Off-label direct oral anticoagulants dosing in atrial fibrillation and venous thromboembolism is associated with higher mortality

2021 ◽  
Author(s):  
Francisco Aguilar ◽  
Kevin B. Lo ◽  
Eduardo E. Quintero ◽  
Ricardo J. Torres ◽  
Wikien A. Hung ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Venous Thromboembolism ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Off Label

The Combination of Oral Anticoagulant and Antiplatelet Therapies: Stay One Step Ahead

2020 ◽  
Vol 25 (5) ◽  
pp. 391-398
Author(s):  
Fabiana Lucà ◽  
Simona Giubilato ◽  
Stefania Angela Di Fusco ◽  
Angelo Leone ◽  
Stefano Poli ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Venous Thromboembolism ◽  
Antiplatelet Therapy ◽  
Oral Anticoagulant ◽  
Acute Coronary Syndromes ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Clinical Scenarios ◽  
Coronary Syndromes

Antithrombotic drugs, which include antiplatelets and anticoagulants, are effective in prevention and treatment of many cardiovascular disorders such as acute coronary syndromes, stroke, and venous thromboembolism and are among the drugs most commonly prescribed worldwide. The advent of direct oral anticoagulants, which are safer alternatives to vitamin K antagonists and do not require laboratory monitoring, has revolutionized the treatment of nonvalvular atrial fibrillation and venous thromboembolism. The combination of oral anticoagulant and antiplatelet therapy is required in many conditions of great clinical impact such as the coexistence of atrial fibrillation and coronary artery disease, with indication to percutaneous coronary intervention. However, strategies that combine anticoagulant and antiplatelet therapies lead to a significant increase in bleeding rates and it is crucial to find the right combination in the single patient in order to optimize the ischemic and bleeding risk. The aim of this review is to explore the evidence and controversies regarding the optimal combination of anticoagulant and antiplatelet therapy through the consideration of past dogmas and new perspectives from recent clinical trials and to propose a tailored therapeutic approach, according to specific clinical scenarios and individual patient characteristics. In particular, we separately explored the clinical settings of stable and acute coronary syndromes and percutaneous revascularization in patients with atrial fibrillation.

FEIBA™ for Patients on Direct Oral Anticoagulants Requiring Urgent Surgery

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4259-4259
Author(s):  
Joseph Shaw ◽  
Gregoire Le Gal ◽  
Melanie Tokessy ◽  
Nancy Cober ◽  
Elianna Saidenberg ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Venous Thromboembolism ◽  
Vitamin K ◽  
Major Bleeding ◽  
Femur Fracture ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Ischemic Bowel ◽  
Urgent Surgery ◽  
Thrombotic Complications

