Atrial Fibrillation In France Research Articles

Impact of exceeding low-risk alcohol drinking guidelines on hypertension, hemorrhagic stroke and atrial fibrillation in France

Impact of exceeding low-risk alcohol drinking guidelines on hypertension, hemorrhagic stroke and atrial fibrillation in France

Incidence, epidemiology, risk factors and prognosis of atrio-esophageal fistula following percutaneous catheter ablation. An exhaustive natiowide registry

A rare but often fatal complication of atrial fibrillation (AF) ablation is the formation of an atrioesophageal fistula (AEF) whose true prevalence and risk factors remain obscure. To determine incidence, epidemiology, risk factors and prognosis of AEF using a “ as exhaustive as possible” nationwide survey. All French centres performing AF ablation were identified and survey were sent concerning the habits, techniques of AF ablation and eventual cases of AEF. Eighty-two of the 103 centres (80%) performing ablation of AF in France were included in the study performing 129286 ablations from 2006 (93% of the total AF ablation in France). Thirty-three fistula were declared (0.026% risk per procedure) with a stable annual incidence over time, unchanged after the advent of thermal probe. The survey had been completed for 30 of the 33 fistula cases (26 AEF, 4 esopericardial fistula). Sensitivity of CT scan for AEF diagnosis was 81%. Mortality was 60%, significantly lower in case of surgical management (31 vs. 93%, P = 0.001). No case of AEF happened after cryo-ablation and only two AEF occurred in redo-ablation. In multivariate analysis, lack of use of contact force catheters and the realisation of posterior/roof ablation lines emerged as independent factors associated with the risk of AEF with OR 23.6 (95% CI [4.5; 21]) P = 0.0002 and OR 3.7 (95% CI [1.1, 13]) P = 0.04) while the lack of thermal probes remained of borderline significance ( Fig. 1 ). The rate of AEF after AF ablation in a nationwide and well exhaustive survey can be evaluated to 0.026% with an annual incidence remaining stable over time. A normal CT scan does not rule out the diagnosis. Prognosis remains poor with a mortality of 60% and crucially dependant of immediate surgical correction.

Incidence, epidemiology, risk factors and prognosis of atrio-esophageal fistula following percutaneous catheter ablation. An exhaustive natiowide registry

Abstract Introduction A rare but often fatal complication of atrial fibrillation (AF) ablation is the formation of an atrioesophageal fistula (AEF) whose true prevalence and risk factors remain obscure. Objective To determine incidence, epidemiology, risk factors and prognosis of AEF using a – as exhaustive as possible – nationwide survey Method All French centers performing AF ablation were identified and survey were sent concerning the habits, techniques of AF ablation and eventual cases of AEF. Results 82 of the 103 centers (80%) performing ablation of AF in France were included in the study performing 129286 ablations from 2006 (93% of the total AF ablation in France). 33 AEF were declared (26 AEF and 4 esopericardial fistula) (0.026% risk per procedure) with a stable annual incidence over time, unchanged after the advent of thermal probe. Sensititvity of CT scan for AEF diagnosis was 81%. Mortality was 60%, significantly lower in case of surgical mangement (31 vs 93%, p=0.001). No case of AEF happened after cryoablation and only two AEF occurred in redo ablation. In multivariate analysis, lack of use of contact force catheters and the realization of posterior/roof ablation lines emerged as independent factors associated with the risk of AEF with OR 23.6 (95% CI [4.5; 21]) p=0.0002 and OR 3.7 (95% CI [1.1, 13]) p=0.04) while the lack of thermal probes remained of borderline significance. Conclusion The rate of AEF after AF ablation in a nationwide and well exhaustive survey can be evaluated to 0.026% with an annual incidence remaining stable over time. A normal CT scan does not rule out the diagnosis. Prognosis remains poor with a mortality of 60% and crucially dependant of immediate surgical correction. Funding Acknowledgement Type of funding source: None

Real-world cost-effectiveness of rivaroxaban compared with vitamin K antagonists in the context of stroke prevention in atrial fibrillation in France.

