American heart journalPub Date : 2026-04-01Epub Date: 2025-12-18DOI: 10.1016/j.ahj.2025.107326
Israel Júnior Borges do Nascimento MD, MSc , Renato D. Lopes MD, PhD , Marcos Venicius Malveira De Lima , Matheus de Freitas Itaborahy , Alexander C. Fanaroff MD, PhD , Brijesh Sathian MD, PhD , Holger Thiele MD, PhD , Bruno Ramos Nascimento
{"title":"Coevolutionary analysis of evidence and recommendations in STEMI clinical practice guidelines: A 33-year meta-research study of ACC, AHA, and ESC","authors":"Israel Júnior Borges do Nascimento MD, MSc , Renato D. Lopes MD, PhD , Marcos Venicius Malveira De Lima , Matheus de Freitas Itaborahy , Alexander C. Fanaroff MD, PhD , Brijesh Sathian MD, PhD , Holger Thiele MD, PhD , Bruno Ramos Nascimento","doi":"10.1016/j.ahj.2025.107326","DOIUrl":"10.1016/j.ahj.2025.107326","url":null,"abstract":"<div><h3>Background</h3><div>ST-Segment Elevation Myocardial Infarction (STEMI) is considered the main cause of mortality and morbidity for decades globally. Regularly, cardiology-related medical organizations publish clinical practice guidelines (CPGs) to support healthcare professionals in the diagnosis, management, and prevention of future cardiovascular events. Nevertheless, the level of evidence (LOE) and classification of recommendations (CORs) endorsing STEMI-associated CPGs recommendations have not been systematically appraised.</div></div><div><h3>Purpose</h3><div>This meta-research study evaluated and described the CORs and LOE over time for STEMI guidelines endorsed by the American Heart Association (AHA), American College of Cardiology (ACC), and European Society of Cardiology (ESC), from 1990 to 2023.</div></div><div><h3>Data sources</h3><div>We initially searched on PubMed and AHA/ACC/ESC electronic repositories to obtain STEMI-related CPGs, published from 1990 to 2023, including their immediate predecessors.</div></div><div><h3>Study Selection</h3><div>Guidelines related to acute in-hospital STEMI management were included; recommendations related to unstable angina/Non–STEMI were excluded.</div></div><div><h3>Data Extraction</h3><div>Data management was performed by 2 content experts. Recommendations on pharmacological and nonpharmacological interventions (PI and NPI, respectively) were extracted ipsilaterally, further processed and coded based on thematic analysis fundamentals. Recommendation's recordings associated with each recommendation were maintained as the primary guideline publication without team's specialist judgement. Pharmacological-related recommendations were categorized in accordance with the Anatomical Therapeutic Chemical Classification System by the WHO Collaborating Centre for Drug Statistics Methodology. Changes in the proportion and LOE were evaluated longitudinally, using chi-square test (x<sup>2</sup>). Data visualization included heatmaps, linear plots, and Sankey diagrams.</div></div><div><h3>Data Synthesis</h3><div>Twenty-six guidelines (2,139 STEMI-specific recommendations) were evaluated. We observed an overall predominance of recommendations relying on moderate (proportion of 30.1% of LOE-B recommendations) or low (proportion of 28.9% of LOE-C recommendations) quality of evidence over the 33-year span. Only 17.7% of processed recommendations were based on high quality of evidence. Pharmacological interventions were more often LOE-A compared with NPI (21.5% vs 13.8%; <em>P</em>-value < 0.05). Most abstracted PI related to anticoagulants and dual anti-platelet therapies, while the most frequent category of NPI were related to percutaneous coronary interventions and implantable cardiac devices. Two consecutive guidelines comparison revealed that LOE and COR assigned to corresponding recommendation were minimal.</div></div><div><h3>Limitations</h3><div>Restriction to only AHA/ACC/ESC guidelines and prim","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107326"},"PeriodicalIF":3.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145800414","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: 2026-01-02DOI: 10.1016/j.ahj.2026.107340
