Safety and efficacy of bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes with positive biomarkers undergoing percutaneous coronary intervention
Research article published in Coron Artery Dis (2020)
Abstract
OBJECTIVES: There are limited data on bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) with positive biomarkers of myocardial necrosis (troponin and/or creatine kinase-myocardial band isoenzyme). We sought to evaluate the safety and efficacy of bivalirudin monotherapy in patients with positive biomarkers from the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. PATIENTS AND METHODS: We compared the net adverse clinical events [composite ischemia - (death, myocardial infarction, or unplanned ischemic revascularization) - or noncoronary artery bypass graft surgery (CABG)-related major bleeding] among patients with biomarker-positive NSTE-ACS in the ACUITY trial overall and by antithrombotic strategy. RESULTS: Among 13 819 patients with NSTE-ACS enrolled in ACUITY, 4728 patients presented with positive biomarkers and underwent an early invasive strategy. Of those, 1547 were randomized to heparin plus a glycoprotein IIb/IIIa inhibitor (GPI), 1555 to bivalirudin plus GPI, and 1626 to bivalirudin monotherapy. Compared with biomarker-negative patients, biomarker-positive patients had higher 30-day rates of net adverse clinical events (14.0 vs. 12.4%; P = 0.04), all-cause death (1.3 vs. 0.5%; P = 0.001), cardiac death (1.1 vs. 0.5%; P = 0.005), and non-CABG-related major bleeding (6.5 vs. 5.2%, P = 0.03). At 30 days, bivalirudin monotherapy was associated with significantly less non-CABG-related major bleeding (bivalirudin monotherapy 4.1% vs. bivalirudin plus GPI 8.4% vs. heparin plus GPI 7.1%) with comparable rates of composite ischemia (bivalirudin monotherapy 9.2% vs. bivalirudin plus GPI 9.9% vs. heparin plus GPI 8.4%). In a multivariable model, bivalirudin monotherapy was associated with a significant reduction in non-CABG-related major bleeding but was not associated with an increased risk of death, myocardial infarction, unplanned revascularization or stent thrombosis. CONCLUSION: Compared with heparin plus GPI or bivalirudin plus GPI, bivalirudin monotherapy provides similar protection from ischemic events with less major bleeding at 30 days among patients with NSTE-ACS and positive biomarkers.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Resumen
ACUITY trial analysis of 4,728 biomarker-positive NSTE-ACS patients; bivalirudin monotherapy significantly reduced non-CABG major bleeding (4.1% vs 8.4%/7.1%) at 30 days.
Por qué esto importa para la hirudoterapia
Este análisis del ensayo ACUITY evaluó la monoterapia con bivalirudina frente a heparina más inhibidor de la glucoproteína IIb/IIIa (GPI) o bivalirudina más GPI en 4.728 pacientes con síndrome coronario agudo sin elevación del ST con biomarcadores positivos, que presentaban biomarcadores positivos y se sometían a una estrategia invasiva precoz. A los 30 días, la monoterapia con bivalirudina se asoció con una hemorragia mayor no relacionada con CABG significativamente menor (4,1 % frente a 8,4 % frente a 7,1 %), con tasas comparables de isquemia compuesta, y no se asoció con un aumento del riesgo de muerte, infarto de miocardio, revascularización no planificada ni trombosis del stent. El resumen no contiene ninguna mención a sanguijuelas, hirudoterapia ni sustancias derivadas de sanguijuelas, y no puede inferirse ninguna conexión defendible con el ámbito de la ASH a partir del resumen por sí solo. Se trata puramente de un ensayo cardiológico que compara estrategias antitrombóticas.
Citación
Safety and efficacy of bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes with positive biomarkers undergoing percutaneous coronary intervention.
Huang X et al. · Coron Artery Dis, 2020
Contexto clínico relacionado
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Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: 18 de junio de 2026