Efficacy and safety of edoxaban compared with warfarin according to the burden of diseases in patients with atrial fibrillation: insights from the ENGAGE AF-TIMI 48 trial

2019 ◽  
Vol 6 (3) ◽  
pp. 167-175 ◽  
Author(s):  
André M Nicolau ◽  
Ramon Corbalan ◽  
Jose C Nicolau ◽  
Christian T Ruff ◽  
Wolfgang Zierhut ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Oral Anticoagulants ◽  
Concomitant Disease ◽  
Efficacy And Safety ◽  
Treatment Groups ◽  
Comorbidity Index ◽  
Post Hoc ◽  
The Impact ◽  
Burden Of Diseases

Abstract Aims Non-vitamin K antagonist oral anticoagulants represent a new option for prevention of embolic events in patients with atrial fibrillation (AF). However, little is known about the impact of non-cardiac comorbidities on the efficacy and safety profile of these drugs. Methods and results In a post hoc analysis of the ENGAGE AF-TIMI 48 trial, we analysed 21 105 patients with AF followed for an average of 2.8 years and randomized to either a higher-dose edoxaban regimen (HDER), a lower-dose edoxaban regimen, or warfarin. We used the updated Charlson Comorbidity Index (CCI) to stratify the patients according to the burden of concomitant disease (CCI = 0, 1, 2, 3, and ≥4). The treatment groups were then compared for safety, efficacy, and net clinical outcomes across CCI categories. There were 32.0%, 7.3%, 42.1%, 12.7%, and 6.0% of patients with CCI scores of 0, 1, 2, 3, and ≥4, respectively. A CCI score ≥4 was associated with significantly higher rates of thromboembolic events, bleeding, and death compared to CCI = 0 (P < 0.05 for each). The annualized rates of the primary net clinical outcome (stroke/systemic embolism, major bleeding, or death) for CCI = 0, 1, 2, 3, or ≥4 were 5.9%, 8.7%, 6.6%, 10.3%, and 13.6% (Ptrend < 0.001). There were no significant interactions between treatment with HDER vs. warfarin and efficacy, safety, and net outcomes across the CCI groups (P-interaction > 0.10 for each). Conclusion  Although increasing CCI scores are associated with worse outcomes, the efficacy, safety, and net clinical outcomes of edoxaban vs. warfarin were independent of the degree of comorbidity present.

scholarly journals Atrial fibrillation and clinical outcomes 1 to 3 years after myocardial infarction

Open Heart ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e001726
Author(s):  
Anthony P Carnicelli ◽  
Ruth Owen ◽  
Stuart J Pocock ◽  
David B Brieger ◽  
Satoshi Yasuda ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Oral Anticoagulants ◽  
Adverse Outcomes ◽  
Increased Risk ◽  
History Of ◽  
The Impact

ObjectiveAtrial fibrillation (AF) and myocardial infarction (MI) are commonly comorbid and associated with adverse outcomes. Little is known about the impact of AF on quality of life and outcomes post-MI. We compared characteristics, quality of life and clinical outcomes in stable patients post-MI with/without AF.Methods/resultsThe prospective, international, observational TIGRIS (long Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease) registry included 8406 patients aged ≥50 years with ≥1 atherothrombotic risk factor who were 1–3 years post-MI. Patient characteristics were summarised by history of AF. Quality of life was assessed at baseline using EQ-5D. Clinical outcomes over 2 years of follow-up were compared. History of AF was present in 702/8277 (8.5%) registry patients and incident AF was diagnosed in 244/7575 (3.2%) over 2 years. Those with AF were older and had more comorbidities than those without AF. After multivariable adjustment, patients with AF had lower self-reported quality-of-life scores (EQ-5D UK-weighted index, visual analogue scale, usual activities and pain/discomfort) than those without AF. CHA2DS2-VASc score ≥2 was present in 686/702 (97.7%) patients with AF, although only 348/702 (49.6%) were on oral anticoagulants at enrolment. Patients with AF had higher rates of all-cause hospitalisation (adjusted rate ratio 1.25 [1.06–1.46], p=0.008) over 2 years than those without AF, but similar rates of mortality.ConclusionsIn stable patients post-MI, those with AF were commonly undertreated with oral anticoagulants, had poorer quality of life and had increased risk of clinical outcomes than those without AF.Trial registration numberClinicalTrials: NCT01866904.

