Smartphone Application Helps Improve Adherence to Oral Anticoagulants in Patients with Atrial Fibrillation (Preprint)

2021 ◽  
Author(s):  
Keitaro Senoo ◽  
Tomonori Miki ◽  
Takashi Ohkura ◽  
Hibiki Iwakoshi ◽  
Tetsuro Nishimura ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Medication Adherence ◽  
Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Low Grade ◽  
Grade Group ◽  
Time Points ◽  
The Mean ◽  
High Level

BACKGROUND Atrial fibrillation (AF) is a significant risk factor for stroke, especially in aging societies. Anticoagulation therapy is used to prevent stroke and, the efficacy and safety profiles of novel oral anticoagulants (NOACs) are comparable with those of vitamin-K antagonists (VKAs). Although NOACs do not require regular monitoring of anticoagulatory effects, there are concerns that they tend to be less long-lasting and have poorer adherence among patients than VKAs. A new application (the “Smart AF app”) was developed as a tool to improve adherence to oral anticoagulant medication in elderly individuals with AF. OBJECTIVE The aim of the present study was to evaluate the utility of the Smart AF app in individuals with AF. METHODS Patients with AF were enrolled at Kyoto Prefectural University of Medicine hospitals between May 2019 and September 2020. Follow-up was planned at 1, 3, and 6 months after enrollment, and questionnaire reminders were automatically sent to patient applications at designated follow-up time points. A questionnaire-based survey of medication adherence was performed electronically using the self-reported 8-item Morisky Medication Adherence Scale (MMAS-8) as the survey tool. RESULTS A total of 136 patients with AF were enrolled in this study. During the follow-up period, 111 patients underwent follow-up at 1 month, 109 at 3 months, and 96 at 6 months. The mean age of the enrolled patients was 64.3 years, and males accounted for 79.4% of the study population. The mean CHADS2 score was 1.2, with hypertension being the most common comorbidity. At the time of enrollment, 126 and 10 patients were taking oral NOACs and oral warfarin, respectively. At baseline, mean adherence measured according to the MMAS-8 was 6.14 (SD 1.52), and 6.87 (SD 1.30) at 1 month, 6.69 (SD 1.53) at 3 months, and 6.98 (SD 1.34) at 6 months, demonstrating a significant increase at all time points compared with enrollment (all P<.01). The overall improvement in medication adherence with the intervention was attributed to an improvement of 77.8% in the high-grade group to a high level and 45.3% in the medium-grade group to a high level, and 72% in the low-grade group to a medium or high level. CONCLUSIONS The Smart AF app improved medication adherence, even among elderly patients in whom AF is prevalent. In medication administration, an approach that emphasizes education using mobile health technology, simple reminder function, and patient engagement, may be helpful.

scholarly journals Plasma natriuretic peptide level is an independent determinant of major clinical outcomes in atrial fibrillation patients without heart failure: the Fushimi AF Registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y Hamatani ◽  
M Iguchi ◽  
Y Aono ◽  
K Ishigami ◽  
S Ikeda ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Clinical Outcomes ◽  
Prognostic Marker ◽  
Oral Anticoagulants ◽  
Systemic Embolism ◽  
The Mean

