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How to manage bleeding in patients on oral anticoagulants: New ACC guideline

M3 India Newsdesk Sep 15, 2020

The ACC 2020 consensus guideline enumerates the steps for the management of bleeding in patients treated with DOACs and VKAs. The recommendations include guidance on the strategies for general bleeding management, temporary or permanent cessation of therapy, advice on using reversal agent, and indications and timing for restarting anticoagulant treatment.

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The American College of Cardiology (ACC) consensus guideline enumerates the strategies to be followed for managing bleeding in patients treated with direct-acting oral anticoagulants (DOACs) and vitamin K antagonist (VKAs). The recommendations include guidance for:

  • Temporary or permanent cessation of therapy
  • Approaches to manage bleeding
  • Treatment considerations with a reversal agent
  • Indications and timing for restarting anticoagulant treatment

Key takeaways from the ACC expert consensus

Assessing bleed severity

The evaluation of bleed severity in patients treated with oral anticoagulants (OACs) is essential to make treatment decisions to maintain haemostasis and protect organ function.

  • During the initial assessment, a focused history and physical examination, with collection of vital signs and laboratory evaluation is recommended.
  • Haemodynamic instability should be assessed promptly and repeated frequently.
  • Cases with major bleeding (with or without haemodynamic instability) should be closely monitored, preferably in the acute or critical care setting.

Defining bleed severity

In the updated the guideline, the classification for bleeding classification has been simplified and bleeding is now categorised as major or non-major. Bleeding is considered major if one or more of the following are involved (all other bleeding is categorised as non-major):

Bleeding in a critical site - Critical site bleeds include bleeds that compromise the organ’s function such as intracranial haemorrhage and other central nervous system bleeds (e.g., intraocular, spinal).

Haemodynamic instability - An increased heart rate may be the first sign of haemodynamic instability due to blood loss. Furthermore, a systolic blood pressure <90 mmHg, a decrease in systolic blood pressure >40 mmHg , or orthostatic blood pressure changes (systolic blood pressure drop ≥20 mmHg or diastolic blood pressure drop ≥10 mmHg upon standing) can indicate haemodynamic instability.

Overt bleeding with haemoglobin drop ≥2 g/dL or administration of ≥2 units of packed RBCs - Bleeding events causing a haemoglobin drop ≥2 g/dL or requiring transfusion of ≥2 units of RBCs have been associated with a significantly increased mortality risk.

Managing major bleeds

Bleeding cases which necessitate hospitalisation, surgical procedure, or transfusion, requires interruption of the anticoagulant and antiplatelet along with suitable measures to control the source of bleeding.

Reversal of OAC is recommended if an agent is available. In cases with ongoing bleeding and/or haemodynamic instability, local measures to control bleeding (e.g., pressure, packing) should be combined with volume resuscitation.

While managing major bleeds, comorbidities and potential complications of aggressive fluid resuscitation should be considered, as this could worsen bleeding and subsequent outcome.

Managing non-major Bleeds

In cases with non-major bleed, routine reversal of the OAC is not recommended, however, it is suggested to temporarily discontinue OAC therapy until the patient is clinically stable and haemostasis has been achieved. To determine if the OAC should be temporarily held in a patient with a nonmajor bleed, the following points should be considered:

  • Patient characteristics
  • The nature of the bleed
  • The intensity of anticoagulation

Laboratory measurement

Measuring anticoagulant activity is important in anticoagulated patient who presents with clinically relevant bleeding or needs an urgent unplanned procedure.

  1. Unless a concomitant defect in coagulation (e.g., disseminated intravascular coagulation) is suspected, patients taking a VKA may be evaluated with the prothrombin time (PT)/international normalised ratio (INR).
  2. Tests suitable for dabigatran quantitation include the dilute thrombin time, ecarin clotting time, and ecarin chromogenic assay. When quantitative tests of anticoagulant effect are not available, a qualitative test such as thrombin time (TT) and activated partial thromboplastin time (aPTT) may be used for qualitative assessment to exclude clinically relevant drug levels.
  3. For patients with dabigatran, a normal TT or aPTT usually excludes clinically relevant levels if sensitive reagents are used. Anti-factor Xa levels (either general or drug-specific) can be used to exclude clinically relevant levels for factor Xa inhibitors.

Reversal/haemostatic strategies

In cases with life-threatening bleeding or major bleeding that does not resolve with initial management, use of an anticoagulant “reversal” or haemostatic agent is recommended. Reversal agents are not recommended in most patients with a non-major bleeding event.

  1. Vitamin K is a specific reversal agent for VKAs; however, the administration of vitamin K does not result in immediate correction of coagulopathy. Hence, for the patient with a major bleed warranting reversal, administration must be accompanied by a repletion strategy (if 4-factor prothrombin complex concentrate [4F-PCC] is unavailable, PCCs or plasma may be used).
  2. For patients taking warfarin or other VKA, use of a 4F-PCC is advised for reversal. Fresh frozen plasma can be used if a 4F-PCC is not available. 4F-PCCs contains around 25 times (25 U/mL) the concentration of vitamin K–dependent factors as compared with plasma (1 U/mL); therefore, PCC can be administered in a much smaller volume at a much faster infusion rate (8×) compared with plasma.
  3. For patients taking dabigatran, idarucizumab 5 mg IV should be used for reversal. PCC or activated PCC can be used if idarucizumab is not available.
  4. For patients taking factor Xa inhibitors, use of andexanet alpha is recommended for reversal. PCC can be used if andexanet alpha is not available.

Considerations for restarting anticoagulation

Once bleeding is controlled, patients should be assessed for restarting their anticoagulant therapy.

  • In patient with low thromboembolic risk (e.g., atrial fibrillation with CHA2DS2-VASc score <2-3, provoked venous thromboembolism >3 months prior), discontinuing anticoagulation is recommended
  • If bleeding occurred in a critical organ or the source has not been identified, then a delayed restart of anticoagulation is recommended
  • All other cases, patients should likely restart their anticoagulation as soon as it is medically safe to do so
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