[Fine-tuning of antithrombotic therapy in patients with non-valvular atrial fibrillation. The AFINVA register]. / Adecuación del tratamiento antitrombótico en los pacientes con fibrilación auricular no valvular. Registro AFINVA.

OBJECTIVE: To determine whether antithrombotic treatment (ATT) in patients with non-valvular atrial fibrillation in a health area complies with the recommendations of current clinical guidelines. DESIGN: Prospective observational study. LOCATION: Primary Health Care Centres and Cardiology Department of a Health Department of the Valencian Community, Spain. PARTICIPANTS: A total of 505 patients with nonvalvular atrial fibrillation were included in the study. MAIN MEASUREMENTS: ATT was deemed to be inappropriate in patients with a CHA2DS2-VASc score ≥1 and who were not under oral anticoagulation, in patients treated with antivitaminK drugs, and poor control of oral anticoagulation, or with antiplatelet therapy inappropriately associated with anticoagulation, and in patients on ATT with a CHA2DS2-VASc score=0. RESULTS: The median age was 77.4±10years. The ATT was considered inadequate in 58% of cases. Factors independently associated with inadequate ATT were age (OR: 1.02 [1-1.04]; P=.029), hypothyroidism (OR: 1.98 [1.14-3.43]; P=.015), ischaemic heart disease (OR: 1.3 [1.15-2.59]; P=.008) and paroxysmal non-valvular AF (OR: 2.11 [1.41-3.17]; P<.0001). CONCLUSIONS: These data underline the high prevalence of inadequate ATT in daily practice, as well its different causes.

[Clinical characteristics of patients with atrial fibrillation treated with direct oral anticoagulants attended in primary care setting. The SILVER-AP study]. / Perfil clínico de pacientes con fibrilación auricular tratados con anticoagulantes orales de acción directa atendidos en atención primaria. Estudio SILVER-AP.

OBJECTIVE: To analyse the clinical characteristics and management of patients with non-valvular atrial fibrillation (NVAF) treated with direct oral anticoagulants (DOAC). DESIGN: Observational, cross-sectional and multicentre study. LOCATION: Autonomous Communities in which the general practitioner can prescribe DOAC (n=9). PARTICIPANTS: The study included a total of 790 patients on chronic treatment with anticoagulants, and on whom therapy was changed, as well as being currently on treatment with DOAC for at least for 3 months. MAIN MEASURES: A record was made of the sociodemographic and clinical management date. RESULTS: Mean age was 78.6±8.4 years, and 50.5% of patients were men. Mean CHADS2 score was 2.6±1.2, mean CHA2DS2-VASc score was 4.3±1.6, and the mean HAS-BLED score was 2.3±1.0. Mean duration of treatment with DOAC was 15.8±12.5 months. Rivaroxaban was the DOAC most frequently prescribed (57.8%), followed by dabigatran (23.7%), and apixaban (18.5%). Of the patients receiving rivaroxaban, 70.2% were taking the dose of 20mg/daily. Of the patients receiving dabigatran, 41.7% were taking the dose of 150mg twice daily, and in the case of apixaban, 56.2% were taking the dose of 5mg twice daily. Satisfaction (ACTS Burdens scale 52.0±7.2 and ACTS Benefits scale 12.1±2.2), and therapeutic adherence (97.8% of patients took their medication regularly) with DOAC were high. CONCLUSIONS: Patients treated with DOAC in Spain have a high thromboembolic risk. A significant proportion of patients receive a lower dose of DOAC than that recommended according to their clinical profile. Satisfaction and medication adherence are high.

[Cost-effectiveness analysis of apixaban versus acetylsalicylic acid in the prevention of stroke in patients with non-valvular atrial fibrillation in Spain]. / Análisis coste-utilidad de apixabán frente al ácido acetilsalicílico en la prevención del ictus en pacientes con fibrilación auricular no valvular en España.

