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

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 -