Impact of coronary artery disease on clinical outcomes after TAVR: Insights from the BRAVO-3 randomized trial
Randomized controlled trial published in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (2023)
Abstract
OBJECTIVE: To determine the prognostic impact of coronary artery disease (CAD) in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR). BACKGROUND: CAD is a common comorbidity among patients undergoing TAVR and studies provide conflicting data on its prognostic impact. METHODS: The Bivalirudin on Aortic Valve Intervention Outcomes-3 (BRAVO-3) randomized trial compared the use of bivalirudin versus UFH in 802 high-surgical risk patients undergoing transfemoral TAVR for severe symptomatic aortic stenosis. Patients were stratified according to the presence or absence of history of CAD as well as periprocedural anticoagulation. The coprimary endpoints were net adverse cardiac events (NACE; a composite of all-cause mortality, myocardial infarction, stroke, or major bleeding) and major Bleeding Academic Research Consortium (BARC) bleeding ≥3b at 30 days postprocedure. RESULTS: Among 801 patients, 437 (54.6%) had history of CAD of whom 223 (51.0%) received bivalirudin. There were no significant differences in NACE (adjusted odds ratio [OR]: 1.04; 95% confidence interval [CI]: 0.69-1.58) or BARC ≥ 3b bleeding (adjusted OR: 0.84; 95% CI: 0.51-1.39) in patients with vs without CAD at 30 days. Among CAD patients, periprocedural use of bivalirudin was associated with similar NACE (OR: 0.80; 95% CI: 0.47-1.35) and BARC ≥ 3b bleeding (OR: 0.64; 95% CI: 0.33-1.25) compared with UFH, irrespective of history of CAD (p-interaction = 0.959 for NACE; p-interaction = 0.479 for major bleeding). CONCLUSION: CAD was not associated with a higher short-term risk of NACE or major bleeding after TAVR. Periprocedural anticoagulation with bivalirudin did not show any advantage over UFH in patients with and without CAD.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Resumen
To determine the prognostic impact of coronary artery disease (CAD) in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR).
Por qué esto importa para la hirudoterapia
Este análisis del ensayo aleatorizado BRAVO-3 (801 pacientes sometidos a TAVR transfemoral) examinó si la enfermedad arterial coronaria (EAC) afectaba los desenlaces a 30 días y si la bivalirudina periprocedimiento frente a la heparina no fraccionada difería según el estado de EAC, sin encontrar diferencias significativas en los eventos cardíacos adversos netos ni en la hemorragia mayor. Para ASH, esto es relevante porque la bivalirudina es un inhibidor directo de la trombina derivado de la hirudina, el anticoagante presente en la saliva de la sanguijuela medicinal, por lo que los datos de desenlaces comparativos sobre un terapéutico derivado de la sanguijuela ayudan a caracterizar la huella traslacional del secretoma de la sanguijuela en la anticoagulación procedimental moderna. Un matiz honesto: el ensayo no fue diseñado para detectar interacciones entre la EAC y el tratamiento, y estos hallazgos se refieren a un análogo farmacéutico de la hirudina en un contexto procedimental específico —no a la terapia con sanguijuelas en sí, ni constituyen una prueba de eficacia diferencial entre anticoagulantes derivados de la sanguijuela y convencionales.
Citación
Impact of coronary artery disease on clinical outcomes after TAVR: Insights from the BRAVO-3 randomized trial
Feldman D et al. · Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2023
Contexto clínico relacionado
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Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: 18 de junio de 2026