Abstract Background Atrial fibrillation (AF) increases the risk of death, stroke/systemic embolism and heart failure (HF). Plasma natriuretic peptide (NP) level is an important prognostic marker in HF patients. However, little is known regarding the prognostic significance of plasma NP level in AF patients without HF. Purpose The aim of this study is to investigate the relationship between plasma NP level and clinical outcomes such as all-cause death, stroke/systemic embolism and HF hospitalization during follow-up period in AF patients without HF. Methods The Fushimi AF Registry is a community-based prospective survey of AF patients in our city. The inclusion criterion of the registry is the documentation of AF at 12-lead electrocardiogram or Holter monitoring at any time, and there are no exclusion criteria. We started to enroll patients from March 2011, and follow-up data were available for 4,466 patients by the end of November 2019. From the registry, we excluded 1,220 patients without a pre-existing HF (defined as having one of the following; prior hospitalization for HF, New York Heart Association class ≥2, or left ventricular ejection fraction &lt;40%). Among 3,246 AF patients without HF, we investigated 1,189 patients with the data of plasma BNP (n=401) or N-terminal pro-BNP (n=788) level at the enrollment. We divided the patients according to the quartile of each plasma BNP or NT-pro BNP level and compared the backgrounds and outcomes between these 4 groups stratified by plasma NP level. Results Of 1,189 patients, the mean age was 72.1±10.2 years, 454 (38%) were female and 684 (58%) were paroxysmal AF. The mean CHADS2 and CHA2DS2-VASc score were 1.6±1.1 and 2.9±1.5, respectively. Oral anticoagulants were prescribed in 671 (56%) at baseline. The median (interquartile range) BNP and N-terminal pro-BNP level were 84 (38, 176) and 500 (155, 984) pg/ml, respectively. Patients with high plasma NP level were older, and demonstrated lower prevalence of paroxysmal AF, higher CHADS2 and CHA2DS2-VASc scores and higher prevalence of chronic kidney disease and oral anticoagulants prescription (all P&lt;0.01). A total of 165 all-cause death, 114 stroke/systemic embolism and 103 HF hospitalization occurred during the median follow-up period of 5.0 years. Kaplan-Meier curves demonstrated that higher plasma NP level was significantly associated with the incidences of all-cause death, stroke/systemic embolism and HF hospitalization in AF patients without HF (Figure 1A). Multivariable Cox regression analysis revealed that plasma NP level could stratify the risk of clinical outcomes even after adjustment by type of AF, CHA2DS2-VASc score, chronic kidney disease and oral anticoagulant prescription (Figure 1B). Conclusion Plasma NP level is a significant prognostic marker for all-cause death, stroke/systemic embolism and HF hospitalization in AF patients without HF, suggesting the importance of measuring plasma NP level in AF patients even without HF. Figure 1 Funding Acknowledgement Type of funding source: None

P4766Edoxaban Treatment in routiNe clinical prActice for patients with atrial fibrillation (AF) in Europe (ETNA-AF-Europe): 1-year follow-up according to body mass index

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Weiss ◽  
R De Caterina ◽  
P Kelly ◽  
P Monteiro ◽  
J C Deharo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Body Weight ◽  
Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Normal Weight ◽  
Routine Practice ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Background Non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have substantially improved anticoagulation therapy for prevention of stroke and systemic embolism in patients with atrial fibrillation (AF), and available routine care data have so far broadly confirmed the safety of different NOACs in routine practice. However, such data for edoxaban are scarce, especially in extremely low and high body weight (BW). These extreme BWs may affect the bioavailability, distribution, and half-life of NOACs and, consequently, outcomes of treatment. Methods We analysed outcomes in normal-weight (BMI 18.5–25) vs overweight (BMI 25–30) and obese (BMI >30) patients enrolled into the ETNA-AF-Europe observational study (NCT02944019) collecting information on patients treated with edoxaban in 825 sites in 10 European countries. This snapshot analysis set includes data of 7,672 patients (56.3% of all enrolled patients) which have completed their 1-year follow-up visit (mean follow-up: 343.5 days). Results Median patient age was 74 years for all patients, 76 years for patients with a BMI 18.5–25 (group 1), 75 years for patients with BMI 25–30 (group 2), and 72 for patients with a BMI >30 (group 3). CrCl was 64 mL/min for patients with a BMI 18.5–25, 68 mL/min for patients with BMI 25–30, and 72 mL/min for patients with a BMI >30. The CHA2DS2-VASc (mean 3.1±1.38) and HAS-BLED (mean 2.5±1.10) score did not differ significantly between groups. As expected, diabetes and hypertension were significantly less prevalent in leaner patients and - accordingly - inversely correlated to age. There was no correlation between body weight and life-threatening bleeding (group 1: 0.28%; group 2: 0.40%; group 3: 0.14%). Also, stroke rates (group 1: 0.74%; group 2: 0.81%; group 3: 0.76%) did not differ between groups. Conclusion BMI, within the range here assessed, does not affect 1-year outcomes in European AF patients treated with edoxaban. Acknowledgement/Funding Daiichi Sankyo Europe GmbH, Munich, Germany

NOAC Adherence of Patients with Atrial Fibrillation in the Real World: Dosing Frequency Matters?

