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

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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Two-year outcomes of patients with atrial fibrillation treated with rivaroxaban: results from RIVER registry

European Heart Journal ◽

10.1093/eurheartj/ehab724.0578 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

J Beyer-Westendorf ◽

A.J Camm ◽

S Virdone ◽

K.A.A Fox ◽

K.S Pieper ◽

...

Keyword(s):

Atrial Fibrillation ◽

Vitamin K ◽

Major Bleeding ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Real Life ◽

Nonvalvular Atrial Fibrillation ◽

Funding Sources ◽

European Society Of Cardiology

Abstract Introduction Non-vitamin-K oral anticoagulants (NOACs) were recommended in preference to oral vitamin K antagonists (VKAs) in the 2020 updated guidelines for stroke prevention in atrial fibrillation (AF), from the European Society of Cardiology (ESC). Rivaroxaban is a NOAC that is approved in many countries worldwide for reducing the risk of stroke or systemic embolism in patients with nonvalvular atrial fibrillation (AF). Purpose To explore the baseline characteristics, dosing and 2-year outcomes of patients with AF treated with rivaroxaban. Methods RIVaroxaban Evaluation in Real Life setting (RIVER) is a prospective international, multicenter registry of patients with newly diagnosed non-valvular AF treated with rivaroxaban for the prevention of thromboembolic stroke and at least one investigator-determined risk factor for stroke. Results A total of 5043 patients were enrolled into RIVER between January 2015 and June 2017. Mean (SD) age at diagnosis was 69.5 (11.0) years and 55.7% were males. Caucasian patients represented the largest proportion of patients in RIVER (80.3%), followed by Asians (5.5%) and hispanic/latino (3.7%). Almost all patients (98.5%) were prescribed a single daily dose of rivaroxaban, most commonly 20 mg (77.3%) and 15 mg (20.4%), while a 10 mg dose was prescribed in only 2.3% of patients. During the 2-year follow-up, the rates (95% CI) of all-cause mortality, stroke/SE, and major bleeding were 2.75 (2.43 to 3.12), 0.89 (0.72; 1.11), and 1.26 (1.05 to 1.52) per 100 person years, respectively (Figure 1). The most common cardiovascular cause of death was congestive heart failure (30.4%) and myocardial infarction (11.4%). Leading non-cardiovascular causes of death were malignancy (27.4%), respiratory failure (18.9%) and infections/sepsis (13.2%). Over 2 years, 710 (14.1%) of patients discontinued rivaroxaban. The corresponding proportions at 6 months and 1 year were 7.8% and 10.8%, respectively. Out of all the patients who discontinued, 62 (8.7%) restarted rivaroxaban during their follow-up (Table 1). Conclusion During 2 years of follow up in the international, prospective RIVER registry, rivaroxaban treatment for AF was associated with low rates of stroke or major bleeding. FUNDunding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): This work was supported by an unrestricted research grant from Bayer AG, Berlin, Germany, to TRI, London, UK. This work is supported by KANTOR CHARITABLE FOUNDATION for the Kantor-Kakkar Global Centre for Thrombosis Science.

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Epidemiological data on the use of traditional anticoagulants in cardiovascular disease

ESC CardioMed ◽

10.1093/med/9780198784906.003.0059 ◽

2018 ◽

pp. 281-288

Author(s):

Christina Reith ◽

Colin Baigent

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Cardiovascular Disease ◽

Venous Thromboembolism ◽

Heart Valves ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Epidemiological Data ◽

Prosthetic Heart Valves ◽

Coronary Syndrome

Traditional anticoagulants (e.g. parenteral heparins and oral vitamin K antagonists such as warfarin (coumadin), acenocoumarol, dicoumarol, phenprocoumon, phenindione, and fluindione) are widely used, including in coronary heart disease, atrial fibrillation, prosthetic heart valves, and heart failure, and as prophylaxis and treatment for venous thromboembolism. The parenteral anticoagulants are typically used in acute coronary syndrome, as initial treatment for venous thromboembolism, or as bridging therapy perioperatively, while the oral anticoagulants form the mainstay of traditional anticoagulant therapy for other indications.

