Perfil clínico de pacientes con fibrilación auricular tratados con anticoagulantes orales de acción directa atendidos en atención primaria. Estudio SILVER-AP

Figuera, Mariano de la; Cinza, Sergio; Marín, Núria; Egocheaga, Isabel; Prieto, Miguel A.

doi:10.1016/j.aprim.2017.05.009

Cited by 20 publications

(8 citation statements)

References 33 publications

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“…In this regard, the protocol asked for a consecutive recruitment of patients coming to the routine clinical visits, and in case of patients do not capable to answer the questions, the study provided the possibility for including the caregiver. Despite the study limitations, the collected results were coherent with the reported in similar studies, in both terms, patients profile [ 32 , 33 ] and reported preferences [ 22 , 24 , 29 ], minimising the impact of the study limitations and providing robustness to the presented results.…”

Section: Discussionsupporting

confidence: 83%

Treatment preferences as basis for decision making in patients using direct oral anticoagulants in Spain

Gavín

Grandes

García

et al. 2020

J Thromb Thrombolysis

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Treatment preferences are considered a relevant decision-making driver by the main atrial fibrillation (AF) guidelines. Direct Oral Anticoagulants (DOACs), considered as similar clinically, have administration differences useful for treatment individualization. Preferences, priorities and satisfaction of DOAC users were assessed through an observational, multicentric (25 hospitals), cross-sectional study including adult AF-patients (and/or caregivers) in Spain. Three study groups were considered according to DOAC posology preferences: (A) once-daily, with water; (B) once-daily, with food; (C) twice-daily. Overall, 332 patients and 55 caregivers were included. Mean (SD) age was 73.7 (10.7) years [58.7 (13.9) for caregivers]; 51.5% women [69.1% for caregivers]; 80.7% showed comorbidities and poly-pharmacy [6.6 (3.3) drugs/day]. No statistically significant differences were shown among study groups. Once-daily administration was preferred by 274 patients (82.5%) [60.8% (Group A); 21.7% (Group B); 17.5% (Group C)], and 47 caregivers (85.5%) [58.2% (Group A); 27.3% (Group B); 14.5% (Group C)]. Once-daily DOACs were prescribed in 42.8% of the patients. Bleeding risk was the main concern for both, patients and caregivers, followed by DOAC posology and interactions. Although treatment satisfaction (patients and caregivers) was high (9.0 and 9.1 points, respectively), match between individual treatment preferences and real prescriptions was only shown in 41.0% of AF-patients, evidencing a need for patient involvement on treatment decision-making. There is not a patient profile linked to treatment preferences, and clinical criteria must be the main driver for decision-making. However, for most AF-patients (elderly patients), aged, with comorbidity, poly-pharmacy and high cardiovascular risk, once-daily DOACs would be the preferred option.

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Section: Discussionsupporting

confidence: 83%

Treatment preferences as basis for decision making in patients using direct oral anticoagulants in Spain

Gavín

Grandes

García

et al. 2020

J Thromb Thrombolysis

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“…Accordingly, real-world studies evaluating DOACs in the Spanish population are scarce. A few retrospective studies have been published based on databases containing electronic health records [17,18,19,20,21] or prospective registries [11], but most of these studies have focused exclusively on the distribution of the different DOACs/doses prescribed and patients characteristics [17,18,19,20,21] and only a few have analyzed stroke and bleeding events [11,12,13,22]. To our knowledge, the study by Cerda et al [13], performed in a cohort of 1443 patients from a single center is the only one with a comparable methodology to ours, showing similar basal characteristics and follow-up of our cohort of patients.…”

Section: Discussionmentioning

confidence: 99%

Direct Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation: A Real-World Experience from a Single Spanish Regional Hospital

Rodilla¹,

Orts-Martinez²,

Sanz-Caballer³

et al. 2021

Preprint

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The aim is to evaluate a program for direct oral anticoagulants (DOACs) management in nonvalvular atrial fibrillation (NVAF) patients, according to patient profiles, appropriateness of dosing, patterns of crossover, effectiveness and safety. This is an observational and longitudinal retrospective study in a cohort of patients attended in daily clinical practice in a single regional hospital in Spain with a systematic follow-up plan for up to 3 years for patients initiating dabigatran, rivaroxaban or apixaban between JAN/2012-DEC/2016. We analyzed 490 episodes of treatment (apixaban 2.5 mg: 9.4%, apixaban 5 mg: 21.4%, dabigatran 75 mg: 0.6%, dabigatran 110 mg: 12,4%, dabigatran 150 mg: 19.8%, rivaroxaban 15 mg: 17.8% and rivaroxaban 20 mg: 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. 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. Patients taking apixaban 2.5 mg were older, had higher CHA2DS2VASc score and lower creatinine clearance. Patients taking dabigatran 150 mg and rivaroxaban 20 mg were younger, had lower CHA2DS2VASc and higher creatinine clearance. 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 where 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 (RR: 4.2; CI: 1.5-11.8; p=0.006) and age (RR: 1.2; CI: 1.1-1.4; p=0.006) were independent predictors of stroke/TIA. Concurrent platelet inhibitors (RR: 7.1; CI: 2.3-21.8; p=0.001), male gender (RR: 2.1; CI: 1.2-3.7; p=0.0012) and age (RR: 1.1; CI: 1.02-1.13; p=0.005) were independent predictors of BE. This study complements the scant data available on the use of DOACs in NVAF patients in Spain, confirming a good safety and effectiveness profile

