Atrial Fibrillation Prevalence Rates and Its Association with Cardiovascular-Kidney-Metabolic Factors: SIMETAP-AF Study.

Background and Objectives: Atrial fibrillation (AF) is the most frequent arrhythmia and the main cause of hospital admissions for cardioembolic stroke. The SIMETAP research project aims to update the prevalence rates of cardiovascular, renal, or metabolic factors and to evaluate their respective associations with factors that could be related. The present study aims to assess the AF prevalence rates in an adult population and its association with cardiovascular-kidney-metabolic (CKM) factors. Materials and Methods: This cross-sectional observational study was conducted in a primary care setting, with a population-based random sample of 6588 people aged 18.0-102.8 years. Crude and adjusted prevalence rates of AF were calculated. The associations of CKM factors with AF were assessed using bivariate and multivariate analysis. Results: The age- and sex-adjusted prevalence rates of AF were 2.9% in the overall adult population, 6.1% in the population aged ≥50 years, and 12.9% in the population aged ≥70 years, with no significant differences by sex. AF prevalence in the population under 50 years of age barely reached 1‰. Heart failure (HF), hypertension, chronic kidney disease (CKD), stroke, low HDL-cholesterol, and prediabetes were independent CKM factors associated with AF in the overall population, as were the same factors, except prediabetes, in the population ≥50 years old (p < 0.001). High or very high vascular risk was present in 92.4% [95% CI: 89.1-95.7]) of the population with AF. Conclusions: The adjusted prevalence rate of AF in the population aged 50 years or older was 6.1%, twice that of the overall adult population and half that of the population aged 70 years or older. The main independent CKM factors associated with AF were HF, stroke, CKD, hypertension, and low HDL-cholesterol.

Prevalence Rates of Arterial Hypertension According to the Threshold Criteria of 140/90 or 130/80 mmHg and Associated Cardiometabolic and Renal Factors: SIMETAP-HTN Study.

Background and objectives: Arterial hypertension (HTN) is the leading preventable cause of atherosclerotic cardiovascular diseases (ASCVD) and death from all causes. This study aimed to determine the prevalence rates of HTN diagnosed according to the threshold diagnostic criteria 130/80 mmHg and 140/90 mmHg, to compare blood pressure (BP) control, and to evaluate their associations with cardiovascular diseases and cardiometabolic and renal risk factors. Materials and Methods: This was a cross-sectional observational study conducted in primary care with a population-based random sample: 6588 people aged 18.0-102.8 years. Crude and adjusted prevalence rates of HTN were calculated. BP control was compared in HTN patients with and without ASCVD or chronic kidney disease (CKD). Their associations with cardiovascular diseases and cardiometabolic and renal factors were assessed using bivariate and multivariate analysis. Results: Adjusted prevalence rates of HTN diagnosed according to 140/90 and 130/90 criteria were 30.9% (32.9% male; 29.7% female) and 54.9% (63.2% male; 49.3% female), respectively. BP < 130/80 mmHg was achieved in 60.5% of HTN patients without ASCVD or CKD according to 140/90 criterion, and 65.5% according to 130/80 criterion. This BP-control was achieved in 70% of HTN patients with ASCVD and 71% with CKD, according to both criteria. Coronary heart disease (CHD), heart failure, atrial fibrillation, stroke, diabetes, prediabetes, low glomerular filtration rate (eGFR), hyperuricemia, hypercholesterolemia, obesity, overweight, and increased waist-to-height ratio were independently associated with HTN according to both criteria. Conclusions: Almost a third of the adult population has HTN according to the 140/90 criterion, and more than half according to the 130/90 criterion, with a higher prevalence in men. The main clinical conditions associated with HTN were heart failure, diabetes, CHD, low eGFR, and obesity.

Concordance between automated oscillometric measurement of ankle-brachial index and traditional measurement by eco-Doppler in patients without peripheral artery disease.

