Do baseline characteristics and treatments account for geographical disparities in the outcomes of patients with newly diagnosed atrial fibrillation? The prospective GARFIELD-AF registry

ObjectiveIn patients with newly diagnosed atrial fibrillation (AF), do baseline risk factors and stroke prevention strategies account for the geographically diverse outcomes.DesignGlobal Anticoagulant Registry in the FIELD-Atrial Fibrillation is a prospective multinational non-interventional registry of patients with newly diagnosed AF (n=52 018 patients).SettingInvestigator sites (n=1317) were representative of the care settings/locations in each of the 35 participating countries. Treatment decisions were all determined by the local responsible clinicians.ParticipantsThe patients (18 years and over) with newly diagnosed AF had at least 1 investigator-determined stroke risk factor and patients were not required to meet specific thresholds of risk score for anticoagulant treatment.Main outcomes and measuresObserved 1-year event rates and risk-standardised rates were derived.ResultsRates of death, non-haemorrhagic stroke/systemic embolism and major bleeding varied more than three-to-four fold across countries even after adjustment for baseline factors and antithrombotic treatments. Rates of anticoagulation and antithrombotic treatment varied widely. Patients from countries with the highest rates of cardiovascular mortality and stroke were among the least likely to receive oral anticoagulants. Beyond anticoagulant treatment, variations in the treatment of comorbidities and lifestyle factors may have contributed to the variations in outcomes. Countries with the lowest healthcare Access and Quality indices (India, Ukraine, Argentina, Brazil) had the highest risk-standardised mortality.ConclusionThe variability in outcomes across countries for patients with newly diagnosed AF is not accounted for by baseline characteristics and antithrombotic treatments. Residual mortality rates were correlated with Healthcare Access and Quality indices. The findings suggest the management of patients with AF needs to not only address guideline indicated and sustained anticoagulation, but also the treatment of comorbidities and lifestyle factors.Trial registration numberNCT01090362.

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Patient perception of anticoagulant treatment for stroke prevention (RE-SONANCE study)

Open Heart ◽

10.1136/openhrt-2019-001202 ◽

2020 ◽

Vol 7 (1) ◽

pp. e001202 ◽

Cited By ~ 1

Author(s):

Dragos Vinereanu ◽

Dmitry Napalkov ◽

Jutta Bergler-Klein ◽

Bela Benczur ◽

Martin Ciernik ◽

...

Keyword(s):

Atrial Fibrillation ◽

Stroke Prevention ◽

Treatment Satisfaction ◽

International Study ◽

Vitamin K Antagonist ◽

Patient Treatment ◽

Anticoagulant Treatment ◽

Newly Diagnosed ◽

Anticoagulation Treatment

ObjectiveWe evaluated atrial fibrillation (AF) patients’ perceptions of anticoagulation treatment with dabigatran or a vitamin K antagonist (VKA) for stroke prevention, according to accepted indications.MethodsThe RE-SONANCE observational, prospective, multicentre, international study used the validated Perception on Anticoagulant Treatment Questionnaire (PACT-Q) to assess patients with AF already taking a VKA who were switched to dabigatran (cohort A), and newly diagnosed patients initiated on either dabigatran or a VKA (cohort B). Visit 1 (V1) was at baseline, and visit 2 (V2) and visit 3 (V3) were at 30–45 and 150–210 days after baseline, respectively. Primary outcomes were treatment satisfaction and convenience in cohort A at V2 and V3 versus baseline, and in cohort B for dabigatran and a VKA at V2 and V3.ResultsThe main analysis set comprised 4100 patients in cohort A and 5365 in cohort B (dabigatran: 3179; VKA: 2186). In cohort A, PACT-Q2 improved significantly (p<0.001 for all) for treatment convenience (mean change V1 vs V2=20.72; SD=21.50; V1 vs V3=24.54; SD=22.85) and treatment satisfaction (mean change V1 vs V2=17.60; SD=18.76; V1 vs V3=21.04; SD=20.24). In cohort B, mean PACT-Q2 scores at V2 and V3 were significantly higher (p<0.001 for all) for dabigatran versus a VKA for treatment convenience (V2=18.38; SE =0.51; V3=23.34; SE=0.51) and satisfaction (V2=15.88; SE=0.39; V3=19.01; SE=0.41).ConclusionsSwitching to dabigatran from long-term VKA therapy or newly initiated dabigatran is associated with improved patient treatment convenience and satisfaction compared with VKA therapy.

