Meta-analysis comparing bivalirudin versus heparin monotherapy on ischemic and bleeding outcomes after percutaneous coronary intervention.
Review published in The American journal of cardiology (2012)
Abstract
With femoral access, bivalirudin decreases risks of major bleeding after percutaneous coronary intervention (PCI) and provides better net clinical benefit compared to unfractionated heparin (UFH) plus planned glycoprotein IIb/IIIa inhibitors. Whether this benefit exists compared to UFH monotherapy is less clear. We performed a systematic review and meta-analysis to compare outcomes in patients undergoing transfemoral PCI with UFH or bivalirudin. Randomized trials (n = 3) and observational studies (n = 13) comparing bivalirudin to UFH monotherapy were reviewed. Primary outcomes were 30-day rates of major adverse cardiovascular events (MACEs) including death, myocardial infarction (MI), urgent revascularization, as well as all-cause mortality, MI, major bleeding, and blood transfusion. We collected data from 16 studies involving 32,492 patients undergoing PCI. Most observational studies were performed in the United States, whereas all randomized trials were done in Europe. Compared to UFH monotherapy, bivalirudin was associated with similar risk of MACEs (odds ratios [OR] 0.92, 95% confidence interval [CI] 0.75 to 1.12), a substantial 45% relative decrease in major bleeding (OR 0.55, 95% CI 0.43 to 0.72), and a trend in the decrease of transfusion (OR 0.87, 95% CI 0.70 to 1.08). A decrease in mortality was seen in observational studies (OR 0.62, 95% CI 0.45 to 0.85) but remained inconclusive in randomized trials (OR 0.63, 95% CI 0.20 to 2.01). MI rate was similar with the 2 anticoagulants. In conclusion, in patients undergoing transfemoral PCI, the benefit of bivalirudin over UFH monotherapy is driven by a significant decrease in major bleeding with similar rates of MACE. As PCI practice moves toward other bleeding-avoidance strategies such as the radial approach, future studies should focus on the interaction between anticoagulant strategy and access-site choice.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Resumen
With femoral access, bivalirudin decreases risks of major bleeding after percutaneous coronary intervention (PCI) and provides better net clinical benefit compared to unfractionated heparin (UFH) plus planned glycoprotein IIb/IIIa inhibitors. Whether this benefit exists compared to UFH monotherapy is less clear.
Por qué esto importa para la hirudoterapia
Este metaanálisis de 16 estudios (3 aleatorizados, 13 observacionales; 32.492 pacientes) comparó la bivalirudina con la heparina no fraccionada en monoterapia durante la intervención coronaria percutánea transfemoral, reportando MACE a 30 días similares, pero una reducción relativa sustancial del 45% en hemorragia mayor con bivalirudina. La bivalirudina es un inhibidor directo sintético de la trombina modelado a partir de la hirudina, el anticoagulante característico del secretoma de la sanguijuela medicinal, por lo que este extenso cuerpo de evidencia ilustra directamente cómo un concepto farmacológico derivado de la sanguijuela se comporta a escala en la cardiología intervencionista moderna. La señal de ahorro de hemorragia—sin compromiso isquémico aparente—ayuda a explicar por qué la anticoagulación basada en hirudina ha permanecido influyente mucho más allá de la terapia con sanguijuelas vivas. Una advertencia honesta es que la mayoría de los datos contribuyentes son observacionales y de origen estadounidense, la reducción de mortalidad fue no concluyente en los ensayos aleatorizados (OR 0,63; IC 95% 0,20–2,01), y los autores advierten que la ventaja podría atenuarse a medida que el acceso radial y otras estrategias de evitación de hemorragia desplacen a la ICP femoral.
Citación
Meta-analysis comparing bivalirudin versus heparin monotherapy on ischemic and bleeding outcomes after percutaneous coronary intervention.
Bertrand et al. · The American journal of cardiology, 2012
Contexto clínico relacionado
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Añadido a la biblioteca ASH: May 28, 2026 · Última actualización del sitio: 18 de junio de 2026