American heart journal最新文献_第4页

Risk of cardiovascular events after influenza infection-related hospitalizations in adults with congenital heart disease: A nationwide population based study 先天性心脏病患者因流感感染住院后发生心血管事件的风险--一项基于全国人口的研究。

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2024-09-04 DOI: 10.1016/j.ahj.2024.08.023

Background

Cardiovascular complications due to viral infection pose a significant risk in vulnerable patients such as those with congenital heart disease (CHD). Limited data exists regarding the incidence of influenza and its impact on cardiovascular outcomes among this specific patient population.

Methods

A retrospective cohort study was designed using the Canadian Congenital Heart Disease (CanCHD) database—a pan-Canadian database of CHD patients with up to 35 years of follow-up. CHD patients aged 40 to 65 years with influenza virus-associated hospitalizations between 2010 and 2017 were identified and 1:1 matched with CHD patients with limb fracture hospitalizations on age and calendar time. Our primary endpoint was cardiovascular complications: heart failure, acute myocardial infarction, atrial arrhythmia, ventricular arrhythmia, heart block, myocarditis, and pericarditis.

Results

Of the 303 patients identified with incident influenza virus-associated hospitalizations, 255 were matched to 255 patients with limb fracture hospitalizations. Patients with influenza virus-related hospitalizations showed significantly higher cumulative probability of cardiovascular complications at 1 year (0.16 vs. 0.03) and 5 years (0.33 vs. 0.15) compared to patients hospitalized with bone fracture. Time-dependent hazard function modeling demonstrated a significantly higher risk of cardiovascular complications within 9 months postdischarge for influenza-related hospitalizations. This association was confirmed by Cox regression model (average hazard ratio throughout follow-up: 2.48; 95% CI: 1.59-3.84).

Conclusions

This pan-Canadian cohort study of adults with CHD demonstrated an association between influenza virus-related hospitalization and risk of cardiovascular complications during the 9 months post discharge. This data is essential in planning surveillance strategies to mitigate adverse outcomes and provides insights into interpreting complication rates of other emerging pathogens, such as COVID-19.

背景：病毒感染导致的心血管并发症对先天性心脏病（CHD）患者等易感人群构成重大风险。有关流感发病率及其对这一特殊患者群体心血管后果影响的数据有限：我们利用加拿大先天性心脏病（CanCHD）数据库设计了一项回顾性队列研究，该数据库是一个泛加拿大先天性心脏病患者数据库，随访时间长达 35 年。研究人员对 2010 年至 2017 年期间因流感病毒住院的 40 岁至 65 岁先天性心脏病患者进行了鉴定，并根据年龄和日历时间与因肢体骨折住院的先天性心脏病患者进行了 1:1 匹配。我们的主要终点是心血管并发症：心力衰竭、急性心肌梗死、房性心律失常、室性心律失常、心脏传导阻滞、心肌炎和心包炎：在 303 例流感病毒相关住院患者中，有 255 例与 255 例肢体骨折住院患者相匹配。与骨折住院患者相比，流感病毒相关住院患者在一年（0.16 对 0.03）和五年（0.33 对 0.15）后出现心血管并发症的累积概率明显更高。时间依赖性危险函数模型显示，与流感相关的住院患者在出院后九个月内出现心血管并发症的风险明显更高。Cox回归模型证实了这一关联（整个随访期间的平均危险比：2.48；95% CI：1.59 - 3.84）：这项针对患有冠心病的成年人的泛加拿大队列研究表明，流感病毒相关住院治疗与出院后九个月内心血管并发症风险之间存在关联。这些数据对于规划监测策略以减轻不良后果至关重要，并为解读 COVID-19 等其他新病原体的并发症发生率提供了启示。

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引用次数: 0

Blood and urine metal levels in patients with diabetes and cardiovascular disease 糖尿病和心血管疾病患者血液和尿液中的金属水平

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2024-09-04 DOI: 10.1016/j.ahj.2024.07.003

引用次数: 0

Long term safety and outcomes after atrial shunting for heart failure with preserved or mildly reduced ejection fraction: 5-year and 3-year follow-up in the REDUCE LAP-HF I and II trials 射血分数保留或轻度降低的心力衰竭患者进行心房分流术后的长期安全性和疗效：REDUCE LAP-HF I 和 II 试验的 5 年和 3 年随访。

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2024-09-03 DOI: 10.1016/j.ahj.2024.08.014

Background

There is a little evidence regarding long-term safety and efficacy for atrial shunt devices in heart failure (HF).

