Relation of Renal Dysfunction to Quality of Anticoagulation Control in Patients with Atrial Fibrillation: The FANTASIIA Registry

Background One-third of atrial fibrillation (AF) patients have chronic kidney disease (CKD), a condition that itself increases thromboembolic and major bleeding risks, especially in patients with severe CKD. Bleeding would be accentuated by suboptimal anticoagulation control with vitamin K antagonists (VKA). Purpose This article aimed to investigate the incidence of cardiovascular events, mortality and quality of anticoagulation in relation to CKD in a ‘real-world’ prospective cohort of AF patients included in the FANTASIIA registry. Methods We analysed consecutive AF patients who were prospectively recruited with a year of follow-up. The quality of anticoagulation was estimated by time in therapeutic range (TTR). The annual incidence of events was analysed. Results We studied 1,936 patients (male: 55.7%, mean: 73.8 ± 9.4 years): 445 (22.9%) had normal function, 698 (36.1%) had mild CKD, 713 (36.8%) had moderate CKD and 80 (4.2%) had severe CKD. Patients with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (severe CKD) had lower TTR (53.3 ± 25.6% vs. 61.8 ± 25.1%, p = 0.007) and higher proportion of poor TTR (67.2 vs. 51.8%; p = 0.014) than patients with eGFR ≥30 mL/min/1.73 m2. Severe CKD was significantly associated with cardiovascular mortality (hazard ratio [HR]: 9.33; p = 0.002), major bleeding (HR: 2.94; p = 0.036) and major adverse cardiovascular events (MACE) (HR: 4.93; p = 0.004). Importantly, 375 patients (21.1%) showed a deteriorating eGFR of ≥10 mL/min during the follow-up, with significantly higher mortality and cardiovascular events. Conclusion In a prospective and real-world AF registry, approximately 67% of patients with severe CKD had poor anticoagulation control while taking VKA. The presence of severe CKD was an independent factor for cardiovascular mortality, MACE and major bleeding. Worsening eGFR of only ≥10 mL/min during follow-up was significantly associated with mortality and major bleeding.

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2MACE score predicts cardiovascular adverse events in real-world atrial fibrillation patients under rivaroxaban therapy. Data from EMIR study

European Heart Journal ◽

10.1093/eurheartj/ehab724.2484 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

M Esteve Pastor ◽

F Marin ◽

M Anguita ◽

M Sanmartin ◽

C Rafols ◽

...

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

High Risk ◽

Adverse Events ◽

Cardiovascular Mortality ◽

Real World ◽

Cardiovascular Events ◽

Major Adverse Cardiovascular Events

Abstract Background Atrial Fibrillation (AF) patients have higher risk of major adverse cardiovascular events (MACEs). In 2015, the 2MACE score (2 points for metabolic syndrome and age ≥75, and 1 point for myocardial infarction [MI] or revascularization, congestive heart failure [ejection fraction ≤40%] and thromboembolism [stroke or transient ischemic attack]) was described to stratify cardiovascular risk and 2MACE≥3 was related with high risk of MACE in AF patients but a long-term validation in prospective patients under direct anticoagulants has not been performed yet. The aim of this study was to analyse the incidence of cardiovascular events and to validate the 2MACE score as predictor of MACEs. Methods EMIR study [acronym from 'Estudio observacional para la identificaciόn de los factores de riesgo asociados a eventos cardiovasculares Mayores en pacientes con fIbrilaciόn auricular no valvular tratados con un anticoagulante oral directo (Rivaroxaban)'] was an observational, multicenter, post-authorization and prospective study that involved AF patients under oral anticoagulation with rivaroxaban at least 6 months before enrolment. We analyzed baseline clinical characteristics and adverse events after 2.5 years of follow up: annual incidence of thromboembolic events, MACE (composite of nonfatal MI, coronary revascularization and cardiac death) and cardiovascular mortality were analyzed. Results We analyzed 1,433 patients (55.5% women, mean 74.2±9.7 years). 385 (26.9%) patients had 2MACE score ≥3 and of those high-risk patients, 42.1% had previous coronary disease, 12.5% had previous peripheral artery disease, 40.7% had diabetes mellitus, 39% heart failure and 50% had chronic kidney disease (GFR<60 ml/min). After 2.5 (2.2–2.6) years of follow-up, we observed patients with 2MACE score ≥3 had higher rate of adverse events (Table), specially of higher rate of cardiovascular mortality and MACE. Patients with 2MACE score ≥3 had RR 4.09 (2.59–6.45; p<0.001) for MACE. Indeed, patients with 2MACE score ≥3 had around 6-fold risk of cardiovascular death due heart failure than patients with 2MACE score <3 (0.17%/year vs 1.09%/year; p=0.003). 2MACE score had suitable predictive performance for MACE (AUC 0.638 [(0.534–0.742); p=0.010). Conclusion In a Real-world AF patients under rivaroxaban therapy from EMIR registry, the 2MACE score is a good predictor of long-term cardiovascular events, MACE and major bleeding. A 2MACE score ≥3 categorize patients at “high-risk” with almost 4-fold risk of MACE in a long-term follow-up. FUNDunding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Bayer Hispania S.L. Table 1. Adverse events according to 2MACE