ObjectiveThe objective was to assess the real-world cost-effectiveness of rivaroxaban, versus vitamin K antagonists (VKAs), for stroke prevention in patients with atrial fibrillation (AF) from a French national health insurance perspective.MethodsA Markov model was developed with a lifetime horizon and cycle length of 3 months. All inputs were drawn from real-world evidence (RWE) studies: data on baseline patient characteristics at model entry were obtained from a French RWE study, clinical event rates as well as persistence rates for the VKA treatment arm were estimated from a variety of RWE studies, and a meta-analysis provided comparative effectiveness for rivaroxaban compared to VKA. Model outcomes included costs (drug costs, clinical event costs, and VKA monitoring costs), quality-adjusted life-years (QALY) and life-years (LY) gained, incremental cost per QALY, and incremental cost per LY. Sensitivity analyses were performed to test the robustness of the model and to better understand the results drivers.ResultsIn the base-case analysis, the incremental total cost was €714 and the total incremental QALYs and LYs were 0.12 and 0.16, respectively. The resulting incremental cost/QALY and incremental cost/LY were €6,006 and €4,586, respectively. The results were more sensitive to the inclusion of treatment-specific utility decrements and clinical event rates.ConclusionsAlthough there is no official willingness-to-pay threshold in France, these results suggest that rivaroxaban is likely to be cost-effective compared to VKA in French patients with AF from a national insurance perspective.

Apixaban for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation in France: The PAROS cross-sectional study of routine clinical practice

Non-vitamin K antagonist oral anticoagulants (NOACs), including apixaban, are recommended for prevention of stroke and systemic embolism in non-valvular atrial fibrillation (NVAF). To describe the characteristics of patients starting anticoagulant treatment, identify the characteristics associated with apixaban prescription, and describe apixaban use in France. This was a non-interventional multicentre French study. Patients with NVAF (aged≥18 years) with anticoagulant treatment started in the preceding 3 months were evaluated in four groups (NOAC [apixaban, dabigatran or rivaroxaban] or vitamin K antagonist [VKA]). Data from 2027 patients were eligible for analysis. Mean age was 73.0±11.2 years, 56.6% were men and 80.2% were anticoagulant naïve. Stage≥4 chronic kidney disease was present in 2.2% of patients prescribed apixaban, none of those prescribed dabigatran or rivaroxaban, and 16.8% of those prescribed VKAs. The median CHA2DS2-VASc score was 3 for all three NOACs and 4 for VKAs; the median HAS-BLED score was≥3 for 2.5-5.9% of patients prescribed NOACs and 12.0% of those prescribed VKAs. Apixaban was more likely to be prescribed than other NOACs in older patients with higher bleeding risk and decreased renal function, and VKAs in patients with lower bleeding risk and better renal function. Patients received a reduced dose (5mg/day; 30.4% patients) or a full dose (10mg/day; 69.6% patients) of apixaban. Only 79.3% of patients prescribed apixaban had doses consistent with the summary of product characteristics; underdosing was more frequent than overdosing. Off-label use of apixaban was observed, mainly in elderly patients, despite normal renal function and weight. Initiation of apixaban versus NOACs was more common among patients with increased age, higher bleeding risk and decreased renal function, whereas initiation of apixaban versus VKAs was more common among patients with lower bleeding risk and better renal function.

Use of oral anticoagulants in the treatment of non-valvular atrial fibrillation in France: Patient characteristics from the NAXOS cohort study

Oral anticoagulants (OAC: vitamin K antagonists [VKAs], dabigatran, rivaroxaban, and apixaban) are used for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). While results from pivotal randomized trials are available, French-specific, “real-life” data pertaining to the four OAC treatments available are awaited. This analysis of the NAXOS study aimed to describe demographic and clinical characteristics of NVAF patients initiating an OAC. All patients aged ≥ 18 years with NVAF and newly initiating one of the study OACs (i.e. no dispensation of the same OAC in the 24 prior months) between 2014 and 2016 were identified in the French national health insurance database (SNIIRAM–a comprehensive in- and outpatient healthcare consumption database). Patients were allocated to 4 different treatment cohorts. To maximise the comparability of populations, only OAC-naive patients (i.e. no dispensation of any OAC during the 24 months prior) were studied. Overall, 321,501 AC-naive NVAF patients aged 18+ were identified. Of these, 112,628 (35.0%) initiated VKAs, while 87,565 (27.2%), 100,063 (31.1%), and 21,245 (6.6%) initiated apixaban, rivaroxaban and dabigatran, respectively. Median follow-up durations were 218, 213, 205 and 186 days for VKA, apixaban, rivaroxaban and dabigatran cohorts, respectively. Males represented 48.8% of patients in VKA cohort (mean age: 78.5), 51.2% in apixaban cohort (mean age: 74.7), 55.1% in rivarobaxan cohort (mean age: 72) and 54.1% in dabigatran cohort (mean age: 72.7). Median age-adjusted Charlson score was 6 in the VKA cohort, and 4 in the other three cohorts. The NAXOS study confirms the widespread use of OAC treatments in France, suggesting differences between cohorts for age, gender and comorbidities. Thanks to large cohort sizes and prolonged follow-up, longitudinal analyses will allow assessment of real-life effects of OAC therapy in NVAF.

