Guidelines


Added reassurance from expert guidance


References:

  1. Konstantinides SV, et al. Eur Heart J. 2019;ehz405. doi:10.1093/eurheartj/ehz405.
  2. Khorana A, et al. J Thromb Haemost. 2018;16(9):1891–1894.
  3. Key N, et al. J Clin Oncol. 2019; JCO1901461. doi: 10.1200/JCO.19.01461.
  4. Farge D, et al. Lancet Oncol. 2019; e566–e581.

2019 ESC Guidelines for the Diagnosis and Management of Acute Pulmonary Embolism6


Reference:

  1. Konstantinides SV, et al. Eur Heart J. 2019;ehz405. doi:10.1093/eurheartj/ehz405.

How 2019 ESC Guidelines benefits your PE patients?

Implementation of the 2019 ESC Guidelines for Acute PE in your clinical practice

What is new for rivaroxaban and what evidence was considered in the 2019 ESC Guidelines for Acute PE

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


In August 2019, the European Society of Cardiology (ESC) 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 Xarelto in PE are1:

For patients without cancer1

  1. NOACs, such as Xarelto, are now first choice for anticoagulation in patients eligible for NOACs
  2. 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
  3. For extended anticoagulation, a reduced dose of Xarelto (10 mg once daily) can be considered after the first 6 months of treatment

For patients with cancer1

  1. Xarelto can be considered as an alternative to low-molecular weight heparin (LMWH), with the exception of patients with gastrointestinal cancer
  2. 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

For patients without cancer1:


1. NOACs, such a Xarelto are now first choice for anticoagulation in patients eligible for NOACs1

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 Xarelto, in preference to a vitamin K antagonist (VKA). This guideline receives the highest class and level of recommendation (IA).1

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

2. Carefully selected low-risk patients should be considered for early discharge and home treatment, as long as proper outpatient care and anticoagulation treatment can be provided1.

In addition to recommending a NOAC such as Xarelto 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 (HoTPE) study, a multicentre, single-arm, phase 4 trial, that found that early discharge and home treatment with Xarelto provides a balance of efficacy and safety in selected patients with acute low-risk PE.4

Figure 2. Recommendation for early discharge and home treatment, as per the 2019 ESC guidelines.1

3. For extended anticoagulation, a reduced dose of Xarelto (10mg once daily) can be considered after the first 6 months of treatment1.

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

Figure 3. 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 Xarelto in patients who have suffered a PE in the absence of cancer is shown below:1

Figure 4. Summary of the 2019 ESC guidelines relevant to PE patients eligible to receive Xarelto who do not have cancer.1

Footnotes- Xarelto is not recommended as an alternative to unfractionated heparin in patients with pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy since the safety and efficacy of Xarelto have not been established in these clinical situations

For patients with cancer:


1. Xarelto can be considered as an alternative to low-molecular weight heprin (LMWH), with the exception of patients with gastrointestinal cancer1.

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 gruelling treatment schedule. The 2019 ESC guidelines now recommend that Xarelto should be considered as an alternative to LMWH for at least 6 months, in patients who do not have gastrointestinal cancer.

Figure 5. Recommendations for the regimen and the duration of anticoagulation after PE in patients with active cancer, as per the 2019 ESC guidelines.1

2. Extended anticoagulation (beyond the first 6 months) should be considered for an indefinite period or until the cancer is cured1.

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 Xarelto in patients who have suffered a PE and have active cancer, is shown below:1

Figure 7. Summary of the 2019 ESC guidelines relevant to PE patients eligible to receive Xarelto 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 Xarelto over the acute and extended phases in PE patients with and without active cancer.1 Xarelto 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:

  1. Konstantinides SV, Meyer G, Becattini C, et al. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2019 Aug 31. Epub ahead of print.
  2. 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):2017–2023.
  3. Weitz JI, Lensing AWA, Prins MH, et al. Rivaroxaban or aspirin for extended treatment of venous thromboembolism. N Engl J Med 2017;376(13):1211–1222.
  4. 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 May 23. Epub ahead of print.
  5. Xarelto® (rivaroxaban). Summary of Product Characteristics, as approved by the European Commission.
  6. 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.

Role of Direct Oral Anticoagulants in the Treatment of Cancer-Associated Venous Thromboembolism: Guidance From the SSC of the ISTH7


Reference:

  1. Khorana A, et al. J Thromb Haemost. 2018;16(9):1891–1894. doi:10.1111/jth.14219

Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: ASCO Clinical Practice Guideline Update8


Reference:

  1. Key N, et al. J Clin Oncol. 2019; JCO1901461. doi: 10.1200/JCO.19.01461.

2019 International Clinical Practice Guidelines for the Treatment and Prophylaxis of Venous Thromboembolism in Patients With Cancer


Early maintenance (up to 6 months) and long term (beyond 6 months):9


Treatment of VTE recurrance in patients with cancer under anticoagulation:9


References

  1. Farge D, et al. Lancet Oncol. 2019; e566–e581. doi:10.1016/S1470-2045(19)30336-5.

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