Balaji Tamarappoo MD, PhD , Rafal Wolny MD, PhD , Guadalupe Flores Tomasino MD , Daniel Berman MD , Eileen Handberg PhD , Carl J. Pepine MD , Margaret C. Lo MD , Matthew Budoff MD , Leslee Shaw PhD , Chrisandra Shufelt MD , Janet Wei MD , Martha Gulati MD, MS , C. Noel Bairey Merz MD , Damini Dey PhD
{"title":"Design and rationale of the WARRIOR ancillary study for coronary CT angiographic analysis","authors":"Balaji Tamarappoo MD, PhD , Rafal Wolny MD, PhD , Guadalupe Flores Tomasino MD , Daniel Berman MD , Eileen Handberg PhD , Carl J. Pepine MD , Margaret C. Lo MD , Matthew Budoff MD , Leslee Shaw PhD , Chrisandra Shufelt MD , Janet Wei MD , Martha Gulati MD, MS , C. Noel Bairey Merz MD , Damini Dey PhD","doi":"10.1016/j.ahj.2026.107340","DOIUrl":"10.1016/j.ahj.2026.107340","url":null,"abstract":"<div><h3>Background</h3><div>Over 50% of women evaluated for suspected ischemia have no obstructive coronary artery disease (INOCA). Statins, angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) are effective in intermediate outcome trials; however, impact on coronary plaque has not been well characterized.</div></div><div><h3>Objectives</h3><div>The Women’s IschemiA TRial to Reduce Events In Non-ObstRuctive CAD (WARRIOR NCT03417388) trial testing intensive medical therapy (IMT) (high intensity statin, ACEI or ARB and low dose aspirin) vs usual care (UC) in women with suspected INOCA offers the opportunity to evaluate the impact of IMT vs UC on plaque composition, and chest pain symptoms by coronary CT angiography (CCTA). We hypothesize that IMT provides beneficial data on plaque composition impacting flow reserve and trial outcomes.</div></div><div><h3>Methods</h3><div>This WARRIOR ancillary study will consecutively enroll 200 eligible participants randomized to IMT vs UC by baseline and exit CCTA. Changes in plaque and peri‑coronary artery adipose tissue attenuation (PCAT) characteristics will be quantified.</div></div><div><h3>Results</h3><div>Results will address: (1) Changes in coronary plaque characteristics and their hemodynamic significance using AI-enabled quantification of CCTA; (2) Changes in plaque inflammatory characteristics through pericoronary adipose tissue (PCAT) density analysis; (3) Plaque burden, composition and PCAT density changes related to angina score (Seattle Angina Questionnaire [SAQ]), (4) Derive a quantitative machine learning risk score (MLRS) using CCTA-derived variables for prediction of change in angina.</div></div><div><h3>Conclusions</h3><div>The ancillary study will be the first to quantify the impact of IMT vs UC on plaque composition, and outcomes in women with suspected INOCA.</div></div><div><h3>Trial Registration</h3><div>WARRIOR Ancillary Study for CCTA Analysis, NCT05035056</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107340"},"PeriodicalIF":3.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145899098","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: 2026-01-03DOI: 10.1016/j.ahj.2026.107339
Roberto Diletti MD, PhD , Joost Daemen MD, PhD , Benjamin Faurie MD , Marco Barbierato MD , Didier Tchetche MD , Thomas Hovasse MD , Koen Teeuwen MD, PhD , Rohit M. Oemrawsingh MD, PhD , Abdelhakim Allali MD, PhD , Gianluca Campo MD, PhD , Johan Bennett MD, PhD , Fernando Alfonso MD , Kambis Mashayekhi MD, PhD , Raul Moreno MD, PhD , Youssef S. Abdelwahed MD, PhD , Admir Dedic MD, PhD , Jose M. de la Torre Hernandez MD, PhD , John C. Murphy MB, BCH, MD, MRCP , Ignacio Amat-Santos MD, PhD , Joseph Dens MD, PhD , Nicolas M. Van Mieghem MD, PhD
