Objective To compare the effectiveness and safety of the anticoagulant therapy between dabigatran etexilate and warfarin for patients with sinus arrhythmia in dilated cardiomyopathy Methods Total 127 patients with dilated cardiomyopathy who met the criteria of this research were divided into three groups, including the control group (42 patients, placebo, po), dabigatran etexilate group (45 patients, 150 mg,bid,po) and warfarin group (40 patients, 2.5 mg·d-1,po). Regular clinical follow-up lasted for 21 months. Results The incidence of thromboembolic events in the control group, dabigatran etexilate group and the warfarin group was 21.4%, 0.0%, 5.4% (P<0.01), and the incidence of bleeding events was 2.3%, 2.9% and 18.9% (P<0.01). There was no statistical difference of the incidence of thromboembolism between dabigatran etexilate group and warfarin group (P>0.05), and the incidence of total bleeding in dabigatran etexilate group was lower than that in warfarin group(P<0.05) Conclusion Anticoagulant therapy can effectively reduce the incidence of thromboembolic patients suffering from dilated cardiomyopathy with sinus rhythm and left ventricular dysfunction. Furthermore, as to the incidence rate of adverse events, dabigatran etexilate is lower than warfarin.
MISCHIE AN,CHIONCELV,DROCI,et al.Anticoagula-tion in patients with dilated cardiomyopathy,lowejection fraction,and sinus rhythm:back to the drawing board[J].,2013,31(5):298-302.
Heart failure patients present an important thrombo-embolic risk, including symptomatic or silent peripheral arterial embolism, pulmonary embolism, and stroke. Patients in sinus rhythm who have concomitant depressed (< 35%) left ventricular ejection fraction have a 4% rate of embolic events. Several prospective randomized trials of anticoagulation in this group of patients were either underpowered or had a short period of follow-up. Even though in two studies warfarin had a slight advantage over aspirin (in the WATCH and WARCEF trials), it was at the cost of an increased risk in major hemorrhage. To decrease bleeding rates and to improve anticoagulant effect, new treatment strategies have to be tested. Novel anticoagulants (dabigatran, rivaroxaban, and apixaban) seem to be a promising alternative.
HEINZMANND,GAWAZM,SEIZERP,et al.Risk strati-fication in dilated cardiomyopathy:is the arrhythmogenic substrate stable over time?[J].,2017,5(5):394.
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[7]
YAO XX,ABRAHAM AS,SANGARALINGHAM LR,et al.Effectiveness and safety of dabigatran,rivaroxaban,and apixaban versus warfarin in nonvalvular atrial fibrillation[J].,2016,5(6):e003725.
Background The introduction of non???vitamin K antagonist oral anticoagulants has been a major advance for stroke prevention in atrial fibrillation; however, outcomes achieved in clinical trials may not translate to routine practice. We aimed to evaluate the effectiveness and safety of dabigatran, rivaroxaban, and apixaban by comparing each agent with warfarin. Methods and Results Using a large US insurance database, we identified privately insured and Medicare Advantage patients with nonvalvular atrial fibrillation who were users of apixaban, dabigatran, rivaroxaban, or warfarin between October 1, 2010, and June 30, 2015. We created 3 matched cohorts using 1:1 propensity score matching: apixaban versus warfarin (n=15??390), dabigatran versus warfarin (n=28??614), and rivaroxaban versus warfarin (n=32??350). Using Cox proportional hazards regression, we found that for stroke or systemic embolism, apixaban was associated with lower risk (hazard ratio [HR] 0.67, 95% CI 0.46???0.98, P=0.04), but dabigatran and rivaroxaban were associated with a similar risk (dabigatran: HR 0.98, 95% CI 0.76???1.26, P=0.98; rivaroxaban: HR 0.93, 95% CI 0.72???1.19, P=0.56). For major bleeding, apixaban and dabigatran were associated with lower risk (apixaban: HR 0.45, 95% CI 0.34???0.59, P<0.001; dabigatran: HR 0.79, 95% CI 0.67???0.94, P<0.01), and rivaroxaban was associated with a similar risk (HR 1.04, 95% CI 0.90???1.20], P=0.60). All non???vitamin K antagonist oral anticoagulants were associated with a lower risk of intracranial bleeding. Conclusions In patients with nonvalvular atrial fibrillation, apixaban was associated with lower risks of both stroke and major bleeding, dabigatran was associated with similar risk of stroke but lower risk of major bleeding, and rivaroxaban was associated with similar risks of both stroke and major bleeding in comparison to warfarin.
