Apixaban may be safer for older patients with AF vs. rivaroxaban
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Anticoagulation with rivaroxaban for patients with atrial fibrillation aged 65 years or more was associated with greater risk for major ischemic and hemorrhagic events compared with apixaban, according to data published in JAMA.
“Millions of patients with atrial fibrillation, the most common sustained cardiac arrhythmia, take oral anticoagulants to prevent strokes. The most commonly prescribed medications for this purpose are now rivaroxaban and apixaban, which are more convenient to use than warfarin, formerly the standard of care for stroke prevention in atrial fibrillation,” Wayne A. Ray, PhD, professor of health policy at the Vanderbilt University School of Medicine, told Healio. “However, there is controversy concerning the relative safety and efficacy of these, as there are no large trials comparing them directly. To provide data to inform clinical practice, we conducted a large study of comparative efficacy and safety.”
Researchers utilized computerized enrollment and claims files from 581,451 U.S. Medicare beneficiaries with AF who initiated anticoagulation with rivaroxaban (Xarelto, Janssen Pharmaceuticals) or apixaban (Eliquis, Bristol Myers Squibb/Pfizer) from January 2013 through November 2018 (mean age, 77 years; 50% women; 23% receiving reduced dose).
The primary outcome was a composite of major ischemic and hemorrhagic events and secondary outcomes included nonfatal extracranial bleeding and total mortality.
Rivaroxaban vs. apixaban for AF
Researchers reported that the adjusted rate of the primary outcome was 16.1 per 1,000 person-years for patients taking rivaroxaban compared with 13.4 per 1,000 person-years for those taking apixaban (HR = 1.18; 95% CI, 1.12-1.24)
Compared with apixaban, rivaroxaban was associated with greater risk for the individual components of the primary outcome including:
- major ischemic events (8.6 vs. 7.6 per 1,000 person-years; HR = 1.12; 95% CI, 1.04-1.2);
- hemorrhagic events (7.5 vs. 5.9 per 1,000 person-years; HR = 1.26; 95% CI, 1.16-1.36); and
- fatal extracranial bleeding (1.4 vs. 1 per 1,000 person-years; HR = 1.41; 95% CI, 1.18-1.7).
Compared with the apixaban group, patients with AF who were taking rivaroxaban had greater risk for secondary outcomes including:
- nonfatal extracranial bleeding (39.7 vs. 18.5 per 1,000 person-years; HR = 2.07; 95% CI, 1.99-2.15);
- fatal ischemic/hemorrhagic events (4.5 vs. 3.3 per 1,000 person-years; HR = 1.34; 95% CI, 1.21-1.48); and
- total mortality (44.2 vs. 41 per 1,000 person-years; HR = 1.06; 95% CI, 1.02-1.09)
Moreover, risk for the primary outcome was greater among patients taking rivaroxaban compared with apixaban, regardless of whether they were receiving a reduced dose (27.4 vs. 21 per 1,000 person-years; HR = 1.28; 95% CI, 1.16-1.4) or a standard dose (13.2 vs. 11.4 per 1,000 person-years; HR = 1.13; 95% CI, 1.06-1.21).
“Our study offers compelling evidence that apixaban is preferable to rivaroxaban for stroke prevention in patients with atrial fibrillation, with both reduced rates of severe bleeding complications as well as better efficacy for reducing stroke occurrence.” Ray told Healio. “Our opinion is that the totality of the data — the pivotal clinical trials, the anticoagulant pharmacokinetics, our and other observational studies — indicate that apixaban should be the preferred oral anticoagulant for stroke prevention in atrial fibrillation.”
‘Reasonable assurance’ of the efficacy and safety of apixaban
In a related editorial, Enrico G. Ferro, MD, clinical fellow in medicine at Beth Israel Deaconess Medical Center, and colleagues discussed the implications of these findings.
“In the absence of randomized trials directly comparing DOACs, the choice of DOAC in clinical practice settings is determined by clinician preference, local practices, and insurance coverage,” Ferro and colleagues wrote. “This apparent randomness of treatment selection can be exploited to examine the comparative effectiveness of these treatments.
“The report by Ray et al in this issue of JAMA represents the largest and most contemporary evidence from clinical settings on the differential effectiveness and safety associated with apixaban and rivaroxaban,” the authors wrote. “In the prescient words of Askey and Cherry, these investigators may have provided “reasonable assurance” that apixaban is more effective and safer than rivaroxaban for patients with atrial fibrillation.”
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