Cardiology and Therapy最新文献

Introduction: Cardiogenic shock (CS) is a life-threatening failure of the heart to supply adequate blood, requiring immediate treatment. Although nowadays Impella^® heart pumps and veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) are both widely employed in routine clinical practice for the management of patients with CS, extensive comparative information on their cost-effectiveness is lacking. The aim of the present study was to conduct a cost-effectiveness analysis comparing Impella to VA-ECMO in patients with CS from the National Healthcare Service (NHS) perspective in Italy. A secondary objective was to compare costs from both NHS and hospital perspectives.

Methods: A Markov model projected, on a lifetime horizon, life years (LYs), quality-adjusted life years (QALYs), and costs associated with Impella and VA-ECMO. Costs from the NHS perspective were estimated mainly through Italian reimbursement rates, while hospital costs were derived from a clinical center in Italy.

Results: From an NHS perspective, Impella showed lower costs and better life expectancy and patients' quality of life (€50,303, 1.544 LYs, 0.905 QALYs) compared to VA-ECMO (€76,795, 1.391 LYs, 0.784 QALYs). DRG overall reimbursements for Impella (€49,998) do not completely cover the hospital costs and the cost for the technology (€57,770). Conversely, the hospital cost for the strategy VA-ECMO (€52,190) is lower than the NHS overall reimbursements (€76,790).

Conclusions: Our analysis suggests that Impella may be cost-saving over VA-ECMO, while also providing better health outcomes for patients with CS; however, discrepancies in costs and reimbursement rates were observed, likely due to variability in patient care and hospital resource utilization. Future real-world studies are needed to confirm these findings, but decision-makers can use this data as an initial reference for health technology assessments in Italy.

Introduction: Real-world data on atrial fibrillation (AF) in the Middle East and North Africa (MENA) region, including Egypt, are sparse. The aim of the FLOW-AF registry was to evaluate the characteristics, treatment patterns, and clinical and economic outcomes of newly diagnosed non-valvular atrial fibrillation (NVAF) patients within the MENA region, including Egypt.

Methods: This multicenter, prospective, observational registry enrolled newly diagnosed patients with NVAF from January 2020 to December 2022 at eight private-sector healthcare centers in Egypt. Data were collected at enrollment (baseline), and then at 6-month and 12-month follow-up. Baseline data included demographics, AF characteristics, medical history, and antithrombotic treatment patterns. Follow-up data included clinical events, healthcare resource utilization, and related costs.

Results: A total of 723 patients were enrolled. Overall, 51.87% were females, and the mean age was 61.9 years. All patients attended the private health sector. The mean (standard deviation) CHA₂DS₂-VASc and HAS-BLED risk scores were 2.37 (1.55) and 1.46 (1.18), respectively. Non-vitamin K antagonist oral anticoagulants (62.52%), vitamin K antagonists (22.28%), and antiplatelet therapy (9.85%) were among the prescribed treatments. Rates of transient ischemic attack and all-cause mortality were 2.64% and 0.83%, respectively; all other outcomes (stroke, bleeding, myocardial infarction, systemic embolism) occurred at a rate of ≤ 0.41%. Antithrombotic medications were the major contributors to per-patient total yearly cost (USD 381.2).

Conclusions: The FLOW-AF study showed that patients with NVAF in Egypt are younger and exhibit lower mean baseline CHA₂DS₂-VASc and HAS-BLED scores compared to Western and other Eastern regions. Additional research, including a broader study population with a longer follow-up, is essential to comprehensively assess the characteristics and outcomes of the NVAF population in Egypt.

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: Anthracyclines treat a myriad of malignancies; however, they are known to lead to cancer therapy-related cardiomyopathy (CTRC). Randomized controlled trials (RCTs) evaluating the role of angiotensin converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARBs) in primary prevention of CTRC have yielded mixed results.

Methods: A systematic search of MEDLINE, Cochrane, and Scopus databases was performed to identify RCTs that evaluated outcomes in patients receiving anthracyclines and ACEi or ARBs versus control. The primary outcome was occurrence of CTRC. All data were pooled using a random-effects model.

Results: The final analysis included 10 RCTs, with 1049 patients assessed. The weighted follow-up period was 16.8 months. The average age was 43.2 years and 90% were female. Breast cancer (80%) and lymphomas (13%) were the most common malignancies. There was no statistically significant difference between the groups with regards to occurrence of CTRC (16% vs 24%; risk ratio (RR) 0.67, 95% confidence interval (CI) [0.31, 1.45]). Compared with control, ACEi/ARBs were associated with favorable absolute changes in left ventricular ejection fraction (LVEF) (standardized mean difference (SMD) + 1.20%, 95% CI [0.40, 2.00]), left ventricular end-diastolic volume (SMD - 0.36 mL, 95% CI [- 0.66, - 0.06]), and left ventricular end-systolic volume (SMD - 1.04 mL, 95% CI [- 1.79, - 0.29]). There was also a lower risk of arrhythmias in the ACEi/ARBs group compared to control (1.6% vs 8.0%; RR 0.30, 95% CI [0.10, 0.94]), but no difference in all-cause mortality (2.8% vs 3.2%; RR 0.82, 95% CI [0.26, 2.61]), or heart failure (1.2% vs 7.1%; RR 0.40, 95% CI [0.03, 4.54]).

