American heart journal最新文献

{"title":"Occult cancer in patients with unprovoked venous thromboembolism: Rationale, design, and methods of the VaLRIETEs study and the SOME-RIETE trial","authors":"Maria Barca-Hernando MD, PhD ,&nbsp;Sonia Otalora-Valderrama MD, PhD ,&nbsp;Juan Jose Lopez-Nuñez MD, PhD ,&nbsp;Jose Portillo-Sanchez MD, PhD ,&nbsp;Javier Pagan-Escribano MD, PhD ,&nbsp;Patricia Lopez-Miguel MD ,&nbsp;Isabelle Mahe MD, PhD ,&nbsp;Elisabeth Mena-Muñoz MD ,&nbsp;Ines Jou-Segovia MD ,&nbsp;Egidio Imbalzano MD ,&nbsp;Paloma Agudo-de Blas MD, PhD ,&nbsp;Alicia Lorenzo-Hernandez MD, PhD ,&nbsp;Carmen Diaz-Pedroche MD, PhD ,&nbsp;Jesus Aibar-Gallizo MD, PhD ,&nbsp;Gloria de la Red-Bellvis MD ,&nbsp;Fatima del Molino-Sanz MD ,&nbsp;Cristina Amado-Fernandez MD ,&nbsp;Jose Luis Fernandez-Reyes MD ,&nbsp;Aurora Villalobos-Sanchez MD, PhD ,&nbsp;Juan Bosco Lopez-Saez MD, PhD ,&nbsp;Luis Jara-Palomares MD, PhD","doi":"10.1016/j.ahj.2025.02.004","DOIUrl":"10.1016/j.ahj.2025.02.004","url":null,"abstract":"<div><h3>Background</h3><div>Unprovoked venous thromboembolism (VTE) is considered when no clear major provoking factor for VTE is identified. Although the 1-year risk of diagnosing new cancer in these patients can be as high as 5%, the benefits of extensive screening remain uncertain. It is possible that in a risk-enriched population of patients, screening yields benefit. Recently, the RIETE score, a composite score including sex, age, chronic pulmonary disease, anemia, platelet count and previous VTE, was found to improve risk prediction for identification of occult cancer in patients with unprovoked VTE. As for screening tests, whole body 18F-fluorodeoxyglucose Positron Emission/Computed Tomography (18F-FDG PET/CT) is a promising and sensitive tool for occult cancer screening.</div></div><div><h3>Methods</h3><div>This manuscript summarizes the rationale and design of 2 prospective studies in patients with unprovoked symptomatic VTE: (1) ValRIETE is an international, multicenter, prospective, adaptative, cohort study that plans to include 1,550 patients; the adaptive design permits a sample size increase depending on the results of the predefined interim analysis. This study will enable the external validation of the RIETE score, with several ancillary aims related to additional clinical and biomarker predictors. Recruitment began in December 2022. (2) SOME-RIETE is an open-label, randomized, multicenter clinical trial that plans to enroll 650 patients with a RIETE score ≥3 to compare limited screening with limited screening plus whole body 18F-FDG PET/CT. The primary outcome is cancer diagnosis within 3 months after VTE event. Secondary outcomes include cancer diagnosis and mortality at 12 months.</div></div><div><h3>Conclusions</h3><div>This study provides clinically meaningful data on and the utility of extended screening of cancer by 18F-FDG PET/CT.</div></div><div><h3>Study Registration</h3><div>VaLRIETE study: ethics committee of the Virgen del Rocio University Hospital, Sevilla (Spain). <span><span>https://www.juntadeandalucia.es/salud/portaldeetica/xhtml/inicio/inicio.iface</span><svg><path></path></svg></span> (1687-N-22).</div></div><div><h3>Trial Registration</h3><div><em>SOME-RIETE:</em> <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (NCT03937583).