OBJECTIVE: To assess the cost-effectiveness of apixaban versus acetylsalicylic acid (ASA) in stroke prevention in patients with non-valvular atrial fibrillation (NVAF) with contraindications of vitamin K antagonists in Spain. METHODS: A Markov model was adapted, simulating the patient's lifetime. The safety and efficacy of the drugs were obtained from AVERROES clinical trial. The analysis was done from the Spanish National Health System (NHS) and societal perspective. The cost of drugs was calculated according to the recommended doses. The cost of NVAF complications and disease management was obtained from Spanish sources. RESULTS: In a cohort of 1,000 patients with NVAF, during their lifetime numerous complications could be avoided with apixaban versus ASA (48 ischemic strokes, 10 systemic embolism and 53 related deaths). In each patient treated with apixaban more life-years (0.303 LYG) and more quality-adjusted life-years (0.277 QALYs) could be gained. Apixaban would generate more costs per patient for the NHS (€1,742 per patient) but savings would result from the social perspective (€2,887 saved per patient). The cost per LYG and QALY gained would be of €5,749 and €6,289 for the NHS. Apixaban would be dominant (more effective with less costs than ASA) from the societal perspective. The results were stable in both deterministic and probabilistic sensitivity analyses. CONCLUSIONS: According to this model, when costs and estimated lifetime outcomes achieved with apixaban are compared with those of ASA, apixaban was assessed to be a cost-effective treatment for the prevention of stroke in patients with NVAF in Spain.

Nonvalvular atrial fibrillation and retinal vein occlusion: The Valdecilla Cohort.

INTRODUCTION AND OBJECTIVES: Retinal vein occlusion (RVO) and nonvalvular atrial fibrillation (NVAF) are associated with vascular risk factors (VRF) and aging. The aim of this study is to analyze differences in the prevalence of VRF, vascular events, glaucoma, and anticoagulant treatment in patients with NVAF and RVO compared to a control group of the general population from the same geographic area. METHODS: This is a prospective, single-center, case-control study. All patients diagnosed with RVO from December 2008 to March 2020 as well as a control group were included. Clinical, laboratory, electrocardiographic, and carotid ultrasound variables were analyzed. RESULTS: A total of 386 patients with RVO and 343 controls were studied. Patients with RVO and NVAF were older and more of them had hypertension, a history of vascular events, and carotid atheromatosis than subjects with RVO without NVAF. In patients with NVAF who were on anticoagulants, those who had RVO differed from the controls with NVAF in that they had a higher prevalence of glaucoma (32 vs. 5.3%; p<0.034), with no significant differences regarding age, VRF, vascular events, or type of anticoagulant therapy (acenocumarol or direct-acting oral anticoagulants). CONCLUSIONS: Patients with RVO and NVAF were older and had a higher prevalence of hypertension and carotid atheromatosis than subjects with RVO without NVAF. Patients with NVAF and RVO had higher prevalence of glaucoma than subjects with NVAF without RVO. In patients with NVAF, it is recommended to optimized VRF treatment and glaucoma control to prevent the development of RVO.

Patterns and outcomes of switching direct oral anticoagulants in non-valvular atrial fibrillation: A real-world experience from Spain.

AIMS: The aim is to evaluate a management program for direct oral anticoagulants (DOACs) in non-valvular atrial fibrillation (NVAF) patients according to their profiles, appropriateness of dosing, patterns of crossover, effectiveness and safety. This is an observational and longitudinal prospective study in a cohort of patients attended in daily clinical practice in a regional hospital in Spain with 3-year a follow-up plan for patients initiating dabigatran, rivaroxaban or apixaban between JAN/2012-DEC/2016. METHODS: We analyzed 490 episodes of treatment (apixaban 2.5 9.4%, apixaban 5 21.4%, dabigatran 75 0.6%, dabigatran 110 12,4%, dabigatran 150 19.8%, rivaroxaban 15 17.8% and rivaroxaban 20 18.6%) in 445 patients. 13.6% of patients on dabigatran, 9.7% on rivaroxaban, and 3.9% on apixaban switched to other DOACs or changed dosing. RESULTS: Apixaban was the most frequent DOAC switched to. The most frequent reasons for switching were toxicity (23.8%), bleeding (21.4%) and renal deterioration (16.7%). Inappropriateness of dose was found in 23.8% of episodes. Rates of stroke/transient ischemic attack (TIA) were 1.64/0.54 events/100 patients-years, while rates of major, clinically relevant non-major (CRNM) bleeding and intracranial bleeding were 2.4, 5, and 0.5 events/100 patients-years. Gastrointestinal and genitourinary bleeding were the most common type of bleeding events (BE). On multivariable analysis, prior stroke and age were independent predictors of stroke/TIA. Concurrent platelet inhibitors, male gender and age were independent predictors of BE. CONCLUSION: This study complements the scant data available on the use of DOACs in NVAF patients in Spain, confirming a good safety and effectiveness profile.

