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.
Aged
Aged, 80 and over
Anticoagulants
/ adverse effects
Antithrombins
/ adverse effects
Aortic Valve Stenosis
/ complications
Catheterization, Peripheral
/ adverse effects
Cerebrovascular Disorders
/ etiology
Europe
Female
Femoral Artery
Hemorrhage
/ chemically induced
Heparin
/ adverse effects
Hirudins
/ adverse effects
Hospital Mortality
Humans
Male
Myocardial Infarction
/ etiology
North America
Peptide Fragments
/ adverse effects
Peripheral Arterial Disease
/ complications
Punctures
Randomized Controlled Trials as Topic
Recombinant Proteins
/ adverse effects
Retrospective Studies
Risk Assessment
Risk Factors
Time Factors
Transcatheter Aortic Valve Replacement
/ adverse effects
Treatment Outcome
TAVR
bivalirudin
heparin
peripheral artery disease
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
01 09 2020
01 09 2020
Historique:
received:
28
06
2019
revised:
18
09
2019
accepted:
21
11
2019
pubmed:
7
12
2019
medline:
7
4
2021
entrez:
7
12
2019
Statut:
ppublish
Résumé
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). 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. 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. 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 31808295
doi: 10.1002/ccd.28642
pmc: PMC7540270
doi:
Substances chimiques
Anticoagulants
0
Antithrombins
0
Hirudins
0
Peptide Fragments
0
Recombinant Proteins
0
Heparin
9005-49-6
bivalirudin
TN9BEX005G
Types de publication
Comparative Study
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
E377-E386Informations de copyright
© 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.
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