</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 81-93"},"PeriodicalIF":3.7,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143456673","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":"Patient characteristics, presentation, causal microorganisms, and overall mortality in the NatIonal Danish endocarditis stUdieS (NIDUS) registry","authors":"Katra Hadji-Turdeghal MD ,&nbsp;Peter Laursen Graversen MD ,&nbsp;Jacob Eifer Møller MDDMSc ,&nbsp;Niels Eske Bruun MDDMSc ,&nbsp;Jonas A. Povlsen MDPh.D. ,&nbsp;Claus Moser MDPh.D ,&nbsp;Morten Smerup MDPh.D. ,&nbsp;Peter Søgaard MDDMSc ,&nbsp;Hanne Sortsøe Jensen MDPh.D ,&nbsp;Peter Godsk Jørgensen MD ,&nbsp;Andreas Dalsgaard Jensen MD ,&nbsp;Jeppe K. Petersen MDPhD ,&nbsp;Eva Havers-Borgersen MD ,&nbsp;Jannik Helweg-Larsen MDPh.D. ,&nbsp;Daniel Faurholt-Jepsen MDPh.D. ,&nbsp;Henning Bundgaard MDDMSc ,&nbsp;Kasper Iversen MDDMSc ,&nbsp;Lauge Østergaard MDPhD. ,&nbsp;Lars Køber MDDMSc ,&nbsp;Emil L. Fosbøl MDPhD.","doi":"10.1016/j.ahj.2025.02.006","DOIUrl":"10.1016/j.ahj.2025.02.006","url":null,"abstract":"<div><h3>Background</h3><div>Most knowledge on infective endocarditis (IE) comes from large IE cohorts that include patients from tertiary hospitals, leading to referral bias and retrospective population-based studies. This highlights the need for a more detailed characterization of IE in unselected patient cohorts.</div></div><div><h3>Methods</h3><div>In the National Danish Endocarditis Studies (NIDUS) registry, all hospitalizations in Denmark from 2016 to 2021 with an IE diagnosis were reviewed and validated using electronic medical records (EMR) by healthcare professionals under the supervision of IE experts. Episodes meeting the European Society of Cardiology 2015 modified diagnostic criteria for possible or definite IE were included.</div></div><div><h3>Results</h3><div>We screened 4390 unique patients, of whom 3557 (81%) were included in the NIDUS registry. Of the 3557 unique patients, 2832 (79.6%) were classified as definite IE and 725 (20.4%) as possible IE. The age was 73.7 years, and most patients were men (68.3%). In total, 689 (19.4%) underwent surgery during hospitalization. The most frequent comorbidities were diabetes (23.7%), heart failure (18.7%), and chronic kidney disease (17.4%). Most patients presented with fever (61.1%), followed by dyspnea (33.0%) and myalgias (27.0%). Sepsis was found in 828 (23.3%) patients, while 378 (10.6%) had signs of embolization at admission. Positive blood cultures were identified in 3191 (89.7%) patients, and the most frequent microbiological etiology was <em>Staphylococcus aureus</em> (31.9%). The in-hospital mortality was 17.3%, and the 1-year mortality rate was 31.3%.</div></div><div><h3>Conclusion</h3><div>The NatIonal Danish endocarditis studies (NIDUS) registry provides comprehensive, granular, and nationwide data on a cohort of patients with infective endocarditis, revealing that when selection is not restricted to tertiary hospitals or voluntary registries, some important differences emerge. Patients with IE are on average older, have a similar burden of comorbidities, and less often undergo surgery. Minimizing selection bias with the use of a national registry provides a clearer picture of IE as it occurs in real-world clinical settings.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"285 ","pages":"Pages 119-132"},"PeriodicalIF":3.7,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design, rationale, and characterization of the mobile health based occupational cardiovascular risk intervention study (mHealth-OPEN study)","authors":"Yixin Tian PhD ,&nbsp;Xin Wang MD ,&nbsp;Zhen Hu PhD ,&nbsp;Xue Yu MS ,&nbsp;Min Shao MS ,&nbsp;Chuanxi Zhang MS ,&nbsp;Dedi Zhang MS ,&nbsp;Wenping Shan MS ,&nbsp;Chenye Chang MS ,&nbsp;Chenda Zhang MS ,&nbsp;Yuxuan Nie MS ,&nbsp;Congyi Zheng PhD ,&nbsp;Xue Cao PhD ,&nbsp;Xuyan Pei PhD ,&nbsp;Yujie Zhang MS ,&nbsp;Nuerguli Tuerdi MS ,&nbsp;Zengwu Wang PhD","doi":"10.1016/j.ahj.2025.02.005","DOIUrl":"10.1016/j.ahj.2025.02.005","url":null,"abstract":"<div><h3>Background</h3><div>The substantial workforce and suboptimal cardiovascular health highlights the urgent need for workplace interventions. This ongoing cluster-randomized trial aims to evaluate the effectiveness, feasibility, and acceptability of a mobile health (mHealth) based comprehensive intervention program to improve cardiovascular health among employees.