HUANGC,SIUM,VUL,et al.Factors influencing doctors'selection of dabigatran in non-valvular atrial fibrillation[J].,2013,19(5):938-943.
This study was designed to examine the factors that influence doctors' decision in initiating or switching from warfarin to dabigratran.A survey questionnaire was sent to 181 doctors who were most likely to prescribe dabigatran (e.g. cardiologists and general internists) at the University of California, San Francisco Medical Center between November 2011 and February 2012. Survey participants were asked to complete an electronic or a paper version of the questionnaire, which consisted of 17 multiple-choice questions. Fisher's exact test and Cochran-Mantel-Haenszel test were used to compare survey responses between cardiologists and general internists.A total of 65 survey responses were received (35.9% response rate). There were 13 cardiologists and 51 general internists who participated in the study. Cost (25%), renal function (21%) and CHADS2 score (18%) were the three factors doctors considered most often to determine a patient's eligibility for dabigatran in warfarin-na茂ve patients. On the other hand, histories of unstable international normalized ratio (37%) and missed appointments (17%) along with cost (19%) were most often considered in patients on warfarin. Cardiologists had prescribed dabigatran more often and had a significantly higher level of comfort with prescribing the drug than general internists (P = 0.003; 77% vs. 27%).Cost was the most important factor influencing doctors' decision to prescribe dabigatran. Safety and effectiveness of dabigatran as well as patient preference were additional factors influencing their decision. General internists were less comfortable with prescribing dabigatran than cardiologists.
CONNOLLY SJ,EZEKOWITZ MD,YUSUFS,et al.Dabigatran versus warfarin in patients with atrial fibrillation[J].,2009,361(6):1139-1151.
Background: Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known. Methods: We conducted a randomized, double-blind, double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation (median follow-up, 2.8 years). The primary efficacy end point was stroke or systemic embolism. Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period. The principal safety end point was major bleeding. Results: The annualized rate of the primary end point during treatment was 1.50% with warfarin (median time in the therapeutic range, 68.4%), as compared with 1.18% with high-dose edoxaban (hazard ratio, 0.79; 97.5% confidence interval [CI], 0.63 to 0.99; P<0.001 for noninferiority) and 1.61% with low-dose edoxaban (hazard ratio, 1.07; 97.5% CI, 0.87 to 1.31; P=0.005 for noninferiority). In the intention-to-treat analysis, there was a trend favoring high-dose edoxaban versus warfarin (hazard ratio, 0.87; 97.5% CI, 0.73 to 1.04; P=0.08) and an unfavorable trend with low-dose edoxaban versus warfarin (hazard ratio, 1.13; 97.5% CI, 0.96 to 1.34; P=0.10). The annualized rate of major bleeding was 3.43% with warfarin versus 2.75% with high-dose edoxaban (hazard ratio, 0.80; 95% CI, 0.71 to 0.91; P<0.001) and 1.61% with low-dose edoxaban (hazard ratio, 0.47; 95% CI, 0.41 to 0.55; P<0.001). The corresponding annualized rates of death from cardiovascular causes were 3.17% versus 2.74% (hazard ratio, 0.86; 95% CI, 0.77 to 0.97; P=0.01), and 2.71% (hazard ratio, 0.85; 95% CI, 0.76 to 0.96; P=0.008), and the corresponding rates of the key secondary end point (a composite of stroke, systemic embolism, or death from cardiovascular causes) were 4.43% versus 3.85% (hazard ratio, 0.87; 95% CI, 0.78 to 0.96; P=0.005), and 4.23% (hazard ratio, 0.95; 95% CI, 0.86 to 1.05; P=0.32). Conclusions: Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes. (Funded by Daiichi Sankyo Pharma Development; ENGAGE AF-TIMI 48 ClinicalTrials.gov number, NCT00781391.)