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Design and rationale of DUTCH-AF: a prospective nationwide registry programme and observational study on long-term oral antithrombotic treatment in patients with atrial fibrillation

BMJ Open ◽

10.1136/bmjopen-2019-036220 ◽

2020 ◽

Vol 10 (8) ◽

pp. e036220

Author(s):

Gordon Chu ◽

Jaap Seelig ◽

Emmy M Trinks-Roerdink ◽

Anouk P van Alem ◽

Marco Alings ◽

...

Keyword(s):

Atrial Fibrillation ◽

The Netherlands ◽

Adverse Events ◽

Prediction Models ◽

Hospital Admissions ◽

Clinical Care ◽

Tertiary Care ◽

Anticoagulation Therapy ◽

Anticoagulant Treatment ◽

Newly Diagnosed

IntroductionAnticoagulation therapy is pivotal in the management of stroke prevention in atrial fibrillation (AF). Prospective registries, containing longitudinal data are lacking with detailed information on anticoagulant therapy, treatment adherence and AF-related adverse events in practice-based patient cohorts, in particular for non-vitamin K oral anticoagulants (NOAC). With the creation of DUTCH-AF, a nationwide longitudinal AF registry, we aim to provide clinical data and answer questions on the (anticoagulant) management over time and of the clinical course of patients with newly diagnosed AF in routine clinical care. Within DUTCH-AF, our current aim is to assess the effect of non-adherence and non-persistence of anticoagulation therapy on clinical adverse events (eg, bleeding and stroke), to determine predictors for such inadequate anticoagulant treatment, and to validate and refine bleeding prediction models. With DUTCH-AF, we provide the basis for a continuing nationwide AF registry, which will facilitate subsequent research, including future registry-based clinical trials.Methods and analysisThe DUTCH-AF registry is a nationwide, prospective registry of patients with newly diagnosed ‘non-valvular’ AF. Patients will be enrolled from primary, secondary and tertiary care practices across the Netherlands. A target of 6000 patients for this initial cohort will be followed for at least 2 years. Data on thromboembolic and bleeding events, changes in antithrombotic therapy and hospital admissions will be registered. Pharmacy-dispensing data will be obtained to calculate parameters of adherence and persistence to anticoagulant treatment, which will be linked to AF-related outcomes such as ischaemic stroke and major bleeding. In a subset of patients, anticoagulation adherence and beliefs about drugs will be assessed by questionnaire.Ethics and disseminationThis study protocol was approved as exempt for formal review according to Dutch law by the Medical Ethics Committee of the Leiden University Medical Centre, Leiden, the Netherlands. Results will be disseminated by publications in peer-reviewed journals and presentations at scientific congresses.Trial registration numberTrial NL7467, NTR7706 (https://www.trialregister.nl/trial/7464).

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Newly Diagnosed Atrial Fibrillation in Acute Myocardial Infarction

Journal of the American Heart Association ◽

10.1161/jaha.121.021417 ◽

2021 ◽

Author(s):

Yuki Obayashi ◽

Hiroki Shiomi ◽

Takeshi Morimoto ◽

Yodo Tamaki ◽

Moriaki Inoko ◽

...

Keyword(s):

