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Rivaroxaban demonstrates an increasingly favorable benefit–risk profile with advancing age in patients with NVAF or VTE.
A new analysis of randomized controlled trial data has confirmed that the anticoagulant rivaroxaban offers a favorable and increasingly positive benefit–risk profile in older adults with nonvalvular atrial fibrillation (NVAF) or venous thromboembolism (VTE), despite concerns about elevated bleeding risks with age. Using data from multiple landmark trials—ROCKET-AF for NVAF and the EINSTEIN series (deep vein thrombosis [DVT], pulmonary embolism [PE], Extension, and CHOICE) for VTE—the researchers assessed both thrombotic and bleeding outcomes across different age groups (<65, 65–75, and >75 years).
The evaluation focused on net clinical benefit, a composite outcome encompassing major ischemic and bleeding events. In ROCKET-AF, which compared rivaroxaban to warfarin in NVAF sufferers, rivaroxaban showed a consistent net benefit across all age groups, with the most substantial advantage witnessed in those over 75 (−150 events per 10,000 patient-years). Similar findings emerged from the pooled EINSTEIN DVT and PE data, where rivaroxaban decreased the combined incidence of recurrent VTE and major bleeding, particularly in older patients (−544 events per 10,000 in those >75 years).
Extended treatment results from EINSTEIN-Extension (rivaroxaban vs placebo) revealed consistently lower event rates with rivaroxaban, again showing increasing benefit with age (up to −601 per 10,000 patients). In EINSTEIN CHOICE, both rivaroxaban 20 mg and 10 mg outperformed aspirin in preventing recurrent VTE with an acceptable bleeding risk, especially in older age groups. These findings underscore rivaroxaban’s overall benefit in older populations, offering reassurance to clinicians weighing stroke and VTE prevention against bleeding risk. The data suggest that advancing age, rather than tipping the scale against anticoagulation, may actually boost rivaroxaban's clinical value.
Drugs & Aging
Benefit–Risk Assessment of Rivaroxaban in Older Patients With Nonvalvular Atrial Fibrillation or Venous Thromboembolism
Paul P. Dobesh et al.
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