Tratamiento antiarrítmico actual de la fibrilación auricular no valvular en España: datos del Registro FANTASIIA

[Abstract] Introduction and objectives. Recently, there have been many developments in the management of nonvalvular atrial fibrillation, antiarrhythmic and anticoagulant therapy, and nonpharmacological treatment, but these developments are not applied immediately in clinical practice. The aim of this study was to identify the overall management and antiarrhythmic therapy used in the current general population of patients with nonvalvular atrial fibrillation in Spain. Methods. A prospective, observational study of 1318 consecutive anticoagulated patients with nonvalvular atrial fibrillation, recruited between June 2013 and March 2014. We analyzed the patients’ general characteristics, management, and antiarrhythmic therapy. Results. Mean age was 73.8 ± 9.4 years; 42.5% were women. Atrial fibrillation was paroxysmal in 28% of the patients, permanent in 50%, persistent in 17.6%, long-standing persistent in 4.5%, and new-onset in 66 patients (5%). A rhythm control strategy was chosen in 39.4% of the patients and rate control in 60.6%. Beta-blockers were prescribed in 60.2% of the patients, digoxin in 19.5%, and calcium channel antagonists in 10.7%. The antiarrhythmic agents used were amiodarone (12.6%), flecainide (8.9%), propafenone (0.4%), sotalol (0.5%), and dronedarone (2.3%). Cardioversion had been performed previously in 41.9% of the patients, ablation in 3.4%, and atrial appendage closure in 0.2%. Conclusions. Currently, patients with nonvalvular atrial fibrillation in Spain are managed mainly with rate control, and beta-blockers in particular. They receive few antiarrhythmic agents and only a very small number of these patients undergo nonpharmacological treatments.[Resumen] Introducción y objetivos. Recientemente se han producido numerosas novedades en el manejo de la fibrilación auricular no valvular y el tratamiento antiarrítmico, anticoagulante y no farmacológico empleado, pero su aplicación a la clínica no es inmediata. El objetivo del trabajo es conocer las características generales de manejo y tratamiento antiarrítmico de una población general de pacientes con fibrilación auricular no valvular actualmente en España. Métodos. Estudio observacional y prospectivo de 1.318 pacientes consecutivos con fibrilación auricular no valvular, anticoagulados y reclutados entre junio de 2013 y marzo de 2014. Se analizan sus características generales, el manejo y el tratamiento antiarrítmico utilizado. Resultados. La media de edad era 73,8 ± 9,4 años; eran mujeres el 42,5%. La fibrilación auricular fue paroxística en el 28% de los casos, permanente en el 50%, persistente en el 17,6%, persistente de larga duración en el 4,5% y de novo en 66 pacientes (5%). Se eligió control del ritmo en el 39,4% de los casos y de frecuencia en el 60,6%. Tomaron bloqueadores beta el 60,2%, digoxina el 19,5% y antagonistas del calcio el 10,7%. Los antiarrítmicos empleados fueron amiodarona (12,6%), flecainida (8,9%), propafenona (0,4%), sotalol (0,5%) y dronedarona (2,3%). Se realizó cardioversión previa en el 41,9%, ablación en el 3,4% y cierre de orejuela en el 0,2%. Conclusiones. Actualmente en nuestro país se maneja a los pacientes con fibrilación auricular no valvular preferentemente con control de frecuencia, sobre todo con bloqueadores beta, reciben pocos antiarrítmicos y se los somete en muy baja proporción a tratamientos no farmacológicos

Influence of sex on long-term prognosis in patients with atrial fibrillation treated with oral anticoagulants. Results from the prospective, nationwide FANTASIIA study