FREUDENBERGER RS,HELLKAMP AS,HALPERIN JL,et al.Risk of thromboembolism in heart failure:an analysis from the sudden cardiac death in heart failure trial (SCD-HeFT)[J].,2007,115(20):2637-2641.
BACKGROUND -In patients with heart failure,rates of clinically apparent stroke range from 1.3% to 3.5% per year. Little is known about the incidence and risk factors in the absence of atrial fibrillation. In the Sudden Cardiac Death in Heart Failure Trial(SCD-HeFT),2521 patients with moderate heart failure were randomized to receive amiodarone,implanted cardioverter-defibrillators(ICDs),or placebo. METHODS AND RESULTS -We determined the incidence of stroke or peripheral or pulmonary embolism in patients with no history of atrial fibrillation(n=2114),predictors of thromboembolism and the relationship to left ventricular ejection fraction. Median follow-up was 45.5 months. Kaplan-Meier estimates(95% CIs) for the incidence of thromboembolism by 4 years were 4.0% (3.0% to 4.9% ),with 2.6% (1.1% to 4.1% ) in patients randomized to amiodarone,3.2% (1.8% to 4.7% ) in patients randomized to ICD,and 6.0% (4.0% to 8.0% ) in patients randomized to placebo(approximate rates of 0.7% ,0.8% ,and 1.5% per year,respectively). By multivariable analysis,hypertension(P=0.021) and decreasing left ventricular ejection fraction(P=0.023) were significant predictors of thromboembolism; treatment with amiodarone or ICD treatment was a significant predictor of thromboembolism-free survival(P=0.014 for treatment effect; hazard ratio95% CI versus placebo,0.570.33 to 0.99 for ICD; 0.440.24 to 0.80 for amiodarone). Inclusion of atrial fibrillation during follow-up in the multivariable model did not affect the significance of treatment assignment as a predictor of thromboembolism. CONCLUSIONS -In the SCD-HeFT patient cohort,which reflects contemporary treatment of patients with moderately symptomatic systolic heart failure,patients experienced thromboembolism events at a rate of 1.7% per year without antiarrhythmic therapy. Those treated with amiodarone or ICDs had lower risk of thromboembolism than those given placebo. Hypertension at baseline and lower ejection fraction were independent predictors of risk.
BAKALLIA,GEORGIEVSKA-ISMAILL,KOçINAJ D,et al.Prevalence of left chamber cardiac thrombi in patients with dilated left ventricle at sinus rhythm:the role of transesophageal echocardiography[J].,2013,41(1):38-45.
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KOBERL,TORP-PEDERSENC,MCMURRAY JJ,et al.Increased mortality after dronedarone therapy for severe heart failure[J].,2008,358(25):2678-2687.
Dronedarone is a novel antiarrhythmic drug with electrophysiological properties that are similar to those of amiodarone, but it does not contain iodine and thus does not cause iodine-related adverse reactions. Therefore, it may be of value in the treatment of patients with heart failure.In a multicenter study with a double-blind design, we planned to randomly assign 1000 patients who were hospitalized with symptomatic heart failure and severe left ventricular systolic dysfunction to receive 400 mg of dronedarone twice a day or placebo. The primary end point was the composite of death from any cause or hospitalization for heart failure.After inclusion of 627 patients (310 in the dronedarone group and 317 in the placebo group), the trial was prematurely terminated for safety reasons, at the recommendation of the data and safety monitoring board, in accordance with the board's predefined rules for termination of the study. During a median follow-up of 2 months, 25 patients in the dronedarone group (8.1%) and 12 patients in the placebo group (3.8%) died (hazard ratio in the dronedarone group, 2.13; 95% confidence interval [CI], 1.07 to 4.25; P=0.03). The excess mortality was predominantly related to worsening of heart failure--10 deaths in the dronedarone group and 2 in the placebo group. The primary end point did not differ significantly between the two groups; there were 53 events in the dronedarone group (17.1%) and 40 events in the placebo group (12.6%) (hazard ratio, 1.38; 95% CI, 0.92 to 2.09; P=0.12). More increases in the creatinine concentration were reported as serious adverse events in the dronedarone group than in the placebo group.In patients with severe heart failure and left ventricular systolic dysfunction, treatment with dronedarone was associated with increased early mortality related to the worsening of heart failure. (ClinicalTrials.gov number, NCT00543699.)
