Why the study?
Does rivaroxaban prevent recurrent VTE safely in older adults with DVT or PE compared to standard treatment or placebo?
Does rivaroxaban prevent recurrent VTE safely in older adults with DVT or PE compared to standard treatment or placebo?
Rivaroxaban is an effective and safe alternative to standard vitamin K antagonist therapy for the treatment and extended prevention of VTE in older adults, including those with renal insufficiency or fragility.
Supports rivaroxaban for extended VTE prevention in frail older adults; leaves open need for dedicated RCTs in renal insufficiency.
Rivaroxaban is a factor Xa inhibitor recently approved for use in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). Older adults are at an increased risk for venous thromboembolism (VTE), and rivaroxaban offers an alternative to standard treatment including vitamin K antagonists. This review evaluates the literature supporting this new indication with a focus on the safety and efficacy in older adults as well as those with renal insufficiency and fragility, which the EINSTEIN-PE study defined as those older than 75 years of age, weighing 50 kg or less, or with a creatine clearance (Clcr) of less than 50 mL/min. Three large studies (EINSTEIN-PE, -DVT, -EXT) provide an evaluation of recurrent VTE and bleeding events with the use of rivaroxaban. EINSTEIN-DVT and EINSTEIN-PE showed rivaroxaban to be equivalent to standard treatment in the overall population as well as in older adults and those with renal insufficiency and fragility. Further, EINSTEIN-EXT showed benefit of rivaroxaban over placebo for extended VTE protection (i.e., longer than 6 to 12 months of treatment), both overall and in the subgroups of those older than 75 years of age and with a Clcr of 50 mL/min to < 80 mL/min..
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Mitchell et al. (2014) studied this question.
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