Bivalirudin as compared to unfractionated heparin in patients undergoing percutaneous coronary revascularization: A meta-analysis of 22 randomized trials
Systematic review published in Thrombosis research (2015)
Abstract
UNLABELLED: Bivalirudin has gained ground against unfractionated heparin (UFH) in percutaneous coronary interventions (PCI), due to a reported better safety profile. However, whether bivalirudin may provide also advantages in clinical outcome beyond the known benefits in major bleedings, is still a debated matter and was, therefore, the aim of present meta-analysis of randomized trials, evaluating efficacy and safety of bivalirudin as compared with UFH in PCI. METHODS AND STUDY OUTCOMES: Literature archives (Pubmed, EMBASE, Cochrane) and main scientific sessions were scanned. Primary endpoint was overall mortality. Secondary endpoints were: 1) mortality within 30-days; 2) overall and within 30-days non fatal myocardial infarction; 3) overall and within 30-days stent thrombosis. Safety endpoints were major bleedings (per protocol definition or TIMI classification). A prespecified analysis was conducted according to clinical presentation (Elective, ACS, STEMI). RESULTS: A total of 22 randomized clinical were finally included, involving 40156 patients randomized to bivalirudin (52.9%) or to UFH (47.1%). Death occurred in 1100 (2.8%) of patients, with no difference between bivalirudin and UFH (2.7% vs 2.8% OR[95%C]=0.94[0.83,-.06], p=0.32, phet=0.48). The results did not change according to clinical presentation. By meta-regression analysis, the effects on mortality were not related to patients risk profile (r=-0.38(-0.89-0.14), p=0.15) or the reduction in bleeding complications (r=-0.008(-0.86-0.85), p=0.98). A significant increase in short-term stent thrombosis was observed with bivalirudin (OR[95%CI]=1.42 [1.10-1.83], p=0.006). However, Bivalirudin significantly reduced bleedings according to both study protocol definition (OR[95%CI]=0.62[0.56-0.69],p<0.00001; phet=0.0003) or TIMI major criteria (OR[95%CI]=0.65[0.53-0.79],p<0.0001, phet=0.95). CONCLUSIONS: In present meta-analysis, among patients undergoing PCI, bivalirudin, as compared with UFH, is associated with a significant reduction in major bleeding complications that, however, does not translate into mortality benefits. Furthermore, bivalirudin is associated with higher rate of 30-days stent thrombosis and recurrent MI among STEMI patients.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Resumen
Bivalirudin has gained ground against unfractionated heparin (UFH) in percutaneous coronary interventions (PCI), due to a reported better safety profile.
Por qué esto importa para la hirudoterapia
Este metanálisis (tipo de publicación: Meta-Análisis) de 22 ensayos aleatorizados (40 156 pacientes) evaluó la eficacia y seguridad de la bivalirudina frente a la heparina no fraccionada (UFH) en la intervención coronaria percutánea, con el criterio principal de valoración de mortalidad global. La bivalirudina no mostró diferencias en mortalidad en comparación con la UFH (2,7 % frente a 2,8 %), pero se asoció con reducciones significativas de la hemorragia mayor y un aumento significativo de la trombosis del stent a corto plazo (30 días) (OR 1,42), con tasas más elevadas de infarto de miocardio recurrente entre los pacientes con STEMI; la reducción de la hemorragia no se tradujo en un beneficio en términos de mortalidad. El resumen no menciona sanguijuelas, hirudina ni hirudoterapia, por lo que la relevancia del artículo con el dominio de ASH no resulta aparente a partir del texto fuente.
Citación
Bivalirudin as compared to unfractionated heparin in patients undergoing percutaneous coronary revascularization: A meta-analysis of 22 randomized trials
Verdoia M et al. · Thrombosis research, 2015
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Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: 18 de junio de 2026