COKKINOS DV,HARALABOPOULOS GC,KOSTIS JB,et al.Efficacy of antithrombotic therapy in chronic heart failure:the HELAS study[J].,2006,8(4):428-432.
Abstract Top of page Abstract 1.Introduction 2.Methods 3.Results 4.Discussion Appendix A. HELAS Committees and Investigators References Background: It is not clear if long-term antithrombotic treatment has a beneficial effect on the incidence of thromboembolism in chronic heart failure (CHF). The HELAS study (Heart failure Long-term Antithrombotic Study) is a multicentre, randomised, double-blind, placebo-controlled trial to evaluate antithrombotic treatment in patients with CHF. Methods: 197 HF patients (EF <35%) were enrolled. Patients with Ischaemic Heart Disease were randomised to receive either aspirin 325 mg or warfarin. Patients with Dilated Cardiomyopathy (DCM) were randomised to receive either warfarin or placebo. Results: Analysis of the data from 312 patient years showed an incidence of 2.2 embolic events per 100 patient years, with no significant difference between groups. The incidence of myocardial infarction, hospitalisation, exacerbation of heart failure, death and haemorrhage were not different between the groups. No peripheral or pulmonary emboli were reported. Echocardiographic follow-up for 2 years showed an overall increase in left ventricular ejection fraction from 28.2卤6 to 30.3-7 p <0.05, which was most obvious in patients with DCM taking warfarin (EF 26.8卤5.3 at baseline, 30.7卤10 at 2 years, p <0.05). Conclusions: (1) Overall embolic events are rare in heart failure regardless of treatment. (2) Treatment does not seem to affect outcome.
CLELAND J GF,FINDLAYI,JAFRIS,et al.The warfarin/aspirin study in heart failure (WASH):a randomized trial comparing antithrombotic strategies for patients with heart failure[J].,2004,148(1):157-164.
The Warfarin/Aspirin Study in Heart failure (WASH) provides no evidence that aspirin is effective or safe in patients with heart failure. The benefits of warfarin for patients with heart failure in sinus rhythm have not been established. Antithrombotic therapy in patients with heart failure is not evidence based but commonly contributes to polypharmacy.
NIEMEIJER MN,LEENING MJ,VAN DEN BERG M E,et al.Subclinical abnormalities in echocardiographic parameters and risk of sudden cardiac death in a general population:the rotterdam study[J].,2016,22(1):17-23.
Abstract BACKGROUND: Subclinical cardiac dysfunction has been associated with increased mortality, and heart failure increases the risk of sudden cardiac death (SCD). Less well known is whether subclinical cardiac dysfunction is also a risk factor for SCD. Our objective was to assess the association between echocardiographic parameters and SCD in a community-dwelling population free of heart failure. METHODS AND RESULTS: We computed hazard ratios (HRs) for left atrium diameter, left ventricular (LV) end-diastolic dimension, LV end-systolic dimension, LV mass, qualitative LV systolic function, LV fractional shortening, and diastolic function. During a median follow-up of 6.3 years in 4,686 participants, 68 participants died because of SCD. Significant associations with SCD were observed for qualitative LV systolic function and LV fractional shortening. For moderate/poor qualitative LV systolic function, the HR for SCD was 2.54 (95% confidence interval [CI] 1.10-5.87). Each standard deviation decrease in LV fractional shortening was associated with an HR of 1.36 (95% CI 1.09-1.70). CONCLUSIONS: Subclinical abnormalities in LV systolic function were associated with SCD risk in this general population. Although prediction of SCD remains difficult and traditional cardiovascular risk factors are of greatest importance, this knowledge might guide future directions to prevent SCD in persons with subclinical cardiac dysfunction. Copyright 2016 Elsevier Inc. All rights reserved.
KO?INAJ D,et al.Prevalence of left chamber cardiac thrombi in patients with dilated left ventricle at sinus rhythm:the role of transesophageal echocardiography
VAN DEN BERG M E,et al.Subclinical abnormalities in echocardiographic parameters and risk of sudden cardiac death in a general population:the rotterdam study