2019 ◽  
Vol 120 (02) ◽  
pp. 306-313 ◽  
Author(s):  
Jongmin Hwang ◽  
Seongwook Han ◽  
Han-Joon Bae ◽  
Seung-Woon Jun ◽  
Sang-Woong Choi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Medication Adherence ◽  
Real World ◽  
Oral Anticoagulants ◽  
Once Daily ◽  
Cardiology Department ◽  
Dosing Frequency ◽  
Adherence Scale ◽  
The Mean ◽  
The Difference

Abstract Background and Objectives Nonvitamin K antagonist oral anticoagulants (NOACs) require stricter medication adherence. We investigated the NOACs adherence in real-world practice. Methods We screened all patients in our cardiology department the day before their outpatient appointment, over a 5-month period. We enrolled 719 consecutive patients who were taking NOACs for atrial fibrillation. The patients were contacted by phone or text to bring the remnant pills with them without any information why. Adherence was measured by the percentage of prescribed doses taken (PDT) (number of doses taken/number of doses expected to be taken from the last prescription × 100 [%]) and the Morisky Medication Adherence Scale (MMAS)-8. Results All 4 NOACs (apixaban 47.8%, dabigatran 21.2%, rivaroxaban 18.4%, and edoxaban 12.6%) were prescribed. The mean duration that the patients had been taking NOACs was 7.2 ± 5.7 months. The PDT was 95.4 ± 9.1% in the once-daily dosing group and 93.4 ± 12.7% in the twice-daily group, and the difference was statistically significant (p = 0.017). The mean MMAS was 2.6 ± 0.8. The proportion of patients with a PDT < 80% was 7.8%. They had a significantly higher MMAS than the PDT ≥ 80% group (3.4 vs. 2.5; p = 0.000). Conclusion Most patients who were taking NOACs had excellent adherence regardless of the dosing frequency. An MMAS ≥ 3 could be used as a simple screening tool for a poor NOAC adherence.

Risk of intracerebral haemorrhage in Chinese patients with atrial fibrillation on warfarin with cerebral microbleeds: the IPAAC-Warfarin study

2018 ◽  
Vol 90 (4) ◽  
pp. 428-435 ◽  
Author(s):  
Yannie Soo ◽  
Jill M Abrigo ◽  
Kam Tat Leung ◽  
Suk Fung Tsang ◽  
Hing Lung Ip ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Intracerebral Haemorrhage ◽  
Primary Outcome ◽  
Oral Anticoagulants ◽  
Final Analysis ◽  
Cerebral Microbleeds ◽  
Chinese Patients ◽  
The Mean

Background and purposeCerebral microbleeds (CMBs), which predict future intracerebral haemorrhage (ICH), may guide anticoagulant decisions for atrial fibrillation (AF). We aimed to evaluate the risk of warfarin-associated ICH in Chinese patients with AF with CMBs.MethodsIn this prospective, observational, multicentre study, we recruited Chinese patients with AF who were on or intended to start anticoagulation with warfarin from six hospitals in Hong Kong. CMBs were evaluated with 3T MRI brain at baseline. Primary outcome was clinical ICH at 2-year follow-up. Secondary outcomes were ischaemic stroke, systemic embolism, mortality of all causes and modified Rankin Scale ≥3. Outcome events were compared between patients with and without CMBs.ResultsA total of 290 patients were recruited; 53 patients were excluded by predefined criteria. Among the 237 patients included in the final analysis, CMBs were observed in 84 (35.4%) patients, and 11 had ≥5 CMBs. The mean follow-up period was 22.4±10.3 months. Compared with patients without CMBs, patients with CMBs had numerically higher rate of ICH (3.6% vs 0.7%, p=0.129). The rate of ICH was lower than ischaemic stroke for patients with 0 to 4 CMBs, but higher for those with ≥5 CMBs. CMB count (C-index 0.82) was more sensitive than HAS-BLED (C-index 0.55) and CHA2DS2-VASc (C-index 0.63) scores in predicting ICH.ConclusionsIn Chinese patients with AF on warfarin, presence of multiple CMBs may be associated with higher rate of ICH than ischaemic stroke. Larger studies through international collaboration are needed to determine the risk:benefit ratio of oral anticoagulants in patients with AF of different ethnic origins.