scholarly journals Continuation or discontinuation of oral anticoagulants after an increase in HAS-BLED scores and the risks of clinical outcomes in patients with atrial fibrillation. a nationwide cohort study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T.F Chao ◽  
J.N Liao ◽  
G.Y.H Lip ◽  
S.A Chen
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Oral Anticoagulants ◽  
Antiplatelet Agents ◽  
Bleeding Risk ◽  
Risk Profile ◽  
Bleeding Events ◽  
Concurrent Use ◽  
The Impact

Abstract Background The bleeding risk profile of patients with atrial fibrillation (AF) may change over time and the increment of HAS-BLED score (a validated bleeding risk score) is perceived to result in discontinuations of oral anticoagulants (OACs). The goal of the present study was to investigate the changes of HAS-BLED scores of AF patients initially with a low bleeding risk (HAS-BLED 0–2). Second, the impact of continuation or discontinuation of OACs on clinical outcomes after patients' bleeding risk profile worsened (ie HAS-BLED increased) were also studied. Methods The present study used the Taiwan nationwide health insurance research (NHIRD) database. From year 2000 to 2015, a total of 24,990 AF patients aged >20 years with a CHA2DS2-VASc score >1 (males) or >2 (females) having a HAS-BLED score of 0–2 who were treated with OACs (warfarin or NOACs) were identified and followed up for changes of the HAS-BLED scores. The risks of clinical outcomes were compared between patients who continued or stopped OAC's once their HAS-BLED score increased to ≥3. Results Mean HAS-BLED score of study population continuously increased from 1.54 (SD 1.63) at baseline, to 3.33 (SD 1.36) at the end of follow up with increasing age and incident comorbidities (Figure A). At end of 1 year, 5,229 (20.9%) patients had an increment of their HAS-BLED score to ≥3, mainly due to newly diagnosed impaired renal function, occurrences of bleeding events and concurrent use of antiplatelet agents or NSAIDs. Among 4,777 patients who consistently had a HAS-BLED score > =3, 1,062 (22.2%) stopped their use of OACs. Patients who kept on OACs (n=3,715; 77.8%) even after their HAS-BLED score increased to ≥3 were associated with a lower risk of ischemic stroke (aHR 0.601), major bleeding (aHR 0.780), all-cause mortality (aHR 0.876) and any adverse events (aHR 0.748) (Figure B). Conclusions For patients whose HAS-BLED scores increased to ≥3, the continuation of OACs (which occurred in the majority of patients) was associated with better clinical outcomes. An increased HAS-BLED score in AF patients is not a reason to withhold OACs, but reminds physicians to correct modifiable bleeding risk factors and follow up patients more closely. The low risk of bleeding despite continuing OAC in high HAS-BLED score patients may reflect the early reviews and careful follow-up of these “high risk” patients (as recommended in guidelines). Funding Acknowledgement Type of funding source: None

Abstract 152: Adherence to Rivaroxaban versus Apixaban Among Patients With Atrial Fibrillation: Analysis of Overall Population and Subgroups of Prior Oral Anticoagulant Users

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Colleen A McHorney ◽  
Concetta Crivera ◽  
François Laliberté ◽  
Guillaume Germain ◽  
Willy Wynant ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Oral Anticoagulants ◽  
Absolute Difference ◽  
Propensity Score Methods ◽  
Proportion Of Days Covered ◽  
Comorbidity Index ◽  
Baseline Characteristics ◽  
Poor Outcomes

