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ROCKET AF: Xarelto similar to warfarin for safety, efficacy in elderly patients
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The efficacy and safety of rivaroxaban relative to warfarin did not differ with age, which suggests that rivaroxaban is a viable alternative in patients aged at least 75 years, according to new data from the ROCKET AF trial.
In a prespecified secondary analysis, researchers compared the performance of rivaroxaban (Xarelto, Janssen Pharmaceuticals) with warfarin in the ROCKET AF population aged at least 75 years and compared outcomes of that subgroup with those of younger patients in the trial.
All patients had nonvalvular atrial fibrillation and at least two risk factors for stroke.
Forty-four percent (n=6,229) of the study population was aged at least 75 years. All patients were randomly assigned warfarin (target international normalized ratio: 2-3) or rivaroxaban 20 mg daily (15 mg daily if creatinine clearance <50 mL/min). The primary endpoint was stroke or systemic embolism.
Outcomes worse in older patients
Jonathan L. Halperin
Jonathan L. Halperin, MD,
from the Icahn School of Medicine at Mount Sinai, and colleagues found that, compared with younger patients, those aged at least 75 years had a higher rate of the primary outcome (2.57% per 100 patient-years vs. 2.05% per 100 patient-years; P=.0068) and a higher rate of major bleeding (4.63% per 100 patient-years vs. 2.74% per 100 patient-years; P<.0001).Rates of stroke and systemic embolism were consistent between patients assigned rivaroxaban and warfarin, whether aged at least 75 years (rivaroxaban, 2.29% per 100 patient-years; warfarin, 2.85% per 100 patient-years; HR=0.8; 95% CI, 0.63-1.02) or younger than 75 years (rivaroxaban, 2% per 100 patient-years; warfarin, 2.05% per 100 patient-years; HR=0.95; 95% CI, 0.76-1.19).
Rates of major bleeding between patients assigned rivaroxaban and warfarin were also similar, whether they were aged at least 75 years (rivaroxaban, 4.86% per 100 patient-years; warfarin, 4.4% per 100 patient-years; HR=1.11; 95% CI, 0.92-1.34) or younger than 75 years (rivaroxaban, 2.69% per 100 patient-years; warfarin, 2.79% per 100 patient-years; HR=0.96; 95% CI, 0.78-1.19).
Rates of hemorrhagic stroke were similar across age and assigned anticoagulant. The researchers found no interaction between patient age and the relative safety of rivaroxaban vs. warfarin (P=.2654).
Pronounced benefit in elderly
“While there is no universally accepted method of calculating the net clinical benefit of antithrombotic therapy, one approach is based on the avoidance of ischemic stroke, severe (life-threatening) bleeding, including intracranial hemorrhage, and all-cause mortality,” Halperin and colleagues wrote. “When considered this way, the benefit of rivaroxaban compared with warfarin is more pronounced in elderly patients than in younger patients, mainly due to prevention of non-hemorrhagic stroke.
“Although rivaroxaban caused more clinically relevant non-major bleeding, it carried less risk of intracranial bleeding, a particular concern in the elderly,” they wrote. “Simplifying anticoagulation management in the elderly is a substantial advantage. The availability of rivaroxaban and other factor Xa inhibitors may allow anticoagulation of a higher proportion of high-risk elderly patients with AF, offering protection against stroke.”
Disclosure: The study was funded by Johnson & Johnson Pharmaceutical Research and Development and Bayer HealthCare. See the full study for a list of the researchers’ relevant financial disclosures.
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