J Nutr Health Aging Volume 19, Number 2, 2015

THERAPEUTIC MANAGEMENT IN AMBULATORY ELDERLY PATIENTS WITH ATRIAL FIBRILLATION: THE S.AGES COHORT O. HANON1,2, J.S. VIDAL1,2, G. PISICA-DONOSE1,2, L. BENATTAR-ZIBI3, P. BERTIN4, G. BERRUT5, E. CORRUBLE6, G. DERUMEAUX7, B. FALISSARD8, F. FORETTE2,9, F. PASQUIER10, M. PINGET11, R. OURABAH12, L. BECQUEMONT13, N. DANCHIN14 FOR THE S.AGES INVESTIGATORS 1. Assistance Publique–Hôpitaux de Paris, Hôpital Broca, Service de Gériatrie, Paris, France; 2. Université Paris Descartes, Sorbonne Paris Cité, Equipe d’Accueil 4468, Paris, France; 3. ORPEA/ CLINEA, Puteaux, France; 4. CHU Limoges, Service de Rhumatologie, Limoges, France; 5. CHRU de Nantes - Pôle de soins gériatriques - Hôpital Saint Jacques 44000 Nantes; 6. INSERM U 669, Université Paris-Sud, Faculté de médecine Paris-Sud, Département de Psychiatrie, Hôpital de Bicêtre, Assistance Publique–Hôpitaux de Paris; 94230 Le Kremlin Bicêtre, France; 7. Exploration Fonctionnelles Cardiovasculaires; Hôpital Louis Pradel; Hospices Civils de Lyon, Bron, France; 8. INSERM U 669, Université Paris-Sud, Faculté de médecine Paris-Sud Département de Biostatistiques; Assistance Publique Hôpitaux de Paris, Hôpital Paul Brousse, le Kremlin Bicêtre, France; 9. Fondation Nationale de Gérontologie; 10. CHU Lille, Neurologie - Hôpital Roger Salengro. 59000 Lille; 11. Service d’Endocrinologie, Diabète, Maladies de la Nutrition (Pôle NUDE), Hôpitaux Universitaires de Strasbourg et Centre européen d’étude du Diabète (CeeD), Université de Strasbourg; 12. Département médecine générale, Faculté de médecine Paris-Sud, Université Paris-Sud, Le Kremlin-Bicêtre, France; 13. Département de Pharmacologie, Faculté de médecine Paris-Sud, Université Paris-Sud; Assistance Publique Hôpitaux de Paris, Hôpital Bicêtre, le Kremlin Bicêtre, France; 14. AP-HP, Hôpital européen Georges Pompidou, Service de Gériatrie, Paris, France. Corresponding author: Professor O. Hanon, Hôpital Broca, Service de Gérontologie, 54-56 rue Pascal, Paris, 75013, France. E-mail: [email protected], Tel: + 33 1 44 08 30 30, Fax: + 33 1 44 08 35 10.

Abstract: Few epidemiologic studies have specifically focused on very old community dwelling population with atrial fibrillation (AF). The objectives of the AF-S.AGES cohort were to describe real-life therapeutic management of non-institutionalized elderly patients with AF according to age groups, i.e., 65-79 and ≥ 80 and to determine the main factors associated with anticoagulant treatment in both groups. Methods: Observational study (N=1072) aged ≥ 65 years old, recruited by general practitioners. Characteristics of the sample were first evaluated in the overall sample and according to age (< 80 or ≥ 80 years) and to use of anticoagulant treatment at inclusion. Logistic models were used to analyze the determinants of anticoagulant prescription among age groups. Results: Mean age was 78.0 (SD=6.5) years and 42% were ≥ 80 years. Nineteen percent had paroxysmal AF, 15% persistent, 56% permanent and 10% unknown type, 77% were treated with vitamin K antagonists (VKA), 17% with antiplatelet therapy with no differences between age groups. Rate-control drugs were more frequently used than rhythm-control drugs (55% vs. 37%, p < 0.001). VKA use was associated with permanent AF, younger age and cancer in patients ≥ 80 years old and with permanent AF and preserved functional autonomy in patients < 80 years old. Hemorrhagic scores were independently associated with non-use of VKA whereas thromboembolic scores were not associated with VKA use. Conclusions: In this elderly AF outpatient population, use of anticoagulant therapy was higher even after 80 years than in previous studies suggesting that recent international guidelines are better implemented in the elderly population. Key words: Atrial fibrillation, elderly, anticoagulation, vitamin K antagonists.

