Atrial Fibrillation In Germany Research Articles

EE288 Decision Model to Evaluate the Cost of Clinical Events Associated with Switching from Apixaban to Rivaroxaban Among Patients with Non-Valvular Atrial Fibrillation in Germany

EE288 Decision Model to Evaluate the Cost of Clinical Events Associated with Switching from Apixaban to Rivaroxaban Among Patients with Non-Valvular Atrial Fibrillation in Germany

Anticoagulant Treatment Adherence and Persistence in German Patients with Atrial Fibrillation.

Treatment adherence and persistence impact the effectiveness of edoxaban for the prevention of thromboembolism in patients with atrial fibrillation (AF). The objective of this analysis was to assess adherence and persistence of edoxaban vs. other non-vitamin K antagonist oral anticoagulants (NOACs) and vitamin K antagonists (VKAs). Utilizing a German claims database, adults with AF with the first pharmacy claim identified for edoxaban, apixaban, dabigatran, rivaroxaban, or VKAs from January 2013 to December 2017 were included in a propensity score-matched analysis. The first pharmacy claim was the index claim. Adherence (i.e., proportion of days covered [PDC]) and persistence (proportion of patients who continued therapy) were compared between edoxaban and other therapies. Patients receiving once-daily (QD) vs. twice-daily (BID) NOAC were also analyzed. Overall, 21,038 patients were included (1236 edoxaban, 6053 apixaban, 1306 dabigatran, 7013 rivaroxaban, and 5430 VKA). After matching, baseline characteristics were well balanced across cohorts. Adherence was significantly higher for edoxaban vs. apixaban, dabigatran, and VKAs (all P < 0.0001). Significantly more edoxaban patients continued therapy vs. rivaroxaban (P = 0.0153), dabigatran (P < 0.0001), and VKAs (P < 0.0001). Time to discontinuation was significantly longer for edoxaban vs. dabigatran, rivaroxaban, and VKAs (all P < 0.0001). More patients receiving NOACs QD had a PDC ≥ 0.8 compared with those receiving NOACs BID (65.3 vs. 49.6%, respectively; P < 0.05); persistence rates were comparable between QD and BID groups. Patients with AF receiving edoxaban had significantly higher adherence and persistence compared with those receiving VKAs. This trend was also seen in NOAC QD regimens vs. NOAC BID regimens for adherence. These results provide insight into how adherence and persistence may contribute to the effectiveness of edoxaban for stroke prevention in patients with AF in Germany.

Time Trends in Patient Characteristics of New Rivaroxaban Users with Atrial Fibrillation in Germany and the Netherlands.

Use of the direct oral anticoagulant rivaroxaban has strongly increased in Europe since its market approval for non-valvular atrial fibrillation in 2011. Patients characteristics of rivaroxaban initiators may have changed over time but this has not been investigated so far. We aimed to describe time trends of patient baseline characteristics among new rivaroxaban users with non-valvular atrial fibrillation from 2011 to 2016/17 in two European countries. We used data from Germany (German Pharmacoepidemiological Research Database) and the Netherlands (PHARMO Database Network). We included new rivaroxaban users with (i) a first dispensing between 2011 and 2016/17, (ii) ≥2 years of age, and (iii) a diagnosis of non-valvular atrial fibrillation and described their baseline medication and comorbidity prior to starting rivaroxaban stratified by year of inclusion. Overall, 130,652 new rivaroxaban users were included during the study period (Germany: N=127,743, the Netherlands: N=2909). The sex ratio and median age remained relatively stable over time. The proportion of patients without prior use of oral anticoagulants before initiation of rivaroxaban increased in both countries between 2011 and 2016/17 (Germany: from 51 to 76%, the Netherlands: from 57 to 85%). In Germany, we observed a relative decrease by 27% in the proportion of new rivaroxaban users with a history of ischemic stroke and by 18% in the proportion with a transient ischemic attack at baseline. No such a pattern was observed in the Netherlands. The proportion of patients with heart failure at baseline showed a three-fold increase in the Netherlands, while there was a relative decrease by 12% in Germany. Patient characteristics of new rivaroxaban users with non-valvular atrial fibrillation changed between 2011 and 2016/17, but changes differed between countries. These patterns have methodological implications. They have to be considered in the interpretation of observational studies comparing effectiveness and safety of oral anticoagulants, especially regarding potential bias due to unmeasured confounding.