Conclusions: ACEi/ARBs therapy was not associated with a reduction in CTRC among patients with cancer receiving anthracyclines. However, there were favorable changes in LVEF and left ventricular remodeling with ACEi/ARBs therapy. Further large-scale studies are needed to better understand the potential role of ACEi/ARBs in preventing long-term cardiotoxicity.

Introduction: The ROsulord® sAfety for patients with Dyslipidemia study (ROAD study) in the Republic of Korea investigated the safety and efficacy of rosuvastatin in routine clinical practice.

Methods: This non-interventional, multicenter, prospective, observational study was conducted over a period of approximately 4.6 years and involved 14,243 participants. During this study, we assessed the adverse events, changes in laboratory test results, and efficacy endpoints associated with rosuvastatin use.

Results: The findings revealed a notably low adverse event rate of 1.63%, indicating a favorable safety profile for rosuvastatin in the management of dyslipidemia. Importantly, no clinically significant incidences of statin-associated myopathy, hepatotoxicity, or diabetes were observed during the study period. Moreover, this study demonstrated significant improvements in lipid profiles among patients receiving rosuvastatin treatment, with a reduction in total cholesterol, low-density lipoprotein cholesterol, and triglyceride levels. These improvements contributed to a lower cardiovascular risk in the study population.

Conclusion: Overall, these findings suggest that rosuvastatin is safe and effective in managing dyslipidemia in real-world clinical settings, providing clinicians with valuable insights into the benefits and risks associated with statin therapy in this patient population.

In addition to traditional risk factors, patients with breast cancer are at an increased risk of atrial fibrillation due to cancer itself and certain cancer therapies. Atrial fibrillation in these patients adds to their morbidity and mortality. The precise mechanisms leading to the increased atrial fibrillation in patients with breast cancer are not well understood. The main goal of atrial fibrillation management in this population is to facilitate uninterrupted cancer treatment while addressing the arrhythmia and other cardiovascular sequelae of cancer treatment. Rhythm control is often challenging to implement in patients with breast cancer during active antineoplastic therapy because of the need for uninterrupted anticoagulation, potential drug-drug interactions between cancer treatments and antiarrhythmic medications, and the increased likelihood of atrial fibrillation recurrence. Prevention of thromboembolism and anticoagulation can also be challenging in patients with breast cancer as a result of the increased risk of cancer-related procoagulant state and coagulopathies. The integration of a cardio-oncology team and a multidisciplinary approach are crucial for better outcomes. The therapeutic interventions should be tailored toward individual patients' profiles through a shared decision-making approach. The precise mechanisms leading to the increased atrial fibrillation in patients with breast cancer are not well understood, highlighting the gaps in our knowledge. More research is required to reduce these gaps, refine risk stratification, and optimize treatment strategies in these patients.

Introduction: Data on the prevalence of hypertrophic cardiomyopathy (HCM), characteristics of patients with HCM, and treatment patterns in Japan are limited. This study aimed to estimate the prevalence of HCM and describe the patient characteristics, treatment patterns, and utilization of medical expense subsidies in Japan, using payer claims data from insurers.

Methods: This retrospective study of patients with HCM in Japan utilized payer claims data from insurers (Advanced Elderly Medical Service System [AEMSS], Kokuho, and Kempo) from January 1, 2017, to December 31, 2021. The prevalence of HCM was calculated annually; while medication use, comorbidities, and usage of medical expense subsidies were described for 2021 as representative data.

Results: The estimated prevalence of HCM increased from 9.3/10,000 people in 2017 to 11.1/10,000 people in 2021. In 2021, the highest prevalence was observed in patients aged 85-89 years (39.0/10,000 people). For patients with HCM, mean (standard deviation) age was 82.5 (5.5) years (AEMSS), 66.7 (9.2) years (Kokuho), and 53.4 (14.0) years (Kempo). Hypertension was the most common comorbidity (AEMSS, 90.7%; Kokuho, 85.7%; Kempo, 71.4%), followed by heart failure (AEMSS, 77.3%; Kokuho, 64.4%; Kempo, 56.9%). Mental health disorders were reported in 22.4% (AEMSS), 16.3% (Kokuho), and 11.3% (Kempo) of patients with HCM. Beta-blockers were the most frequently prescribed medications (AEMSS, 65.1%; Kokuho, 63.2%; Kempo, 56.6%). A small proportion of patients whose HCM was diagnosed in 2021 received medical expense subsidies (AEMSS, 2.6%; Kokuho, 4.6%).

Conclusions: This study is the first to evaluate the prevalence of HCM in Japan using data from the general population as the denominator. It indicated that patients with HCM are typically > 50 years old, have a high prevalence of comorbidities, are commonly treated with beta-blockers, and rarely receive medical expense subsidies for designated intractable diseases. About one-fifth of the patients had mental health disorders.