Myocardial Infarction ◽

Heart Failure ◽

Atrial Fibrillation ◽

Acute Myocardial Infarction ◽

Major Bleeding ◽

Coronary Revascularization ◽

Newly Diagnosed ◽

Heart Failure Hospitalization ◽

Baseline Characteristics

Background It remains controversial whether long‐term clinical impact of newly diagnosed atrial fibrillation (AF) in the acute phase of acute myocardial infarction (AMI) is different from that of prior AF diagnosed before the onset of AMI. Methods and Results The current study population from the CREDO‐Kyoto AMI (Coronary Revascularization Demonstrating Outcome Study in Kyoto Acute Myocardial Infarction) Registry Wave‐2 consisted of 6228 patients with AMI who underwent percutaneous coronary intervention. The baseline characteristics and long‐term clinical outcomes were compared according to AF status (newly diagnosed AF: N=489 [7.9%], prior AF: N=589 [9.5%], and no AF: N=5150 [82.7%]). Median follow‐up duration was 5.5 years. Patients with newly diagnosed AF and prior AF had similar baseline characteristics with higher risk profile than those with no AF including older age and more comorbidities. The cumulative 5‐year incidence of all‐cause death was higher in newly diagnosed AF and prior AF than no AF (38.8%, 40.7%, and 18.7%, P <0.001). The adjusted hazard ratios (HRs) for mortality of newly diagnosed AF and prior AF relative to no AF remained significant with similar magnitude (HR, 1.31; 95% CI, 1.12–1.54; P <0.001, and HR, 1.32; 95% CI, 1.14–1.52; P <0.001, respectively). The cumulative 5‐year incidence of stroke decreased in the order of newly diagnosed AF, prior AF and no AF (15.5%, 12.9%, and 6.3%, respectively, P <0.001). The higher adjusted HRs of both newly diagnosed AF and prior AF relative to no AF were significant for stroke, with a greater risk of newly diagnosed AF than that of prior AF (HR, 2.05; 95% CI, 1.56–2.69; P <0.001, and HR, 1.33; 95% CI, 1.00–1.78; P =0.048, respectively). The higher stroke risk of newly diagnosed AF compared with prior AF was largely driven by the greater risk within 30 days. The higher adjusted HRs of newly diagnosed AF and prior AF relative to no AF were significant for heart failure hospitalization (HR, 1.73; 95% CI, 1.35–2.22; P <0.001, and HR, 2.23; 95% CI, 1.82–2.74; P <0.001, respectively) and major bleeding (HR, 1.46; 95% CI, 1.23–1.73; P <0.001, and HR, 1.36; 95% CI, 1.15–1.60; P <0.001, respectively). Conclusions Newly diagnosed AF in AMI had risks for mortality, heart failure hospitalization, and major bleeding higher than no AF, and comparable to prior AF. The risk of newly diagnosed AF for stroke might be higher than that of prior AF.

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Patient perception and treatment convenience of dabigatran versus vitamin K antagonist when used for stroke prophylaxis in atrial fibrillation: Real-world Evaluation of Long-term Anticoagulant Treatment Experience (RE-LATE) study

Open Heart ◽

10.1136/openhrt-2021-001745 ◽

2021 ◽

Vol 8 (2) ◽

pp. e001745

Author(s):

Young-Soo Lee ◽

Yong Seog Oh ◽

Eue-Keun Choi ◽

Alan Koay Choon Chern ◽

Panyapat Jiampo ◽

...

Keyword(s):

Atrial Fibrillation ◽

South Korea ◽

East Asia ◽

Vitamin K ◽

Real World ◽

Stroke Prevention ◽

Treatment Satisfaction ◽

South East Asia ◽

Anticoagulant Treatment ◽

Newly Diagnosed

PurposeDabigatran is a direct thrombin inhibitor approved for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). Real-world data about patient preference, satisfaction and convenience in patients in Asia are not available. The study aimed to explore the perception of patients with newly diagnosed NVAF regarding dabigatran versus vitamin K antagonists (VKAs), when used for stroke prevention.Patients and methodsThis was a multinational, multicentre, non-interventional study involving 49 sites across 5 countries in South East Asia and South Korea where 934 patients newly diagnosed with NVAF were initiated on either dabigatran (N=591) or VKA (N=343). Data were collected at baseline and over two follow-up visits across 6 months. Treatment satisfaction and patient convenience were evaluated using the Perception on Anticoagulant Treatment Questionnaire-2 (PACT-Q2).ResultsThe mean age of the patients was 65.9±10.4 years, and 64.2% were male. Mean CHA2DS2-VASc score was 2.4±1.5, and mean HAS-BLED score was 1.2±0.9. At baseline, patients initiated on dabigatran had higher stroke risk, bleeding risk, creatinine clearance and proportion of patients with concomitant illnesses compared with patients initiated on VKAs. Treatment convenience was perceived to be significantly better with dabigatran versus VKAs at visits 2 and 3 (p=0.0423 and 0.0287, respectively). Treatment satisfaction was significantly better with dabigatran compared with VKAs at visit 3 (p=0.0300).ConclusionIn this study, dabigatran is associated with better patient perception in terms of treatment convenience and satisfaction compared with VKAs when used for stroke prevention in newly diagnosed NVAF patients from South East Asia and South Korea.Trial registration numberNCT02849509.Plain language summaryPatient satisfaction with dabigatran versus VKAs in South East Asia. Patients with atrial fibrillation are at high risk of stroke and require anticoagulants for stroke prevention. Two such anticoagulants are dabigatran and VKAs. We wanted to compare the extent of satisfaction and treatment convenience among newly diagnosed patients with atrial fibrillation from the South East Asian region when they were given either dabigatran or VKAs. Consenting patients filled out a standardised questionnaire called the PACT-Q2 over three visits after they were started on either dabigatran (591 patients) or VKAs (343 patients). We found that satisfaction and convenience were significantly higher when patients received dabigatran than when they received VKAs.

