Cardiology and Therapy最新文献

Introduction: Heart failure (HF) is one of the most common complications in patients with hypertrophic cardiomyopathy (HCM); however, there are limited data on HCM burden in Japan. We evaluated the burden of HF hospitalization and factors that predispose patients with HCM to HF hospitalization.

Methods: This retrospective observational database study used a hospital-based claims database from January 01, 2011, to December 31, 2023, provided by Medical Data Vision Co., Ltd. The primary objective of the study was to calculate the incidence of first HF hospitalization after HCM diagnosis. A nested case-control design compared patients with or without hospitalization to identify factors associated with HF hospitalization. Hospitalization costs and outcomes after discharge were also described.

Results: Of 12,145 patients with newly diagnosed HCM without HF hospitalization, 525 were hospitalized with HF during the follow-up period. The mean age ± standard deviation (SD) of the overall study population at cohort entry date was 71.4 ± 14.0 years, and 45.8% were female patients. The incidence of HF hospitalization was 17.2 events/1000 patient-years. Patients with HCM hospitalized for HF had higher rates of comorbidities, including HF (45.9%), diabetes mellitus (28.6%), hypertension (23.0%), atrial fibrillation (AF; 21.3%), myocardial infarction (MI; 17.5%), arrhythmia except AF (15.0%), and dyslipidemia (13.1%), than patients without HF hospitalization. Significant predictors of hospitalization among patients with HCM were AF (odds ratio [OR] 1.63; 95% confidence interval [CI] 1.18-2.25; p = 0.003), MI (OR 1.68; 95% CI 1.20-2.35; p = 0.003), HF (OR 1.82; 95% CI 1.39-2.39; p < 0.001), chronic obstructive pulmonary disease (OR 2.30; 95% CI 1.08-4.89; p = 0.031), and loop diuretics (OR 4.35; 95% CI 3.33-5.69; p < 0.001). The average costs, length of hospital stay, and overall mortality rate associated with HF hospitalization were 1035 kJPY (~ 156,750 USD), 20.0 days, and 8.8%, respectively.

Conclusions: HF hospitalization in patients with HCM imposes a significant clinical and economic burden.

Introduction: There is scarce evidence on the prognostic impact of ambulatory blood pressure monitoring (ABPM) in patients with coronary heart disease (CHD). We aimed to investigate the risks of all-cause and cardiovascular mortality associated with office and ambulatory blood pressure (BP) in patients with CHD.

Methods: Prospective, observational study with 2679 patients (mean age 67 years, 35% women) with CHD, selected from the Spanish ABPM Registry. Associations between BP indices, as well as BP phenotypes, with all-cause and cardiovascular mortality were assessed by means of Cox-survival models adjusted for clinical confounders and alternative BP measures.

Results: During a median follow-up of 8.7 years, 740 patients (27.6%) died, 331 (12.4%) from cardiovascular causes. Office systolic BP was not associated with mortality, while 24-h (hazard ratio: 1.36; 95% confidence interval: 1.26-1.47), daytime (1.33; 1.23-1.44) and nighttime (1.33; 1.24-1.43) systolic BP were all associated with all-cause mortality, after adjustment for confounders and office BP. Masked hypertension (1.49; 1.10-2.01), sustained hypertension (1.46; 1.19-1.80), isolated daytime hypertension (1.80; 1.21-2.68) and isolated nighttime hypertension (1.33; 1.09-1.63), but not white-coat hypertension, were all associated with an increased risk of mortality compared to reference groups. A blunted nocturnal dipping (1.08; 1.01-1.16, for 1 standard deviation change in systolic night-to-day ratio) was also associated with an increased risk of death. Similar results were obtained for cardiovascular mortality.

Conclusion: ABPM indices are more closely related with the risk of death than office BP in patients with CHD. These results emphasize the use of ABPM for a more accurate BP evaluation in this group of patients. Graphical abstract available for this article.

Introduction: Patients with amyloid transthyretin (ATTR) amyloidosis typically experience rapid disease progression, poor treatment outcomes, irreversible loss of health-related quality of life (HRQoL), and premature mortality. Early diagnosis is vital. However, diagnostic delays and misdiagnosis are common due to under-recognition of early signs and symptoms.

