Aim: Atrial fibrillation is the most commonly sustained cardiac arrhythmia, increasing the risk of stroke and systemic embolic events. This systematic review and network meta-analysis (NMA) aimed to compare real-world evidence (RWE) on the effectiveness and safety of edoxaban with other direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF) in Europe.
Materials & methods: Searches from January 2013 to December 2022 identified comparative observational studies assessing effectiveness/safety outcomes in patients with NVAF. Bayesian NMA estimated comparative effectiveness/safety of edoxaban with other DOACs and VKAs.
Results: The review identified 57 studies analyzing data from 24 unique databases; 33 studies were included in the base-case analyses. DOACs showed benefit over VKAs for most outcomes, of which major bleeding and all-cause mortality were most commonly reported. Edoxaban demonstrated a comparable effectiveness/safety profile to other DOACs and significantly reduced risk of major bleeding (hazard ratio [95% credible interval]: 0.67 [0.54, 0.84]) and intracranial hemorrhage (0.69 [0.51, 0.94]) versus rivaroxaban.
Conclusion: This NMA provides valuable insights into the real-world effectiveness and safety of DOACs and VKAs in Europe, supporting clinical decision-making and adding to the existing evidence base from clinical trials.
Keywords: Systematic review; direct oral anticoagulants; network meta-analysis; non-valvular atrial fibrillation; real-world evidence.
Plain language summary
Atrial fibrillation (AF) is a common heart problem that can cause strokes and blood clots. This study looked at how well and how safely the blood thinner edoxaban works compared to other blood thinners and vitamin K antagonists (VKAs) in people with AF living in Europe. Researchers reviewed studies from 2013 to 2022 and included European studies that compared these blood thinners in people with AF. They used an analytical method to estimate statistical comparisons of effectiveness and safety between treatments. A total of 57 studies were identified and 33 were included in the analysis. The results showed that most newer blood thinners (direct oral anticoagulants [DOACs]) were better than VKAs for preventing serious bleeding events and death. Edoxaban was found to be as effective and safe as other newer blood thinners and had a lower risk of major bleeding and bleeding in the brain compared with rivaroxaban. This study gives useful information about the real-world use of these blood thinners in Europe, which helps doctors make better treatment choices for their patients.
Keywords:oral anticoagulants; europe; systematic review; network meta-analysis