Key result
DOACs probably reduce mortality ~11% vs control in older AF patients, with variable bleeding risks.
Why the study?
Balancing stroke prevention and bleeding risk in atrial fibrillation is challenging, prompting an assessment of the safety of long-term DOAC use in older adults.
Do direct oral anticoagulants reduce mortality and bleeding compared to vitamin K antagonists, aspirin, or placebo in older adults (≥ 65 years) with atrial fibrillation?
Meta-Analysis (n=63,374)
Do direct oral anticoagulants reduce mortality and bleeding compared to vitamin K antagonists, aspirin, or placebo in older adults (≥ 65 years) with atrial fibrillation?
In older adults (≥ 65 years) with atrial fibrillation, DOACs probably reduce mortality compared to standard care, and low-dose DOACs likely reduce bleeding risk, though bleeding risk varies widely with high-dose DOACs and may increase in the very old (≥ 85 years).
Balancing stroke prevention and risk of bleeding in patients with atrial fibrillation (AF) is challenging. Direct oral anticoagulants (DOACs) are by now considered standard of care for treating patients with AF in international guidelines. Our objective was to assess the safety of long-term intake of DOACs in older adults with AF. We included RCTs in elderly (≥ 65 years) patients with AF. A systematic search in MEDLINE and EMBASE was performed on 19 April 2022. For determination of risk of bias, the RoB 2 tool was applied. We pooled outcomes using random-effects meta-analyses. The quality of evidence was assessed using GRADE. Eleven RCTs with a total of 63,374 patients were identified. Two RCTs compared apixaban with either warfarin or aspirin, four edoxaban with either placebo, aspirin, or vitamin K antagonists (VKAs), two dabigatran with warfarin and three rivaroxaban with warfarin. DOACs probably reduce mortality in elderly patients with AF (HR 0.89 95%CI 0.77 to 1.02). Low-dose DOACs likely reduce bleeding compared to VKAs (HR ranged from 0.47 to 1.01). For high-dose DOACS the risk of bleeding varied widely (HR ranged from 0.80 to 1.40). We found that low-dose DOACs probably decrease mortality in AF patients. Moreover, apixaban and probably edoxaban are associated with fewer major or clinically relevant bleeding (MCRB) events compared to VKAs. For dabigatran and rivaroxaban, the risk of MCRB varies depending on dose. Moreover, subgroup analyses indicate that in the very old (≥ 85) the risk for MCRB events might be increased when using DOACs.Registration: PROSPERO: CRD42020187876.
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Doni et al. (2023) conducted a meta-analysis in Atrial fibrillation in older adults (n=63,374). Direct oral anticoagulants (DOACs) vs. Vitamin K antagonists, aspirin, or placebo was evaluated on All-cause mortality (HR 0.89, 95% CI 0.77 to 1.02). Direct oral anticoagulants probably reduce mortality (HR 0.89) in older adults with atrial fibrillation compared to control treatments, while the risk of major bleeding varies depending on the dose and specific agent.
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