Cargando…

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

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7540270/
https://www.ncbi.nlm.nih.gov/pubmed/31808295
http://dx.doi.org/10.1002/ccd.28642
_version_ 1783591169458962432
author 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
author_facet 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
author_sort Zilberszac, Robert
collection PubMed
description 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.
format Online
Article
Text
id pubmed-7540270
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher John Wiley & Sons, Inc.
record_format MEDLINE/PubMed
spelling pubmed-75402702020-10-09 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 Catheter Cardiovasc Interv VALVULAR AND STRUCTURAL HEART DISEASES 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. John Wiley & Sons, Inc. 2019-12-05 2020-09-01 /pmc/articles/PMC7540270/ /pubmed/31808295 http://dx.doi.org/10.1002/ccd.28642 Text en © 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle VALVULAR AND STRUCTURAL HEART DISEASES
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
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic VALVULAR AND STRUCTURAL HEART DISEASES
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7540270/
https://www.ncbi.nlm.nih.gov/pubmed/31808295
http://dx.doi.org/10.1002/ccd.28642
work_keys_str_mv AT zilberszacrobert clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT chandiramanirishi clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT hengstenbergchristian clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT sartorisamantha clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT caodavide clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT chandrasekharjaya clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT schaferulrich clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT tchetchedidier clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT violiniroberto clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT jegerraban clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT vanbelleeric clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT boekstegerspeter clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT hambrechtrainer clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT tronchristophe clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT dumenteilnicolas clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT linkeaxel clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT tenbergjurrienm clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT deliargyrisefthymiosn clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT anthopoulosprodromos clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT mehranroxana clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial
AT dangasgeorge clinicaloutcomesaftertavrwithheparinorbivalirudinasperiproceduralanticoagulationinpatientswithandwithoutperipheralarterialdiseaseresultsfromthebravo3randomizedtrial