Abstract Introduction: A recent Canadian population based review showed a rapid increase in use of direct oral anticoagulants (DOACs) for prevention of systemic embolism in patients with atrial fibrillation (AF) (Xu et al.). These drugs offer advantages over traditional vitamin K antagonists (VKA) including fixed dosing regimens and elimination of laboratory monitoring. In Canada, patients receiving VKA requiring urgent surgery are reversed with prothrombin complex concentrates (PCC) with or without vitamin K. DOAC specific antidotes are under development and use of PCCs or activated PCC for the purposes of DOAC reversal for emergent procedures is controversial. We describe the use of activated PCC (FEIBA™) in patients receiving the DOACs (dabigatran, apixaban, or rivaroxaban) who required urgent surgical intervention. Methods: A retrospective review of patients receiving DOACs and requiring urgent reversal of anticoagulation effect for procedures or surgery at The Ottawa Hospital between January 2013 and June 2014 are included. Major bleeding was defined using the ISTH criteria (Schulman et al.). The primary outcome was major bleeding peri-operatively and secondary outcome was adverse embolic and thrombotic events during follow up. Results: Five patients were identified: two patients were on rivaroxaban, two were on apixaban, and one was on dabigatran. Baseline characteristics are shown in Table 1. One patient was on rivaroxaban for secondary prevention of venous thromboembolism (VTE), while the remaining patients had AF. Three patients required laparotomy for bowel obstruction; one patient required open femur fracture repair; and one patient required angiography and stent placement for ischemic bowel. A large majority of patients (80%) had received a dose of anticoagulant on the day of surgery. One patient required intra-operative blood transfusion. There were no embolic or thrombotic complications following FEIBA™ administration and all patients’ survived hospitalization. Conclusions: The use of FEIBA™ for reversal of DOAC effect for urgent surgery in this cohort of patients was effective and not associated with adverse thrombotic complications. Prospective studies evaluating use of potential benefits and harms of FEIBA™ for reversal of DOACs in patients requiring emergent surgery are needed. Abstract 4259. Table 1: Patients on DOACs Requiring Urgent Procedure Patient (Age and Gender) Indication For DOAC [AF(CHADS2); VTE] DOAC and Dosage Surgery/ Procedure Units of PRBCs Transfused FEIBA™ Dose (IU) Adverse Events post-FEIBA™ administration Survived Hospitalization 91 Female AF (4) Rivaroxaban 15 mg daily Femur fracture ORIF 3, intra-operatively 1812 -- Yes 50 Male VTE Apixaban 5 mg BID Laparotomy for SBO 0 1350 -- Yes 50 Female AF (4) Apixaban 2.5 mg BID Angiography + SMA stent for ischemic bowel 0 3918 -- Yes 77 Male AF (2) Rivaroxaban 20 md daily Laparotomy for incarcerated hernia/SBO 0 3241 Venous oozing intra-operatively Yes 78 Male AF (3) Dabigatran 110 mg BID SBO/ Femoral hernia repair 0 6000 -- Yes AF = atrial fibrillation; BID = twice daily; CHADS = congestive heart failure, hypertension, age, diabetes, stroke; DOAC = direct oral anticoagulant; IU = international units; ORIF = open reduction internal fixation; PRBC = packed red blood cells; SBO = small bowel obstruction; SMA = superior mesenteric artery; VTE = venous thromboembolism References: Schulman, S et al. J Thromb Haemost 2010; 8: 202–4. Xu, Y et al. CMAJ Open 2013; 1:E115-E119. Disclosures Off Label Use: FEIBA is an activated prothrombin complex concentrate that was used during management of patients on direct oral anticoagulants requiring urgent surgery..

scholarly journals Characteristics and outcomes in patients with atrial fibrillation receiving direct oral anticoagulants in off-label doses

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Alexandros Briasoulis ◽  
Yubo Gao ◽  
Chakradhari Inampudi ◽  
Paulino Alvarez ◽  
Rabea Asleh ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Off Label

scholarly journals Management of Anticoagulant Treatment and Anticoagulation-Related Complications in Nonagenarians

2020 ◽  
Vol 40 (03) ◽  
pp. 292-300
Author(s):  
Michela Giustozzi ◽  
Lana A. Castellucci ◽  
Geoffrey D. Barnes
Keyword(s):  
Atrial Fibrillation ◽  
Venous Thromboembolism ◽  
Elderly Patients ◽  
Intracranial Hemorrhage ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Coagulation Cascade ◽  
Anticoagulant Treatment ◽  
Treatment Needs ◽  
Oral Anticoagulant Treatment

AbstractGiven the aging population, the burden of age-dependent diseases is growing. Despite this, elderly patients are often underrepresented in clinical trials and little data are available on current anticoagulant management and outcomes in this unique population, especially those aged 90 years or older. There is uncertainty, and a fear of “doing harm,” that often leads to de-prescription of antithrombotic agents in nonagenarian patients. Decision-making concerning the use of anticoagulant treatment needs to balance the risk of thrombotic events against the risk of major bleeding, especially intracranial hemorrhage. In this perspective, the development of direct oral anticoagulants (DOACs), acting as direct and selective inhibitors of a specific step or enzyme of the coagulation cascade, has dramatically changed oral anticoagulant treatment. In fact, given the lower incidence of intracranial hemorrhage, the favorable overall efficacy and safety, and the lack of routine monitoring, DOACs are the currently recommended anticoagulant agents for the treatment of both atrial fibrillation and venous thromboembolism even in very elderly patients. However, given the limited data available on the management of anticoagulation in nonagenarians, a few unanswered questions remain. In this review, we focused on recent evidence for anticoagulant treatment in atrial fibrillation and venous thromboembolism along with management of anticoagulation-related bleeding in nonagenarians.

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