American heart journal最新文献

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Exercise treadmill testing for efficacy evaluation in randomized, controlled trials 随机对照试验中运动跑步机试验的疗效评价。
IF 3.5 2区 医学
American heart journal Pub Date : 2026-07-01 Epub Date: 2026-02-11 DOI: 10.1016/j.ahj.2026.107379
Andrew Morrow PhD , Robin Young PhD , George R. Abraham BMBCh , Stephen Hoole DM , Joana Maria Gomes Oliveira MSc , John P. Greenwood MBChB, PhD , Jayanth Ranjit Arnold BMBCh, MA, DPhil , Vanessa Ferreira SB, MD, DPhil , Roby Rakhit BSc(Hons), MBBS MD , Gavin Galasko BA, BM, MA, DM , Aish Sinha BSc, MRCP , Divaka Perera MD, FRCP , Rasha Al-Lamee MBBS, PhD , Ioakim Spyridopoulos MD , Ashish Kotecha MBBS , Gerald Clesham MA, PhD , Thomas J. Ford MBChB(Hons), PhD , Anthony Davenport MA, PhD , Sandosh Padmanabhan MBBS, PhD , Juan Carlos Kaski MD, DSc , Colin Berry BSc, MBChB, PhD
{"title":"Exercise treadmill testing for efficacy evaluation in randomized, controlled trials","authors":"Andrew Morrow PhD ,&nbsp;Robin Young PhD ,&nbsp;George R. Abraham BMBCh ,&nbsp;Stephen Hoole DM ,&nbsp;Joana Maria Gomes Oliveira MSc ,&nbsp;John P. Greenwood MBChB, PhD ,&nbsp;Jayanth Ranjit Arnold BMBCh, MA, DPhil ,&nbsp;Vanessa Ferreira SB, MD, DPhil ,&nbsp;Roby Rakhit BSc(Hons), MBBS MD ,&nbsp;Gavin Galasko BA, BM, MA, DM ,&nbsp;Aish Sinha BSc, MRCP ,&nbsp;Divaka Perera MD, FRCP ,&nbsp;Rasha Al-Lamee MBBS, PhD ,&nbsp;Ioakim Spyridopoulos MD ,&nbsp;Ashish Kotecha MBBS ,&nbsp;Gerald Clesham MA, PhD ,&nbsp;Thomas J. Ford MBChB(Hons), PhD ,&nbsp;Anthony Davenport MA, PhD ,&nbsp;Sandosh Padmanabhan MBBS, PhD ,&nbsp;Juan Carlos Kaski MD, DSc ,&nbsp;Colin Berry BSc, MBChB, PhD","doi":"10.1016/j.ahj.2026.107379","DOIUrl":"10.1016/j.ahj.2026.107379","url":null,"abstract":"<div><div>Exercise treadmill testing measures functional capacity and inducible myocardial ischemia and has historically served as an endpoint in phase 2 trials. The Precision Medicine with Zibotentan in Microvascular Angina trial evaluated the selective endothelin-A receptor antagonist zibotentan as a potential disease-modifying therapy for microvascular angina. The trial had a randomized, double-blind, cross-over design and the primary outcome was exercise duration. Compared with placebo, zibotentan at a dose of 10-mg daily for 12-weeks did not improve exercise duration or angina symptoms. In this prespecified analysis, exercise duration was compared across four sequential study visits and the factors associated with within-trial changes were evaluated. Exercise test duration increased progressively in all participants during sequential trial phases, independent of treatment with either zibotentan or placebo. This improvement in exercise duration was associated with female sex (interaction <em>p</em>-value = .0213; effect estimate [95% confidence interval]) 34.95 [13.99, 55.78] seconds, <em>P</em> = .002). In conclusion, the exercise test has limitations as an objective endpoint of efficacy in randomized trials.</div><div>PRIZE; <span><span>https://clinicaltrials.gov/study/NCT04097314</span><svg><path></path></svg></span></div><div>Clinicaltrials.gov Registration: NCT04097314.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"297 ","pages":"Article 107379"},"PeriodicalIF":3.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146193978","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
Effect of age on restrictive and liberal transfusion outcomes in patients with anemia and myocardial infarction 年龄对贫血和心肌梗死患者限制性和自由输血结局的影响。
IF 3.5 2区 医学
American heart journal Pub Date : 2026-07-01 Epub Date: 2026-02-19 DOI: 10.1016/j.ahj.2026.107381
Andrew M. Goldsweig MD, MS , Colleen M. Ballantyne MPH , Harvey D. White MD , Jinnette Dawn Abbott MD , Dean A. Fergusson PhD , Brandon M. Herbert MPH, PhD , Shaun G. Goodman MD, MSc , Jeffrey L. Carson MD , Maria M. Brooks PhD , MINT Investigators