Prognostic impact of the presence of chronic kidney disease on percutaneous left trial appendage closure for atrial fibrillation: A single center experience.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) has been proposed as an alternative to anticoagulation therapy in patients with nonvalvular atrial fibrillation (NVAF) to decrease the thromboembolic risk, while avoiding the risks of chronic anticoagulation. This option may be attractive in patients with NVAF and chronic kidney disease (CKD), since they exhibit both high thromboembolic and bleeding risks. OBJECTIVE: To evaluate the prognostic impact of the presence of CKD in patients with atrial fibrillation undergoing LAAC peri-procedure and during the follow-up as compared with patients with preserved renal function. METHODS: Retrospective, observational study that included 124 consecutive patients with atrial fibrillation undergoing LAAC in a university hospital, and the results were evaluated according to the baseline renal function of the patients. RESULTS: The median age was 75,5 years (IQR 67,6-80) and 62,1% were men, the median of CHA2DS2-Vasc and HASBLED scores was 4 (IQR 3-4) for both scores. Up to 57,3% of the total sample had CKD. Baseline characteristics were similar between groups, but CKD patients were older and had a higher HASBLED score. During the procedure, no thromboembolic, bleeding events, or deaths were observed. Combining the time of hospitalization and follow-up, no significant differences were observed between groups in the annual rate of thromboembolic events (0.97/100 patient-years [100PY] vs 4.06/100PY, P =,09), but there was a higher rate of bleeding events (5.67/100PY vs. 13.3/100PY, P =,033) and mortality among CKD patients (6.50/100PY vs. 17.2/100PY, P =,009), with an odds ratio of 2.711 (95% CI 1,96-6,95). In the multivariate analysis a preserved eGFR was independently associated with a lower mortality risk. CONCLUSIONS: LAAC is a valid alternative to oral anticoagulation in patients with CKD and atrial fibrillation, with a low rate of peri- and post-procedure complications, although CKD patients exhibited a higher risk of bleeding and mortality during the follow-up. However, these higher rates may not be necessarily related to the procedure.

Prognostic impact of the presence of chronic kidney disease on percutaneous left trial appendage closure for atrial fibrillation: A single center experience. / Impacto pronóstico de la enfermedad renal crónica sobre el cierre percutáneo de la orejuela izquierda en la fibrilación auricular: una experiencia unicéntrica.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) has been proposed as an alternative to anticoagulation therapy in patients with nonvalvular atrial fibrillation to decrease the thromboembolic risk, while avoiding the risks of chronic anticoagulation. This option may be attractive in patients with nonvalvular atrial fibrillation and chronic kidney disease (CKD), since they exhibit both high-thromboembolic and bleeding risks. OBJECTIVE: To evaluate the prognostic impact of the presence of CKD in patients with atrial fibrillation undergoing LAAC peri-procedure and during the follow-up as compared with patients with preserved renal function. METHODS: Retrospective, observational study that included 124 consecutive patients with atrial fibrillation undergoing LAAC in a university hospital, and the results were evaluated according to the baseline renal function of the patients. RESULTS: The median age was 75.5 years (IQR 67.6-80) and 62.1% were men, the median of CHA2DS2-Vasc and HASBLED scores was 4 (IQR 3-4) for both scores. Up to 57.3% of the total sample had CKD. Baseline characteristics were similar between groups, but CKD patients were older and had a higher HASBLED score. During the procedure, no thromboembolic, bleeding events, or deaths were observed. Combining the time of hospitalization and follow-up, no significant differences were observed between groups in the annual rate of thromboembolic events (0.97/100 patient-years [100PY] vs. 4.06/100PY, p=.09), but there was a higher rate of bleeding events (5.67/100PY vs. 13.3/100PY, p=.033) and mortality among CKD patients (6.50/100PY vs. 17.2/100PY, p=.009), with an odds ratio of 2.711 (95% CI 1.96-6.95). In the multivariate analysis, a preserved eGFR was independently associated with a lower mortality risk. CONCLUSIONS: LAAC is a valid alternative to oral anticoagulation in patients with CKD and atrial fibrillation, with a low-rate of peri- and post-procedure complications, although CKD patients exhibited a higher risk of bleeding and mortality during the follow-up. However, these higher rates may not be necessarily related to the procedure.

Why are antithrombotic drugs not prescribed to octogenarian patients with atrial fibrillation at risk of stroke?