GARFIELD-AF: risk profiles, treatment patterns and 2-year outcomes in patients with atrial fibrillation in Germany, Austria and Switzerland (DACH) compared to 32 countries in other regions worldwide.

The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is a worldwide non-interventional study of stroke prevention in patients with non-valvular AF. 52,080 patients with newly diagnosed AF were prospectively enrolled from 2010 to 2016. 4121 (7.9%) of these patients were recruited in DACH [Germany (n = 3567), Austria (n = 465) and Switzerland (n = 89) combined], and 47,959 patients were from 32 countries in other regions worldwide (ORW). Hypertension was most prevalent in DACH and ORW (85.3% and 75.6%, respectively). Diabetes, hypercholesterolaemia, carotid occlusive disease and vascular disease were more prevalent in DACH patients vs ORW (27.6%, 49.4%, 5.8% and 29.0% vs 21.7%, 40.9%, 2.8% and 24.5%). The use of non-vitamin K antagonist oral anticoagulants (NOACs) increased more in DACH over time. Management of vitamin K antagonists was suboptimal in DACH and ORW (time in therapeutic range of INR ≥ 65% in 44.6% and 44.4% of patients or ≥ 70% in 36.9% and 36.0% of patients, respectively). Adjusted rates of cardiovascular mortality and MI/ACS were higher in DACH while non-haemorrhagic stroke/systemic embolism was lower after 2-year follow-up. Similarities and dissimilarities in AF management and clinical outcomes are seen in DACH and ORW. The increased use of NOAC was associated with a mismatch of risk-adapted anticoagulation (over-and-undertreatment) in DACH. Suboptimal control of INR requires educational activities in both regional groups. Higher rates of cardiovascular death in DACH may reflect the higher risk profile of these patients and lower rates of non-haemorrhagic stroke could be associated with increased NOAC use.

Comparison of clinical outcomes of edoxaban versus apixaban, dabigatran, rivaroxaban, and vitamin K antagonists in patients with atrial fibrillation in Germany: A real-world cohort study

BackgroundThe aim of the study was to compare the real-world effectiveness and safety in atrial fibrillation (AF) patients treated with edoxaban versus other oral anticoagulants (OACs) (apixaban, dabigatran, rivaroxaban, and vitamin K antagonists [VKA]) in Germany. Methods and resultsUsing a representative database of 3.5 million statutory health-insured lives in Germany, a retrospective cohort study was conducted to examine ischemic stroke (IS) or systemic embolism (SE) and major bleeding in AF patients initiating anticoagulant therapy from January 2014 through June 2017. Inverse probability of treatment weighting using propensity score was applied for baseline covariate adjustment. Cox proportional hazards models were used to estimate the adjusted risk (hazard ratio [HR]) of each outcome comparing edoxaban versus other OACs.Among 21,038 patients treated with OACs, 1236 edoxaban, 6053 apixaban, 1306 dabigatran, 7013 rivaroxaban, and 5430 VKA patients were included. The adjusted combined risks of IS or SE were lower (p < 0.05) for each edoxaban pairwise comparison with other OACs (HR: 0.83 vs. apixaban, 0.60 vs. dabigatran, 0.72 vs. rivaroxaban, 0.64 vs. VKA). Edoxaban favored lower risks of major bleeding compared with rivaroxaban (HR: 0.74) and VKA (HR: 0.47). No differences in the risk of major bleeding were found between edoxaban and apixaban (p = 0.33), and between edoxaban and dabigatran (p = 0.06). ConclusionsEdoxaban was associated with better effectiveness compared with other OACs in AF patients from Germany. Edoxaban also demonstrated a favorable safety profile.

