American heart journalPub Date : 2026-07-01Epub Date: 2026-02-19DOI: 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 , 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","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}
{"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 , 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","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}
American heart journalPub Date : 2026-07-01Epub Date: 2026-02-18DOI: 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 , 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","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}
Serge Korjian, C Michael Gibson, Jonathan Seltzer, Kenneth W Mahaffey, Norman Stockbridge, Patrick R Lawler, Krishna Pundi, Brian A Bergmark, Mark C Petrie, Christopher R deFilippi, Stephen J Nicholls, A Michael Lincoff, Carolyn S P Lam, Kazuhiro Sase, Sanjeev P Bhavnani, Marc P Bonaca, Sanket S Dhruva, Roxana Mehran, Renato D Lopes, Eri Kato, Nicholas A Marston
{"title":"Cardiovascular Regulatory Science: Accelerating the Path from Bench to Bedside.","authors":"Serge Korjian, C Michael Gibson, Jonathan Seltzer, Kenneth W Mahaffey, Norman Stockbridge, Patrick R Lawler, Krishna Pundi, Brian A Bergmark, Mark C Petrie, Christopher R deFilippi, Stephen J Nicholls, A Michael Lincoff, Carolyn S P Lam, Kazuhiro Sase, Sanjeev P Bhavnani, Marc P Bonaca, Sanket S Dhruva, Roxana Mehran, Renato D Lopes, Eri Kato, Nicholas A Marston","doi":"10.1016/j.ahj.2026.107487","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107487","url":null,"abstract":"<p><p>Regulatory science (RS) is a field dedicated to developing and applying scientific methods, tools, standards, and evidence-based frameworks to improve regulatory policies and decision-making related to medical and device products. The acceleration of cardiovascular innovations over the past two decades has underscored the need for efficient evidence generation and streamlined regulatory pathways for new drugs and devices. RS seeks to address these challenges by strengthening the evidence base that informs policy and guidance, enhancing transparency, expediting approval processes, and enabling more agile responses to emerging public health needs. By evaluating innovative trial designs and employing advanced statistical methods, RS can reduce resource demands of clinical trials while preserving scientific integrity. RS also facilitates the standardization of biomarker evaluations and surrogate endpoints, supporting advancements in precision medicine. In addition to clinical evaluation, RS can enhance post-marketing surveillance by utilizing real-world evidence and advanced analytics to promptly identify safety signals, ensuring patient safety and continuous product monitoring. RS also supports global regulatory harmonization efforts, reducing redundancies and accelerating access to therapies across regions. RS aims to guide the development of regulatory policies, refine communication strategies to optimize the use of medical products, and maintain efficient, transparent, and scientifically rigorous regulatory frameworks. Continued investment in RS is essential for improving patient outcomes in cardiovascular medicine by safeguarding safety while accelerating innovation and access to therapies.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107487"},"PeriodicalIF":3.5,"publicationDate":"2026-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147961938","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}
American heart journalPub Date : 2026-05-01Epub Date: 2026-01-06DOI: 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 , 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","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 & 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}
American heart journalPub Date : 2026-05-01Epub Date: 2026-01-13DOI: 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 , 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","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}
American heart journalPub Date : 2026-05-01Epub Date: 2026-01-12DOI: 10.1016/j.ahj.2026.107351
Omar Cantu-Martinez MD , Marat Fudim MD, MHS , David F. Kong MD , Ryan J. Tedford MD , Philip G. Jones MS , Andrew J. Sauer MD , Timothy J. Fendler MD, MS , John A. Spertus MD, MPH
{"title":"Accuracy of site versus core laboratory interpretations of right heart catheterization hemodynamics","authors":"Omar Cantu-Martinez MD , Marat Fudim MD, MHS , David F. Kong MD , Ryan J. Tedford MD , Philip G. Jones MS , Andrew J. Sauer MD , Timothy J. Fendler MD, MS , John A. Spertus MD, MPH","doi":"10.1016/j.ahj.2026.107351","DOIUrl":"10.1016/j.ahj.2026.107351","url":null,"abstract":"<div><div>An accurate interpretation of hemodynamics measured by right heart catheterization (RHC) is crucial for guiding the management of heart failure and pulmonary hypertension. We evaluated the concordance and variability between site-reported and core laboratory-adjudicated interpretations of invasive hemodynamic measurements.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"295 ","pages":"Article 107351"},"PeriodicalIF":3.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145984252","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}
