AJ Camm

AS Go

AS Zigmond

CS Miller

D Poli

EM Hylek

L Bamber

PC Deedwania

PJ McCabe

S Cohen

S Fumagalli

English

Stefano Fumagalli

Francesca Cardini

Anna T. Roberts

Serena Boni

Debbie Gabbai

Silvia Calvani

Marta Casalone Rinaldi

Stefania Manetti

Francesca Tarantini

Niccolò Marchionni

Crossref

SHORT COMMUNICATIONPsychological effects of treatment with new oral anticoagulantsin elderly patients with atrial fibrillation: a preliminary reportStefano Fumagalli • Francesca Cardini • Anna T. Roberts • Serena Boni •Debbie Gabbai • Silvia Calvani • Marta Casalone Rinaldi • Stefania Manetti •Francesca Tarantini • Niccolo` MarchionniReceived: 5 May 2014 / Accepted: 15 May 2014 / Published online: 1 June 2014 The Author(s) 2014. This article is published with open access at Springerlink.comAbstractBackground and aims Atrial fibrillation (AF) is the mostcommon arrhythmia in elderly people, yet oral anticoagu-lation is underused in the aged. We tried to determinewhether new oral anticoagulants (NOA) have greater psy-chological tolerability than warfarin.Methods Age-, gender-matched groups of AF patientsreceiving NOA (N = 15) or warfarin (N = 15) wereassessed with the Anti-Clot Treatment Scale (ACTS) andthe Perceived Stress Scale (PSS).Results Patients were old (81 ± 9 years). NOA groupshowed greater psychological satisfaction, with lowertherapy-related burden (ACTS burdens: 16.3 ± 4.5 vs.32.9 ± 10.2, p \ 0.001) and higher awareness of benefits(ACTS benefits: 13.0 ± 1.3 vs. 10.8 ± 1.9, p = 0.001).Even stress was lower (PSS: 13.1 ± 4.0 vs. 17.1 ± 4.2,p = 0.013). The multivariate analysis confirmed thesefindings, showing that higher levels of anxiety anddepression could justify more stress in warfarin patients.Conclusions The results of this preliminary study showthat NOA have an improved psychological impact com-pared with warfarin in elderly patients.Keywords Anti-Clot Treatment Scale  Atrialfibrillation  Elderly  New oral anticoagulants  Oralanticoagulation  Perceived Stress ScaleIntroductionAtrial fibrillation (AF) is the most common sustainedarrhythmia in elderly individuals [1]. Epidemiological dataand the greater clinical complexity of old AF patients [2]explain the higher age-associated risk of cardioembolicevents [3]. AF determines about 25 % of all ischemicstrokes [3]. Oral anticoagulation (OA) is highly effective inpreventing cardioembolism [1], and is effective and safealso at advanced ages [4]. Current guidelines recommendOA not only for all AF patients but for all those with ahistory of AF and a CHA2DS2-VASc score C1, even in thepresence of sinus rhythm; since an age C75 years is worthtwo points, it follows that all elderly patients should beanticoagulated [1]. However, warfarin is not ideal forelderly patients: its dose is inversely related to age [5]; thetime in therapeutic range (TTR) is influenced by cognitivefunction [5]; falls are associated with an increased inci-dence of bleedings [4]. New oral anticoagulants (NOA),with their stable and predictable clinical pharmacology, actrapidly, do not need a laboratory monitoring and do notinterfere with other drugs or food; therefore, they couldrepresent a real breakthrough for OA in elderly individuals[5].Aim of this preliminary study was to compare the psy-chological effects of treatment with NOA and with war-farin in old AF patients. Greater satisfaction and less stresscould increase adherence to treatment, reducing the risk ofcardioembolism.S. Fumagalli (&)  A. T. Roberts  S. Boni  D. Gabbai S. Calvani  M. Casalone Rinaldi  F. Tarantini  N. MarchionniIntensive Care Unit and Geriatric Arrhythmology Unit,Division of Geriatric Cardiology and Medicine, and ResearchUnit of Medicine of Aging, Department of Experimentaland Clinical Medicine, University of Florence andAOU Careggi, Viale Pieraccini, 6, 50139 Florence, Italye-mail: fumadue@tin.itF. Cardini  S. ManettiSchool of Nursing, University of Florence, Florence, Italy123Aging Clin Exp Res (2015) 27:99–102DOI 10.1007/s40520-014-0243-xMethodsPatientsWe enrolled all patients who were prescribed a NOA (for AFor for a history of AF, previously treated with external car-dioversion—ECV—or catheter ablation) in our Centre fromJuly to September 2013 (in Italy use of dabigatran and riv-aroxaban was approved in June and August 2013, respec-tively). They were age and gender matched with a populationreceiving warfarin. Exclusion criteria were: (1) clinicalinstability or modifications of medical therapy in the last3 months; (2) any attempted cardioversion in the last month;(3) catheter ablation of AF in the last 3 months. All patientsgave their informed consent to participate in the