Results from the phase III EINSTEIN CHOICE study presented at the American College of Cardiology (ACC) 66th Annual Scientific Session in Washington DC show that rivaroxaban (Xarelto® ▼) provides superior protection against recurrent venous thromboembolism (VTE) for patients who have completed 6 to 12 months of anticoagulation therapy (for pulmonary embolism or symptomatic deep vein thrombosis) than daily aspirin.
VTE affects approximately 1 in every 1,000 people in the UK1 and each year more than 25,000 people in the UK die from VTE.2 In patients with VTE, anticoagulation therapy is recommended for 3 months or longer, depending on the balance between the risk of recurrent VTE and the risk of bleeding. However, the risk for patients with unprovoked VTE or with ongoing risk factors experiencing a second event is up to 10% in the first year if treatment is stopped.3 The study, simultaneously published in The New England Journal of Medicine, demonstrated that 10 mg once daily of the oral Factor Xa inhibitor reduced relative risk of recurrent VTE by 74% compared with aspirin 100 mg once daily.
“This data is very significant for clinical practice as it helps to address an important question that arises daily. At the moment due to a lack of robust clinical evidence many doctors are reluctant to continue anticoagulation therapy for longer durations because of uncertainty around the benefit-risk balance,” comments Dr Alexander T. Cohen, Principal study investigator, Guys & St Thomas’ Hospitals, Kings College London. “The findings from EINSTEIN CHOICE demonstrate the benefit of prescribing rivaroxaban for the extended treatment of VTE. Once approved, rivaroxaban 10 mg once daily, alongside the currently approved 20 mg once daily, will provide doctors with an additional weapon in their armamentarium in the battle to reduce the risk of recurrent VTEs, alleviating some of the pressure on our hospitals, reducing VTE-related deaths and improving the quality of life for people who have experienced an unprovoked VTE or are living with ongoing risk factors.”
“The threat of a secondary VTE is very real for people who have stopped receiving treatment after 3, 6 or 12 months. A lot of the men and women we speak to describe a ‘dark cloud’ hanging over them as they fear the worst from the watch and hope for the best approach,” comments Professor Simon Noble, Thrombosis UK. “We welcome the data released today that will enable people who have had an unprovoked VTE, or who are at high risk, to live their lives with more certainty knowing that by receiving extended treatment their risk of a recurrent VTE is significantly reduced.”
Dr Luis Felipe Graterol, Medical Director, Bayer UK, said: “We are excited to see results that have such important implications for daily clinical practice. This reinforces our long-term commitment to cardiovascular health across both our current and future indications to help support better care and outcomes for people with cardiovascular disease in the UK. Bayer has a robust heritage in addressing unmet needs in cardiovascular health, and a strong pipeline of new indications that we hope will make a real difference in everyday clinical practice.”
- NHS England. Venous thromboembolism. Available at: https://www.england.nhs.uk/patientsafety/venous-thromb/ [Last accessed March 2017].
- National Clinical Guideline Centre – Acute and Chronic Conditions. 2010. Venous thromboembolism: reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to hospital.
- Weitz JI, Bauersachs R, Beyer-Westendorf J, et al. Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study. Thromb Haemost 2015;114:645-50.