Dynamic assessment of CHA2DS2-VASc and HAS-BLED scores for predicting ischemic stroke and major bleeding in atrial fibrillation patients.

INTRODUCTION AND OBJECTIVES: Stroke and bleeding risks in atrial fibrillation (AF) are often assessed at baseline to predict outcomes years later. We investigated whether dynamic changes in CHA2DS2-VASc and HAS-BLED scores over time modify risk prediction. METHODS: We included patients with AF who were stable while taking vitamin K antagonists. During a 6-year follow-up, all ischemic strokes/transient ischemic attacks (TIAs) and major bleeding events were recorded. CHA2DS2-VASc and HAS-BLED were recalculated every 2-years and tested for clinical outcomes at 2-year periods. RESULTS: We included 1361 patients (mean CHA2DS2-VASc and HAS-BLED 4.0±1.7 and 2.9±1.2). During the follow-up, 156 (11.5%) patients had an ischemic stroke/TIA and 269 (19.8%) had a major bleeding event. Compared with the baseline CHA2DS2-VASc, the CHA2DS2-VASc recalculated at 2 years had higher predictive ability for ischemic stroke/TIA during the period from 2 to 4 years. Integrated discrimination improvement (IDI) and net reclassification improvement (NRI) showed improvements in sensitivity and better reclassification. The CHA2DS2-VASc recalculated at 4 years had better predictive performance than the baseline CHA2DS2-VASc during the period from 4 to 6 years, with an improvement in IDI and an enhancement of the reclassification. The recalculated HAS-BLED at 2-years had higher predictive ability than the baseline score for major bleeding during the period from 2 to 4 years, with significant improvements in sensitivity and reclassification. A slight enhancement in sensitivity was observed with the HAS-BLED score recalculated at 4 years compared with the baseline score. CONCLUSIONS: In AF patients, stroke and bleeding risks are dynamic and change over time. The CHA2DS2-VASc and HAS-BLED scores should be regularly reassessed, particularly for accurate stroke risk prediction.

Factor XI in Carriers of Antiphospholipid Antibodies: Elevated Levels Associated with Symptomatic Thrombotic Cases, While Low Levels Linked to Asymptomatic Cases.

Antiphospholipid syndrome (APS) is a thromboinflammatory disorder caused by circulating antiphospholipid autoantibodies (aPL) and characterized by an increased risk of thrombotic events. The pathogenic mechanisms of these antibodies are complex and not fully understood, but disturbances in coagulation and fibrinolysis have been proposed to contribute to the thrombophilic state. This study aims to evaluate the role of an emerging hemostatic molecule, FXI, in the thrombotic risk of patients with aPL. Cross-sectional and observational study of 194 consecutive and unrelated cases with aPL recruited in a single center: 82 asymptomatic (AaPL) and 112 with primary antiphospholipid syndrome (APS). Clinical and epidemiological variables were collected. The profile of aPL was determined. Plasma FXI was evaluated by Western blotting and two coagulation assays (FXI:C). In cases with low FXI, molecular analysis of the F11 gene was performed. FXI:C levels were significantly higher in patients with APS than in patients with AaPL (122.8 ± 33.4 vs. 104.5 ± 27.5; p < 0.001). Multivariate analysis showed a significant association between symptomatic patients with aPL (APS) and high FXI (>150%) (OR = 11.57; 95% CI: 1.47-90.96; p = 0.020). In contrast, low FXI (<70%), mostly caused by inhibitors, was less frequent in the group of patients with APS compared to AaPL (OR = 0.17; 95%CI: 0.36-0.86; p = 0.032). This study suggests that FXI levels may play a causal role in the prothrombotic state induced by aPLs and holds the promise of complementary treatments in APS patients by targeting FXI.

Reducing bleeding risk in patients on oral anticoagulation therapy.