{"title":"Intravascular ultrasound guidance for complex high-risk indicated procedures: The IVUS CHIP trial study design","authors":"Roberto Diletti MD, PhD , Joost Daemen MD, PhD , Benjamin Faurie MD , Marco Barbierato MD , Didier Tchetche MD , Thomas Hovasse MD , Koen Teeuwen MD, PhD , Rohit M. Oemrawsingh MD, PhD , Abdelhakim Allali MD, PhD , Gianluca Campo MD, PhD , Johan Bennett MD, PhD , Fernando Alfonso MD , Kambis Mashayekhi MD, PhD , Raul Moreno MD, PhD , Youssef S. Abdelwahed MD, PhD , Admir Dedic MD, PhD , Jose M. de la Torre Hernandez MD, PhD , John C. Murphy MB, BCH, MD, MRCP , Ignacio Amat-Santos MD, PhD , Joseph Dens MD, PhD , Nicolas M. Van Mieghem MD, PhD","doi":"10.1016/j.ahj.2026.107339","DOIUrl":"10.1016/j.ahj.2026.107339","url":null,"abstract":"<div><h3>Background</h3><div>Intravascular ultrasound (IVUS) guidance for percutaneous coronary intervention (PCI) has been associated with a reduction in clinical events. Whereas most evidence is generated in Asian-Pacific populations, its global adoption remains low.</div></div><div><h3>Methods</h3><div>The IVUS complex high-risk indicated procedures (CHIP) trial is a multicenter, international, event-driven, randomized superiority trial comparing IVUS-guided PCI with angio-guided PCI during complex high-risk indicated procedures. The primary endpoint is target vessel failure, defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target vessel revascularization. The IVUS CHIP trial utilizes an event-driven approach. The outcomes for the primary endpoint are first reported when at least 169 patients with a primary endpoint have been confirmed. A total of 2020 patients will be enrolled in 37 European sites.</div></div><div><h3>Conclusions</h3><div>The aim of the IVUS CHIP trial is to assess the superiority of an IVUS-guided approach vs an angio-guided approach in patients undergoing complex high-risk indicated procedures in terms of the study primary endpoint of target vessel failure.</div></div><div><h3>Trial Registration</h3><div>The IVUS CHIP trial is registered at ClinicalTrial.gov and assigned the identifier NCT04854070.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107339"},"PeriodicalIF":3.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145905456","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: 2025-12-29DOI: 10.1016/j.ahj.2025.107334
Alan Cohen MD , Anita Cohen
{"title":"Another perspective on democracy, healthcare and the public good","authors":"Alan Cohen MD , Anita Cohen","doi":"10.1016/j.ahj.2025.107334","DOIUrl":"10.1016/j.ahj.2025.107334","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107334"},"PeriodicalIF":3.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145877472","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: 2025-12-31DOI: 10.1016/j.ahj.2025.107337
Francisco B. Alexandrino MD , Reid Schlesinger MD , Jared Bird MD , Eunjung Lee PhD , Abhishek J. Deshmukh MBBS , Vuyisile T. Nkomo MD, MPH , Jae K. Oh , Peter A. Noseworthy MD , Patricia A. Pellikka MD , Zachi Attia PhD , Francisco Lopez-Jimenez MD , Paul A. Friedman , Garvan C. Kane MD, PhD , Sorin V. Pislaru MD, PhD , Gal Tsaban MD, PhD
{"title":"Integrating AI-ECG and point-of-care cardiac ultrasound for screening structural heart disease: A proof-of-concept study","authors":"Francisco B. Alexandrino MD , Reid Schlesinger MD , Jared Bird MD , Eunjung Lee PhD , Abhishek J. Deshmukh MBBS , Vuyisile T. Nkomo MD, MPH , Jae K. Oh , Peter A. Noseworthy MD , Patricia A. Pellikka MD , Zachi Attia PhD , Francisco Lopez-Jimenez MD , Paul A. Friedman , Garvan C. Kane MD, PhD , Sorin V. Pislaru MD, PhD , Gal Tsaban MD, PhD","doi":"10.1016/j.ahj.2025.107337","DOIUrl":"10.1016/j.ahj.2025.107337","url":null,"abstract":"<div><h3>Background</h3><div>Early structural heart disease (SHD) detection is crucial for improving prognostic outcomes, but widely accessible screening methods are lacking. The advent of artificial intelligence-enabled electrocardiograms (AI-ECG) and point-of-care cardiac-ultrasonography (POCCUS) offers promising new approaches for patient screening. We explored the feasibility and potential of integrating these innovative technologies into a practical SHD screening framework.