American heart journalPub Date : 2026-05-01Epub Date: 2026-01-12DOI: 10.1016/j.ahj.2026.107353
Eesha Nachnani , Kashish Goel MD , Alexander E. Sullivan MD MSCI
{"title":"Comparative performance of large language models on cardiovascular certification simulation exam","authors":"Eesha Nachnani , Kashish Goel MD , Alexander E. Sullivan MD MSCI","doi":"10.1016/j.ahj.2026.107353","DOIUrl":"10.1016/j.ahj.2026.107353","url":null,"abstract":"<div><div>Artificial intelligence (AI) is becoming increasingly prevalent in medical practice and has demonstrated sufficient clinical acumen to pass several licensing examinations. We tested the ability of 3 popular large-language models, ChatGPT-4.0 (OpenAI), Gemini (Google), and Bing AI (Microsoft), to pass a cardiovascular medicine board-style exam. Of these AI platforms, only ChatGPT-4.0 was able to achieve a score similar to human participants.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"295 ","pages":"Article 107353"},"PeriodicalIF":3.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145984263","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}
American heart journalPub Date : 2026-04-01Epub Date: 2025-12-06DOI: 10.1016/j.ahj.2025.107325
Mathias Holm Sørgaard MD, PhD , Andreas Torp Kristensen MD , Kristian Eskesen MD, PhD , Klaus Fuglsang Kofoed MD, PhD, DMSc , Jesper James Linde MD, PhD , Henning Kelbæk , Michael Ottesen MD, PhD , Keld Neland MD, PhD , Charlotte Kragelund MD, PhD , Mette Lykke Norgaard Bertelsen MD, PhD , Jens Dahlgaard Hove MD, PhD , Gorm Mørk MD, PhD , Ole Peter Kristiansen MD, PhD , Thomas Engstrøm MD, PhD, DMSc , Jacob Thomsen Lønborg MD, PhD, DMSc , Jørgen Tobias Kühl MD, PhD, DMSc , Signe Stelling Risom RN, PhD , Paul Blanche MSc, PhD , Niels Thue Olsen MD, PhD
{"title":"Coronary computed tomography angiography versus invasive coronary angiography for interventional triage in acute coronary syndrome: Design of the randomized TRACTION trial","authors":"Mathias Holm Sørgaard MD, PhD , Andreas Torp Kristensen MD , Kristian Eskesen MD, PhD , Klaus Fuglsang Kofoed MD, PhD, DMSc , Jesper James Linde MD, PhD , Henning Kelbæk , Michael Ottesen MD, PhD , Keld Neland MD, PhD , Charlotte Kragelund MD, PhD , Mette Lykke Norgaard Bertelsen MD, PhD , Jens Dahlgaard Hove MD, PhD , Gorm Mørk MD, PhD , Ole Peter Kristiansen MD, PhD , Thomas Engstrøm MD, PhD, DMSc , Jacob Thomsen Lønborg MD, PhD, DMSc , Jørgen Tobias Kühl MD, PhD, DMSc , Signe Stelling Risom RN, PhD , Paul Blanche MSc, PhD , Niels Thue Olsen MD, PhD","doi":"10.1016/j.ahj.2025.107325","DOIUrl":"10.1016/j.ahj.2025.107325","url":null,"abstract":"<div><h3>Purpose</h3><div>In patients admitted with acute coronary syndrome, invasive coronary angiography (ICA) is performed to determine which patients need revascularization. Coronary computed tomography angiography (CCTA) offers a widely available, non-invasive alternative that could reduce patient discomfort, procedural risks, and healthcare costs. The current trial aims to determine whether CCTA is noninferior to ICA in determining the interventional strategy for patients admitted with non-ST elevation acute coronary syndrome (NSTE-ACS)(<span><span>Central Illustration</span></span>).</div></div><div><h3>Methods</h3><div>TRACTION (Team-based Interventional Triage in Acute Coronary Syndrome Based on Noninvasive Coronary Computed Tomography Angiography Versus Invasive Coronary Angiography) is a multicenter, randomized, open-label, noninferiority trial enrolling 2,300 patients. Patients hospitalized with non-ST elevation myocardial infarction or unstable angina with ischemic changes on ECG will be randomized 1:1 to CCTA vs ICA (standard of care). In the CCTA group, a Coronary Team reviews the CCTA and clinical information to determine the interventional strategy. The primary composite endpoint is major adverse cardiac events at 1 year, comprised of all-cause mortality, nonfatal myocardial infarction, hospitalization due to refractory angina, or hospitalization due to heart failure. Secondary outcomes include cardiovascular death, revascularization, symptom status, procedure-related adverse events, and resource utilization. The trial is designed to demonstrate noninferiority if the 95% confidence interval excludes an absolute risk difference of the primary endpoint larger than 5%.</div></div><div><h3>Perspectives</h3><div>If CCTA is shown to be noninferior to ICA in patients admitted with NSTE-ACS, CCTA could become the preferred management in a large group of patients. This could result in fewer patients exposed to invasive procedures and improved resource utilization.</div><div>ClinicalTrials.gov identifier: NCT06101862</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107325"},"PeriodicalIF":3.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145707173","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}