In patients with newly diagnosed atrial fibrillation, NOACs were associated with a lower risk of any bleeding (HR 0.85; 95% CI 0.73-0.98) and all-cause mortality compared to VKAs.
Observational (n=52,032)
Yes
Do NOACs reduce bleeding and mortality in patients with newly diagnosed atrial fibrillation compared to VKAs in real-world practice?
In a large, real-world global registry of patients with newly diagnosed atrial fibrillation, NOACs were associated with significantly lower risks of any bleeding and all-cause mortality compared to VKAs.
Hazard Ratio: 0.85 (95% CI 0.73–0.98)
In atrial fibrillation (AF), lower risks of death and bleeding with non-vitamin-K oral anticoagulants (NOACs) were reported in meta-analyses of controlled trials, but whether these findings hold true in real-world practice remains uncertain. Risks of bleeding and death were assessed in 52 032 patients with newly diagnosed AF enrolled in GARFIELD-AF (Global Anticoagulant Registry in the FIELD-Atrial Fibrillation), a worldwide prospective registry. Baseline treatment was vitamin K antagonists (VKAs) with or without antiplatelet (AP) agents (VKA ± AP) (20 151; 39.3%), NOACs ± AP agents (14 103; 27.5%), AP agents only (10 748; 21.0%), or no antithrombotics (6219; 12.1%). One-year follow-up event rates (95% confidence interval CI) of minor, clinically relevant nonmajor (CRNM), and major bleedings were 2.29 (2.16-2.43), 1.10 (1.01-1.20), and 1.31 (1.21-1.41) per 100 patient-years, respectively. Bleeding risk was lower with NOACs than VKAs for any bleeding (hazard ratio (HR) 95% CI), 0.85 0.73-0.98) or major bleeding (0.79 0.60-1.04). Compared with no bleeding, the risk of death was higher with minor bleeding (adjusted HR aHR, 1.53 1.07-2.19), CRNM bleeding (aHR, 2.59 1.80-3.73), and major bleeding (aHR, 8.24 6.76-10.04). The all-cause mortality rate was lower with NOACs than with VKAs (aHR, 0.73 0.62-0.85). Forty-five percent (114) of all deaths occurred within 30 days, and 40% of these were from intracranial/intraspinal hemorrhage (ICH). The rates of any bleeding and all-cause death were lower with NOACs than with VKAs. Major bleeding was associated with the highest risk of death. CRNM bleeding and minor bleeding were associated with a higher risk of death compared to no bleeding. Death within 30 days after a major bleed was most frequently related to ICH. This trial was registered at www.clinicaltrials.gov as #NCT01090362.
Bassand et al. (Fri,) conducted a observational in newly diagnosed atrial fibrillation (n=52,032). NOACs vs. VKAs was evaluated on any bleeding (HR 0.85, 95% CI 0.73-0.98). In patients with newly diagnosed atrial fibrillation, NOACs were associated with a lower risk of any bleeding (HR 0.85; 95% CI 0.73-0.98) and all-cause mortality compared to VKAs.