Impact of diabetes mellitus on short term vascular complications after TAVR: Results from the BRAVO-3 randomized trial
Randomized controlled trial published in International journal of cardiology (2019)
Abstract
AIMS: The impact of diabetes mellitus (DM) on clinical outcomes after transcatheter aortic valve replacement (TAVR) remains unclear. The aim of this study was to investigate the impact of DM on short-term clinical outcomes after TAVR in a large randomized trial population. METHODS AND RESULTS: BRAVO-3 trial randomized 802 patients undergoing trans-femoral TAVR to procedural anticoagulation with bivalirudin or unfractionated heparin. The study population was divided according to the presence of DM, and further stratified according to the use of insulin. Net adverse cardiovascular outcomes (NACE - death, myocardial infarction (MI), stroke or major bleeding by Bleeding Academic Research Consortium (BARC) type 3b or above) was the primary outcome in-hospital and at 30-days. Of the total 802 randomized patients, 239 (30%) had DM at baseline, with 87 (36%) being treated with insulin. At 30-days, DM patients experienced numerically higher rates of net adverse cardiovascular events (16.3% vs. 14.4%, p=0.48) and acute kidney injury (19.7% vs. 15.1%, p=0.11), while non-DM (NDM) patients had numerically higher rates of cerebrovascular accidents (3.6% vs. 1.7%, p=0.22). After multivariable adjustment, DM patients had higher odds of vascular complications at 30-days (OR 1.57, p=0.03) and life-threatening bleeding both in-hospital (OR 1.50, p=0.046) and at 30-days (OR 1.50, p=0.03) with the excess overall risk primarily attributed to the higher rates observed among non-insulin dependent DM patients. CONCLUSIONS: Patients with DM had higher adjusted odds of vascular and bleeding complications up to 30-days post-TAVR. Overall, there was no significant association between DM and early mortality following TAVR.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Resumen
The impact of diabetes mellitus (DM) on clinical outcomes after transcatheter aortic valve replacement (TAVR) remains unclear.
Por qué esto importa para la hirudoterapia
Utilizando la población del ensayo aleatorizado BRAVO-3, este estudio investigó el impacto de la diabetes mellitus en los desenlaces clínicos a corto plazo tras el reemplazo valvular aórtico transcatéter (TAVR). El ensayo aleatorizó originalmente a los pacientes a anticoagulación procedural con bivalirudina o heparina no fraccionada, pero este análisis secundario se centra en predecir complicaciones en pacientes diabéticos. Su relevancia para la hirudoterapia es totalmente indirecta, ya que la bivalirudina fue uno de los anticoagulantes procedimentales utilizados, pero el resumen no describe su origen farmacológico ni su relación con compuestos derivados de la sanguijuela. El estudio no evalúa sanguijuelas, extractos de sanguijuela ni la eficacia específica de la bivalirudina en sí. Por lo tanto, no ofrece evidencia directa para el dominio de la ASH.
Citación
Impact of diabetes mellitus on short term vascular complications after TAVR: Results from the BRAVO-3 randomized trial
Goel R et al. · International journal of cardiology, 2019
Contexto clínico relacionado
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Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: 18 de junio de 2026