical and Elixir Medical. Prodromos Anthopoulos is a former employee of The Medicines Company, currently Head of Medical, Europe for Arena Pharmaceuticals. Julian D. Widder is a consultant and proctor for Medtronic and New Valve Technology, Hechingen. Christian Hengstenberg has received proctoring fees from Boston Scientific and Edwards. Raban Jeger has received speaker honoraria and research support from B. Braun and speaker honoraria from Cardionovum and Nipro. Nicolas Meneveau reports grants and personal fees from Bayer Healthcare, grants and personal fees from BMS Pfizer, personal fees from ASTRA ZENECA, personal fees from TERUMO, grants and personal fees from Abbott, outside the submitted work. All other authors report no disclosures relevant to the present article. Publisher Copyright: © 2021 Wiley Periodicals LLC.
(Peer reviewed)