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Cardiologist Perceptions on Automated Alerts and Messages To Improve Heart Failure Care. 心脏病专家对自动提示和信息改善心衰护理的看法。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-16 DOI: 10.1016/j.ahj.2024.10.007
Samuel D Maidman, Saul Blecker, Harmony R Reynolds, Lawrence M Phillips, Margaret M Paul, Arielle R Nagler, Adam Szerencsy, Archana Saxena, Leora I Horwitz, Stuart D Katz, Amrita Mukhopadhyay

Electronic health record (EHR)-embedded tools are known to improve prescribing of guideline-directed medical therapy (GDMT) for patients with heart failure. However, physicians may perceive EHR tools to be unhelpful, and may be therefore hesitant to implement these in their practice. We surveyed cardiologists about two effective EHR-tools to improve heart failure care, and they perceived the EHR tools to be easy to use, helpful, and improve the overall management of their patients with heart failure.

众所周知,电子健康记录(EHR)嵌入式工具可改善心衰患者的指导性医疗疗法(GDMT)处方。然而,医生可能会认为电子病历工具没有帮助,因此在实践中犹豫不决。我们就两种有效改善心衰护理的电子病历工具对心脏病学家进行了调查,他们认为电子病历工具易于使用、有帮助并能改善心衰患者的整体管理。
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引用次数: 0
Real-World Exploration of LDL-Cholesterol Management in Patients with Atherosclerotic Cardiovascular Disease. 动脉粥样硬化性心血管疾病患者低密度脂蛋白胆固醇管理的真实世界探索。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-16 DOI: 10.1016/j.ahj.2024.10.009
Nishant P Shah, Hillary Mulder, Betsy Lydon, Karen Chiswell, Xingdi Hu, Zachary Lampron, Lauren Cohen, Manesh R Patel, Susan Taubes, Wenliang Song, Suresh R Mulukutla, Anum Saeed, Daniel P Morin, Steven M Bradley, Adrian F Hernandez, Neha J Pagidipati

Background: Although guidelines recommend low-density lipoprotein cholesterol (LDL-C) to be <70mg/dL in patients with atherosclerotic cardiovascular disease (ASCVD), the rate of achieving this goal remains suboptimal. We sought to understand real world contemporary practice patterns of LDL-C management in patients with ASCVD, and whether LDL-C testing influenced management across US health systems.

Methods: A retrospective cohort study utilizing electronic medical record data from five health systems participating in the CardioHealth Alliance was performed on patients with an LDL-C measurement in 2021 and prior ASCVD. Multivariable regression modeling was used to determine the relationship of clinical factors with achievement of guideline directed LDL-C target. Changes in lipid lowering therapy (LLT) after LDL-C testing were also described.

Results: Among 216,074 patients with ASCVD, 129,886 (60.1%) had uncontrolled LDL-C (i.e. ≥70 mg/dL). Compared with participants with controlled LDL-C (<70mg/dL), those with uncontrolled LDL-C were more frequently female (50.9% vs 35.1%), or Black (13.7% vs. 10.3%), and less commonly had coronary artery disease as the form of vascular disease (73.0% vs. 83.5% %), heart failure (21.3% vs. 29.1% %), diabetes (34.1% vs. 48.2%), atrial fibrillation (19.3% vs. 26.1%), or chronic kidney disease (25.1% vs. 32.2%). In multivariable analyses, the factors most strongly associated with failure to achieve LDL-C control were female sex (RR 1.13 [95% CI 1.12-1.14] p <0.001) and Black race (1.15 [1.14-1.17] p <0.001). Among the 53,957 (41.5%) of those with uncontrolled LDL-C ≥70 mg/dL not on lipid lowering therapy (LLT) at baseline, only 21% were initiated on any LLT within 6 months of the uncontrolled LDL-C value.

Conclusions: Within five diverse large health systems in the CardioHealth Alliance, more than half of the patients with ASCVD had uncontrolled LDL-C with significant disparities based on sex and race at baseline. The vast majority were not initiated on any lipid lowering therapy within 6 months of an elevated test result indicating persistent gaps in care that will likely worsen health inequities in outcomes. This highlights the urgent need for implementation efforts to improve equitable care.

背景:尽管指南建议对低密度脂蛋白胆固醇(LDL-C)进行测量,但该研究并没有对其进行评估:利用参加 CardioHealth 联盟的五个医疗系统的电子病历数据,对在 2021 年测量过低密度脂蛋白胆固醇并有 ASCVD 病史的患者进行了一项回顾性队列研究。研究采用多变量回归模型来确定临床因素与实现指南指导的 LDL-C 目标之间的关系。此外,还描述了低密度脂蛋白胆固醇检测后降脂治疗(LLT)的变化:在 216,074 名 ASCVD 患者中,129,886 人(60.1%)的低密度脂蛋白胆固醇未得到控制(即≥70 mg/dL)。与低密度脂蛋白胆固醇(LDL-C)已得到控制的患者相比(结论:低密度脂蛋白胆固醇(LDL-C)未得到控制的患者占60.1%:在 CardioHealth 联盟的五个不同的大型医疗系统中,一半以上的 ASCVD 患者的低密度脂蛋白胆固醇(LDL-C)未得到控制,且基线时的性别和种族差异显著。绝大多数患者在检测结果升高后的 6 个月内都没有开始接受任何降脂治疗,这表明护理方面的差距依然存在,很可能会加剧健康结果的不平等。这凸显了改善公平护理的迫切需要。
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引用次数: 0
Effects of fortified eggs and time-restricted eating on cardiometabolic health: The prosperity trial. 强化鸡蛋和限时进食对心脏代谢健康的影响:PROSPERITY 试验。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-15 DOI: 10.1016/j.ahj.2024.10.005
Nina Nouhravesh, Josephine Harrington, Laura H Aberle, Cynthia L Green, Kathleen Voss, Dave Holdsworth, Kurt Misialek, Bartel T Slaugh, Mandee Wieand, William S Yancy, Neha Pagidipati, Robert J Mentz