{"title":"Effect of age on restrictive and liberal transfusion outcomes in patients with anemia and myocardial infarction","authors":"Andrew M. Goldsweig MD, MS ,&nbsp;Colleen M. Ballantyne MPH ,&nbsp;Harvey D. White MD ,&nbsp;Jinnette Dawn Abbott MD ,&nbsp;Dean A. Fergusson PhD ,&nbsp;Brandon M. Herbert MPH, PhD ,&nbsp;Shaun G. Goodman MD, MSc ,&nbsp;Jeffrey L. Carson MD ,&nbsp;Maria M. Brooks PhD ,&nbsp;MINT Investigators","doi":"10.1016/j.ahj.2026.107381","DOIUrl":"10.1016/j.ahj.2026.107381","url":null,"abstract":"<div><div>For patients with anemia and myocardial infarction (MI), the randomized, 3,504-patient MINT trial found that a liberal transfusion threshold (10 g/dL) may be preferable to a restrictive threshold (8 g/dL) in terms of death or MI. The relative effects of liberal versus restrictive transfusion in younger and older patients are unknown. The present prespecified MINT substudy found no significant interaction between age and transfusion strategy for death or MI, heart failure, revascularization procedures, cardiac death, pulmonary embolism or deep vein thrombosis, bacteremia or pneumonia, and death at 30 and 180 days. A liberal transfusion approach appears to be safe and may be the preferred transfusion strategy in anemic patients with MI, regardless of age.</div><div>MINT Trial, ClinicalTrials.gov Number NCT02981407, <span><span>https://www.minttrial.org/</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"297 ","pages":"Article 107381"},"PeriodicalIF":3.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146775918","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
Rationale and design of a pragmatic randomized clinical trial assessing a smartphone-based digital health intervention in hypertension: The ELFIE-HYPERTENSION trial 评估基于智能手机的高血压数字健康干预的实用随机临床试验的基本原理和设计:elfie高血压试验。
IF 3.5 2区 医学
American heart journal Pub Date : 2026-07-01 Epub Date: 2026-02-10 DOI: 10.1016/j.ahj.2026.107380
Eduardo Martins MD, PhD , Caio A.M. Tavares MD, PhD , Leandro Favaro MD , Frederico Monfardini , Jean-Jacques Mourad MD, PhD , Kamlesh Khunti MD, PhD , Gianluigi Savarese MD, PhD , Otávio Berwanger MD, PhD , Karla Santo MD, PhD
{"title":"Rationale and design of a pragmatic randomized clinical trial assessing a smartphone-based digital health intervention in hypertension: The ELFIE-HYPERTENSION trial","authors":"Eduardo Martins MD, PhD ,&nbsp;Caio A.M. Tavares MD, PhD ,&nbsp;Leandro Favaro MD ,&nbsp;Frederico Monfardini ,&nbsp;Jean-Jacques Mourad MD, PhD ,&nbsp;Kamlesh Khunti MD, PhD ,&nbsp;Gianluigi Savarese MD, PhD ,&nbsp;Otávio Berwanger MD, PhD ,&nbsp;Karla Santo MD, PhD","doi":"10.1016/j.ahj.2026.107380","DOIUrl":"10.1016/j.ahj.2026.107380","url":null,"abstract":"<div><h3>Background</h3><div>Hypertension represents a major contributor to the global cardiovascular (CV) disease burden, yet it remains inadequately controlled largely due to poor treatment adherence. Emerging digital health technologies hold promise for improving blood pressure (BP) management and CV outcomes, but the lack of evidence, unavailability in most countries, and out-of-pocket costs have hindered the widespread use of these technologies in clinical practice.</div></div><div><h3>Objectives</h3><div>To assess in a randomized controlled trial whether a digital health intervention (DHI) based on the free Elfie solution compared to usual care will reduce systolic blood pressure (SBP) in adults with uncontrolled hypertension (SBP ≥ 140 mmHg).</div></div><div><h3>Methods</h3><div>This is a pragmatic, open-label, randomized parallel arm, international, multicenter clinical trial. Adult individuals with hypertension are randomly assigned to usual care or a DHI based on the Elfie solution. Elfie offers a comprehensive set of features designed to enhance self-monitoring, adherence and education, complemented with a gamification feature to boost engagement. The primary outcome is office SBP measured at 6 months. Secondary outcomes include medication adherence, diastolic BP, BP control achievement, hypertension knowledge, self-care, health-related quality of life and process outcomes assessing app usage and engagement.