Incident Risk Factors and Major Bleeding in Patients with Atrial Fibrillation Treated with Oral Anticoagulants: A Comparison of Baseline, Follow-up and Delta HAS-BLED Scores with an Approach Focused on Modifiable Bleeding Risk Factors

2018 ◽  
Vol 47 (04) ◽  
pp. 768-777 ◽  
Author(s):  
Tze-Fan Chao ◽  
Yenn-Jiang Lin ◽  
Shih-Lin Chang ◽  
Li-Wei Lo ◽  
Yu-Feng Hu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Modifiable Risk Factors ◽  
The Mean ◽  
Regular Review

Aim When assessing bleeding risk in patients with atrial fibrillation (AF), risk stratification is often based on the baseline risks. We aimed to investigate changes in bleeding risk factors and alterations in the HAS-BLED score in AF patients. We hypothesized that a follow-up HAS-BLED score and the ‘delta HAS-BLED score’ (reflecting the change in score between baseline and follow-up) would be more predictive of major bleeding, when compared with baseline HAS-BLED score. Methods and Results A total of 19,566 AF patients receiving warfarin and baseline HAS-BLED score ≤2 were studied. After a follow-up of 93,783 person-years, 3,032 major bleeds were observed. The accuracies of baseline, follow-up, and delta HAS-BLED scores as well as cumulative numbers of baseline modifiable bleeding risk factors, in predicting subsequent major bleeding, were analysed and compared. The mean baseline HAS-BLED score was 1.43 which increased to 2.45 with a mean ‘delta HAS-BLED score’ of 1.03. The HAS-BLED score remained unchanged in 38.2% of patients. Of those patients experiencing major bleeding, 76.6% had a ‘delta HAS-BLED’ score ≥1, compared with only 59.0% in patients without major bleeding (p < 0.001). For prediction of major bleeding, AUC was significantly higher for the follow-up HAS-BLED (0.63) or delta HAS-BLED (0.62) scores, compared with baseline HAS-BLED score (0.54). The number of baseline modifiable risk factors was non-significantly predictive of major bleeding (AUC = 0.49). Conclusion In this ‘real-world’ nationwide AF cohort, follow-up HAS-BLED or ‘delta HAS-BLED score’ was more predictive of major bleeding compared with baseline HAS-BLED or the simple determination of ‘modifiable bleeding risk factors’. Bleeding risk in AF is a dynamic process and use of the HAS-BLED score should be to ‘flag up’ patients potentially at risk for more regular review and follow-up, and to address the modifiable bleeding risk factors during follow-up visits.

Adherence to Oral Anticoagulants in Atrial Fibrillation: An Australian Survey

2018 ◽  
Vol 23 (4) ◽  
pp. 337-343 ◽  
Author(s):  
Kehinde O. Obamiro ◽  
Leanne Chalmers ◽  
Kenneth Lee ◽  
Bonnie J. Bereznicki ◽  
Luke R. Bereznicki
Keyword(s):  
Atrial Fibrillation ◽  
Medication Adherence ◽  
Online Survey ◽  
Information Overload ◽  
Oral Anticoagulants ◽  
Cancer Information ◽  
Related Factors ◽  
Suboptimal Adherence ◽  
High Level ◽  
Predictors Of Adherence

Background: The aim of this study was to investigate the proportion of patients who have suboptimal adherence to oral anticoagulant (OAC), identify the predictors of adherence, and determine whether patient-related factors vary across adherence levels in Australia. Methods: Respondents were recruited for an online survey using Facebook. Survey instruments included the Morisky Medication Adherence Scale, the Anticoagulation Knowledge Tool, the Perception of Anticoagulant Treatment Questionnaires, and a modified Cancer Information Overload scale. Predictors of medication adherence were identified using ordinal regression analysis. Results: Of the 386 responses eligible for analysis, only 54.9% reported a high level of adherence. Participants aged 65 years or younger were less likely to have high adherence compared to older participants (odds ratio [OR], 0.54; 95% confidence interval [CI], 0.33-0.88; P = .013), while females were more likely to be highly adherent compared to males (OR, 1.69; 95% CI, 1.08-2.64; P = .023). The analyses showed that age, gender, treatment satisfaction, information overload, concerns about making mistake when taking OACs, and cost of medication were significant predictors of adherence. Conclusion: Self-reported suboptimal adherence to OAC is common among patients with atrial fibrillation. A focus on supporting people who are at higher risk of suboptimal adherence is needed to maximize the benefit of OAC therapy in this population.

scholarly journals Anticoagulation in Atrial Fibrillation Cardioversion: What Is Crucial to Take into Account