INTRODUCTION: Oral anticoagulation (OAC) significantly mitigates thromboembolism risks in atrial fibrillation (AF) and venous thromboembolism (VTE) patients yet concern about major bleeding events persist. In fact, clinically relevant hemorrhages can be life-threatening. Bleeding risk is dynamic and influenced by factors such as age, new comorbidities, and drug therapies, and should not be assessed solely based on static baseline factors. AREAS COVERED: We comprehensively review the bleeding risk associated with OAC therapy. Emphasizing the importance of assessing both thromboembolic and bleeding risks, we present clinical tools for estimating stroke and systemic embolism (SSE) and bleeding risk in AF and VTE patients. We also address overlapping risk factors and the dynamic nature of bleeding risk. EXPERT OPINION: The OAC management is undergoing constant transformation, motivated by the primary objective of mitigating thromboembolism and bleeding hazards, thereby amplifying patient safety throughout the course of treatment. The future of OAC embraces personalized approaches and innovative therapies, driven by advanced pathophysiological insights and technological progress. This holds promise for improving patient outcomes and revolutionizing anticoagulation practices.

Emergency department management of atrial fibrillation: 2023 consensus from the Spanish Society of Emergency Medicine (SEMES), the Spanish Society of Cardiology (SEC), and the Spanish Society of Thrombosis and Hemostasis (SETH). / Manejo de la fibrilación auricular en los servicios de urgencias hospitalarios: actualización a 2023 del consenso de la Sociedad Española de Medicina de Urgencias (SEMES), la Sociedad Española de Cardiología (SEC) y la Sociedad Española de Trombosis y Hemostasia (SETH).

OBJECTIVES: Atrial fibrillation (AF) is the most prevalent sustained arrhythmia managed in emergency departments, and the already high prevalence of this arrhythmia is increasing in Spain. This serious condition associated with increased mortality and morbidity has a negative impact on patient quality of life and the functioning of the health care system. The management of AF requires consideration of diverse clinical variables and a large number of possible therapeutic approaches, justifying action plans to coordinate the work of several medical specialties in the interest of providing appropriate care and optimizing resources. This consensus statement brings together recommendations for emergency department management of AF based on available evidence adapted to special circumstances. The statement was drafted by a multidisciplinary team of specialists from the Spanish Society of Emergency Medicine (SEMES), the Spanish Society of Cardiology (SEC), and the Spanish Society of Thrombosis and Hemostasis (SETH). Strategies for stroke prophylaxis, measures to bring heart rate and heart rhythm under control, and related diagnostic and logistic issues are discussed in detail.

OBJETIVO: La fibrilación auricular (FA) es la arritmia sostenida de mayor prevalencia en los servicios de urgencias (SU), y en España presenta una frecuentación elevada y creciente. Esta arritmia es una enfermedad grave, que incrementa la mortalidad y asocia una relevante morbilidad e impacto en la calidad de vida de los pacientes y en el funcionamiento de los servicios sanitarios. La diversidad de aspectos clínicos a considerar y el elevado número de opciones terapéuticas posibles justifican la implementación de estrategias de actuación coordinadas entre los diversos profesionales implicados, con el fin de incrementar la adecuación del tratamiento y optimizar el uso de recursos. Este documento, realizado por un grupo multidisciplinario de expertos en arritmias cardiacas miembros de la Sociedad Española de Medicina de Urgencias y Emergencias, la Sociedad Española de Cardiología y la Sociedad Española de Trombosis y Hemostasia, recoge las recomendaciones para el manejo de la FA en los SU hospitalarios, basadas en la evidencia disponible y adaptadas a las especiales circunstancias de los mismos. En él se analizan con detalle las estrategias de profilaxis tromboembólica, control de frecuencia y control del ritmo, y los aspectos logísticos y diagnósticos relacionados.

