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
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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. / Zilberszac, Robert; Chandiramani, Rishi; Hengstenberg, Christian; Sartori, Samantha; Cao, Davide; Chandrasekhar, Jaya; Schafer, Ulrich; Tchetche, Didier; Violini, Roberto; Jeger, Raban; Van Belle, Eric; Boekstegers, Peter; Hambrecht, Rainer; Tron, Christophe; Dumenteil, Nicolas; Linke, Axel; Ten Berg, Jurriën M; Deliargyris, Efthymios N; Anthopoulos, Prodromos; Mehran, Roxana; Dangas, George.
in: CATHETER CARDIO INTE, Jahrgang 96, Nr. 3, 01.09.2020, S. E377-E386.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - 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
AU - Zilberszac, Robert
AU - Chandiramani, Rishi
AU - Hengstenberg, Christian
AU - Sartori, Samantha
AU - Cao, Davide
AU - Chandrasekhar, Jaya
AU - Schafer, Ulrich
AU - Tchetche, Didier
AU - Violini, Roberto
AU - Jeger, Raban
AU - Van Belle, Eric
AU - Boekstegers, Peter
AU - Hambrecht, Rainer
AU - Tron, Christophe
AU - Dumenteil, Nicolas
AU - Linke, Axel
AU - Ten Berg, Jurriën M
AU - Deliargyris, Efthymios N
AU - Anthopoulos, Prodromos
AU - Mehran, Roxana
AU - Dangas, George
N1 - © 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.
PY - 2020/9/1
Y1 - 2020/9/1
N2 - 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.
AB - 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.
KW - Aged
KW - Aged, 80 and over
KW - Anticoagulants/adverse effects
KW - Antithrombins/adverse effects
KW - Aortic Valve Stenosis/complications
KW - Catheterization, Peripheral/adverse effects
KW - Cerebrovascular Disorders/etiology
KW - Europe
KW - Female
KW - Femoral Artery
KW - Hemorrhage/chemically induced
KW - Heparin/adverse effects
KW - Hirudins/adverse effects
KW - Hospital Mortality
KW - Humans
KW - Male
KW - Myocardial Infarction/etiology
KW - North America
KW - Peptide Fragments/adverse effects
KW - Peripheral Arterial Disease/complications
KW - Punctures
KW - Randomized Controlled Trials as Topic
KW - Recombinant Proteins/adverse effects
KW - Retrospective Studies
KW - Risk Assessment
KW - Risk Factors
KW - Time Factors
KW - Transcatheter Aortic Valve Replacement/adverse effects
KW - Treatment Outcome
U2 - 10.1002/ccd.28642
DO - 10.1002/ccd.28642
M3 - SCORING: Journal article
C2 - 31808295
VL - 96
SP - E377-E386
JO - CATHETER CARDIO INTE
JF - CATHETER CARDIO INTE
SN - 1522-1946
IS - 3
ER -