Comparative effectiveness and safety of rivaroxaban with other oral anticoagulants in older adults with nonvalvular atrial fibrillation: population-based analysis in response to updated Beers Criteria.
Concerns have been raised regarding the updated Beers Criteria that recommended avoiding rivaroxaban use for long-term treatment of older adults with nonvalvular atrial fibrillation (AF).
We sought to compare the effectiveness and safety of rivaroxaban with oral anticoagulants in older adults with nonvalvular AF.
We used an administrative healthcare database and included adults with AF aged ≥65 years who were new users of rivaroxaban or the comparators. We created 3 pairwise comparisons: rivaroxaban vs warfarin; rivaroxaban vs dabigatran; and rivaroxaban vs apixaban. Study outcomes included stroke or systemic embolism (effectiveness) and gastrointestinal or intracranial bleeding (safety). In the propensity score-matched sample, we used Cox proportional hazards regression to estimate hazard ratios (HRs) and 95% CIs.
In the matched cohorts, use of rivaroxaban (vs warfarin) increased risk of bleeding (HR, 1.13; 95% CI, 1.03-1.23) with no difference in ischemic stroke or systemic embolism (HR, 0.90; 95% CI, 0.79-1.02); use of rivaroxaban (vs dabigatran) increased risk of bleeding (HR, 1.18; 95% CI, 1.03-1.35) with no difference in ischemic stroke and systemic embolism (HR, 1.00; 95% CI, 0.83-1.22); and use of rivaroxaban (vs apixaban) increased risk of stroke and systemic embolism (HR, 1.23; 95% CI, 1.08-1.40) and bleeding (HR, 1.60; 95% CI, 1.45-1.76).
In this comparative effectiveness and safety study of older adults with nonvalvular AF, use of rivaroxaban was associated with a significantly increased risk of ischemic stroke and systemic embolism compared with apixaban and bleeding compared with warfarin, dabigatran, and apixaban. Our findings may inform anticoagulant selection in older adults with nonvalvular AF.
Dawwas GK
，Cuker A
《-》
Comparative Effectiveness and Safety of Direct Oral Anticoagulants vs Warfarin among Nursing Home Residents with Atrial Fibrillation: A Retrospective Cohort Study.
Residents of nursing homes are usually excluded from clinical trials, including trials to assess treatments for common conditions such as nonvalvular atrial fibrillation (NVAF). We aimed to quantify the real-world comparative safety and effectiveness of direct-acting oral anticoagulants (DOACs) vs warfarin among nursing home residents with NVAF.
Retrospective cohort study using 100% national Minimum Data Set and linked Medicare claims from January 2011 through December 2018.
Long-term care nursing home residents aged ≥66 years enrolled in fee-for-service Medicare. We included individuals diagnosed with NVAF newly initiating oral anticoagulants.
We identified exposure to DOACs (apixaban, dabigatran, rivaroxaban, and edoxaban) vs warfarin. Outcomes were hospitalization for ischemic stroke/systemic embolism, major bleeding, pneumonia (negative control outcome), and all-cause death. We used inverse probability of treatment weighting competing risk regression models for clinical outcomes and Cox proportional hazards regression for all-cause death.
Of 38,983 individuals newly initiating anticoagulants, 19,366 (49.7%) initiated DOACs and 19,617 (50.3%) initiated warfarin. In the inverse probability of treatment weighting analysis, compared with warfarin, there was no statistically significant association between DOAC use and ischemic stroke/systemic embolism [4.5 vs 4.7 events per 100 person-years; adjusted hazard ratio (aHR), 0.94; 95% CI, 0.84-1.05] or major bleeding (12.6 vs 12.4 events per 100 person-years; aHR, 1.03; 95% CI, 0.96-1.10). DOACs use was associated with a modest but statistically significant lower risk of all-cause death (48.1 vs 49.0 events per 100 person-years; IPTW analysis aHR, 0.95; 95% CI, 0.91-0.98).
Among nursing home residents with NVAF, DOACs and warfarin were associated with a similar risk of ischemic stroke/systemic embolism and major bleeding. However, the use of DOACs was associated with a slightly reduced risk of all-cause mortality.
Mehta HB
，Xiao X
，An H
，Alexander GC
... -
《-》
Comparative safety and effectiveness of oral anticoagulants in patients with non-valvular atrial fibrillation and high risk of gastrointestinal bleeding: A nationwide French cohort study.
This observational study compared effectiveness and safety of direct oral anticoagulants (DOACs; apixaban, rivaroxaban, dabigatran) or vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF) at high risk for gastrointestinal bleeding (GIB).
Anticoagulant-naïve adults with NVAF with ≥1 GIB risk factor, initiating anticoagulant treatment January 2016-December 2019, and covered by the French national health data system were eligible. Outcomes included major bleeding (MB) and stroke/systemic embolism (SE). Patient characteristics were balanced using propensity score matching.
A total of 314,184 patients were identified with 162,150 (51.5%) in the apixaban cohort, 88,427 (28.1%) in the rivaroxaban cohort, 16,465 (5.2%) in the dabigatran cohort, and 47,142 (15.0%) in the VKA cohort (mean age 79.0 years, standard deviation 10.5; 51.0% female). A total of 45,124 apixaban-VKAs, 38,737 rivaroxaban-VKAs, 16,415 dabigatran-VKAs, 88,414 apixaban-rivaroxaban, 16,464 apixaban-dabigatran, and 16,459 rivaroxaban-dabigatran pairs were retained after propensity score matching. Apixaban had lower risk of MB versus dabigatran (hazard ratio [HR], 0.72; 95% confidence interval [CI], 0.63-0.83) and rivaroxaban (HR, 0.63; 95% CI, 0.59-0.66). Apixaban had lower risk of GIB versus dabigatran (HR, 0.46; 95% CI, 0.37-0.56) and rivaroxaban (HR, 0.54; 95% CI, 0.49-0.59). Risk of GIB was similar with dabigatran versus rivaroxaban (HR, 1.05; 95% CI, 0.89-1.24). Apixaban had lower risk of stroke/SE versus rivaroxaban (HR, 0.90; 95% CI, 0.84-0.96), while risk was similar versus dabigatran (HR, 1.1; 95% CI, 0.9-1.3). All DOACs had lower risk of MB and stroke/SE versus VKAs (p<0.001 for all).
DOACs had improved safety and effectiveness from bleeding and stroke/SE, respectively, versus VKAs among patients with NVAF at high risk for GIB. Apixaban was associated with lower MB and GIB risk versus other DOACs. For stroke/SE, apixaban was associated with reduced risk versus rivaroxaban and similar risk versus dabigatran.
Lip GYH
，Benamouzig R
，Martin AC
，Pesce G
，Gusto G
，Quignot N
，Khachatryan A
，Dai F
，Sedjelmaci F
，Chaves J
，Subash R
，Mokgokong R
... -
《PLoS One》
ResearchGate
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