American heart journal最新文献_第8页

Association of obesity subphenotypes with indices of cardiac remodeling in the Framingham heart study 弗雷明汉心脏研究中肥胖亚表型与心脏重塑指数的关联

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-10-19 DOI: 10.1016/j.ahj.2025.107292

William J. He MD MHS , Brenton R. Prescott MS , Vanessa Xanthakis PhD , Gary F. Mitchell MD , Susan Cheng MD , Ramachandran S. Vasan MD

Background

Previous studies have reported that obesity-related metabolic abnormalities (eg, diabetes and hypertension) lead to myocardial dysfunction and adverse cardiac remodeling. However, it is unclear whether such cardiac remodeling is from obesity or obesity-related metabolic abnormalities. We hypothesize that overweight and obesity are associated with adverse cardiac remodeling independent of associated metabolic abnormalities.

Methods

We evaluated 6,639 participants from the Framingham Heart Study who underwent echocardiography and had no prevalent cardiovascular disease. Individuals were classified into 6 obesity sub-phenotypes based on metabolic health (metabolically healthy or metabolically unhealthy) and body mass index (normal weight, overweight, or obese). Obesity subphenotypes were related to echocardiographic measures using multivariable regression analyses.

Results

Mean age was 49 years and 55% were women. Overweight and obesity were consistently associated with adverse cardiac remodeling in both metabolic healthy and unhealthy participants. Among metabolically healthy participants, compared to the normal weight group (referent), overweight and obesity were significantly associated with increased left ventricular mass (11.6 and 21.4 gm), left atrium end-systolic dimension (0.27 and 0.48 cm), global longitudinal strain (0.82 and 1.06%), and the ratio of early diastolic trans-mitral flow velocity to early diastolic mitral annulus velocity (0.35 and 0.87) (all P < .001). Additionally, obesity was significantly associated with mitral annular plane systolic excursion (0.08 cm, P < .001) and relative wall thickness (0.01, P = .001) compared to the normal weight referent group.

Conclusions

Increasing body weight was associated with adverse cardiac remodeling regardless of metabolic health status, which suggests that obesity may directly increase the risk of adverse cardiac remodeling.

背景：已有研究报道肥胖相关的代谢异常（如糖尿病和高血压）导致心肌功能障碍和不良的心脏重构。然而，目前尚不清楚这种心脏重塑是由肥胖还是肥胖相关的代谢异常引起的。我们假设超重和肥胖与不良的心脏重构相关，独立于相关的代谢异常。方法：我们评估了来自弗雷明汉心脏研究的6639名参与者，他们接受了超声心动图检查，没有流行的心血管疾病。根据代谢健康（代谢健康或代谢不健康）和体重指数（正常体重、超重或肥胖），将个体分为六种肥胖亚表型。使用多变量回归分析，肥胖亚表型与超声心动图测量结果相关。结果：平均年龄49岁，女性占55%。在代谢健康和不健康的参与者中，超重和肥胖始终与不良心脏重构相关。在代谢健康的参与者中，与正常体重组（参照）相比，超重和肥胖与左心室质量（11.6和21.4 gm）、左心房收缩末期尺寸（0.27和0.48 cm）、总纵向应变（0.82和1.06%）以及舒张早期二尖瓣血流速度与舒张早期二尖瓣环速度之比（0.35和0.87）显著相关（均p）。无论代谢健康状况如何，体重增加都与不良心脏重构相关，这表明肥胖可能直接增加不良心脏重构的风险。

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引用次数: 0

Distal versus conventional radial large-bore access for percutaneous coronary intervention of complex coronary lesions: Rationale and design of the DISCO COMPLEX randomized superiority trial 复杂冠状动脉病变经皮冠状动脉介入治疗的远端与传统桡骨大口径通道：DISCO complex随机优势试验的基本原理和设计。

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-10-18 DOI: 10.1016/j.ahj.2025.107291

Juan F. Iglesias MD , Gregor Leibundgut MD , Dik Heg PhD , Gabriele L. Gasparini MD , Grigorios Tsigkas MD, PhD , Claudiu Ungureanu MD , Giuseppe Colletti MD , Sophie Degrauwe MD , Panagiotis Xaplanteris MD, PhD , Karsten Schenke MD , Alexandru Achim MD , Maarten AH van Leeuwen MD, PhD , Maia Muresan MSc , Shigeru Saito MD , Gregory A. Sgueglia MD, PhD , Adel Aminian MD

Rationale

Distal radial access (DRA) has emerged as a promising alternative to conventional transradial access (TRA) for coronary angiography and percutaneous coronary intervention (PCI). However, existing randomized evidence on DRA primarily involves low-risk patients undergoing diagnostic angiography or noncomplex PCI using ≤6 French (Fr) introducer sheaths. The clinical benefits of DRA among patients undergoing PCI for complex coronary lesions using large-bore guide catheters remain therefore uncertain.