AIM: To evaluate the concordance between automated oscillometric measurement (WatchBP® Office ABI) of the ankle- brachial index (ABI) and the traditional measurement by eco-Doppler in a Spanish population without peripheral artery disease attended in primary care. METHODS: The ABI was determined by both methods in a general population aged ≥ 18 years, from the RICARTO study. The intraclass correlation coefficient was calculated to assess the concordance between both techniques and the Bland-Altman plot was determined to analyze the agreement between them. RESULTS: A total of 322 subjects (mean age 47.7 ± 16.0 years; 54.3% women) were included in the study. With regard to cardiovascular risk factors, 70.5% of subjects had dyslipidemia, 26.7% hypertension, 24.8% obesity, 8.4% diabetes and 25.5% were smokers. Mean ABI measured by eco-Doppler and the automated method were 1.17 ± 0.1 and 1.2 ± 0.1, respectively (mean differences - 0.03 ± 0.09; p < 0.001). The Pearson correlation coefficient and the intraclass correlation coefficient were in both cases 0.70. CONCLUSIONS: The automated oscillometric measurement of ABI is a reliable and useful alternative to conventional eco-Doppler determination in the general population without peripheral artery disease attended in primary care.

Hyperuricaemia Prevalence Rates According to Their Physiochemical and Epidemiological Diagnostic Criteria and Their Associations with Cardio-Renal-Metabolic Factors: SIMETAP-HU Study.

Background: Scientific societies disagree on serum uric acid (SUA) thresholds for the diagnosis of hyperuricaemia (HU) according to epidemiological or physiochemical criteria (SUA ≥ 7.0 mg/dL for men and ≥6.0 mg/dL for women [HU-7/6]; SUA ≥ 7.0 mg/dL for both genders [HU-7/7], respectively). HU is not included among the diagnostic criteria for metabolic syndrome or cardiovascular-renal-metabolic syndrome (CKM), although it promotes atherosclerosis and is associated with renal and cardiometabolic diseases. Both issues are of utmost importance and need to be clarified, hence the present study aims to assess the prevalence rates of HU and their associations with CKM factors. Methods: A cross-sectional observational study was conducted on a random population-based sample of 6489 adults. Bivariate and multivariate analyses were performed on the most well-known renal and cardiometabolic variables of the populations with and without HU-7/7 and HU-7/6. Results: The adjusted prevalence rates for HU-7/6 were 13.4% in adult population (18.4% in men; 9.6% in women) and 10.2% (18.4% in men; 3.8% in women) for HU-7/7. The main factors associated independently with HU for both genders were low estimated glomerular filtration rate, hypertension, hypertriglyceridaemia, and alcoholism, regardless of the criteria chosen, as well as albuminuria in women and central obesity in men. Conclusions: The prevalence rates of HU increase linearly with age for both genders. The associations of CKM factors with HU diagnosed according to physiochemical criterion are more similar between men and women than those using epidemiological criteria.

Heart Failure Prevalence Rates and Its Association with Other Cardiovascular Diseases and Chronic Kidney Disease: SIMETAP-HF Study.

INTRODUCTION AND OBJECTIVES: Heart failure (HF) is a major health problem that causes high mortality and hospitalization rates. This study aims to determine the HF prevalence rates in populations aged both ≥18 years and ≥50 years and to assess its association with cardiovascular diseases and chronic kidney disease. METHODS: A cross-sectional observational study was conducted in a primary care setting, with a population-based random sample of 6588 people aged 18.0-102.8 years. Crude and adjusted prevalence rates of HF were calculated. The associations of renal and cardiometabolic factors with HF were assessed in both populations using univariate, bivariate and multivariate analysis. RESULTS: The HF crude prevalence rates were 2.8% (95%CI: 2.4-3.2) in adults (≥18 years), and 4.6% (95%CI: 4.0-5.3) in the population aged ≥ 50 years, without significant differences between males and females in both populations. The age- and sex-adjusted prevalence rates were 2.1% (male: 1.9%; female: 2.3%) in the overall adult population, and 4.5% (male: 4.2%; female: 4.8%) in the population aged ≥ 50 years, reaching 10.0% in the population aged ≥ 70 years. Atrial fibrillation, hypertension, low estimated glomerular filtration rate (eGFR), coronary heart disease (CHD), stroke, sedentary lifestyle, and diabetes were independently associated with HF in both populations. A total of 95.7% (95%CI: 92.7-98.6) of the population with HF had an elevated cardiovascular risk. CONCLUSIONS: This study reports that HF prevalence increases from 4.5% in the population over 50 years to 10% in the population over 70 years. The main clinical conditions that are HF-related are sedentary lifestyle, atrial fibrillation, hypertension, diabetes, low eGFR, stroke, and CHD.

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.

