From the Guidelines
Bleeding risk in the UK is primarily caused by a combination of modifiable and non-modifiable factors, including anticoagulant medications, antiplatelet drugs, and certain medical conditions, as outlined in the 2016 ESC guidelines 1. According to the guidelines, modifiable bleeding risk factors include hypertension, labile INR or time in therapeutic range <60% in patients on vitamin K antagonists, medication predisposing to bleeding, and excess alcohol consumption. The following are key points to consider:
- Modifiable bleeding risk factors:
- Hypertension (especially when systolic blood pressure is >160 mmHg)
- Labile INR or time in therapeutic range <60% in patients on vitamin K antagonists
- Medication predisposing to bleeding, such as antiplatelet drugs and non-steroidal anti-inflammatory drugs
- Excess alcohol (≥8 drinks/week)
- Non-modifiable bleeding risk factors:
- Age (>65 years)
- History of major bleeding
- Previous stroke
- Dialysis-dependent kidney disease or renal transplant
- Cirrhotic liver disease
- Malignancy
- Genetic factors Healthcare providers should assess bleeding risk using tools like the HAS-BLED score before initiating anticoagulation therapy, weighing the benefits against potential bleeding complications, particularly for patients with multiple risk factors 1. In patients with atrial fibrillation, the use of anticoagulant medications such as apixaban, rivaroxaban, dabigatran, and edoxaban, as well as antiplatelet drugs like aspirin, clopidogrel, prasugrel, and ticagrelor, should be carefully considered, taking into account the patient's individual risk factors and the potential for bleeding complications 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Bleeding Risk Factors
According to the studies, the following factors contribute to bleeding risk in patients taking anticoagulants:
- Concurrent use of pharmacodynamic interacting drugs, such as antiplatelet drugs or selective serotonin reuptake inhibitors 2
- Older age, anemia, and renal disease 3
- High thrombotic risk patients, regardless of hemorrhagic risk, are less likely to receive vitamin K, which may increase bleeding risk 4
- Supratherapeutic INR levels ≥ 5.0 in non-bleeding outpatients 4
Management of Bleeding Risk
The management of bleeding risk in patients taking anticoagulants is not standardized, and international guidelines are contradictory 5. However, some studies suggest that:
- Risk prediction tools can be used to estimate bleeding risk in clinical practice, particularly for patients at the lower spectrum of thromboembolic risk 3
- A standardized approach to managing warfarin-associated coagulopathy and vitamin K intervention using patient-specific characteristics and index INR values may be effective 4
- The concurrent use of oral anticoagulants and aspirin increases the risk of bleeding 6
UK Guidelines
The UK Clinical Practice Research Datalink linked to Hospital Episode Statistics (2008-2015) was used to assess the association between concurrent use of potential pharmacokinetic or pharmacodynamic interacting drugs and major bleeding among direct oral anticoagulant (DOAC) users 2. The study found that the concurrent use of pharmacodynamic interacting drugs was associated with an increased risk of major bleeding. However, there is no direct evidence from the studies provided that specifically outlines the UK guidelines for managing bleeding risk in patients taking anticoagulants.