Methods

The REDUCE LAP-HF I (n = 44) and II (n = 621) trials (RCT-I and -II) were multicenter, randomized, sham-controlled trials of patients with HF and ejection fraction >40%. Outcome data were analyzed from RCT-I, a mechanistic trial with 5-year follow-up, and RCT-II, a pivotal trial identifying a responder group (n = 313) defined by exercise PVR <1.74 WU and no cardiac rhythm management device with 3-year follow-up.

Results

At 5 years in RCT I, there were no differences in cardiovascular (CV) mortality, HF events, embolic stroke, or new-onset atrial fibrillation between groups. After 3 years in RCT II, there was no difference in the primary outcome (hierarchical composite of CV mortality, stroke, HF events, and KCCQ) between shunt and sham in the overall trial. Compared to sham, those with responder characteristics in RCT-II had a better outcome with shunt (win ratio 1.6 [95% CI 1.2-2.2], P = .006; 44% reduction in HF events [shunt 9 vs. control 16 per 100 patient-years], P = .005; and greater improvement in KCCQ overall summary score [+17.9 ± 20.0 vs. +7.6 ± 20.4], P < .001), while nonresponders had significantly more HF events. Shunt treatment at 3 years was associated with a higher rate of ischemic stroke (3.2% vs. 0%, 95% CI 2%-6.1%, P = .032) and lower incidence of worsening kidney dysfunction (10.7% vs. 19.3%, P = .041).

Conclusions

With up to 5 years of follow up, adverse events were low in patients receiving atrial shunts. In the responder group, atrial shunt treatment was associated with a significantly lower HF event rate and improved KCCQ compared to sham through 3 years of follow-up.

Clinicaltrials.gov registration:

NCT02600234, NCT03088033.

背景：关于心房分流装置在心力衰竭（HF）患者中的长期安全性和有效性，目前证据不足：关于心房分流装置在心力衰竭（HF）中的长期安全性和疗效，目前证据不足：REDUCE LAP-HF I (n=44) 和 II (n=621) 试验（RCT-I 和 -II）是针对射血分数大于 40% 的心力衰竭患者进行的多中心、随机、假对照试验。对 RCT-I 和 RCT-II 的结果数据进行了分析，RCT-I 是一项随访 5 年的机理试验，而 RCT-II 则是一项关键性试验，根据运动 PVR 确定了反应组（313 人）：在 RCT I 的 5 年随访中，各组之间在心血管（CV）死亡率、高血压事件、栓塞性中风或新发心房颤动方面没有差异。RCT II 试验 3 年后，在整个试验中，分流组与假体组的主要结果（CV 死亡率、中风、高频事件和 KCCQ 的分层复合结果）没有差异。与假体相比，RCT-II 中具有响应者特征的患者使用分流术的疗效更好（获胜比为 1.6 [95% CI 1.2-2.2]，P=0.006；高频事件减少 44%[每 100 患者年分流 9 例与对照组 16 例]，P=0.005；KCCQ 总分改善更大[+17.9±20.0 与 +7.6±20.4]，PC 结论：在长达5年的随访中，接受心房分流术的患者不良事件较少。在随访 3 年的应答组中，心房分流治疗与假治疗相比，可显著降低 HF 事件发生率并改善 KCCQ：NCT02600234、NCT03088033。

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引用次数: 0

Arrhythmias in congenital heart disease: A nationwide cohort study 先天性心脏病心律失常：全国队列研究。

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2024-09-02 DOI: 10.1016/j.ahj.2024.08.020

Background

As more patients with congenital heart disease (CHD) survive into adulthood, the population of adults with CHD is expanding. This trend is accompanied by an increasing incidence of complications, including arrhythmias. However, the long-term risk of arrhythmias remains sparsely investigated.

Methods

In this observational cohort study, all Danish patients with CHD born from 1977 to 2024 were identified using registries and followed from date of birth until the occurrence of arrhythmia, emigration, death, or end of follow-up (March 2024). The risk of arrhythmias was assessed among patients with CHD and compared to age- and sex-matched controls from the background population.