Improved adherence to anticoagulant therapy with once-daily regimen: a real-world study in patients with atrial fibrillation in Germany

Abstract Background Adherence and persistence to non-VKA oral anticoagulants (NOACs) are important to achieve optimal clinical outcomes in patients with atrial fibrillation (AF). Dosing frequency may play a role in adherence and persistence to NOAC therapy. Among the NOACs that are currently available, edoxaban and rivaroxaban are given once daily (QD) while dabigatran and apixaban are given twice daily (BID). Purpose The objective of the study was to compare the adherence and persistence in AF patients receiving QD versus BID NOAC regimens in Germany. Methods Using an administrative database from our institution (Deutsche Analysedatenbank für Evaluation und Versorgungsforschung) between January 2013 and December 2017, a retrospective cohort study was conducted to compare the 6-month adherence in NOAC-naïve AF patients who initiated anticoagulant therapy. Continuous enrolment for 12 months before anticoagulant initiation was required to assess baseline characteristics. Adherence was measured using proportion of days covered (PDC) and medication possession ratio (MPR). Proportions of patients with PDC ≥80% and MPR ≥80% were also measured. Treatment discontinuation was defined as a prescription supply gap of ≥90 days. Inverse probability treatment weighting using propensity score was applied to control for differences in baseline characteristics. Results A total of 8249 (1236 edoxaban, 7013 rivaroxaban) and 7359 (6053 apixaban, 1306 dabigatran) patients who received QD and BID regimens were included. The two regimen groups were well balanced after weighting. Patients who received QD regimens had a significantly higher mean PDC at 6 months compared to those who received BID regimens (0.78 vs. 0.72, p&amp;lt;0.05). The proportion of patients with PDC ≥80% was significantly higher for QD versus BID regimens (65.3% vs. 49.6%, p&amp;lt;0.05). Similarly, the mean MPR was higher for QD versus BID regimens (0.81 vs. 0.74, p&amp;lt;0.05), with more QD patients having MPR ≥80% than BID patients (69.5% vs. 53.3%, p&amp;lt;0.05). Six-month persistence rates were comparable between the two regimen groups (73.4% vs. 74.2%, p=0.13). Conclusions Adherence to once-daily regimens of NOAC was significantly higher compared to adherence to twice-daily NOAC regimens. Future research is needed to examine the relationship between adherence to NOAC treatment and clinical outcomes in AF patients, and factors affecting persistence. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This study was sponsored by Daiichi Sankyo Inc

Comparison of clinical outcomes with edoxaban versus apixaban, dabigatran, rivaroxaban, and vitamin K antagonist in patients with atrial fibrillation in Germany: a real-world cohort study