Design

DISCO COMPLEX is an investigator-initiated, prospective, multicenter, international, open-label, randomized, controlled trial with a blinded outcome assessment and superiority design. The trial will compare in a 1:1 ratio large-bore DRA versus conventional TRA using a 7-Fr introducer sheath in 708 patients undergoing PCI for complex coronary lesions (chronic total occlusions, left main disease, heavily calcified lesions, or complex bifurcations) with a 7-Fr guide catheter. The primary hypothesis is that large-bore DRA is superior to conventional TRA with respect to the incidence of forearm radial artery occlusion (RAO) assessed by Doppler ultrasound at hospital discharge. The prespecified DISCOPHILE COMPLEX hand function substudy is a noninferiority trial evaluating whether large-bore DRA is not inferior to conventional TRA with respect to change in full-Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire score from baseline to 12 months in participants of the DISCO COMPLEX trial.

Enrolment status

The trial aims to recruit a total of 708 patients from 10 to 15 participating centers across Europe. The first patient was enrolled on August 31, 2023. As of August 20, 2025, 385 patients have been included.

Conclusion

DISCO COMPLEX is the first randomized clinical trial designed to test the superiority of large-bore DRA over conventional TRA in reducing RAO rates among patients undergoing complex PCI with 7-Fr guide catheters.

Trial Registration

Clinicaltrials.gov: Identifier, NCT05490238.

理由：桡动脉远端通路（DRA）已成为传统经桡动脉通路（TRA）的替代方案，用于冠状动脉造影和经皮冠状动脉介入治疗（PCI）。然而，现有的DRA随机证据主要涉及使用≤6个French （Fr）导管套进行诊断性血管造影或非复杂PCI的低风险患者。因此，DRA在使用大口径导管接受复杂冠状动脉病变PCI治疗的患者中的临床益处仍不确定。设计：DISCO COMPLEX是一项研究者发起的、前瞻性、多中心、国际、开放标签、随机对照试验，采用盲法结局评估和优势设计。该试验将对708例因复杂冠状动脉病变（慢性全闭塞、左主干疾病、严重钙化病变或复杂分叉）使用7-Fr导管接受PCI的患者进行大口径DRA与使用7-Fr导管的传统TRA的1:1比例的比较。主要假设是大口径DRA在出院时通过多普勒超声评估前臂桡动脉闭塞（RAO）的发生率方面优于常规TRA。预先指定的DISCOPHILE COMPLEX手功能亚研究是一项非劣效性试验，评估大孔径DRA在DISCO COMPLEX试验参与者从基线到12个月的手臂、肩膀和手的全面残疾（DASH）问卷评分的变化方面是否不劣于常规TRA。入组状况：该试验旨在从欧洲10至15个参与中心招募总共708名患者。第一位患者于2023年8月31日入组。截至2025年8月20日，共纳入385例患者。结论：DISCO COMPLEX是首个随机临床试验，旨在测试大口径DRA在降低采用7-Fr导管的复杂PCI患者的RAO率方面优于传统TRA。

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引用次数: 0

Worsening heart failure events in adults with mild-to-moderate chronic kidney disease 成人轻中度慢性肾病患者心衰事件加重

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-10-17 DOI: 10.1016/j.ahj.2025.107290

Linda Ye MD , Michael P. Girouard MD, MBA , Alan S. Go MD , Jane Y. Liu MPH , Rishi V. Parikh MPH , Thida C. Tan MPH , Emily S. Lee MD , Grace Sun BA , Rami Halaseh MD , Ankeet S. Bhatt MD, MBA, ScM , Leonid Pravoverov MD , Sijie Zheng MD , Jana Svetlichnaya MD , Jesse K. Fitzpatrick MD , Harshith R. Avula MD, MPH , Keane K. Lee MD, MS , Sirtaz Adatya MD , David Ouyang MD , Parag Goyal MD, MSc , Alexander T. Sandhu MD, MS , Andrew P. Ambrosy MD, MPH

Background

Chronic kidney disease (CKD) is a major risk factor for heart failure (HF). However, the burden of worsening HF (WHF) events among adults with mild-to-moderate CKD has not been well described.