Results

A total of 45,820 patients with CHD (50.9% men) were identified and matched with 183,280 controls from the background population. During a median follow-up of 21.5 years, 2.6% of patients with CHD and 0.2% of controls developed arrhythmias—corresponding to incidence rates (IR) of 1.2 (95% CI 1.2-1.3) and 0.1 (95% CI 0.1-0.1) per 1,000 PY, respectively, and a hazard ratio (HR) of 16.4 (95% CI 14.4-18.7). The most common arrhythmias in patients with CHD were advanced atrioventricular block (IR 0.4 [95% CI 0.4-0.4] per 1,000 PY) and atrial flutter/fibrillation (IR 0.5 [95% CI 0.5-0.6] per 1,000 PY). Patients with malformations of the heart chambers, transposition of the great arteries, tetralogy of Fallot, and atrioventricular septal defect were at the highest risk of arrhythmias. Moreover, the risk of arrhythmias among those with ASD was not negligible. In patients with CHD, arrhythmia was associated with a significantly higher risk of death (HR of 6.9 [95% CI 5.9-8.1]).

Conclusions

Patients with CHD are at significantly higher risk of arrhythmias than the background population, and those with complex CHD are at particularly high risk. In patients with CHD, arrhythmia is associated with an increased risk of death. Additional studies are warranted to investigate how we can improve the diagnosis and management of arrhythmias in CHD.

背景：随着越来越多的先天性心脏病（CHD）患者存活到成年，患有先天性心脏病的成人群体也在不断扩大。伴随这一趋势的是包括心律失常在内的并发症发病率不断上升。然而，有关心律失常长期风险的研究仍然很少：在这项观察性队列研究中，通过登记册确定了 1977 年至 2024 年出生的所有丹麦先天性心脏病患者，并从出生日期开始进行随访，直至发生心律失常、移民、死亡或随访结束（2024 年 3 月）。对心脏病患者的心律失常风险进行了评估，并与背景人群中年龄和性别匹配的对照组进行了比较：共发现 45,820 名先天性心脏病患者（50.9% 为男性），并与 183,280 名背景人群中的对照组进行了配对。在中位 21.5 年的随访期间，2.6% 的冠心病患者和 0.2% 的对照组患者出现了心律失常，对应的发病率 (IR) 分别为每 1,000 人 1.2 例（95%CI 1.2-1.3）和 0.1 例（95%CI 0.1-0.1），危险比 (HR) 为 16.4（95%CI 14.4-18.7）。先天性心脏病患者最常见的心律失常是晚期房室传导阻滞（IR 0.4 [95%CI 0.4-0.4] per 1,000 PY）和心房扑动/颤动（IR 0.5 [95%CI 0.5-0.6] per 1,000 PY）。心室畸形、大动脉转位、法洛氏四联症和房间隔缺损患者发生心律失常的风险最高。此外，ASD 患者发生心律失常的风险也不容忽视。在患有冠心病的患者中，心律失常与显著较高的死亡风险相关（HR 为 6.9 [95%CI 5.9-8.1]）：结论：患有冠心病的患者发生心律失常的风险明显高于其他人群，而患有复杂冠心病的患者发生心律失常的风险尤其高。在冠心病患者中，心律失常与死亡风险增加有关。我们有必要开展更多的研究，探讨如何改进对冠心病心律失常的诊断和管理。

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引用次数: 0

Contributors to high left ventricular ejection fraction in women with ischemia and no obstructive coronary artery disease: Results from the Women's Ischemia Syndrome Evaluation—Coronary Vascular Dysfunction (WISE-CVD) Study 缺血且无阻塞性冠状动脉疾病的女性左心室射血分数高的原因：女性缺血综合征评估-冠状动脉血管功能障碍（WISE-CVD）研究结果。

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2024-09-02 DOI: 10.1016/j.ahj.2024.08.021

Background

There are sex differences in left ventricular ejection fraction (LVEF) relevant to prognosis where women experience greater mortality at relatively higher LVEF compared to men, yet mechanistic understanding of this adverse prognosis is limited. Women with suspected ischemia with no obstructive coronary disease (INOCA) develop heart failure with preserved ejection fraction (HFpEF), yet contributors to LVEF remain largely unknown.