Manejo de la fibrilación auricular en los servicios de urgencias hospitalarios: actualización a 2023 del consenso de la Sociedad Española de Medicina de Urgencias (SEMES), la Sociedad Española de Cardiología (SEC) y la Sociedad Española de Trombosis y Hem / Emergency department management of atrial fibrillation: 2023 consensus from the Spanish Society of Emergency Medicine (SEMES), the Spanish Society of Cardiology (SEC), and the Spanish Society of Thrombosis and Hemostasis (SETH)

La fibrilación auricular (FA) es la arritmia sostenida de mayor prevalencia en los servicios de urgencias (SU), y en España presenta una frecuentación elevada y creciente. Esta arritmia es una enfermedad grave, que incrementa la mortalidad y asocia una relevante morbilidad e impacto en la calidad de vida de los pacientes y en el funcionamiento de los servicios sanitarios. La diversidad de aspectos clínicos a considerar y el elevado número de opciones terapéuticas posibles justifican la implementación de estrategias de actuación coordinadas entre los diversos profesionales implicados, con el fin de incrementar la adecuación del tratamiento y optimizar el uso de recursos. Este documento, realizado por un grupo multidisciplinario de expertos en arritmias cardiacas miembros de la Sociedad Española de Medicina de Urgencias y Emergencias, la Sociedad Española de Cardiología y la Sociedad Española de Trombosis y Hemostasia, recoge las recomendaciones para el manejo de la FA en los SU hospitalarios, basadas en la evidencia disponible y adaptadas a las especiales circunstancias de los mismos. En él se analizan con detalle las estrategias de profilaxis tromboembólica, control de frecuencia y control del ritmo, y los aspectos logísticos y diagnósticos relacionados. (AU)

Atrial fibrillation (AF) is the most prevalent sustained arrhythmia managed in emergency departments, and the already high prevalence of this arrhythmia is increasing in Spain. This serious condition associated with increased mortality and morbidity has a negative impact on patient quality of life and the functioning of the health care system. The management of AF requires consideration of diverse clinical variables and a large number of possible therapeutic approaches, justifying action plans to coordinate the work of several medical specialties in the interest of providing appropriate care and optimizing resources. This consensus statement brings together recommendations for emergency department management of AF based on available evidence adapted to special circumstances. The statement was drafted by a multidisciplinary team of specialists from the Spanish Society of Emergency Medicine (SEMES), the Spanish Society of Cardiology (SEC), and the Spanish Society of Thrombosis and Hemostasis (SETH). Strategies for stroke prophylaxis, measures to bring heart rate and heart rhythm under control, and related diagnostic and logistic issues are discussed in detail. (AU)

Impact of particulate matter on the incidence of atrial fibrillation and the risk of adverse clinical outcomes: A review.

BACKGROUND: Atrial fibrillation (AF) is common and increases the risk of stroke and mortality. Previous studies have suggested that air pollution is an important risk factor for new-onset AF. Herein, we review the evidence regarding: 1) the association between exposure to particulate matter (PM) and new-onset AF, and 2) the risk of worse clinical outcomes in patients with pre-existent AF and their relation to PM exposure. METHODS: A selection of studies between 2000 and 2023 linking PM exposure and AF was performed through searches in PubMed, Scopus, Web of Science, and Google Scholar. RESULTS: 17 studies from different geographical areas demonstrated that exposure to PM was associated with an increased risk of new-onset AF, although the results were heterogeneous regarding the temporal pattern (short- or long-term) ultimately related to AF. Most of the studies concluded that the risk of new-onset AF increased between 2 %-18 % per 10 µg/m3 increment in PM2.5 or PM10 concentrations, whereas the incidence (percentage of change of incidence) increased between 0.29 %-2.95 % per 10 µg/m3 increment in PM2.5 or PM10. Evidence about the association between PM and adverse events in patients with pre-existent AF was scarce but 4 studies showed a higher risk of mortality and stroke (between 8 %-64 % in terms of hazard ratio) in patients with pre-existent AF when PM exposure was higher. CONCLUSIONS: Exposure to PM (both PM2.5 and PM10) is a risk factor for AF, and a risk factor for mortality and stroke in patients who already suffer from AF. Since the relationship between PM and AF is independent of the region of the world, PM should be considered as a global risk factor for both AF and worse clinical outcomes in AF patients. Specific measures to prevent air pollution exposure need to be adopted.

The Atrial Fibrillation Better Care (ABC) Pathway and Clinical Outcomes in Patients with Atrial Fibrillation: the Prospective Murcia AF Project Phase II Cohort.