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Safety and Efficacy of Vitamin K Antagonists versus Rivaroxaban in Hemodialysis Patients with Atrial Fibrillation: A Multicenter Randomized Controlled Trial

Journal of the American Society of Nephrology ◽

10.1681/asn.2020111566 ◽

2021 ◽

pp. ASN.2020111566

Author(s):

An S. De Vriese ◽

Rogier Caluwé ◽

Hans Van Der Meersch ◽

Koen De Boeck ◽

Dirk De Bacquer

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Cardiovascular Events ◽

Vitamin K Antagonists ◽

Vitamin K2 ◽

Composite Outcome ◽

End Point ◽

Life Threatening ◽

K2 Group

BackgroundIn patients with normal renal function or early stage CKD, the risk-benefit profile of direct oral anticoagulants (DOACs) is superior to that of vitamin K antagonists (VKAs). In patients on hemodialysis, the comparative efficacy and safety of DOACs versus VKAs are unknown.MethodsIn the Valkyrie study, 132 patients on hemodialysis with atrial fibrillation were randomized to a VKA with a target INR of 2–3, 10 mg rivaroxaban daily, or rivaroxaban and vitamin K2 for 18 months. Patients continued the originally assigned treatment and follow-up was extended for at least an additional 18 months. The primary efficacy end point was a composite of fatal and nonfatal cardiovascular events. Secondary efficacy end points were individual components of the composite outcome and all-cause death. Safety end points were life-threatening, major, and minor bleeding.ResultsMedian (IQR) follow-up was 1.88 (1.01–3.38) years. Premature, permanent discontinuation of anticoagulation occurred in 25% of patients. The primary end point occurred at a rate of 63.8 per 100 person-years in the VKA group, 26.2 per 100 person-years in the rivaroxaban group, and 21.4 per 100 person-years in the rivaroxaban and vitamin K2 group. The estimated competing risk–adjusted hazard ratio for the primary end point was 0.41 (95% CI, 0.25 to 0.68; P=0.0006) in the rivaroxaban group and 0.34 (95% CI, 0.19 to 0.61; P=0.0003) in the rivaroxaban and vitamin K2 group, compared with the VKA group. Death from any cause, cardiac death, and risk of stroke were not different between the treatment arms, but symptomatic limb ischemia occurred significantly less frequently with rivaroxaban than with VKA. After adjustment for competing risk of death, the hazard ratio for life-threatening and major bleeding compared with the VKA group was 0.39 (95% CI, 0.17 to 0.90; P=0.03) in the rivaroxaban group, 0.48 (95% CI, 0.22 to 1.08; P=0.08) in the rivaroxaban and vitamin K2 group and 0.44 (95% CI, 0.23 to 0.85; P=0.02) in the pooled rivaroxaban groups.ConclusionsIn patients on hemodialysis with atrial fibrillation, a reduced dose of rivaroxaban significantly decreased the composite outcome of fatal and nonfatal cardiovascular events and major bleeding complications compared with VKA.Clinical Trial registry name and registration number:Oral Anticoagulation in Hemodialysis, NCT03799822

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P3474Relationship between international normalized ratio variability, quality of anticoagulation control and outcomes in patients with atrial fibrillation: an AFFIRM post-hoc analysis

European Heart Journal ◽

10.1093/eurheartj/ehz745.0345 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

M Proietti ◽

G F Romiti ◽

B Olshansky ◽

G Y H Lip

Keyword(s):

