September 30, 2019

European Society of Cardiology recommends (rivaroxaban) XARELTO® 2.5 mg plus acetylsalicylic acid for patients at high risk of heart attacks, strokes and death due to chronic coronary syndromes

  • Clinical practice guidelines from the European Society of Cardiology (ESC) recommend XARELTO® vascular dose (2.5 mg twice daily) plus acetylsalicylic acid (ASA) low dose once daily in the management of patients with chronic coronary syndromes (CCS) as well as for patients with diabetes and lower extremity arterial disease
  • New guidelines include a change in nomenclature from ‘stable coronary artery disease’ to ‘chronic coronary syndromes’ to better reflect the continuous high risk of heart attacks, strokes and death within this patient population

MISSISSAUGA, ON, September 30, 2019 – The European Society of Cardiology (ESC) has published new clinical practice guidelines on the management of diabetes and ‘chronic coronary syndromes (CCS)’, which replace the 2013 recommendations for the management of stable coronary artery disease (CAD). The guidelines now recommend that treatment with XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily) plus acetylsalicylic acid (ASA) low dose once daily should be considered in the treatment of patients with chronic coronary syndromes at high risk of further events and low risk of bleeding. Another new ESC guideline addressing diabetes also includes such a recommendation for this regimen in patients with diabetes and lower extremity arterial disease. A new analysis of the COMPASS study published in the Journal of the American College of Cardiology in July this year has demonstrated that patients with high risk factors benefited most from dual pathway inhibition with XARELTO® and ASA.[i]

Professor John Eikelboom, Associate Professor, Division of Hematology & Thromboembolism, Department of Medicine, McMaster University in Hamilton, Ontario, said: “Chronic coronary syndromes remain a leading cause of morbidity and mortality worldwide. It´s a progressive condition that is never stable. Adding new treatment recommendations, including the Class IIa recommendation for XARELTO® in combination with ASA, to the updated ESC clinical practice guidelines is therefore a significant step forward in the management of CCS and increases opportunities for patients to benefit from new treatment options.”

Adding a second antithrombotic drug, like XARELTO®, to ASA is now recommended for patients with multi vessel CAD with at least one of the following risk factors: peripheral arterial disease (PAD), recurrent myocardial infarction, diabetes mellitus requiring medication or chronic kidney disease (CKD). It is also recommended for patients with a previous myocardial infarction who are at high risk of ischemic events and have a low risk of bleeding.

In patients with diabetes and chronic symptomatic lower extremity arterial disease - which represents the majority of patients with PAD - without high bleeding risk, the combination of XARELTO® vascular dose and ASA should be considered. The ESC guidelines on CCS and diabetes are the first international guidelines to recommend XARELTO® vascular dose plus ASA.

The new guidelines also include a change in nomenclature from stable coronary artery disease to CCS. The change reflects the reality that these patients with CCS are at continuous risk for heart attacks and strokes. The underlying disease status of coronary artery disease, atherosclerotic plaque accumulation, is a dynamic process that can lead to life threatening thrombotic events including strokes and heart attacks, which remain the main cause of death worldwide.

This recommendation is based on data from the Phase III COMPASS study, which showed that rivaroxaban vascular dose of 2.5mg twice daily, plus ASA 100 mg once daily reduced the composite risk of stroke, cardiovascular death and heart attack by 24% (relative risk reduction) compared with ASA 100 mg once daily alone in patients with CAD or PAD,[ii] including a 42% relative risk reduction in stroke and an 18% mortality reduction. The Phase III randomized controlled COMPASS study was published in 2017, after it was stopped one year ahead of schedule due to overwhelming efficacy.

A new analysis of the COMPASS study published in the Journal of the American College of Cardiology in July of this year demonstrated that the protection provided by XARELTO® vascular dose plus ASA 100 mg once daily is especially pronounced in patients with at least one of the following risk factors: involvement of two or more vascular beds, diabetes, renal impairment, or a history of heart failure. These patients had a two-fold increase in vascular events when compared to those individuals without these risk factors.

“We are pleased to see that the ESC recognizes the benefits that adding XARELTO® 2.5 mg twice daily on top of ASA can bring to patients and included the treatment in its updated 2019 guidelines just two years after the COMPASS study was published,” said Dr Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG’s Pharmaceuticals Division and Chief Medical Officer. “The vascular dose (XARELTO® 2.5 mg twice daily) plus ASA provides us with a major opportunity to change clinical practice and better treat patients suffering from CAD and/or PAD”.

The guidelines also emphasize the crucial role of healthy lifestyle behaviors, medication and other preventive actions in decreasing the risk of subsequent cardiovascular events and mortality.

About XARELTO® (rivaroxaban)

Rivaroxaban is a non-vitamin K antagonist oral anticoagulant (NOAC), which helps to prevent blood from clotting, and is marketed under the brand name XARELTO®. XARELTO® is approved for four indications in Canada:

XARELTO® (rivaroxaban) film-coated tablet (10 mg, 15 mg, 20 mg) is indicated for the:

  • prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip replacement (THR) or total knee replacement (TKR) surgery.
  • treatment of venous thromboembolic events (deep vein thrombosis [DVT], pulmonary embolism [PE]) and prevention of recurrent DVT and PE.
  • prevention of stroke and systemic embolism in patients with atrial fibrillation, in whom anticoagulation is appropriate.

XARELTO® (rivaroxaban) film-coated tablet (2.5 mg), in combination with 75 mg – 100 mg acetylsalicylic acid (ASA), is indicated for the:

  • prevention of stroke, myocardial infarction and cardiovascular death, and for the prevention of acute limb ischemia and mortality in patients with coronary artery disease (CAD) with or without peripheral artery disease (PAD).

While licences may differ from country to country, across all indications, XARELTO® is approved in more than 130 countries.

Rivaroxaban was discovered by Bayer, and is being jointly developed with Janssen Research & Development, LLC. XARELTO® is marketed outside the U.S. by Bayer and in the U.S. by Janssen Pharmaceuticals, Inc. (Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson).

Anticoagulant medicines are potent therapies used to prevent or treat serious illnesses and potentially life-threatening conditions. Before initiating therapy with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.

The full product monograph is available here https://www.bayer.ca/omr/online/XARELTO®-pm-en.pdf.

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[i] Anand SS, Eikelboom JW, Dyal L, et al. J Am Coll Cardiol 2019; 73(25):3271-3280

[ii] Eikelboom, JW, Connolly SJ, Bosch J, et al. N Engl J Med 2017; 377:1319-1330.