BACKGROUND: The Atrial fibrillation Better Care (ABC) pathway was proposed for a more holistic or integrated care approach to atrial fibrillation (AF) management. We investigated whether adherence with the ABC pathway reduced the risk of adverse clinical outcomes in real-world AF patients starting vitamin K antagonist (VKAs) therapy. METHODS: Prospective cohort study including AF outpatients starting VKA therapy from July 2016 to June 2018. Patients were considered as adherent if all ABC pathway criteria (A: Avoid stroke; B: Better symptom control; and C: Cardiovascular risk factors/comorbidities management) were fulfilled. The primary endpoints were all-cause mortality, net clinical outcomes (NCOs), major adverse cardiovascular events (MACE), and composite thrombotic/thromboembolic events at 2 years. RESULTS: We enrolled 1045 patients (51.6% female; median age 77 [70-83] years). Of these, 63.0% (658) were adherent to the ABC pathway and 37% (387) were considered non-adherent. Compared to non-adherent patients, those who were ABC adherent had lower event rates for all-cause mortality (13.76 vs. 6.56; p<0.001), NCOs (19.65 vs. 11.94; p<0.001), and MACE (11.88 vs. 7.75; p=0.006) during the follow-up. Adjusted Cox regression analyses demonstrated that the ABC pathway adherent care reduced the risks of all-cause mortality (aHR 0.57, 95% CI 0.42-0.78), NCOs (aHR 0.72, 95% CI 0.56-0.92), and cardiovascular mortality (aHR 0.54, 95% CI 0.32-0.90). Event-free survivals for all-cause mortality, NCOs (both log-rank p-values <0.001), and MACE (log-rank p-value = 0.004) were also higher in ABC pathway adherent patients. CONCLUSIONS: In this real-world prospective cohort of AF patients starting VKA therapy, adherence to the ABC pathway management at baseline significantly reduced the risk of NCOs, all-cause mortality, and cardiovascular death at 2 years.

Imaging in atrial fibrillation: A way to assess atrial fibrosis and remodeling to assist decision-making.

The 2020 ESC atrial fibrillation (AF) guidelines suggest the novel 4S-AF scheme for the characterization of AF. Imaging techniques could be helpful for this objective in everyday clinical practice, and information derived from these techniques reflects basic aspects of the pathophysiology of AF, which may facilitate treatment decision-making, and optimal management of AF patients. The aim of this review is to provide an overview of the mechanisms associated with atrial fibrosis and to describe imaging techniques that may help the management of AF patients in clinical practice. Transthoracic echocardiography is the most common procedure given its versatility, safety, and simplicity. Transesophageal echocardiography provides higher resolution exploration, and speckle tracking echocardiography can provide incremental functional and prognostic information over conventional echocardiographic parameters. In addition, LA deformation imaging, including LA strain and strain rate, are related to the extent of fibrosis. On the other hand, multidetector-row computed tomography and cardiac magnetic resonance provide higher resolution data and more accurate assessment of the dimensions, structure, and spatial relationships of the LA. Imaging is central when deciding on catheter ablation or cardioversion, and helps in selecting those patients who will really benefit from these procedures. Moreover, imaging enhances the understanding of the underlying mechanisms of atrial remodeling and might assists in refining the risk of stroke, which help to select the best medical therapies/interventions. In summary, evaluation of LA enlargement, LA remodeling and fibrosis with imaging techniques adds clinical and prognostic information and should be assessed as a part of routine comprehensive AF evaluation.

Polypharmacy and adverse events in atrial fibrillation: Main cause or reflection of multimorbidity?