</div></div><div><h3>Conclusions</h3><div>The ELFIE-HYPERTENSION trial is an international multicenter pragmatic randomized clinical trial, investigating the effects of an innovative, free and scalable DHI to improve BP control. If proven effective, this intervention can be easily and widely implemented in the management of hypertension in a variety of clinical settings globally.</div></div><div><h3>Trial registration number</h3><div>The trial is registered at the Clinicaltrials.gov (NCT06242483).</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"297 ","pages":"Article 107380"},"PeriodicalIF":3.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146177376","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
A comprehensive set of per-protocol analyses of the myocardial ischemia and transfusion (MINT) trial 心肌缺血和输血(MINT)试验的综合方案分析。
IF 3.5 2区 医学
American heart journal Pub Date : 2026-07-01 Epub Date: 2026-02-18 DOI: 10.1016/j.ahj.2026.107382
Brandon M. Herbert PhD, MPH , Jeffrey L. Carson MD , Marnie Bertolet PhD , John H. Alexander MD, MHS , Shaun G. Goodman MD, MSc , Dean A. Fergusson PhD , Gregory Ducrocq MD , Renato D. Lopes MD, PhD , Tabassome Simon MD, PhD , Philippe Gabriel Steg MD , Paul C. Hebert MD, MHSc , Maria Mori Brooks PhD , MINT Investigators
{"title":"A comprehensive set of per-protocol analyses of the myocardial ischemia and transfusion (MINT) trial","authors":"Brandon M. Herbert PhD, MPH ,&nbsp;Jeffrey L. Carson MD ,&nbsp;Marnie Bertolet PhD ,&nbsp;John H. Alexander MD, MHS ,&nbsp;Shaun G. Goodman MD, MSc ,&nbsp;Dean A. Fergusson PhD ,&nbsp;Gregory Ducrocq MD ,&nbsp;Renato D. Lopes MD, PhD ,&nbsp;Tabassome Simon MD, PhD ,&nbsp;Philippe Gabriel Steg MD ,&nbsp;Paul C. Hebert MD, MHSc ,&nbsp;Maria Mori Brooks PhD ,&nbsp;MINT Investigators","doi":"10.1016/j.ahj.2026.107382","DOIUrl":"10.1016/j.ahj.2026.107382","url":null,"abstract":"<div><div>We conducted a series of analyses to estimate the per-protocol effect of restrictive versus liberal transfusion strategies on 30-day death and death or recurrent myocardial infarction (MI) among patients from the Myocardial Ischemia and Transfusion (MINT) trial. Multiple analytic approaches were used to estimate the per-protocol effect, including analyses based on different definitions of adherence (site-reported, time-based, transfusion delay) and an instrumental variable analysis. Analyses based on adherence definitions found a restrictive strategy was associated with a substantially greater risk of 30-day death or recurrent MI, while the instrumental variable analysis estimated a moderate treatment effect similar to the original ITT result.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"297 ","pages":"Article 107382"},"PeriodicalIF":3.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146257192","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
Response to the Letter: Time Alignment Considerations in Evaluating AI-ECG Guidance of Pulmonary Valve Replacement Timing in Repaired Tetralogy of Fallot. 回复信件:评估人工智能心电图指导修复法洛四联症肺动脉瓣置换术时机的时间一致性考虑。
IF 3.5 2区 医学
American heart journal Pub Date : 2026-05-06 DOI: 10.1016/j.ahj.2026.107471
Joshua Mayourian, Lynn A Sleeper, Anne Marie Valente, Tal Geva
{"title":"Response to the Letter: Time Alignment Considerations in Evaluating AI-ECG Guidance of Pulmonary Valve Replacement Timing in Repaired Tetralogy of Fallot.","authors":"Joshua Mayourian, Lynn A Sleeper, Anne Marie Valente, Tal Geva","doi":"10.1016/j.ahj.2026.107471","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107471","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107471"},"PeriodicalIF":3.5,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855748","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
Time-alignment considerations in evaluating AI-ECG-guided pulmonary valve replacement timing in repaired tetralogy of Fallot. 评估人工智能心电图引导下修复法洛四联症肺动脉瓣置换术时机的时间一致性考虑。
