scholarly journals ANDEXANET ALFA FOR ACUTE BLEEDING DURING TREATMENT WITH ENOXAPARIN

2021 ◽  
Vol 77 (18) ◽  
pp. 1856
Author(s):  
Thijs F. van Haaps ◽  
Alexander P. Benz ◽  
Lizhen Xu ◽  
Michiel Coppens ◽  
John W. Eikelboom ◽  
...  
Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Alexander P Benz ◽  
Lizhen Xu ◽  
John W Eikelboom ◽  
Saskia Middeldorp ◽  
Truman J Milling ◽  
...  

Introduction: We previously reported results of a prospective cohort study evaluating andexanet alfa (andexanet) for anticoagulation reversal in patients with acute bleeding on a factor Xa inhibitor. Study enrollment continued to accumulate additional data on patients on edoxaban, which are presented here. Methods: Patients with acute major bleeding within 18 hours of edoxaban intake were prospectively enrolled. Patients received a 400 or 800 mg bolus and a 480 or 960 mg 2-hour follow-on infusion of andexanet, depending on edoxaban dosage and time of last dose. The co-primary efficacy outcomes were change in anti-factor Xa activity and the rate of excellent or good hemostasis, 12 hours after andexanet treatment, as determined by an independent adjudication committee. Efficacy was analyzed in patients with confirmed major bleeding and baseline anti-factor Xa activity ≥75 ng/mL. Safety was analyzed in all patients. Results: A total of 36 patients (mean age 82 years, 61.1% male and 91.7% with atrial fibrillation) with acute major bleeding on edoxaban received andexanet. The primary site of bleeding was intracranial in 29 (80.6%) patients. In the efficacy population (n=20), median anti-factor Xa activity decreased from 160.5 (interquartile range [IQR] 106.2-222.2) ng/mL at baseline to 50.9 (IQR 19.9-119.4) ng/mL at the end of bolus (median decrease 69.2%, 95% confidence interval [CI] 25.5-80.2%). Excellent or good hemostasis at 12 hours was achieved in 75.0% (95% CI 50.9-91.3%) of patients overall and in 81.3% (95% CI 54.4-96.0%) of those with intracranial hemorrhage (ICH). Within 30 days, a total of 4 (11.1%) patients experienced at least one thrombotic event and 4 (11.1%) others died. Conclusions: In patients with acute bleeding on edoxaban, andexanet significantly decreased anti-factor Xa activity. Excellent or good hemostasis at 12 hours was observed in 75.0% of patients overall and 81.3% of those with ICH. Thrombotic events occurred at a rate expected in such patients.


Author(s):  
Alexander P. Benz ◽  
Lizhen Xu ◽  
John W. Eikelboom ◽  
Saskia Middeldorp ◽  
Truman J. Milling ◽  
...  

Abstract Background Andexanet alfa (andexanet) is approved for specific anticoagulation reversal in patients with life-threatening or uncontrolled bleeding during treatment with rivaroxaban or apixaban. There is limited experience with andexanet in patients with acute bleeding on edoxaban. Methods Patients with acute major bleeding within 18 hours of edoxaban intake were prospectively enrolled. Patients received a bolus and 2-hour follow-on infusion of andexanet. The co-primary efficacy outcomes were change in antifactor Xa activity and the percentage of patients achieving excellent or good hemostasis, 12 hours after andexanet treatment. Efficacy was analyzed in patients with confirmed major bleeding and baseline antifactor Xa activity ≥40 ng/mL. Safety was analyzed in all patients. Results Thirty-six patients (mean age: 82 years, 61.1% male and 91.7% with atrial fibrillation) with acute major bleeding on edoxaban received andexanet. The primary site of bleeding was intracranial in 29 patients (80.6%). In the efficacy population (n = 28), median antifactor Xa activity decreased from 121.1 (interquartile range [IQR]: 70.3–202.4) ng/mL at baseline to 24.0 (IQR: 77.7–83.7) ng/mL at the end of andexanet bolus (median decrease: 68.9%, 95% confidence interval [CI]: 56.1–77.7%). Excellent or good hemostasis at 12 hours was achieved in 78.6% (95% CI: 59.0–91.7%) of patients. Within 30 days, four patients (11.1%) experienced a thrombotic event and four others (11.1%) died. Conclusion In patients with acute major bleeding on edoxaban, andexanet significantly decreased antifactor Xa activity. Hemostatic efficacy was similar to that observed in patients with bleeding on rivaroxaban or apixaban. Thrombotic events occurred at a rate expected in such patients.