Methods

In 370 women with suspected ischemia with no obstructive coronary disease (INOCA) who prospectively underwent cardiac magnetic resonance imaging (CMRI), we investigated the contributions of LV morphology, function, and myocardial perfusion reserve on LVEF using univariate and multiple linear regression.

Results

A majority 71% of participants had high LVEF (>65%), followed by 24% having normal LVEF (55%-65%), and only 5% having low EF (<55%). Baseline characteristics were comparable among the 3 groups, with the exception of age which was 6 years higher in the high LVEF group (P < .01). Women in the high LVEF group also had the lowest LV cavity volume, greatest LV mass-volume ratio, and highest LV end-systolic elastance (all P < .05, adjusted for age, BMI, diabetes, and blood pressure). Myocardial perfusion reserve index was low in all groups (mean MPRI < 2.1) but was not significantly different across the spectrum of LVEF (P = .458).

Conclusions

Taken together, these data demonstrate that the majority of women with suspected INOCA have elevated LVEF related to smaller, thicker ventricles with greater contractility. Future work is needed to better understand the specific mechanisms driving morphologic and functional changes in women with INOCA, and relations to longer-term HFpEF and mortality.

Clinical Trials Registration

NCT02582021.

背景：左心室射血分数（LVEF）的性别差异与预后有关，与男性相比，女性在LVEF相对较高的情况下死亡率更高，但对这种不良预后的机理了解有限。疑似无梗阻性冠状动脉疾病（INOCA）缺血的女性会出现射血分数保留型心力衰竭（HFpEF），但 LVEF 的影响因素在很大程度上仍然未知：方法：在370名接受了心脏磁共振成像（CMRI）前瞻性检查的疑似无梗阻性冠状动脉疾病（INOCA）女性患者中，我们使用单变量和多元线性回归法研究了左心室形态、功能和心肌灌注储备对LVEF的影响：结果：71%的参与者具有高 LVEF（>65%），24%的参与者具有正常 LVEF（55-65%），仅有 5%的参与者具有低 EF：综上所述，这些数据表明，大多数疑似 INOCA 患者的 LVEF 升高与心室较小、较厚且收缩力较强有关。未来的工作需要更好地了解驱动 INOCA 女性患者形态和功能变化的具体机制，以及与长期高房颤和死亡率的关系：临床试验注册：NCT02582021。

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引用次数: 0

Low-dose colchicine for the prevention of cardiovascular events after percutaneous coronary intervention: Rationale and design of the COL BE PCI trial 低剂量秋水仙碱预防经皮冠状动脉介入术后心血管事件：COL BE PCI 试验的原理和设计：简称：COL BE PCI 试验的原理和设计。

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2024-09-02 DOI: 10.1016/j.ahj.2024.08.022

Introduction

Patients with coronary artery disease (CAD) remain vulnerable to future major atherosclerotic events after revascularization, despite effective secondary prevention strategies. Inflammation plays a central role in the pathogenesis of CAD and recurrent events. To date, there is no specific anti-inflammatory medicine available with proven effective, cost-efficient, and favorable benefit-risk profile, except for colchicine. Initial studies with colchicine have sparked major interest in targeting atherosclerotic events with anti-inflammatory agents, but further studies are warranted to enforce the role of colchicine role as a major treatment pillar in CAD. Given colchicine's low cost and established acceptable long-term safety profile, confirming its efficacy through a pragmatic trial holds the potential to significantly impact the global burden of cardiovascular disease.

Methods

The COL BE PCI trial is an investigator-initiated, multicenter, double-blind, event-driven trial. It will enroll 2,770 patients with chronic or acute CAD treated with percutaneous coronary intervention (PCI) at 19 sites in Belgium, applying lenient in- and exclusion criteria and including at least 30% female participants. Patients will be randomized between 2 hours and 5 days post-PCI to receive either colchicine 0.5 mg daily or placebo on top of contemporary optimal medical therapy and without run-in period. All patients will have baseline hsCRP measurements and a Second Manifestations of Arterial Disease (SMART) risk score calculation. The primary endpoint is the time from randomization to the first occurrence of a composite endpoint consisting of all-cause death, spontaneous non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization. The trial is event-driven and will continue until 566 events have been reached, providing 80% power to detect a 21 % reduction in the primary endpoint taking a premature discontinuation of 15% into account. We expect a trial duration of approximately 44 months.