BACKGROUND: Previous evidence indicated that atrial fibrillation (AF) patients with polypharmacy presented increased probability of adverse events. We investigated the prevalence of polypharmacy, risk factors for polypharmacy, and the impact of polypharmacy in clinical outcomes in a 'real-world' cohort of AF patients starting vitamin K antagonists (VKAs). METHODS: Prospective study including AF outpatients starting VKA therapy from July, 2016 to June, 2018. At inclusion, all concomitant drugs were carefully collected and recorded. Polypharmacy was defined as the intake of ≥ 5 concomitant drugs. During 2-years of follow-up, ischemic strokes/transient ischemic attacks (TIAs), fatal/nonfatal myocardial infarctions (MIs), bleeding events, venous thromboembolisms, and all-cause deaths were recorded. RESULTS: 1050 patients (51.5 % females, median age 77 [69-83] years) were included, and the prevalence of polypharmacy was 32.9 % (345). Female sex (OR 1.5; 95 % CI 1.11-2.03), hypertension (OR 2.53; 95 % CI 1.51-4.22), diabetes (OR 3.11; 95 % CI 2.31-4.17), vascular disease (OR 3.08; 95 % CI 2.19-4.33), heart failure (OR 1.86; 95 % CI 1.35-2.58) and dyslipidemia (OR 2.61; 95 % CI 1.9-3.58) were independently associated to the polypharmacy. Patients with polypharmacy showed significantly higher incidence of major bleeding, net clinical outcomes (composite of major bleeding, ischemic stroke/TIA, and mortality), MACE (composite of ischemic stroke/TIA, MI, and cardiovascular death), and composite thrombotic/thromboembolic events; being an independent risk factor for major bleeding (HR 1.77, 95 % CI 1.07-2.92), and composite thrombotic/thromboembolic events (HR 1.55, 95 % CI 1.05-2.31). CONCLUSION: In this "real world" AF cohort, polypharmacy was highly prevalent and conditioned worse prognosis due to its association with bleeding and thromboembolic events.

Predicting performance of the HAS-BLED and ORBIT bleeding risk scores in patients with atrial fibrillation treated with Rivaroxaban: Observations from the prospective EMIR Registry.

BACKGROUND: Assessing bleeding risk during the decision-making process of starting oral anticoagulation (OAC) therapy in atrial fibrillation (AF) patients is essential. Several bleeding risk scores have been proposed for vitamin K antagonist users but, few studies have focused on validation of these bleeding risk scores in patients taking direct oral anticoagulants (DOACs). The aim was to compare the predictive ability of HAS-BLED and ORBIT bleeding risk scores in AF patients taking rivaroxaban in the EMIR ('Estudio observacional para la identificación de los factores de riesgo asociados a eventos cardiovasculares mayores en pacientes con fibrilación auricular no valvular tratados con un anticoagulante oral directo [Rivaroxaban]) Study. METHODS AND RESULTS: EMIR Study was an observational, multicenter, post-authorization, and prospective study that involved AF patients under OAC with rivaroxaban at least 6 months before enrolment. We analysed baseline clinical characteristics and adverse events after 2.5 years of follow-up and validated the predictive ability of HAS-BLED and ORBIT scores for major bleeding (MB) events.We analysed 1433 patients with mean age of 74.2 ± 9.7 (44.5% female). Mean HAS-BLED score was 1.6 ± 1.0 and ORBIT score was 1.1 ± 1.2. The ORBIT score categorised a higher proportion of patients as 'low-risk' (87.1%) compared with 53.5% using the HAS-BLED score. There were 33 MB events (1.04%/year) and 87 patients died (2.73%/year). Both HAS-BLED and ORBIT had a good predictive ability for MB{Area under the curve (AUC) 0.770, [95% confidence interval (CI) 0.693-0.847; P <0.001] and AUC 0.765 (95% CI 0.672-0.858; P <0.001), respectively}. There was a non-significant difference for discriminative ability of the two tested scores (P = 0.930) and risk reclassification in terms of net reclassification improvement (NRI) -5.7 (95% CI -42.4-31.1; P = 0.762). HAS-BLED score showed the best calibration and ORBIT score showed the largest mismatch in calibration, particularly in higher predicted risk patients. CONCLUSION: In a prospective real-world AF population under rivaroxaban from EMIR registry, the HAS-BLED score had good predictive performance and calibration compared with ORBIT score for MB events. ORBIT score presented worse calibration than HAS-BLED in this DOAC treated population.

