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.
Catheter Cardiovasc Interv
; 96(3): E377-E386, 2020 09 01.
Article
en En
| MEDLINE
| ID: mdl-31808295
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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Estenosis de la Válvula Aórtica
/
Fragmentos de Péptidos
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Cateterismo Periférico
/
Heparina
/
Antitrombinas
/
Arteria Femoral
/
Enfermedad Arterial Periférica
/
Reemplazo de la Válvula Aórtica Transcatéter
/
Anticoagulantes
Tipo de estudio:
Diagnostic_studies
/
Etiology_studies
/
Observational_studies
/
Risk_factors_studies
Límite:
Aged80
País/Región como asunto:
America do norte
/
Europa
Idioma:
En
Revista:
Catheter Cardiovasc Interv
Asunto de la revista:
CARDIOLOGIA
Año:
2020
Tipo del documento:
Article
País de afiliación:
Austria