Efficacy and safety of bempedoic acid in acute coronary syndrome. Design of the clinical trial ES-BempeDACS.

INTRODUCTION AND OBJECTIVES: Only about 1 out of every 3 patients with acute myocardial infarction (AMI) achieve low-density lipoprotein cholesterol (LDL-C) values <55mg/dL in the first year. The present study aims to evaluate the impact of early intensive therapy on lipid control after an AMI. METHODS: An independent, prospective, pragmatic, controlled, randomized, open-label, evaluator-blinded clinical trial (PROBE design) will analyze the efficacy and safety of an oral lipid-lowering triple therapy: high-potency statin+bempedoic acid (BA) 180mg+ezetimibe (EZ) 10mg versus current European-based guidelines (high-potency statin±EZ 10mg), in AMI patients. LDL-C will be determined within the first 48hours. Patients with LDL-C ≥ 115mg/dL (without previous statin therapy), ≥ 100mg/dL (with previous low-potency or high-potency statin therapy at submaximal dose), or ≥ 70mg/dL (with previous high-potency statin therapy at high dose) will be randomly assigned 1:1 between 24 and 72hours post-AMI to the BA/EZ combination or to statin±EZ, without BA. The primary endpoint is the proportion of patients reaching LDL-C <55mg/dL at 8 weeks after treatment. RESULTS: The results of this study will provide novel information for post-AMI LDL-C control by evaluating the usefulness of an early intensive lipid-lowering strategy based on triple oral therapy. CONCLUSIONS: Early intensive lipid-lowering triple oral therapy vs the treatment recommended by current clinical practice guidelines could facilitate the achievement of optimal LDL-C levels in the first 2 months after AMI (a high-risk period). IDENTIFICATION NUMBER: EudraCT 2021-006550-31.

Vascular protection with rivaroxaban in the comprehensive management of atrial fibrillation.

INTRODUCTION: In addition to an increased risk of thromboembolic complications, patients with atrial fibrillation (AF) are at risk for vascular events. Consequently, complete vascular protection is warranted in these patients. AREAS COVERED: A narrative search was conducted on PubMed (MEDLINE), using the MeSH terms [Rivaroxaban] + [Atrial fibrillation] + [Cardiovascular] + [Vascular] + [Treatment]. Original data from clinical trials, prospective and retrospective studies, useful reviews and experimental studies, were selected. EXPERT OPINION: The ROCKET-AF trial showed that rivaroxaban is effective in reducing the risk of stroke, with a lower risk of fatal and intracranial bleeding compared to warfarin. Remarkably, experimental data have provided a number of pathogenic mechanisms through which rivaroxaban could provide beneficial vascular properties beyond its antithrombotic activity. Moreover, in the AF population, additional to its ability to reduce the risk of thromboembolic complications, rivaroxaban is associated with a lower risk of myocardial infarction, major adverse cardiac and limb events, and vascular mortality in patients with diabetes, also attenuating renal impairment during follow-up. These findings suggest that rivaroxaban may provide a comprehensive vascular protection in patients with AF.

Trade-off between the effects of embolic versus bleeding events on mortality in elderly patients with atrial fibrillation.

INTRODUCTION AND OBJECTIVES: Clinical decision-making on anticoagulation in elderly patients with atrial fibrillation (AF) requires clinicians to consider not only the incidence of embolic and bleeding events, but also the risk of death following these adverse events. We aimed to analyze the trade-off between embolic and bleeding events with respect to mortality in elderly patients with AF. METHODS: The study cohort comprised all patients aged ≥ 75 years from a Spanish health area diagnosed with AF between 2014 and 2017 (n=9365). The risk of death was investigated using Cox proportional hazards models, including embolic and bleeding events as time-dependent binary indicators. RESULTS: During a median follow-up of 4.0 years, both embolic and bleeding events were associated with a higher risk of death (adjusted HR, 2.39; 95%CI, 2.12-2.69; and adjusted HR, 1.79; 95%CI, 1.64-1.96, respectively). The relative risk of death was 33% higher following an embolism than following a bleeding event (rRR, 1.33; 95%CI, 1.15-1.55), although for transient ischemic attack the risk was lower than for bleeding (rRR, 0.79; 95%CI, 0.63-0.99). The risk of death associated with intracranial hemorrhage was similar to that of major embolisms (RR, 1.00; 95%CI, 0.75-1.29). CONCLUSIONS: In elderly AF patients, embolic events appeared to be associated with a higher risk of mortality than extracranial bleeding, except for transient ischemic attacks, which have a better prognosis. For ICH, the mortality risk was similar to that of major embolism.