Background: Given the increasing interest in dietary interventions to improve cardiovascular health, this trial assessed the impact of fortified eggs (FE) versus nonegg supplemented diet and time-restricted eating (TRE) versus usual care diet on cardiovascular biomarkers.

Methods: The study was a unblinded, 2-by-2 factorial design, which randomized patients, with either a prior cardiovascular event or 2 cardiovascular risk factors, to FE or a nonegg supplemented diet and TRE or usual care diet. Patients randomized to FE were instructed to consume at least 12 FE/week (with eggs provided); those on a nonegg supplemented diet restricted egg consumption to <2 eggs/week. TRE participants were instructed to consume all calories within an 8-hour window daily and fasted for the remaining 16 hours. Patients randomized to usual diet were advised to maintain current dietary habits. Follow-up was performed in-person at 1 and 4 months, and telephone calls at 2 and 3 months. Co-primary endpoints were 4-month LDL- and HDL-cholesterol. Secondary endpoints included additional lipids, cardiometabolic- and inflammatory biomarkers and micronutrient levels at 4-months.

Results: Overall, 140 patients were randomized with median (25th, 75th percentiles) age 66 (58, 73) years; 72 (51%) women, 38 (27%) Black, and 33 (24%) with diabetes mellitus. The difference in least squares (LS) means from baseline to 4-months for HDL and LDL levels revealed no significant clinical difference between FE vs nonegg supplemented diet (HDL: -0.64 mg/dL [95% CI: -3.86, 2.58]; LDL: -3.14 mg/dL [-10.81, 4.52]) and TRE vs usual care diet (HDL: 1.51 mg/dL [-1.65, 4.68]; LDL 1.17 mg/dL [-6.36, 8.70]). Prespecified subgroups revealed a nonsignificant HDL increase and LDL decrease with FE in patients ≥65 years.

Conclusions: These data did not demonstrate clinically relevant differences in changes in LDL and HDL levels over 4 months with FE and TRE compared with nonegg supplemented diet and usual care diet, respectively, providing evidence that adverse short-term lipid and biomarker changes did not occur with FE consumption.

Trial registration: ClinicalTrials.gov Identifier: NCT04673721.

背景:鉴于人们对改善心血管健康的饮食干预越来越感兴趣,本试验评估了强化鸡蛋(FE)与非鸡蛋补充饮食、限时进食(TRE)与常规饮食对心血管生物标志物的影响:该研究采用非盲法、2乘2因子设计,将曾发生过心血管事件或具有两种心血管风险因素的患者随机分配到添加鸡蛋或不添加鸡蛋的饮食中,以及限时进食或常规饮食中。随机摄入 FE 的患者被要求每周至少摄入 12 FE(提供鸡蛋);摄入非鸡蛋补充饮食的患者则限制鸡蛋摄入量:共有 140 名患者接受了随机治疗,中位数(第 25 个百分位数,第 75 个百分位数)年龄为 66(58,73)岁;72(51%)名女性,38(27%)名黑人,33(24%)名糖尿病患者。高密度脂蛋白和低密度脂蛋白水平从基线到 4 个月的最小二乘法(LS)均值差异显示,FE 与非鸡蛋补充饮食(高密度脂蛋白:-0.64 mg/dL [95% CI:-3.86, 2.58];低密度脂蛋白:-3.14 mg/dL [-10.81, 4.52])和 TRE 与常规护理饮食(高密度脂蛋白:1.51 mg/dL [-1.65, 4.68];低密度脂蛋白 1.17 mg/dL [-6.36, 8.70])之间没有显著的临床差异。预先指定的亚组显示,在≥65 岁的患者中,高密度脂蛋白随 FE 的增加而增加,低密度脂蛋白随 FE 的减少而减少,但不显著:这些数据表明,与不补充鸡蛋的饮食和常规护理饮食相比,食用 FE 和 TRE 4 个月后低密度脂蛋白和高密度脂蛋白水平的变化没有临床相关性差异,提供了食用 FE 不会导致短期血脂和生物标志物发生不良变化的证据:试验注册:ClinicalTrials.gov Identifier:试验注册:ClinicalTrials.gov Identifier:NCT04673721。
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引用次数: 0
Methylprednisolone for acute type A aortic dissection patients undergoing total arch replacement: Design and rationale of the Medal trial 对接受全弓置换术的急性 A 型主动脉夹层患者使用甲基强的松龙:Medal 试验的设计与原理:简短标题 Medal试验的研究方案。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-11 DOI: 10.1016/j.ahj.2024.10.003

Background

The mortality and morbidity of emergency total aortic arch replacement (TAAR) for acute type A aortic dissection (ATAAD) is high, which is partly due to the excessively activated systemic inflammatory response. Methylprednisolone, an anti-inflammatory agent, might suppress the systemic inflammatory response and lead to improved outcomes. However, the protective effects of methylprednisolone on TAAR for ATAAD were not clarified. The usage and dosage varied in different centers across the world.

