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ELIQUIS® (apixaban) is indicated for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA), age ≥75 years, hypertension, diabetes mellitus, symptomatic heart failure (NYHA Class ≥II); treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults; and, prevention of venous thromboembolic events (VTE) in patients who have undergone elective hip or knee replacement surgery.

What’s new

ELIQUIS® (apixaban) in treatment guidelines

ELIQUIS for the treatment of DVT / PE and prevention of recurrent DVT / PE is supported by treatment guidelines

The NICE Guideline for venous thromboembolic diseases (NG158) recommends ELIQUIS as an option for anticoagulation treatment for confirmed proximal DVT / PE:1

These are a selection of recommendations taken from the full guidelines. See publication for further information.

1.3.5: Offer anticoagulation treatment for at least 3 months to people with confirmed proximal DVT or PE.

1.3.7: When offering anticoagulation treatment, take into account comorbidities, contraindications and the person's preferences. Follow the recommendations on anticoagulation treatment in the sections on: DVT or PE in people at extremes of body weight; PE with haemodynamic instability; DVT or PE with renal impairment or established renal failure;* DVT or PE with active cancer;† DVT or PE with triple antiphospholipid syndrome.‡

1.3.8: Offer either apixaban or rivaroxaban to people with confirmed proximal DVT or PE [but see recommendations for people with any of the clinical features listed in 1.3.7].

If neither apixaban nor rivaroxaban is suitable offer:

  • low molecular weight heparin (LMWH) for at least 5 days followed by dabigatran or edoxaban or
  • LMWH concurrently with a vitamin K antagonist (VKA) for at least 5 days, or until the INR is at least 2.0 in 2 consecutive readings, followed by a VKA on its own

Adapted from NICE NG158.1 See full guidance for further details.

NICE NG158 recommends ELIQUIS as an option for long-term anticoagulation for secondary prevention in appropriate patients:1

This is a recommendation taken from the full guidelines. See publication for further information.

1.4.8: For people who do not have renal impairment, active cancer, established triple positive antiphospholipid syndrome or extreme body weight (less than 50 kg or more than 120 kg):

  • offer continued treatment with the current anticoagulant if it is well tolerated or
  • if the current treatment is not well tolerated, or the clinical situation or person's preferences have changed, consider switching to apixaban if the current treatment is a direct-acting anticoagulant other than apixaban

* ELIQUIS should be used with caution in patients with severe renal impairment (CrCl 15–29 ml/min) for the treatment of DVT / PE and prevention of recurrent DVT / PE.2 ELIQUIS is not recommended in patients with CrCl <15 ml/min, or in patients undergoing dialysis.2

† Patients with active cancer can be at high risk of both venous thromboembolism and bleeding events. When ELIQUIS is considered for DVT or PE treatment in cancer patients, a careful assessment of the benefits against the risks should be made.2

‡ DOACs, including ELIQUIS are not recommended in patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.2

Duration of overall therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding.2

The decision to stop or continue anticoagulation should always include patient involvement.3

SMC DVT / PE advice for the use of ELIQUIS in VTE (SMC No. 1029/15) following a full submission states apixaban (ELIQUIS) is accepted for use within NHS Scotland for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.4

Determining which patients should be considered for long-term treatment for prevention of recurrent DVT / PE

NICE NG158 recommends considering stopping anticoagulation 3 months (3–6 months for people with active cancer) after a provoked DVT / PE (if the provoking factor is no longer present and the clinical course has been uncomplicated) defining it as:1

DVT or PE in a person with a recent (within 3 months) and transient major clinical risk factor for VTE, such as surgery, trauma, significant immobility (bedbound, unable to walk unaided or likely to spend a substantial proportion of the day in bed or in a chair), pregnancy or puerperium – or in a person who is having hormonal therapy (combined oral contraceptive pill or hormone replacement therapy).

NICE NG158 recommends considering continuing anticoagulation beyond 3 months (6 months for people with active cancer) after an unprovoked DVT / PE, defining it as:1

DVT or PE in a person with no recent major clinical risk factor for VTE (see provoked DVT or PE) who is not having hormonal therapy (combined oral contraceptive pill or hormone replacement therapy).

Avoid use of ELIQUIS during pregnancy and breastfeeding.2,5

The decision to stop or continue anticoagulation should be individually tailored and balanced against bleeding risk, taking into account individual patient preferences.6

ESC 2019 PE Guidance

In 2019, the ESC published recommendations helping to guide healthcare professionals when to consider / recommend extended anticoagulation in PE patients.5

The 2019 ESC guidelines show examples of transient / reversible and persistent risk factors for VTE, classified by the estimated risk of long-term recurrence:

FOOTNOTES

CrCl = Creatinine Clearance   DVT = Deep Vein Thrombosis   ESC = European Society of Cardiology   LMWH = Low Molecular Weight Heparin   NICE = National Institute for Health and Care Excellence   PE = Pulmonary Embolism   SMC = Scottish Medicine Consortium   VKA = Vitamin K Antagonist   VTE = Venous Thromboembolism

REFERENCES

  1. NICE Guideline NG158. Venous thromboembolic diseases: diagnosis, management and thrombophilia testing. March 2020.
  2. ELIQUIS® (apixaban) Summary of Product Characteristics. Available at www.medicines.org.uk.
  3. NICE Quality Standard (QS15). Patient experience in adult NHS services. February 2012.
  4. SMC advice. Apixaban 2.5 mg and 5 mg film-coated tablet (ELIQUIS) SMC No. (1029/15) February 2015.
  5. Konstandinides SV et al. Eur Heart J 2020: 41; 543–603.
  6. Mazzolai L et al. Eur Heart J 2018; 39: 4208–4218.
  7. Baglin T et al. Lancet 2003; 362: 523–526.
  8. Iorio A et al. Arch Intern Med 2010; 170: 1710–1716.