Assessment and mitigation of bleeding risk in atrial fibrillation and venous thromboembolism: A Position Paper from the ESC Working Group on Thrombosis, in collaboration with the European Heart Rhythm Association, the Association for Acute CardioVascular Care and the Asia-Pacific Heart Rhythm Society

Abstract

Whilst there is a clear clinical benefit of oral anticoagulation (OAC) in patients with atrial fibrillation (AF) and venous thromboembolism (VTE) in reducing the risks of thromboembolism, major bleeding events (especially intracranial bleeds) may still occur and be devastating. The decision to initiate and continue anticoagulation is often based on a careful assessment of both the thromboembolism and bleeding risk. The more common and validated bleeding risk factors have been used to formulate bleeding risk stratification scores, but thromboembolism and bleeding risk factors often overlap. Also, many factors that increase bleeding risk are transient and modifiable, such as variable international normalized ratio values, surgical procedures, vascular procedures, or drug-drug and food-drug interactions. Bleeding risk is also not a static 'one off' assessment based on baseline factors but is dynamic, being influenced by ageing, incident comorbidities, and drug therapies. In this Consensus Document, we comprehensively review the published evidence and propose a consensus on bleeding risk assessments in patients with AF and VTE, with the view to summarizing 'best practice' when approaching antithrombotic therapy in these patients. We address the epidemiology and size of the problem of bleeding risk in AF and VTE, review established bleeding risk factors, and summarize definitions of bleeding. Patient values and preferences, balancing the risk of bleeding against thromboembolism are reviewed, and the prognostic implications of bleeding are discussed. We propose consensus statements that may help to define evidence gaps and assist in everyday clinical practice.

Keywords: Atrial fibrillation; Bleeding; Oral anticoagulation; Risk assessment; Venous thromboembolism.

Figure 1

ABC pathway and improved outcomes in patients with AF. ABC, Atrial fibrillation Better Care; AF, atrial fibrillation.

Figure 2

Common bleeding sources with oral anticoagulant therapy.

Figure 3

Risk factors for anticoagulation-related bleeding.

Figure 4

A in the atrial fibrillation better care pathway. ABC, Atrial fibrillation Better Care; APT, antiplatelet therapy; BP, blood pressure; CHA₂DS₂-VASc, congestive heart failure, hypertension, age 75 years (2 points), diabetes, stroke/TIA/thromboembolism (2 points), vascular disease, age 65–74 years, sex category (female); DM, diabetes mellitus; HAS-BLED, (uncontrolled) hypertension, abnormal renal, or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs/drink (alcohol); HF, heart failure; NOAC, non-vitamin K antagonist oral anticoagulant; NSAIDs, non-steroidal anti-inflammatory drugs; OAC, oral anticoagulation; OSA, obstructive sleep apnoea; TTR, time in the therapeutic range; VKA, vitamin K antagonist. Adapted from Ref.

Figure 5

Simplified algorithm for selecting the periprocedural management strategy of OAC in patients undergoing an elective surgery or invasive procedure. ^aBridging with parenteral heparin is generally not necessary with DOACs. DOAC, direct oral anticoagulant; OAC, oral anticoagulation.

Figure 6

Management of antithrombotics in patients presenting with ACS and/or requiring PCI or stents. ACS, acute coronary syndrome; PCS, percutaneous coronary interventions.