Methods and results

The Medal trial is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate whether 500 mg methylprednisolone IV before cardiopulmonary bypass could reduce the incidence of postoperative major organ injury, compared to placebo. Adult patients with the diagnosis with ATAAD, awaiting emergency total aortic arch replacement with hypothermic circulatory arrest and selective cerebral perfusion will be included in the trial. A total of 340 eligible subjects from 9 large cardiovascular centers will be randomized in a 1:1 ratio to receive 500 mg methylprednislone or placebo before cardiopulmonary bypass. The primary outcome is postoperative major adverse outcome [defined as all-cause death or postoperative neurological deficit or KDIGO II -III acute kidney injury or respiratory syndrome (tracheal intubation> 72 hours, tracheostomy or re-intubation) until postoperative day 30 or patient discharge]. The study has received approval from the local Ethics Committees of the 9 participating centers, and enrolled its first subject in June 24, 2022. As of September 5, 2024, 323 subjects have been enrolled. Results of the Medal trial will be published once data collection and analysis have been completed.

Conclusions

The Medal trial will determine the effectiveness of 500 mg methylprednisolone on the outcomes of patients with ATAAD undergoing TAAR.

Registration

URL https://www.chictr.org.cn/searchprojEN.html (Chinese Clinical Trial Registry). Unique identifier: ChiCTR2200059286
背景:急性 A 型主动脉夹层(ATAAD)急诊全主动脉弓置换术(TAAR)的死亡率和发病率很高,部分原因是过度激活的全身炎症反应。甲基强的松龙是一种抗炎药物,可抑制全身炎症反应,从而改善预后。然而,甲基强的松龙对 ATAAD TAAR 的保护作用尚未明确。方法和结果:Medal 试验是一项前瞻性、多中心、随机、双盲、安慰剂对照、平行组试验,旨在评估与安慰剂相比,在心肺旁路术前静脉注射 500 mg 甲基强的松龙是否能降低术后主要器官损伤的发生率。被诊断为 ATAAD 的成人患者将被纳入该试验,他们正在等待通过低体温循环停滞和选择性脑灌注进行急诊全主动脉弓置换术。来自九个大型心血管中心的 340 名合格受试者将按 1:1 的比例随机分配,在心肺旁路术前接受 500 毫克甲基强的松龙或安慰剂治疗。主要结果是术后主要不良反应[定义为全因死亡或术后神经功能缺损或 KDIGO II -III 急性肾损伤或呼吸综合征(气管插管> 72 小时、气管切开或再次插管),直至术后第 30 天或患者出院]。该研究已获得九个参与中心当地伦理委员会的批准,并于 2022 年 6 月 24 日招募了第一名受试者。截至 2024 年 9 月 5 日,已有 323 名受试者入组。Medal试验的结果将在数据收集和分析完成后公布:Medal试验将确定500毫克甲基强的松龙对接受TAAR治疗的ATAAD患者的疗效:URL https://www.chictr.org.cn/searchprojEN.html(中国临床试验注册中心)。唯一标识符:ChiCTR2200059286。
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引用次数: 0
The left atrial appendage exclusion for prophylactic stroke reduction (leaaps) trial: rationale and design. 排除左心房阑尾以预防性减少中风(leaaps)试验:原理与设计。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-10 DOI: 10.1016/j.ahj.2024.10.006
Richard P Whitlock, Patrick M McCarthy, Marc W Gerdisch, Basel Ramlawi, John H Alexander, David Z Rose, Jeffrey S Healey, Yashasvi Awasthi Sharma, Emilie P Belley-Côté, Stuart J Connolly

Introduction: Left atrial appendage exclusion (LAAE) has been shown in randomized trials to reduce ischemic stroke risk in patients undergoing cardiac surgery with known atrial fibrillation (AF). Many patients undergoing cardiac surgery without pre-existing AF are at risk of stroke and may benefit from LAAE.