Prognosis of Systolic Pressure 130 to 139 According to Risk. A Prospective Cohort Study Between 1992 and 2019.

BACKGROUND: Guidelines recommend pharmacological treatment for systolic blood pressure (SBP) of 130 to 139 mm Hg in secondary prevention. However, uncertainty persists in primary prevention in low cardiovascular risk patients (CVR). METHODS: Cohort study representative of the general population of Albacete/Southeast Spain. We examined 1029 participants with untreated blood pressure and free of cardiovascular disease, followed-up during 1992 to 2019. Cox regression modeled the association of SBP with cardiovascular morbidity and mortality (outcome-1) and cardiovascular morbidity and all-cause mortality (outcome-2). RESULTS: Participants' mean age was 44.8 years (53.8%, women; 77.1% at low-CVR); 20.3% had SBP 120 to 129; 13.0% 130 to 139 at low-CVR and 3.4% at high-CVR; and 27.4% ≥140 mm Hg. After a 25.7-year median follow-up, 218 outcome-1 and 302 outcome-2 cases occurred. Unadjusted hazard ratios of outcome-1 for these increasing SBP categories (versus <120) were 2.72, 2.27, 11.54, and 7.52, respectively; and 2.69, 2.32, 10.55, and 7.34 for outcome-2 (all P<0.01). After adjustment for other risk factors, hazard ratio (95% CI) of outcome-1 were 1.49 (0.91-2.44), 1.65 (0.94-2.91, P=0.08), 1.36 (0.72-2.57), and 1.82 (1.15-2.88), respectively, and 1.39 (0.91-2.11), 1.69 (1.05-2.73), 1.09 (0.63-1.88), and 1.64 (1.11-2.41) for outcome-2. Compared with 130 to 139 at low-CVR, hazard ratio for 130 to 139 at high-CVR was 4.85 for outcome-1 (P<0.001) and 4.43 for outcome-2 (P<0.001). CONCLUSIONS: In this primary prevention population of relatively young average age, untreated SBP of 130 to 139 mm Hg at low-CVR had long-term prognostic value and might benefit from stricter SBP targets. High-CVR patients had nonsignificant higher risk (limited sample size) but 4-fold greater risk when compared with low-CVR. Overall, results indicate the importance of risk stratification, supporting risk-based decision-making.

Should atrial fibrillation be considered a vascular disease? The need for a comprehensive vascular approach.

INTRODUCTION: Atrial fibrillation (AF) cannot be considered an isolated disease. Patients with AF should be managed using a comprehensive approach that is not limited to stroke prevention. AREAS COVERED: In this manuscript, the potential role of AF as a vascular disease that is managed as part of a holistic approach was reviewed. EXPERT OPINION: The residual risk of stroke in patients with AF reaches 1-2% annually, despite appropriate anticoagulation therapy. Additionally, patients with AF may develop cognitive impairment through stroke-independent pathways. Furthermore, patients with AF may have a higher risk of developing atherosclerotic vascular disease in various vascular beds and chronic kidney disease; conversely, patients with atherosclerotic disease may have an increased risk of developing AF. AF should be considered a truly systemic vascular disease, since it brings together several hemodynamic and systemic changes, including inflammation, oxidative stress, activation of the renin-angiotensin-aldosterone and sympathetic systems, as well as a prothrombotic state and endothelial dysfunction. In this regard, patients with AF should be treated based on a holistic approach that is not limited to oral anticoagulation but includes complete vascular protection.

Benefits of dapagliflozin in the whole spectrum of heart failure in clinical practice: the RICA registry.

Aims: To determine the projected benefits of dapagliflozin after an acute heart failure (HF) event in Spain. Methods: A multicenter and prospective study that included subjects aged 50 years or older consecutively admitted with HF to internal medicine departments in Spain. The projected clinical benefits of dapagliflozin were calculated via pooled analysis of the DAPA-HF and DELIVER trials. Results: A total of 5644 subjects were analyzed, of whom 79.2% were eligible for dapagliflozin, according to criteria of the DAPA-HF and DELIVER trials. Full implementation of dapagliflozin would imply a 1-year absolute risk reduction of 2.3% for death (number needed to treat = 43) and 5.7% (number needed to treat = 17) for HF rehospitalization. Conclusion: Treatment with dapagliflozin could significantly reduce HF burden in clinical practice.

