Efficacy and Safety of Rivaroxaban Compared With Warfarin Among Elderly Patients With Nonvalvular Atrial Fibrillation in the ROCKET AF Trial

Study Questions:

Are the efficacy and safety profiles of rivaroxaban for stroke prevention in atrial fibrillation (AF) similar for elderly and younger patients?


In the ROCKET AF trial, rivaroxaban (15-20 mg daily adjusted for renal function) was compared to warfarin for stroke prevention in 14,264 patients with AF at moderate-high risk of stroke. In this prespecified secondary analysis, the efficacy and safety outcomes were compared in older and younger patients.


A total of 6,229 patients (44%) ages ≥75 years experienced more stroke and systemic embolism (2.57% vs. 2.05%/100 patient-years, p = 0.0068) as well as more major bleeding (4.63% vs. 2.74%/100 patient-years, p < 0.0001) when compared to younger patients. In older patients, stroke and systemic embolism rates were similar between patients treated with rivaroxaban and warfarin (2.29% vs. 2.85%/100 patient-years; hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.63-1.02), as were major bleeding rates (4.86% vs. 4.40%/100 patient-years; HR, 1.11; 95% CI, 0.92-1.34). There was no interaction between age and rivaroxaban response.


The authors concluded that elderly patients had higher stroke and major bleeding rates than younger patients, but that the efficacy and safety of rivaroxaban relative to warfarin did not differ with age. They concluded that this analysis supports rivaroxaban as a safe and effective alternative to warfarin for stroke prevention in elderly AF patients.


This prespecified secondary analysis of the ROCKET AF study highlights two important aspects of AF in elderly patients. First, elderly AF patients are at increased risk of both bleeding and stroke. Second, the use of rivaroxaban appears to be as effective and safe in elderly patients as in younger patients. In general, practitioners should not avoid anticoagulants in elderly AF patients simply because of their increased bleeding risk. Instead, practitioners should remember that elderly AF patients are also at increased risk of stroke and appear to realize similar efficacy from rivaroxaban as warfarin. With fewer drug–drug interactions than warfarin, this analysis highlights the potential benefits of rivaroxaban for elderly AF patients.

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