Why the study?
Does oral rivaroxaban improve outcomes compared to standard of care in patients with acute symptomatic pulmonary embolism?
Does oral rivaroxaban improve outcomes compared to standard of care in patients with acute symptomatic pulmonary embolism?
Oral rivaroxaban offers a simplified, effective, and safer alternative to standard enoxaparin/VKA therapy for the treatment of acute symptomatic pulmonary embolism.
May support rivaroxaban in acute PE; leaves open prospective confirmation in dedicated trials.
Pulmonary embolism (PE), which can develop as a consequence of deep vein thrombosis (DVT), is a serious and potentially fatal venous thromboembolic event. Patients with PE are at increased risk of venous thromboembolism (VTE) recurrence and serious complications such as chronic thromboembolic pulmonary hypertension. Anticoagulants, namely heparins and vitamin K antagonists (VKAs), have been the main treatments for PE in patients who are haemodynamically stable. However, use of these agents can be complex and is associated with an increased risk of bleeding (a characteristic that is common to all anticoagulants). Simplified, effective treatment regimens for PE would be very beneficial for patients, physicians and payers. Compared with DVT, PE is a different clinical manifestation of VTE; phase III trials have now started to focus specifically on patients with PE. Trials in patients with PE can provide further information on the optimal management of these patients. Results of the phase III EINSTEIN PE study demonstrated non-inferiority in the efficacy and safety of oral rivaroxaban compared with standard of care (enoxaparin/VKA) for the treatment of patients with acute symptomatic PE (with or without symptomatic DVT). Rates of major bleeding were significantly lower in patients receiving rivaroxaban. This review will discuss the findings of recent trials, particularly the potential impact of single, oral agents for both the initial and long-term treatment of a range of patients with PE, and how these results may influence the clinical management of PE.
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Paolo Prandoni (2012) studied this question.
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