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“…The SILVER-AP study was an observational, cross-sectional, and multicenter study that included patients with NVAF attended by primary care physicians from those autonomous communities in which the primary care physician could prescribe DOACs directly (9 autonomous communities). Patients had to be on chronic treatment with anticoagulants, but on current treatment with DOACs for at least 3 months 26–28…”

Section: Methodsmentioning

confidence: 99%

“…In this context, it is important to analyze the clinical management of rivaroxaban not limited to a specific area or specialty in Spain. The aim of this analysis was to determine the clinical profile and use in clinical practice of patients taking rivaroxaban in Spain, using data from the following studies: HEROIC ( Perfil de pacientes con fibrilación auricular novalvular tratados con rivaroxaban en España: la desigualdad en el acceso a los anticoagulantes orales directos )23; 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 )24,25; BRONCE-AP ( Estudio observacional de corte transversal para evaluar el uso de recursos y las características sociodemográficas y clínicas de los pacientes diagnosticados de FANV con riesgo de ictus o embolia sistémica, en tratamiento anticoagulante y que son atendidos en consultas de atención primaria )26,27; SILVER-AP ( Estudio observacional de corte transversal para evaluar las características sociodemográficas y clínicas de los pacientes diagnosticados de FANV con riesgo de ictus o embolia sistémica, que reciben tratamiento para el control adecuado de su coagulación y que son atendidos en consultas de atención primaria )26–28; ALADIN ( Validación del cuestionario ACTS en pacientes con Fibrilación Auricular tratados con anticoagulantes orales en consultas de medicina interna y neurología de España )29–31; ESPARTA ( Estudio sobre el seguimiento en la práctica clínica de las recomendaciones sobre el tratamiento con anticoagulantes orales en pacientes con fibrilación auricular de edad avanzada ) 32–34. In addition, our data were compared with those of the XANTUS study15,35 and the ROCKET-AF trial 12…”

Section: Introductionunclassified

Clinical profile and management of rivaroxaban in patients with atrial fibrillation in routine practice in Spain: data from six nationwide studies

Anguita

Figuera

Cabeza

et al. 2019

DIC

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AimsTo analyze the clinical profile and management of patients with nonvalvular atrial fibrillation taking rivaroxaban in routine practice in Spain.MethodsClinical data from the observational studies HEROIC (cardiology and hematology; n=1,727), EMIR (cardiology; n=1,493), BRONCE-AP (primary care; n=133), SILVER-AP (primary care; n=457), ALADIN (internal medicine and neurology; n=249), and ESPARTA (internal medicine; n=110) of patients taking rivaroxaban were analyzed. The clinical profile was compared with those of the XANTUS and ROCKET-AF studies.ResultsOverall, mean age was 74.9±9.4 years, CHA2DS2-VASc score was 3.7±1.5, and 43.2% had a HAS-BLED score ≥3. Patients included in the HEROIC and EMIR studies were older and more frequently had a creatinine clearance <50 mL/min and a higher thromboembolic risk than those in the XANTUS study, and patients included in the ALADIN study were older and had more prior cerebrovascular disease, but a lower thromboembolic risk than those in the ROCKET-AF trial. In those studies with available data, medication adherence and satisfaction with rivaroxaban were high.ConclusionBearing in mind differences according to the clinical setting of each study, atrial fibrillation patients taking rivaroxaban in Spain were elderly and had a high thromboembolic risk. Medication adherence and satisfaction with rivaroxaban were high.

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Perfil clínico de pacientes con fibrilación auricular tratados con anticoagulantes orales de acción directa atendidos en atención primaria. Estudio SILVER-AP

Abstract: 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.

Cited by 20 publications

References 33 publications

Treatment preferences as basis for decision making in patients using direct oral anticoagulants in Spain

Treatment preferences as basis for decision making in patients using direct oral anticoagulants in Spain

Direct Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation: A Real-World Experience from a Single Spanish Regional Hospital

Clinical profile and management of rivaroxaban in patients with atrial fibrillation in routine practice in Spain: data from six nationwide studies

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