IF 3.5 2区 医学
American heart journal Pub Date : 2026-05-06 DOI: 10.1016/j.ahj.2026.107470
Isaac Zablah, Dr Yolly Molina, Dr Edil Argueta
{"title":"Time-alignment considerations in evaluating AI-ECG-guided pulmonary valve replacement timing in repaired tetralogy of Fallot.","authors":"Isaac Zablah, Dr Yolly Molina, Dr Edil Argueta","doi":"10.1016/j.ahj.2026.107470","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107470","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107470"},"PeriodicalIF":3.5,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855711","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
Serial Assessment of NT-proBNP and High-Sensitivity Cardiac Troponin with Glucagon-Like Peptide-1 Receptor Agonist Therapy in Type 2 Diabetes: Insights from EXSCEL. NT-proBNP和高敏心肌肌钙蛋白联合胰高血糖素样肽-1受体激动剂治疗2型糖尿病的系列评估:来自EXSCEL的见解
IF 3.5 2区 医学
American heart journal Pub Date : 2026-05-06 DOI: 10.1016/j.ahj.2026.107475
Veraprapas Kittipibul, Maggie Nguyen, Paul Welsh, John B Buse, Harald Sourij, Adrian F Hernandez, Rury R Holman, Svati H Shah, Robert J Mentz
{"title":"Serial Assessment of NT-proBNP and High-Sensitivity Cardiac Troponin with Glucagon-Like Peptide-1 Receptor Agonist Therapy in Type 2 Diabetes: Insights from EXSCEL.","authors":"Veraprapas Kittipibul, Maggie Nguyen, Paul Welsh, John B Buse, Harald Sourij, Adrian F Hernandez, Rury R Holman, Svati H Shah, Robert J Mentz","doi":"10.1016/j.ahj.2026.107475","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107475","url":null,"abstract":"<p><strong>Background: </strong>In the EXSCEL trial, exenatide did not reduce major adverse cardiovascular events (MACE), but heterogeneity of benefit and the role of cardiac biomarkers remain uncertain. We evaluated the prognostic value of baseline and 1-year changes in N-terminal pro B-type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin I (cTnI), and whether baseline biomarker concentrations modified exenatide effects.</p><p><strong>Methods: </strong>EXSCEL randomized 14,752 adults with type 2 diabetes to exenatide 2 mg weekly (EQW) or placebo. In a biomarker cohort, 4,292 participants had serial NT-proBNP or cTnI at baseline and 1 year. Biomarkers were log transformed and Cox models related baseline concentrations and 1-year change to MACE, all-cause mortality (ACM), cardiovascular (CV) death, hospitalization for heart failure (hHF), adjusting for clinical covariates and the alternate biomarker. Treatment interaction was tested with biomarker by treatment terms.</p><p><strong>Results: </strong>Over median 1,480 days follow-up, 529 MACE, 310 all cause deaths, 193 CV deaths, and 157 hHF events occurred. Baseline NT-proBNP was strongly prognostic (adjusted HR per 1 integer unit 1.63 for MACE, 1.85 for ACM, 2.17 for CV death, and 2.17 for hHF; all p<0.001). Baseline cTnI was also prognostic with a nonlinear pattern, with risk rising mainly above the median. Per SD rise in NT-proBNP over 1 year predicted later MACE (HR 1.85) and CV death (HR 2.81; both p<0.001). Baseline NT-proBNP didn't modify treatment effects. Baseline cTnI didn't modify EQW treatment effect on MACE but lower rates of CV deaths and hHF with EQW were observed at higher cTnI concentrations.</p><p><strong>Conclusions: </strong>NT-proBNP and cTnI were strong prognostic markers of adverse outcomes in patients with type 2 diabetes and their 1-year increases signaled higher subsequent risk. Baseline cTnI may mark heterogeneity of EQW response, but mortality interactions are hypothesis generating and require confirmation.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107475"},"PeriodicalIF":3.5,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855766","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
BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs (BASELINE trial): A protocol update. 球囊膨胀与自膨胀经导管瓣膜治疗退行性生物假体(基线试验):方案更新。
IF 3.5 2区 医学
American heart journal Pub Date : 2026-05-06 DOI: 10.1016/j.ahj.2026.107469