</div></div><div><h3>Methods and results</h3><div>We conducted a 1-year, 2-arm, parallel-group, cluster-randomized controlled multicenter trial involving 10,000 participants (aged 18-65, including 1,600 participants with high cardiovascular risk) across 20 workplaces. Workplaces were randomly assigned in a 1:1 ratio to either the intervention or control group. We established a mHealth based multifaceted cardiovascular risk management system that enables intelligent management. The intervention groups received a mHealth-based management with primary prevention inventions for all participants and additional cardiovascular risk interventions for participants with high cardiovascular risk via the system. The control groups received usual care. Primary outcomes included percentage changes in hypertension, diabetes, and dyslipidemia control rates among participants with high cardiovascular risk, and percentage changes in the rate of regular physical activity among all the participants, from baseline to 12-month follow-up. Secondary outcomes included changes in blood pressure, glucose, lipid, treatment adherence, behavioral factors, questionnaire scores, and incidence of major cardiovascular events. By now, baseline recruitment has been completed, with comparable characteristics between management and control groups.</div></div><div><h3>Conclusions</h3><div>This rigorous designed mHealth-based workplace intervention demonstrates potential for nationwide implementation, offering cardiovascular benefits for employees.</div></div><div><h3>Clinical trial registration</h3><div><span><span>www.chictr.org.cn</span><svg><path></path></svg></span>. Identifier: ChiCTR2200066196.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 32-41"},"PeriodicalIF":3.7,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmaco-invasive strategy and dosing of tenecteplase in STEMI patients 60 to <75 years: An inter-trial comparison of the STREAM-1 and STREAM-2 trials","authors":"Kevin R. Bainey MD, MSc ,&nbsp;Robert C. Welsh MD ,&nbsp;Yinggan Zheng MA, MEd ,&nbsp;Alexandra Arias-Mendoza MD ,&nbsp;Arsen D. Ristić MD, PhD ,&nbsp;Oleg V. Averkov MD, PhD ,&nbsp;Yves Lambert MD ,&nbsp;Tracy Temple BScN, RN ,&nbsp;Eric Ly BHK ,&nbsp;Kris Bogaerts PhD ,&nbsp;Peter Sinnaeve MD, PhD ,&nbsp;Cynthia M. Westerhout PhD ,&nbsp;Frans Van de Werf MD, PhD ,&nbsp;Paul W. Armstrong MD ,&nbsp;STREAM-2 Investigators","doi":"10.1016/j.ahj.2025.02.002","DOIUrl":"10.1016/j.ahj.2025.02.002","url":null,"abstract":"<div><h3>Background</h3><div>Previous studies indicate a safety risk with full-dose TNK in elderly patients. In a study of patients ≥60 years STREAM-2 (STrategic Reperfusion Early After Myocardial infarction-2), a pharmaco-invasive (PI) strategy with half-dose TNK was similar (in efficacy and safety) to primary percutaneous coronary intervention (PPCI) in ST-elevation myocardial infarction (STEMI) patients presenting &lt;3 hours. While no treatment difference ± 75 years was observed, the role of this half-dose PI strategy in patients &lt;75 years is unknown. In this comparison of STEAM-1 and -2, we analyzed PI strategies with full-dose (STREAM-1) versus half-dose TNK (STREAM-2) to evaluate their relative efficacy and safety in this younger STEMI cohort.</div></div><div><h3>Methods</h3><div>We evaluated patients 60 to &lt;75 years from STREAM-1 and STREAM-2 receiving PI treatment versus PPCI for their resolution of ST-elevation after fibrinolysis and angiography, primary efficacy composite of 30-day all-cause death, myocardial infarction, heart failure, and shock, and safety events.