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      Selection of Non-vitamin K Antagonist Oral Anticoagulant for Stroke Prevention in Atrial Fibrillation Based on Patient Profile: Perspectives from Vietnamese Experts. Part 2

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          Abstract

          Part 1 of this review provided an overview of AF in Vietnam, with a particular focus on primary and secondary stroke prevention. Part 2 explores the management of AF in special, high-risk and clinically common patient populations, including those with renal impairment, diabetes, the elderly, and those with coronary artery disease. Furthermore, Part 2 addresses the challenges posed by patients with AF who have a bioprosthetic valve, a group situated in a grey area of consideration. Managing AF in these patient groups presents unique clinical challenges that require careful consideration. Physicians are tasked with addressing specific clinical questions to identify the optimal anticoagulation strategy for each individual. To inform these decisions, subgroup analyses from pivotal studies are presented alongside real-world data derived from clinical practice. By synthesising available information and considering the nuanced clinical context, the aim is to provide informed perspectives that align with current medical knowledge and contribute to the enhancement of patient care in these challenging scenarios.

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          Most cited references86

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            Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.

            The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, may provide more consistent and predictable anticoagulation than warfarin. In a double-blind trial, we randomly assigned 14,264 patients with nonvalvular atrial fibrillation who were at increased risk for stroke to receive either rivaroxaban (at a daily dose of 20 mg) or dose-adjusted warfarin. The per-protocol, as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism. In the primary analysis, the primary end point occurred in 188 patients in the rivaroxaban group (1.7% per year) and in 241 in the warfarin group (2.2% per year) (hazard ratio in the rivaroxaban group, 0.79; 95% confidence interval [CI], 0.66 to 0.96; P<0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 patients in the rivaroxaban group (2.1% per year) and in 306 patients in the warfarin group (2.4% per year) (hazard ratio, 0.88; 95% CI, 0.74 to 1.03; P<0.001 for noninferiority; P=0.12 for superiority). Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group (14.9% per year) and in 1449 in the warfarin group (14.5% per year) (hazard ratio, 1.03; 95% CI, 0.96 to 1.11; P=0.44), with significant reductions in intracranial hemorrhage (0.5% vs. 0.7%, P=0.02) and fatal bleeding (0.2% vs. 0.5%, P=0.003) in the rivaroxaban group. In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. (Funded by Johnson & Johnson and Bayer; ROCKET AF ClinicalTrials.gov number, NCT00403767.).
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              Apixaban versus Warfarin in Patients with Atrial Fibrillation

              Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin. In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause. The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P<0.001 for noninferiority; P=0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P<0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P=0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P<0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P=0.42). In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. (Funded by Bristol-Myers Squibb and Pfizer; ARISTOTLE ClinicalTrials.gov number, NCT00412984.).
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                Author and article information

                Journal
                Eur Cardiol
                Eur Cardiol
                ECR
                European Cardiology Review
                Radcliffe Cardiology
                1758-3756
                1758-3764
                15 December 2023
                2023
                : 18
                : e62
                Affiliations
                [1. ] Tam Duc Heart Hospital Ho Chi Minh City, Vietnam
                [2. ] Surgical Intensive Care Unit, Heart Institute Ho Chi Minh City, Vietnam
                [3. ] Vietnam Heart Institute, Bach Mai Hospital Hanoi, Vietnam
                [4. ] Hanoi Medical University Hanoi, Vietnam
                [5. ] Cardiovascular Department, Cho Ray Hospital Ho Chi Minh City, Vietnam
                [6. ] University of Medicine and Pharmacy at Ho Chi Minh City Ho Chi Minh City, Vietnam
                [7. ] Cardiovascular Center, Vinmec Hospital Ho Chi Minh City, Vietnam
                [8. ] Vietnam Heart Institute, Bach Mai Hospital Hanoi, Vietnam
                [9. ] Stroke Center, Bach Mai Hospital Hanoi, Vietnam
                [10. ] VNU-University of Medicine and Pharmacy Hanoi, Vietnam
                [11. ] Cerebrovascular Disease Department, People's 115 Hospital
                [12. ] Pham Ngoc Thach University of Medicine Ho Chi Minh City, Vietnam
                Author notes

                Disclosure: THQH has received honoraria for scientific presentations from Bayer and Pfizer. MTT, VLN and HMP have received honoraria for scientific presentations from Bayer, Pfizer, Boehringer Ingelheim and Daiichi Sankyo. SVH, NTV and TNH have received honoraria for scientific presentations from Bayer, Pfizer and Boehringer Ingelheim. TQN and LTP have received honoraria for scientific presentations from Bayer and Boehringer Ingelheim. TDM has received grants from Bayer for research and honoraria for scientific presentations from Bayer, Pfizer and Boehringer Ingelheim.

                Funding: The medical writing fee and the article processing charge were funded by Bayer Vietnam. The funder had no role in the design, execution, interpretation or writing of the study.

                Correspondence: Thang Huy Nguyen, Department of Cerebrovascular Disease, 115 People’s Hospital, 527 Su Van Hanh St, Ward 12, District 10, Ho Chi Minh City, Vietnam, 700000. E: nguyenhuythang115@ 123456gmail.com
                Article
                10.15420/ecr.2023.25
                10762676
                38174218
                e9d3df9d-c2c5-4241-9bdd-6cfe2cf5556d
                Copyright © The Author(s), 2023. Published by Radcliffe Group Ltd.

                This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.

                History
                : 23 May 2023
                : 18 August 2023
                Page count
                Pages: 9
                Categories
                Atrial Fibrillation

                atrial fibrillation,renal impairment,diabetes,coronary artery disease,elderly,bioprosthetic valve

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