Background: Medication nonadherence predicts poor outcomes among patients with non-valvular atrial fibrillation (NVAF). Understanding differences in adherence rates among non-vitamin K oral anticoagulants (NOACs) could guide treatment decisions, promote adherence and improve clinical outcomes. Objective: To compare adherence to rivaroxaban and apixaban among the overall NVAF population and subgroups at higher risk for adverse clinical outcomes (e.g., prior OAC use, multiple comorbidities, and with risk factors for nonadherence). Methods: Using healthcare claims from the Truven Health Analytics MarketScan database from 7/2012-7/2015, adult patients with 2 dispensings of rivaroxaban or apixaban at least 180 days apart, with > 60 days of supply, ≥ 6 months of pre- and post-index eligibility, ≥ 2 atrial fibrillation diagnoses pre- or post-index, and without valvular involvement were identified. Propensity score methods were used to create matched cohorts of rivaroxaban and apixaban patients, adjusting for demographics, risk factors for nonadherence (e.g., bipolar, anxiety), previous OAC use, and clinical characteristics. Adherence was assessed using the percentage of patients with proportion of days covered ≥0.8 at 6 months. Subgroups of patients with prior OAC use, prior OAC use and a Quan-Charlson Comorbidity index ≥2, and prior OAC use with/without nonadherence risk factors were evaluated. Results: 14,635 NVAF subjects were included in each of 2 matched cohorts. All baseline characteristics were balanced between cohorts. At 6 months, significantly more rivaroxaban users were adherent to treatment as compared to apixaban users (82.4% vs 78.5%; absolute difference of 3.9%; P<0.01). Rivaroxaban users had significantly higher adherence rates in all subgroups examined with prior OAC agents (Figure). Conclusion: Rivaroxaban users had consistently higher adherence rates than apixaban users overall and among all NVAF subgroups examined.

scholarly journals Direct Oral Anticoagulants for Very Elderly People With Atrial Fibrillation

2016 ◽  
Vol 23 (1) ◽  
pp. 58-63 ◽  
Author(s):  
Samantha Pasca ◽  
Ugo Venturelli ◽  
Antonella Bertone ◽  
Giovanni Barillari
Keyword(s):  
Atrial Fibrillation ◽  
Elderly People ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Good Alternative ◽  
Efficacy And Safety ◽  
Very Elderly ◽  
First Choice ◽  
The Impact

Background: Four direct oral anticoagulants (DOACs) have been licensed for the treatment of atrial fibrillation (AF); efficacy and safety have been shown in clinical trials, but its real use in elderly and very elderly people is still unclear. Aim: To evaluate the impact of DOACs in our patients (pts) aged ≥75 years and switched from other treatments. Methods: From September 2013 to May 2015, all consecutive pts aged ≥75 years, males and females, in treatment for AF and switched to DOACs are considered in this study. Follow-up (FU) was scheduled after 3 and 6 months by phone and after 12 months by visit. Results: Two hundred thirty-two pts in treatment for AF were switched to DOACs, among these 143 (61.6%) pts aged ≥75 years (mean age, 81 years). The medium FU was 9.6 months, during which 4 minor bleedings in 4 different pts and 1 clinically relevant nonmajor bleeding were reported, all treated with temporary cessation or reduction in DOACs. Two strokes occurred in pts in treatment with dabigatran 110 mg, both resolved without serious sequelae; 2.8% of pts had nausea, itching, vomiting, or discomfort, half of these returned to acenocumarol, and the remaining switched to other DOAC. Four pts died, but the deaths were not related to anticoagulation. Conclusion: As reported for general people, also in our elderly population, DOACs resulted in a good alternative to old antithrombotic therapies. Efficacy and safety associated with a higher compliance by pts bring these drugs to be the first choice for long-term anticoagulation.

scholarly journals A Systematic Review of the Efficacy and Safety of Direct Oral Anticoagulants in Atrial Fibrillation Patients with Diabetes Using a Risk Index

2021 ◽  
Vol 10 (13) ◽  
pp. 2924
Author(s):  
Domenico Acanfora ◽  
Marco Matteo Ciccone ◽  
Valentina Carlomagno ◽  
Pietro Scicchitano ◽  
Chiara Acanfora ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Risk Index ◽  
Direct Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Efficacy Rate ◽  
Cochrane Central Register ◽  
Efficacy And Safety

