So-Ryoung Lee1, Eue-Keun Choi2, Chan Soon Park3, Kyung-Do Han4, Jin-Hyung Jung4, Seil Oh5, Gregory Y H Lip6. 1. Division of Cardiology, Department of Internal Medicine, Soon Chun Hyang University Hospital Seoul, Seoul, Republic of Korea. 2. Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: choiek17@snu.ac.kr. 3. Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Republic of Korea. 4. Department of Medical Statistics, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea. 5. Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea. 6. Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Chest & Heart Hospital, Liverpool, United Kingdom; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
Abstract
BACKGROUND: It is unclear whether the overall effectiveness and safety of direct oral anticoagulants (DOACs) are consistent in patients with nonvalvular atrial fibrillation (AF) and extremely low body weight (<50 kg). OBJECTIVES: This study compared DOACs with warfarin in AF patients with low body weight. METHODS: Using data from the Korean National Health Insurance Service database from January 2014 to December 2016, AF patients with body weight ≤60 kg and who were treated with oral anticoagulants (n = 14,013 taking DOACs and n = 7,576 taking warfarin) were included and examined for ischemic stroke, intracranial hemorrhage (ICH), gastrointestinal bleeding, major bleeding, all-cause death, and composite outcome. The propensity score weighting was used to balance the 2 groups. RESULTS: Baseline characteristics were well balanced between the 2 groups (mean age 73 years, mean CHA2DS2-VASc score 4, and 28% of patients weighed <50 kg). DOACs were associated with lower risks of ischemic stroke (hazard ratio [HR]: 0.591; 95% confidence interval [CI]: 0.510 to 0.686) and major bleeding (HR: 0.705; 95%: CI 0.601 to 0.825), which were caused by a reduction in ICH (HR: 0.554; 95% CI: 0.429 to 0.713) compared with warfarin. DOAC improved the net clinical benefit compared with warfarin (HR for composite outcome: 0.660; 95% CI: 0.606 to 0.717), and this was consistent in patients who weighed <50 kg (HR for composite outcome: 0.665; 95% CI: 0.581 to 0.762). CONCLUSIONS: In this real-world Asian AF population with low body weight, DOACs showed better effectiveness and safety than warfarin. These results were consistent in patients with extremely low body weight. Regular dosages of DOACs showed comparable results as reduced dosages of DOACs in both effectiveness and safety.
BACKGROUND: It is unclear whether the overall effectiveness and safety of direct oral anticoagulants (DOACs) are consistent in patients with nonvalvular atrial fibrillation (AF) and extremely low body weight (<50 kg). OBJECTIVES: This study compared DOACs with warfarin in AFpatients with low body weight. METHODS: Using data from the Korean National Health Insurance Service database from January 2014 to December 2016, AFpatients with body weight ≤60 kg and who were treated with oral anticoagulants (n = 14,013 taking DOACs and n = 7,576 taking warfarin) were included and examined for ischemic stroke, intracranial hemorrhage (ICH), gastrointestinal bleeding, major bleeding, all-cause death, and composite outcome. The propensity score weighting was used to balance the 2 groups. RESULTS: Baseline characteristics were well balanced between the 2 groups (mean age 73 years, mean CHA2DS2-VASc score 4, and 28% of patients weighed <50 kg). DOACs were associated with lower risks of ischemic stroke (hazard ratio [HR]: 0.591; 95% confidence interval [CI]: 0.510 to 0.686) and major bleeding (HR: 0.705; 95%: CI 0.601 to 0.825), which were caused by a reduction in ICH (HR: 0.554; 95% CI: 0.429 to 0.713) compared with warfarin. DOAC improved the net clinical benefit compared with warfarin (HR for composite outcome: 0.660; 95% CI: 0.606 to 0.717), and this was consistent in patients who weighed <50 kg (HR for composite outcome: 0.665; 95% CI: 0.581 to 0.762). CONCLUSIONS: In this real-world Asian AF population with low body weight, DOACs showed better effectiveness and safety than warfarin. These results were consistent in patients with extremely low body weight. Regular dosages of DOACs showed comparable results as reduced dosages of DOACs in both effectiveness and safety.
Authors: Vincenzo Russo; Emilio Attena; Matteo Baroni; Roberta Trotta; Marius Constantin Manu; Paulus Kirchhof; Raffaele De Caterina Journal: J Clin Med Date: 2022-06-28 Impact factor: 4.964