The alternative CPCR demonstrated an improvement in the incidence of good recovery. Based upon these findings, randomized studies of this hypothermia are needed.
bleeding complications among patients with AF, compared with use of vitamin K antagonists. 2-5 Review of real-world registries in Japan has indicated the incidence rate of stroke with DOAC therapy to be similar to that with warfarin but with a lower risk for major bleeding events for DOACs A trial fibrillation (AF) is the most common arrhythmia in elderly individuals, currently affecting approximately 0.6% of the Japanese population, and the prevalence of AF is expected to continue to rise in Japan, affecting an estimated 10 million people by 2030. 1 AF is a strong risk factor for stroke and death. Randomized clinical trials (RCTs) have shown the benefit of direct oral anticoagulant (DOAC) therapy in reducing the risk of stroke and Editorial p 707
BackgroundLarge-scale investigations on the use of oral anticoagulants including direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) have not included Japanese patients.MethodsWe established the multicenter SAKURA AF Registry to support prospective observational research on the status of anticoagulation treatment, especially with DOAC, for AF in Japan. We enrolled 3266 AF patients treated with warfarin (n=1577) or any of 4 DOACs (n=1689) from 63 institutions (2 cardiovascular centers, 13 affiliated hospitals or community hospitals, and 48 private clinics) in the Tokyo area.ResultsWe conducted our first analysis of the registry data, and although we found equivalent mean age between the DOAC and warfarin users (71.8±9.5 vs. 72.3±9.4 years, p=0.2117), we found a slightly lower risk of stroke (CHADS2 score of 0 or 1 [46.9% vs. 39.4%, p<0.0001]) and significantly better creatinine clearance in DOAC users (70.4±27 vs. 65.6±25.7 mL/min, p<0.0001). Importantly, we documented under-dosing in 32% of warfarin users and inappropriate-low-dosing in 19.7–27.6% of DOAC users.ConclusionsOur initial analysis of the SAKURA AF Registry data clarified the real-world use of anticoagulants, which includes DOACs and warfarin in Japan. The DOAC users were at a lower risk for stroke than the warfarin users. In 20–30% of DOAC users, the dose was inappropriately reduced.
A high follow-up rate allowed us to obtain reliable data on the status of OAC use and therapeutic outcomes among AF patients in Japan. Warfarin and DOACs appear to yield equivalent 3-year stroke and all-cause mortality rates, but DOACs appear to reduce the risk of major bleeding.
The burden of anticoagulation treatment affects patient satisfaction, which in turn affects adherence to treatment. Thus, we must thoroughly understand the advantages of direct oral anticoagulants (DOACs) over vitamin K antagonists (VKAs)/warfarin given for stroke prevention in patients with atrial fibrillation (AF). We compared satisfaction with anticoagulation therapy between 654 DOAC and 821 warfarin users enrolled in the SAKURA AF Registry. Satisfaction was assessed by means of the Anti-Clot Treatment Scale (ACTS), which includes 12-item burdens and 3-item benefits scales, and the treatment satisfaction questionnaire for medication II (TSQM II), which includes 2-item effectiveness, 3-item side effects, 3-item convenience, and 2-item global satisfaction domains. There were no significant between-group differences in TSQM II convenience (67.6 14.5 versus 68.9 14.5, P = 0.280), effectiveness (65.0 13.3 versus 66.0 15.0, P = 0.422), side effects (93.6 13.7 versus 92.8 14.4, P = 0.067), and global satisfaction (64.7 14.9 versus 66.0 14.6, P = 0.407) scores. In contrast, although there was no significant between-group difference in the ACTS benefits scores (9.8 3.1 versus 10.1 3.2, P = 0.051), the ACTS burdens scores (54.5 6.3 versus 52.7 6.9, P < 0.0001) were significantly higher in the DOAC users, independent of age, sex, and DOAC type. We can expect greater burden satisfaction with anticoagulation treatment in patients given a DOAC versus VKA/warfarin. The reduced burden of treatment will translate to greater patient adherence to their treatment plans and a positive effect on clinical outcomes.
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