[Abstract] Background: While many risk factors for Atrial Fibrillation (AF) have been identified, there are important differences in their relative impact between sexes. The aim of our study was to investigate the influence of sex as a long-term predictor of adverse events in “real world” AF patients treated with direct oral anticoagulants. Methods: The FANTASIIA registry is a prospective, national and multicentric study including outpatients with anticoagulated AF patients. Baseline characteristics and adverse events at 3 years of follow-up were collected and classified by sex. Cox multivariate analysis was performed to investigate the role of sex in major events and composite outcomes. Results: A total of 1956 patients were included in the study. 43.9% of them were women, with a mean age of 73.8 ± 9.4 years (women were older 76.5 ± 7.9 vs 71.7 ± 10.1, p<0.001). Women had higher rate of cardiovascular risk factors and higher mean of CHA2DS2-VASc (4.4 ± 1.4 vs 3.7 ± 1.6, p<0.001) and HAS-BLED (2.1 ± 1.0 vs 1.9 ± 1.1, p<0.001) than men. After 3 years of follow-up, rates of major events were similar in both groups with limit difference for all-cause mortality (4.4%/year in women vs 5.6%/year in men; p = 0.056). However, all the composite events were more frequent in women. We observed in the non-adjusted adverse events lower rate of all-cause mortality (HR 0.62, 95%CI 0.47–0.81; p<0.001), composite 1 outcomes (HR 0.80, 95%CI 0.65–0.98; p = 0.029) and composite 2 (HR 0.77, 95%CI 0.64–0.94; p = 0.010) in women compared with men. In multivariate Cox regression analysis observed that female sex was an independently protector factor for all-cause mortality and for the composite outcomes 1 and 2. Conclusions: In this “real world” study of anticoagulated AF patients, women could have a protective role against development of adverse events, mainly on all-cause mortality and combined events.Instituto de Salud Carlos III; RD12/0042/0068Instituto de Salud Carlos III; RD12/0042/0010Instituto de Salud Carlos III; RD12/0042/0069Instituto de Salud Carlos III; RD12/0042/006

Estimating the Prevalence of Cardiac Amyloidosis in Old Patients with Heart Failure—Barriers and Opportunities for Improvement: The PREVAMIC Study

Background: Cardiac amyloidosis (CA) could be a common cause of heart failure (HF). The objective of the study was to estimate the prevalence of CA in patients with HF. Methods: Observational, prospective, and multicenter study involving 30 Spanish hospitals. A total of 453 patients >= 65 years with HF and an interventricular septum or posterior wall thickness > 12 mm were included. All patients underwent a Tc-99m-DPD/PYP/HMDP scintigraphy and monoclonal bands were studied, following the current criteria for non-invasive diagnosis. In inconclusive cases, biopsies were performed. Results: The vast majority of CA were diagnosed non-invasively. The prevalence was 20.1%. Most of the CA were transthyretin (ATTR-CM, 84.6%), with a minority of cardiac light-chain amyloidosis (AL-CM, 2.2%). The remaining (13.2%) was untyped. The prevalence was significantly higher in men (60.1% vs 39.9%, p = 0.019). Of the patients with CA, 26.5% had a left ventricular ejection fraction less than 50%. Conclusions: CA was the cause of HF in one out of five patients and should be screened in the elderly with HF and myocardial thickening, regardless of sex and LVEF. Few transthyretin-gene-sequencing studies were performed in older patients. In many patients, it was not possible to determine the amyloid subtype

Cancer impact prognosis on mortality in patients with acute heart failure: analysis of the epicter study

Introduction: Heart failure (HF) and cancer are currently the leading causes of death worldwide, with an increasing incidence with age. Little is known about the treatment received and the prognosis of patients with acute HF and a prior cancer diagnosis. Objective: to determine the clinical characteristics, palliative treatment received, and prognostic impact of patients with acute HF and a history of solid tumor. Methods: The EPICTER study ('Epidemiological survey of advanced heart failure') is a cross-sectional, multicenter project that consecutively collected patients admitted for acute HF in 74 Spanish hospitals. Patients were classified into two groups according to whether they met criteria for acute HF with and without solid cancer, and the groups were subsequently compared. A multivariable logistic regression analysis was conducted, using the forward stepwise method. A Kaplan-Meier survival analysis was performed to evaluate the impact of solid tumor on prognosis in patients with acute HF. Results: A total of 3127 patients were included, of which 394 patients (13%) had a prior diagnosis of some type of solid cancer. Patients with a history of cancer presented a greater frequency of weight loss at admission: 18% vs. 12% (p = 0.030). In the cancer group, functional impairment was noted more frequently: 43% vs. 35%, p = 0.039). Patients with a history of solid cancer more frequently presented with acute HF with preserved ejection fraction (65% vs. 58%, p = 0.048) than reduced or mildly reduced. In-hospital and 6-month follow-up mortality was 31% (110/357) in patients with solid cancer vs. 26% (637/2466), p = 0.046. Conclusion: Our investigation demonstrates that in-hospital mortality and mortality during 6-month follow-up in patients with acute HF were higher in those subjects with a history of concomitant solid tumor cancer diagnosis

Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial

Background: Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke. Methods: We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515. Findings: Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years and were assessed for the primary outcome. The primary composite outcome occurred in 338 (7%) of 4731 patients at an incidence rate of 4·6 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an incidence rate of 5·9 events per 100 person-years in the placebo group (hazard ratio 0·78, 95% CI 0·68–0·90), which indicated that albiglutide was superior to placebo (p&lt;0·0001 for non-inferiority; p=0·0006 for superiority). The incidence of acute pancreatitis (ten patients in the albiglutide group and seven patients in the placebo group), pancreatic cancer (six patients in the albiglutide group and five patients in the placebo group), medullary thyroid carcinoma (zero patients in both groups), and other serious adverse events did not differ between the two groups. There were three (&lt;1%) deaths in the placebo group that were assessed by investigators, who were masked to study drug assignment, to be treatment-related and two (&lt;1%) deaths in the albiglutide group. Interpretation: In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. Evidence-based glucagon-like peptide 1 receptor agonists should therefore be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes. Funding: GlaxoSmithKline

Canagliflozin and renal outcomes in type 2 diabetes and nephropathy

BACKGROUND Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium–glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes. METHODS In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to &lt;90 ml per minute per 1.73 m2 of body-surface area and albuminuria (ratio of albumin [mg] to creatinine [g], &gt;300 to 5000) and were treated with renin–angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of &lt;15 ml per minute per 1.73 m2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes. Prespecified secondary outcomes were tested hierarchically. RESULTS The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. At that time, 4401 patients had undergone randomization, with a median follow-up of 2.62 years. The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 per 1000 patient-years, respectively (hazard ratio, 0.70; 95% confidence interval [CI], 0.59 to 0.82; P=0.00001). The relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P&lt;0.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P=0.002). The canagliflozin group also had a lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01) and hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P&lt;0.001). There were no significant differences in rates of amputation or fracture. CONCLUSIONS In patients with type 2 diabetes and kidney disease, the risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years

Estudio de los efectos de los sueros y plasmas de sujetos normo e hiperlipémicos en células monocitomacrofágicas humanas infectadas y sin infectar con "chlamydia pneumoniae"

Tesis doctoral inédita leída en la Universidad Autónoma de Madrid. Facultad de Medicina. Departamento de Medicina. Fecha de lectura: 22 de Septiembre de 200

Influence of sex on long-term prognosis in patients with atrial fibrillation treated with oral anticoagulants. Results from the prospective, nationwide FANTASIIA study

Background While many risk factors for Atrial Fibrillation (AF) have been identified, there are important differences in their relative impact between sexes. The aim of our study was to investigate the influence of sex as a long-term predictor of adverse events in “real world” AF patients treated with direct oral anticoagulants. Methods The FANTASIIA registry is a prospective, national and multicentric study including outpatients with anticoagulated AF patients. Baseline characteristics and adverse events at 3 years of follow-up were collected and classified by sex. Cox multivariate analysis was performed to investigate the role of sex in major events and composite outcomes. Results A total of 1956 patients were included in the study. 43.9% of them were women, with a mean age of 73.8 ± 9.4 years (women were older 76.5 ± 7.9 vs 71.7 ± 10.1, p<0.001). Women had higher rate of cardiovascular risk factors and higher mean of CHA 2DS 2-VASc (4.4 ± 1.4 vs 3.7 ± 1.6, p<0.001) and HAS-BLED (2.1 ± 1.0 vs 1.9 ± 1.1, p<0.001) than men. After 3 years of follow-up, rates of major events were similar in both groups with limit difference for all-cause mortality (4.4%/year in women vs 5.6%/year in men; p = 0.056). However, all the composite events were more frequent in women. We observed in the non-adjusted adverse events lower rate of all-cause mortality (HR 0.62, 95%CI 0.47–0.81; p<0.001), composite 1 outcomes (HR 0.80, 95%CI 0.65–0.98; p = 0.029) and composite 2 (HR 0.77, 95%CI 0.64–0.94; p = 0.010) in women compared with men. In multivariate Cox regression analysis observed that female sex was an independently protector factor for all-cause mortality and for the composite outcomes 1 and 2. Conclusions In this “real world” study of anticoagulated AF patients, women could have a protective role against development of adverse events, mainly on all-cause mortality and combined events.Sin financiación8.989 JCR (2020) Q1, 12/167 Medicine, General & Internal2.625 SJR (2020) Q1, 9/131 Internal MedicineNo data IDR 2020UE