Abstract Background Vitamin K antagonists (VKA) and non-VKA oral anticoagulants (NOACs) are used to prevent thromboembolic conditions in patients with atrial fibrillation (AF). Unlike VKA, NOACs have fixed dosage schemes, do not require regular laboratory tests, and have fewer drug and food interactions. The use of NOACs has increased substantially in recent years in Germany. However, there is limited evidence on the comparative effectiveness and safety between different NOACs and VKA in real-world settings. Purpose The objective of the study was to compare the clinical outcomes, including systemic embolism (SE), ischemic stroke (IS), and major bleeding, of edoxaban with other NOACs (apixaban, dabigatran, rivaroxaban) and VKA in AF patients in Germany. Methods Using an administrative database from our institution (Deutsche Analysedatenbank für Evaluation und Versorgungsforschung) between January 2013 and December 2017, a retrospective cohort study was conducted to compare the effectiveness (risk of SE or IS) and safety (risk of major bleeding) in NOAC-naïve AF patients who initiated anticoagulant therapy. Continuous enrolment for 12 months before anticoagulant initiation was required to assess baseline characteristics. Patients were followed up until (1) the first outcome event (SE, IS, or major bleeding), (2) disenrollment from health plans, or (3) discontinuation of the index NOAC or VKA or therapy switch, whichever occurred first. Inverse probability treatment weighting (IPTW) using propensity score was applied to control for differences in baseline characteristics. Cox proportional hazards models were used to estimate the hazard ratios (HR) for each outcome comparing edoxaban versus other NOACs and VKA. Sensitivity analyses were conducted with follow-up period cut-off at 1 year. Results A total of 1236 edoxaban, 6053 apixaban, 1306 dabigatran, 7013 rivaroxaban, and 5430 VKA patients were included. Patient cohorts were well balanced after weighting. The adjusted risks of SE or IS were lower for edoxaban compared to apixaban (HR 0.83, 95% CI 0.69–0.99), dabigatran (HR 0.54, 95% CI 0.40–0.74), rivaroxaban (HR 0.72, 95% CI 0.60–0.87), and VKA (HR 0.65, 95% CI 0.53–0.78) (all p&amp;lt;0.05). Edoxaban was associated with a significantly lower risk of major bleeding compared to dabigatran (HR 0.73, 95% CI 0.55–0.98), rivaroxaban (HR 0.74, 95% CI 0.63–0.87), and VKA (HR 0.47, 95% CI 0.40–0.55) (all p&amp;lt;0.05). The risk of major bleeding was comparable between edoxaban and apixaban (HR 1.09, 95% CI 0.92–1.30, p=0.33). Results were consistent in the sensitivity analyses. Conclusions Edoxaban was associated with a significantly lower risk of SE or IS compared to other NOACs and VKA, indicating improved effectiveness. Edoxaban also had a favourable safety profile with a significantly lower risk of major bleeding compared to dabigatran, rivaroxaban, and VKA. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This study was sponsored by Daiichi Sankyo Inc.

Comparative effectiveness of rivaroxaban versus a vitamin K antagonist in patients with renal impairment treated for non-valvular atrial fibrillation in Germany — A retrospective cohort study

BackgroundThe risk of thromboembolic events is increased in patients with non-valvular atrial fibrillation (NVAF) and renal impairment. The risk of bleeding events is increased if these patients are treated with anticoagulants and further increased in those with active cancer. MethodsRELOAD, a retrospective database study, assessed the outcomes of patients with NVAF prescribed rivaroxaban versus phenprocoumon. Here, we present a subgroup analysis evaluating effectiveness and safety of rivaroxaban versus phenprocoumon in patients with NVAF and renal impairment. Analyses were additionally stratified by patients with and without evidence of cancer at baseline. ResultsWhen using the ‘one tablet per day’ definition of estimating drug exposure time, the incidence of the primary endpoint of ischaemic stroke was significantly lower in patients (without evidence of cancer at baseline) receiving rivaroxaban 15 mg or 20 mg once daily versus those receiving phenprocoumon (2.40 vs 3.51 events per 100 patient-years, respectively; hazard ratio [HR] = 0.72, 95% confidence interval [CI] 0.55–0.94, p = 0.015); with the incidence of the primary safety outcome of intracranial haemorrhage being numerically lower (0.57 vs 0.89 events per 100 patient-years, respectively; HR = 0.66, 95% CI 0.38–1.14, p = 0.14). Similar results were observed when using the ‘empirical defined daily dose’ definition to estimate drug exposure time and when including patients with evidence of cancer. ConclusionThe prescription of rivaroxaban in patients with NVAF and renal impairment was associated with a lower incidence of ischaemic stroke and intracranial haemorrhage versus phenprocoumon in patients without evidence of cancer.

