TY - JOUR

T1 - Effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in atrial fibrillation

T2 - a Scandinavian population-based cohort study

AU - Halvorsen, Sigrun

AU - Johnsen, Søren P.

AU - Madsen, Morten

AU - Linder, Marie

AU - Sulo, Gerhard

AU - Ghanima, Waleed

AU - Gislason, Gunnar

AU - Hohnloser, Stefan H

AU - Jenkins, Aaron

AU - Al-Khalili, Faris

AU - Tell, Grethe S

AU - Ehrenstein, Vera

PY - 2022

Y1 - 2022

N2 - Aims Using Scandinavian population-based registries, we assessed risk of stroke/systemic embolism (SE) and bleeding with non-vitamin K antagonist oral anticoagulants compared with warfarin in anticoagulation-naive patients with atrial fibrillation (AF). Methods and results This historical cohort study included 219 545 AF patients [median age 74 years; 43% women; mean CHA(2)DS(2)-VASc (congestive heart failure, hypertension, age >= 75 years, diabetes mellitus, stroke or transient ischaemic attack, vascular disease, age 65-74 years, sex category) score 3.3] initiating apixaban, dabigatran, rivaroxaban, or warfarin in Denmark, Norway, and Sweden (1 January 2013 to 31 December 2016). The primary endpoints were stroke/SE and major bleeding. The median follow-up times were 9.7 (3.9-21.5) months for stroke/SE and 9.6 (3.8-21.3) months for bleeding. Apixaban and warfarin initiators were older and had higher CHA(2)DS(2)-VASc scores compared with dabigatran and rivaroxaban initiators. After 1:1 propensity score matching, three cohorts were created: apixaban-warfarin (n = 111 162), dabigatran-warfarin (n = 56 856), and rivaroxaban-warfarin (n = 61 198). Adjusted hazard ratios (HRs) were estimated using a Cox regression. For stroke/SE, adjusted HRs against warfarin were 0.96 [95% confidence interval (CI): 0.87-1.06] for apixaban, 0.89 (95% CI: 0.80-1.00) for dabigatran, and 1.03 (95% CI: 0.92-1.14) for rivaroxaban. For major bleeding, the HRs against warfarin were 0.73 (95% CI: 0.67-0.78) for apixaban, 0.89 (95% CI: 0.82-0.97) for dabigatran, and 1.15 (95% CI: 1.07-1.25) for rivaroxaban. The results in the dabigatran cohort did not hold in all dose-defined subgroups. Conclusion In this large Scandinavian study among AF patients initiating oral anticoagulation, those initiating dabigatran, apixaban, and rivaroxaban had similar rates of stroke/SE to patients initiating warfarin. Rates of major bleeding were lower with apixaban and dabigatran and higher with rivaroxaban, each compared with warfarin.

AB - Aims Using Scandinavian population-based registries, we assessed risk of stroke/systemic embolism (SE) and bleeding with non-vitamin K antagonist oral anticoagulants compared with warfarin in anticoagulation-naive patients with atrial fibrillation (AF). Methods and results This historical cohort study included 219 545 AF patients [median age 74 years; 43% women; mean CHA(2)DS(2)-VASc (congestive heart failure, hypertension, age >= 75 years, diabetes mellitus, stroke or transient ischaemic attack, vascular disease, age 65-74 years, sex category) score 3.3] initiating apixaban, dabigatran, rivaroxaban, or warfarin in Denmark, Norway, and Sweden (1 January 2013 to 31 December 2016). The primary endpoints were stroke/SE and major bleeding. The median follow-up times were 9.7 (3.9-21.5) months for stroke/SE and 9.6 (3.8-21.3) months for bleeding. Apixaban and warfarin initiators were older and had higher CHA(2)DS(2)-VASc scores compared with dabigatran and rivaroxaban initiators. After 1:1 propensity score matching, three cohorts were created: apixaban-warfarin (n = 111 162), dabigatran-warfarin (n = 56 856), and rivaroxaban-warfarin (n = 61 198). Adjusted hazard ratios (HRs) were estimated using a Cox regression. For stroke/SE, adjusted HRs against warfarin were 0.96 [95% confidence interval (CI): 0.87-1.06] for apixaban, 0.89 (95% CI: 0.80-1.00) for dabigatran, and 1.03 (95% CI: 0.92-1.14) for rivaroxaban. For major bleeding, the HRs against warfarin were 0.73 (95% CI: 0.67-0.78) for apixaban, 0.89 (95% CI: 0.82-0.97) for dabigatran, and 1.15 (95% CI: 1.07-1.25) for rivaroxaban. The results in the dabigatran cohort did not hold in all dose-defined subgroups. Conclusion In this large Scandinavian study among AF patients initiating oral anticoagulation, those initiating dabigatran, apixaban, and rivaroxaban had similar rates of stroke/SE to patients initiating warfarin. Rates of major bleeding were lower with apixaban and dabigatran and higher with rivaroxaban, each compared with warfarin.

KW - Anticoagulants

KW - Atrial fibrillation

KW - Bleeding

KW - Cohort study

KW - Stroke

KW - PATIENT REGISTRY

KW - RIVAROXABAN

KW - VALIDATION

KW - DABIGATRAN

KW - MANAGEMENT

KW - APIXABAN

KW - EFFICACY

KW - QUALITY

KW - WORLD

U2 - 10.1093/ehjqcco/qcab048

DO - 10.1093/ehjqcco/qcab048

M3 - Journal article

C2 - 34244745

VL - 8

SP - 577

EP - 587

JO - European Heart Journal - Quality of Care and Clinical Outcomes

JF - European Heart Journal - Quality of Care and Clinical Outcomes

SN - 2058-5225

IS - 5

ER -