Objectives

This study assessed the burden of WHF in a contemporary cohort of adults with mild-to-moderate CKD.

Methods

We identified adults with mild-to-moderate CKD (eGFR 30-59 mL/min/1.73m² or eGFR ≥60 mL/min/1.73m² with albuminuria) within a large, integrated healthcare delivery system from 2012 to 2021. Outcomes included hospitalizations, emergency department visits, and outpatient encounters for WHF, stratified by HF status and level of CKD.

Results

Among 375,495 adults with mild-to-moderate CKD, mean age was 64 ± 16 years, 54% were women, mean eGFR was 76 ± 26 mL/min/1.73m², and 6.5% had prior known HF. CKD stages G1A2 (31.6%), G2A2 (24.9%), and G3aA1 (25.1%) were most prevalent. Rates (95% CI) per 100 person-years for WHF events were 1.85 (1.83-1.87) for hospitalizations, 0.85 (0.84-0.86) for emergency department visits, and 0.83 (0.81-0.84) for outpatient encounters, resulting in a cumulative rate of 2.42 (2.40-2.44). Event rates were higher at lower eGFR and higher albuminuria levels.

Conclusions

WHF is a common source of morbidity in adults with earlier stage CKD, and particularly high in those with lower eGFR and greater albuminuria. These findings underscore the importance of implementing available and emerging cardioprotective and renoprotective therapies in this high-risk population.

背景：慢性肾脏疾病（CKD）是心力衰竭（HF）的主要危险因素。然而，在患有轻中度CKD的成人中，HF （WHF）事件恶化的负担尚未得到很好的描述。目的：本研究评估了当代轻至中度CKD成人队列中WHF的负担。方法：我们在2012-2021年的大型综合医疗保健服务系统中确定了轻度至中度CKD （eGFR 30-59 ml/min/1.73m²或eGFR≥60 ml/min/1.73m²伴有蛋白尿）的成人。结果包括住院、急诊科就诊和WHF门诊就诊，按HF状态和CKD水平分层。结果：在375,495名轻中度CKD成人患者中，平均年龄为64±16岁，54%为女性，平均eGFR为76±26 ml/min/1.73m²，6.5%既往已知HF。CKD分期G1A2（31.6%）、G2A2（24.9%）和G3aA1（25.1%）最为常见。住院患者每100人年WHF事件发生率（95% CI）为1.85(1.83-1.87)，急诊患者为0.85(0.84-0.86)，门诊患者为0.83(0.81-0.84)，累计发生率为2.42（2.40-2.44）。eGFR越低，蛋白尿越高，事件发生率越高。结论：WHF是早期CKD成人发病的常见原因，在eGFR较低和蛋白尿较多的患者中发病率尤其高。这些发现强调了在这一高危人群中实施现有的和新兴的心脏保护和肾保护疗法的重要性。

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引用次数: 0

Functional coronary angiogram findings in angina with non-obstructive coronary arteries patients with coronary slow flow ANOCA患者冠状动脉慢血流的功能性冠状动脉造影表现。

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-10-09 DOI: 10.1016/j.ahj.2025.107287

Olivia Girolamo BMedSc , Muhammad Dzafir Ismail MBBS, MMed , Rosanna Tavella BSc, PhD , Eng Lee Ooi MBBS, PhD , Sivabaskari Pasupathy BSc, PhD , Sarena La BMedSc , Abdul Sheikh MBBS, MD , Christopher Zeitz MBBS, PhD , John Beltrame BSc, BMBS, PhD

Background

The Coronary Slow Flow Phenomenon (CSFP) is considered a coronary microvascular disorder and has been defined as a corrected thrombolysis in myocardial infarction frame count (cTFC) ≥25 frames. Recent invasive physiology studies have reported that cTFC is not a surrogate marker for coronary microvascular dysfunction (CMD), defined by an abnormal Coronary Flow Reserve (CFR), questioning the integrity of CSFP. This study evaluates the Functional Coronary Angiography (FCA) findings of patients with and without CSFP, as well as the relationship between cTFC and invasive coronary functional measures.