Diabetes mellitus (DM) represents an independent risk factor for chronic AF and is associated with unfavorable outcomes. We aimed to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF), with and without diabetes mellitus (DM), using a new risk index (RI) defined as: RI =Rate of EventsRate of Patients at Risk. In particular, an RI lower than 1 suggests a favorable treatment effect. We searched MEDLINE, MEDLINE In-Process, EMBASE, PubMed, and the Cochrane Central Register of Controlled Trials. The risk index (RI) was calculated in terms of efficacy (rate of stroke/systemic embolism (stroke SEE)/rate of patients with and without DM; rate of cardiovascular death/rate of patients with and without DM) and safety (rate of major bleeding/rate of patients with and without DM) outcomes. AF patients with DM (n = 22,057) and 49,596 without DM were considered from pivotal trials. DM doubles the risk index for stroke/SEE, major bleeding (MB), and cardiovascular (CV) death. The RI for stroke/SEE, MB, and CV death was comparable in patients treated with warfarin or DOACs. The lowest RI was in DM patients treated with Rivaroxaban (stroke/SEE, RI = 0.08; CV death, RI = 0.13). The RIs for bleeding were higher in DM patients treated with Dabigatran (RI110 = 0.32; RI150 = 0.40). Our study is the first to use RI to homogenize the efficacy and safety data reported in the DOACs pivotal studies against warfarin in patients with and without DM. Anticoagulation therapy is effective and safe in DM patients. DOACs appear to have a better efficacy and safety profile than warfarin. The use of DOACs is a reasonable alternative to vitamin-K antagonists in AF patients with DM. The RI can be a reasonable tool to help clinicians choose between DOACs or warfarin in the peculiar set of AF patients with DM.

scholarly journals Plasma natriuretic peptide level is an independent determinant of major clinical outcomes in atrial fibrillation patients without heart failure: the Fushimi AF Registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y Hamatani ◽  
M Iguchi ◽  
Y Aono ◽  
K Ishigami ◽  
S Ikeda ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Clinical Outcomes ◽  
Prognostic Marker ◽  
Oral Anticoagulants ◽  
Systemic Embolism ◽  
The Mean

Abstract Background Atrial fibrillation (AF) increases the risk of death, stroke/systemic embolism and heart failure (HF). Plasma natriuretic peptide (NP) level is an important prognostic marker in HF patients. However, little is known regarding the prognostic significance of plasma NP level in AF patients without HF. Purpose The aim of this study is to investigate the relationship between plasma NP level and clinical outcomes such as all-cause death, stroke/systemic embolism and HF hospitalization during follow-up period in AF patients without HF. Methods The Fushimi AF Registry is a community-based prospective survey of AF patients in our city. The inclusion criterion of the registry is the documentation of AF at 12-lead electrocardiogram or Holter monitoring at any time, and there are no exclusion criteria. We started to enroll patients from March 2011, and follow-up data were available for 4,466 patients by the end of November 2019. From the registry, we excluded 1,220 patients without a pre-existing HF (defined as having one of the following; prior hospitalization for HF, New York Heart Association class ≥2, or left ventricular ejection fraction &lt;40%). Among 3,246 AF patients without HF, we investigated 1,189 patients with the data of plasma BNP (n=401) or N-terminal pro-BNP (n=788) level at the enrollment. We divided the patients according to the quartile of each plasma BNP or NT-pro BNP level and compared the backgrounds and outcomes between these 4 groups stratified by plasma NP level. Results Of 1,189 patients, the mean age was 72.1±10.2 years, 454 (38%) were female and 684 (58%) were paroxysmal AF. The mean CHADS2 and CHA2DS2-VASc score were 1.6±1.1 and 2.9±1.5, respectively. Oral anticoagulants were prescribed in 671 (56%) at baseline. The median (interquartile range) BNP and N-terminal pro-BNP level were 84 (38, 176) and 500 (155, 984) pg/ml, respectively. Patients with high plasma NP level were older, and demonstrated lower prevalence of paroxysmal AF, higher CHADS2 and CHA2DS2-VASc scores and higher prevalence of chronic kidney disease and oral anticoagulants prescription (all P&lt;0.01). A total of 165 all-cause death, 114 stroke/systemic embolism and 103 HF hospitalization occurred during the median follow-up period of 5.0 years. Kaplan-Meier curves demonstrated that higher plasma NP level was significantly associated with the incidences of all-cause death, stroke/systemic embolism and HF hospitalization in AF patients without HF (Figure 1A). Multivariable Cox regression analysis revealed that plasma NP level could stratify the risk of clinical outcomes even after adjustment by type of AF, CHA2DS2-VASc score, chronic kidney disease and oral anticoagulant prescription (Figure 1B). Conclusion Plasma NP level is a significant prognostic marker for all-cause death, stroke/systemic embolism and HF hospitalization in AF patients without HF, suggesting the importance of measuring plasma NP level in AF patients even without HF. Figure 1 Funding Acknowledgement Type of funding source: None