Stroke prevention in patients with acute ischemic stroke and atrial fibrillation in Germany - a cross sectional survey

BackgroundAtrial fibrillation (AF) is present in 15–20% of patients with acute ischemic stroke. Oral anticoagulation reduces the risk of AF-related recurrent stroke but clinical guideline recommendations are rather vague regarding its use in the acute phase of stroke. We aimed to assess the current clinical practice of medical stroke prevention in AF patients during the acute phase of ischemic stroke.MethodsIn April 2017, a standardized anonymous questionnaire was sent to clinical leads of all 298 certified stroke units in Germany.ResultsOverall, 154 stroke unit leads participated (response rate 52%). Anticoagulation in the acute phase of stroke is considered feasible in more than 90% of AF patients with ischemic stroke. Clinicians assume that about two thirds of all AF patients (range 20–100%) are discharged on oral anticoagulation. According to local preferences, acetylsalicylic acid is given orally in the majority of patients with delayed initiation of oral anticoagulation. A non-vitamin K-dependent oral anticoagulant (NOAC) is more often prescribed than a vitamin K-dependent oral anticoagulant (VKA). VKA is more often chosen in patients with previous VKA intake than in VKA naive patients. In the minority of patients, stroke unit leads discuss the prescription of a specific oral anticoagulant with the treating general practitioner. Adherence to medical stroke prevention after hospital discharge is not assessed on a regular basis in any patient by the majority of participating stroke centers.ConclusionsEarly secondary stroke prevention in AF patients in German stroke units is based on OAC use but prescription modalities vary in clinical practice.

Long-term health benefits of stroke prevention with apixaban versus vitamin K antagonist warfarin in patients with non-valvular atrial fibrillation in Germany: a population-based modelling study

ABSTRACTBackground: Patients with non-valvular atrial fibrillation (NVAF) have a five times higher stroke risk. For more than 50 years, vitamin K antagonists (VKAs) have been the primary medication for stroke prevention. Apixaban, a non-vitamin K oral anticoagulant (NOAC), has demonstrated better efficacy and safety characteristics than the VKA warfarin in the ARISTOTLE trial. This study aims to quantify the potential societal effects of using apixaban instead of VKA in the German NVAF population from 2017 to 2030.Methods: Using an existing Markov model and a dynamic population approach, we modelled the health benefits of apixaban in patients with NVAF compared to VKA therapy in the German population from 2017 to 2030.Results: The results represent the extrapolated direct long-term health benefits of apixaban over VKA therapy for the German NVAF population. From 2017 until 2030, the use of apixaban instead of a VKA could avoid 52,185 major clinical events. This includes 15,383 non-fatal strokes or SEs, 22,483 non-fatal major bleeds, and 14,319 all-cause deaths, which correspond to 109,887 life years gained.Conclusion: This study demonstrated that using apixaban instead of VKA for stroke prevention can lead to considerable reduction in cardiovascular events.

PRM208 - VALIDATION OF THE ENGLISH VERSION OF THE ADHERENCE ASSESSMENT QUESTIONNAIRE (AAQ)

Adherence to chronic medication is known to be far from optimal, and that negatively influences effectiveness of respective treatments. The aim of this study was to validate the English version of a measurement instrument (Adherence Assessment Questionnaire: AAQ) that assesses the extent of medication-related non-adherence (NA). The existing AAQ – originally developed and validated in patients with atrial fibrillation in Germany - was translated to English using forward-backward translation. The AAQ consists of 8 items formulated as statements (4-point-Likert-scale from “strongly agree” to “strongly disagree”) and one additional item formulated as visual analogue scale (depicting proportion of adherent days in past two weeks). Additionally, two items measuring a patient's tendency to answer in a socially desirable way were added to the AAQ. The questionnaire was submitted through a crowd-sourcing internet marketplace (Amazon Mechanical Turk). Participants aged ≥18 years who had been taking chronic medication for at least three months were included. Internal consistency and factor analysis were evaluated to detect existing subscales measuring different types of adherence. 248 patients were included (aged <30 years/31-50 years/<50 years: 20.2%/53.6%/26.2%; 70.2% female; average number of medication needed to be taken: 3.2). The AAQ demonstrated very good internal consistency (Cronbach’s alpha: 0.757). Based on an identified threshold, 33.9% of the patients could be classified to be NA. Excluding all patients with a high probability of social desirability answering behavior, the NA rate increased to 36.8%. Factor analysis identified two subscales: unintentional adherence scale (37.8% of the variance) and intentional adherence scale (14.1% of the variance). The majority of NA patients was affected by both intentional and unintentional NA (77.4%), 6.0%/16.6% were affected only by intentional NA/unintentional NA. The English version of the AAQ is a suitable instrument for assessing the level of adherence as well as identification of specific NA subtypes.