Atrial Fibrillation ◽

Regression Analysis ◽

Standard Deviation ◽

Major Bleeding ◽

International Normalized Ratio ◽

Cox Regression Analysis ◽

Increased Risk ◽

Anticoagulation Control

Abstract Introduction Quality of anticoagulation control is essential to ensure better clinical outcomes in patients with atrial fibrillation (AF). Time in therapeutic range (TTR) is recommended as a measure of the quality of anticoagulation control. The International normalized ratio (INR) variability has been suggested as an alternative index, even though large independent validations for this index are still lacking. Purpose To provide validation of clinical usefulness of INR variability as a measure of the quality of anticoagulation control in a large cohort of AF patients. Methods Data from the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) trial were analysed. INR variability was defined as the standard deviation (SD) of mean INR values [INR-SD] recorded throughout the follow-up observation for each patient. All patients with available INR values were included in the analysis. Stroke, major bleeding, cardiovascular (CV) death and all-cause death were study outcomes. Results Among the original 4060 patients, a total of 3185 (78.4%) were available for analysis. Mean (SD) INR-SD was 0.58 (0.25). According to INR-SD patients were categorized into four quartiles. Mean (SD) CHA2DS2-VASc score was increased (p=0.040), with no difference in proportions of CHA2DS2-VASc ≥2 (p=0.582) between the subgroups. A significant inverse correlation was found between INR-SD and TTR (Spearman's Rho: −0.536, p<0.001). Continuous INR-SD, after multiple adjustments, was inversely associated with TTR (standardized beta: −0.451, p<0.001) and directly associated with SAMe-TT2R2score (standardized beta: 0.084, p<0.001). A fully adjusted Cox multivariate regression analysis found that INR-SD was directly associated with increased risk of stroke, major bleeding and all-cause death (Table). An INR-SD ≥0.85 was directly associated with all the study outcomes, on multivariate analysis (Table). Cox Regression Analysis INR-SD INR-SD ≥0.85 HR (95% CI) HR (95%) Stroke 2.52 (1.34–4.67) 1.62 (1.00–2.63) Major Bleeding 2.43 (1.49–3.96) 1.61 (1.10–2.36) CV Death 1.50 (0.87–2.59) 1.54 (1.07–2.24) All-Cause Death 1.79 (1.21–2.66) 1.55 (1.17–2.05) CI = Confidence Interval; CV = Cardiovascular; HR = Hazard Ratio; INR-SD = International Normalized Ratio Standard Deviation. Conclusions INR variability, expressed as INR-SD, was significantly correlated and associated with TTR. Both continuous INR-SD and INR-SD ≥0.85 were significantly associated with a higher risk of all study adverse outcomes. Acknowledgement/Funding None

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Evaluation of SAMe-TT2R2 risk score for predicting the quality of anticoagulation control in a real-world cohort of patients with non-valvular atrial fibrillation on vitamin-K antagonists

EP Europace ◽

10.1093/europace/euu353 ◽

2015 ◽

Vol 17 (5) ◽

pp. 711-717 ◽

Cited By ~ 37

Author(s):

R. R.-Y. Abumuaileq ◽

E. Abu-Assi ◽

S. Raposeiras-Roubin ◽

A. Lopez-Lopez ◽

A. Redondo-Dieguez ◽

...

Keyword(s):

Atrial Fibrillation ◽

Risk Score ◽

Vitamin K ◽

Real World ◽

Vitamin K Antagonists ◽

Anticoagulation Control

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Cessation of oral anticoagulation in relation to mortality and the risk of thrombotic events in patients with atrial fibrillation

Thrombosis and Haemostasis ◽

10.1160/th13-07-0556 ◽

2013 ◽

Vol 110 (12) ◽

pp. 1189-1198 ◽

Cited By ~ 155

Author(s):

Pilar Gallego ◽

Vanessa Roldan ◽

Francisco Marín ◽

Marta Romera ◽

Mariano Valdés ◽

...