OBJECTIVE: In non-valvular atrial fibrillation (NVAF) patients at risk of stroke, anticoagulant drugs are less likely to be received by older patients than younger patients. In this study, an attempt is made to discover whether the reasons reported by physicians for denying anticoagulant drugs prescription differ between older and younger atrial fibrillation patients. MATERIALS AND METHODS: A retrospective, cross-sectional, multicentre study was conducted from October 2014 to July 2015. The study comprised patients aged ≥18 years diagnosed with NVAF, with a moderate to high stroke risk (CHADS2 score ≥2). Patients were stratified according to age (<80 and ≥80 years). RESULTS: A total of 1309 NVAF patients were evaluated, of whom 40.1% were ≥80 years old. Older patients were predominantly women with higher mean time since diagnosis of AF, with a higher rate of permanent NVAF, and with higher thromboembolic risk. In patients for whom physicians decided not to prescribe any anticoagulant agents, the following reasons were significantly more frequent in patients aged ≥80 years compared to younger patients: cognitive impairment, perceived high bleeding risk, falls, difficult access to monitoring, non-neoplastic terminal illness, and perceived low thromboembolic risk. Uncontrolled hypertension was a significantly more frequent reason for non-prescription of anticoagulant agents in patients aged <80 year. CONCLUSIONS: Octogenarian patients with NVAF and a moderate to high risk of stroke had a different as regards reasons for not being prescribed anticoagulant agents, which should be taken into account in order to improve.

Direct oral anticoagulants versus vitamin K antagonists in real-world patients with nonvalvular atrial fibrillation. The FANTASIIA study.

INTRODUCTION AND OBJECTIVES: To compare the long-term results of direct oral anticoagulants (DOAC) vs vitamin K antagonists (VKA) in real-world-patients with nonvalvular atrial fibrillation (NVAF) in a nationwide, prospective study. METHODS: The FANTASIIA registry prospectively included outpatients with AF anticoagulated with DOAC or VKA (per protocol, proportion of VKA and DOAC 4:1), consecutively recruited from June 2013 to October 2014 in Spain. The incidence of major events was analyzed and compared according to the anticoagulant treatment received. RESULTS: A total of 2178 patients were included in the study (mean age 73.8±9.4 years), and 43.8% were women. Of these, 533 (24.5%) received DOAC and 1645 (75.5%) VKA. After a median follow up of 32.4 months, patients receiving DOAC vs those receiving VKA had lower rates of stroke-0.40 (95%CI, 0.17-0.97) vs 1.07 (95%CI,0.79-1.46) patients/y, P=.032-, severe bleedings-2.13 (95%CI, 1.45-3.13) vs 3.28 (95%CI, 2.75-3.93) patients/y; P = .044-, cardiovascular death-1.20 (95%CI, 0.72-1.99) vs 2.45 (95%CI, 2.00-3.00) patients/y; P = .009-, and all-cause death-3.77 (95%CI, 2.83-5.01) vs 5.54 (95%CI, 4.83-6.34) patients/y; P = .016-. In a modified Cox regression model by the Andersen-Gill method for multiple events, hazard ratios for patients receiving DOAC were: 0.42 (0.16-1.07) for stroke; 0.47 (0.20-1.16) for total embolisms; 0.76 (0.50-1.15) for severe bleedings; 0.67 (0.39-1.18) for cardiovascular death; 0.86 (0.62-1.19) for all-cause death, and 0.82 (0.64-1.05) for the combined event consisting of stroke, embolism, severe bleeding, and all-cause death. CONCLUSIONS: Compared with VKA, DOAC is associated with a trend to a lower incidence of all major events, including death, in patients with NVAF in Spain.

[What would you do with a patient with non-valvular atrial fibrillation treated with direct-acting oral anticoagulants who had to undergo gastroscopy or colonoscopy?] / ¿Qué haría usted ante un paciente con fibrilación auricular no valvular en tratamiento con anticoagulantes orales de acción directa que tiene que hacerse una gastroscopia o colonoscopia?

In Spain, approximately 25% of patients anticoagulated due to non-valvular atrial fibrillation use a direct-acting anticoagulant (DOAC). It is foreseeable that most of them at some point in their lives should undergo invasive procedures or surgical treatments. This makes the management of DOAC in these situations essential in order to perform the procedure with maximum safety and minimise the risk to the maximum of haemorrhage and thrombosis. The management of this situation is based on the evaluation of the haemorrhagic risk of the patient, and the procedure to be performed, the risk of thromboembolism, and renal function. The pharmacokinetic characteristics of the DOAC also should be taken into account, especially its half-life, the degree of renal elimination and its peak action.

Patients with non-valvular atrial fibrillation on vitamin k antagonists or direct-acting oral anticoagulants: patients profile and long-term follow up outcomes.