Comparative Effectiveness of Rivaroxaban VS Vitamin K Antagonist In Routine Care Patients Treated For Non-Valvular Atrial Fibrillation In Germany – A Renal Impairment Subgroup Analysis

Comparative Effectiveness of Rivaroxaban VS Vitamin K Antagonist In Routine Care Patients Treated For Non-Valvular Atrial Fibrillation In Germany – A Renal Impairment Subgroup Analysis

Real life anticoagulation treatment of patients with atrial fibrillation in Germany: extent and causes of anticoagulant under-use.

Oral anticoagulation (OAC) with either new oral anticoagulants (NOACs) or Vitamin-K antagonists (VKAs) is recommended by guidelines for patients with atrial fibrillation (AF) and a moderate to high risk of stroke. Based on a claims-based data set the aim of this study was to quantify the stroke-risk dependent OAC utilization profile of German AF patients and possible causes of OAC under-use. Our claims-based data set was derived from two German statutory health insurance funds for the years 2007-2010. All prevalent AF-patients in the period 2007-2009 were included. The OAC-need in 2010 was assumed whenever a CHADS2- or CHA2DS2-VASC-score was >1 and no factor that disfavored OAC use existed. Causes of OAC under-use were analyzed using multivariate logistic regression. 108,632 AF-prevalent patients met the inclusion criteria. Average age was 75.43 years, average CHA2DS2-VASc-score was 4.38. OAC should have been recommended for 56.1/62.9 % of the patients (regarding factors disfavouring VKA/NOAC use). For 38.88/39.20 % of the patient-days in 2010 we could not observe any coverage by anticoagulants. Dementia of patients (OR 2.656) and general prescription patterns of the treating physician (OR 1.633) were the most important factors increasing the risk of OAC under-use. Patients who had consulted a cardiologist had a lower risk of being under-treated with OAC (OR 0.459). OAC under-use still seems to be one of the major challenges in the real-life treatment of AF patients. Our study confirms that both patient/disease characteristics and treatment environment/general prescribing behaviour of physicians may explain the OAC under-use in AF patients.

Perioperatives Management und Therapie von Blutungskomplikationen

The new oral anticoagulants directly inhibit either thrombin (Dabigatran, Pradaxa®,) or activated Factor X (rivaroxaban, Xarelto®, and apixaban, Eliquis®) and have been approved for thromboprophylaxis after hip and knee replacement surgery and stroke prevention in non-valvular atrial fibrillation. Moreover, rivaroxaban has been approved for the treatment of deep venous thrombosis, prevention of pulmonary embolism and anticoagulation after acute myocardial infarction. The direct FXa-inhibitor edoxaban (Lixiana®) expects approval for the prevention of stroke in atrial fibrillation in Germany in 2014. The half lives of all direct anticoagulants range between 8 and 17 hours. Dabigatran (Pradaxa®) and rivaroxaban (Xarelto®) are mainly excreted by the kidneys, apixaban (Eliquis®) by the liver (75%) and edoxaban (Lixiana®) by the kidneys (40%) and the faeces in 60%. Prior to surgery a shorter cessation is expected compared to the vitamin k antagonists phenprocoumon (Marcumar®, Falithrom®) and warfarin (Coumadin®). For acute bleedings caused by the direct thrombin inhibitor dabigatran (Pradaxa®) hemodialysis is recommended to eliminate the drug from the plasma. Due to the high protein binding the direkt FXa-inhibitors rivaroxaban (Xarelto®) and apixaban (Eliquis®) can not be hemodialysed. For edoxaban (Lixiana®) no data on elimination by renal replacement therapy are available. In case of life-threatening bleeding the replacement of a prothrombin complex preparation (PCC) containing the factors II, VII, IX and X and, second line, activated factor concentrates as recombinant factor VIIa or activated prothrombin complex preparations are recommended.