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Oral Anticoagulation ◽

Cardiovascular Events ◽

Vitamin K Antagonists ◽

Bleeding Risk ◽

Vascular Events ◽

Coronary Syndrome ◽

Independent Risk Factors

SummaryBleeding risk (often perceived, rather than actual) is a common reason for cessation of oral anticoagulation with Vitamin K antagonists (VKA). We investigate clinical outcomes in a consecutive population of VKA naïve atrial fibrillation (AF) patients, who initiated VKA therapy in our clinic. We included consecutive VKA-naíve patients with non valvular AF, initiated on VKA therapy in our anticoagulation outpatient clinic in 2009. During follow-up, adverse events [thrombotic/vascular events (stroke, acute coronary syndrome, acute heart failure and cardiac death), major bleeding and death], and VKA cessation were recorded. At the end of the follow-up, we determined time within therapeutic range (TTR), using a linear approximation (Rosendaal method). We studied 529 patients (49% male, median age 76), median follow-up 835 days (IQR 719−954). During this period 114 patients stopped VKA treatment. 63 patients suffered a thrombotic/cardiovascular event (5.17%/year, 27 thrombotic/ischaemic strokes), 51 major bleeding (4.19%/year) and 48 died (3.94%/year). Median TTR was 54% (34a57). On multivariate analysis (adjusted by CHA2DS2-VASc score), VKA cessation was associated with death [Hazard Ratio (HR) 3.43; p<0.001], stroke [4.21; p=0.001] and thrombotic/cardiovascular events [2.72; p<0.001]. Independent risk factors for major bleeding were age [1.08; p<0.001], previous stroke [1.85; p=0.049], and TTR [0.97; p=0.001], but not VKA cessation. In conclusion, in AF patients AF, VKA cessation is independently associated with mortality stroke and cardiovascular events. Specifically, VKA cessation independently increased the risk of stroke, even after adjusting for CHA2DS2-VASc score. TTR was an independent risk factor for major bleeding following initiation of VKA therapy.Note: The editorial process for this paper was fully handled by Prof Christian Weber, Editor in Chief.

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Direct Anticoagulants Versus Vitamin K Antagonists in Patients Aged 80 Years or Older With Atrial Fibrillation in a “Real-world” Nationwide Registry: Insights From the FANTASIIA Study

Journal of Cardiovascular Pharmacology and Therapeutics ◽

10.1177/1074248420916316 ◽

2020 ◽

Vol 25 (4) ◽

pp. 316-323

Author(s):

Martín Ruiz Ortiz ◽

Javier Muñiz ◽

María Asunción Esteve-Pastor ◽

Francisco Marín ◽

Inmaculada Roldán ◽

...

Keyword(s):

Atrial Fibrillation ◽

Vitamin K ◽

Real World ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Left Ventricular ◽

Anticoagulant Treatment ◽

Cancer History

Objective: To describe major events at follow up in octogenarian patients with atrial fibrillation (AF) according to anticoagulant treatment: direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs). Methods: A total of 578 anticoagulated patients aged ≥80 years with AF were included in a prospective, observational, multicenter study. Basal features, embolic events (stroke and systemic embolism), severe bleedings, and all-cause mortality at follow up were investigated according to the anticoagulant treatment received. Results: Mean age was 84.0 ± 3.4 years, 56% were women. Direct oral anticoagulants were prescribed to 123 (21.3%) patients. Compared with 455 (78.7%) patients treated with VKAs, those treated with DOACs presented a lower frequency of permanent AF (52.9% vs 61.6%, P = .01), cancer history (4.9% vs 10.9%, P = .046), renal failure (21.1% vs 32.2%, P = .02), and left ventricular dysfunction (2.4% vs 8.0%, P = .03); and higher frequency of previous stroke (26.0% vs 16.6%, P = .02) and previous major bleeding (8.1% vs 3.6%, P = .03). There were no significant differences in Charlson, CHA2DS2VASc, nor HAS-BLED scores. At 3-year follow up, rates of embolic events, severe bleedings, and all-cause death (per 100 patients-year) were similar in both groups (DOACs vs VKAs): 0.34 vs 1.35 ( P = .15), 3.45 vs 4.41 ( P = .48), and 8.2 vs 11.0 ( P = .18), respectively, without significant differences after multivariate analysis (hazard ratio [HR]: 0.25, 95% confidence interval [CI]: 0.03-1.93, P = .19; HR: 0.88, 95% CI: 0.44-1.76, P = .72 and HR: 0.84, 95% CI: 0.53-1.33, P = .46, respectively). Conclusion: In this “real-world” registry, the differences in major events rates in octogenarians with AF were not statistically significant in those treated with DOACs versus VKAs.

