BACKGROUND: Based on the results from randomized controlled trials (RCTs), new oral anticoagulants (NOACs) seem attractive alternatives to vitamin K antagonists (VKAs) because of their effectiveness, safety, and ease of use. However, the use of NOACs in unselected elderly patients with atrial fibrillation (AF) in primary care is arguable. OBJECTIVES: To assess the evidence for the effectiveness and safety of NOACs compared with VKAs in elderly patients with nonvalvular AF in primary care. METHODS: Starting from the meta-analysis of Ruff et al. (Lancet 2014;383:955-62), we used the GRADE-approach to make a transparent and explicit judgement of the quality of evidence. RESULTS: The meta-analysis reviewed four non-inferiority RCTs, including 58 634 AF patients with an average age of 70-73 years. Inconsistency of results, indirectness of evidence, and imprecision of risk reductions resulted in downgrading of the quality of evidence available from these studies. The quality of evidence for a decrease in all-cause stroke and systemic embolism (RR: 0.81; 95%CI: 0.73-0.91) for elderly patients using NOACs compared to VKAs in routine primary care was low. The quality of evidence for a lower risk for haemorrhagic stroke (RR: 0.49; 95% CI: 0.38-0.64) and for a lower risk of intracranial bleeding (RR: 0.48; 95% CI: 0.39-0.59) was moderate. CONCLUSION: There is uncertainty about effectiveness and safety of NOACs in unselected elderly patients with AF in primary care. Therefore, the balance between benefit and harm is still unclear. For this reason, routine use of NOACs is not recommended in elderly patients in primary care.
BACKGROUND: Based on the results from randomized controlled trials (RCTs), new oral anticoagulants (NOACs) seem attractive alternatives to vitamin K antagonists (VKAs) because of their effectiveness, safety, and ease of use. However, the use of NOACs in unselected elderly patients with atrial fibrillation (AF) in primary care is arguable. OBJECTIVES: To assess the evidence for the effectiveness and safety of NOACs compared with VKAs in elderly patients with nonvalvular AF in primary care. METHODS: Starting from the meta-analysis of Ruff et al. (Lancet 2014;383:955-62), we used the GRADE-approach to make a transparent and explicit judgement of the quality of evidence. RESULTS: The meta-analysis reviewed four non-inferiority RCTs, including 58 634 AFpatients with an average age of 70-73 years. Inconsistency of results, indirectness of evidence, and imprecision of risk reductions resulted in downgrading of the quality of evidence available from these studies. The quality of evidence for a decrease in all-cause stroke and systemic embolism (RR: 0.81; 95%CI: 0.73-0.91) for elderly patients using NOACs compared to VKAs in routine primary care was low. The quality of evidence for a lower risk for haemorrhagic stroke (RR: 0.49; 95% CI: 0.38-0.64) and for a lower risk of intracranial bleeding (RR: 0.48; 95% CI: 0.39-0.59) was moderate. CONCLUSION: There is uncertainty about effectiveness and safety of NOACs in unselected elderly patients with AF in primary care. Therefore, the balance between benefit and harm is still unclear. For this reason, routine use of NOACs is not recommended in elderly patients in primary care.