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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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Changes in Prescribing Antithrombotic Therapy in Patients with Atrial Fibrillation in the Multidisciplinary Hospital in Volgograd from 2012 to 2020

Rational Pharmacotherapy in Cardiology ◽

10.20996/1819-6446-2021-12-06 ◽

2022 ◽

Vol 17 (6) ◽

pp. 831-836

Author(s):

A. S. Gerasimenko ◽

O. V. Shatalova ◽

V. S. Gorbatenko ◽

V. I. Petrov

Keyword(s):

Atrial Fibrillation ◽

Clinical Practice ◽

Clinical Guidelines ◽

Antithrombotic Therapy ◽

Heart Valves ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

International Normalized Ratio ◽

Prosthetic Heart Valves ◽

Discharge From Hospital

Aim. To study the frequency of prescribing antithrombotic agents in patients with non-valvular atrial fibrillation (AF) in real clinical practice, to evaluate changes of prescriptions from 2012 till 2020.Material and methods. The medical records of inpatients (Form 003/y) with the diagnosis AF, hospitalized in the cardiological department were analyzed. According to the inclusion criteria, the patients were over 18 years of age, established diagnosis of non-valvular AF. There were two exclusion criteria: congenital and acquired valvular heart disease and prosthetic heart valves. In retrospective analysis we have included 263 case histories in 2012, 502 ones in 2016 and 524 in 2020. CHA2DS2-VASc score was used for individual stroke risk assessment in AF. The rational use of the antithrombotic therapy was evaluated according with current clinical practice guidelines at analyzing moment.Results. During period of observation the frequency of antiplatelet therapy significantly decreased from 25,5% to 5,5% (р<0.001), decreased the frequency of administration of warfarin from 71,9% to 18,3% (р<0.001). The frequency of use of direct oral anticoagulants increased in 2020 compared to 2016 (р<0.001). For patients with a high risk of stroke anticoagulant therapy was administered in 71.8% of cases in 2012, 88.5% in 2016 and 92.5% in 2020. Before discharge from hospital majority of patients (72%) achieved a desired minimum international normalized ratio (INR) from 2.0 to 3.0 in 2012. In 2016 and 2020 an only 33% and 40.6% of patients achieved INR (2.0-3.0).Conclusion. Doctors have become more committed to following clinical guidelines during the period of the investigation. In 2020 antithrombotic therapy for atrial fibrillation was suitable according to current clinical guidelines.

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P675Current status of anticoagulation in patients with breast cancer and atrial fibrillation

European Heart Journal ◽

10.1093/eurheartj/ehz747.0281 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

A Pardo Sanz ◽

L M Rincon ◽

P Guedes Ramallo ◽

L Belarte ◽

G De Lara ◽

...

Keyword(s):

Breast Cancer ◽

Atrial Fibrillation ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Bleeding Risk ◽

Bleeding Events ◽

Patients With Cancer ◽

Oncologic Patients

Abstract Aims Balance between embolic and bleeding risk is challenging in patients with cancer. There is a lack of specific recommendations for the use of antithrombotic therapy in oncologic patients with atrial fibrillation (AF). We compared the embolic and bleeding risk, the preventive management and the incidence of events between patients with and without cancer. We further evaluated the effectiveness and safety of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) within patients with cancer. Methods The AMBER-AF registry is an observational multicentre study that analysed patients with non-valvular AF treated in Oncology and Cardiology Departments in Spain. 1237 female patients with AF were enrolled: 637 with breast cancer and 599 without cancer. Mean follow-up was 3.1 years. Results Both groups were similar in age, CHA2DS2-VASc and HASB-LED scores. Lack of guidelines recommended therapies was more frequent among patients with cancer. Compared with patients without cancer, adjusted rates of stroke (hazard ratio [95% confidence interval]) in cancer patients were higher (1.56 [1.04–2.35]), whereas bleeding rates remained similar (1.25 [0.95–1.64]). Within the group of patients with cancer, the use of DOACs vs VKAs did not entail differences in the adjusted rates of stroke (0.91 [0.42–1.99]) or severe bleedings (1.53 [0.93–2.53]). Follow-up events Conclusions Antithrombotic management of AF frequently differs in patients with breast cancer. While breast cancer is associated with a higher risk of incident stroke, bleeding events remained similar. Patients with cancer treated with DOACs experienced similar rates of stroke and bleeding as those with VKAs.