Conclusion

The COL BE PCI Trial aims to assess the effectiveness and safety of administering low-dose colchicine for the secondary prevention in patients with both chronic and acute coronary artery disease undergoing PCI. Trial registration: ClinicalTrials.gov: NCT06095765.

尽管采取了有效的二级预防策略，但冠状动脉疾病（CAD）患者在接受血管再通手术后仍很容易发生严重的动脉粥样硬化事件。炎症在冠心病和复发事件的发病机制中起着核心作用。迄今为止，除秋水仙碱外，尚无其他经证实有效、经济、效益与风险兼顾的特效抗炎药物。对秋水仙碱的初步研究引发了人们对使用抗炎药物治疗动脉粥样硬化事件的浓厚兴趣，但要使秋水仙碱成为治疗 CAD 的主要药物，还需要进一步的研究。鉴于秋水仙碱的低成本和可接受的长期安全性，通过实用性试验确认其疗效有可能对全球心血管疾病负担产生重大影响。COL BE PCI 试验是一项由研究者发起的多中心、双盲、事件驱动试验。它将在比利时的 19 个地点招募 2770 名接受经皮冠状动脉介入治疗（PCI）的慢性或急性 CAD 患者，采用宽松的纳入和排除标准，女性参与者至少占 30%。患者将在经皮冠状动脉介入术后 2 小时至 5 天内随机接受秋水仙碱 0.5 毫克/天或安慰剂治疗，并在此基础上接受当代最佳药物治疗，不设磨合期。所有患者都将接受基线 hsCRP 测量和动脉疾病第二次表现（SMART）风险评分计算。主要终点为从随机化到首次出现复合终点的时间，复合终点包括全因死亡、自发性非致死性心肌梗死、非致死性中风或冠状动脉血运重建。该试验是由事件驱动的，将持续到 566 个事件发生为止，考虑到 15%的过早停药率，该试验将提供 80% 的功率来检测主要终点 21% 的降低率。我们预计试验持续时间约为 44 个月。COL BE PCI 试验旨在评估对接受 PCI 治疗的慢性和急性冠状动脉疾病患者使用小剂量秋水仙碱进行二级预防的有效性和安全性。试验注册：ClinicalTrials.gov：NCT06095765。

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引用次数: 0

Temporal trends in infection-related hospitalizations among patients with heart failure: A Danish nationwide study from 1997 to 2017 心力衰竭患者感染相关住院治疗的时间趋势：1997-2017 年丹麦全国性研究。

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2024-08-30 DOI: 10.1016/j.ahj.2024.08.016

Background

Despite improved survival, hospitalization is still common among patients with heart failure (HF).

Objective

This study aimed to examine temporal trends in infection-related hospitalization among HF patients and compare it to temporal trends in the risk of HF hospitalization and death.

Methods

Using Danish nationwide registers, we included all patients aged 18 to 100 years, with HF diagnosed between January 1, 1997 and December 31, 2017, resulting in a total population of 147.737 patients. The outcomes of interest were primarily infection-related hospitalization and HF hospitalization and secondarily all-cause mortality. The Aalen Johansen's estimator was used to estimate 5-year absolute risks for the primary outcomes. Additionally, cox analysis was used for adjusted analyses.

Results

The population had a median age of 74 [64, 82] years and 57.6 % were males. Patients with HF had a higher risk of infection over time 16.4 % (95% CI 16.0-16.8) in 1997 to 2001 vs 24.5% (95% CI 24.0-24.9) in 2012 to 2017. In contrast, they had a lower risk of HF hospitalization 26.5% (95% CI 26.1-27.0) in 1997 to 2001 vs 23.2% (95% CI 22.8-23.7) in 2012 to 2017. The risk of infection stratified by infection type showed similar trends for all infection types and marked the risk of pneumonia infection as the most significant in all subintervals.

Conclusion

In the period from 1997 to 2017, we observed patients with HF had an increased risk of infection-related hospitalization, driven by pneumonia infections. In contrast, the risk of HF hospitalization decreased over time.