scholarly journals Clinical outcomes of Japanese atrial fibrillation patients with combined valvular heart disease: the Fushimi AF Registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Doi ◽  
K Ishigami ◽  
Y Aono ◽  
S Ikeda ◽  
Y Hamatani ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Heart Disease ◽  
Incidence Rate ◽  
Clinical Outcomes ◽  
Valvular Heart Disease ◽  
Cardiac Death ◽  
Clinical Characteristics ◽  
Valve Disease ◽  
The Impact

Abstract Background We previously reported that valvular heart disease (VHD) was not at the significant risk of stroke/systemic embolism (SE), but was associated with an increased risk of hospitalization for heart failure (HF) in Japanese atrial fibrillation patients. However, the impact of combined VHD on clinical outcomes has been little known. Purpose The aim of this study is to investigate the prevalence of combined VHD and its clinical characteristics and impact on outcomes such as stroke/SE, all-cause death, cardiac death and hospitalization for HF. Method The Fushimi AF Registry is a community-based prospective survey of AF patients in one of the wards of our city which is a typical urban district of Japan. We started to enroll patients from March 2011, and follow-up data were available for 4,466 patients by the end of November 2019. In the entire cohort, echocardiography data were available for 3,574 patients. 68 AF patients with prosthetic heart valves were excluded and we compared clinical characteristics and outcomes between 488 single VHD (103 Aortic valve disease (AVD), 315 mitral valve disease (MVD), 70 tricuspid valve disease (TVD)) and 158 combined VHD (46 AVD and MVD, 11 AVD and TVD, 66 MVD and TVD, 35 AVD and MVD and TVD). Result Compared with single VHD, patients with combined VHD were older (combined vs. single VHD: 78.5 vs. 76.0 years, respectively; p&lt;0.01), more likely to have persistent/permanent type AF (73.4% vs. 63.9%, p=0.02) and prescription of warfarin (63.1% vs. 53.8%, p=0.04). Combined VHD was less likely to have diabetes mellitus (13.9% vs. 23.6%, p=0.01) and dyslipidemia (26.6% vs. 40.4%, p&lt;0.01). Sex, body weight, hypertension, pre-existing HF were comparable between the two groups. During the median follow-up of 1,474 days, the incidence rate of stroke/SE was not significantly different between the two groups (1.58 vs. 1.89 per 100 person-years, respectively, log rank p=0.10). The incidence rate of all-cause death (7.35 vs. 5.33, p=0.65), cardiac death (1.20 vs. 0.99, p=0.91) and hospitalization for HF (5.55 vs. 4.43, p=0.53) were also not significantly different. We previously reported AVD had significant impacts on cardiac adverse outcomes in AF patients, and we further analyzed event rates between combined VHD including AVD (AVD and MVD/TVD) and without AVD (MVD and TVD). Combined VHD with AVD group had higher incidence rate of all-cause death (10.7 vs. 5.79, p=0.03) than that without AVD group. However, the incidence rate of stroke/SE (1.98 vs. 1.56, p=0.59), cardiac death (0.98 vs. 1.14, p=0.68), hospitalization for HF (8.03 vs. 5.38, p=0.17) were not significantly different between the two groups. Conclusion As compared with single VHD, the risk of stroke/SE, all-cause death, cardiac death and hospitalization for HF in combined VHD was not significantly different. Among patients with combined VHD, those having AVD had higher incidence rate of all-cause death than those without AVD. Figure 1 Funding Acknowledgement Type of funding source: None

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