</div></div><div><h3>Methods</h3><div>Outpatients undergoing ECG at the Mayo Clinic ECG laboratory between November 2023 and February 2024 were pragmatically offered POCCUS, performed by novice operators and reviewed by expert echocardiographers. AI-ECG and POCCUS findings were integrated to assess SHD, including reduced left ventricular systolic function (ejection-fraction<50%), aortic stenosis, and increased left ventricular wall thickness suggestive of cardiac amyloidosis or hypertrophic cardiomyopathy. Operators were blinded to patients’ comorbidities and formal echocardiogram results.</div></div><div><h3>Results</h3><div>Of 486 patients (median-age 64 years; 49% women), 286 had available formal echocardiography, with 17.5% having SHD. AI-ECG had a 32% positive predictive value (PPV) and a 94% negative predictive value (NPV) to detect any SHD. Adding POCCUS increased the overall PPV to 64% with an NPV of 93%, with an increase in diagnostic accuracy from 67% to 88%. Notably, 89.5% (17/19) of the “false positives” by AI-ECG + POCCUS had less-than-moderate-SHD. Applying the AI-ECG + POCCUS screening workflow on the entire cohort resulted in a number-needed-to-screen of 8 to identify 1 patient requiring formal echocardiography.</div></div><div><h3>Conclusions</h3><div>The integration of AI-ECG and POCCUS holds promise as a potentially effective screening method for SHD, facilitating improved patient selection for formal echocardiography.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107337"},"PeriodicalIF":3.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145892136","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 : 2026-03-01Epub Date: 2025-11-21DOI: 10.1016/j.ahj.2025.107308
Benjamin L. Magod MD , Zachary H. Hughes MD , Anusha Manjunath MD , Tingqing Wu , Rebecca Harrap , Benjamin Bryner MD , Sabra Lewsey MD, MPH , Kambiz Ghafourian MD, MPH , Olise Oputa , Duc Pham MD , Kiersten Rasberry , Anjan Tibrewala MD, MS , Jane Wilcox MD, MSc , Quentin R. Youmans MDMSc , Ike S. Okwuosa MD
{"title":"Incidence and risk factors for malignancy after heart transplantation- Analysis of the UNOS Registry","authors":"Benjamin L. Magod MD , Zachary H. Hughes MD , Anusha Manjunath MD , Tingqing Wu , Rebecca Harrap , Benjamin Bryner MD , Sabra Lewsey MD, MPH , Kambiz Ghafourian MD, MPH , Olise Oputa , Duc Pham MD , Kiersten Rasberry , Anjan Tibrewala MD, MS , Jane Wilcox MD, MSc , Quentin R. Youmans MDMSc , Ike S. Okwuosa MD","doi":"10.1016/j.ahj.2025.107308","DOIUrl":"10.1016/j.ahj.2025.107308","url":null,"abstract":"<div><h3>Background</h3><div>Malignancy threatens to limit survival in heart transplant recipients. Improved understanding of cancer risk is needed to direct prevention and screening strategies following heart transplantation. This study aims to describe the incidence, demographics, and risk factors associated with de novo malignancy, lymphoproliferative disorders, and solid-organ malignancy subtypes.</div></div><div><h3>Methods</h3><div>We analyzed the incidence, types, and predictors of malignancy in 50,370 heart transplant recipients from the United Network for Organ Sharing registry.</div></div><div><h3>Results</h3><div>The incidence of de novo post-transplant malignancy at 10 years was 20.6%. The incidence at 10 years by malignancy type was: nonmelanoma skin cancer (9.0%), solid-organ cancer (6.2%), and lymphoproliferative disorder (1.2%). Older age (OR, 1.05; 95%CI, 1.049-1.060), male gender (female vs male; OR, 0.63; 95%CI, 0.58-0.68), induction immunosuppression with OKT3 (OR, 1.47; 95%CI, 1.23-1.76) or >1 induction agent (OR, 1.44; 95%CI, 1.14-1.82), history of cigarette use (OR, 1.19; 95%CI, 1.11-1.28) and hospitalization for infection (OR, 1.26; 95% CI, 1.18-1.34) were associated with increased incidence of de novo malignancy.