| BackgroundAtrial fibrillation(AF),referred to as atrial fibrillation,is a common persistent arrhythmia.Patients are at increased risk of stroke and higher mortality than sinus rhythm.Nonvalvular atrial fibrillation(NVAF)refers to atrial fibrillation caused by coronary heart disease,hypertension,hyperthyroidism cardiomyopathy,and non-organ heart disease in addition to rheumatic valvular disease,mechanical or biological prosthetic heart valve,and mitral valve repair.It is an important independent risk factor for ischemic stroke,with a six-fold increase in the incidence of stroke.Current professional society guidelines recommend treatment with an oral anticoagulant for patients with AF who are at an increased risk of thromboembolism.Past use of warfarin has significantly reduced the risk of stroke in patients with AF.Furthermore,warfarin treatment has a narrow therapeutic range,interacts with food and other drugs,and requires regular international normalized ratio(INR)monitoring and frequent dose adjustments.In recent years,novel oral anticoagulants(NOACs)rivaroxaban and dabigatran has been approved for stroke prevention in AF in randomized controlled trials,owing to its noninferiority in both efficacy and safety when compared to warfarin.In addition,anticoagulant monitoring is not required,and the significant reduction in drug-food interactions also changes the prospects for stroke prevention in AF.Several studies have comparatively analyzed the clinical benefits of NOACs rivaroxaban and dabigatran versus warfarin.However,their study included only a relatively small number of Asian patients,especially the Chinese in East Asia.There was no comparative analysis of NVAF patients with higher blood risk.(In 2010,the European Society of Cardiology’s guidelines for the treatment of AF introduced for the first time a HAS-BLED risk assessment procedure and patients with atrial fibrillation whose HAS-BLED score ≥3 had a high bleeding risk).However,in clinical practice,patients with AF with multiple complications tend to have high bleeding risk.Therefore,this study specifically conducted a comparative analysis on Asian patients with AF with high bleeding risk.ObjectivesTo compare the clinical benefits of NOACs rivaroxaban and dabigatran versus warfarin in patients with NVAF with high bleeding risk.MethodsThe study data were collected from patients hospitalized between May 31,2016 and May 31,2019 in 11 wards(including 2 critical care units)of the Department of Cardiology at The First Affiliated Hospital of Zhengzhou University,Heyi,and Zhengdong Hospital.Patients with NVAF with high bleeding risk were selected according to inclusion and exclusion criteria.Study participants were divided into three groups:(i)Rivaroxaban group(ii)dabigatran group(iii)Warfarin group.Each patient was followed-up for 730 days but death from the beginning of medication by inquiring about hospitalization case,related inspection and inspection,medical advice and telephone contact.Endpoints related to all-cause death,stroke,myocardial infarction(MI),systemic embolism,and fatal and critical organ bleeding were recorded during drug administration.Exclusion of lost follow-up,failure to adhere to the prescribed medication,change to other types of anticoagulants,the number of patients eligible for the study was 787 oral rivaroxaban,514 oral dabigatran and 459 oral warfarin in 1760 cases with high bleeding risk(HAS-BLED score ≥3).SPSS25.0 software was used for statistical analysis.The primary efficacy end point was determined to be a noninferiority margin of 1.46 with a one-sided alpha level of 0.025 by the non-inferiority test.The risk ratios,confident intervals(CIs),and P-values of efficacy end points and safety end points were calculated using the multivariate Cox proportional risk model,P ≤0.05 indicated statistical difference.By plotting the cumulative rate of events over time,the difference between the occurrence of two sets of data events was apparent.Results1.Rivaroxaban vs WarfarinResults of the primary efficacy benefit endpoint were obtained from 104 patients(13.2%)in the rivaroxaban group and 88(19.2%)patients in the warfarin group(HR: 0.681 in the rivaroxaban group;95% CI: 0.512–0.906;P <0.001 for noninferiority).The principal safety end points were observed in 49(6.23%)patients in the rivaroxaban group and in 55(11.98%)patients in the warfarin group(HR: 0.469 in the rivaroxaban group;95% CI: 0.314–0.702;P <0.001).With respect to secondary efficacy and benefit endpoints,28(3.56%)patients in the rivaroxaban group and 22(4.79%)patients in the warfarin group died,with an HR of 0.760(95% CI: 0.435–1.329;P=0.336);32(4.07%)patients in the rivaroxaban group;and 26(5.66%)patients in the warfarin group had MI,with an HR of 1.940(95% CI: 0.495–1.069,P=0.254)in the rivaroxaban group.2.Dabigatran vs WarfarinResults of the primary efficacy benefit endpoint were obtained from 81 patients(15.76%)in the dabigatran group and 88(19.2%)patients in the warfarin group,(HR: 0.876 in the dabigatran group;95% CI: 0.646-1.189;P <0.001 for noninferiority).The principal safety end points were observed in 36(7.00%)patients in the dabigatran group and in 55(11.98%)patients in the warfarin group(HR: 0.627 in the dabigatran group;95% CI: 0.405–0.971;P =0.037).With respect to secondary efficacy and benefit endpoints,31(6.03%)patients in the dabigatran group and 22(4.79%)patients in the warfarin group died,with an HR of 1.195(95% CI: 0.669–2.136;P=0.547);31(6.03%)patients in the dabigatran group;and 26(5.66%)patients in the warfarin group had MI,with an HR of 1.042(95% CI: 0.619–1.755,P=0.877)in the rivaroxaban group.3.Dabigatran vs RivaroxabanResults of the primary efficacy benefit endpoint were obtained from 81 patients (15.76%)in the dabigatran group and 104(13.21%)patients in the rivaroxaban group(HR:0.860 in the rivaroxaban group;95%CI:0.637-1.162;P=0.327).The principal safety end points were observed in 36(7.00%)patients in the dabigatran group and in 49(6.23%)patients in the rivaroxaban group(HR: 0.801 in the rivaroxaban group;95% CI: 0.512-1.255;P=0.333).With respect to secondary efficacy and benefit endpoints,31(6.03%)patients in the dabigatran group and 28(3.56%)patients in the rivaroxaban group died,with an HR of 0.725(95% CI:0.425-1.238;P=0.239);31(6.03%)patients in the dabigatran group;and 32(4.07%)patients in the rivaroxaban group had MI,with an HR of 0.668(95% CI: 0.405-1.102;P=0.114)in the rivaroxaban group.Conclusions1.Rivaroxaban and dabigatran is non-inferior to warfarin in the prevention of stroke and systemic embolism in patients with high blood NVAF.Rivaroxaban and dabigatran is superior to warfarin in reducing fatal bleeding and bleeding in critical organs.2.Dabigatran did not differ from rivaroxaban in the prevention of stroke and systemic embolism in patients with high blood NVAF.There was also no significant difference between dabigatran and rivaroxaban in reducing fatal bleeding and bleeding in critical organs. |
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