Xafran, a drug utilization study of rivaroxaban in stroke prevention in atrial fibrillation in France using a claim database

Little is known about the utilization of rivaroxaban in real life treatment settings in France. Objectives of this study were to describe the conditions of use and treatment persistence in patients with atrial fibrillation and treated with rivaroxaban for stroke prevention (SP-AF). A cohort study was performed using a representative sample of the French nationwide database. All adults who initiated rivaroxaban for SP-AF between 01/08/2012 and 31/12/2014 were included and followed for one year. Inappropriate use of rivaroxaban's was defined as use inconsistent with the summary of product characteristics. In this study, 1278 patients were included, 687 (53.8%) were men and the mean age was 73.4years; 123 patients (9.6%) had a stroke and 78 (6.1%) a major bleeding event in the three years before rivaroxaban initiation. At treatment initiation 236 (18.5%) had chronic congestive heart failure, 991 (77.5%) hypertension, 247 (19.3%) diabetes and 9 (0.7%) HIV, hepatitis B or C infection. No anticoagulant had been administered in the six previous months for 777 patients (60.8%); 160 patients (12.5%) had an inappropriate use of rivaroxaban in SP-AF. At 6 and 12 months after the first delivery with rivaroxaban, 62.8%, and 51.7% (68.5% and 60.5% in sensitivity analyses) of the patients were still treated with rivaroxaban. The proportion of patients with a continuous medication availability above 80% was 96.1%. The characteristics of patients in this study are similar to patients treated with this drug in other observational studies. Adherence and persistence with rivaroxaban can be considered good.

Stroke prevention, 1-year clinical outcomes and healthcare resource utilization in patients with atrial fibrillation in France: Data from the GARFIELD-AF registry

GARFIELD-AF is a non-interventional worldwide study of adults with atrial fibrillation. To analyse the characteristics of the 1399 patients recruited in France from August 2010 to July 2015, their 1-year outcomes and healthcare resource utilization. Patients aged ≥18 years with newly diagnosed atrial fibrillation (≤6 weeks' duration) and ≥1 stroke risk factor were eligible. Patient demographics, medical history and antithrombotic treatment were recorded at baseline. The incidences of stroke/systemic embolism, major bleeding, all-cause mortality, cardiovascular and non-cardiovascular mortality, new acute coronary syndrome and congestive heart failure were recorded during a 1-year follow-up. The median age was 76.0 years; 44.5% of patients were female. The median CHA2DS2-VASc and HAS-BLED scores were 4.0 and 2.0, respectively. At diagnosis, 78.9% of patients received anticoagulant therapy±antiplatelet therapy; more patients received vitamin K antagonists (VKAs; 46.0%) than direct oral anticoagulants (DOACs; 32.9%). The median proportion of time in the therapeutic range for VKAs was 65.6%. Between 2010 and 2015, anticoagulant prescription increased, driven by the growing use of DOACs±antiplatelet therapy (1.1% to 50.0%), whereas prescription of VKAs±antiplatelet therapy decreased (74.4% to 32.3%). All-cause mortality was the most frequent event (6.75 per 100 person-years). Risk-adjusted event rates for France showed that stroke/systemic embolism and all-cause mortality occurred more frequently than in GARFIELD-AF overall, whereas the rates of major bleeding were similar. In terms of healthcare resource utilization, the highest cost was associated with inpatients. Patients enrolled in France had higher rates of mortality and stroke/systemic embolism than in GARFIELD-AF overall. Conversely, the risk of major bleeding was not higher.