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Abstract 14344: Prognostic Factors of Atrial Fibrillation Patients With Coronary Artery Disease: The Fushimi Af Registry

Circulation ◽

10.1161/circ.142.suppl_3.14344 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Nobutoyo Masunaga ◽

Hisashi Ogawa ◽

Yuya Aono ◽

Syuhei Ikeda ◽

KOSUKE DOI ◽

...

Keyword(s):

Diabetes Mellitus ◽

Heart Failure ◽

Atrial Fibrillation ◽

Prognostic Factors ◽

Major Bleeding ◽

Cardiac Death ◽

Cardiovascular Events ◽

Factors Associated ◽

Artery Disease

Background: Atrial fibrillation (AF) patients are likely to have concomitant coronary artery disease (CAD). A new strategy of antithrombotic therapy in AF patients with stable CAD was demonstrated in recent randomized clinical trials. Now that antithrombotic therapy for AF patients with CAD has reached a major turning point, it is important to know the prognostic factors in those patients. Purpose: In this study, we investigated clinical characteristics, cardiovascular events and prognostic factors in AF patients with CAD. Methods: The Fushimi AF Registry, a community-based prospective survey, was designed to enroll all of the AF patients who visited the participating medical institutions in Fushimi-ku, Kyoto, Japan. Follow up data including prescription status were available in 4,441 patients from March 2011 to November 2019. Of 4,441 patients, 645 patients had a history of CAD at enrollment. Results: The mean age was 76.4±8.6 and 65.9% were male. Averages of CHA 2 DS 2 -VASc score and HAS-BLED score were 4.41 and 2.35, respectively. Oral anticoagulant (OAC) was prescribed in 52.9% of those patients and antiplatelet drug (APD) was prescribed in 70.4%. The combination of OAC and APD was prescribed in 36.0%. During follow-up period (median 1,495 days), cardiac death occurred in 51 patients, composite of cardiac death, myocardial infarction (MI) and stroke in 136, and major bleeding in 77 (1.8, 5.1 and 2.9 per 100 person-years, respectively). In multivariate analysis, factors associated with composite of cardiac death, MI and stroke in AF patients with CAD were low body weight (<=50kg) (hazard ratio [95% confidence interval]; 1.62 [1.07-2.47]), previous stroke (1.69 [1.13-2.52]), heart failure (1.47 [1.02-2.11]), hypertension (0.60 [0.41-0.87]) and diabetes mellitus (1.62 [1.13-2.32]). Furthermore, factors associated with major bleeding in AF patients with CAD were anemia (male: hemoglobin<12 g/dl, female: hemoglobin<11 g/dl) (1.82 [1.09-3.04]) and thrombocytopenia (<150,000 /μL) (3.02 [1.29-7.03]). Conclusion: In Japanese AF patients with CAD, low body weight, previous stroke, heart failure, hypertension and diabetes mellitus were associated with cardiovascular events, and anemia and thrombocytopenia were associated with major bleeding.

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Murcia atrial fibrillation project II: protocol for a prospective observational study in patients with atrial fibrillation

BMJ Open ◽

10.1136/bmjopen-2019-033712 ◽

2019 ◽

Vol 9 (12) ◽

pp. e033712

Author(s):

José Miguel Rivera-Caravaca ◽

Francisco Marín ◽

María Asunción Esteve-Pastor ◽

Josefa Gálvez ◽

Gregory Y.H. Lip ◽

...

Keyword(s):

