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PE ESC 2019 Guidelines

What’s changed for rivaroxaban in the 2019 update to the ESC guidelines?

The European Society of Cardiology (ESC) has just announced the release of its latest guidelines on the management of acute pulmonary embolism (PE), which have been updated for the first time since 2014. New and revised recommendations for the use of rivaroxaban in PE are:1

 

For patients without cancer1

 

  • NOACs, such as rivaroxaban, are now first choice for anticoagulation in patients eligible for NOACs
  • Carefully selected low-risk patients should be considered for early discharge and home treatment, as long as proper outpatient care and anticoagulant treatment can be provided
  • For extended anticoagulation, a reduced dose of rivaroxaban (10 mg once daily) can be considered after the first 6 months of treatment
     

For patients with cancer1

 

  • Rivaroxaban can be considered as an alternative to low-molecular weight heparin (LMWH), with the exception of patients with gastrointestinal cancer
  • Extended anticoagulation (beyond the first 6 months) should be considered for an indefinite period or until the cancer is cured

These updates are a reflection of the robustness of the evidence from well-conducted clinical trials, including select-d2, EINSTEIN CHOICE3 and HoT-PE.4

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You can start protecting eligible patients in the acute phase with first-line rivaroxaban1

To protect patients in that crucial acute phase after the initial PE event, the ESC 2019 guidelines recommend that eligible patients receive an NOAC, such as rivaroxaban, in preference to a vitamin K antagonist (VKA). This guideline receives the highest class and level of recommendation (IA).1

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Figure 1. Adapted recommendation for the initiation of anticoagulation in the acute phase treatment of intermediate- or low-risk patients, as per the 2019 ESC guidelines.1

Anticoagulant treatment for at least 3 months is recommended by ESC 2019 guidelines for all patients without cancer who have experienced PE.1

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Figure 2. Adapted recommendation for the regimen and duration of anticoagulation after pulmonary embolism in patients without cancer, as per the 2019 ESC guidelines.1

Protect patients with rivaroxaban from the comfort of their homes with early discharge and home treatment in selected low-risk patients1

In addition to recommending a NOAC such as rivaroxaban in the acute phase, the ESC 2019 guidelines also endorse the early discharge and home treatment with an anticoagulant of carefully selected low risk patients.1 This is based in part on the results of the Home Treatment of Pulmonary Embolism (HoT-PE) study, a multicentre, single-arm, phase 4 trial, that found that early discharge and home treatment with rivaroxaban provides a balance of efficacy and safety in selected patients with acute low-risk PE.4

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Figure 3. Recommendation for early discharge and home treatment, as per the 2019 ESC guidelines.1

Extended treatment with a reduced dose of rivaroxaban is recommended to provide protection from the devastation of a recurrent event1

To protect patients without cancer from a recurrent event, the ESC 2019 guidelines recommend using a reduced dose of a NOAC such as rivaroxaban 10 mg once daily.1 This recommendation reflects the data that shows that rivaroxaban provides protection that can stay the course, safe-guarding patients against catastrophic PE events, while keeping the risk of bleeding events minimal.3

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Figure 4. Recommendation for NOAC dose for extended anticoagulation, as per the 2019 ESC guidelines.1

This is in-line with the European label for rivaroxaban, which allows you the flexibility to tailor dosing to each patient’s individual risk by allowing a choice between 10 mg and 20 mg doses (in patients without a high risk of thrombosis).5

 

A summary of the ESC 2019 recommendations for the use of rivaroxaban in patients who have suffered a PE in the absence of cancer is shown below:1

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Figure 5. Summary of the 2019 ESC guidelines relevant to PE patients eligible to receive rivaroxaban who do not have cancer.1

You can protect patients with PE and cancer with rivaroxaban, so they can focus on what matters most

Patients with PE and cancer face the dual threat of an increased risk of PE recurrence and higher chance of major bleeding, compared with patients with PE who do not have a malignancy.6 In this delicate situation, patients who have suffered a PE and have cancer need a treatment that can protect them from these risks without adding to their already grueling treatment schedule. The 2019 ESC guidelines now recommend rivaroxaban as an alternative to LMWH for at least 6 months, in patients who do not have gastrointestinal cancer. Beyond 6 months, the recommendations ask you to consider anticoagulative therapy for an indefinite period or until the cancer is cured.1

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Figure 6. Recommendations for the regimen and the duration of anticoagulation after PE in patients with active cancer, as per the 2019 ESC guidelines.1

A summary of the ESC 2019 recommendations for the use of rivaroxaban in patients who have suffered a PE and have active cancer is shown below:1

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Figure 7. Summary of the 2019 ESC guidelines relevant to PE patients eligible to receive rivaroxaban who have active cancer.1

Summary

The updates to the ESC recommendations for the management of PE are strongly evidence-based, and reflect the strength of the clinical trial data that support the use of rivaroxaban over the acute and extended phases in PE patients with and without active cancer.1 Rivaroxaban can be your partner in protecting as many patients as you need to, for as long as they require it. It will help you protect their future and all they hold dear.

References
  • Konstantinides SV, et al. Eur Heart J. 2020;41:543–603. Konstantinides SV, et al. Eur Heart J. 2020;41:543–603. Return to content
  • Young AM, Marshall A, Thirlwall J, et al. Comparison of an oral Factor Xa inhibitor with low molecular weight heparin in patients with cancer with venous thromboembolism: results of a randomized trial (SELECT-D). J Clin Oncol. 2018;36(20):2017–23. Return to content
  • Weitz, J. I. et al., N Engl J Med 2017; 376:1211-223. Return to content
  • Barco S., Schmidtmann I., Ageno W. et al. Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban: an international multicentre single-arm clinical trial. Eur Heart J. 2019;00:1–10. Return to content
  • Xarelto® (rivaroxaban). Summary of Product Characteristics, as approved by the European Commission. Return to content
  • Prandoni P, Lensing AW, Piccioli A, et al. Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis. Blood. 2002;100(10):3484–8. Return to content

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