Heart failure is a severe condition that is associated with a high risk of complications. This means that it is important to start using new therapies that have demonstrated a clinical benefit. Clinical trials have shown that dapagliflozin reduces the risk of developing these complications in patients with heart failure. However, it is important to find out whether the results of clinical trials are also seen in real-life populations. We estimated the potential benefits of dapagliflozin in people admitted to hospital more than once with heart failure. The study took place in Spain. Our data suggest that treatment with dapagliflozin could reduce the complications associated with heart failure in real-life patients.

Projected clinical benefits of dapagliflozin in patients with heart failure with preserved ejection fraction.

Aims: To address the projected clinical benefits of dapagliflozin among patients with heart failure (HF) with mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF). Methods: A multicenter, prospective, cohort study of patients ≥50 years admitted with HF to Spanish internal medicine departments. The projected clinical benefits of dapagliflozin were calculated from the DELIVER trial. Results: A total of 4049 patients were included; 3271 (80.8%) were eligible for dapagliflozin treatment, according to DELIVER criteria. Within 1 year after discharge, 22.2% were rehospitalized for HF and 21.6% died. Implementation of dapagliflozin would translate into an absolute risk reduction of 1.3% for mortality and 5.1% for HF readmission. Conclusion: HF patients with preserved or mildly reduced ejection fraction have a high risk of events. The use of dapagliflozin could substantially reduce the HF burden.

Heart failure (HF) with preserved ejection fraction is frequent in clinical practice, particularly in the elderly. In HF with preserved ejection fraction, the heart still pumps a similar proportion of blood, but the heart muscle has become thicker. This means there is less space inside the heart to fill with blood, so too little is pumped out each time. Until very recently, no drugs had been shown to provide significant benefits on the outcome of the condition or the chance of recovery for these patients. Fortunately, recent clinical trials have demonstrated that treatment with drugs called SGLT2 inhibitors (e.g., dapagliflozin) could reduce the chance of being admitted to hospital or dying from HF. We investigated the benefits for patients who took dapagliflozin after being admitted to hospital and had HF with mildly reduced or preserved ejection fraction. We saw substantial benefits in this population.

Projected effectiveness of dapagliflozin in heart failure with reduced ejection fraction in clinical practice.

Aim: To estimate the projected effectiveness of dapagliflozin in subjects with heart failure (HF) with reduced ejection fraction in clinical practice in Spain. Materials & methods: This multicenter cohort study included subjects aged 50 years or older consecutively hospitalized for HF in internal medicine departments in Spain. The projected clinical benefits of dapagliflozin were estimated based on results from the DAPA-HF trial. Results: A total of 1595 patients were enrolled, of whom 1199 (75.2%) were eligible for dapagliflozin. Within 1 year after discharge, 21.6% of patients eligible for dapagliflozin were rehospitalized for HF and 20.5% died. Full implementation of dapagliflozin led to an absolute risk reduction of 3.5% for mortality (number needed to treat = 28) and 6.5% (number needed to treat = 15) for HF readmission. Conclusion: Treatment with dapagliflozin in clinical practice may markedly reduce mortality and readmissions for HF.

Heart failure with reduced ejection fraction is a severe disease with a high risk of hospitalization and mortality. With this condition, the heart muscle cannot pump properly. This means that not enough blood is pumped from the heart, reducing the amount of oxygen to the body. Fortunately, there are treatments that reduce this risk, in patients with heart failure. SGLT2 inhibitors, including dapagliflozin, are among the first therapies given to patients with heart failure. In this study, we investigated the potential benefits of adding dapagliflozin to the treatment of patients admitted to the hospital in Spain for heart failure with reduced ejection fraction. Our data showed that dapagliflozin was able to reduce the risk of further events (e.g., heart attack) in these patients.

Clinical characteristics, treatment, and blood pressure control in patients with hypertension seen by primary care physicians in Spain: the IBERICAN study.