Methods: Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) is an international, prospective, randomized, multicenter, blinded trial evaluating the effectiveness of LAAE in preventing ischemic stroke or systemic embolism in patients undergoing cardiac surgery at increased risk of AF and ischemic stroke. The trial will enroll 6500 patients at increased risk of stroke in whom a cardiac surgery is planned at 250 sites worldwide. Eligible patients are ≥18 years old, have no pre-existing AF but are at increased risk for AF and stroke (based on age, CHA2DS2-VASc score, left atrium size or brain natriuretic peptide). Patients are randomized 1:1 to receive either LAAE with AtriClip or no LAAE during cardiac surgery. Healthcare providers outside of the operating room and the patient will be blinded to allocation. The primary effectiveness endpoint is the first occurrence of ischemic stroke, systemic arterial embolism, or surgical or endovascular LAA closure. The powered secondary effectiveness endpoint is ischemic stroke or systemic arterial embolism. The primary safety endpoint is the occurrence of one of the following events (through 30 days): pericardial effusion requiring percutaneous or surgical treatment, peri-operative major bleeding, deep sternal wound infection, or myocardial infarction. Other endpoints include mortality, rehospitalizations, clinically diagnosed AF, transient ischemic attack, and cognitive and quality of life assessments. Follow-up is every 6 months for a minimum of 5 years; primary analysis occurs when 469 patients have had an ischemic stroke or systemic embolism.

Conclusion: The results of the LeAAPS trial will demonstrate whether LAAE with AtriClip at the time of other routine cardiac surgery reduces stroke or systemic arterial embolism during long-term follow-up in patients at high risk of stroke without pre-existing AF.

Trial registration: ClinicalTrials.gov, Identifier: NCT05478304, https://clinicaltrials.gov/study/NCT05478304?term=%20NCT05478304&rank=1.

导言:随机试验显示,左心房阑尾切除术(LAAE)可降低已知存在心房颤动(AF)的心脏手术患者的缺血性卒中风险。许多接受心脏手术的患者既往没有房颤,但也有中风风险,可能会从 LAAE 中获益:减少预防性卒中的左心房阑尾置换术(Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction,LeAAPS)是一项国际性、前瞻性、随机、多中心、盲法试验,旨在评估左心房阑尾置换术在预防缺血性卒中或全身性栓塞方面的效果,对象是接受心脏手术且房颤和缺血性卒中风险较高的患者。该试验将在全球 250 个地点招募 6500 名计划接受心脏手术的中风风险增加的患者。符合条件的患者年龄≥18岁,既往无房颤,但房颤和中风风险增加(基于年龄、CHA2DS2-VASc评分、左心房大小或脑钠尿肽)。患者按 1:1 随机分配,在心脏手术期间接受使用 AtriClip 的 LAAE 或不接受 LAAE。手术室外的医护人员和患者均为分配盲人。主要有效性终点是首次发生缺血性中风、全身动脉栓塞、手术或血管内 LAA 封闭。有动力的次要有效性终点是缺血性中风或全身动脉栓塞。主要安全性终点是发生以下事件之一(至 30 天):需要经皮或手术治疗的心包积液、围手术期大出血、胸骨深伤口感染或心肌梗死。其他终点包括死亡率、再次住院、临床诊断为房颤、短暂性脑缺血发作以及认知和生活质量评估。随访时间为每 6 个月一次,至少 5 年;当 469 名患者发生缺血性中风或全身性栓塞时,将进行主要分析:LeAAPS试验的结果将证明在进行其他常规心脏手术时使用AtriClip进行LAAE是否能在长期随访中减少无房颤的中风高危患者的中风或全身动脉栓塞:试验注册:ClinicalTrials.gov, Identifier:NCT05478304, https://clinicaltrials.gov/study/NCT05478304?term=%20NCT05478304&rank=1.
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引用次数: 0
Prospective study on the impact of different antithrombotic therapies on subclinical leaflet thickening and its temporal dynamics in transcatheter aortic valves—The NOTION-4 trial 不同抗血栓疗法对经导管主动脉瓣亚临床瓣叶增厚及其时间动态影响的前瞻性研究--NOTION-4 试验:抗血栓疗法和TAV-HALT。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-05 DOI: 10.1016/j.ahj.2024.10.002

Background

Transcatheter aortic valve replacement (TAVR) has become the standard-of-care treatment for a majority of patients with severe, symptomatic aortic stenosis. The postprocedural antithrombotic therapeutic management is still a topic of debate and could affect the incidence of HALT, a phenomenon which can be assessed by 4-dimensional computed tomography (4DCT).

Trial design

The NOTION-4 trial is a randomized controlled trial comprising TAVR patients with no indication for oral anticoagulant (OAC) therapy, comparing lifelong single antiplatelet therapy (standard arm) versus early 3-month direct oral anticoagulant (DOAC) therapy followed by single antiplateletet therapy (experimental arm). The incidence of HALT and clinical endpoints will be evaluated in both groups at 3 months, 1 year and 5 years after randomization. The primary endpoint is the number of patients with at least 1 bioprosthetic aortic valve leaflet with HALT as assessed by cardiac 4DCT imaging at 1 year. The trial is powered for superiority testing and started enrollment in 2021. In total, 324 patients will be included. The last patient is expected to be enrolled by the end of 2024 and the primary endpoint is to be presented in 2026.

Conclusion and perspective

The NOTION-4 trial aims to study whether an early 3-month DOAC therapy after TAVR can result in a sustained lower incidence of HALT in transcatheter aortic valves. This trial holds the potential to give valuable insights into whether early OAC therapy should be integrated in future guidelines for post-TAVR antithrombotic therapeutic management.

