Sociedad Americana de Hirudoterapia

Bivalirudin versus heparin during PCI in NSTEMI: individual patient data meta-analysis of large randomized trials

IPD meta-analysis published in Circulation (2023)

Última actualización: 18 de junio de 2026Revisado por: ASH Editorial Board
Artículo de investigación — revisión de evidenciaReferencia del artículo
Evidence: Meta-analysisEnsayos clínicosDesarrollo de fármacosBikdeli B et al. · Circulation, 2023

Abstract

BACKGROUND: The benefit:risk profile of bivalirudin versus heparin anticoagulation in patients with non-ST-segment-elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) is uncertain. Study-level meta-analyses lack granularity to provide conclusive answers. We sought to compare the outcomes of bivalirudin and heparin in patients with non-ST-segment-elevation myocardial infarction undergoing PCI. METHODS: We performed an individual patient data meta-analysis of patients with non-ST-segment-elevation myocardial infarction in all 5 trials that randomized ≥1000 patients with any myocardial infarction undergoing PCI to bivalirudin versus heparin (MATRIX [Minimizing Adverse Hemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox], VALIDATE-SWEDEHEART [Bivalirudin Versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry Trial], ISAR-REACT 4 [Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 4], ACUITY [Acute Catheterization and Urgent Intervention Triage Strategy], and BRIGHT [Bivalirudin in Acute Myocardial Infarction vs Heparin and GPI Plus Heparin Trial]). The primary effectiveness and safety end points were 30-day all-cause mortality and serious bleeding. RESULTS: A total of 12 155 patients were randomized: 6040 to bivalirudin (52.3% with a post-PCI bivalirudin infusion), and 6115 to heparin (53.2% with planned glycoprotein IIb/IIIa inhibitor use). Thirty-day mortality was not significantly different between bivalirudin and heparin (1.2% versus 1.1%; adjusted odds ratio, 1.24 [95% CI, 0.86-1.79]; P=0.25). Cardiac mortality, reinfarction, and stent thrombosis rates were also not significantly different. Bivalirudin reduced serious bleeding (both access site-related and non-access site-related) compared with heparin (3.3% versus 5.5%; adjusted odds ratio, 0.59; 95% CI, 0.48-0.72; P<0.0001). Outcomes were consistent regardless of use of a post-PCI bivalirudin infusion or routine lycoprotein IIb/IIIa inhibitor use with heparin and during 1-year follow-up. CONCLUSIONS: In patients with non-ST-segment-elevation myocardial infarction undergoing PCI, procedural anticoagulation with bivalirudin and heparin did not result in significantly different rates of mortality or ischemic events, including stent thrombosis and reinfarction. Bivalirudin reduced serious bleeding compared with heparin arising both from the access site and nonaccess sites.

Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.

Publication typeMeta-AnalysisJournal ArticleResearch Support, Non-U.S. Gov't
Indexed MeSH termsHumansHeparinNon-ST Elevated Myocardial InfarctionAnticoagulantsPercutaneous Coronary InterventionRandomized Controlled Trials as TopicHirudinsPeptide FragmentsMyocardial InfarctionHemorrhageThrombosisRecombinant Proteins

Resumen

Individual patient-data meta-analysis of large bivalirudin-vs-heparin RCTs in NSTEMI PCI. Bivalirudin associated with reduced major bleeding without ischemic penalty.

Por qué esto importa para la hirudoterapia

Este metaanálisis de datos individuales de pacientes provenientes de 5 ensayos aleatorizados grandes (12.155 pacientes con infarto de miocardio sin elevación del segmento ST sometidos a ICP) comparó la bivalirudina con la heparina para la anticoagulación durante el procedimiento. La bivalirudina es un análogo peptídico sintético de la hirudina, el inhibidor directo de la trombina originalmente aislado de la saliva de la sanguijuela medicinal, lo que hace que estos hallazgos sean relevantes para comprender cómo se comporta un anticoagulante derivado del secretoma de la sanguijuela en la práctica moderna. El estudio no encontró diferencias significativas en la mortalidad a 30 días ni en los eventos isquémicos, pero la bivalirudina redujo el sangrado grave en comparación con la heparina (3,3 % frente a 5,5 %; odds ratio ajustada 0,59; P<0,0001). Una advertencia clave es que estos hallazgos corresponden a un análogo farmacéutico diseñado utilizado en cardiología intervencionista, no a la terapia con sanguijuelas ni a la hirudina nativa, y la ventaja en cuanto a sangrado debe sopesarse frente a desenlaces isquémicos similares.

Citación

Bivalirudin versus heparin during PCI in NSTEMI: individual patient data meta-analysis of large randomized trials.

Bikdeli B et al. · Circulation, 2023

DOI

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Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: 18 de junio de 2026

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