Introduction: Clinical trial evidence supports early low-density lipoprotein cholesterol (LDL-C) goal achievement in patients with atherosclerotic cardiovascular disease (ASCVD), but real-world evidence in Asia is lacking. We investigated the effects of early LDL-C goal achievement on recurrent major cardiovascular events (MACEs) among patients with very-high-risk ASCVD in South Korea.

Methods: We included adult patients hospitalized with ASCVD (acute coronary syndrome [ACS], stable angina, ischemic stroke, transient ischemic attack, peripheral arterial disease, or asymptomatic coronary artery disease) at a major Korean tertiary hospital from 2000 to 2020. Patients were categorized into early or non-early target LDL-C groups based on LDL-C measured 4-12 weeks post-discharge (< 55 vs. ≥ 55 mg/dl). The primary outcome was recurrent MACEs, including myocardial infarction, ischemic stroke, all-cause mortality, hospitalization for unstable angina, and coronary revascularization. The secondary outcome was health resource use (frequency/length of stay [LOS]).

Results: During follow-up (mean: 5 years), the early target LDL-C group (n = 5702) had a lower risk of recurrent MACEs compared with the non-early target LDL-C group (n = 11,232; adjusted hazard ratio [95% CI]: 0.89 [0.82-0.96]). The effect was most pronounced in patients with ACS (0.73 [0.63-0.85]), particularly for recurrent MACEs within 6 months (0.61 [0.44-0.87]). The early target LDL-C group had 19% lower frequency and 31% shorter LOS for cardiovascular-related hospitalizations than the non-early group.

Conclusions: Early LDL-C goal achievement was associated with lower recurrent MACEs in patients with very-high-risk ASCVD in South Korea, especially in patients with ACS. These findings underscore the importance of early LDL-C management in improving cardiovascular outcomes.

Introduction: This prospective, single-arm pharmacodynamic study assessed the effect of colchicine (COLC) [Strides Pharma UK Ltd, Watford, Hertfordshire, England] 0.5 mg administered orally once daily for 14 days on platelet reactivity with respect to aspirin reaction units (ARUs) and P2Y₁₂ reaction units (PRUs).

Methods: Twenty-two patients with stable coronary artery disease (CAD) on dual antiplatelet therapy (DAPT) with daily maintenance aspirin and clopidogrel were recruited. Baseline platelet function was evaluated with the VerifyNow™ ARU and PRU assays (Werfen, Bedford, MA, USA) and assessed post-completion of COLC 0.5 mg once daily for 14 days.

Results: In this study, the median ARU baseline score was 463, and post-COLC it was 436, which was not statistically significant (p = 0.485). The mean difference in scores was -18.31 (95% confidence interval [CI] -74.34 to 37.71, p = 0.504). At baseline, 27.3% of the patients had "aspirin resistance" or were non-responders, compared to 13.6% post-COLC (p = 0.423). The median baseline PRU score was 210, and post-COLC it was 199, which was also not statistically significant (p = 0.581). The mean difference in scores was -7.31 (95% CI -31.1 to 16.5, p = 0.530). At baseline, 50% of the patients had "clopidogrel resistance" or were non-responders, compared to 45.5% post-COLC (p = 0.999). Two patients experienced mild gastrointestinal upset during the trial without interruption of COLC, and there were no serious adverse events or treatment-emergent adverse events.

Conclusions: There were no significant differences in ARUs and PRUs post-COLC trial in patients with stable CAD. This pilot pharmacodynamic study could be clinically informative in patients on DAPT. Further studies are required to confirm these exploratory findings.

Trial registration: ClinicalTrials.gov identifier, NCT06567678, prospectively registered 20/8/2024.

Introduction: Oral anticoagulants (OAC) reduce the risk of stroke among patients with atrial fibrillation (AF). However, adherence remains suboptimal. We focused on primary nonadherence to OAC and its associations with patient characteristics-specifically social determinants of health collected in electronic health records (EHR).

Methods: This retrospective cohort study used EHR data linked to prescription fill data from a large, integrated Midwestern community healthcare system. Adult patients with an incident AF diagnosis from 2020 to 2021 and a first OAC prescription (index visit) were included. Primary nonadherence was defined as failure to fill an initial OAC prescription within 30 days. Outcomes included 1-year all-cause mortality, first stroke, and first bleed after first OAC prescription. Multivariable logistic regression models evaluated the likelihood of primary nonadherence, and multivariable Cox proportional hazard models evaluated the association between primary nonadherence with outcomes.

Results: Among 8679 patients, 46% were female, 82% were non-Hispanic white, and the mean age was 71.3 ± 12.1 years. Twenty-one percent were primary nonadherent. The odds of primary nonadherence were greater among patients who were non-Hispanic Black, older (≥ 75 years), male, lacking commercial insurance, not employed/retired, and referred to social work; similar results were observed for secondary nonadherence. Primary nonadherence was associated with an increased risk of all-cause mortality (hazard ratio, 1.69; 95% confidence interval, 1.42-2.01).

Conclusion: These results reveal disparities in primary nonadherence among patients with a new AF diagnosis. There is a need to develop and test interventions for primary nonadherence that are implemented in disadvantaged patients, among whom nonadherence is highest.