Objectives: To determine the clinical profile, according to the history of hypertension, the risk of developing hypertension, current antihypertensive treatment and BP control rates in patients with hypertension from the IBERICAN cohort. Methods: IBERICAN is an ongoing prospective cohort study, whose primary objective is to determine the frequency, incidence, and distribution of CVRF in the adult Spanish population seen in primary care settings. This analysis shows the baseline clinical characteristics of patients with hypertension. Adequate BP control was defined as BP <140/90 mmHg according to 2013 ESH/ESC guidelines. Results: A total of 8,066 patients were consecutively included, of whom 3,860 (48.0%) had hypertension. These patients were older (65.8 ± 10.9 vs. 51.6 ± 14.7 years; p < 0.001), had more cardiovascular risk factors, target organ damage and cardiovascular disease (CVD) in comparison with those without hypertension. The risk of hypertension increased with the presence of associated CV risk factors and comorbidities, particularly diabetes, obesity and the metabolic syndrome, and decreased with the intensity of physical activity. Regarding antihypertensive treatments, 6.1% of patients did not take any medication, 38.8% were taking one antihypertensive drug, 35.5% two drugs, and 19.6% three or more antihypertensive drugs. Overall, 58.3% achieved BP goals <140/90 mmHg. A greater probability of BP control was observed with increasing age of patients and the greater number of antihypertensive drugs. Blood pressure control was lower in hypertensive patients with diabetes, obesity, the metabolic syndrome, increased urinary albumin excretion, higher pulse pressure, and lack of antihypertensive treatment. Conclusions: About half of patients attended in primary care settings have hypertension in Spain. Patients with hypertension have a worse CV clinical profile than non-hypertensive patients, with greater association of CVRF and CVD. Around four out of ten patients do not achieve the recommended BP goals, and higher use of combination therapies is associated with a better BP control.

Identifying the patient with heart failure to be treated with vericiguat.

The pathophysiology of heart failure with reduced ejection fraction (HFrEF) is a complex process in which a number of neurohormonal systems are involved. Targeting only some of these systems, but not all, translates into a partial benefit of HF treatment. The nitric oxide-soluble guanylate cyclase (sGC)-cGMP pathway is impaired in HF, leading to cardiac, vascular and renal disturbances. Vericiguat is a once-daily oral stimulator of sGC that restores this system. No other disease-modifying HF drugs act on this system. Despite guidelines recommendations, a substantial proportion of patients are not taking all recommended drugs or when taking them, they do so at low doses, limiting their potential benefits. In this context, treatment should be optimized considering different parameters, such as blood pressure, heart rate, renal function, or potassium, as they may interfere with their implementation at the recommended doses. The VICTORIA trial showed that adding vericiguat to standard therapy in patients with HFrEF significantly reduced the risk of cardiovascular death or HF hospitalization by 10% (NNT 24). Furthermore, vericiguat does not interfere with heart rate, renal function or potassium, making it particularly useful for improving the prognosis of patients with HFrEF in specific settings and clinical profiles.

Optimizing the management of patients with worsening heart failure: beyond heart failure hospitalization.

INTRODUCTION: Worsening heart failure (HF) is associated with a high risk of death and HF hospitalization. AREAS COVERED: A systematic search was conducted on PubMed (MEDLINE), using the MeSH terms [Heart failure] + [Worsening] + [Treatment] + [Vulnerable period] up to February 2023. Original data from clinical trials, and observational studies were critically analyzed. EXPERT OPINION: Although the vulnerable period has been traditionally limited to the first 6 months after HF hospitalization, the fact is that there are other clinical scenarios in which the patient is particularly vulnerable. These vulnerable patients may also include those that require parenteral administration of diuretics in the day hospital or emergency department, those in which the increase of oral diuretic dose in an outpatient setting is needed to relief congestive symptoms, as well as those that remain symptomatic despite treatment. On the other hand, HF is a complex disease in which different neurohormonal systems are involved. Therefore, to actually reduce the HF burden, a comprehensive management, targeting all the neurohormonal systems that are involved in the pathogenesis of HF, through the use of those drugs that have demonstrated to positively modify the clinical course of HF, is needed.

Impact of physician's perception about LDL cholesterol control in clinical practice when treating patients in Spain.

