1. 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.
- Author
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Zilberszac R, Chandiramani R, Hengstenberg C, Sartori S, Cao D, Chandrasekhar J, Schafer U, Tchetche D, Violini R, Jeger R, Van Belle E, Boekstegers P, Hambrecht R, Tron C, Dumenteil N, Linke A, Ten Berg JM, Deliargyris EN, Anthopoulos P, Mehran R, and Dangas G
- Subjects
- Aged, Aged, 80 and over, Anticoagulants adverse effects, Antithrombins adverse effects, Aortic Valve Stenosis complications, Aortic Valve Stenosis diagnosis, Aortic Valve Stenosis mortality, Cerebrovascular Disorders etiology, Cerebrovascular Disorders mortality, Europe, Female, Hemorrhage chemically induced, Hemorrhage mortality, Heparin adverse effects, Hirudins adverse effects, Hospital Mortality, Humans, Male, Myocardial Infarction etiology, Myocardial Infarction mortality, North America, Peptide Fragments adverse effects, Peripheral Arterial Disease diagnosis, Peripheral Arterial Disease mortality, Punctures, Randomized Controlled Trials as Topic, Recombinant Proteins adverse effects, Recombinant Proteins therapeutic use, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Anticoagulants therapeutic use, Antithrombins therapeutic use, Aortic Valve Stenosis surgery, Catheterization, Peripheral adverse effects, Catheterization, Peripheral mortality, Femoral Artery, Heparin therapeutic use, Peptide Fragments therapeutic use, Peripheral Arterial Disease complications, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement mortality
- Abstract
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., (© 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.)
- Published
- 2020
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