Introduction: The arrival of direct-acting oral anticoagulants (DOACs) has led to a change in the management of non-valvular atrial fibrillation (NVAF) in recent years. The objectives of this study are to determine the level of therapeutic control of anticoagulation with vitamin K antagonists (VKA) and its possible involvement in major adverse cardiovascular events (MACE) and to evaluate differences between the group on VKA with respect to the group on DOACs. Patients and methods: Prospective cohort study that included consecutive patients diagnosed with NVAF in Cardiology Consultations with a clinical follow-up of 18 months. Demographic, clinical and analytical differences between groups were analyzed, including the level of therapeutic control of anticoagulation on the VKA group and its association with MACE. Results: Overall, 273 patients were included: 46.5% on VKA, 42.5% on DOACs, 11% without antithrombotic treatment. Patients on VKA spent 62.1% of their time within therapeutic range (TTR by the Rosendaal formule). There were no differences in MACE depending on anticoagulation control. The DOACs group presented lesser MACE rate than the VKA group (13.4 vs. 4.3%; 0.90; HR 0.90; 0.83-0.98 p = 0.01) with lower cardiovascular mortality (0.0 vs. 5.5%; HR, 0.94; 0.90-0.98; p = 0.01) and total mortality (0.9 vs. 12.6%; HR, 0.88; 0.82-0.94; p < 0.01) although without significant differences in hemorrhagic (0.9 vs. 4.7 %; p = 0.07), or ischemic events (2.6 vs. 0.8%, p = 0.27). Conclusions: Patients on VKA have a different clinical profile than those who receive DOACs. Patients on VKA have an inadequate control of the anticoagulation in quite the half of the cases. The VKA group presented more MACE than the DOACs group.

Introducción: La llegada de los anticoagulantes directos (ACD) ha supuesto un cambio en el tratamiento de la fibrilación auricular no valvular (FANV) en los últimos años. Los objetivos de este estudio son determinar el grado de control de la anticoagulación con antivitamina K (AVK) y su posible implicación en efectos cardiovasculares adversos mayores (ECAM) y evaluar las diferencias entre el grupo en tratamiento con AVK respecto del grupo con ACD. Pacientes y métodos: Estudio de cohorte prospectivo que incluyó a pacientes consecutivos diagnosticados con FANV valorados en el Servicio de Cardiología con un seguimiento de 18 meses. Se analizaron diferencias demográficas, clínicas y analíticas entre grupos, incluido el grado de control de la anticoagulación del grupo AVK y su posible relación con ECAM. Resultados: Se incluyó a 273 pacientes: 46.5% tratados con AVK, 42.5% con ACD y 11% sin tratamiento anticoagulante. El control de la anticoagulación con AVK fue del 62.1%, sin diferencias en ECAM en función de control. El grupo ACD presentó menos ECAM que el grupo de AVK (13.4 vs. 4.3%; HR, 0.90; 0.83-0.98; p = 0.01), con una menor mortalidad cardiovascular (0.0 vs. 5.5%; HR, 0.94; 0.90-0.98; p = 0.01) y total (0.9 vs. 12.6%; HR, 0.88; 0.82-0.94; p < 0,01), aunque sin diferencias significativas en eventos hemorrágicos (0.9 vs. 4.7%; p = 0.07) ni isquémicos (2.6 vs. 0.8%; p = 0.27). Discusión: Los pacientes con AVK poseen un perfil clínico diferente en comparación con los que reciben ACD. El control de anticoagulación del grupo de AVK fue inadecuado en casi la mitad de los casos. El grupo de AVK presentó más ECAM que el grupo de ACD.

Long-term Event Reduction After Left Atrial Appendage Closure. Results of the Iberian Registry II.