1979 ◽  
Vol 12 (2) ◽  
pp. 455-464 ◽  
Author(s):  
Joseph W. Walike ◽  
Jonathan Chinn
Keyword(s):  

Author(s):  
Veronica Ojetti ◽  
Angela Saviano ◽  
Mattia Brigida ◽  
Luisa Saviano ◽  
Alessio Migneco ◽  
...  

Background : Major bleeding is a life-threatening condition and a medical emergency with high mortality risk. It is often the complication of anticoagulant’s intake. Anticoagulants are commonly used for the prevention and the treatment of thrombotic events. The standard therapy with vitamin K antagonist (warfarin) has been frequently replaced by direct oral anticoagulants (DOACs). The latter agents (rivaroxaban, apixaban, edoxaban, dabigatran, betrixaban) showed a better efficacy and safety compared to standard warfarin treatment and they are recommended for the reduction of ischemic stroke. Literature data reported a high risk of gastrointestinal bleeding with DOACs, in particular with dabigatran and rivaroxaban. In case of life-threatening gastrointestinal bleeding, these patients could benefit from the use of reversal agents. Methods: We performed an electronic search on PUBMED of the literature concerning reversal agents for DOACs and gastrointestinal bleeding in the Emergency Department from 2004 to 2020. AIM: This review summarizes the current evidences about three reversal agents idarucizumab, andexanet alfa and ciraparantag, and the use of the first two in the emergency setting in patients with an active major bleeding or who need urgent surgery to offer physicians indications for a better management approach in order to increase patient’s safety. Conclusion: Although these agents have been marketed for five years (idarucizumab) and two years (andexanet alfa) respectively, and despite guidelines considering antidotes as first-line agents in treating life-threatening hemorrhage when available, these antidotes seem to gain access very slowly in the clinical practice. Cost, logistical aspects and need for plasma level determination of DOAC for an accurate therapeutic use probably have an impact on this phenomenon.. An expert multidisciplinary bleeding team should be established so as to implement international guidelines based on local resources and organization.


Author(s):  
Isadore Budnick ◽  
Jessica Davis ◽  
Anirudh Sundararaghavan ◽  
Samuel Konkol ◽  
Chelsea Lau ◽  
...  

Background: Fibrinogen (FIB) levels less than 150 mg/dL have been associated with increased rates of bleeding and lower survival in critically ill cirrhosis patients. Objective: We aimed to determine if treatment with cryoprecipitate (CRYO) for low FIB levels were associated with bleeding complications or survival. Patients / Methods: 237 cirrhosis patients admitted to an intensive care unit at a tertiary care liver transplant center with initial FIB levels less than 150 mg/dL were retrospectively assessed for CRYO transfusion, bleeding events, and survival outcomes. Results: The mean MELD score was 27.2 (95% CI 26.0 - 28.3) and CLIF-C Acute on Chronic Liver Failure (ACLF) score was 53.4 (51.9 - 54.8). Ninety-nine (41.8%) were admitted for acute bleeding and the remainder were admitted for non-bleeding illnesses. FIB level on admission correlated strongly with disease severity. After adjusting for disease severity, FIB on admission was not an independent predictor of 30-day survival (HR 0.99, 95% CI 0.99 - 1.01, p = 0.68). CRYO transfusion increased FIB levels but had no independent effect on mortality or bleeding complications (HR 1.10, 95% CI 0.72 - 1.70, p = 0.65). Conclusions: In cirrhosis patients with critical illness, low FIB levels on presentation reflect severity of illness but are not independently associated with 30-day mortality. Treatment of low FIB with CRYO also does not affect survival or bleeding complications suggesting FIB is an additional marker of severity of illness but is not itself a direct factor in the pathophysiology of bleeding in critically ill cirrhosis patients.