Atrial Fibrillation ◽

Observational Study ◽

Heart Valves ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Real Life ◽

Poor Quality ◽

Prosthetic Heart Valves

IntroductionAtrial fibrillation (AF) is characterised by a high stroke risk. Vitamin K antagonists (VKAs) are the most commonly used oral anticoagulants (OACs) in Spain, but their efficacy and safety depend on the time in therapeutic range of International Normalized Ratio (INR) 2.0–3.0 over 65%–70%. Unfortunately, the difficulties of maintaining an optimal level of anticoagulation and the complications of VKAs (particularly haemorrhagic ones), frequently lead to cessation of this therapy, which has been associated with higher risk of adverse events (AEs), including ischaemic stroke. Our aims are as follows: (1) to evaluate the quality of oral anticoagulation with VKAs, the prevalence of poor quality of anticoagulation, and to identify factors predisposing to poor quality anticoagulation; and (2) to identify patients who will stop OAC and to investigate what factors influence the decision of OAC withdrawal.Methods and analysisProspective observational cohort study including outpatients newly diagnosed with AF and naïve for OACs from July 2016 to June 2018 in an anticoagulation clinic. Patients with prosthetic heart valves, rheumatic mitral valves or valvular AF will be excluded. Follow-up will extend for up to 3 years. During this period, the INR results and changes in the anticoagulant therapy will be recorded, as well as all AEs, or any other information that would be relevant to the proper conduct of research.Ethics and disseminationAll patients were informed about the nature and purpose of the study, and the protocol was approved by the Ethics Committee of Hospital General Universitario Morales Meseguer (reference: EST:20/16). This is an observational study focusing on ‘real life’ practice and therefore all treatments and follow-up will be performed in accordance to the routine clinical practice with no specific interventions or visits. The results of our study will be disseminated by presentations at national and international meetings, and publications in peer-reviewed journals.

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Time to therapeutic range (TtTR), anticoagulation control, and cardiovascular events in vitamin K antagonists–naive patients with atrial fibrillation

American Heart Journal ◽

10.1016/j.ahj.2018.03.004 ◽

2018 ◽

Vol 200 ◽

pp. 32-36 ◽

Cited By ~ 6

Author(s):

Daniele Pastori ◽

Pasquale Pignatelli ◽

Francesco Cribari ◽

Roberto Carnevale ◽

Mirella Saliola ◽

...

Keyword(s):

Atrial Fibrillation ◽

Vitamin K ◽

Therapeutic Range ◽

Cardiovascular Events ◽

Vitamin K Antagonists ◽

Anticoagulation Control

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P4765Men who live alone have poor anticoagulation control: results from Danish registries

European Heart Journal ◽

10.1093/eurheartj/ehz745.1141 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

A N Bonde ◽

J Bjerre ◽

M Proietti ◽

G Gislason ◽

G Y H Lip ◽

...

Keyword(s):

Atrial Fibrillation ◽

Vitamin K Antagonists ◽

International Normalized Ratio ◽

Living Alone ◽

Efficacy And Safety ◽

Men And Women ◽

Anticoagulation Control ◽

Cohabitation Status ◽

Multivariable Adjustment

Abstract Background Efficacy and safety of vitamin K antagonists (VKAs) depend on quality of anticoagulation control, usually measured as time in therapeutic range (TTR). Factors that predict low TTR on VKAs could be used to identify patients who might benefit from interventions, or who would be better treated with a non-VKA oral anticoagulant (NOAC). Patients living alone may have difficulties in taking their medications, managing their diets, or coming to clinic for monitoring. Purpose To assess influence of cohabitation status on TTR with VKA among men and women. Methods We identified all Danish patients with atrial fibrillation (AF) who initiated VKA between 1997 and 2012, and studied patients who had 6 months of continuous VKA use and international normalized ratio (INR) monitoring. Patients were divided according to sex and whether they lived alone or with others. We calculated TTR using the Rosendaal method, and INR variability using Fihns method. We used a linear regression model to test for associations between TTR and covariates, and adjusted for age, income, medications and comorbidities. Results We identified 4,772 AF patients with 6 months of continuous VKA use and INR monitoring. 713 (15%) were men living alone, 1,073 (23%) were women living alone, 2,164 (45%) were men not living alone and 822 (17%) were women not living alone. INR was measured a median of 11 (interquartile range 8–15) times during the 180 days of VKA use, but men who lived alone had 0.6 (95% confidence interval (CI): 0.2 to 1.2) fewer INR measurements during the period. Median TTR was lowest among men living alone (57.2%), followed by women living alone (58.8%), women not living alone (61.0%) and men not living alone (62.5%). After multivariable adjustment, men who lived alone had a 3.6% (CI −5.6 to −1.6) lower TTR compared with men not living alone, but women who lived alone did not have significantly lower TTR (P=0.80) compared with women not living alone. Living alone had significantly greater effect on TTR among men than among women (interaction P=0.02). Men living alone also had higher adjusted INR variability (0.2, CI 0.0 to 0.4) compared with men not living alone. Conclusion Living alone was significantly related to low quality of anticoagulation control among men, but not among women. Acknowledgement/Funding this study was funded by an unrestricted grant from the Capital Region of Denmark, Foundation for Health Research

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