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
Randomized trial subanalysis published in Catheterization and Cardiovascular Interventions (2019)
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.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Zusammenfassung
BRAVO-3 subanalysis comparing bivalirudin vs UFH for TAVR anticoagulation in patients with vs without peripheral arterial disease. PAD patients have more vascular complications regardless of anticoagulation choice.
Warum dies für die Hirudotherapie relevant ist
Diese randomisierte Multizenterstudie (BRAVO-3, n=802) verglich Bivalirudin mit unfraktioniertem Heparin als periprozedurale Antikoagulation während des transfemoralen Transkatheter-Aortenklappenersatzes und analysierte die Ergebnisse bei Patienten mit und ohne periphere arterielle Verschlusskrankheit (PAVK). Die Zusammenfassung berichtet keine signifikanten Unterschiede zwischen Bivalirudin und Heparin hinsichtlich Mortalität, schwerer unerwünschter kardiovaskulärer Ereignisse, schwerer Blutungen oder zerebrovaskulärer Ereignisse bei Patienten mit oder ohne PAVK, wobei Bivalirudin jedoch bei PAVK-Patienten mit höheren Raten minorer vaskulärer Komplikationen assoziiert war. Die Zusammenfassung erwähnt weder Blutegel, Hirudin, Blutegelspeichel noch eine aus Blutegeln stammende Herkunft von Bivalirudin und beschreibt die Studie nicht als Sekundäranalyse. Aus der Zusammenfassung lässt sich keine vertretbare Relevanz für die Hirudotherapie ableiten.
Zitation
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 R et al. · Catheterization and cardiovascular interventions, 2019
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