Sacubitril/valsartan versus enalapril in chronic Chagas cardiomyopathy with heart failure: Baseline characteristics of the PARACHUTE-HF trial.

Aims: The PARACHUTE-HF trial (NCT04023227) is evaluating the effect of sacubitril/valsartan compared with enalapril on a hierarchical composite of cardiovascular events (cardiovascular death, first heart failure hospitalization), and change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels in participants with heart failure and reduced ejection fraction (HFrEF) caused by chronic Chagas cardiomyopathy (CCC). We describe the baseline characteristics of participants in PARACHUTE-HF compared with prior HFrEF trials.

Methods And Results: PARACHUTE-HF, a multicentre, active-controlled, open-label trial, enrolled 922 participants with confirmed CCC, New York Heart Association (NYHA) functional class II-IV, and left ventricular ejection fraction (LVEF) ≤40%.

Early Withdrawal of Aspirin after PCI in Acute Coronary Syndromes.

Background: Whether potent P2Y12 inhibitor monotherapy without aspirin initiated shortly after successful percutaneous coronary intervention (PCI) is effective and safe for patients with acute coronary syndromes is unclear.

Methods: We conducted a multicenter, open-label, randomized trial in Brazil involving patients with acute coronary syndromes who had undergone successful PCI. Patients were assigned in a 1:1 ratio within the first 4 days of hospitalization to stop treatment with aspirin and receive potent P2Y12 inhibitor monotherapy (ticagrelor or prasugrel) or to receive dual antiplatelet therapy (aspirin and a potent P2Y12 inhibitor) for 12 months.

Mavacamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy.

Background: Mavacamten is approved to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). However, its effects in nonobstructive HCM remain uncertain.

Methods: We conducted a phase 3, international, double-blind, placebo-controlled, clinical trial to determine whether mavacamten improves functional capacity and patient-reported health status among adults with symptomatic nonobstructive HCM.

Cost-effectiveness of Apixaban vs Aspirin for the Reduction of Thrombo-Embolism in High-Risk Patients with Device-Detected Atrial Fibrillation: Insights from the ARTESiA trial.

Background And Aims: Apixaban was superior to aspirin for the prevention of stroke or systemic embolism in participants with subclinical atrial fibrillation (SCAF) in the Apixaban for the Reduction of Thrombo-Embolism in Patients with Subclinical Atrial Fibrillation (ARTESiA) trial. This was especially true for those with CHA2DS2-VASc score >4. Understanding the cost-effectiveness of treating SCAF is important for decision makers.

Polypill and RiskOMeter to Prevent StrOke and CogniTive ImpairmEnt in Primary Health Care (PROMOTE) Randomized Clinical Trial: Rationale and Design.

Introduction: Stroke and dementia have common modifiable risk factors. Current prevention strategies primarily focus on high-risk populations, leaving a gap in addressing the broader population. We report the protocol for a randomized controlled trial (RCT) that aims to evaluate the feasibility, tolerability, and effectiveness of a polypill (valsartan 80mg, amlodipine 5mg, and rosuvastatin 10mg), with and without use of the Stroke Riskometer app, on systolic blood pressure (SBP) and other cardiovascular disease (CVD) risk factors at 9 months after randomization in a population of low to borderline CVD risk.

Overcoming Barriers to Developing and Implementing Novel Therapies for Hypertension.

Hypertension is the single most important modifiable risk factor for preventable disability and death worldwide and disproportionately affects socially disadvantaged populations. We face a paradox-blood pressure control is low and recent trends suggest it is even declining, despite the availability of inexpensive and effective therapies. A variety of barriers on the system, patient, and healthcare provider side hinder effective drug-based risk factor management.

Echocardiographic Changes With Mavacamten in Nonobstructive Hypertrophic Cardiomyopathy: Exploratory Insights From the ODYSSEY-HCM Trial.

Background: Symptomatic nonobstructive hypertrophic cardiomyopathy (nHCM) lacks approved therapies. The ODYSSEY-HCM trial (A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy; NCT05582395), the largest to date in HCM patients, evaluating the efficacy of mavacamten in symptomatic adults with nHCM, did not demonstrate improvements in its primary endpoints (functional capacity and patient-reported health status).

Objectives: This exploratory analysis of the phase 3, randomized, placebo-controlled trial evaluated echocardiographic changes in nHCM patients from baseline to week 48.