Characteristics and management of patients with stroke and major hemorrhagic episodes with atrial fibrillation under vitamin K antagonist therapy. EVENTHO study

Introduction and objective: In Spain, vitamin K antagonists (VKA) remain the standard treatment for the prevention of thromboembolic and hemorrhagic complications in patients with atrial fibrillation (AF), despite the high risks of suffering adverse effects. The objective of this study was to characterize the profile of VKA-treated patients suffering from stroke/systemic embolism (SE) or major hemorrhagic episodes, their evolution and the actions taken after those episodes.Materials and methodsEVENTHO was an observational multicenter study conducted in 22 Anticoagulation Spanish Units. The study included patients ≥18 years with AF who suffered major hemorrhagic episodes (67.8%) or stroke/SE (32.1%) during 2016 whileon VKA treatment [acenocoumarol (98.2%) or warfarin (1.8%)]. Time in therapeutic range (TTR) was calculated according to the Rosendaal method based on the international normalized ratio (INR) values of the previous 6 months.ResultsThe study included 585 patients (median age [range] 82.3 [43.6–96.2] years; 51.1% men; mean [95% confidence interval, CI] CHA2DS2-VASc: 4.3 [4.2–4.4] and HAS-BLED: 2.2 [2.1–2.3]). Poor anticoagulation and VKA maintenance were higher in patients with major hemorrhagic episode (p<0.0001). The most common situations after hospital discharge were: functional dependence, neurological sequelae and death.ConclusionsIn the sample studied, half of the AF patients who suffered stroke/SE or major hemorrhagic episode had inadequate TTR and, despite this, after hospital discharge, they restarted treatment with VKA. These results highlight the need to evaluate safer and effective therapeutic alternatives in AF patients with poor TTR control after suffering a stroke/SE or major hemorrhagic episode. (AU)

Introducción y objetivo: En España, los antagonistas de la vitamina K (AVK) siguen siendo el tratamiento estándar para la prevención de las complicaciones tromboembólicas y hemorrágicas en pacientes con fibrilación auricular (FA), a pesar del alto riesgo de presentar efectos adversos. El objetivo de este estudio fue caracterizar el perfil de los pacientes tratados con AVK que experimentaron un ictus/embolia sistémica o hemorragia mayor, su evolución y las acciones realizadas tras esos episodios.Materiales y métodosEVENTHO fue un estudio multicéntrico observacional realizado en 22 unidades españolas de anticoagulación. Se incluyó en el estudio a pacientes≥18 años con FA que habían tenido hemorragia mayor (67,8%) o ictus/embolia sistémica (32,1%) durante 2016 y estaban en tratamiento con AVK (acenocumarol [98,2%] o warfarina [1,8%]). El tiempo en rango terapéutico (TRT) se calculó según el método de Rosendaal basado en los valores del índice internacional normalizado de los 6 meses previos.ResultadosEl estudio incluyó a 585 pacientes (edad mediana 82,3 [rango 43,6-96,2] años; 51,1% hombres; CHA2DS2-VASc medio 4,3 [IC 95% 4,2-4,4] y HAS-BLED medio 2,2 [IC 95% 2,1-2,3]). La mala anticoagulación y el mantenimiento de los AVK fueron mayores en los pacientes con hemorragia mayor (p<0,0001). Las situaciones más frecuentes tras el alta hospitalaria fueron: dependencia funcional, secuelas neurológicas y muerte.ConclusionesEn la muestra estudiada, la mitad de los pacientes con FA que tuvieron ictus/embolia sistémica o hemorragia mayor presentaban un TRT inadecuado y, a pesar de ello, tras el alta hospitalaria, reiniciaron el tratamiento con AVK. Estos resultados destacan la necesidad de evaluar alternativas terapéuticas más seguras y eficaces en pacientes con FA con mal control del TRT tras sufrir un ictus/embolia sistémica o hemorragia mayor. (AU)

Assessment and Mitigation of Bleeding Risk in Atrial Fibrillation and Venous Thromboembolism: Executive Summary of a European and Asia-Pacific Expert Consensus Paper.

