Abstract
Patient frailty amongst patients with nonvalvular atrial fibrillation (NVAF) is associated with adverse health outcomes and increased risk of mortality. Additional evidence is needed to evaluate effective and safe NVAF treatment in this patient population. This subgroup analysis of the ARISTOPHANES study compared the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) amongst frail NVAF patients prescribed nonvitamin K antagonist oral anticoagulants (NOACs) or warfarin. This comparative retrospective observational study of frail, older NVAF patients who initiated apixaban, dabigatran, rivaroxaban or warfarin from 01JAN2013-30SEP2015 was conducted using Medicare and 3 US commercial claims databases. To compare each drug, 6 propensity score-matched (PSM) cohorts were created. Patient cohorts were pooled from 4 databases after PSM. Cox models were used to estimate hazard ratios (HR) of S/SE and MB. Amongst NVAF patients, 34% (N=150487) met frailty criteria. Apixaban and rivaroxaban were associated with a lower risk of S/SE vs warfarin (apixaban: HR: 0.61, 95% CI: 0.55-0.69; rivaroxaban: HR: 0.79, 95% CI: 0.72-0.87). For MB, apixaban (HR: 0.62, 95% CI: 0.57-0.66) and dabigatran (HR: 0.79, 95% CI: 0.70-0.89) were associated with a lower risk and rivaroxaban (HR: 1.14, 95% CI: 1.08-1.21) was associated with a higher risk vs warfarin. Amongst this cohort of frail NVAF patients, NOACs were associated with varying rates of stroke/SE and MB compared with warfarin. Due to the lack of real-world data regarding OAC treatment in frail patients, these results may inform clinical practice in the treatment of this patient population.
Highlights
Frailty is a clinical state characterized by loss of biological reserves, failure of homoeostatic mechanisms and increased vulnerability to negative health-related outcomes [1, 2]
Amongst this cohort of frail nonvalvular AF (NVAF) patients, non-vitamin K antagonist (VKA) oral anticoagulant (NOAC) were associated with varying rates of stroke/systemic embolism (SE) and major bleeding (MB) compared with warfarin
Clinical trials have demonstrated NOACs have noninferior rates of stroke/SE and MB compared with warfarin [35,36,37], and these trends are consistent amongst older (≥75 years) NVAF patients [38,39,40]
Summary
Frailty is a clinical state characterized by loss of biological reserves, failure of homoeostatic mechanisms and increased vulnerability to negative health-related outcomes [1, 2]. Atrial fibrillation (AF) is the most common arrhythmia amongst older patients and is associated with high frailty risk [4, 5]. Amongst AF patients, in addition to older age, frailty is associated with increased stroke incidence, mortality, symptom severity and length of hospital stay [1, 8,9,10]. The European Society of Cardiology guidelines for AF management specifies that frail and older patients are more likely to benefit from OAC than younger patients, and all available evidences show NOACs are noninferior to VKA treatment for cardiovascular risk [11]. Patient frailty amongst patients with nonvalvular atrial fibrillation (NVAF) is associated with adverse health outcomes and increased risk of mortality. Additional evidence is needed to evaluate effective and safe NVAF treatment in this patient population
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