study.Clinical variables, the ability to manage own medica-tion, health-related quality of life (HRQL), as evaluatedwith the European Quality of Life Questionnaire (EQ-5D-3L) and Visual Analog Scale (EQ-VAS), and the HospitalAnxiety and Depression Scale (HADS) [6] score wereconsidered for each patient.Psychological assessmentWe assessed all patients after at least 4 weeks of treatment,using the Anti-Clot Treatment Scale (ACTS), which spe-cifically addresses the degree of psychological satisfactionassociated with chronic OA, defining the burdens andbenefits of treatment [7]. At the same time, we adminis-tered the Perceived Stress Scale (PSS), which assesses towhich extent patients feel that their life is dominated byincontrollable and unpredictable factors [8].Statistical analysisWe used IBM SPSS for Windows (ver. 20.0). Continuousvariables are expressed as mean ± SD, categorical variablesas raw numbers and percentages. Different distributions ofcontinuous variables were verified with Student’s t test andanalysis of variance, or with the related non-parametric testsin the case of non-normal variables. The Chi-square test wasused for categorical variables. Simple and multivariate linearregression models were employed to assess the independentrole of NOA in determining ACTS and PSS scores. Statisticalsignificance was attributed for p values \0.05.ResultsStudy populationWe assessed 17 patients receiving a NOA (dabigatran:N = 16, rivaroxaban: N = 1); two were excluded(dabigatran: N = 1, rivaroxaban: N = 1) because treat-ment had been started \4 weeks before. The warfaringroup consisted of 15 patients, of which ten in follow-upafter ECV of persistent AF. Two other patients, treatedwith ECV \4 weeks before assessment, were notenrolled because the procedure could bias the tests.Modal duration of OA was 4 months. The prevalence ofpatients with dominant sinus rhythm (NOA: N = 12,80 % vs. Warfarin: N = 12, 80 %, p = 1.000) or withpermanent AF (NOA: N = 3, 20 % vs. Warfarin: N = 1,6.7 %, p = 0.598) did not differ between groups.Enrolled subjects were old (mean age: 81 ± 9 years);hypertension and chronic heart failure were the mostcommon comorbidities. Scores of both CHA2DS2-VAScand HASBLED were high, as was the average numberof drugs taken daily (Table 1). Almost all patients wereindependent in BADL and IADL (93.3 and 76.7 %,respectively).More warfarin patients had a score over the 70th per-centile of HADS total score (46.7 vs. 13.3 %; p = 0.046).Table1 Characteristics of patients by treatment groupWarfarin(N = 15)NOA(N = 15)pAge (years) 79 ± 10 84 ± 7 0.158Men (n, %) 11 (73.3) 9 (60.0) 0.700Higher education (n, %) 8 (53.3) 5 (33.3) 0.462Retired (n, %) 13 (86.7) 14 (93.3) 1.000Married (n, %) 10 (66.7) 5 (33.3) 0.143Living alone (n, %) 1 (6.7) 4 (26.7) 0.180IADL—Drugs (n, %) 12 (80.0) 8 (53.0) 0.245Bleeding (n, %) 4 (26.7) 2 (13.3) 0.651CHF (n, %) 7 (46.7) 6 (40.0) 1.000Cognitive impairment(n, %)4 (26.7) 6 (40.0) 0.291CVD (n, %) 3 (20.0) 6 (40.0) 0.427Diabetes (n, %) 3 (20.0) 1 (6.7) 0.598Hypertension (n, %) 11 (73.3) 13 (86.7) 0.651Myocardial infarction(n, %)6 (40.0) 2 (13.3) 0.215Renal failure (n, %) 3 (20.0) 2 (13.3) 1.000CHA2DS2-VASc (score) 4.2 ± 1.6 4.4 ± 1.3 0.711HASBLED (score) 2.9 ± 1.3 3.0 ± 0.8 0.734Pacemaker (n, %) 1 (6.7) 4 (26.7) 0.330ASA (n, %) 3 (20.0) 0 (0.0) 0.224Thienopyridines (n, %) 2 (13.3) 1 (6.7) 1.000Drugs (n) 7.4 ± 3.3 5.9 ± 3.7 0.236Higher education high school diploma or university degree, IADL-Drugs patients who do not manage therapy by themselves, CHFchronic heart failure, Cognitive impairment mild cognitive impair-ment, CVD TIA/Stroke, ASA aspirin100 Aging Clin Exp Res (2015) 27:99–102123Psychological satisfaction and type of OANOA were significantly associated to a higher degree ofpsychological satisfaction when compared to warfarin. Asassessed with ACTS, the psychological burden related totherapy was lower while benefits were higher in subjectsreceiving NOA (Fig. 1), who showed a higher global score(68.7 ± 4.7 vs. 49.9 ± 10.0, p \ 0.001). Psychologicalsatisfaction with NOA was greater in all items, except foritems 14 (p = 0.051) and 15 (p = 0.157), which specifi-cally explore feelings of protection and reassurance cor-related to OA.A multivariate regression analysis model (R = 0.815,p \ 0.001) confirmed that ACTS score was significantlyhigher in the NOA treatment group (?17.8 ± 2.7 vs.warfarin; p \ 0.001) and lower in patients with a previoushemorrhage (-7.2 ± 3.4 vs. no hemorrhagic event;p = 0.043).Psychological stress and type of OAPSS score was lower in NOA than in warfarin patients(Fig. 1).In univariate analysis, PSS score was higher in thosewith a previous ECV. The