VPB0995 - The clinical use of idarucizumab for dabigatran reversal in Aragón (Spain), new data

Tuesday, July 12, 2022

6:30 PM – 7:30 PM

Location: Exhibition

Presentation Format: Virtual

Presenting Author(s)

Sonia Angós Vázquez

Hematology resident
Hospital Lozano Blesa
zaragoza, Aragon, Spain

Co-Author(s)

Alicia Ortiz Lopez

HEMATOLOGY RESIDENT
HEMATOLOGY RESIDENT
Zaragoza, Aragon, Spain
NG

Natalia María Gemperle Ortiz

Haematology Resident
Hospital Lozano Blesa
Zaragoza, Aragon, Spain
Irene Rivas Estabén, MD

Hematology resident
Hospital Lozano Blesa
Andorra (Teruel), Aragon, Spain
MM

Maria del Mar Moles Guerrero

Hematology resident
Hospital Lozano Blesa
zaragoza, Aragon, Spain
VM

Victoria Murillo Cortés

Hematology resident
Hospital Lozano Blesa
zaragoza, Aragon, Spain
OG

OLGA GAVIN Gavín Sebastian, PhD

Hematology service
Hospital Lozano Blesa
zaragoza, Aragon, Spain
MD

Manuela Dobón Rebollo

Hematology Service
Hospital Lozano Blesa
Zaragoza, Aragon, Spain
JC

Jose Manuel Calvo Viñas

Hematology Service
Hospital Miguel Servet
Zaragoza, Aragon, Spain
IC

Isabel Cuesta Gallardo

Hematology Service
Hospital Obispo Polanco
Teruel, Aragon, Spain
PP

Pedro Jose Paul Vidaller

Hematology Service
Hospital Comarcal de Barbastro
Barbastro, Aragon, Spain
MP

Miguel Paricio Moreno

Hematology Service
Hospital de Alcañiz
Alcañiz, Aragon, Spain
LP

Luis Palomera Bernal

Hematology service
Hospital Lozano Blesa
zaragoza, Aragon, Spain

Background: Idarucizumab is a specific reversal agent of dabigatran anticoagulant effect in major bleeding and emergency surgeries. Real-world evidence for idarucizumab in Spain is limited.

Aims: Analyze idarucizumab management and results in current clinical practice in Aragón hospitals (Spain).

Methods: 46 patients that received idarucizumab (January 2016 – December 2021) were registered in this observational, multicenter, retrospective study. We analyzed clinical variables and laboratory tests; efficacy, safety and thrombogenic capacity of idarucizumab, and related mortality with its use.

Results: 46 patients needed idarucizumab in Aragon. Most patients were male (58.6%), ≥75 years (63%) and used dabigatran 110 mg (65.21%). The indications of idarucizumab were emergency surgeries in 63.04%; major bleeding in 30.43%, 1 off-label use, 1 lumbar puncture and 1 suspected stroke. Surgeries requiring reversal anticoagulation were 31.03% abdominal surgery, 34.18% vascular, 13.79% traumas, 10.34% cardiothoracic, 6.89% urological and 3.44% neurological surgery. The use of the drug in major bleeding was in 50% with cerebral hemorrhage, 7.14% with retroperitoneal hemorrhage and 42.86% gastrointestinal bleeding. Adverse events were shown in three operated patients (10.34%); femoral artery bleeding, retrocardiac hematoma and cerebral hemorrhage. Another had kidney failure and none had thrombotic events after idarucizumab administration. Activated partial thromboplastin time (aPTT) or prothrombin times (PT) were prolonged in 86.95% patients prior to idarucizumab infusion. Complete reversal (aPTT ≤40 seconds) was shown in 76% of the patients. Six patients (13.04%) died in relation with intraventricular hemorrhage, heart transplant complications, septic shock, hypovolemic shock, bleeding from ruptured aneurysm and multi-organic failure respectively.

Conclusion(s): Our series includes 46 patients treated with idarucizumab to reverse the anticoagulation effect of dabigatran in hospitals of Aragon. The clinical use of idarucizumab was safe and conducted according to the authorized label, although it would be recommendable the development of standardized hospital protocols to guarantee an optimal drug use.