INTRODUCTION AND OBJECTIVES: Many patients with nonvalvular atrial fibrillation are still left without protection due to a contraindication for anticoagulants. This study aimed to establish the occurrence of stroke and major bleeding events in patients with nonvalvular atrial fibrillation and left atrial appendage closure with long-term follow-up and to explore the factors associated with higher long-term mortality. METHODS: Analysis of a multicenter single cohort prospectively recruited from 2009 to 2015. Thromboembolic and bleeding events were compared with those expected from CHA2DS2-VASc and HAS-BLED scores. Multivariate analysis examined variables associated with mortality during follow-up. RESULTS: A total of 598 patients (1093 patient-years) with a contraindication for anticoagulants were recruited (median 75.4 years). The success rate of left atrial appendage closure device implantation was 95.8%. Thirty patients (5%) experienced periprocedural complications. The rate of events (per 100 patient-years) during follow-up (mean 22.9 months; median 16.1 months) was as follows: death 7.0%; ischemic stroke 1.6% (vs 8.5% expected according to CHA2DS2-VASc; P < .001); intracranial hemorrhage 0.8%; gastrointestinal bleeding 3.2%; severe bleeding 3.9% (vs 6.3% expected by HAS-BLED, P = .002). These results were improved in the subgroup of 176 patients with follow-up > 24 months (mean follow-up 46.6 months, 683 patient-years) for severe bleeding 2.6% (vs 6.3% expected by HAS-BLED, P < .033). The factors significantly associated with higher mortality were age (HR, 1.1), intracranial hemorrhage (HR, 6.8), and stroke during follow-up (HR, 2.7). CONCLUSIONS: Left atrial appendage closure significantly reduced the incidence of stroke and bleeding events and the benefit was maintained. Intracranial hemorrhage, age and stroke were associated with higher mortality.

Would the Use of Edoxaban Be Cost-effective for the Prevention of Stroke and Systemic Embolism in Patients With Nonvalvular Atrial Fibrillation in Spain?

INTRODUCTION AND OBJECTIVES: To assess the cost-effectiveness of edoxaban vs acenocoumarol in the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF) in Spain. METHODS: Markov model, adapted to the Spanish setting from the perspective of the National Health System, stimulating the progression of a hypothetical cohort of patients with NVAF throughout their lifetime, with different health states: stroke, haemorrhage, and other cardiovascular complications. Efficacy and safety data were obtained from the available clinical evidence (mainly from the phase III ENGAGE AF-TIMI 48 study). The costs of managing NVAF and its complications were obtained from Spanish sources. RESULTS: Edoxaban use led to 0.34 additional quality-adjusted life years (QALY) compared with acenocoumarol. The incremental cost with edoxaban was 3916€, mainly because of higher pharmacological costs, which were partially offset by lower costs of treatment monitoring and managing NVAF events and complications. The cost per QALY was 11 518€, within the thresholds commonly considered cost-effective in Spain (25 000-30 000 €/QALY). The robustness of the results was confirmed by various sensitivity analyses. CONCLUSIONS: Edoxaban is a cost-effective alternative to acenocoumarol in the prevention of stroke and systemic embolism in patients with NVAF in Spain.

[Differences in the management of patients with atrial fibrillation according to whether primary care or the specialist initiates treatment with direct oral anticoagulants. The SILVER-AP and BRONCE-AP studies]. / Diferencias en el manejo de los pacientes con fibrilación auricular según inicie el tratamiento con anticoagulantes orales de acción directa el médico de atención primaria o el especialista. Estudios SILVER-AP y BRONCE-AP.

OBJECTIVES: To determine the clinical characteristics and management of patients with non-valvular atrial fibrillation (NVAF) treated with direct oral anticoagulants (DOAC) according to who initiates their prescription, the Primary Care (PC) physician or referring the patient to a specialist. MATERIAL AND METHODS: Two observational, cross-sectional and multicentre studies were compared for this purpose. The SILVER-AP study was performed in those autonomous communities in which the PC physician can prescribe DOAC directly, and the BRONCE-AP study in those autonomous communities in which the PC physician has to refer the patient to the specialist to start treatment with DOAC. Patients on chronic treatment with anticoagulants, in whom therapy was changed, and those that were on current treatment with DOAC for at least 3months, were included. RESULTS: A total of 1,036 patients (790 from SILVER-AP study and 246 from BRONCE-AP study) were included. Compared with the BRONCE-AP study, those patients included in SILVER-AP were older and had more comorbidities, as well as a higher thromboembolic and haemorrhagic risk (CHA2DS2-VASc 4.3±1.6 vs. 3.8±1.8; P<.001; HAS-BLED 2.1±0.8 vs. 1.8±1.0; P<.001). Therapeutic adherence and satisfaction with treatment were high. Low doses of DOAC were frequently prescribed, particularly with dabigatran. CONCLUSIONS: Those patients in whom the PC physician can prescribe DOAC directly have a worse clinical profile, as well as a higher thromboembolic and haemorrhagic risk than those patients in whom the PC physician has to refer to the specialist.

Clinical characteristics and management of patients with atrial fibrillation treated with direct oral anticoagulants according to blood pressure control.