Introduction Atrial fibrillation (AF) is the most common form of arrhythmia in the elderly. Its prevalence is estimated to be approximately 1.5–2% of the general population and increases with age up to 15% in subjects ≥ 80 years old (1). AF is associated with an increased risk of stroke particularly in the older subjects. After 75 years, the annual risk of stroke is estimated to be 8% per year (2). Therefore, recent guidelines highlight the importance of anticoagulant treatment in the elderly with AF and give a high importance to age ≥ 75 years old in the thromboembolic CHA2DS2-VASc score (double weight) (3, 4). The benefits of anticoagulant therapy are evidenced in interventional and observational studies and these benefits appear to be even greater among older subjects (5). The BAFTA trial, composed of patients over 75 years old (6), shows a high benefit of vitamin K antagonists (VKA) compared with aspirin with no evidence of an increased risk of major hemorrhagic events. Fewer studies are available in very old subjects aged 80 years and over. In the WASPO study (7), composed of AF octogenarians, warfarin significantly reduces Received July 7, 2014 Accepted for publication September 16, 2014

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the risk of adverse events including stroke and serious bleeding, compared with aspirin. Despite these data, studies in real-life show a high underuse of oral anticoagulation therapy in AF patients especially in the elderly population (8). Reasons for this under-prescription include fear of bleeding related to co-morbidities and, polypharmacy, cognitive disorders and falls but also lack of knowledge of guidelines. Few epidemiologic studies have specifically focused on very old populations with AF and thus few data on therapeutic management of patients over 80 years are available. The objectives of the AF-S.AGES cohort (Sujets AGÉS) were to describe the real-life therapeutic management of non-institutionalized elderly patients with atrial fibrillation according to age-groups, i.e., 65-79 and ≥ 80 years and to determine the main factors associated with anticoagulant treatment in both groups. Methods The S.AGES methodology and study design has been described elsewhere (9). It is a non-interventional prospective

J Nutr Health Aging Volume 19, Number 2, 2015

THERAPEUTIC MANAGEMENT IN AMBULATORY ELDERLY PATIENTS WITH ATRIAL FIBRILLATION: THE S.AGES COHORT cohort study in which the investigators were free to choose which treatments to use but had to collect biological samples. The study (N=3700) is comprised of three different arms composed of non-institutionalized patients aged 65 years and over with one of the following conditions: atrial fibrillation (AF), type 2 diabetes and chronic pain. Patients were recruited and followed by their general practitioners (GP) across France. The patients were followed with medical visits every 6 months for 3 years. For the S.AGES study, 51,179 private-practice GPs from all over France were invited to take part in the study. Two thousand seven hundred investigating GPs were involved to ensure sufficient recruitment over a one-year period. The accepting GPs were randomly assigned to one of the three cohort arms. Each investigator was asked to include between 3 and 10 patients, keeping a ratio of 1/3 of patients between the ages of 65 and 75 and 2/3 of patients over the age of 75 years between June 3rd , 2009 and June 3rd , 2011. For each patient, they performed a clinical evaluation including a Comprehensive Geriatric Assessment (cognition: Mini Mental State Examination (MMSE) (10); autonomy: Activities of Daily Living (ADL) (11) and Instrumental Activities of Daily Living (IADL) (12); mood: Geriatric Depression scale (GDS) (13); nutrition: BMI, weight lost). The investigating GPs recorded patients’ medical data in an on-line based electronic Case Report Form (eCRF); self-evaluations were completed by the patients. Hypertension was defined as blood pressure ≥ 140/90 mmHg or use of anti-hypertensive drugs. Inclusion criterion was presence of AF on an ECG or an ambulatory electrocardiography in the last 12 months. AF was defined according to the European Society of Cardiology Guidelines (3): paroxysmal AF, recurrent episodes that self-terminate within 7 days; persistent AF, recurrent episodes that last longer than 7 days or require termination by cardioversion and permanent AF, ongoing long-term episode accepted by the physician. AF subtype was categorized by the GP. The inclusion criteria in the AF S.AGES arm were age 65 years and older, living in France, coverage by the national health insurance and occurrence of non-valvular AF in the previous 12 months. Exclusion criteria were as follows: patients living in a nursing home at the time of the inclusion, patients unable to give consent, patients participating in a clinical trial and those suffering from a life-threatening non-cardiovascular condition, transient AF (thyrotoxicosis, excessive alcohol consumption, myocarditis, pericarditis, acute phase of myocardial infarction, pulmonary embolism, metabolic disorders, electrocution) and AF occuring less than 3 months after heart surgery. All patients gave and signed an informed consent to participate in the study. The study was approved by the local ethics committee and met all the requirements of the declaration of Helsinki. The study was registered to the clinicaltrials.gov website to the number NCT01065909.