</div></div><div><h3>Results</h3><div>Among 1103 patients, 327 received a full-dose PI strategy (STREAM-1), 289 a half-dose PI strategy (STREAM-2) and 487 PPCI (338 in STREAM-1; 149 in STREAM-2). Half- compared to full-dose TNK resulted in similar proportions of patients achieving ST resolution ≥50% (71.2% vs 68.7%, <em>P = .</em>519): their ICH risks were 2.1% vs 1.5%, <em>P = .</em>605 respectively). Following angiography, PI patients had nominally better ST resolution ≥50% compared to their PPCI counterpart (STREAM-1: 87.7% vs. 83.2%, <em>P = .</em>120; STREAM-2: 88.2% vs. 81.0%, <em>P = .</em>048) with similar primary composite outcome at 30 days (STREAM-1: 14.4% vs. 16.3%, 0.90 [0.62, 1.31]; STREAM-2: 9.0% vs 8.1%, 1.29 [0.64, 2.61]). Major (non-ICH) bleeding markedly declined in STREAM-2 compared to STREAM-1 in both treatment groups (STREAM-1: 7.1% vs. 6.0%; STREAM-2: 0.3% vs. 0.7%).</div></div><div><h3>Conclusions</h3><div>In STEMI patients 60 to &lt;75 years presenting within 3 hours of symptoms, half-dose PI treatment appears as efficacious as a full-dose PI strategy with a low systemic bleeding risk. Half-dose PI treatment deserves consideration when timely PPCI is not attainable in this important STEMI sub-group.</div></div><div><h3>Clinicaltrials.gov registration numbers</h3><div>NCT00623623, NCT02777580.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 20-31"},"PeriodicalIF":3.7,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424556","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":"Transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis aged 70 years or younger: A NOTION-2 substudy","authors":"Troels Højsgaard Jørgensen MD, PhD ,&nbsp;Hans Gustav Hørsted Thyregod MD, PhD ,&nbsp;Mikko Savontaus MD, PhD ,&nbsp;Öjvind Bleie MD, PhD ,&nbsp;Evald H Christiansen MD, PhD ,&nbsp;Matti Niemela MD, PhD ,&nbsp;Oskar Angerås MD, PhD ,&nbsp;Ingibjörg J. Gudmundsdóttir MD, DM ,&nbsp;Mika Laine MD, PhD ,&nbsp;Andreas Rück MD, PhD ,&nbsp;Bernard Prendergast MD, DMSc ,&nbsp;Martin Leon MD, PhD ,&nbsp;Lars Søndergaard MD, DMSc ,&nbsp;Ole De Backer MD, PhD ,&nbsp;NOTION-2 investigators","doi":"10.1016/j.ahj.2025.02.003","DOIUrl":"10.1016/j.ahj.2025.02.003","url":null,"abstract":"<div><div>This NOTION-2 sub-study revealed distinct outcomes for transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in low surgical risk patients aged ≤ 70 years with a tricuspid or bicuspid aortic valve stenosis (AS). One year after intervention, the risk of death, stroke or rehospitalization in patients with tricuspid AS was similar after TAVR when compared to SAVR (absolute risk difference: −2.0%; 95% confidence interval (CI): −11.8% to 7.7%) Conversely, in patients with bicuspid AS, TAVR was associated with a significantly higher risk of adverse outcomes (absolute risk difference: 13.8%; 95% CI: 1.2% to 26.3%). These analyses are exploratory, but highlight the importance of tailoring the intervention to the patient's clinical risk profile, life expectancy, native aortic valve morphology and the anticipated risks associated with TAVR or SAVR.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 67-70"},"PeriodicalIF":3.7,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424563","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prospective randomized single-blind multicenter study to assess the safety and effectiveness of the SELUTION SLR 014 drug eluting balloon in the treatment of subjects with in-stent restenosis: Rationale and design","authors":"Donald E. Cutlip MD ,&nbsp;Roxana Mehran MD ,&nbsp;Gheorghe Doros PhD ,&nbsp;Vladimir Kaplinskiy MD ,&nbsp;Jane Lee PhD ,&nbsp;Luke Zheng BS ,&nbsp;Milan Kausik MD ,&nbsp;Eric Osborn MD, PhD ,&nbsp;Ron Waksman MD","doi":"10.1016/j.ahj.2025.02.001","DOIUrl":"10.1016/j.ahj.2025.02.001","url":null,"abstract":"<div><h3>Background</h3><div>Repeat drug-eluting stenting is superior to balloon angioplasty for prevention of recurrent in-stent restenosis (ISR), but carries a potential disadvantage of multiple layers of stent. The safety and effectiveness of a sirolimus drug-eluting balloon as an alternative has not been assessed.