Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure < 100 mmHg (n = 1127), estimated glomerular filtration rate < 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation

Conservative treatment versus invasive approach in elderly patients with myocardial infarction without ST-segment elevation

Myocardial infarction without ST segment elevation is one of the most common causes of hospitalization of the elderly patient [1]. Coronarography followed by revascularization, is performed in the vast majority of cases of myocardial infarction without ST segment elevation, in the regions with a well-developed health system. The decision to perform the procedure, the type of approach (early/late) and the selection of the type of myocardial revascularization depend on numerous factors such as: associated comorbidities, clinical presentation, the risk group in which the patient is framed, fragility, cognitive status, life expectancy etc. [2,3]. Older patients often present with various comorbidities, having a higher risk of complications and an unfavorable evolution. Thus, it was observed that invasively treatment is less commonly used in elderly patients with comorbidities, even if, the current guideline recommends that the invasive strategy should be considered in all patients with NSTEMI, regardless of age. At the same time, this subgroup of patients is not so well represented in the studies performed so far, the type of treatment chosen, being most often at the discretion of the attending physician [1,2]. Objective The present study aims to analyze the evolution of a subgroup of patients ≥ 70 years of age, with different comorbidities, with the diagnosis of myocardial infarction without ST segment elevation, according to the type of treatment applied: conservative versus invasive strategy (diagnostic coronarography ± revascularization, if appropriate)

Efficiency of sFlt-1/PlGF Ratio in Preeclampsia Diagnosis

Background and Objectives: Preeclampsia is a health issue characterized by a new onset of hypertension after 20 weeks of gestation and proteinuria. This is a multiple organ disorder and is associated with significant maternal and fetal mortality. Material and Methods: The study is a prospective one and included 69 pregnant women (17 with hypertension without criteria for PE, 26 with severe PE and 26 with moderate PE) with an age of gestation between 24 and 40 weeks. Subjects were chosen from those who referred to the Oradea County Emergency Clinical Hospital, Department of Obstetrics-Gynecology between January 2020 and December 2022. We collected other characteristics from observation sheets and from patients and we measured the sFlt-1/PlGF ratio after 20 weeks of pregnancy if patients presented with suspected preeclampsia. All the results were collected in Excel analysis by SPSS. Results: In our study, 37.68% had severe preeclampsia, the same percentage had moderate PE and 24.63% presented only with hypertension. The mean of sFLT-1/PlGF for severe preeclampsia was 78.282 ng/mL, and for moderate, it was 50.154 ng/mL. For those who did not have criteria for preeclampsia, it was 29.076 ng/mL. When we compared the values of sFLT-1/PlGF in moderate PE and hypertension, we found that there was a statistically significant difference between this two, and the same conclusion was also obtained for severe PE and hypertension and for severe and moderate PE. Conclusions: This marker can be useful for improving the outcomes for pregnant women with preeclampsia. In addition, for newborns, sFlt-1/PlGF can be helpful because we can correctly and promptly manage a patient affected by this disease before 34 weeks of pregnancy. Our study demonstrates that the correlation between the values of sFlt-1/PlGF and the type of preeclampsia are positive; thus, if the values are high, the pregnant woman likely will develop severe preeclampsia with early onset. In addition, the sFlt-1/PlGF ratio has the highest accuracy for differentiating PE patients from pregnant women who did not develop sign and symptoms for preeclampsia. Our results are in line with the conclusions of other studies that researched the association between sFlt-1/PlGF and clinical diagnosis of preeclampsia

Safety and Efficacy of Modern Stents in Patients with Metabolic Syndrome

The impact of metabolic syndrome (MS) on stent performance and outcomes of patients underwent percutaneous coronary intervention (PCI), including stent implantation, had not yet been fully established. The aim of the present study was to investigate long-term safety and efficacy of 2nd generation DES vs. other stent types in MS patients underwent successful PCI for an acute coronary event. Descriptive epidemiology, angiographic characteristics and one-year clinical outcomes, including major adverse cardiovascular events (MACE) and target lesion revascularization (TLR) procedures were evaluated according to the stent type inserted for 204 patients. The occurrence of TLR (6.62% vs. 9.43%, p = 0.50) and the composite outcomes (20.52% vs. 24.52%, p = 0.54) did not differ significantly between patients having 2nd generation drug eluting stents (DES) or other stent types implanted at the index procedure. It seems that the PCI in acute coronary syndrome (ACS) is similarly efficient regardless of the stent type, suggesting that for the treatment of ACS in MS patients, all stent types show similar results, in terms of TLR or MACE