Antigone Kostea, Sraman Chatterjee, Nicolas M Van Mieghem, Rutger-Jan Nuis
{"title":"BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs (BASELINE trial): A protocol update.","authors":"Antigone Kostea, Sraman Chatterjee, Nicolas M Van Mieghem, Rutger-Jan Nuis","doi":"10.1016/j.ahj.2026.107469","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107469","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107469"},"PeriodicalIF":3.5,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855739","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
Design and rationale of the GUARD-OAC: A randomized controlled trial evaluating proton pump inhibitor cotherapy for gastrointestinal protection in patients requiring direct oral anticoagulants GUARD-OAC的设计和基本原理:一项随机对照试验,评估质子泵抑制剂协同治疗对需要直接口服抗凝剂的患者的胃肠道保护作用。
IF 3.5 2区 医学
American heart journal Pub Date : 2026-05-01 Epub Date: 2026-01-06 DOI: 10.1016/j.ahj.2026.107341
Hyo-Jeong Ahn , So-Ryoung Lee , Soonil Kwon , Tae-Min Rhee , Young Soo Lee , Sang-Jin Han , Ki-Woon Kang , Jaemin Shim , Hee Tae Yu , Il-Young Oh , Hyoung-Seob Park , Jin-Kyu Park , Sung-Won Jang , Sung Ho Lee , Seung-Young Roh , Kwang Jin Chun , Hyung Wook Park , Kyung-Yeon Lee , Seil Oh , Eue-Keun Choi
{"title":"Design and rationale of the GUARD-OAC: A randomized controlled trial evaluating proton pump inhibitor cotherapy for gastrointestinal protection in patients requiring direct oral anticoagulants","authors":"Hyo-Jeong Ahn ,&nbsp;So-Ryoung Lee ,&nbsp;Soonil Kwon ,&nbsp;Tae-Min Rhee ,&nbsp;Young Soo Lee ,&nbsp;Sang-Jin Han ,&nbsp;Ki-Woon Kang ,&nbsp;Jaemin Shim ,&nbsp;Hee Tae Yu ,&nbsp;Il-Young Oh ,&nbsp;Hyoung-Seob Park ,&nbsp;Jin-Kyu Park ,&nbsp;Sung-Won Jang ,&nbsp;Sung Ho Lee ,&nbsp;Seung-Young Roh ,&nbsp;Kwang Jin Chun ,&nbsp;Hyung Wook Park ,&nbsp;Kyung-Yeon Lee ,&nbsp;Seil Oh ,&nbsp;Eue-Keun Choi","doi":"10.1016/j.ahj.2026.107341","DOIUrl":"10.1016/j.ahj.2026.107341","url":null,"abstract":"<div><h3>Background</h3><div>Direct oral anticoagulants (DOACs) are the cornerstone of thromboembolic prevention in patients with atrial fibrillation, venous thromboembolism, or other cardiovascular conditions. However, DOAC use is associated with an increased risk of bleeding, with gastrointestinal (GI) bleeding being the most common site of major bleeding. Proton pump inhibitors (PPIs) are reasonably used during combined antithrombotic therapy or based on individual bleeding risk; nonetheless, evidence supporting their benefit in patients receiving DOAC therapy remains limited.</div></div><div><h3>Methods</h3><div>The Gastrointestinal protection Using proton-pump inhibitor in pAtients who RequireD Oral AntiCoagulants (GUARD-OAC) trial is a prospective, multicenter, open-label, randomized controlled trial evaluating the GI protective effect of PPI coadministration with DOAC. Eligible participants are patients with cardio- or cerebrovascular disease requiring long-term anticoagulation (≥1 year), who are currently receiving or initiating DOAC therapy, and have a HAS-BLED score of ≥1. The primary outcome is a composite of upper GI clinical events, including bleeding, symptomatic gastroduodenal ulcer, persistent pain of presumed GI origin with underlying multiple erosive disease, obstruction, or perforation. The secondary outcomes are the individual components of the primary outcome, GI symptoms or signs, cardiovascular or all bleeding events, and all-cause mortality. Assuming a 40% relative risk reduction of the primary outcome in the PPI plus DOAC group compared to the DOAC alone group, a total of 3,846 patients will be enrolled and followed for one year. A Clinical Events Committee will adjudicate clinical outcomes and adverse events for causality and attribution, and an independent Data Safety Monitoring Board will oversee the study. The GUARD-OAC trial is funded by the Ministry of Health &amp; Welfare, Republic of Korea.</div></div><div><h3>Conclusions</h3><div>The GUARD-OAC trial is the first randomized controlled trial exploring the efficacy of PPI cotherapy in patients receiving DOACs, providing evidence that may inform future guidelines on GI protection in this population.</div></div><div><h3>Trial registration</h3><div>Clinical Research Information Service, Identifier KCT0006848.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"295 ","pages":"Article 107341"},"PeriodicalIF":3.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145931782","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