Apixaban in the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation in France: Rationale and design of the PAROS cross-sectional study

Atrial fibrillation (AF) is the most common arrhythmia worldwide, and its prevalence is expected to increase with population ageing. The use of vitamin K antagonists (VKAs) for the prevention of stroke and/or systemic embolism in patients with non-valvular atrial fibrillation (NVAF) was recently challenged by non-VKA oral anticoagulants (NOACs), demonstrating a favourable risk-benefit profile, with reductions in stroke, intracranial haemorrhage and mortality, similar major bleeding, but increased gastrointestinal bleeding. Nevertheless, data on their use in a "real-life" setting are scarce for France. To compare the characteristics of patients with AF newly anticoagulated with either VKAs or NOACs, to describe the reasons for discontinuing the previous anticoagulant strategy and/or choosing the newly initiated anticoagulant treatment, and to precisely describe the prescriptions of patients newly initiated with apixaban. This is a nationwide multicentre non-interventional cross-sectional study conducted in patients with AF by a representative stratified sample of cardiologists in France. Over a 12-month accrual period, consecutive patients aged ≥18 years with NVAF, for whom anticoagulant treatment (VKAs or NOACs) has been initiated within the last three months before the index consultation, will be included. The primary outcome will be the comparison of anticoagulant-naïve patient characteristics, co-morbidities and treatment history among the anticoagulant subgroups. Secondary endpoints will include a description of the reasons for discontinuing the previous anticoagulant strategy and/or for initiating and choosing the newly initiated anticoagulant treatment, as well as the prescription conditions of apixaban. The PAROS study will provide real-life data on the characteristics of NVAF patients and their anticoagulant prescription in France.

Real-life cost of vitamin K antagonist treatment in patients with non-valvular atrial fibrillation in France in 2013

Aims: Data highlighting the cost drivers for non-valvular atrial fibrillation (NVAF) patients in terms of vitamin K antagonist (VKA) treatment and monitoring are lacking in France. This study aimed to evaluate the real-life daily cost of VKA treatment in 2013, in French patients suffering from NVAF.Methods: This longitudinal observational study was performed using the EGB (Echantillon Généraliste des Bénéficiaires) database, a random sample of the French national insurance (NHI) database, which covers 80% of the population. All adult patients whose first NVAF anticoagulant treatment in 2013 was a VKA were analyzed. Costs were calculated for the duration of follow-up and then divided by the number of days of therapy. The analysis was performed both from the French NHI perspective (amount reimbursed by the NHI) and from a collective perspective.Results: In this study, 3,254 NVAF patients treated with VKA in 2013 were included, and this sample comprised 52.6% males. The mean daily cost of VKA treatment was €1.13 (±1.18) according to the collective perspective (89.4% of this cost was associated to INR measurement) and €1.05 (±1.16) according to the NHI perspective.Limitations: As diagnoses associated with procedures are not available in the EGB database, proxies were used, and an algorithm was created to define the AF population.Conclusions: This analysis is the first to consider an exhaustive spectrum of the costs of VKA treatment in France using EGB data. VKA medication requires exhaustive follow-up, and, thus, associated costs are important. The results of the present study confirmed this close follow-up for VKA patients, making the cost of treatment by VKA nearly 10-times more expensive than the cost of medication itself.

P832Persistence after initiation of oral anticoagulant for atrial fibrillation in France

P832Persistence after initiation of oral anticoagulant for atrial fibrillation in France

Burden Of Cardiovascular Complications In Patients With Atrial Fibrillation In France

Atrial fibrillation (AF) is associated with numerous cardiovascular (CV) complications. The objective of this study was to estimate the national annual burden of CV complications in patients with AF in hospitals.

Stroke prevention in patients with atrial fibrillation in France: comparative cost-effectiveness of new oral anticoagulants (apixaban, dabigatran, and rivaroxaban), warfarin, and aspirin