Methods: ANTHOLOGY is an ATTR amyloidosis program, evidence generation, and quality improvement opportunity comprised of two multi-country, longitudinal, observational, real-world evidence studies: OverTTuRe (ClinicalTrials.gov identifier, NCT06355934) and MaesTTRo (NCT06465810). OverTTuRe will retrospectively extract and analyze secondary data from a broad spectrum of sources, and MaesTTRo will prospectively collect and analyze data from patient-reported outcome questionnaires, electronic health records, and insurance claims.

Planned outcomes: The primary objectives of OverTTuRe are to describe contemporary patient characteristics, treatment patterns and disease outcomes, and to characterize healthcare resource utilization (HCRU) and HRQoL in patients diagnosed with ATTR amyloidosis. Describing patient characteristics and HCRU before diagnosis is a secondary objective. The primary objectives of MaesTTRo are to describe patient characteristics, disease history and treatment patterns from diagnosis, and to prospectively define and assess the real-world effectiveness of current therapies. Secondary objectives are to compare the characteristics of patients according to the therapy received and compare the real-world effectiveness of current therapies. Exploratory objectives are to identify risk factors for disease progression and to describe healthcare costs.

Conclusions: ANTHOLOGY aims to broaden understanding of the contemporary epidemiology of ATTR amyloidosis, identify opportunities to accelerate diagnosis, and assess real-world comparative effectiveness of treatments. This knowledge will be used to define world-class patient care, improve treatment outcomes and HRQoL, inform updates to clinical practice guidelines and treatment pathways, and transform ATTR amyloidosis management through evidence aimed at improving the quality of the current standard of care TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT06355934 (OverTTuRe) and NCT06465810 (MaesTTRo).

Introduction: The aim of this study was to assess the applicability of an external control arm (ECA) approach in the clinical development of the oral factor XIa inhibitor asundexian for stroke prevention in patients with atrial fibrillation (AF), using prospectively collected data from the phase 2 PACIFIC-AF trial (NCT04218266) and real-world individual-level data from patients with AF treated with apixaban in the Optum^® de-identified Electronic Health Record data set (Optum^® EHR) 2013-2019.

Methods: To build ECAs, real-world patients meeting trial eligibility criteria were matched to patients enrolled in PACIFIC-AF. The primary outcome was the composite of International Society on Thrombosis and Haemostasis-defined major bleeding or clinically relevant non-major bleeding. Event rates were compared between PACIFIC-AF and ECAs at 85 days of trial duration and projected up to 2 years.

Results: Overall, 160,153 real-world patients met PACIFIC-AF eligibility criteria and were matched to patients from the PACIFIC-AF apixaban arm on 101 variables, with matching ratios of 1:10, 1:5, and 1:1. At day 85, the number of events for the primary outcome was 92 (3.68%) in the 1:10 ECA (2500 patients) and 6 (2.40%) in the PACIFIC-AF apixaban arm (250 patients), with incidence rates of 16.67 (90% confidence interval [CI] 13.92-19.63) and 11.10 (90% CI 4.83-19.45) per 100 person-years, respectively.

Conclusions: ECAs matching the PACIFIC-AF apixaban arm could be built from EHRs with concordant event rates for key trial endpoints. The ECA approach enabled the determination of event rates for treatment duration up to 2 years, thereby informing the asundexian pivotal phase 3 trial in AF.

Transthyretin amyloidosis (ATTR amyloidosis) is a systemic disease affecting multiple organ systems, particularly the heart and peripheral nervous system. Decades of research suggest the disease is caused by the dissociation, misfolding, and aggregation of transthyretin (TTR), resulting in extracellular deposition of amyloid fibrils in tissue and organs. If untreated, ATTR amyloidosis leads to substantial functional impairment, quality-of-life burden, and mortality. Because dissociation of the TTR tetramer is rate-limiting for aggregation and amyloid fibril formation, small molecules that bind to and stabilize the natively folded tetramer of TTR have been developed. Subunit exchange experiments demonstrated that tafamidis and acoramidis effectively slow TTR tetramer dissociation and aggregation in plasma at concentrations achieved with approved oral doses in patients with ATTR amyloidosis. In randomized controlled clinical trials, these TTR kinetic stabilizers have significantly reduced cardiomyopathy progression and improved quality of life in patients with variant or wild-type disease (tafamidis is also approved to slow polyneuropathy progression). Current availability of two kinetic stabilizers has increased interest in their pharmacological properties and clinical effects, including potential similarities and disparities. In this review, the mechanisms involved in TTR kinetic stabilization are summarized with preclinical and clinical study findings on the use of the kinetic stabilizers tafamidis and acoramidis.

Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have emerged as a transformative class of therapies initially developed for glycemic control in type 2 diabetes mellitus. Now, they are also getting recognized for their broader cardiometabolic effects. In this review, we discuss the mechanism of action of GLP-1 RAs, focusing on their proposed cardiometabolic impact and the key clinical trials that have demonstrated improvement in cardiovascular outcomes. GLP-1 RAs have demonstrated benefits in coronary artery disease, heart failure, blood pressure, and atrial fibrillation irrespective of type 2 diabetes mellitus status, with new possible applications in peripheral arterial disease. Findings thus far have been translated into recommendations in clinical guidelines by the American College of Cardiology, American Heart Association, European Society of Cardiology, and American Diabetes Association. As GLP-1 RAs become more prevalent in treating diabetes and patients with cardiovascular disease (CVD) or risk factors for CVD, clinicians will ultimately manage the practical aspects of patient selection, dosing, special considerations, and side effects of these medications. Ongoing and future clinical trials are expected to further define the cardiovascular role of GLP-1 RAs, expand their therapeutic indications, and solidify their place in the evolving landscape of cardiovascular care.

Subclinical atherosclerosis precedes overt cardiovascular disease and can be detected through surrogate markers such as arterial stiffness (AS) and carotid intima-media thickness (CIMT). This review examines the diagnostic and prognostic roles of AS and CIMT, highlighting their potential to improve cardiovascular risk stratification. Although traditional risk prediction models remain the cornerstone of primary prevention, they often fail to identify individuals at risk who lack conventional risk factors. Emerging evidence suggests that integrating CIMT and AS into risk assessment may improve the reclassification of individuals with intermediate risk. However, their routine use remains controversial due to methodological heterogeneity, variability in predictive value, and the prioritization of alternative imaging biomarkers such as carotid plaque or coronary artery calcium (CAC). This article critically assesses the strengths and limitations of AS and CIMT, discussing their potential utility as biomarkers, explores their application into clinical practice, and comprehensively summarizes the latest research.

Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive disease caused by the deposition of insoluble amyloid fibrils derived from misfolded transthyretin (TTR). The treatment landscape is rapidly evolving, with disease-modifying therapies now targeting distinct steps in disease progression. Management requires both disease-modifying treatment and symptom-guided treatment of heart failure and arrhythmias, along with device therapy and consideration of advanced heart failure interventions (i.e., heart transplantation) in select patients. Therapeutic advances have significantly increased treatment possibilities, selection of appropriate therapy, switching between therapies, combination strategies, and how to monitor treatment response over time. This review summarizes available and investigational therapies for ATTR-CM and considers practical questions that guide clinical decision-making, with the goal of helping clinicians navigate the evolving therapeutic landscape.

Introduction: There is a paucity of data regarding the trends and comparative outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) among patients with polyvascular disease (PVD).

Methods: The Nationwide Readmissions Database (2016-2020) was queried for patients undergoing AVR. Propensity score matching was used to compare the outcomes of TAVR versus SAVR among patients with PVD, and for comparing TAVR among those with versus without PVD. The primary outcome was in-hospital mortality.

Results: The final cohort included 545,409 hospitalizations for AVR. During the study years, there was an increase in the utilization of TAVR versus SAVR among patients with PVD. Patients with PVD undergoing TAVR were older and more likely to be women compared with patients with PVD undergoing SAVR. Compared with SAVR, patients with PVD undergoing TAVR had lower odds of in-hospital mortality (adjusted odds ratio (aOR) 0.26; 95% confidence interval (CI) 0.19-0.35), acute myocardial infarction (AMI), ischemic stroke, hemorrhagic stroke, and major bleeding, but higher odds of pacemaker and non-elective 90-day readmissions (aOR 1.13; 95% CI 1.01-1.26). TAVR among patients with versus without PVD showed similar in-hospital mortality (aOR 1.10; 95% CI 0.94-1.20), while there were higher odds of AMI, ischemic stroke, and vascular complications after TAVR in patients with PVD. A higher burden of atherosclerotic vascular beds conferred higher mortality with SAVR more than with TAVR, while a higher burden of atherosclerotic vascular beds conferred a higher risk of ischemic stroke and readmissions after both TAVR and SAVR.

Conclusions: Nationwide data demonstrated that patients with PVD who undergo TAVR were associated with lower in-hospital mortality and major cardiovascular complications compared with those who undergo SAVR. Patients with PVD have similar mortality to those with no PVD undergoing TAVR, but were associated with a higher risk for complications and readmission.