Methods

FCA utilizing a pressure-Doppler flow wire during adenosine infusion, and acetylcholine provocation, was undertaken in 103 patients with angina and non-obstructive coronary artery disease (<50% stenosis; ANOCA).

Results

The FCA findings revealed CMD (i.e. CFR<2) in 43%, inducible coronary artery spasm (58%) and microvascular spasm (13%) in patients with the CSFP (n = 69), which was similar to those without CSFP (n = 34). However, the CSFP patients had a lower resting coronary blood flow velocity (19 ± 7 vs 23 ± 7cm/s, P = .009) with higher resting microvascular resistance (5.8 ± 1.9 vs 4.4 ± 1.7mmHg/cm/s, P = .006) and higher hyperemic microvascular resistance (2.35 ± 1.09 vs 1.94 ± 0.93, P = .049), despite a similar hyperemic CFR (2.25 ± 0.84 vs 2.26 ± 0.58, P = .971) compared to those without CSFP. Furthermore, the cTFC as a continuous measure, correlated with resting coronary blood flow, resting/hyperemic resistance but not CFR.

Conclusion

The conventional marker of CMD (i.e. CFR <2) was similar in patients with/without the CSFP. However alternative hemodynamic markers of impaired coronary microvascular function were abnormal in patients with the CSFP, including resting/hyperemic coronary microvascular resistance. Moreover, cTFC is a simple semi-quantitative marker correlated with coronary microvascular resistance and thus has clinical utility in the diagnosis of the CSFP.

背景：冠状动脉慢血流现象（CSFP）被认为是冠状动脉微血管疾病，并被定义为心肌梗死帧数(cTFC)≥25帧时的纠正溶栓。最近的侵入性生理学研究报道，cTFC不是冠状动脉微血管功能障碍（CMD）的替代标志物，CMD是由冠状动脉血流储备异常（CFR）定义的，这对ccsf的完整性提出了质疑。本研究评估有和无ccsf患者的功能性冠状动脉造影（FCA）结果，以及cTFC与有创冠状动脉功能测量的关系。方法：对103例心绞痛合并非阻塞性冠状动脉疾病患者，在腺苷输注和乙酰胆碱激发下，采用压力多普勒血流线进行FCA检查（结果：FCA检查显示CMD（即CFR））

{"title":"Functional coronary angiogram findings in angina with non-obstructive coronary arteries patients with coronary slow flow","authors":"Olivia Girolamo BMedSc , Muhammad Dzafir Ismail MBBS, MMed , Rosanna Tavella BSc, PhD , Eng Lee Ooi MBBS, PhD , Sivabaskari Pasupathy BSc, PhD , Sarena La BMedSc , Abdul Sheikh MBBS, MD , Christopher Zeitz MBBS, PhD , John Beltrame BSc, BMBS, PhD","doi":"10.1016/j.ahj.2025.107287","DOIUrl":"10.1016/j.ahj.2025.107287","url":null,"abstract":"<div><h3>Background</h3><div>The Coronary Slow Flow Phenomenon (CSFP) is considered a coronary microvascular disorder and has been defined as a corrected thrombolysis in myocardial infarction frame count (cTFC) ≥25 frames. Recent invasive physiology studies have reported that cTFC is not a surrogate marker for coronary microvascular dysfunction (CMD), defined by an abnormal Coronary Flow Reserve (CFR), questioning the integrity of CSFP. This study evaluates the Functional Coronary Angiography (FCA) findings of patients with and without CSFP, as well as the relationship between cTFC and invasive coronary functional measures.</div></div><div><h3>Methods</h3><div>FCA utilizing a pressure-Doppler flow wire during adenosine infusion, and acetylcholine provocation, was undertaken in 103 patients with angina and non-obstructive coronary artery disease (<50% stenosis; ANOCA).</div></div><div><h3>Results</h3><div>The FCA findings revealed CMD (i.e. CFR<2) in 43%, inducible coronary artery spasm (58%) and microvascular spasm (13%) in patients with the CSFP (<em>n</em> = 69), which was similar to those without CSFP (<em>n</em> = 34). However, the CSFP patients had a lower resting coronary blood flow velocity (19 ± 7 vs 23 ± 7cm/s, <em>P = .</em>009) with higher resting microvascular resistance (5.8 ± 1.9 vs 4.4 ± 1.7mmHg/cm/s, <em>P = .</em>006) and higher hyperemic microvascular resistance (2.35 ± 1.09 vs 1.94 ± 0.93, <em>P = .</em>049), despite a similar hyperemic CFR (2.25 ± 0.84 vs 2.26 ± 0.58, <em>P = .</em>971) compared to those without CSFP. Furthermore, the cTFC as a continuous measure, correlated with resting coronary blood flow, resting/hyperemic resistance but not CFR.</div></div><div><h3>Conclusion</h3><div>The conventional marker of CMD (i.e. CFR <2) was similar in patients with/without the CSFP. However alternative hemodynamic markers of impaired coronary microvascular function were abnormal in patients with the CSFP, including resting/hyperemic coronary microvascular resistance. Moreover, cTFC is a simple semi-quantitative marker correlated with coronary microvascular resistance and thus has clinical utility in the diagnosis of the CSFP.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107287"},"PeriodicalIF":3.5,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145257129","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