While there is a clear clinical benefit of oral anticoagulation in patients with atrial fibrillation (AF) and venous thromboembolism (VTE) in reducing the risks of thromboembolism, major bleeding events (especially intracranial bleeds) may still occur and be devastating. The decision for initiating and continuing anticoagulation is often based on a careful assessment of both thromboembolism and bleeding risk. The more common and validated bleeding risk factors have been used to formulate bleeding risk stratification scores, but thromboembolism and bleeding risk factors often overlap. Also, many factors that increase bleeding risk are transient and modifiable, such as variable international normalized ratio values, surgical procedures, vascular procedures, or drug-drug and food-drug interactions. Bleeding risk is also not a static "one-off" assessment based on baseline factors but is dynamic, being influenced by aging, incident comorbidities, and drug therapies. In this executive summary of a European and Asia-Pacific Expert Consensus Paper, we comprehensively review the published evidence and propose a consensus on bleeding risk assessments in patients with AF and VTE, with a view to summarizing "best practice" when approaching antithrombotic therapy in these patients. We address the epidemiology and size of the problem of bleeding risk in AF and VTE, and review established bleeding risk factors and summarize definitions of bleeding. Patient values and preferences, balancing the risk of bleeding against thromboembolism, are reviewed, and the prognostic implications of bleeding are discussed. We propose consensus statements that may help to define evidence gaps and assist in everyday clinical practice.

Relationship between temporal rhythm-based classification of atrial fibrillation and stroke: real-world vs. clinical trial.

BACKGROUND: The risk of stroke according to clinical classification of atrial fibrillation (AF) remains poorly defined. Here, we assessed the impact of AF type on stroke risk in vitamin K antagonist-treated patients with AF in 'real-world' and 'clinical trial' cohorts. METHODS: Post-hoc analysis of patient-level data from the Murcia AF Project and AMADEUS trial. Clinical classification of AF was based on contemporary recommendations from international guidelines. Study endpoint was the incidence rate of ischaemic stroke. Stroke risk was determined using CHA2DS2-VASc score and CARS. A modified CHA2DS2-VAS'c' score that applied one additional point for a 'c' criterion of continuous AF (i.e. non-paroxysmal AF) was calculated. RESULTS: We included 5,917 patients: 1,361 (23.0%) real-world and 4,556 (77.0%) clinical trial. Baseline demographics were balanced in the real-world cohort but clinical trial participants with non-pAF (vs. pAF) were older, male-predominant and had more comorbidities. Crude stroke rates were comparable between the groups in real-world patients (IRR 0.72 [95% CI,0.37-1.28], p = 0.259) though clinical trial participants with non-pAF had a significantly higher crude rate of stroke events (IRR 4.66 [95%,CI,2.41-9.48], p < 0.001). Using multivariable analysis, AF type was not independently associated with stroke risk in the real-world (adjusted HR 1.41 [95% CI,0.80-2.50], p = 0.239) and clinical trial (adjusted HR 1.16 [95% CI,0.62-2.20], p = 0.646) cohorts, after accounting for other risk factors. There was no significant improvement in the CHA2DS2-VAS'c' compared to CHA2DS2-VASc score in either cohorts (p > 0.05). CONCLUSIONS: Overall, our results support the need for anticoagulation based on thromboembolic risk profile rather than AF type.

Relation of the 'Atrial Fibrillation Better Care (ABC) Pathway' to the Quality of Anticoagulation in Atrial Fibrillation Patients Taking Vitamin K Antagonists.

The Atrial Fibrillation Better Care (ABC) pathway was proposed for a more integrated atrial fibrillation (AF) care. We investigated if adherence to the ABC pathway was associated to the quality of anticoagulation control in a cohort of AF outpatients starting vitamin K antagonists (VKAs) between July 2016 and June 2018. Patients were considered adherent to the ABC pathway if they met all of its components. The time in therapeutic range (TTR) was estimated at one year. In total, 1045 patients (51.6% female; median age 77 years; 63% ABC pathway adherent) were included. At one year, 474 (51.6%) of 919 patients with international normalized ratio (INR) data for TTR estimation had a TTR < 65%. Among ABC pathway non-adherent patients, a greater proportion had TRT < 65% (56.4% vs. 43.6%, p = 0.025), and TTR < 70% (64.9% vs. 35.1%, p = 0.033), with lower mean TTR in non-adherent patients (59.4 ± 22.3% vs. 63.9 ± 21.1%; p = 0.004). Logistic regression models demonstrated that the ABC pathway adherence in its continuous (aOR: 0.75, 95% CI 0.59−0.96) and categorical (aOR: 0.75, 95% CI 0.57−0.98) forms was independently associated with TTR ≥ 65%. In this 'real-world' cohort of AF patients starting VKAs, the ABC pathway adherent patients had better TTR, and more ABC criteria fulfilled increased the probability of achieving good TTR.