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Statistical analysis Descriptive analyses are presented in terms of the number and percentage of patients, for qualitative and ordinal variables, and in terms of mean and standard deviation for quantitative variables. General characteristics of the sample were first evaluated in the overall sample and according to age groups (< 80 or ≥ 80 years) and according to the use of oral anticoagulant treatment at inclusion excluding 4 patients treated with heparin. Therefore, in the latter analysis all patients treated with oral anticoagulant were treated with VKA. Comparisons between groups were made by logistic regression adjusted for sex because gender was strongly associated with age groups and with anticoagulant treatment. To analyze the determinants of VKA prescription among participants ≥ 80 years old and < 80 years old, we constructed two separate logistic models by including the different factors associated with VKA prescription (p < 0.15) with backward elimination of the variables least associated with anticoagulant use. The two models are presented as forest plots. For categorical variables, the odds ratios (OR) of the different values are given. Thromboembolic risk scores (CHADS2 (14) and CHA2DS2VASc (15)) and hemorrhagic risk scores (HEMORR2HAGES (16) and HAS-BLED (17)) were calculated for each patient although there were some missing values (CHADS2 N=23, CHA 2 DS 2 -VASc N=23, HEMORR 2 HAGES N=210 and HAS-BLED N=205). The relationships between anticoagulant treatment and HAS-BLED, HEMORR2HAGES, CHADS2and CHA2DS2-VASc were analyzed by including the different scores separately because of colinearity issue in the final models among participant < 80 or ≥ 80 years old. Results Of the 2700 general practitioners that accepted to participate in the study, 287 included more than one patient in the AF cohort, up to 10 patients. On average they included 3.74 patients. A total of 1072 patients were included in the AF cohort of the S.AGES study. Socio-demographic and biological characteristics and comorbidities of the overall sample and according to age groups (more or less than 80 years old) are shown Table 1. Mean age was 78.0 (SD=6.5) years, 447 (41.7%) were older than 80 years, 581 (54.2%) were male, and the mean BMI was 27.9 (SD=5.2) kg/m2. Patients 80 years and older had a lower BMI, lived more often alone at home, and had a lower current alcohol and tobacco consumption than participants younger than 80 years old. Compared with participants younger than 80 years, older participants were more impaired on ADL and IADL scores and had lower cognitive function (MMSE scores). Comorbidities were not significantly different between the two age groups except for heart failure and falls more frequent in the older

J Nutr Health Aging Volume 19, Number 2, 2015

JNHA: GERIATRIC SCIENCE Table 1 General characteristics in the overall sample and according to the age groups General characteristics, % (n)

Overall N=1072

< 80 yo N=625

≥ 80 yo N=447

p†

Age (year), M (SD)

78.0 (6.5)

73.6 (4.1)

84.2 (3.3)

-

Men

54.2 (581)

59.7 (373)

46.5 (208)

Therapeutic management in ambulatory elderly patients with atrial fibrillation: the S.AGES cohort.

Few epidemiologic studies have specifically focused on very old community dwelling population with atrial fibrillation (AF). The objectives of the AF-...
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