scale was directly related withHADS (p \ 0.001) and inversely related with HASBLED(p = 0.012) and EQ VAS (p = 0.032).A first multivariate linear regression analysis model(R = 0.708, p \ 0.001) confirmed the inverse associationbetween PSS and NOA assumption (-3.4 ± 1.2 vs. war-farin; p = 0.010), HASBLED (b = -1.8 ± 0.6;p = 0.005) and EQ VAS (b = -0.10 ± 0.04; p = 0.019).The introduction into the model (R = 0.765, p \ 0.001) ofthe variable expressing a HADS score C70th percentile(b = ?4.4 ± 1.2 vs. \70th percentile; p = 0.001) madethe use of NOA not significant (p = 0.853).DiscussionIn an elderly AF population, NOA, when compared towarfarin, are more psychologically acceptable. NOApatients’ ACTS scores were significantly higher thanwarfarin patients’ in 15 of the 17 items. This confirmssimilarly positive results from the EINSTEIN-DVT study,which randomized 1,472 patients to rivaroxaban or enox-aparin plus vitamin K antagonists for the treatment of deepvein thrombosis not associated with pulmonary embolism[9].NOA patients also showed lower levels of psychologicalstress. In a first multivariate model, NOA and higher valuesof HASBLED and EQ-VAS were associated with lowerstress levels. When we introduced the variable related tothe presence of an elevated HADS score in the regression,NOA lost their statistical association with PSS. This couldbe due to several factors. HASBLED is largely influencedby age and several comorbidities common in the elderly,and it has already been proven that patients aged C65 yearshave significantly lower PSS scores [10]. In an AF popu-lation HRQL is influenced mainly by the presence ofanxiety or depression [11], and in our warfarin-treatedgroup, there was a higher prevalence of patients with aHADS score C70th percentile. We can conclude that apossible reason for lower PSS score in NOA patients isNOA treatment’s positive effects on anxiety and depressionsymptoms [12].OA is still significantly underused in elderly patients: inthe Euro Heart Survey on atrial fibrillation only 56 % AFFig. 1 Scores of Anti-ClotTreatment Scale (left panel),and of Perceived Stress Scale(right panel), by type of oralanticoagulation (NAO new oralanticoagulants)Aging Clin Exp Res (2015) 27:99–102 101123subjects aged [80 years received Vit. K antagonists [13].Furthermore, in these patients, OA treatment is often pre-maturely interrupted after only a few weeks, usually fromfear of adverse effects (especially bleeding) [14]. Ourresults combined with NOAs’ superior safety (a 51 %lower incidence of intracranial hemorrhages than warfarin)and effectiveness (22 % reduction of cardioembolic eventsvs. warfarin) [15] allow us to hope that the new drugs couldexpand and maintain prescription of OA in old and very oldpatients.Study limitationsThe main limitation of the study is the small sample size.Second, some warfarin patients had received ECV in thepast, a factor determining psychological discomfort.However, after adjustment, our results were not altered bythe procedure. Third, some NOA patients had alreadyreceived warfarin in the past, a behavior possibly increas-ing the beneficial effects of the new drug. Fourth, all NOApatients received dabigatran so we have no data aboutrivaroxaban or apixaban.In conclusion, despite these limitations, our findingsseem to show that NOA therapy is psychologically betteraccepted than warfarin in elderly AF patients. Accordingly,compliance to OA should significantly increase, allowingto reduce the incidence of cardioembolic complications,particularly severe in terms of disability and mortality atadvanced ages. On this basis, our results can represent aspringing board for future studies: by retrospective poweranalyses (power: 90 %; two-sided type 1 error rate: 0.05)we estimate about 35 patients per group to test ourhypothesis in a randomized controlled clinical trial.Conflict of interest On behalf of all authors, the correspondingauthor states that there is no conflict of interest.Open Access This article is distributed under the terms of theCreative Commons Attribution License which permits any use, dis-tribution, and reproduction in any medium, provided the originalauthor(s) and the source are credited.References1. 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Aging Clinical and Experimental Research

Psychological effects of treatment with new oral anticoagulants in elderly patients with atrial fibrillation: a preliminary report

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Psychological effects of treatment with new oral anticoagulants in elderly patients with atrial fibrillation: a preliminary report

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