Effects of Mavacamten on Cardiac Biomarkers in Nonobstructive Hypertrophic Cardiomyopathy: Insights From the ODYSSEY-HCM Trial.

Background: No therapy is approved for patients with symptomatic nonobstructive hypertrophic cardiomyopathy (nHCM). The ODYSSEY-HCM (A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy [ODYSSEY-HCM]; NCT05582395) trial, the largest to date in patients with hypertrophic cardiomyopathy (HCM), evaluating the efficacy of mavacamten in symptomatic adults with nHCM, did not demonstrate improvements in its primary endpoints (functional capacity and patient-reported health status).

Objectives: The current exploratory analysis from the ODYSSEY-HCM trial reports the associations between: 1) baseline biomarkers (N-terminal pro-B-type natriuretic peptide [NT-proBNP] and high-sensitivity cardiac troponin I [cTnI]) with clinical, exercise, and echocardiographic characteristics; and 2) comparing changes in these biomarkers from baseline to week 48 between mavacamten and placebo groups.

Characteristics of patients prescribed SGLT-2i and/or GLP-1RA among cardiology clinics in the US: insights from the COORDINATE-diabetes trial.

Background: Antihyperglycemic agents with cardiovascular (CV) benefits, including SGLT-2i and GLP-1RA, are underused in clinical practice, particularly by cardiologists. Understanding the prescribing patterns of these agents by cardiologists may aid in implementation efforts.

Methods: The COORDINATE-Diabetes trial enrolled participants with type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD) from US cardiology clinics and evaluated the impact of cluster randomization to a multifaceted implementation intervention versus usual care on proportional prescription of evidence-based therapies; the present analyses focus on SGLT2i and GLP-1 RA prescription.

Medicare Coverage Gap Status, Adherence to Oral Anticoagulation, and Stroke Rates in Patients with Atrial Fibrillation.

Background: Prior to 2025, Medicare Part D included a coverage gap during which beneficiaries were responsible for substantially higher portions of medication costs. The impact of this on oral anticoagulant (OAC) prescription fills and subsequent stroke in patients with atrial fibrillation (AF) is not known.

Methods: Using Centers for Medicare and Medicaid Services claims data from 2016-2018, we evaluated OAC prescription fills in patients with AF by assessing their proportion of days covered on OAC before, during, and after their coverage gap.

Outcomes in Older Patients After Switching to a Newer Anticoagulant or Remaining on Warfarin: The COMBINE-AF Substudy.

Background: Whether frail, elderly patients with atrial fibrillation (AF) on a vitamin K antagonist (VKA) should switch to a direct-acting oral anticoagulant (DOAC) was studied in the FRAIL-AF trial and remains controversial.

Objectives: The purpose of this study was to evaluate, in the COMBINE-AF data set, the impact on clinical outcomes of switching frail, elderly AF patients from VKA to DOAC.

Methods: COMBINE-AF consists of individual patient-level data from 71,683 patients with AF in 4 randomized clinical trials comparing DOAC vs warfarin.

Apixaban for stroke prevention in subclinical atrial fibrillation detected by an implantable cardiac monitor: A subgroup analysis of ARTESiA.

Background: The ARTESiA trial randomized patients with a pacemaker (PM), implantable cardioverter-defibrillator (ICD), or implantable cardiac monitor (ICM) and with subclinical atrial fibrillation to either apixaban or aspirin.

Objective: We aimed to explore the effects of apixaban in the subset of patients with an ICM.

Methods: We assessed the efficacy outcome of stroke or systemic embolism and the safety outcome of major bleeding, stratifying by device type.

Study Design Update of the Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: FRAGILE Trial.

The Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients (FRAGILE Trial) is a multicenter, randomized controlled trial comparing off-pump and on-pump coronary artery bypass grafting in frail or pre-frail patients undergoing coronary artery bypass grafting. This manuscript presents an update to the FRAGILE Trial study design, detailing protocol modifications made in response to the time gap between the study's conception and its actual implementation. These changes were implemented early in the trial and were formally approved by the Ethics Committee, ensuring the scientific and ethical integrity of the study and reinforcing its relevance to address a gap in a vulnerable patient population.

Blood Pressure Control and Anthropometric Differences in Afro-Descendants and Other Ethnic Groups in Hypertensive Brazilian Populations.