Objectives:To conduct an economic evaluation of the currently prescribed treatments for stroke prevention in patients with non-valvular atrial fibrillation (NVAF) including warfarin, aspirin, and novel oral anticoagulants (NOACs) from a French payer perspective.Methods:A previously published Markov model was adapted in accordance to the new French guidelines of the Commission for Economic Evaluation and Public Health (CEESP), to adopt the recommended efficiency frontier approach. A cohort of patients with NVAF eligible for stroke preventive treatment was simulated over lifetime. Clinical events modeled included strokes, systemic embolism, intracranial hemorrhage, other major bleeds, clinically relevant non-major bleeds, and myocardial infarction. Efficacy and bleeding data for warfarin, apixaban, and aspirin were obtained from ARISTOTLE and AVERROES trials, whilst efficacy data for other NOACs were from published indirect comparisons. Acute medical costs were obtained from a dedicated analysis of the French national hospitalization database (PMSI). Long-term medical costs and utility data were derived from the literature. Univariate and probabilistic sensitivity analyses were performed to assess the robustness of the model projections.Results:Warfarin and apixaban were the two optimal treatment choices, as the other five treatment strategies including aspirin, dabigatran 110 mg, dabigatran in sequential dosages, dabigatran 150 mg, and rivaroxaban were strictly dominated on the efficiency frontier. Further, apixaban was a cost-effective alternative vs warfarin with an incremental cost of €2314 and an incremental quality-adjusted life year (QALY) of 0.189, corresponding to an incremental cost-effectiveness ratio (ICER) of €12,227/QALY.Conclusions:Apixaban may be the most economically efficient alternative to warfarin in NVAF patients eligible for stroke prevention in France. All other strategies were dominated, yielding apixaban as a less costly yet more effective treatment alternative. As formally requested by the CEESP, these results need to be verified in a French clinical setting using stroke reduction and bleeding safety observed in real-life patient cohorts using these anticoagulants.

PCV67 - Application of New French Guidelines for Economic Evaluations: A Cost-Effectiveness Analysis of Apixaban in Patients with Non-Valvular Atrial Fibrillation in France

To evaluate the cost-effectiveness of apixaban in the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF) from a French payer perspective. A Markov model was developed in accordance to the new French guidelines of the Commission for Economic Evaluation and Public Health (CEESP) that also recommends applying efficiency frontier. A hypothetical cohort of patients with NVAF, 70 years old eligible for stroke preventive treatment (CHADS2≥1) was simulated over lifetime. Clinical events modeled included strokes, systemic embolism, intracranial hemorrhage, other major bleeds, clinically relevant non-major bleeds and myocardial infarction. Treatment efficacy and bleeding data was obtained from ARISTOTLE. Efficacy data are from published indirect comparisons. Acute medical costs of stroke and hemorrhage were obtained from a dedicated analysis of the French national hospitalization database (PMSI). Long-term medical costs and utility data were derived from the literature. Univariate and probabilistic sensitivity analyses (PSA) were also performed to assess the robustness of the model projections. Three strategies were strictly dominated: aspirin, dabigatran 110mg, and dabigatran in sequential dosages. Two others were extendidly dominated: rivaroxaban and dabigatran 150mg. The efficiency frontier was constructed by connecting the remaining strategies: warfarin and apixaban. Apixaban resulted in an incremental additional cost of 2,870€ and an incremental QALY of 0.189, corresponding to an ICER of 15,157€/QALY versus warfarin. The PSA indicated that the probabilities for apixaban being cost-effective versus warfarin were respectively 80% and 90% at the informal willing-to-pay thresholds of 30,000€ and 50,000€. Sensitivity analysis identified stroke risk with apixaban and intracranial hemorrhage risk with warfarin as the variables most influencing the results. Apixaban may be the most economically efficient alternative to warfarin in NVAF patients eligible for stroke prevention in France. All other strategies are dominated. However, uncertainty surrounding these results should be investigated through real life data.

Incidence and Cost of Stroke and Hemorrhage in Patients Diagnosed with Atrial Fibrillation in France

Stroke represents a major complication of atrial fibrillation (AF). The current anticoagulation options for stroke prevention increase hemorrhage risk. The objective of the study was to estimate the incidence and costs of hospitalization for stroke and hemorrhage in patients with AF who are eligible for stroke prevention. Patients hospitalized for AF were identified from the French National hospital database (Programme Médicalisé des Systèmes d'Information) and a calculated stroke risk score (congestive heart failure, hypertension [blood pressure consistently >140/90 mm Hg], age ≥75 years, diabetes mellitus, and previous stroke, transient ischemic attack [CHADS2]). Adult patients eligible for stroke prevention (CHADS2 >0) were enrolled. The incidence of hospitalization for stroke and hemorrhage was calculated over a 2-year period. Costs of acute care were determined using diagnosis related groups (DRGs) and corresponding National Hospital Tariffs. Rehabilitation costs were analyzed for patients with strokes and classified by stroke severity. Sixty-one thousand five hundred eighty-two patients were identified with a mean age of 75.0±11.0years and a mean CHADS2 score of 1.90±0.99. The 24-month cumulative incidence of any stroke was 32.1 cases/1,000 patients with AF (ischemic, 60%; hemorrhagic, 24%; unspecified, 16%), and that of hemorrhage was 53.1 cases/1,000 patients with AF (gastrointestinal, 26%; intracranial, 5%; other, 69%). The mean costs of ischemic and hemorrhagic strokes were €4,848 and €7,183 (mild), €10,909 and €14,298 (moderate), €29,065 and €29,701 (severe), and €6,035 and €4,590 (fatal), respectively. The mean costs of hemorrhage by type were €3,601 (gastrointestinal), €7,331 (intracranial), €3,941 (other major), and €2,552 (nonmajor). The incidence and cost of hospitalization for hemorrhage should be considered in the global burden of AF. These data should be useful for pharmacoeconomic evaluation of new oral anticoagulant medications. Such real-world studies may be relevant for monitoring mid- to long-term morbidity and mortality in the AF population.

