Individual Patient Data Pooled Analysis of Randomized Trials of Bivalirudin versus Heparin in Acute Myocardial Infarction: Rationale and Methodology
Systematic review published in Thromb Haemost (2019)
Abstract
BACKGROUND: Individual randomized controlled trials (RCTs) of periprocedural anticoagulation with bivalirudin versus heparin during percutaneous coronary intervention (PCI) have reported conflicting results. Study-level meta-analyses lack granularity to adjust for confounders, explore heterogeneity, or identify subgroups that may particularly benefit or be harmed. OBJECTIVE: To overcome these limitations, we sought to develop an individual patient-data pooled database of RCTs comparing bivalirudin versus heparin. METHODS: We conducted a systematic review to identify RCTs in which ≥1,000 patients with acute myocardial infarction (AMI) undergoing PCI were randomized to bivalirudin versus heparin. RESULTS: From 738 identified studies, 8 RCTs met the prespecified criteria. The principal investigators of each study agreed to provide patient-level data. The data were pooled and checked for accuracy against trial publications, with discrepancies addressed by consulting with the trialists. Consensus-based definitions were created to resolve differing antithrombotic, procedural, and outcome definitions. The project required 3.5 years to complete, and the final database includes 27,409 patients (13,346 randomized to bivalirudin and 14,063 randomized to heparin). CONCLUSION: We have created a large individual patient database of bivalirudin versus heparin RCTs in patients with AMI undergoing PCI. This endeavor may help identify the optimal periprocedural anticoagulation regimen for patient groups with different relative risks of adverse ischemic versus bleeding events, including those with ST-segment and non-ST-segment elevation MI, radial versus femoral access, use of a prolonged bivalirudin infusion or glycoprotein inhibitors, and others. Adherence to standardized techniques and rigorous validation processes should increase confidence in the accuracy and robustness of the results.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Resumen
Individual randomized controlled trials (RCTs) of periprocedural anticoagulation with bivalirudin versus heparin during percutaneous coronary intervention (PCI) have reported conflicting results.
Por qué esto importa para la hirudoterapia
Este artículo describe la justificación y la metodología para crear una base de datos agrupada de datos individuales de pacientes de ocho ensayos controlados aleatorizados (RCTs) que comparan bivalirudina frente a heparina en 27.409 pacientes con infarto agudo de miocardio (IM) sometidos a intervención coronaria percutánea. El análisis planificado tiene como objetivo identificar las estrategias óptimas de anticoagulación periprocedimiento entre subgrupos con diferentes riesgos hemorrágicos e isquémicos, incluyendo diferentes tipos de IM, sitios de acceso y regímenes farmacológicos. El resumen no presenta resultados — es exclusivamente metodológico — y no contiene ninguna mención de sanguijuelas, hirudoterapia ni compuestos derivados de sanguijuelas. No puede establecerse ninguna conexión defendible con el dominio de ASH a partir de este resumen, que se centra enteramente en el diseño de una base de datos clínica para comparar dos anticoagulantes farmacéuticos.
Citación
Individual Patient Data Pooled Analysis of Randomized Trials of Bivalirudin versus Heparin in Acute Myocardial Infarction: Rationale and Methodology.
Bikdeli B et al. · Thromb Haemost, 2019
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Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: 18 de junio de 2026