Background: The prevalence of hypertension (HT) and blood pressure (BP) control varies among ethnic-racial groups, but studies on this issue and correlations between BP and body mass index (BMI) in the black Brazilian population are scarce.

Methods: Cross-sectional study in individuals included in the First Brazilian Hypertension Registry. Relationships between variables were analysed by a binary logistic regression analysis.

Atrial fibrillation progression in patients with device-detected subclinical atrial fibrillation: Insights from the ARTESiA trial.

Background: The Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Subclinical Atrial Fibrillation (ARTESiA) trial enrolled patients with subclinical atrial fibrillation (SCAF) lasting < 24 hours.

Objective And Methods: We assessed the association of SCAF progression to clinical atrial fibrillation or SCAF > 24 hours with adverse outcomes and predictors of SCAF progression.

Results: During follow-up (4.

Comparative Prognosis by Stress ECG and Stress Imaging: Results From the ISCHEMIA Trial.

Background: Limited contemporary evidence exists on risk prediction by stress imaging and exercise electrocardiography (ECG) among patients with chronic coronary syndromes (CCS). Objectives From the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) study, prognosis was examined by core laboratory-defined stress imaging and exercise ECG findings in CCS patients.

Methods: A total of 5,179 patients (qualifying by stress nuclear imaging [n = 2,567], echocardiography [n = 1,085], cardiac magnetic resonance [CMR] [n = 257], and ECG [n = 1,270]) were randomized.

Record-Breaking Endurance of 366 Marathons in 366 Days: A Case Study.

Background: A Brazilian athlete has proposed setting a new world record for consecutive marathons by running 366 marathons in 366 consecutive days. The impact of such a feat on the cardiovascular system is unknown.

Objective: To monitor the cardiovascular system to assess the athlete's cardiovascular adaptations or maladaptations over the period.

Acute Heart Failure in Patients with Chagas Cardiomyopathy: Results of the I Brazilian Heart Failure Registry (BREATHE).

Background: Although the clinical features of chronic Chagas' cardiomyopathy (CCC) have been well established, clinical data about the patients are scarce.

Objectives: The current analysis reports the results of the I Brazilian Heart Failure Registry (BREATHE) assessing baseline characteristics and clinical outcomes of patients with acute heart failure due to CCC.

Methods: BREATHE enrolled a total of 3,013 adult patients hospitalized with acute heart failure.

Pre-treatment lysis time of plasma-derived fibrin clots and bleeding in patients on oral anticoagulants for atrial fibrillation in the ARISTOTLE trial.

Background And Aims: Oral anticoagulation reduces stroke risk in patients with atrial fibrillation (AF) but increases bleeding. Longer fibrin clot lysis time has been shown to predict adverse cardiovascular outcomes in acute coronary syndromes. This study explored relationships between fibrin clot lysis time at randomization and clinical outcomes in patients with AF enrolled in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in AF (ARISTOTLE) trial.

Impact of Apolipoprotein A-I Infusions on Cardiovascular Events Post-MI by Neutrophil-Lymphocyte Ratio and LDL-Cholesterol Levels.

Background: The AEGIS-II (ApoA-I Event Reducing in Ischemic Syndromes-II; NCT03473223) trial evaluated CSL112, a human plasma-derived apolipoprotein A-I therapy, for reducing cardiovascular events after acute myocardial infarction (AMI). Given CSL112's potential anti-inflammatory properties, we conducted an exploratory post hoc analysis to determine if its efficacy is influenced by baseline neutrophil-lymphocyte ratio (NLR), a marker of systemic inflammation, and low-density lipoprotein cholesterol (LDL-C).

Objectives: The purpose of this study was to investigate the association of baseline NLR and cardiovascular events and explore whether NLR and LDL-C modify CSL112's efficacy in post-AMI patients.

Incidence and associated factors with atrial fibrillation in patients with transthyretin amyloidosis cardiomyopathy: Insights from the multicenter REACT-SP registry.

Introduction: Atrial fibrillation (AF) presents a treatment challenge in patients with amyloidosis cardiomyopathy, particularly in transthyretin amyloidosis cardiomyopathy (ATTR-CM). Identifying factors associated with AF is important for early diagnosis and intervention.

Purpose: This study aims to identify factors linked to AF in ATTR-CM patients.