Trial registration

NOTION-4, ClinicalTrials.gov ID NCT06449469, https://clinicaltrials.gov/study/NCT06449469
背景:经导管主动脉瓣置换术(TAVR)已成为大多数严重无症状主动脉瓣狭窄患者的标准治疗方法。经导管主动脉瓣置换术(TAVR)已成为大多数重度无症状主动脉瓣狭窄患者的标准治疗方法,但术后抗血栓治疗管理仍是一个争论不休的话题,它可能会影响 HALT 的发生率,而 HALT 可通过四维计算机断层扫描(4DCT)进行评估:NOTION-4试验是一项随机对照试验,包括无口服抗凝剂(OAC)治疗指征的TAVR患者,比较终生单一抗血小板治疗(标准组)与早期3个月直接口服抗凝剂(DOAC)治疗后单一抗血小板治疗(实验组)。将在随机分组后的 3 个月、1 年和 5 年对两组的 HALT 发生率和临床终点进行评估。主要终点是通过心脏 4DCT 成像评估 1 年后至少有一片生物人工主动脉瓣叶出现 HALT 的患者人数。该试验已通过优效性测试,并于2021年开始招募患者。总共将纳入 324 名患者。最后一名患者预计将于2024年底入组,主要终点将于2026年公布:NOTION-4 试验旨在研究 TAVR 术后早期 3 个月 DOAC 治疗能否持续降低经导管主动脉瓣的 HALT 发生率。该试验有可能为是否应将早期OAC治疗纳入未来TAVR术后抗血栓治疗指南提供有价值的见解:NOTION-4,ClinicalTrials.gov ID NCT06449469,https://clinicaltrials.gov/study/NCT06449469。
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引用次数: 0
Dual antiplatelet therapy duration and stent type in patients with high bleeding risk: A systematic review and network meta-analysis 高出血风险患者的双联抗血小板疗法持续时间和支架类型:系统综述和网络荟萃分析。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-05 DOI: 10.1016/j.ahj.2024.10.004

Background

It is uncertain whether the efficacy and safety of dual antiplatelet therapy (DAPT) in patients with high bleeding risk (HBR) vary according to DAPT duration and stent type (eg, durable polymer drug-eluting stents (DP-DESs), biodegradable polymer DESs (BP-DESs), or polymer-free drug-coated stents (PF-DCSs)). We aimed to study the stent type and DAPT duration appropriate for patients with HBR.

Methods

PubMed and EMBASE were searched until October 2023. Randomized controlled trials (RCTs) involving patients with HBR that compared standard DAPT (6-12 months) with DP- or BP-DES versus short DAPT (≤3 months) with DP- or BP-DES or PF-DCS or bare-metal stent (BMS) were identified. The primary efficacy outcome was major adverse cardiovascular events (MACEs), defined as cardiovascular death, myocardial infarction (MI), and stroke. The primary safety outcome was major bleeding. Secondary outcomes included MI and stent thrombosis (ST). We performed a network meta-analysis using a random effects model.

Results

Thirteen RCTs with a total of 19,418 patients with HBR were included. Compared to standard DAPT with DP-DES, short DAPT with BMS was associated with a higher risk of MACE and MI. For major bleeding, short DAPT strategies were associated with a lower risk than standard DAPT strategies (e.g. short DAPT with DP-DES vs standard DAPT with DP-DES; HR[95% CI]: 0.48[0.28-0.82]). Interestingly, the use of BP-DES was associated with a higher risk of ST than DP-DES (e.g. standard DAPT with BP-DES vs short DAPT with DP-DES; HR[95% CI]: 2.65[1.03-6.79]).

Conclusions

In patients with HBR who underwent percutaneous coronary intervention, a short DAPT strategy with DP-DES should be used since it offers the best combination of efficacy and safety.
背景:目前尚不确定双重抗血小板疗法(DAPT)在高出血风险(HBR)患者中的疗效和安全性是否会因DAPT持续时间和支架类型(如耐久性聚合物药物洗脱支架(DP-DES)、生物降解聚合物DES(BP-DES)或无聚合物药物涂层支架(PF-DCS))而有所不同。我们旨在研究适合 HBR 患者的支架类型和 DAPT 持续时间:方法:检索了 PubMed 和 EMBASE,检索期至 2023 年 10 月。方法:检索了截至 2023 年 10 月的 PubMed 和 RMBASE,其中涉及 HBR 患者的随机对照试验(RCT)比较了使用 DP 或 BP-DES 的标准 DAPT(6-12 个月)与使用 DP 或 BP-DES 或 PF-DCS 或裸金属支架(BMS)的短期 DAPT(≤3 个月)。主要疗效结果是主要心血管不良事件(MACE),定义为心血管死亡、心肌梗死(MI)和中风。主要安全性结果为大出血。次要结果包括心肌梗死和支架血栓形成(ST)。我们采用随机效应模型进行了网络荟萃分析:结果:共纳入了 13 项 RCT,共计 19,418 名 HBR 患者。与使用DP-DES的标准DAPT相比,使用BMS的短DAPT与更高的MACE和MI风险相关。在大出血方面,短程 DAPT 策略的风险低于标准 DAPT 策略(例如,使用 DP-DES 的短程 DAPT 与使用 DP-DES 的标准 DAPT 相比;HR[95% CI]:0.48[0.28-0.82]).有趣的是,使用 BP-DES 比使用 DP-DES 发生 ST 的风险更高(例如,使用 BP-DES 的标准 DAPT 与使用 DP-DES 的短 DAPT 相比;HR[95% CI]:2.65[1.03-6.79]):结论:对于接受经皮冠状动脉介入治疗的 HBR 患者,应采用带 DP-DES 的短 DAPT 策略,因为它能提供最佳的疗效和安全性组合。
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引用次数: 0
Design and rationale of penn medicine healthy heart, a randomized trial of effectiveness of a centrally organized approach to blood pressure and cholesterol improvement among patients at elevated risk of atherosclerotic cardiovascular disease 宾大医学健康心脏项目的设计与原理:一项针对动脉粥样硬化性心血管疾病高危患者改善血压和胆固醇的集中组织方法有效性的随机试验。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-27 DOI: 10.1016/j.ahj.2024.09.029