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Real-life experience of quality of life, treatment satisfaction, and adherence in patients receiving oral anticoagulants for atrial fibrillation

Patient Preference and Adherence ◽

10.2147/ppa.s131158 ◽

2018 ◽

Vol Volume 12 ◽

pp. 79-87 ◽

Cited By ~ 26

Author(s):

Michaël Benzimra ◽

Béatrix Bonnamour ◽

Martin Duracinsky ◽

Christophe Lalanne ◽

Jean-Pierre Aubert ◽

...

Keyword(s):

Quality Of Life ◽

Atrial Fibrillation ◽

Treatment Satisfaction ◽

Life Experience ◽

Oral Anticoagulants ◽

Real Life

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Thromboembolism and Pregnancy

Thrombosis and Haemostasis ◽

10.1055/s-0037-1615888 ◽

1999 ◽

Vol 82 (08) ◽

pp. 620-625 ◽

Cited By ~ 7

Author(s):

Jeffrey Ginsberg

Keyword(s):

Pregnancy Loss ◽

Heart Valves ◽

Oral Anticoagulants ◽

Poor Quality ◽

Low Molecular Weight ◽

Prosthetic Heart Valves ◽

Antithrombotic Agents ◽

Low Molecular Weight Heparins ◽

Arterial Embolism ◽

Venous Thromboembolic

IntroductionAntithrombotic therapy during pregnancy is used for the treatment and prophylaxis of venous thromboembolic disease, for the prevention and treatment of arterial embolism associated with valvular heart disease and/or prosthetic heart valves, for the prevention of fetal growth retardation and pregnancy loss in patients with antiphospholipid antibodies, and in patients with pregnancy-induced hypertension. Since antithrombotic agents have the potential to produce complications in both the mother and fetus, their use during pregnancy raises concerns. Guidelines are difficult to establish because the evidence upon which recommendations are based is derived primarily from poor-quality studies. This chapter reviews the fetal and maternal effects of antithrombotic agents including oral anticoagulants, unfractionated heparin, low molecular weight heparins (LMWH), and aspirin, and provides recommendations for their use during pregnancy.

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Satisfaction, quality of life and therapy adherence assessment in real life patients transitioning from vitamin K antagonists to direct oral anticoagulants

Journal of Thrombosis and Thrombolysis ◽

10.1007/s11239-020-02070-2 ◽

2020 ◽

Vol 50 (3) ◽

pp. 718-723 ◽

Cited By ~ 1

Author(s):

Alessandra Serrao ◽

Benedetta Lucani ◽

Giovanni Assanto Manfredi ◽

Luciano Fiori ◽

Erminia Baldacci ◽

...

Keyword(s):

Quality Of Life ◽

Vitamin K ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Real Life ◽

Therapy Adherence ◽

Adherence Assessment

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Warfarin Versus Warfarin and Dipyridamole on the Incidence of Arterial Throms Embolism in Prosthetic Heart Valve Patients

10.1055/s-0039-1684653 ◽

1979 ◽

Cited By ~ 1

Author(s):

S.M. Rajah ◽

N. Sreeharan ◽

S. Rao ◽

D.A. Watson

Keyword(s):

Atrial Fibrillation ◽

Heart Valves ◽

Prosthetic Heart Valve ◽

Prosthetic Heart Valves ◽

Post Mortem ◽

Randomised Study ◽

Yearly Incidence ◽

The Mean ◽

Prospective Randomised Study

The effect of Warfarin (W) was compared with a combination of Warfarin and Dipyridamole (W+D) on the incidence of arterial thrombo-embolism in patients with prosthetic heart valves in a prospective randomised study. Sixty-four and 53 patients were allocated to W and W+D. The two groups were comparable as regards age, sex, arrhythmias and site and type of valves. The dose of W was determined by regular monitoring of prothrombin ratio 0.9 - 3) and that of D by monitoring serum D levels to between 2 and 4 μmol/l. The mean period of follow-up was 26.98 months (range 1 to 36) for W and 22.02 months (range 1 to 36) for W+D. Six patients in W and 1 in W+D developed arterial thrombo-embolic episodes giving an incidence of 0.0035 per patient month for W and 0.0009 per patient month for W+D. An actuarial analysis of the yearly incidence of thrombo-embolism confirmed the superiority of W+D over W. Of the 6 failures in W, 5 were in sinus rhythm and 1 in atrial fibrillation and all had cerebral embolic episodes. The failure in W+D was a patient in atrial fibrillation who died suddenly 6 weeks after surgery and the post-mortem showed clots on both mitral and aortic prostheses.

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