背景：尽管生存率有所提高，但心力衰竭（HF）患者住院治疗的情况仍很普遍：尽管生存率有所提高，但心力衰竭（HF）患者住院治疗仍很常见：本研究旨在探讨心衰患者感染相关住院治疗的时间趋势，并将其与心衰住院和死亡风险的时间趋势进行比较：通过丹麦全国范围内的登记，我们纳入了所有年龄在18-100岁之间、在1997年1月1日至2017年12月31日期间确诊为心房颤动的患者，总人数为147737人。研究结果主要是感染相关住院治疗和心房颤动住院治疗，其次是全因死亡率。Aalen Johansen 估计器用于估计主要结果的五年绝对风险。此外，还采用了 cox 分析法进行调整分析：研究对象的中位年龄为 74 [64, 82] 岁，57.6% 为男性。1997-2001年，高血压患者的感染风险为16.4%（95% CI 16.0-16.8），而2012-2017年为24.5%（95% CI 24.0-24.9）。相比之下，1997-2001年与2012-2017年，他们的心房颤动住院风险分别为26.5%（95% CI 26.1-27.0）和23.2%（95% CI 22.8-23.7）。按感染类型分层的感染风险显示出所有感染类型的相似趋势，并标志着肺炎感染风险在所有子区间内最为显著：1997年至2017年期间，我们观察到，在肺炎感染的驱动下，高血压患者与感染相关的住院风险增加。相比之下，随着时间的推移，心房颤动住院风险有所降低。

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引用次数: 0

Accelerometer-measured physical activity in patients with heart failure and reduced ejection fraction: Determinants and relationship with patient-reported health status 加速度计测量的心力衰竭和射血分数降低患者的体力活动：决定因素及与患者自述健康状况的关系。

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2024-08-30 DOI: 10.1016/j.ahj.2024.08.017

Background

Accelerometer-measured physical activity is an increasingly used endpoint in heart failure (HF) trials. We investigated the determinants of accelerometer-measured physical activity and the relationship with patient-reported health status.

Methods

Post-hoc analysis of the Empire HF trial, including outpatients with HF with reduced ejection fraction (HFrEF). Physical activity was quantified as average accelerometer counts per minute (CPM) with higher values representing higher activity. We investigated associations between activity level and clinical variables, including age, sex, and body mass index, as well as patient-reported health status assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ).

Results

Complete data were available in 180 (95%) patients (86% male, mean age 65 year). Baseline median physical activity level was 1,318 CPM (Q1-Q3 1,111-1,585). Age and anemia were independently associated with activity level (β-coefficients: −10 CPM per year age increase [95% CI −16 to −5.1], P = .00015, and −126 CPM for anemia [95% CI −9.1 to −244], P = .035). Significant independent associations were observed between activity level and all KCCQ summary scores (β-coefficient point estimates of 3.7, 4.6, and 4.9 CPM, all P < .02). For 12-week changes in KCCQ-summary scores, only the KCCQ-CSS was associated with activity level; mean increase of 17.5 CPM [95% CI 1.5 to 34.0], P = 0.032, per 5-point increase in KCCQ-CSS. Associations were not modified by treatment allocation (interaction P-values > .05).

Conclusions

In patients with HFrEF, older age and anemia were independently associated with lower activity. Moreover, physical activity only weakly increased with better health status, suggesting that changes in physical activity reflect improvements in patients’ health status to a limited degree. This highlights the need to better understand the endpoint with regards to all other health parameters to ease interpretation in future HF trials.

背景：在心力衰竭（HF）试验中，加速计测量的体力活动越来越多地成为终点。我们研究了加速计测量的体力活动的决定因素以及与患者报告的健康状况之间的关系：方法：对 Empire HF 试验进行事后分析，包括射血分数降低的 HF（HFrEF）门诊患者。体力活动以加速计平均每分钟计数（CPM）进行量化，数值越高代表活动量越大。我们研究了活动量与年龄、性别、体重指数等临床变量以及堪萨斯城心肌病问卷（KCCQ）评估的患者报告健康状况之间的关系：180名（95%）患者（86%为男性，平均年龄65岁）提供了完整的数据。基线体力活动水平中位数为 1318 CPM（Q1-Q3 1111-1585）。年龄和贫血与活动量有独立关联（β系数：年龄每增加一年，活动量增加-10 CPM）：年龄每年增加 -10 CPM [95% CI -16 至 -5.1]，p=0.00015；贫血每年增加 -126 CPM [95% CI -9.1 至 -244]，p=0.035）。活动量与所有 KCCQ 总分之间存在显著的独立关联（β系数点估计值分别为 3.7、4.6 和 4.9 CPM，均为 p0.05）：结论：在心房颤动低氧血症患者中，年龄较大和贫血与活动量较少密切相关。此外，随着健康状况的改善，体力活动量仅有微弱的增加，这表明体力活动量的变化在一定程度上反映了患者健康状况的改善。这突出表明，有必要更好地理解终点与所有其他健康参数的关系，以便于在未来的高血压试验中进行解释。