Assessment and mitigation of bleeding risk in atrial fibrillation and venous thromboembolism: A Position Paper from the ESC Working Group on Thrombosis, in collaboration with the European Heart Rhythm Association, the Association for Acute CardioVascular Care and the Asia-Pacific Heart Rhythm Society.

Whilst there is a clear clinical benefit of oral anticoagulation (OAC) in patients with atrial fibrillation (AF) and venous thromboembolism (VTE) in reducing the risks of thromboembolism, major bleeding events (especially intracranial bleeds) may still occur and be devastating. The decision to initiate and continue anticoagulation is often based on a careful assessment of both the thromboembolism and bleeding risk. The more common and validated bleeding risk factors have been used to formulate bleeding risk stratification scores, but thromboembolism and bleeding risk factors often overlap. Also, many factors that increase bleeding risk are transient and modifiable, such as variable international normalized ratio values, surgical procedures, vascular procedures, or drug-drug and food-drug interactions. Bleeding risk is also not a static 'one off' assessment based on baseline factors but is dynamic, being influenced by ageing, incident comorbidities, and drug therapies. In this Consensus Document, we comprehensively review the published evidence and propose a consensus on bleeding risk assessments in patients with AF and VTE, with the view to summarizing 'best practice' when approaching antithrombotic therapy in these patients. We address the epidemiology and size of the problem of bleeding risk in AF and VTE, review established bleeding risk factors, and summarize definitions of bleeding. Patient values and preferences, balancing the risk of bleeding against thromboembolism are reviewed, and the prognostic implications of bleeding are discussed. We propose consensus statements that may help to define evidence gaps and assist in everyday clinical practice.

Characteristics and management of patients with stroke and major hemorrhagic episodes with atrial fibrillation under vitamin K antagonist therapy. EVENTHO study.

INTRODUCTION AND OBJECTIVE: In Spain, vitamin K antagonists (VKA) remain the standard treatment for the prevention of thromboembolic and hemorrhagic complications in patients with atrial fibrillation (AF), despite the high risks of suffering adverse effects. The objective of this study was to characterize the profile of VKA-treated patients suffering from stroke/systemic embolism (SE) or major hemorrhagic episodes, their evolution and the actions taken after those episodes. MATERIALS AND METHODS: EVENTHO was an observational multicenter study conducted in 22 Anticoagulation Spanish Units. The study included patients ≥18 years with AF who suffered major hemorrhagic episodes (67.8%) or stroke/SE (32.1%) during 2016 whileon VKA treatment [acenocoumarol (98.2%) or warfarin (1.8%)]. Time in therapeutic range (TTR) was calculated according to the Rosendaal method based on the international normalized ratio (INR) values of the previous 6 months. RESULTS: The study included 585 patients (median age [range] 82.3 [43.6-96.2] years; 51.1% men; mean [95% confidence interval, CI] CHA2DS2-VASc: 4.3 [4.2-4.4] and HAS-BLED: 2.2 [2.1-2.3]). Poor anticoagulation and VKA maintenance were higher in patients with major hemorrhagic episode (p<0.0001). The most common situations after hospital discharge were: functional dependence, neurological sequelae and death. CONCLUSIONS: In the sample studied, half of the AF patients who suffered stroke/SE or major hemorrhagic episode had inadequate TTR and, despite this, after hospital discharge, they restarted treatment with VKA. These results highlight the need to evaluate safer and effective therapeutic alternatives in AF patients with poor TTR control after suffering a stroke/SE or major hemorrhagic episode.