OBJECTIVE: To determine the clinical characteristics and management of hypertensive patients with nonvalvular atrial fibrillation (AF) treated with direct oral anticoagulants (DOACs) according to blood pressure (BP) control. METHODS: For this purpose, data from two observational, cross-sectional and multicenter studies were combined. In both studies, patients on chronic treatment with anticoagulants and that were on current treatment with DOACs at least for 3 months were included. Adequate BP was defined as a systolic BP<140mmHg and a diastolic BP<90mmHg (<140/85mmHg if diabetes). RESULTS: Overall, 1036 patients were included. Of these, 881 (85%) had hypertension that were finally analyzed. The presence of other risk factors and cardiovascular disease was common. Mean BP was 132.6±14.3/75.2±9.2mmHg and 70.5% of patients achieved BP goals. Those patients with a poor BP control had more frequently diabetes, and a history of prior labile INR. Patients had a high thromboembolic risk, but without significant differences according to BP control. By contrast, more patients with a poor BP control had a higher bleeding risk (HAS-BLED ≥3: 24.0% vs 35.4%; P<0.001). HAS-BLED score was an independent predictor of poor BP control (odds ratio 1.435; 95% confidence interval 1.216-1.693; P<0.001). Satisfaction with anticoagulant treatment was independent of BP control. CONCLUSIONS: More than two thirds of our patients with hypertension and AF anticoagulated with DOACs achieve BP targets, what is clearly superior to that reported in the general hypertensive population.

Antithrombotic treatment and characteristics of elderly patients with non-valvular atrial fibrillation hospitalized at Internal Medicine departments. NONAVASC registry. / Características y tratamiento antitrombótico de los pacientes ancianos con fibrilación auricular no valvular hospitalizados en Medicina Interna. Registro NONAVASC.

BACKGROUND AND OBJETIVES: The prevalence of non-valvular atrial fibrillation (NVAF) increases with the patient's age and is associated with high morbi-mortality rates. The main goal of this study was to describe the characteristics of hospitalized elderly patients with NVAF and to identify the clinical and functional factors which determine the use of different antithrombotic strategies. PATIENTS AND METHODS: Observational, prospective, multicentre study carried out on patients with NVAF over the age of 75, who had been admitted for any medical condition to Internal Medicine departments. RESULTS: We evaluated 804 patients with a mean age of 85 years (range 75-101), of which 53.9% were females. The prevalence of risk factors and cardiovascular disease was high: hypertension (87.6%), heart failure (65.4%), ischemic cardiomyopathy (24.4%), cerebrovascular disease (22.4%) and chronic kidney disease (45%). Among those cases with previous diagnoses of NVAF, antithrombotic treatment was prescribed in 86.2% of patients: anticoagulants (59.7%), antiplatelet medication (17.8%) and double therapy (8.7%). The factors associated with the use of antithrombotic treatment were history of acute coronary syndrome and atrial fibrillation progression longer than one year. Older age, atrial fibrillation for less than one year, higher HAS-BLED scores and severe cognitive impairment were associated with the use of anti-platelet drugs. Permanent atrial fibrillation favoured the use of anticoagulants. CONCLUSIONS: Hospitalized patients older than 75 years old with NVAF showed numerous comorbidities. The percentage of anticoagulation was small and 18% received only anti-platelet therapy. The patient's age, atrial fibrillation's progression time and the severity of the cognitive impairment influenced this therapy choice.

Healthcare resources and needs in anticoagulant therapy for patients with nonvalvular atrial fibrillation. SAMOA Study. / Recursos y necesidades asistenciales en el tratamiento anticoagulante de los pacientes con fibrilación auricular no valvular. Estudio SAMOA.

INTRODUCTION AND OBJECTIVES: To determine, in the various medical specialties, the healthcare process for anticoagulated patients with nonvalvular atrial fibrillation, to determine the available and necessary resources and to identify potential areas of improvement in the care of these patients. METHODS: We performed a cross-sectional survey of primary care and specialised physicians involved in the care of anticoagulated patients. The questionnaires referred to the healthcare process, the indication and prescription of anticoagulant therapy and the barriers and deficiencies present for these patients. RESULTS: A total of 893 physicians participated in the study, 437 of whom worked in primary care and 456 of whom were specialists (mostly cardiologists). Forty-two percent of the family doctors indicated that they assessed and prescribed anticoagulant therapy, and 66% performed the regular follow-up of these patients. In both healthcare settings, the physicians noted the lack of standardised protocols. There was also a lack of quality control in the treatment. CONCLUSIONS: The role of primary care in managing anticoagulated patients has grown compared with previous reports. The responses of the participating physicians suggest marked gaps in the standardisation of the healthcare process and several areas for improvement in these patients' follow-up. The promotion of training in direct-acting anticoagulant drugs remains pivotal.