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引用次数: 0

Milvexian vs apixaban for stroke prevention in atrial fibrillation: The LIBREXIA atrial fibrillation trial rationale and design 用于预防心房颤动中风的米维仙与阿哌沙班：LIBREXIA 心房颤动试验的原理与设计。

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2024-08-29 DOI: 10.1016/j.ahj.2024.08.011

Background

Direct oral anticoagulants are the standard of care for stroke prevention in eligible patients with atrial fibrillation and atrial flutter; however, bleeding remains a significant concern, limiting their use. Milvexian is an oral Factor XIa inhibitor that may offer similar anticoagulant efficacy with less bleeding risk.

Methods

LIBREXIA AF (NCT05757869) is a global phase III, randomized, double-blind, parallel-group, event-driven trial to compare milvexian with apixaban in participants with atrial fibrillation or atrial flutter. Participants are randomly assigned to milvexian 100 mg or apixaban (5 mg or 2.5 mg per label indication) twice daily. The primary efficacy objective is to evaluate if milvexian is noninferior to apixaban for the prevention of stroke and systemic embolism. The principal safety objective is to evaluate if milvexian is superior to apixaban in reducing the endpoint of International Society of Thrombosis and Hemostasis (ISTH) major bleeding events and the composite endpoint of ISTH major and clinically relevant nonmajor (CRNM) bleeding events. In total, 15,500 participants from approximately 1,000 sites in over 30 countries are planned to be enrolled. They will be followed until both 430 primary efficacy outcome events and 530 principal safety events are observed, which is estimated to take approximately 4 years.

Conclusion

The LIBREXIA AF study will determine the efficacy and safety of the oral Factor XIa inhibitor milvexian compared with apixaban in participants with either atrial fibrillation or atrial flutter.

Trial registration

ClinicalTrials.gov NCT05757869

背景：直接口服抗凝剂是符合条件的心房颤动和心房扑动患者预防中风的标准治疗方法；然而，出血仍是一个重大问题，限制了其使用。Milvexian 是一种口服因子 XIa 抑制剂，可提供类似的抗凝疗效，但出血风险较低：LIBREXIA AF (NCT05757869)是一项全球性的III期、随机、双盲、平行组、事件驱动试验，旨在比较米维仙与阿哌沙班在心房颤动或心房扑动患者中的疗效。参与者被随机分配到米维仙 100 毫克或阿哌沙班（根据标签说明为 5 毫克或 2.5 毫克），每天两次。主要疗效目标是评估米维仙在预防中风和全身性栓塞方面的效果是否优于阿哌沙班。主要安全性目标是评估米维仙在减少国际血栓与止血学会（ISTH）主要出血事件终点以及ISTH主要和临床相关非主要（CRNM）出血事件复合终点方面是否优于阿哌沙班。计划共招募来自 30 多个国家约 1000 个研究机构的 15500 名参与者。他们将接受随访，直至观察到430例主要疗效结果事件和530例主要安全性事件，预计需要约4年时间：LIBREXIA 心房颤动研究将确定口服因子 XIa 抑制剂米维仙与阿哌沙班相比，对心房颤动或心房扑动患者的疗效和安全性：试验注册：ClinicalTrials.gov NCT05757869。

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引用次数: 0

Variations in antihypertensive medication treatment and blood pressure control among Veterans with HIV and existing hypertension 感染艾滋病毒并患有高血压的退伍军人在抗高血压药物治疗和血压控制方面的差异。

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2024-08-29 DOI: 10.1016/j.ahj.2024.08.009

Background

Hypertension is a leading risk factor for cardiovascular disease among patients living with HIV (PLWH). Understanding the predictors and patterns of antihypertensive medication prescription and blood pressure (BP) control among PLWH with hypertension (HTN) is important to improve the primary prevention efforts for this high-risk population. We sought to assess important patient-level correlates (eg, race) and inter-facility variations in antihypertension medication prescriptions and BP control among Veterans living with HIV (VLWH) and HTN.