Rationales

Atherosclerotic Cardiovascular Disease (ASCVD) is the leading cause of morbidity and mortality in the United States. Suboptimal control of hypertension and hyperlipidemia are common factors contributing to ASCVD risk. The Penn Medicine Healthy Heart (PMHH) Study is a randomized clinical trial testing the effectiveness of a system designed to offload work from primary care clinicians and improve patient follow-through with risk reduction strategies by using a centralized team of nonclinical navigators and advanced practice providers, remote monitoring, and bi-directional text messaging, augmented by behavioral science engagement strategies. The intervention builds on prior nonrandomized evaluations of these design elements that demonstrated significant improvement in patients’ systolic blood pressure and LDL Cholesterol (LDL-C).

Primary Hypothesis

Penn Medicine Healthy Heart will significantly improve systolic blood pressure and LDL-C compared to usual care over the 6 months of this intervention.

Design

Randomized clinical trial of Penn Medicine Healthy Heart in patients aged 35-80 years at elevated risk of ASCVD whose systolic blood pressure and LDL-C are not well controlled. The intervention consists of 4 modules that address blood pressure management, lipid management, nutrition, and smoking cessation, offered in a phased approach to give the participant time to learn about each topic, adopt any recommendations, and build a relationship with the care team.

Sites

University of Pennsylvania Health System at primary care practices located in inner-city urban and rural/semi-rural areas.

Primary Outcomes

Improvement in systolic blood pressure and LDL-C.

Secondary Outcomes

Cost-effectiveness analyses are planned to evaluate the health care costs and health outcomes of the intervention approach. An implementation evaluation is planned to understand factors influencing success of the intervention.

Estimated Enrollment

2,420 active patients of Penn Medicine primary care practices who have clinical ASCVD, or who are at elevated risk for ASCVD, and who are (a) not on statins or have LDL-C >100 despite being on statins and (b) had systolic blood pressure >140 at 2 recent ambulatory visits.

Enrollment Dates

March 2024-March 2025. The intervention will last 6 months with a 12-month follow-up to determine whether its effects persist.

Current Status

Enrolling (1,240 enrolled as of August 15, 2024)