</div></div><div><h3>Conclusions</h3><div>De novo malignancy is common, occurring in one-fifth of recipients after heart transplant. Risk factors for de novo malignancy included older age, male gender, induction immunosuppression, and history of cigarette use. Hospitalization for infection is a risk factor that has not been previously described. Improved prevention and personalized screening strategies are needed to reduce the adverse outcome of post-transplant malignancy.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"293 ","pages":"Article 107308"},"PeriodicalIF":3.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145585777","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":"Occlusion vs subocclusion of the left main. The ECG pattern has the word","authors":"Miquel Fiol MD, PhD , Alberto Rodríguez MD , Andrés Carrillo MD, PhD","doi":"10.1016/j.ahj.2025.107303","DOIUrl":"10.1016/j.ahj.2025.107303","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"293 ","pages":"Article 107303"},"PeriodicalIF":3.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145556090","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 : 2026-03-01Epub Date: 2025-11-12DOI: 10.1016/j.ahj.2025.107301
Graham S. Hillis MBChB, PhD , Jarryd S.K. Walker MBChB , Thomas Gilbert BSc(Hons) , Charley A. Budgeon PhD , John K. French MBChB, PhD , Joseph B. Selvanayagam MBBS, DPhil , Vijay A. Dhakshinamurthy MBBS , Richard W. Troughton MBChB, PhD , Jorge Moragues MD , Abdul R. Ihdayhid MBBS, PhD , Thomas J. Ford MBChB, PhD , Sarah Zaman MBBS, PhD , Johanne Neill MBBCh, MD , Philip D. Adamson MBChB, PhD , James Pemberton MD , Erin Doherty MD , Gillian A. Whalley PhD , Kiran Sarathy MBBS , David B. Brieger MBBS, PhD , Chiew Wong MBBS , Ralph A.H. Stewart MBChB, MD
{"title":"Rationale for and design of the REsolution of LEft VENTricular thrombus (RELEVENT) Trial","authors":"Graham S. Hillis MBChB, PhD , Jarryd S.K. Walker MBChB , Thomas Gilbert BSc(Hons) , Charley A. Budgeon PhD , John K. French MBChB, PhD , Joseph B. Selvanayagam MBBS, DPhil , Vijay A. Dhakshinamurthy MBBS , Richard W. Troughton MBChB, PhD , Jorge Moragues MD , Abdul R. Ihdayhid MBBS, PhD , Thomas J. Ford MBChB, PhD , Sarah Zaman MBBS, PhD , Johanne Neill MBBCh, MD , Philip D. Adamson MBChB, PhD , James Pemberton MD , Erin Doherty MD , Gillian A. Whalley PhD , Kiran Sarathy MBBS , David B. Brieger MBBS, PhD , Chiew Wong MBBS , Ralph A.H. Stewart MBChB, MD","doi":"10.1016/j.ahj.2025.107301","DOIUrl":"10.1016/j.ahj.2025.107301","url":null,"abstract":"<div><h3>Rationale</h3><div>Left ventricular (LV) thrombus is a consequence of systolic dysfunction and is associated with an increased risk of stroke and systemic embolism. Anticoagulation with warfarin has been the standard of care. However, following the widespread adoption of direct oral anticoagulants (DOACs) in other settings, these are increasingly used to treat LV thrombus, despite limited randomized data to support equivalent outcomes and safety.</div></div><div><h3>Primary Hypothesis</h3><div>We hypothesize that DOACs will be noninferior to warfarin in the resolution of LV thrombus, without the occurrence of cardiovascular death, stroke, systemic embolism or major bleeding at 3-months.</div></div><div><h3>Design</h3><div>The REsolution of LEft VENTricular thrombus (RELEVENT) trial (ACTRN12618001254280) will test the noninferiority of DOACs compared to warfarin. This prospective trial will randomize 216 patients with best-available imaging confirmed LV thrombus, at a 1:1 ratio to either warfarin or a DOAC, for a duration of 12 to 14 weeks. Any DOAC approved for stroke prevention in atrial fibrillation may be used, according to local preference. The primary endpoint will be the resolution of the thrombus, without the occurrence of cardiovascular death, stroke, systemic embolism or major bleeding at 3-month follow-up. Secondary and other endpoints of interest include components of the primary outcome, changes to thrombus diameter, days alive and out of hospital, disability free survival and quality of life. Patients will be followed up for 3 years to obtain data on long-term management and outcomes.