C0126 Value-based pricing for dabigatran, rivaroxaban and apixaban in patients with non-valvular atrial fibrillation in Germany

Warfarin reduces effectively the incidence of ischemic stroke in patients with non-valvular atrial fibrillation (AF) but increases the risk of major and intracerebral bleeding. The three new oral anticoagulants (NOAC) dabigatran (110mg bid (D220) and 150mg bid (D300), RE-LY trial), rivaroxaban (20mg od, R20, ROCKET trial), and apixaban (5mg bid, A10, ARISTOTLE trial) showed equivalent or superior efficacy and safety compared to warfarin in these patients. We aimed to analyse the value-based price (Euro) for Germany for these NOACs.

Oral anticoagulation use by patients with atrial fibrillation in Germany

Atrial fibrillation (AF) is the most common significant cardiac rhythm disorder. Oral anticoagulation (OAC) is recommended by guidelines in the presence of a moderate to high risk of stroke. Based on an analysis of claims-based data, the aim of this contribution is to quantify the stroke-risk dependent OAC utilisation profile of German AF patients as well as the possible causes and the associated clinical outcomes of OAC under-use. Our data set was derived from two large mandatory German medical insurance funds. Risk stratification of patients was based on the CHADS2-score and the CHA2DS2-VASc-score. Two different scenarios were constructed to deal with factors potentially disfavouring OAC use. Causes of OAC under-use and its clinical consequences were analysed using multivariate analysis. Observation year was 2008. A total of 183,448 AF patients met the inclusion criteria. This represents an AF prevalence of 2.21%. The average CHADS2-score was 2.8 (CHA2DS2-VASc-score: 4.3). On between 40.5 and 48.7% of the observed patient-days, there was no antithrombotic protection by OAC, other anticoagulants or aspirin. Older female patients with a high number of comorbidities had a higher risk of OAC under-use. Patients who had already experienced a thromboembolic event had a lower risk of OAC under-use. In the observation year, 3,367 patients experienced a stroke (incidence rate 1.8%). In our multi-level Poisson random effects estimate, OAC use decreases the stroke rate by almost 80% (IRR 0.236). In conclusion, OAC under-use is widespread in the German market. It is associated with severe clinical consequences.

Register und Studien des Deutschen Kompetenznetzes Vorhofflimmern (AFNET)

The German Competence Network on Atrial Fibrillation (AFNET) is a national interdisciplinary research network funded by the Federal Ministry of Education and Research (BMBF). AFNET was initiated in 2003 and aims at improving treatment of atrial fibrillation (AF), the most frequent sustained cardiac arrhythmia. AFNET has established a nationwide patient registry on diagnostics, therapy, course and complications of AF in Germany. The data analyzed to date demonstrate that patients with AF are likely to have multiple co-morbidities, such as hypertension, valvular heart disease, coronary artery disease, diabetes mellitus and advanced age. Oral anticoagulation is provided to the majority of patients in accordance with the recommendations given by guidelines. Further areas of research deal with the optimal duration of antiarrhythmic therapy following electrical cardioversion of atrial fibrillation and the value of strategies to prevent arrhythmogenic changes, such as fibrosis in the atria, for prevention of further episodes of atrial fibrillation. Additional registry projects were established for patients with catheter-based interventional therapy of atrial fibrillation and surgical ablation to define success, complications and long term results of these recently developed procedures more clearly. Data and insights gathered from these projects were used to further develop standards of care in two international conferences.