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Relationship of aging and incident comorbidities to stroke risk in 594,169 Patients with atrial fibrillation: a nationwide analysis

European Heart Journal ◽

10.1093/ehjci/ehaa946.0630 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

L Fauchier ◽

A Bisson ◽

A Bodin ◽

J Herbert ◽

P Spiesser ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

Stroke Risk ◽

Adverse Outcomes ◽

Baseline Risk ◽

Stroke Risk Factor ◽

Ischemic Stroke Risk ◽

Relationship Of ◽

Better Than

Abstract Background When assessing ischemic stroke risk in patients with atrial fibrillation (AF), the CHA2DS2-VASc score is calculated based on the baseline risk factors, and the outcomes are determined after a follow-up period. However, the stroke risk in patients with AF does not remain static, and with time, patients get older and accumulate more comorbidities. This study hypothesized that the “Delta CHA2DS2-VASc score”, which reflects the change in score between baseline and follow-up, may be predictive of ischemic stroke compared with the baseline or follow-up assessments of the CHA2DS2-VASc score. Methods Based on the France nationwide administrative hospital-discharge database, we collected information for all patients treated with AF between 2010 and 2019 in France. Adverse outcomes were investigated during follow-up. A total of 594,169 patients with AF who did not have comorbidities of the CHA2DS2-VASc score except for age and sex, were studied. The Delta CHA2DS2-VASc score was defined as the change/difference between the baseline and follow-up CHA2DS2-VASc scores. During 1,290,721 person-years, 19,492 patients experienced ischemic stroke. The accuracies of baseline, follow-up, and Delta CHA2DS2-VASc scores in predicting ischemic stroke were analysed and compared. Results The mean baseline CHA2DS2-VASc score was 1.69, which increased to 2.33 during the follow-up, with a mean Delta CHA2DS2-VASc score of 0.64. The CHA2DS2-VASc score increased in 39.8% of patients. Among 19,492 patients who experienced ischemic stroke, 66.0% had a Delta CHA2DS2-VASc score ≥1 compared with only 38.9% in patients without ischemic stroke, and 5,811 (29.8%) patients had ≥2 new-onset comorbidity, the most common being hypertension. The follow-up CHA2DS2-VASc score and Delta CHA2DS2-VASc score were significant predictors of ischemic stroke (C-index 0.670 95% CI 0.667–0.674 and 0.637 95% CI 634–641 respectively) that performed better than baseline CHA2DS2-VASc score (C-index 0.613 95% CI 0.609–0.616, p<0.0001 for DeLong test). Conclusions In this AF cohort, we found that stroke risk (CHA2DS2-VASc score) was non-static, and that many patients developed ≥1 new stroke risk factor(s) before presentation with ischemic stroke. The follow-up CHA2DS2-VASc score and its change (ie Delta CHA2DS2-VASc, reflecting the change in stroke risk profile between baseline and follow-up) were better predictors of ischemic stroke than relying on the baseline CHA2DS2-VASc score. This emphasises how stroke risk in AF is a dynamic process due to increasing age and incident comorbidities, and regular re-assessment of risk is needed. Funding Acknowledgement Type of funding source: None

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Effect of amiodarone on heart rate variability in patients with newly diagnosed atrial fibrillation (clinical observation)

Medical alphabet ◽

10.33667/2078-5631-2020-21-81-85 ◽

2020 ◽

pp. 81-85

Author(s):

E. P. Popova ◽

O. T. Bogova ◽

S. N. Puzin ◽

D. A. Sychyov ◽

V. P. Fisenko

Keyword(s):

Atrial Fibrillation ◽

Heart Rate ◽

Heart Rate Variability ◽

Drug Therapy ◽

Heart Function ◽

Newly Diagnosed ◽

Class Iii ◽

Spectral Parameters ◽

Patient Will ◽

The Individual

Spectral analysis of heart rate variability gives an idea of the role of the autonomic nervous system in the regulation of chronotropic heart function. This method can be used to evaluate the effectiveness of drug therapy. Drug therapy should be carried out taking into account the individual clinical form of atrial fibrillation. Information about the vegetative status of the patient will undoubtedly increase the effectiveness of treatment. In this study, spectral parameters were studied in patients with newly diagnosed atrial fibrillation. The effect of antiarrhythmic drug class III amiodarone on the spectral parameters of heart rate variability was studied.

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