Cardiovascular risk factors, nonvalvular atrial fibrillation and retinal vein occlusion. / Factores de riesgo vascular, fibrilación auricular no valvular y obstrucción venosa retiniana.

OBJECTIVES: To analyse the importance of cardiovascular risk factors, ultrasound findings in the supra-aortic trunk and the presence of anticoagulated nonvalvular atrial fibrillation (NVAF) in patients with retinal vein occlusion (RVO) and in a control group. PATIENTS AND METHODS: A cross-sectional study was conducted of all patients with RVO consecutively referred to the office of internal medicine, comparing them with a control group. We analysed clinical, electrocardiographic and ultrasound variables. RESULTS: We studied 212 patients (114 men and 98 women) with RVO and 212 controls (95 men and 117 women) of similar ages. Arterial hypertension, dyslipidaemia and diabetes mellitus were significantly more prevalent in the patients with RVO than in the controls (73.6 vs. 50%, 64.6 vs. 48.6% and 27.8 vs. 12.3%, respectively). We observed arteriosclerotic lesions in the supra-aortic trunk in 55% of the patients with RVO. The patients with RVO and NVAF had a greater burden of cardiovascular risk factors than the controls with NVAF. There were no differences in terms of the international normalised ratio or in the use of direct anticoagulants between the cases and controls with NVAF. CONCLUSIONS: Cardiovascular risk factors (especially arterial hypertension) and arteriosclerotic involvement of the supra-aortic trunk are highly prevalent in RVO. Anticoagulation does not appear to be effective in preventing RVO.

[From clinical trials to clinical practice. Experience with rivaroxaban in the anticoagulant treatment of patients with non-valvular atrial fibrillation]. / De los ensayos clínicos a la práctica clínica. Evidencias con rivaroxaban en el tratamiento anticoagulante del paciente con fibrilación auricular no valvular.

Despite the information provided by clinical trials is important, there are relevant clinical differences between those patients included in clinical trials and data of daily outpatient clinics. As a result, in some cases, the results of randomized clinical trials could not be directly applied to clinical practice. In this context, to perform «real-life¼ registries is mandatory. In the ROCKET-AF study, rivaroxaban, a once-daily direct oral anticoagulant, was at least as effective as warfarin for preventing stroke or systemic embolism, with similar rates of major bleeding, but with a lesser risk of intracranial, critical and fatal bleedings. In the last years, different large registries have confirmed that rivaroxaban is effective and even safer in real-life patients than in ROCKET-AF. The aim of this review is to update the current evidence about the efficacy, effectiveness and safety of rivaroxaban in real-life patients.

[Control of anticoagulation in patients with non-valvular atrial fibrillation in a primary care clinical practice setting in the different autonomous communities. PAULA study]. / Control de la anticoagulación en pacientes con fibrilación auricular no valvular en práctica clínica de atención primaria en las diferentes comunidades autónomas. Estudio PAULA.

AIMS: To determine the differences between regions in the level of control of patients with non-valvular atrial fibrillation treated with vitamin K antagonists, included in the PAULA study. METHODS: Observational, and coss-sectional/retrospective study, including 139 Primary Care physicians from 99 Health Care centres in all autonomous communities (except La Rioja). Anticoagulation control was defined as the time in therapeutic range assessed by either the direct method (poor control <60%), or the Rosendaal method (poor control <65%). RESULTS: A total of 1,524 patients were included. Small differences in baseline characteristics of the patients were observed. Differences in the percentage of time in therapeutic range were observed, according to the Rosendaal method (mean 69.0±17.7%), from 78.1%±16.6 (Basque Country) to 61.5±14% (Balearic Islands), by the direct method (mean 63.2±17.9%) from 73.6%±16.6 (Basque Country) to 57.5±15.7% (Extremadura). When comparing regions, in those where the Primary Care physicians assumed full control without restrictions on prescription, the percentage of time in therapeutic range by the direct method was 63.89 vs. 60.95% in those with restrictions (p=.006), by Rosendaal method, 69.39% compared with 67.68% (p=.1036). CONCLUSIONS: There are significant differences in the level of control between some regions are still inadequate. Regions in which the Primary Care physicians assumed the management of anticoagulation and without restrictions, time in therapeutic range was somewhat higher, and showed a favourable trend for better control. These findings may have clinical implications, and deserve consideration and specific analysis.