Staged interventional strategies for acute ST-segment elevation myocardial infarction patient with multivessel disease: Rationale and design of a multicenter, randomized STAGED trial 急性st段抬高型心肌梗死合并多血管疾病的分期介入治疗策略:一项多中心、随机分期试验的基本原理和设计
IF 3.5 2区 医学
American heart journal Pub Date : 2026-05-01 Epub Date: 2026-01-13 DOI: 10.1016/j.ahj.2026.107352
Xiang Chen MD, PhD , Suiji Li MD, PhD , Bin Wang MD, PhD , Geng Chen MD , Yaner Yao MD , Yuquan He MD, PhD , Xinhua Wu MD , Youdong Yang MD , Huiyuan Kang MD , Licheng Ding MD , Ye Cheng MD , Qiusheng Shen MD , Haijun Guo MD , Jinping Wang MD, PhD , Shangyu Wen MD , Li Zhu MD , Yulong Xing MD , Qian Tong MD, PhD , Ping Li MD , Yin Liu MD, PhD , Yan Wang MD, PhD
{"title":"Staged interventional strategies for acute ST-segment elevation myocardial infarction patient with multivessel disease: Rationale and design of a multicenter, randomized STAGED trial","authors":"Xiang Chen MD, PhD ,&nbsp;Suiji Li MD, PhD ,&nbsp;Bin Wang MD, PhD ,&nbsp;Geng Chen MD ,&nbsp;Yaner Yao MD ,&nbsp;Yuquan He MD, PhD ,&nbsp;Xinhua Wu MD ,&nbsp;Youdong Yang MD ,&nbsp;Huiyuan Kang MD ,&nbsp;Licheng Ding MD ,&nbsp;Ye Cheng MD ,&nbsp;Qiusheng Shen MD ,&nbsp;Haijun Guo MD ,&nbsp;Jinping Wang MD, PhD ,&nbsp;Shangyu Wen MD ,&nbsp;Li Zhu MD ,&nbsp;Yulong Xing MD ,&nbsp;Qian Tong MD, PhD ,&nbsp;Ping Li MD ,&nbsp;Yin Liu MD, PhD ,&nbsp;Yan Wang MD, PhD","doi":"10.1016/j.ahj.2026.107352","DOIUrl":"10.1016/j.ahj.2026.107352","url":null,"abstract":"<div><h3>Background</h3><div>Complete revascularization (CR) has been shown to reduce the risk of adverse cardiovascular events compared with culprit-only revascularization (COR) in acute ST-segment elevation myocardial infarction (STEMI) patients with multivessel disease (MVD). However, the optimal timing of staged complete revascularization (SCR) after primary percutaneous coronary intervention (PCI) remains unclear.</div></div><div><h3>Trial design</h3><div>The STAGED trial is an investigator-initiated, multicenter, randomized study involving 37 sites, aiming to include 1,586 acute STEMI patients with MVD undergoing successful primary PCI of the culprit lesion followed by SCR. Eligible patients will be assigned to two groups based on the timing of SCR: early-staged PCI and delayed-staged PCI. The primary endpoint is major adverse cardiac event (MACE), including cardiovascular death, myocardial infarction, or ischemia-driven revascularization for both culprit and nonculprit vessels at 12 months since the randomization. The secondary endpoint is individual components of primary endpoint, all-cause death, heart failure-related rehospitalization, stroke, contrast-induced nephropathy, and radiation exposure dose. Follow-up will be conducted through clinic visits or telephone interviews at 1, 3, and 12 months after the index procedure.</div></div><div><h3>Conclusion</h3><div>The STAGED trial is the first randomized controlled study specifically designed to evaluate the clinical efficacy and safety of different timing strategies for SCR in acute STEMI patients with MVD.</div></div><div><h3>Trial registration</h3><div>clinicaltrials.gov, NCT04918030.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"295 ","pages":"Article 107352"},"PeriodicalIF":3.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145987591","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}
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