Key result
Rivaroxaban was non-inferior to standard therapy for preventing recurrent symptomatic venous thromboembolism (2.1% vs 1.8%, p=0.003 for noninferiority) and reduced major bleeding by 50% in patients with acute pulmonary embolism.
Why the study?
Do non-vitamin K antagonist oral anticoagulants prevent recurrent venous thromboembolism in patients with acute pulmonary embolism?
Do non-vitamin K antagonist oral anticoagulants prevent recurrent venous thromboembolism in patients with acute pulmonary embolism?
Non-vitamin K antagonist oral anticoagulants offer an effective, safe, and convenient alternative to traditional anticoagulants for the emergency treatment of acute pulmonary embolism, without the need for routine coagulation monitoring.
May support rivaroxaban in acute PE; leaves open need for prospective validation beyond reviewed evidence.
Pulmonary embolism (PE) is potentially fatal and often requires emergency management. Because PE associated with shock and/or hypotension carries a high risk of sudden death, emergency clinicians must rapidly make a diagnosis and initiate appropriate therapeutic strategies, usually involving anticoagulant treatment. Traditional anticoagulants, such as heparins and vitamin K antagonists, although effective and recommended by guidelines, are associated with limitations. Several targeted, orally administered anticoagulants that may overcome some of these constraints have been developed recently and undergone analysis in randomised, phase III clinical trials. Rivaroxaban, a direct factor Xa inhibitor, was non-inferior to standard therapy with enoxaparin plus a vitamin K antagonist for the prevention of recurrent, symptomatic venous thromboembolism (VTE) in patients with acute PE and led to a 50% reduction in major bleeding. Dabigatran, a direct thrombin inhibitor, was also non-inferior to standard therapy for the prevention of recurrent VTE or VTE-related death when given after a parenteral anticoagulant and had a similar incidence of major bleeding. The results of a phase III study of apixaban, another direct factor Xa inhibitor, for the acute treatment of VTE are expected in the near future. Rivaroxaban is now approved in Europe and the US for the treatment of acute PE and prevention of recurrent VTE. This article reviews the current guidance on the treatment of PE with special focus on the emergency setting, and considers data regarding rivaroxaban and the other non-vitamin K antagonist oral anticoagulants and their potential role, including patients who are and are not appropriate for treatment with these agents. Issues such as drug interactions, reversal of anticoagulant effect and coagulation monitoring are also discussed.
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Goldstein et al. (2013) conducted a review in Acute symptomatic pulmonary embolism (n=4,832). Rivaroxaban vs. Enoxaparin plus a vitamin K antagonist was evaluated on Symptomatic, recurrent VTE (p=0.003 for noninferiority). Rivaroxaban was non-inferior to standard therapy for preventing recurrent symptomatic venous thromboembolism (2.1% vs 1.8%, p=0.003 for noninferiority) and reduced major bleeding by 50% in patients with acute pulmonary embolism.
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