Bivalirudina frente a heparina en pacientes sometidos a implante transcatéter de válvula aórtica

BACKGROUND: We aimed to compare safety and efficacy of the direct thrombin inhibitor bivalirudin with unfractionated heparin (UFH) during transcatheter aortic valve implantation (TAVI). METHODS: In this retrospective analysis, 461 patients underwent TAVI between 2007 and 2012; 339 patients received bivalirudin, and 122 patients received UFH. In the bivalirudin group, the Sapien XT valve was implanted in 159 (46.9%) patients, and 180 (53.1%) received a Medtronic CoreValve. In the UFH group, only the Medtronic CoreValve was implanted. The primary outcome of interest was the incidence of any bleeding. Secondary outcomes of interest were all-cause mortality and cardiovascular mortality at 72 hours after the procedure and at 30 days. RESULTS: No significant difference between the groups was observed for life-threatening bleeding (2.4% for bivalirudin vs 3.3% for UFH; P = 0.59), major bleeding (8.3% vs 8.2%, respectively; P = 0.98) and minor bleeding (8.3% vs 7.4%, respectively; P = 0.76). At 72 hours after the procedure, all-cause mortality was 3.0% in the bivalirudin group and 3.3% for the UFH group (P = 0.88), whereas cardiovascular mortality was 3.0% in the bivalirudin group and 2.5% in the heparin group (P = 0.77). At 30 days, all-cause mortality was 5.3% vs 4.1% in the bivalirudin and heparin groups (P = 0.57) and cardiovascular mortality was 4.4% vs 2.5% (P = 0.33). Device success (Valve Academic Research Consortium 2 composite end point) was 94.0% in the bivalirudin-treated and 92.6% in the UFH-treated patients (P = 0.60). The early safety at 30 days was 85.3% in the bivalirudin-treated group compared with 83.6% in the UFH-treated group (P = 0.65). CONCLUSIONS: Bivalirudin has a safety and efficacy profile similar to weight-adjusted UFH during the TAVI procedure.

Resumen tomado de PubMed (NCBI) para el registro citado, en el idioma original. La versión de referencia es la de la publicación original.

El resumen se deja sin traducir para conservar la redacción original de los autores.

Un análisis retrospectivo de 461 pacientes con TAVI (2007–2012) comparó bivalirudina (339) y heparina no fraccionada (HNF, 122). No hubo diferencias significativas en hemorragia con riesgo vital (2,4 % vs. 3,3 %; p = 0,59), hemorragia mayor (8,3 % vs. 8,2 %) ni mortalidad total a 30 días (5,3 % vs. 4,1 %). Según los autores, la bivalirudina tiene un perfil de seguridad y eficacia similar al de la HNF ajustada por peso.

Explore cómo esta investigación se conecta con la práctica clínica

Más estudios revisados por pares en la categoría «Ensayos clínicos».

• Leech Therapy for Knee Osteoarthritis — The Landmark RCT — Michalsen et al. (2003)
• Leech-Assisted Flap Salvage — Systematic Review of 277 Cases — Whitaker et al. (2012)
• Effects of hirudotherapy on liver functions, lipid profile, and insulin sensitivity in rats with metabolic syndrome — Bilden A et al. (2026)
• Efficacy and Safety of Hirudotherapy for Improving Sperm Quality Parameters in Male Infertility: A Randomized Controlled Trial — Abtahi-Forooshani M et al. (2026)
• Reverse Sural Flap Venous Congestion Successfully Managed With Enoxaparin in a Male Patient With a Traumatic Foot Crush Injury: A Case Report — Velasco-Bustamante J et al. (2026)
• Investigación de los efectos terapéuticos del tratamiento con sanguijuelas medicinales sobre la lesión por isquemia-reperfusión de la extremidad inferior — Ünal K et al. (2026)
• Efficacy of Medicinal Leech Therapy in Diverse Clinical Applications: A Comprehensive Study from Azerbaijan — Farzali S et al. (2025)
• HIRUDOTHERAPY IN RECONSTRUCTIVE SURGERY: CASE-REPORTS AND REVIEW — Heinz P et al. (2020)
• Hirudoterapia en la cicatrización de heridas — Nair H et al. (2022)
• Improvement of patient care through hirudotherapy and the management of leeches from their reception to their disposal in France — Vaesken C et al. (2023)

Ver toda la investigación analizada por la ASH →