Information for Readers 读者资讯

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-10-07 DOI: 10.1016/S0002-8703(25)00343-6

引用次数: 0

Statistical methodological limitations and improvement suggestions in the study of vitamin D deficiency and cardiovascular mortality after heart transplantation 维生素D缺乏与心脏移植后心血管死亡率研究的统计方法局限性及改进建议。

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-10-07 DOI: 10.1016/j.ahj.2025.08.015

Haiying Hu BSc, Linjun Wang BSc

引用次数: 0

Bioimpedance phase angle is associated with increased heart failure hospitalization risk 生物阻抗相位角与心力衰竭住院风险增加有关。

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-10-07 DOI: 10.1016/j.ahj.2025.107288

Kivanc Ozonat PhD , Corey Centen B.Eng , Sarah Smith B.Eng , V. Burak Aydemir PhD , Marat Fudim MD, MHS , Adam D. DeVore MD, MHS

Background

Outcomes for patients living with heart failure (HF) remain poor with high rates of death and hospitalization due to worsening HF. Noninvasive tools may be useful to identify patients at risk for disease progression before these outcomes occur. For example, loss of cell mass and compromised cell membrane integrity throughout the body are associated with chronic disease, mortality, frailty, and malnutrition. As the cell membrane loses its integrity, its electrical capacitance decreases, lowering bioelectrical phase angle. Data collected during the SCALE-HF 1 study (NCT04882449) was used to evaluate bioelectrical phase angle as a marker for heart failure (HF) hospitalization risk. Phase angle was measured by the FDA-cleared Bodyport Cardiac Scale.

Methods

SCALE-HF 1 was a multicenter, prospective, observational study, investigating HF event prediction. Baseline phase angle was measured during the first week in the study with the patient standing barefoot on the Cardiac Scale at home for approximately 20 seconds. HF hospitalizations were independently adjudicated. The analysis was based on univariable and multivariable Cox regression models adjusted for age, sex, race, body mass index (BMI), left ventricular ejection fraction (LVEF), inpatient status at enrollment, and selected comorbidities and laboratory tests.

Results

329 participants with HF were enrolled across 8 US sites with 238 patient-years of follow-up. 312 (95%) of the participants had a baseline phase angle, and 57 (18%) of those had a HF hospitalization during the follow-up period. Participants with baseline phase angle in the lowest quartile (suggesting worse cell membrane integrity) were at increased risk for HF hospitalization compared to participants with baseline phase angle in the highest quartile (Hazard ratio: 3.44, 95% CI: 1.55 to 7.63, P = .002). When adjusted for risk factors selected from age, sex, race, BMI, LVEF, laboratory tests and comorbidities in the multivariable model, participants with baseline phase angle in the lowest quartile continued to be at increased risk for HF hospitalization compared to participants with baseline phase angle in the highest quartile (Hazard ratio: 3.51, 95% CI: 1.73 to 7.12, P < .001).

Conclusions

Phase angle was found to be independently associated with HF hospitalization risk. The noninvasive measurement, acquired with a familiar scale form factor, may help guide remote care and triage.

Trial Registration

ClinicalTrials.gov NCT04882449. https://clinicaltrials.gov/study/NCT04882449.

