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Oral Anticoagulation Beneficial in Frail Patients With Atrial Fibrillation
Quick Takes
- Frail patients with AF are shown to derive a net clinical benefit from OAC treatment in a large retrospective cohort study compared to those not receiving an OAC.
- DOACs were associated with a reduced incidence of ischemic stroke, major bleeding, and cardiovascular death compared to warfarin in frail patients with AF.
Study Questions:
Are oral anticoagulants (OACs) safe and effective in frail patients with atrial fibrillation (AF)?
Methods:
This was a retrospective population-based cohort study of 232,946 OAC-naïve patients ≥65 years old with AF between January 1, 2013–December 31, 2016. Patients were identified from the national health claims database of the National Health Insurance Service of Korea. Exclusion criteria included valvular heart disease (mitral stenosis, prosthetic heart valves, or insurance claims for valve replacement or valvulopathy), end-stage renal disease, or concomitant antiplatelet use. The Hospital Frailty Score was calculated for all patients, with a score ≥5 indicating frailty. Propensity score weighting was used to account for differences between patients receiving OAC or not and across different OAC regimens. The primary outcome was a net adverse clinical endpoint (NACE) of first occurrence of ischemic stroke, major bleeding, or cardiovascular death. Secondary outcomes included the individual components of the NACE.
Results:
Frail patients (n = 83,635) tended to be older (mean age 78.5 years), female, have lower income, higher CHA2DS2-VASc scores, and more comorbidities compared to nonfrail patients (n = 68,071). A total of 28,547 frail patients received OAC treatment (16.7% dabigatran, 26.3% rivaroxaban, 17.2% apixaban, 5.3% edoxaban, and 34.4% received warfarin) for a mean follow-up of 15.1 ± 14.2 months compared to 55,088 frail patients receiving no OAC. Multivariable logistic regression identified younger age, male gender, high income, higher CHA2DS2-VASc, lower HAS-BLED, and lower Hospital Frailty Risk scores as factors independently associated with the likelihood of undergoing OAC treatment in frail AF patients.
A NACE was experienced by a total of 20,190 (24.1%) frail patients with AF, including 5,253 ischemic strokes, 7,424 major bleeds, and 8,142 cardiovascular deaths. OAC use in frail patients with AF was associated with overall lower risks of NACE (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.75-0.82), ischemic stroke (HR, 0.91; 95% CI, 0.86-0.97), and cardiovascular death (HR, 0.52; 95% CI, 0.49-0.55) with no significant difference in major bleeding (HR, 1.02; 95% CI, 0.95-1.1) compared to OAC nonusers. The weighted event rates for NACE were similar for the four direct oral anticoagulants (DOACs) with 24.8 per 100 person-years for edoxaban, 22.6 for rivaroxaban, 21 for apixaban, and 19.9 for dabigatran compared to 30.4 for warfarin. All four DOACs were associated with lower risks of NACE and each individual component compared to warfarin. Sensitivity analysis revealed OAC use was associated with lower risk of NACE in subgroups stratified according to age, gender, and history of stroke or intracranial hemorrhage, with the exception of CHA2DS2-VASc score 1-2 or HAS-BLED score <3.
Conclusions:
This study of frail patients with AF demonstrated that OAC treatment was associated with reduced risks of ischemic stroke and cardiovascular death without an increased risk of major bleeding, suggesting an overall positive net clinical benefit. The use of a DOAC was associated with lower incidence of thrombotic, bleeding, and mortality outcomes compared to warfarin.
Perspective:
Frail patients are commonly encountered in clinical practice and likely under-represented in clinical trial cohorts. Evaluating safe and effective treatment in this cohort of patients at high risk of adverse clinical events is essential, especially as our population ages. This large observational Asian nationwide cohort study in OAC-naïve frail AF patients suggests a favorable net clinical benefit of OAC treatment. These findings suggest that an OAC should be prescribed when indicated, regardless of frailty. Providers should consider that DOACs may be preferable in frail patients with AF due to a lower incidence of ischemic stroke, bleeding, or cardiovascular death compared to warfarin.
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Geriatric Cardiology, Prevention, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Novel Agents
Keywords: Aged, 80 and over, Anticoagulants, Arrhythmias, Cardiac, Atrial Fibrillation, Brain Ischemia, Dabigatran, Frail Elderly, Frailty, Geriatrics, Hemorrhage, Intracranial Hemorrhages, Ischemic Stroke, Patient Care Team, Risk Factors, Rivaroxaban, Secondary Prevention, Stroke, Thrombosis, Vascular Diseases, Warfarin
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