Clinical Trial Registration

NCT06062394
理由:动脉粥样硬化性心血管疾病(ASCVD)是美国发病率和死亡率的主要原因。高血压和高脂血症控制不佳是导致动脉粥样硬化性心血管疾病风险的常见因素。宾大医学健康心脏(PMHH)研究是一项随机临床试验,目的是测试一个系统的有效性,该系统旨在通过使用一个由非临床导航员和高级医疗服务提供者组成的集中团队、远程监控、双向短信以及行为科学参与策略来减轻初级保健临床医生的工作量,并改善患者对降低风险策略的跟踪。该干预措施建立在之前对这些设计元素进行的非随机评估的基础上,这些评估显示患者的收缩压和低密度脂蛋白胆固醇(LDL-C)得到了显著改善:主要假设:在为期 6 个月的干预过程中,与常规护理相比,宾大医学健康心脏项目将明显改善收缩压和低密度脂蛋白胆固醇:设计:在收缩压和低密度脂蛋白胆固醇(LDL-C)控制不佳的 35-80 岁 ASCVD 高危患者中开展宾大医学健康心脏随机临床试验。干预措施包括四个模块,分别涉及血压管理、血脂管理、营养和戒烟,分阶段进行,以便参与者有时间了解每个主题、采纳任何建议并与护理团队建立关系:地点:宾夕法尼亚大学卫生系统位于市内城区和农村/半农村地区的初级保健诊所:收缩压和低密度脂蛋白胆固醇的改善:计划进行成本效益分析,以评估干预方法的医疗成本和健康结果。计划进行一项实施评估,以了解影响干预成功的因素。预计入组人数:宾夕法尼亚大学医学院初级保健实践中的 2420 名活跃患者,这些患者患有临床 ASCVD 或 ASCVD 风险较高,并且 (a) 未服用他汀类药物或尽管服用他汀类药物但 LDL-C > 100,以及 (b) 在最近两次门诊就诊时收缩压>140:入组日期:2024 年 3 月至 2025 年 3 月。干预将持续 6 个月,随访 12 个月,以确定其效果是否持续:临床试验注册:NCT06062394。
{"title":"Design and rationale of penn medicine healthy heart, a randomized trial of effectiveness of a centrally organized approach to blood pressure and cholesterol improvement among patients at elevated risk of atherosclerotic cardiovascular disease","authors":"","doi":"10.1016/j.ahj.2024.09.029","DOIUrl":"10.1016/j.ahj.2024.09.029","url":null,"abstract":"<div><h3>Rationales</h3><div>Atherosclerotic Cardiovascular Disease (ASCVD) is the leading cause of morbidity and mortality in the United States. Suboptimal control of hypertension and hyperlipidemia are common factors contributing to ASCVD risk. The Penn Medicine Healthy Heart (PMHH) Study is a randomized clinical trial testing the effectiveness of a system designed to offload work from primary care clinicians and improve patient follow-through with risk reduction strategies by using a centralized team of nonclinical navigators and advanced practice providers, remote monitoring, and bi-directional text messaging, augmented by behavioral science engagement strategies. The intervention builds on prior nonrandomized evaluations of these design elements that demonstrated significant improvement in patients’ systolic blood pressure and LDL Cholesterol (LDL-C).</div></div><div><h3>Primary Hypothesis</h3><div>Penn Medicine Healthy Heart will significantly improve systolic blood pressure and LDL-C compared to usual care over the 6 months of this intervention.</div></div><div><h3>Design</h3><div>Randomized clinical trial of Penn Medicine Healthy Heart in patients aged 35-80 years at elevated risk of ASCVD whose systolic blood pressure and LDL-C are not well controlled. The intervention consists of 4 modules that address blood pressure management, lipid management, nutrition, and smoking cessation, offered in a phased approach to give the participant time to learn about each topic, adopt any recommendations, and build a relationship with the care team.</div></div><div><h3>Sites</h3><div>University of Pennsylvania Health System at primary care practices located in inner-city urban and rural/semi-rural areas.</div></div><div><h3>Primary Outcomes</h3><div>Improvement in systolic blood pressure and LDL-C.</div></div><div><h3>Secondary Outcomes</h3><div>Cost-effectiveness analyses are planned to evaluate the health care costs and health outcomes of the intervention approach. An implementation evaluation is planned to understand factors influencing success of the intervention.</div></div><div><h3>Estimated Enrollment</h3><div>2,420 active patients of Penn Medicine primary care practices who have clinical ASCVD, or who are at elevated risk for ASCVD, and who are (a) not on statins or have LDL-C &gt;100 despite being on statins and (b) had systolic blood pressure &gt;140 at 2 recent ambulatory visits.</div></div><div><h3>Enrollment Dates</h3><div>March 2024-March 2025. The intervention will last 6 months with a 12-month follow-up to determine whether its effects persist.</div></div><div><h3>Current Status</h3><div>Enrolling (1,240 enrolled as of August 15, 2024)</div></div><div><h3>Clinical Trial Registration</h3><div>NCT06062394</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142339529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Outcome reporting in cardio-obstetrics studies: A systematic review 关于患有心脏病的孕妇的研究结果报告:系统综述:妊娠与心脏病研究的结果。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-24 DOI: 10.1016/j.ahj.2024.09.008

Background

Although considerable variation in the reporting and definition of outcomes in cardio-obstetrics studies is acknowledged, the extent of this variation has not been documented. The primary objective of this systematic review was to highlight this variation and inform the development of a Core Outcome Set for studies on Cardiac disease in Pregnancy (COSCarP).

Methods

Medline, Embase, Web of Science and Cochrane Central databases were searched from 1980 to 2018 to identify all English-language publications on pregnancy and heart disease. Title/abstract screening and data extraction which included details on the study, patient population, and all reported outcomes, was performed in duplicate by 2 reviewers. As the aim of the review was to identify variation in outcome reporting, risk-of-bias assessment was not performed. The study protocol was registered on PROSPERO (CRD42016038218).

Results

The final analysis included 422 cardio-obstetric studies. Maternal mortality or survival were reported in 232/422 studies, with inconsistency in terms of cause of death (all-cause [n = 65], cardiac [n = 55] or obstetric [n = 10]) or timeframe (ranging from in-hospital mortality [n = 11] to mortality 5 years following pregnancy). In 95/232 (41%) studies, the cause and timeframe were not specified. Similar inconsistencies in reporting and definitions were noted for outcomes such as heart failure (n = 298), perinatal loss (n = 296), fetal growth (n = 221), bleeding (n = 205), arrhythmias (n = 202), preterm birth (n = 191), thromboembolism (n = 153) and hypertensive disorders (n = 122). Functioning / life-impact and adverse effects of treatment were sparingly reported in published cardio-obstetric studies.

