Key result
Different regional anticoagulation strategies show no significant difference in major bleeding, mortality, or thromboembolism.
Why the study?
NOAC uptake was much lower and target INR for VKA was higher in the Netherlands than Belgium, prompting evaluation of the effect of these differing strategies on thromboembolism and bleeding.
Does a VKA-predominant anticoagulation strategy with higher target INR compared to a NOAC-predominant strategy affect thromboembolism, bleeding, and mortality in patients with new-onset atrial fibrillation?
Cohort (n=2,891)
Yes
Does a VKA-predominant anticoagulation strategy with higher target INR compared to a NOAC-predominant strategy affect thromboembolism, bleeding, and mortality in patients with new-onset atrial fibrillation?
Despite significant differences in anticoagulation strategies (VKA vs NOAC predominance and different INR targets) between the Netherlands and Belgium, there were no statistically significant differences in mortality, thromboembolism, or major bleeding.
Comparable outcomes despite anticoagulation strategy differences; leaves open whether VKA- or NOAC-predominant approaches affect major events in new-onset AF.
BACKGROUND: The uptake rate of non-vitamin K oral anticoagulants (NOAC) for the treatment of non-valvular atrial fibrillation (AF) was far lower in the Netherlands (NL) compared to Belgium (BE). Also, patients on VKA in NL were treated with a higher target international normalized ratio (INR) range of 2.5 to 3.5. OBJECTIVES: To explore the effect of these differences on thromboembolism (TE) and bleeding. METHODS: Data from the GARFIELD-AF registry was used. Patients with new-onset AF and ≥1 investigator-determined risk factor for stroke were included between 2010 and 2016. Event rates from 2 years of follow-up were used. At diagnosis in NL vs BE, 72.1% vs 14.6% received vitamin K antagonists (VKA) and 17.8% vs 65.5% NOACs, varying greatly across cohorts. Mean INR was 2.9 (±1.0) and 2.4 (±1.0) in NL and BE, respectively. Event rates per 100 patient-years in NL and BE, respectively, of all-cause mortality (3.38 vs 3.90; hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15), ischemic stroke/TE (0.82 vs 0.72; HR 1.14, 95% CI 0.62-2.11), and major bleeding (2.06 vs 1.54; HR 1.33, 95% CI 0.89-1.99) did not differ significantly. CONCLUSIONS: In GARFIELD-AF, despite similar characteristics, patients on anticoagulants were treated differently in NL and BE. Although the rate of major bleeding was 33% higher in NL, variations in bleeding, mortality, and TE rates were not statistically significant.
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Seelig et al. (2020) conducted a cohort in non-valvular atrial fibrillation (n=2,891). Dutch anticoagulation management strategy (predominantly VKA, higher INR target) vs. Belgian anticoagulation management strategy (predominantly NOAC, standard INR target) was evaluated on Major bleeding (events per 100 patient-years) (HR 1.33, 95% CI 0.89-1.99). Despite different anticoagulation strategies between the Netherlands and Belgium, variations in the rates of major bleeding (HR 1.33), all-cause mortality, and thromboembolism were not statistically significant.
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