Key result
In patients with AF, declining renal function was associated with decreased dabigatran prescriptions, though stroke and major bleeding rates in dabigatran users remained low across CrCl categories.
Why the study?
Anticoagulation management in patients with AF and impaired renal function is challenging, prompting evaluation of prescription patterns by renal function and 2-year outcomes among dabigatran users.
Does dabigatran maintain low rates of stroke and major bleeding across different categories of renal impairment in patients with newly diagnosed atrial fibrillation?
Observational (n=15,308)
Yes
Does dabigatran maintain low rates of stroke and major bleeding across different categories of renal impairment in patients with newly diagnosed atrial fibrillation?
In patients with newly diagnosed AF, declining renal function is associated with increased VKA and decreased dabigatran prescription, though dabigatran maintains low rates of stroke and major bleeding across renal impairment categories.
Dabigatran use declined with worsening renal function in AF; hypothesis-generating for safety across CrCl and requires prospective confirmation.
Objective Anticoagulation management in patients with atrial fibrillation (AF) and impaired renal function is challenging. This study aimed to evaluate anticoagulation prescription patterns in relation to renal function and to describe 2-year clinical outcomes among dabigatran users. Methods Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) is an international, prospective, and observational study program involving patients with newly diagnosed AF at risk for stroke. Prescription patterns were assessed by creatinine clearance (CrCl) at enrollment. Dabigatran users were followed for 2 years. Clinical outcomes were standardized for stroke and bleeding risk, based on CHA2DS2-VASc and HAS-BLED scores, with missing values imputed. Results Baseline CrCl values were available for 12,056 of 15,308 eligible patients (79%). With declining renal function, prescriptions increased for vitamin K antagonists (VKAs) and decreased for dabigatran (30–47% and 34–12%, respectively). The prescription of other non-vitamin K antagonists remained similar across CrCl groups (14–19%). In 4,873 dabigatran users, standardized stroke rates were low across all CrCl groups; 0.58/100 patient-years (95% confidence interval [CI]: 0.30–0.90) in CrCl ≥80 mL/min, 0.85 (95% CI: 0.48–1.21) in CrCl 50 to 79 mL/min, and 0.33 (95% CI: 0.06–1.11) in CrCl 30 to 49 mL/min. Similarly, major bleeding rates were low and numerically increased with declining renal function (0.68/100 patient-years, 95% CI: 0.39–1.03; 0.92, 95% CI: 0.58–1.32; and 1.26, 95% CI: 0.66–1.97, respectively). Conclusion In patients with AF, VKA prescriptions increased and dabigatran prescriptions decreased with declining renal function. Rates of stroke and major bleeding in dabigatran patients remained low across the categories of renal impairment.
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Wall et al. (2021) conducted an observational in Atrial Fibrillation (n=15,308). Dabigatran vs. Vitamin K antagonists and other non-vitamin K antagonists was evaluated on Standardized stroke and major bleeding rates. In patients with AF, declining renal function was associated with decreased dabigatran prescriptions, though stroke and major bleeding rates in dabigatran users remained low across CrCl categories.
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