Conclusions

This systematic review hopes to create awareness among cardio-obstetrics teams about the inconsistencies in reporting and defining outcomes which makes it difficult to compare studies and perform meta-analyses. COSCarP which is being developed through international consensus between patients and care-providers will provide cardio-obstetrics teams with a minimal set of outcomes to be reported in future cardio-obstetrics studies.
背景:众所周知,产科心脏病研究的结果报告和定义存在很大差异,但这种差异的程度尚未记录在案。本系统综述的主要目的是强调这种差异,并为妊娠期心脏病研究核心结果集(COSCarP)的制定提供依据:检索了 1980 年至 2018 年期间的 Medline、Embase、Web of Science 和 Cochrane Central 数据库,以确定所有关于妊娠和心脏病的英文出版物。标题/摘要筛选和数据提取包括研究细节、患者人群和所有报告结果,由两名审稿人重复进行。由于综述的目的是确定结果报告中的差异,因此没有进行偏倚风险评估。研究方案已在 PROSPERO(CRD42016038218)上注册:最终分析包括 422 项心外科产科研究。232/422项研究报告了孕产妇死亡率或存活率,但在死亡原因[全因(n=65)、心脏(n=55)或产科(n=10)]或时间范围(从院内死亡(n=11)到妊娠后5年死亡)方面存在不一致。有 95/232 项研究(41%)未说明死亡原因和时间范围。心力衰竭(298 例)、围产期损失(296 例)、胎儿发育(221 例)、出血(205 例)、心律失常(202 例)、早产(191 例)、血栓栓塞(153 例)和高血压疾病(122 例)等结果的报告和定义也存在类似的不一致。心血管产科研究中很少报道治疗对功能/生活的影响和不良反应:本系统性综述希望能让心肺产科团队认识到,由于结果的报告和定义不一致,因此很难对研究进行比较和荟萃分析。COSCarP是通过患者和医疗服务提供者之间的国际共识制定的,它将为心外科产科团队提供一套最基本的结果,供今后的心外科产科研究报告使用。
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引用次数: 0
Subclinical atherosclerosis and brain health in midlife: Rationale and design of the PESA-Brain study 中年亚临床动脉粥样硬化与大脑健康:PESA-脑研究的原理和设计。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-24 DOI: 10.1016/j.ahj.2024.09.028

Rationale

Cognitive decline and dementia have been reportedly linked to atherosclerosis, the main cause of cardiovascular disease. Cohort studies identifying early brain alterations associated with subclinical atherosclerosis are warranted to understand the potential of prevention strategies before cerebral damage becomes symptomatic and irreversible.

Methods & design

The Progression of Early Subclinical Atherosclerosis (PESA) study is a longitudinal observational cohort study that recruited 4,184 asymptomatic middle-aged individuals (40-54 years) in 2010 in Madrid (Spain) to thoroughly characterize subclinical atherosclerosis development over time. In this framework, the PESA-Brain study has been designed to identify early structural, functional and vascular brain changes associated with midlife atherosclerosis and cardiovascular risk factors. The PESA-Brain study targets 1,000 participants at the 10-year follow-up PESA visit and consists of thorough neuropsychological testing, advanced multimodal neuroimaging, and quantification of blood-based neuropathological biomarkers.

Primary hypothesis

We hypothesize that, in middle-age, the presence of cardiovascular risk factors and a high burden of subclinical atherosclerosis will be associated with structural, functional and vascular brain alterations, greater amyloid burden and subtle cognitive impairment. We further hypothesize that the link between subclinical atherosclerosis and poor brain health in midlife will be mediated by cerebrovascular pathology and intracranial atherosclerosis.

Enrollment dates

The PESA-Brain study started in October 2020 and is estimated to be completed by December 2024.

Conclusion

This study is in a unique position to unveil novel relationships between cardiovascular and brain alterations in the health-to-disease transition, which may have important implications for interventional and therapeutic approaches.
ClinicalTrials.gov identifier: NCT01410318.
理由据报道,认知能力下降和痴呆症与动脉粥样硬化有关,而动脉粥样硬化是心血管疾病的主要原因。有必要开展队列研究,确定与亚临床动脉粥样硬化相关的早期脑部变化,以便在脑损伤出现症状和不可逆转之前了解预防策略的潜力:早期亚临床动脉粥样硬化进展(PESA)研究是一项纵向观察性队列研究,2010 年在西班牙马德里招募了 4184 名无症状的中年人(40-54 岁),以全面了解亚临床动脉粥样硬化随时间推移的发展特点。在此框架下,PESA-Brain 研究旨在确定与中年动脉粥样硬化和心血管风险因素相关的早期大脑结构、功能和血管变化。PESA-脑研究的目标是对1000名参与者进行为期10年的PESA随访,包括全面的神经心理学测试、先进的多模态神经影像学检查和基于血液的神经病理学生物标志物的量化:我们假设,在中年时期,心血管风险因素的存在和亚临床动脉粥样硬化的高负担将与大脑结构、功能和血管的改变、更大的淀粉样蛋白负担和细微的认知障碍有关。我们进一步假设,亚临床动脉粥样硬化与中年时大脑健康状况不佳之间的联系将由脑血管病变和颅内动脉粥样硬化介导:PESA-Brain研究于2020年10月开始,预计将于2024年12月完成:这项研究在揭示健康向疾病转变过程中心血管和大脑变化之间的新型关系方面具有独特的地位,可能对干预和治疗方法产生重要影响。试验注册 - 注册表:clinicaltrials.gov;注册号:NCT01410318;注册号:NCT01410318:NCT01410318;网址:https://clinicaltrials.gov/study/NCT01410318。
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引用次数: 0
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American heart journal
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