Safety and Efficacy of Modern Stents in Patients with Metabolic Syndrome

The impact of metabolic syndrome (MS) on stent performance and outcomes of patients underwent percutaneous coronary intervention (PCI), including stent implantation, had not yet been fully established. The aim of the present study was to investigate long-term safety and efficacy of 2nd generation DES vs. other stent types in MS patients underwent successful PCI for an acute coronary event. Descriptive epidemiology, angiographic characteristics and one-year clinical outcomes, including major adverse cardiovascular events (MACE) and target lesion revascularization (TLR) procedures were evaluated according to the stent type inserted for 204 patients. The occurrence of TLR (6.62% vs. 9.43%, p = 0.50) and the composite outcomes (20.52% vs. 24.52%, p = 0.54) did not differ significantly between patients having 2nd generation drug eluting stents (DES) or other stent types implanted at the index procedure. It seems that the PCI in acute coronary syndrome (ACS) is similarly efficient regardless of the stent type, suggesting that for the treatment of ACS in MS patients, all stent types show similar results, in terms of TLR or MACE

Can Fetuin A Be Utilized in the Evaluation of Elderly Patients with Acute Myocardial Infarction?

Background: Lower baseline Fetuin-A (FA) is associated with left ventricular remodeling and cardiovascular death (CVD) at 4 months after acute myocardial infarction (AMI). However, the association between FA levels, incomplete ST segment resolution (STR) following primary percutaneous coronary intervention (PCI) and early mortality in AMI has not been previously studied. Methods: We enrolled 100 patients with AMI, which we divided in two groups: 21 patients who suffered sudden cardiac death (SCD) in the first 7 days after PCI and 79 controls. We measured FA, NT-proBNP and troponin levels and correlated them with the occurrence of death in the first week after revascularization. We also tested the cut-off value of FA to determine STR at 90 min after PCI. Results: SCD was most frequently caused by pump failure (n = 10, 47.6%) and ventricular arrhythmias (n = 9, 42.5%). Plasma FA levels correlated with NT-proBNP values (r = −0.47, p = 0.04) and were significantly lower in patients presenting SCD (115 (95–175) vs. 180 (105–250) ng/mL, p = 0.03). Among all three biomarkers, FA was the only one associated with incomplete STR after PCI on the multivariate logistic regression (cut-off value of 175 ng/mL, Se = 74%, Sp = 61.1%). Death rate was highest (n = 16/55, 30%) in patients with FA levels below the cut-off value of 175 ng/mL. Conclusion: Lower FA is associated with higher early mortality and incomplete STR after primary percutaneous revascularization in patients with AMI. Measurement of FA levels in addition to NT-proBNP, troponin and STR might enable more accurate identification of high-risk patients

Asymptomatic atrial fibrillation:clinical correlates, management and outcomes in the EORP-AF Pilot General Registry

OBJECTIVE: Atrial fibrillation is often asymptomatic, but outcomes require further characterization. The study objective was to investigate the clinical presentation, management, and outcomes in asymptomatic and symptomatic patients with atrial fibrillation who were prospectively enrolled in the EurObservational Research Programme - Atrial Fibrillation (EORP-AF) Pilot General Registry. METHODS: A total of 3119 patients were enrolled, and 1237 (39.7%) were asymptomatic (European Heart Rhythm Association [EHRA] score I). Among symptomatic patients, 963 (51.2%) had mild symptoms (EHRA score II) and 919 (48.8%) had severe or disabling symptoms (EHRA III-IV). Permanent atrial fibrillation was 3-fold more common in asymptomatic patients than in symptomatic patients. RESULTS: On multivariate analysis, male gender (odds ratio [OR], 1.630; 95% confidence interval [CI], 1.384-1.921), older age (OR, 1.019; 95% CI, 1.012-1.026), previous myocardial infarction (OR, 1.681; 95% CI, 1.350-2.093), and limited physical activity (OR, 1.757; 95% CI, 1.495-2.064) were associated significantly with asymptomatic (EHRA I) atrial fibrillation. Fully asymptomatic atrial fibrillation (absence of current and previous symptoms) was present in 520 patients (16.7%) and was associated independently with male gender, age, and previous myocardial infarction. Appropriate guideline-based prescription of oral anticoagulants was lower in these patients, and aspirin was prescribed more frequently. Mortality at 1 year was more than 2-fold higher in asymptomatic patients compared with symptomatic patients (9.4% vs 4.2%, P < .0001) and was associated independently with older age and comorbidities, including chronic kidney disease and chronic heart failure. CONCLUSIONS: Asymptomatic atrial fibrillation is common in daily cardiology practice and is associated with elderly age, more comorbidities, and high thromboembolic risks. A higher 1-year mortality was found in asymptomatic patients compared with symptomatic patients