背景：心力衰竭（HF）患者的预后仍然很差，由于心衰恶化导致的死亡率和住院率很高。非侵入性工具可能有助于在这些结果发生之前识别有疾病进展风险的患者。例如，全身细胞质量损失和细胞膜完整性受损与慢性疾病、死亡率、虚弱和营养不良有关。当细胞膜失去完整性时，其电容量减小，生物电相角降低。SCALE-HF 1研究（NCT04882449）收集的数据用于评估生物电相角作为心力衰竭住院风险的标志。相位角由fda批准的Bodyport心脏秤测量。方法：SCALE-HF 1是一项多中心、前瞻性、观察性研究，旨在探讨心衰事件的预测。基线相位角在研究的第一周测量，患者赤脚站在家里的心脏秤上大约20秒。心衰住院是独立裁决的。分析基于单变量和多变量Cox回归模型，校正了年龄、性别、种族、体重指数（BMI）、左室射血分数（LVEF）、入组时的住院情况、选定的合并症和实验室检查。结果：329名HF患者在美国8个研究中心接受了238例患者年的随访。312名（95%）参与者有基线相位角，57名（18%）参与者在随访期间有心衰住院。基线相位角在最低四分位数的参与者（表明细胞膜完整性较差）与基线相位角在最高四分位数的参与者相比，HF住院的风险增加（风险比：3.44,95%可信区间：1.55至7.63,p=0.002）。在多变量模型中，对年龄、性别、种族、BMI、LVEF、实验室检查和合并症等危险因素进行调整后，基线相位角处于最低四分位数的参与者与基线相位角处于最高四分位数的参与者相比，HF住院的风险继续增加（风险比：3.51,95%置信区间：1.73至7.12）。无创测量，以熟悉的规模形式因素获得，可能有助于指导远程护理和分诊。试验注册：ClinicalTrials.gov NCT04882449。https://clinicaltrials.gov/study/NCT04882449。

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引用次数: 0

Response to letter by Hu regarding article, “Statistical Methodological Limitations and Improvement Suggestions in the Study of Vitamin D Deficiency and Cardiovascular Mortality After Heart Transplantation.” 回复胡先生关于“心脏移植后维生素D缺乏与心血管疾病死亡率研究的统计方法局限性和改进建议”一文的来信。

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-10-07 DOI: 10.1016/j.ahj.2025.08.016

Matthew Gold MD , Sarah Kulkarni MSPH , Arshed Quyyumi MD

引用次数: 0

Effect of opt-in versus opt-out framing on trial recruitment: a study within a trial of the GAMEPAD randomized trial 选择加入与选择退出框架对试验招募的影响：GAMEPAD随机试验的研究

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-10-03 DOI: 10.1016/j.ahj.2025.107285

Tayyab Shah MD , Samantha Coratti BA , David Farraday BA , Laurie Norton MA, MBE , Charles Rareshide MS , Jingsan Zhu MS, MBA , Michael G. Levin MD , Sae-Hwan Park PhD , Scott M. Damrauer MD , Jay S. Giri MD, MHS , Neel P. Chokshi MD, MBA , Benjamin M. Jackson MD, MS , Mitesh S. Patel MD, MBA , Alexander C. Fanaroff MD, MHS

Directly contacting eligible participants with an offer to join a randomized clinical trial (RCT) is an efficient recruitment method, but the effect of different outreach strategies on enrollment fraction and completion of the trial protocol is uncertain. In a study within a trial (SWAT) of an RCT testing a physical activity intervention in patients with peripheral artery disease, eligible patients were randomized to receive an email with an invitation to join the study and a link to the trial’s online platform (“opt-in”) or to receive an email framing participation as part of the standard of care followed by telephone outreach from a study coordinator (“opt-out”). Among 5176 participants contacted by unsolicited email (3909 opt-in, 1267 opt-out), enrollment fraction was 1.0% in the opt-in arm (n = 39) versus 3.6% in the opt-out arm (n = 45) (OR 3.65, 95% CI 2.37-5.64); there were no significant differences between opt-in and opt-out participants in the rate of completion of trial protocol steps. This SWAT of recruitment strategies demonstrates the potential for opt-out framing and active outreach to increase enrollment fraction without compromising protocol completion in direct-to-participant RCTs.