The Costs of Care in Atrial Fibrillation and the Effect of Treatment Modalities in Germany

Objective Atrial fibrillation (AF) is an increasing burden on health-care systems because of an aging population. This study aimed to estimate health-care resource use and costs of treating AF in Germany. Method A 6-month multicenter prospective observational cohort study with additional 3-month retrospective clinical data collection was performed in physician practices. AF-related resource use was documented by 3-month retrospective and 6-month prospective clinical data from physician charts and prospectively by patient questionnaires at 3 and 6 months. Cost calculation was from the health-care payer perspective. Results A total of 361 patients (mean age 71 ± 9 years, 61% male) were recruited from 45 physician practices. Of 311 (86.1%) patients with complete data, 75% had persistent AF; oral anticoagulation and/or aspirin were prescribed in 98%. A rhythm-control strategy was applied in 27%, rate control in 58%, and 15% received neither antiarrhythmic medication nor cardioversion. A higher proportion of rhythm-control patients had paroxysmal AF ( P < 0.001). Mean annual AF-related per-patient cost was 827 Euro ± 1476 (median 386 Euro). 50% of total costs were incurred by 11% of patients, driven by AF-related hospitalizations (44%). Antiarrhythmics and stroke prophylaxis accounted for 20% and 15% of expenditures, respectively. Mean annualized costs were higher for rhythm-control patients than for rate-control patients or those without antiarrhythmic treatment (1572 vs. 780 vs. 544 Euro, P < 0.001). Conclusion This evaluation provides an overview of current treatment modalities and cost of AF management in Germany. Efforts to reduce the economic burden of AF should focus on avoidance of AF hospital admissions and optimization of stroke prevention and rhythm control.

The Registry of the German Competence NETwork on Atrial Fibrillation: patient characteristics and initial management

AimsThe aim of this study was to describe the characteristics of patients with atrial fibrillation (AF) enrolled in the Central Registry of the German Competence NETwork on Atrial Fibrillation (AFNET) and to assess current medical practice in patients treated at various levels of medical care in Germany.Methods and resultsFrom February 2004 to March 2006, 9582 ambulatory and hospitalized patients with ECG-documented AF were enrolled by 194 participating study centres from all levels of medical care in Germany. Clinical type of AF was reported as paroxysmal in 2893, persistent in 1873, and permanent in 3134 patients or classified as a first episode in 1035 patients. Predisposing conditions were common and present in 87.6% of the patients. Most patients were symptomatic with AF (75.1%). Rhythm control in persistent AF was provided to 53.4% of the symptomatic patients and to 47.8% of the patients without symptoms. Anticoagulation for stroke prevention was given to 71.4% of the patients considered eligible by applicable guidelines and to 48.4% of patients with low risk where guidelines do not recommend anticoagulation.ConclusionThis registry provides insight into current medical care of patients with AF in Germany. The use of oral anticoagulation in eligible patients was among the highest reported, whereas decisions on rate and rhythm control often do not follow current recommendations.

The German Competence Network on Atrial Fibrillation (AFNET)

The German Competence Network on Atrial Fibrillation (AFNET) is an interdisciplinary national research network funded by the Federal Ministry of Education and Research (BMBF) since 2003. The AFNET aims at improving treatment of atrial fibrillation (AF), the most frequent sustained arrhythmia of the heart. The AFNET has established a nationwide patient registry on manifestation, diagnostics, and therapy of AF in Germany. The data analyzed to date demonstrate that patients with AF are likely to have multiple comorbidities (hypertension, valvular heart disease, coronary artery disease, diabetes mellitus) and an advanced age. Regarding oral anticoagulation, guideline adherence is very high. Basic research has identified specific changes in atrial tissue during AF-induced remodeling providing the rationale for novel therapeutic interventions. Clinical trials are being carried out to optimize pharmacological and nonpharmacological treatments. The ANTIPAF trial is designed to prove that angiotensin II receptor blockers reduce the incidence of paroxysmal AF. The Flec-SL trial tests the efficacy of a short-term treatment with antiarrhythmic drugs after cardioversion. The Gap-AF trial investigates the impact of complete pulmonary vein (PV) isolation versus incomplete circumferential PV ablation on AF recurrences. The effect of preventive pacing on the recurrence of paroxysmal AF is studied in the BACE-PACE trial.