The combined use of vitamin K antagonists and antiplatelet agents in atrial fibrillation - patterns of use in the European PREFER in AF registry

Purpose: The combined long-term use of vitamin K antagonists (VKA) and antiplatelet (AP) agents in patients with atrial fibrillation (AF) is generally discouraged because it entails increased risk of bleeding in the face of uncertain efficacy benefits. Therefore we evaluated the frequency of such prescription pattern and comorbidity associations. Methods: The PREvention oF thromboembolic events – European Registry in Atrial Fibrillation (PREFER in AF) prospectively enrolled patients with AF in France, Germany, Austria, Switzerland, Italy, Spain and the United Kingdom from Jan 2012 to Jan 2013. Here, we report the patterns of combined therapy with anticoagulants and (single or dual) AP therapy in this population. Results: In 7243 patients enrolled, 4799 (66.3%) were treated with a VKA (warfarin, phenprocoumon, acenocoumarol, fluindione), 808 (11.2%) with an AP alone, and 720 (9.9%) with a VKA + AP (88.8% with ASA, 21.0% with clopidogrel, 3.1% with another AP). Compared with patients only prescribed a VKA, patients on combination treatment had similar age and body mass index, but more often had paroxysmal (28.1 vs. 23.5%) or persistent (29.7 vs. 23.5%) AF (for both, p<0.01), a significantly higher prevalence of diabetes, obesity, dyslipidaemia and chronic renal insufficiency (for all, p<0.05), and significantly more frequent coexisting coronary heart disease (CHD) (58.9 vs. 19.0%; p<0.01) or peripheral arterial disease (PAD) (10.6 vs. 3.8%; p<0.01). Accordingly they had a higher mean CHA2DS2VASc score (3.8 vs. 3.5), and a higher mean HAS-BLED score (2.8 vs. 1.9) (for both, p<0.01). Most of the combination treatments were judged by all means inappropriate according to the 2010/2012 ESC guidelines, not being given because of recent stenting or an acute coronary syndrome. Detailed analyses on the appropriateness of combination therapy will be presented. Conclusions: The combined use of VKA and AP therapy is common in Europe, largely explained by the coexistence of AF with CHD or PAD, and not influenced by considerations on the risks of bleeding or thromboembolism. Such prescription patterns should be the target of appropriate guideline implementation programmes.

Modeling of the Impact on Health Outcomes of the Use of Dabigatran in Patients with Atrial Fibrillation