直接联系符合条件的参与者并邀请他们加入随机临床试验（RCT）是一种有效的招募方法，但不同的外展策略对入组率和试验方案完成的影响是不确定的。在一项测试外周动脉疾病患者身体活动干预的随机对照试验（SWAT）中，符合条件的患者随机收到一封邀请加入研究的电子邮件和试验在线平台的链接（“选择加入”），或者收到一封将参与作为标准护理的一部分的电子邮件，随后是研究协调员的电话外展（“选择退出”）。在通过主动电子邮件联系的5176名参与者中（3909人选择加入，1267人选择退出），选择加入组的入组率为1.0% (n = 39)，选择退出组的入组率为3.6% (n = 45)(OR 3.65, 95% CI 2.37-5.64)；在试验方案步骤的完成率方面，选择加入和选择退出的参与者之间没有显著差异。招募策略的SWAT表明，在直接面向参与者的随机对照试验中，选择退出框架和积极外展在不影响方案完成的情况下增加入组比例的潜力。

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引用次数: 0

Complete revascularization in patients with acute myocardial infarction and multivessel disease: Pooled analysis of Kaplan-Meier-derived individual-patient-data 急性心肌梗死和多血管疾病患者的完全血运重建：kaplan - meier衍生个体患者数据的汇总分析

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-10-02 DOI: 10.1016/j.ahj.2025.107284

Ahmed Abdelaziz MD , Shrouk Ramadan MD , Mohammed Tarek Hasan MD , Muhammad Desouky MD , Karim Atta MBBS , Abdelrahman Hafez MD , Mahmoud Mohamed Shams MD , Ahmed Helmi MD , Rahma AbdElfattah Ibrahim MD , Ahmed Sobhy MD , Rehab Adel Diab MD , Fayed Mohamed Rzk MD , Ahmed Farid Gadelmawla MD , Ziad Mohsen Alenna MD , Mohamed Abdelaziz MD , Mohamed Nabil Hamouda MD , Noha Hammad MD , Daniel Lorenzatti MD , Carl J Lavie MD , Leandro Slipczuk MD, PhD , Gregg W Stone MD

Complete revascularization in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease reduces major adverse cardiac events (MACE) compared with incomplete revascularization, although whether survival is improved is uncertain. For this systematic review and meta-analysis, all randomized trials of complete vs incomplete revascularization in patients with acute MI without cardiogenic shock were identified from PubMed, Scopus, Web of Science, and Cochrane Library databases from inception to December 31, 2024. The primary and major secondary endpoints were MACE and all-cause mortality derived from reconstructed time-to-event individual-patient-data from published Kaplan-Meier curves. Additional outcomes included cardiovascular mortality, MI, and unplanned repeat revascularizations. Outcomes were expressed as hazard ratios with 95% confidence intervals. This study was registered with the PROSPERO (number, CRD42023415428). A total of 9 randomized trials with 9,658 patients (86.8% with STEMI) were identified among whom 4,671 (48.4%) patients had complete revascularization. Patients with complete revascularization had a lower 5-year risk of MACE (HR: 0.59, 95% CI: 0.54 to 0.66, P < .001) compared with incomplete revascularization. Complete revascularization was also associated with lower 5-year risks of all-cause mortality (HR: 0.64, 95% CI: 0.56 to 0.72, P < .001), cardiovascular mortality (HR: 0.82, 95% CI: 0.71 to 0.95, P = .008), MI (HR: 0.69, 95% CI: 0.55 to 0.87, P < .001), and unplanned repeat revascularizations (HR: 0.62, 95% CI: 0.54 to 0.71, P < .001). Complete revascularization results in lower risks of all-cause and cardiovascular mortality, MI, unplanned repeat revascularizations and MACE in patients with acute MI and multivessel disease. These results support current guidelines recommending CR in hemodynamically stable patients with STEMI, emphasizing that this approach may improve survival.

与不完全血运重建术相比，st段抬高型心肌梗死（STEMI）和多血管疾病患者的完全血运重建术可减少主要不良心脏事件（MACE），尽管生存率是否提高尚不确定。在这项系统评价和荟萃分析中，从PubMed、Scopus、Web of Science和Cochrane Library数据库中确定了从开始到2024年12月31日的急性心肌梗死无心源性休克患者的完全与不完全血运重建术的所有随机试验。主要终点和次要终点是MACE和全因死亡率，这些全因死亡率来自于已发表的Kaplan-Meier曲线中重构的个体患者数据。其他结果包括心血管死亡率、心肌梗死和计划外重复血运重建术。结果以95%置信区间的风险比表示。本研究已在PROSPERO注册（编号：CRD42023415428）。共有9项随机试验，9658例患者（86.8%）被确定为STEMI，其中4671例（48.4%）患者完全血运重建术。完全血运重建术患者发生MACE的5年风险较低(HR: 0.59, 95% CI: 0.54 ~ 0.66, p

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