Methods

We studied VLWH with a diagnosis of HTN who received care in the Veterans Health Administration (VHA) from January 2018 to December 2019. We evaluated HTN treatment and blood pressure control across demographic variables, including race, and by medical comorbidities. Data were also compared among VHA facilities. Predictors of HTN treatment and control were assessed in 2-level hierarchical multivariate logistic regression models to estimate odds ratios (ORs). The VHA facility random-effects parameters from the hierarchical models were used to calculate the median odds ratios to characterize the variation across the different VHA facilities.

Results

A total of 17,468 VLWH with HTN (mean age 61 years, 97% male, 54% Black, 40% White) who received care within the VHA facilities in 2018-2019 were included. 73% were prescribed antihypertension medications with higher prescription rates among Black vs White patients (75% vs 71%) and higher prescription rates among patients with a history of cardiovascular disease, diabetes, and kidney disease (>80%), and those receiving antiretroviral therapy and with controlled HIV viral load (∼75%). Only 27% of VLWH with HTN had optimal BP control of systolic BP <130 mmHg and diastolic BP <80 mmHg, with a lower rate of control among Black vs White patients (24% v. 31%). In multivariate regression, Black patients had a higher likelihood of HTN medication prescription (OR 1.32, 95% CI: 1.22-1.42) but were less likely to have optimal BP control (OR 0.82; 0.76-0.88). Important positive correlates of antihypertensive prescription and optimal BP control included: number of outpatient visits in prior year, and histories of diabetes, coronary artery disease, and heart failure. There was about 10% variability in both antihypertensive prescription and BP control patterns between VHA facilities for patients with similar characteristics. There was increased inter-facility variation in antihypertensive prescription among those with a history of heart failure and those not receiving antiretroviral therapy.

Conclusion

In a retrospective analysis of large VHA data, we found that VLWH with HTN have suboptimal antihypertensive medication prescription and BP control. Black VLWH had higher HTN medication prescription rates but lower optimal BP control.

背景：高血压是艾滋病病毒感染者（PLWH）罹患心血管疾病的主要风险因素。了解患有高血压（HTN）的艾滋病病毒感染者的降压药物处方和血压（BP）控制的预测因素和模式，对于改善这一高风险人群的初级预防工作非常重要。我们试图找出患者层面的重要相关因素（如种族），并评估感染艾滋病毒的退伍军人（VLWH）和高血压患者在抗高血压药物处方和血压控制方面的机构间差异：我们研究了 2018 年 1 月至 2019 年 12 月期间在退伍军人健康管理局（VHA）接受治疗的诊断为高血压的 VLWH。我们评估了不同人口统计学变量（包括种族）和不同医疗合并症的高血压治疗和血压控制情况。我们还对退伍军人健康管理局各机构的数据进行了比较。在两级分层多变量逻辑回归模型中评估了高血压治疗和控制的预测因素，以估算出几率比（OR）。分层模型中的VHA设施随机效应参数用于计算中位几率比，以描述不同VHA设施之间的差异：共纳入17468名患有高血压的VLWH（平均年龄61岁，97%为男性，54%为黑人，40%为白人），他们于2018-2019年在VHA设施内接受治疗。73%的患者处方了抗高血压药物，其中黑人与白人患者的处方率更高（75% vs. 71%），有心血管疾病、糖尿病和肾脏疾病病史的患者处方率更高（>80%），接受抗逆转录病毒治疗且HIV病毒载量得到控制的患者处方率更高（∼75%）。在患有高血压的 VLWH 患者中，只有 27% 的人收缩压得到了最佳控制：在对 VHA 大量数据的回顾性分析中，我们发现患有高血压的 VLWH 的降压药物处方和血压控制均未达到最佳水平。黑人超低体重儿的高血压药物处方率较高，但最佳血压控制率较低。

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引用次数: 0