title: Treatment of patients with acute deep vein thrombosis and/or pulmonary embolism: efficacy and safety of non-VKA oral anticoagulants in selected populations.
abstract: Venous thromboembolism (VTE), comprising deep vein thrombosis (DVT) and pulmonary embolism (PE), presents a large clinical burden. Prompt, effective and sustained anticoagulation is vital because of the risk of recurrent events, including life-threatening PE, and complications such as post-thrombotic syndrome and chronic thromboembolic pulmonary hypertension. Dual-drug standard therapy is effective; however, parenteral low molecular weight heparin, coupled with routine coagulation monitoring and dose adjustment of vitamin K antagonists (VKAs), presents challenges for patients and healthcare providers. Non-VKA oral anticoagulants provide a simplified option for VTE treatment. Phase III studies have investigated rivaroxaban and apixaban as single-drug approaches, and edoxaban and dabigatran in conjunction with initial heparin therapy. These agents demonstrated non-inferiority to standard therapy, and most showed significant reductions in major bleeding. However, clinical information is limited in patient subgroups, e.g. fragile patients or patients with renal impairment or cancer, who may be at higher risk of bleeding and/or VTE. A prespecified pooled analysis of the EINSTEIN DVT and EINSTEIN PE studies (8281 patients), undertaken to evaluate clinical outcomes with rivaroxaban versus standard therapy, confirmed the non-inferiority of rivaroxaban, with significant reductions in major bleeding and fewer intracranial and retroperitoneal bleeding events. Consistent efficacy and safety were observed with rivaroxaban, irrespective of fragility, cancer or clot severity. The introduction of the non-VKA oral anticoagulants and approval of rivaroxaban in the EU, US and Canada for the treatment and secondary prevention of DVT and PE offer the potential for improvements in effective care across a broad spectrum of patients with VTE.
authors.affiliation: Department of Cardiothoracic and Vascular Sciences, University of Padua, Padua, Italy. Electronic address: paoloprandoni@tin.it.
authors.forename: Paolo
authors.initials: P
authors.lastname: Prandoni
mesh_terms: D000208:Acute Disease; D000284:Administration, Oral; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D001777:Blood Coagulation / Q000187:drug effects; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D011655:Pulmonary Embolism / Q000188:drug therapy*; D020246:Venous Thrombosis / Q000188:drug therapy*
chemical_list: D000925:Anticoagulants
keywords: Deep vein thrombosis; Fragile; Low molecular weight heparin; Non-VKA oral anticoagulant; Pulmonary embolism; Vitamin K antagonist