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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
Author(s) -
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
Publication year - 2020
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.28642
Subject(s) - bivalirudin , medicine , mace , myocardial infarction , cardiology , adverse effect , randomized controlled trial , heparin , coronary artery disease , valve replacement , surgery , percutaneous coronary intervention , stenosis
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.