BACKGROUND AND AIMS: We aimed to understand the impact of physicians' perception about LDL-cholesterol (LDLc) control on the management of patients with dyslipidemia in Spain. METHODS: We performed a cross-sectional and multicenter study, in which 435 healthcare professionals participated in face-to-face meetings, collecting qualitative and quantitative information related to hypercholesterolemia management. Additionally, aggregated anonymized data of the last 10 patients with hypercholesterolemia attended by each physician were collected. RESULTS: A total of 4,010 patients (8%, 13%, 16% and 61% with low, moderate, high, and very high cardiovascular [CV] risk) were included. Physicians' perception was that 62% of their patients attained LDLc goals (66%, 63%, 61% and 56%, for low, moderate, high and very high CV risk, respectively). However, when looking into the data only 31% (vs 62% p<0.01) of patients attained the LDLc goals (47%, 36%, 22% and 25%, respectively). Overall, 33% of patients were taking high intensity statins, 32% statin/ezetimibe, 21% low/moderate intensity statins and 4% PCSK9 inhibitors. These numbers were 38%, 45%, 8% and 6% for very high risk patients and 44%, 21%, 21% and 4% for high CV risk patients. In 32% of patients, a change in lipid lowering therapy was performed after the visit, mainly combining statins/ezetimibe (55%). CONCLUSIONS: In Spain, most patients with dyslipidemia do not achieve the recommended LDLc goals because of an insufficient intensification of lipid lowering therapy. On the one hand, this is in part due to physicians misperception on preventive LDLc control and the need for repeated advice to patient, and, on the other, to the lack of patient adherence.

Hypercholesterolaemia control in Spain: The same situation with different regional realities. / Control de la hipercolesterolemia en España: una misma situación con diferentes realidades autonómicas.

INTRODUCTION AND OBJECTIVE: The cardiovascular prevention strategy by autonomous communities can be variable since the competences in health are transferred. The objective of the study was to determine the degree of dyslipidaemia control and the lipid-lowering pharmacological therapy used in patients at high/very high cardiovascular risk (CVR) by autonomous communities. METHODS: Observational, cross-sectional, descriptive study based on a consensus methodology. Information on the clinical practice of 145 health areas belonging to 17 Spanish autonomous communities was collected through face-to-face meetings and questionnaires administered to the 435 participating physicians. Furthermore, aggregate non-identifiable data were compiled from 10 consecutive dyslipidaemic patients that each participant had recently visited. RESULTS: Of the 4010 patients collected, 649 (16%) had high and 2458 (61%) very high CVR. The distribution of the 3107 high/very high CVR patients was balanced across regions, but there were inter-regional differences (P<.0001) in the achievement of target LDL-C <70 and <55mg/dL, respectively. High-intensity statins in monotherapy or in combination with ezetimibe and/or PCSK9 inhibitors were used in 44, 21 and 4% of high CVR patients, while in those at very high CVR it rose to 38, 45 and 6%, respectively. The use of these lipid-lowering therapies at national level was significantly different between regions (P=.0079). CONCLUSIONS: Even though the distribution of patients at high/very high CVR was similar between autonomous communities, inter-territorial differences were identified in the degree of achievement of LDL cholesterol therapeutic goal and use of lipid-lowering therapy.

Oral Sodium Chloride in the Prevention of Contrast-Associated Acute Kidney Injury in Elderly Outpatients: The PNIC-Na Randomized Non-Inferiority Trial.

OBJECTIVE: We aimed to test the non-inferiority of oral versus intravenous hydration in the incidence of contrast-associated acute kidney injury (CA-AKI) in elderly outpatients undergoing a contrast-enhanced computed tomography (CE-CT) scan. METHODS: PNIC-Na (NCT03476460) is a phase-2, single-center, randomized, open-label, non-inferiority trial. We included outpatients undergoing a CE-CT scan, >65 years having at least one risk factor for CA-AKI, such as diabetes, heart failure, or an estimated glomerular filtration rate (eGFR) of 30-59 mL/min/1.73 m². Participants were randomized (1:1) to oral sodium-chloride capsules or intravenous hydration. The primary outcome was an increase in serum creatinine >0.3 mg/dL or a reduction in eGFR >25% within 48 h. The non-inferiority margin was set at 5%. RESULTS: A total of 271 subjects (mean age 74 years, 66% male) were randomized, and 252 were considered for the main analysis (per-protocol). A total of 123 received oral hydration and 129 intravenous. CA-AKI occurred in 9 (3.6%) of 252 patients and 5/123 (4.1%) in the oral-hydration group vs. 4/129 (3.1%) in the intravenous-hydration group. The absolute difference between the groups was 1.0% (95% CI -4.8% to 7.0%), and the upper limit of the 95% CI exceeded the pre-established non-inferiority margin. No major safety concerns were observed. CONCLUSION: The incidence of CA-AKI was lower than expected. Although both regimens showed similar incidences of CA-AKI, the non-inferiority was not shown.