Background: Atrial fibrillation (AF) is the main direct cause of stroke. Prevention by anticoagulation or antithrombotic treatment is required, vitamin K antagonists (VKAs) and aspirin being the main agents. Dabigatran etexilate is a novel oral direct thrombin inhibitor. The RE-LY study demonstrated that in patients with AF, the rates of stroke and systemic embolism were similar (at a dose of 110 mg) or lower (at a dose of 150 mg) than those observed in patients treated with warfarin, a VKA. The aim of the present study was to estimate, through modeling, the number of severe events avoided with dabigatran at dosages of 110 mg (D110) or 150 mg (D150) twice daily compared to warfarin, when prescribed in the French population for patients with AF who meet the inclusion criteria of the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) study. Methods: We used a decision tree type model to simulate the outcome at 5 years in a cohort of patients eligible for treatment with dabigatran. We compared 3 hypothetical cohorts: all AF patients are treated with D110, D150 and warfarin. Based on the probabilities of occurrence of the different outcomes observed in the RE-LY study and in the Dijon Stroke Registry, we simulated for each year during 5 years the evolution of the 3 cohorts. The model allows to simulate a prevalent cohort of 461,392 patients at year zero, with a follow-up of 5 years (‘constant prevalence model'), and it can also take into account incident patients during 5 years (‘dynamic prevalence model'). The different events taken into account were: major hemorrhages (excluding hemorrhagic strokes), myocardial infarctions, hemorrhagic strokes, ischemic strokes, recurrence of strokes (without differentiating the mechanism) or deaths. Results: Considering the constant prevalence model, the use of D110 instead of warfarin for the whole target population in France would permit to avoid 10,012 events and to save 18,879 years of life in a period of 5 years. These figures are 13,484 and 27,736 for D150 instead of warfarin. Considering the dynamic prevalence model, the use of D110 for the whole target population in France would permit to avoid 13,620 events and to save 22,674 years of life in a period of 5 years. These figures are 18,186 and 33,091 for D150. Conclusion: The use of dabigatran would lead to a significant reduction of strokes and deaths attributable to AF in France.

PCV109 Antithrombotic Therapy Prescription and Persistence in Patients With Atrial Fibrillation in France and Spain

PCV109 Antithrombotic Therapy Prescription and Persistence in Patients With Atrial Fibrillation in France and Spain

Influence of age on the prescription of vitamin K antagonists in outpatients with permanent atrial fibrillation in France

The aim of the study was to describe the current rate and determinants of the prescription of antithrombotics in outpatients with permanent atrial fibrillation, with a pre-specified emphasis on the influence of age on the prescription of vitamin K antagonists. This was a prospective observational survey in France among 5893 consecutive outpatients with documented permanent atrial fibrillation being seen by 770 physicians from August to December 2002. We recruited physicians from two random lists of general practitioners and cardiologists, respectively, stratified according to their administrative region, from the list of all French private general practitioners and cardiologists. The mean age of patients was 75.8 years. Mean duration since diagnosis of atrial fibrillation was 5.0 years; 31.7% of patients had valvular heart disease and 60.3% hypertension. An antithrombotic was prescribed to 95.5% of patients at the time of consultation. The percentage of patients treated with vitamin K antagonists was 76.4%; it decreased from 86.0% in patients aged 60-70 years to 63.5% in patients aged 80 years or above. On multivariate analysis, high age was a significant predictor (p = 0.001) for the non-prescription of vitamin K antagonists. In patients above 70 years currently receiving an antithrombotic, the probability of prescription of vitamin K antagonists decreased on average by 9.6% per year. Vitamin K antagonists are administered to most outpatients with permanent atrial fibrillation at high thromboembolic risk seen by French physicians in private practice. However, their use decreases with age.

Second Line Pharmacological Management of Paroxysmal and Persistent Atrial Fibrillation in France: A Cost Analysis

Objectives Despite optimal pharmacological treatment a large proportion of patients with atrial fibrillation (Afib) are not arrhythmia-free, and remain at risk for complications such as stroke and cardiac morbidity. If first-line treatment fails, most patients receive second-line pharmacological treatment. The emergence of new technologies aimed at restoring and maintaining sinus rhythm, such as catheter ablation techniques, has increased the interest in the economic aspects of second-line pharmacological treatment. The objective was therefore to calculate the 5-year direct medical costs of second-line pharmacological management of paroxysmal and persistent Afib in France. Methods The analysis was based on clinical and economic literature and the input of cardiologists-electrophysiologists. The analysis included probabilities of stroke, sudden cardiac death, other cardiac and noncardiac death, direct medical costs of drugs, follow-up and complications from the healthcare payer's perspective. Included treatment strategies were (1) rhythm control with class Ic and III antiarrhythmics and (2) rate control, consisting of digoxin combined with a beta-blocker or calcium antagonist. Both strategies included aspirin or anticoagulation therapy. Results The average total 5-year cost of Afib was 16,539 Euro (FF 108,486) per patient. The result was stable to sensitivity analysis on incidence of stroke and type of stroke prevention. The main cost drivers were follow-up visits and hospitalizations and the cost of congestive heart failure. Both items being subject to some variation, they were submitted to sensitivity analysis showing minimal 5-year costs still over 14,483 Euro (FF 95,000). Conclusion Afib management places high demands on medical resources mainly through its complications and comorbidity.