[Impact of frailty and other geriatric syndromes on the clinical management and prognosis of elderly ambulatory patients with heart failure. A prospective and multicentre study]. / Impacto de la FRAgilidad y otros síndromes Geriátricos en el manejo clínico y pronóstico del paciente anciano ambulatorio con Insuficiencia Cardiaca (FRAGIC). Estudio prospectivo y multicéntrico.

BACKGROUND AND OBJECTIVES: Heart failure (HF) is a chronic disease that is often associated with ageing. There are predictive models based on variables that associate it with a poor prognosis, although those do not include common conditions in the elderly, such as frailty or comorbidity. The aim of this study is to determine the clinical and epidemiological characteristics of a cohort of elderly outpatients with HF followed-up by cardiologists. This will include a study of the prevalence of frailty and other geriatric syndromes, as well as their impact on the prognosis, and to evaluate whether these may improve predictive ability of such predictive models. MATERIAL AND METHODS: Observational, prospective, and multicentre study that will include 400 patients ≥75years old with chronic HF followed-up in Spanish tertiary hospitals by cardiology specialists in HF. Patients will undergo a comprehensive geriatric assessment, and prediction of events will be performed based on MAGGIC (Meta-Analysis Global Group in Chronic Heart Failure) and Barcelona-Bio HF calculator scores. The primary endpoint is cardiovascular and overall mortality at 1 and 3years follow-up. RESULTS: This study will assess both the characteristics and prognosis of elderly patients with HF followed-up by cardiologists in Spain and the applicability in the elderly population of scores used in the general population with chronic HF. CONCLUSION: This is the first prospective study that will systematically assess frailty and other geriatric syndromes in the elderly outpatient with HF in Spain and followed-up by cardiologists, thus contributing to improve knowledge about both its prevalence and impact on our patients.

[Impact of antithrombotic treatment and geriatric syndromes in octogenarians with atrial fibrillation and ischaemic heart disease. Atrial Fibrillation and Ischemic Heart Disease in the Elderly]. / Impacto del tratamiento antitrombótico y los síndromes geriátricos en octogenarios con fibrilación auricular y cardiopatía isquémica. Fibrilación Auricular y Cardiopatía Isquémica en Longevos (FACIL).

BACKGROUND AND OBJECTIVES: The prevalence of atrial fibrillation (AF) and ischaemic heart disease (IHC) increases with age. They coexist in up to 20% of octogenarian patients, a situation that poses a therapeutic challenge. Trials that have addressed this scenario, which included a low percentage of octogenarians, showed that double therapy (single antiplatelet + anticoagulation) compared to triple therapy (double antiplatelet + anticoagulation) was associated with less bleeding events, especially with direct oral anticoagulants. These studies did not have sufficient power to detect differences in ischaemic events. On the other hand, prevalent characteristics in the elderly, such as geriatric syndromes, were not assessed in these studies, and are not usually evaluated in clinical practice. Accordingly, their prognostic impact remains unknown in this clinical context. METHODS: Observational, prospective, and multicentre study that will include patients ≥ 80 years with AF and IHC in Spain. Baseline characteristics and geriatric syndromes will be assessed, as well as the choice of antithrombotic treatment. The primary endpoint is cardiovascular and overall mortality at one and three years follow-up. RESULTS: This study will assess both characteristics and prognosis of octogenarian patients with AF and IHC in Spain, the factors involved in the choice of antithrombotic treatment, and the incidence of ischaemic and haemorrhagic events during the short- and long-term follow-up. CONCLUSION: This study will contribute to improve the knowledge in terms of safety and efficacy of the different therapeutic options in older patients with AF and IHC, as well as their prognostic impact.