2021 ◽  
Vol 10 (11) ◽  
pp. 2475
Author(s):  
Olivier Peyrony ◽  
Danaé Gamelon ◽  
Romain Brune ◽  
Anthony Chauvin ◽  
Daniel Aiham Ghazali ◽  
...  

Background: We aimed to describe red blood cell (RBC) transfusions in the emergency department (ED) with a particular focus on the hemoglobin (Hb) level thresholds that are used in this setting. Methods: This was a cross-sectional study of 12 EDs including all adult patients that received RBC transfusion in January and February 2018. Descriptive statistics were reported. Logistic regression was performed to assess variables that were independently associated with a pre-transfusion Hb level ≥ 8 g/dL. Results: During the study period, 529 patients received RBC transfusion. The median age was 74 (59–85) years. The patients had a history of cancer or hematological disease in 185 (35.2%) cases. Acute bleeding was observed in the ED for 242 (44.7%) patients, among which 145 (59.9%) were gastrointestinal. Anemia was chronic in 191 (40.2%) cases, mostly due to vitamin or iron deficiency or to malignancy with transfusion support. Pre-transfusion Hb level was 6.9 (6.0–7.8) g/dL. The transfusion motive was not notified in the medical chart in 206 (38.9%) cases. In the multivariable logistic regression, variables that were associated with a higher pre-transfusion Hb level (≥8 g/dL) were a history of coronary artery disease (OR: 2.09; 95% CI: 1.29–3.41), the presence of acute bleeding (OR: 2.44; 95% CI: 1.53–3.94), and older age (OR: 1.02/year; 95% CI: 1.01–1.04). Conclusion: RBC transfusion in the ED was an everyday concern and involved patients with heterogeneous medical situations and severity. Pre-transfusion Hb level was rather restrictive. Almost half of transfusions were provided because of acute bleeding which was associated with a higher Hb threshold.


Author(s):  
Pushpinder S. Khera ◽  
Pawan K. Garg ◽  
Sarbesh Tiwari ◽  
Narendra Bhargava ◽  
Taruna Yadav ◽  
...  

Abstract Introduction Retrograde transvenous obliteration (RTO) with the assistance of a balloon (BRTO) or a vascular plug (PARTO) is an established method for treating gastric varices (GVs) secondary to portal hypertension. Most of the available studies on RTO have used lipiodol along with sclerosing agents like ethanolamine oleate or sodium tetradecyl sulfate (STS). We evaluated the safety and efficacy of RTO for treating GVs using STS as a sclerosant without lipiodol. Materials and Methods Sixteen patients (nine men, age range 16–74 years) were included in this retrospective study. Twelve patients presented with acute bleeding, two with chronic bleeding, one with large varices without bleeding, and one with refractory hepatic encephalopathy (HE). BRTO was attempted in 14 patients and PARTO in 2 patients. The technical and clinical success and complications of RTO were studied. Results The RTO procedure was technically successful in 14 (14/16, 87.5%) patients, with 13 (13/14, 93%) obtaining clinical success. One patient died due to the early recurrence of bleeding. Three patients had minor intraprocedural complications. Conclusion Retrograde gastric variceal obliteration using STS is safe and technically feasible with high technical and clinical success and low complication rate.


2017 ◽  
Vol 06 (01) ◽  
pp. e15-e17 ◽  
Author(s):  
Mina Rouman ◽  
Alexander Petrovitch ◽  
Eva-Maria Gey ◽  
Thomas Kuntze

Background An aberrant right subclavian artery (RSA) or arteria lusoria is the most common congenital abnormality of the aortic arch with an incidence of 0.3 to 3.0%. Case Description We report a case of a perforated aneurysmal aberrant RSA, managed using a hybrid approach. Conclusion In emergency cases with acute bleeding, we recommend an endovascular approach to avoid the lethal sequel of arterial leakage. Whenever possible, the pulsatile blood flow to the right arm should be restored. Management should be tailored to the nature of the aneurysmal aberrant RSA, patient's comorbidities, and concomitant lesions.


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