2021 ◽  
Vol 10 (15) ◽  
pp. 3212
Author(s):  
Fabiana Lucà ◽  
Simona Giubilato ◽  
Stefania Angela Di Fusco ◽  
Laura Piccioni ◽  
Carmelo Massimiliano Rao ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Thrombus Formation ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Significant Advance ◽  
Thromboembolic Events ◽  
Thromboembolic Risk ◽  
Pharmacological Cardioversion

The therapeutic dilemma between rhythm and rate control in the management of atrial fibrillation (AF) is still unresolved and electrical or pharmacological cardioversion (CV) frequently represents a useful strategy. The most recent guidelines recommend anticoagulation according to individual thromboembolic risk. Vitamin K antagonists (VKAs) have been routinely used to prevent thromboembolic events. Non-vitamin K antagonist oral anticoagulants (NOACs) represent a significant advance due to their more predictable therapeutic effect and more favorable hemorrhagic risk profile. In hemodynamically unstable patients, an emergency electrical cardioversion (ECV) must be performed. In this situation, intravenous heparin or low molecular weight heparin (LMWH) should be administered before CV. In patients with AF occurring within less than 48 h, synchronized direct ECV should be the elective procedure, as it restores sinus rhythm quicker and more successfully than pharmacological cardioversion (PCV) and is associated with shorter length of hospitalization. Patients with acute onset AF were traditionally considered at lower risk of thromboembolic events due to the shorter time for atrial thrombus formation. In patients with hemodynamic stability and AF for more than 48 h, an ECV should be planned after at least 3 weeks of anticoagulation therapy. Alternatively, transesophageal echocardiography (TEE) to rule out left atrial appendage thrombus (LAAT) should be performed, followed by ECV and anticoagulation for at least 4 weeks. Theoretically, the standardized use of TEE before CV allows a better stratification of thromboembolic risk, although data available to date are not univocal.

scholarly journals A Systematic Review of the Efficacy and Safety of Direct Oral Anticoagulants in Atrial Fibrillation Patients with Diabetes Using a Risk Index

2021 ◽  
Vol 10 (13) ◽  
pp. 2924
Author(s):  
Domenico Acanfora ◽  
Marco Matteo Ciccone ◽  
Valentina Carlomagno ◽  
Pietro Scicchitano ◽  
Chiara Acanfora ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Risk Index ◽  
Direct Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Efficacy Rate ◽  
Cochrane Central Register ◽  
Efficacy And Safety

Diabetes mellitus (DM) represents an independent risk factor for chronic AF and is associated with unfavorable outcomes. We aimed to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF), with and without diabetes mellitus (DM), using a new risk index (RI) defined as: RI =Rate of EventsRate of Patients at Risk. In particular, an RI lower than 1 suggests a favorable treatment effect. We searched MEDLINE, MEDLINE In-Process, EMBASE, PubMed, and the Cochrane Central Register of Controlled Trials. The risk index (RI) was calculated in terms of efficacy (rate of stroke/systemic embolism (stroke SEE)/rate of patients with and without DM; rate of cardiovascular death/rate of patients with and without DM) and safety (rate of major bleeding/rate of patients with and without DM) outcomes. AF patients with DM (n = 22,057) and 49,596 without DM were considered from pivotal trials. DM doubles the risk index for stroke/SEE, major bleeding (MB), and cardiovascular (CV) death. The RI for stroke/SEE, MB, and CV death was comparable in patients treated with warfarin or DOACs. The lowest RI was in DM patients treated with Rivaroxaban (stroke/SEE, RI = 0.08; CV death, RI = 0.13). The RIs for bleeding were higher in DM patients treated with Dabigatran (RI110 = 0.32; RI150 = 0.40). Our study is the first to use RI to homogenize the efficacy and safety data reported in the DOACs pivotal studies against warfarin in patients with and without DM. Anticoagulation therapy is effective and safe in DM patients. DOACs appear to have a better efficacy and safety profile than warfarin. The use of DOACs is a reasonable alternative to vitamin-K antagonists in AF patients with DM. The RI can be a reasonable tool to help clinicians choose between DOACs or warfarin in the peculiar set of AF patients with DM.

scholarly journals Budget Impact Analysis of Anticoagulation Clinics in Patients with Atrial Fibrillation under Chronic Therapy with Oral Anticoagulants