Comprehensive Cardiovascular and Renal Protection in Patients with Type 2 Diabetes.

Type 2 diabetes (T2DM) is one of the main public health care problems worldwide. It is associated with a marked increased risk of developing atherosclerotic vascular disease, heart failure, chronic kidney disease and death. It is essential to act during the early phases of the disease, through the intensification of lifestyle changes and the prescription of those drugs that have been shown to reduce these complications, with the aim not only of achieving an adequate metabolic control, but also a comprehensive vascular risk control. In this consensus document, developed by the different specialists that treat these patients (endocrinologists, primary care physicians, internists, nephrologists and cardiologists), a more appropriate approach in the management of patients with T2DM or its complications is provided. A particular focus is given to the global control of cardiovascular risk factors, the inclusion of weight within the therapeutic objectives, the education of patients, the deprescription of those drugs without cardiovascular benefit, and the inclusion of GLP-1 receptor agonists and SGLT2 inhibitors as cardiovascular protective drugs, at the same level as statins, acetylsalicylic acid, or renin angiotensin system inhibitors.

Multicenter prospective comparison of conventional and high-power short duration radiofrequency application for pulmonary vein isolation: the high-power short-duration radiofrequency application for faster and safer pulmonary vein ablation (POWER FAST III) trial.

BACKGROUND: Electrical isolation of pulmonary veins (PV) with high-power short-duration (HPSD) radiofrequency application (RFa) may reduce the duration of atrial fibrillation (AF) ablation, without compromising the procedural efficacy and safety in comparison with the conventional approach. This hypothesis has been generated in several observational studies; the POWER FAST III will test it in a randomized multicenter clinical trial. METHODS: It is a multicenter randomized, open-label and non-inferiority clinical trial with two parallel groups. AF ablation using 70 W and 9-10 s RFa is compared with the conventional technique using 25-40 W RFa guided by numerical lesion indexes. The main efficacy objective is the incidence of atrial arrhythmia recurrences electrocardiographically documented during 1-year follow-up. The main safety objective is the incidence of endoscopically detected esophageal thermal lesions (EDEL). This trial includes a substudy of incidence of asymptomatic cerebral lesions detected by magnetic resonance imaging (MRI) after ablation. RESULTS: A randomized clinical trial compares for the first time high-power short-duration and conventional ablation in order to obtain data about the efficacy and safety of the high-power technique in an adequate methodological context. CONCLUSIONS: The results of the POWER FAST III could support the use of the high-power short-duration ablation in clinical practice. REGISTRATION: ClinicalTrials.gov: NTC04153747.

Achieving Lower LDL-C Levels After a Recent Myocardial Infarction Might Be Associated with Lower Healthcare Resource Use and Costs in Spain.

INTRODUCTION: There is little evidence on the relationship between achieved low-density lipoprotein cholesterol (LDL-C) levels and costs in patients on lipid-lowering therapy (LLT). We described healthcare resource use and costs (direct and indirect) by achieved LDL-C in patients receiving LLT after a recent myocardial infarction (MI) in Spain. METHODS: This was a retrospective observational study of anonymized electronic medical records from seven regions in Spain (BIG-PAC® database; n = 1.9 million). Eligible patients were adults (≥ 18 years) hospitalized for an MI between January 2015 and December 2017, treated with a statin and/or ezetimibe, and having recorded LDL-C values at baseline and during follow-up. Healthcare resource use and direct and indirect costs (in 2018, €) were described by achieved LDL-C levels during a follow-up of 18 months. RESULTS: Of 6025 patients (mean age, 69.7 years; 77% male), only 11% achieved LDL-C goals as defined in the 2016 ESC/EAS guidelines (< 70 mg/dL), and just 1% reached the lower target (< 55 mg/dL) in the current 2019 guidelines. Achieving lower LDL-C levels translated to lower healthcare resource use and costs. Mean total (direct and indirect) costs ranged from €5044 for patients with LDL-C < 55 mg/dL to €7567 for patients with LDL-C ≥ 130 mg/dL. CONCLUSION: Very few patients achieved recommended LDL-C goals despite using LLT. Achieving lower LDL-C levels after an MI might be associated with lower healthcare resource use and costs. Use of more intensive LLT, leading to greater reductions in LDL-C, could therefore be beneficial both from a clinical and an economic perspective.