Standard and reduced doses of dabigatran, rivaroxaban and apixaban for stroke prevention in atrial fibrillation: a nationwide cohort study
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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Standard and reduced doses of dabigatran, rivaroxaban and apixaban for stroke prevention in atrial fibrillation : a nationwide cohort study. / Staerk, L; Gerds, T A; Lip, G .Y. H.; Ozenne, B.; Bonde, A. N.; Lamberts, M.; Fosbøl, E. L.; Torp-Pedersen, C.; Gislason, G. H.; Olesen, J. B.
I: Journal of Internal Medicine, Bind 283, Nr. 1, 2018, s. 45-55.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Standard and reduced doses of dabigatran, rivaroxaban and apixaban for stroke prevention in atrial fibrillation
T2 - a nationwide cohort study
AU - Staerk, L
AU - Gerds, T A
AU - Lip, G .Y. H.
AU - Ozenne, B.
AU - Bonde, A. N.
AU - Lamberts, M.
AU - Fosbøl, E. L.
AU - Torp-Pedersen, C.
AU - Gislason, G. H.
AU - Olesen, J. B.
N1 - © 2017 The Association for the Publication of the Journal of Internal Medicine.
PY - 2018
Y1 - 2018
N2 - BACKGROUND: Comparative data of non-vitamin K antagonist oral anticoagulants (NOAC) are lacking in patients with atrial fibrillation (AF).OBJECTIVE: We compared effectiveness and safety of standard and reduced dose NOAC in AF patients.METHODS: Using Danish nationwide registries, we included all oral anticoagulant-naïve AF patients who initiated NOAC treatment (2012-2016). Outcome-specific and mortality-specific multiple Cox regressions were combined to compute average treatment effects as 1-year standardized differences in stroke and bleeding risks (g-formula).RESULTS: Amongst 31 522 AF patients, the distribution of NOAC/dose was as follows: dabigatran standard dose (22.4%), dabigatran-reduced dose (14.0%), rivaroxaban standard dose (21.8%), rivaroxaban reduced dose (6.7%), apixaban standard dose (22.9%), and apixaban reduced dose (12.2%). The 1-year standardized absolute risks of stroke/thromboembolism were 1.73-1.98% and 2.51-2.78% with standard and reduced NOAC dose, respectively, without statistically significant differences between NOACs for given dose level. Comparing standard doses, the 1-year standardized absolute risk (95% CI) for major bleeding was for rivaroxaban 2.78% (2.42-3.17%); corresponding absolute risk differences (95% CI) were for dabigatran -0.93% (-1.45% to -0.38%) and apixaban, -0.54% (-0.99% to -0.05%). The results for major bleeding were similar for reduced NOAC dose. The 1-year standardized absolute risk (95% CI) for intracranial bleeding was for standard dose dabigatran 0.19% (0.22-0.50%); corresponding absolute risk differences (95% CI) were for rivaroxaban 0.23% (0.06-0.41%) and apixaban, 0.18% (0.01-0.34%).CONCLUSIONS: Standard and reduced dose NOACs, respectively, showed no significant risk difference for associated stroke/thromboembolism. Rivaroxaban was associated with higher bleeding risk compared with dabigatran and apixaban and dabigatran was associated with lower intracranial bleeding risk compared with rivaroxaban and apixaban.
AB - BACKGROUND: Comparative data of non-vitamin K antagonist oral anticoagulants (NOAC) are lacking in patients with atrial fibrillation (AF).OBJECTIVE: We compared effectiveness and safety of standard and reduced dose NOAC in AF patients.METHODS: Using Danish nationwide registries, we included all oral anticoagulant-naïve AF patients who initiated NOAC treatment (2012-2016). Outcome-specific and mortality-specific multiple Cox regressions were combined to compute average treatment effects as 1-year standardized differences in stroke and bleeding risks (g-formula).RESULTS: Amongst 31 522 AF patients, the distribution of NOAC/dose was as follows: dabigatran standard dose (22.4%), dabigatran-reduced dose (14.0%), rivaroxaban standard dose (21.8%), rivaroxaban reduced dose (6.7%), apixaban standard dose (22.9%), and apixaban reduced dose (12.2%). The 1-year standardized absolute risks of stroke/thromboembolism were 1.73-1.98% and 2.51-2.78% with standard and reduced NOAC dose, respectively, without statistically significant differences between NOACs for given dose level. Comparing standard doses, the 1-year standardized absolute risk (95% CI) for major bleeding was for rivaroxaban 2.78% (2.42-3.17%); corresponding absolute risk differences (95% CI) were for dabigatran -0.93% (-1.45% to -0.38%) and apixaban, -0.54% (-0.99% to -0.05%). The results for major bleeding were similar for reduced NOAC dose. The 1-year standardized absolute risk (95% CI) for intracranial bleeding was for standard dose dabigatran 0.19% (0.22-0.50%); corresponding absolute risk differences (95% CI) were for rivaroxaban 0.23% (0.06-0.41%) and apixaban, 0.18% (0.01-0.34%).CONCLUSIONS: Standard and reduced dose NOACs, respectively, showed no significant risk difference for associated stroke/thromboembolism. Rivaroxaban was associated with higher bleeding risk compared with dabigatran and apixaban and dabigatran was associated with lower intracranial bleeding risk compared with rivaroxaban and apixaban.
KW - Administration, Oral
KW - Aged
KW - Anticoagulants/administration & dosage
KW - Atrial Fibrillation/complications
KW - Cohort Studies
KW - Dabigatran/administration & dosage
KW - Denmark
KW - Dose-Response Relationship, Drug
KW - Female
KW - Hemorrhage/chemically induced
KW - Humans
KW - Male
KW - Pyrazoles/administration & dosage
KW - Pyridones/administration & dosage
KW - Registries
KW - Rivaroxaban/administration & dosage
KW - Stroke/etiology
U2 - 10.1111/joim.12683
DO - 10.1111/joim.12683
M3 - Journal article
C2 - 28861925
VL - 283
SP - 45
EP - 55
JO - Journal of Internal Medicine
JF - Journal of Internal Medicine
SN - 0955-7873
IS - 1
ER -
ID: 198707075