2021 ◽  
Vol 12 ◽  
pp. 215013272110002
Author(s):  
William Uribe-Arango ◽  
Juan Manuel Reyes Sánchez ◽  
Natalia Castaño Gamboa
Keyword(s):  
Atrial Fibrillation ◽  
Impact Analysis ◽  
Budget Impact ◽  
Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Group Versus ◽  
Cost Of Care ◽  
Chronic Therapy ◽  
Colombian Government ◽  
The Cost

Objectives To assess budget impact of the implementation of an anticoagulation clinic (AC) compared to usual care (UC), in patients with non-valvular atrial fibrillation (NVAF). Method A decision tree was designed to analyze the cost and events rates over a 1-year horizon. The patients were distributed according to treatment, 30% Direct Oral Anticoagulant (DOAC) regimens and the rest to warfarin. The thromboembolism and bleeding were derived from observational studies which demonstrated that ACs had important impact in reducing the frequency of these events compared with UC, due to higher adherence with DOACs and proportion of time in therapeutic range (TTR) with warfarin. Costs were derived from the transactional platform of Colombian government, healthcare authority reimbursement and published studies. The values were expressed in American dollars (USD). The exchanged rate used was COP $3.693 per dollar. Results During 1 year of follow-up, in a cohort of 228 patients there were estimated 48 bleedings, 6 thromboembolisms in AC group versus 84 bleedings, and 12 thromboembolisms events in patients receiving UC. Total costs related to AC were $126 522 compared with $141 514 in UC. The AC had an important reduction in the cost of clinical events versus UC ($52 085 vs $110 749) despite a higher cost of care facilities ($74 436 vs $30 765). A sensibility analysis suggested that in the 83% of estimations, the AC produced savings varied between $27 078 and $135 391. Conclusions This study demonstrated that AC compared with UC, produced an important savings in the oral anticoagulation therapy for patients with NVAF.

Motivational Interviewing to Support Oral AntiCoagulation adherence in patients with non-valvular Atrial Fibrillation (MISOAC-AF): a randomised clinical trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Tzikas ◽  
A Samaras ◽  
A Kartas ◽  
D Vasdeki ◽  
G Fotos ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Medication Adherence ◽  
Medical Care ◽  
Oral Anticoagulation ◽  
Intervention Group ◽  
Control Group ◽  
Motivational Intervention ◽  
Clinical Events ◽  
Secondary Outcomes

Abstract Background Oral anticoagulation (OAC) is paramount to effective thromboprophylaxis; yet adherence to OAC remains largely suboptimal in patients with atrial fibrillation (AF). Purpose We aimed to assess the impact of an educational, motivational intervention on the adherence to OAC in patients with non-valvular AF. Methods Hospitalised patients with non-valvular AF who received OAC were randomly assigned to usual medical care or a proactive intervention, comprising motivational interviewing and tailored counseling on medication adherence. The primary study outcome was adherence to OAC at 1-year, evaluated as Proportion of Days Covered (PDC) by OAC regimens and assessed through nationwide prescription registers. Secondary outcomes included the rate of persistence to OAC, gaps in treatment, proportion of VKA-takers with labile INR (defined as time to therapeutic range&lt;70%) and clinical events. Results A total of 1009 patients were randomised, 500 in the intervention group and 509 in the control group. At 1-year follow-up, 77.2% (386/500) of patients in the intervention group had good adherence (PDC&gt;80%), compared with 55% (280/509) in the control group (adjusted odds ratio 2.84, 95% confidence interval 2.14–3.75; p&lt;0.001). Mean PDC±SD was 0.85±0.26 and 0.75±0.31, respectively (p&lt;0.001). Patients that received the intervention were more likely to persist in their OAC therapy at 1 year, while usual medical care was associated with more major (≥3 months) treatment gaps [Figure]. Among 212 VKA-takers, patients in the intervention group were less likely to have labile INR compared with those in the control group [21/120 (17.1%) vs 34/92 (37.1%), OR 0.33 95% CI 1.15–0.72, p=0.005]. Clinical events over a median follow-up period of 2 years occurred at a numerically lower, yet non-significant, rate in the intervention group [Table]. Conclusions In patients receiving OAC therapy for non-valvular AF, a motivational intervention significantly improved patterns of medication adherence, without significantly affecting clinical outcomes. Primary and secondary outcomes Funding Acknowledgement Type of funding source: None

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