</div></div><div><h3>Sites</h3><div>Recruitment to the RELEVENT trial is underway in 16 centers in New Zealand and Australia.</div></div><div><h3>Conclusions</h3><div>The RELEVENT trial will help clarify whether DOACs are noninferior to warfarin in the early treatment of LV thrombus. It will also generate important insights into the long-term management and outcomes for patients.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"293 ","pages":"Article 107301"},"PeriodicalIF":3.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145522511","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 : 2026-03-01Epub Date: 2025-11-27DOI: 10.1016/j.ahj.2025.107313
Jiachen Shan MD , Jie Gao MD , Yuye Chen MD , Hongwen Ji MD
{"title":"Efficacy and safety of postoperative autologous blood transfusion in cardiac surgery (RESCUE): Rationale, design, and study protocol of a multicenter randomized controlled trial","authors":"Jiachen Shan MD , Jie Gao MD , Yuye Chen MD , Hongwen Ji MD","doi":"10.1016/j.ahj.2025.107313","DOIUrl":"10.1016/j.ahj.2025.107313","url":null,"abstract":"<div><h3>Background</h3><div>Postoperative bleeding is a major concern in cardiac surgery, often leading to significant transfusion requirements. Despite this high transfusion demand, the use of postoperative autologous blood transfusion (PABT) remains underexplored.</div></div><div><h3>Methods and Results</h3><div>This large-scale, single-blind randomized controlled trial with a 30-day follow-up enrolls patients undergoing elective on- or off-pump coronary artery bypass grafting. Patients with shed mediastinal blood volumes over 500 mL within the first 6 hours postoperatively are randomly assigned 1:1 to either the PABT group or the standard care group. The PABT group receives postoperative autotransfusion and additional allogeneic RBC transfusions if needed, while the standard care group receives allogeneic RBC transfusions only when clinically necessary, without postoperative autotransfusion. The primary efficacy endpoint is the postoperative allogeneic RBC transfusion volume, defined as the cumulative amount transfused from the day of surgery to discharge. Secondary efficacy endpoints include postoperative allogeneic RBC and non-RBC transfusion rates, perioperative hematologic recovery, drainage volume, mechanical ventilation duration, ICU and hospital length of stay. The primary safety endpoint is the incidence of a composite of postoperative infections (pneumonia, bloodstream infections, and surgical site infections). Secondary safety endpoints include a composite of other postoperative complications (renal dysfunction, myocardial infarction, stroke, deep vein thrombosis, and all-cause mortality), individual components of these composites, and 30-day mortality and morbidity. The estimated sample size is 1,232 participants. Patient recruitment is planned from January 2026 to December 2029 and is currently in the preparatory phase. The study is registered at the Chinese Clinical Trial Registry (ChiCTR2500103269, <span><span>https://www.chictr.org.cn/</span><svg><path></path></svg></span>) and was registered on May 27, 2025.</div></div><div><h3>Conclusions</h3><div>The study is designed to identify the efficacy and safety of PABT after cardiac surgery. We hypothesize that PABT has superior efficacy and noninferior safety to the standard care.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"293 ","pages":"Article 107313"},"PeriodicalIF":3.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145627670","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}