</div></div><div><h3>Study Design and Methods</h3><div>The SELUTION4ISR trial is a prospective, multicenter, single-blinded, randomized, controlled trial. A total of 418 subjects with bare metal or drug-eluting stent (DES) ISR with up to 2 previous stent procedures at the target lesion, lesion length &lt;26 mm and reference diameter ≥2.0 mm - ≤4.5 mm will be randomized 1:1 to treatment with either the SELUTION SLR™ DEB (SLR DEB) or standard of care (SOC), which includes either repeat DES or balloon angioplasty without drug coating. A subset of subjects will undergo planned angiographic and optical coherence tomography follow-up. The primary endpoint will be target lesion failure, defined as cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization at 12 months follow-up. The study will sequentially assess noninferiority of the SLR DEB to SOC in the overall cohort, followed by noninferiority then superiority of the SLR DEB to DES in the cohort with only 1 previous stent at the target lesion.</div></div><div><h3>Trial Registration</h3><div>The trial is registered at Clinicaltrials.gov (NCT04280029).</div></div><div><h3>Current Status</h3><div>The trial completed enrollment in July 2024.</div></div><div><h3>Conclusion</h3><div>The SELUTION4ISR study will evaluate the safety and effectiveness of SLR DEB in a prospective, randomized, international, multicenter trial for treatment of coronary ISR.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 11-19"},"PeriodicalIF":3.7,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424559","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":"Information for Readers","authors":"","doi":"10.1016/S0002-8703(25)00025-0","DOIUrl":"10.1016/S0002-8703(25)00025-0","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"281 ","pages":"Page iv"},"PeriodicalIF":3.7,"publicationDate":"2025-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143350257","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":"Intravascular imaging-guided versus angiography-guided percutaneous coronary intervention in patients with diabetes mellitus: Rationale and design of an international, multicenter, randomized IVI-DIABETES trial","authors":"Xiao-Fei Gao ,&nbsp;Jing Kan ,&nbsp;Hao-Yu Wu ,&nbsp;Jing Chen ,&nbsp;Xiang Chen ,&nbsp;Shang-Yu Wen ,&nbsp;Yong-Tai Gong ,&nbsp;Qian Tong ,&nbsp;Jun Luo ,&nbsp;Yi-Bing Shao ,&nbsp;Badar Ul Ahad Gill ,&nbsp;Fazila Tun Nesa Malik ,&nbsp;Teguh Santoso ,&nbsp;Ramesh Daggubati ,&nbsp;Alfredo E. Rodriguez ,&nbsp;Lavarra Francesco ,&nbsp;Afzalur Rahman ,&nbsp;Imad Sheiban ,&nbsp;Sasko Kedev ,&nbsp;Muhammad Munawar ,&nbsp;Shao-Liang Chen","doi":"10.1016/j.ahj.2025.01.017","DOIUrl":"10.1016/j.ahj.2025.01.017","url":null,"abstract":"<div><h3>Background</h3><div>Intravascular imaging (IVI)- guided percutaneous coronary intervention (PCI) can improve clinical outcomes compared with angiography guidance in patients with complex lesions or acute coronary syndrome. However, the impact of this approach among diabetic patients remains unknown.</div></div><div><h3>Trial design</h3><div>IVI-DIABETES trial is an investigator-initiated, prospective, international, multicenter, randomized trial, involving at least 30 sites, aiming to enroll 1,332 diabetic patients with obstructive coronary artery disease undergoing PCI. All enrolled patients are randomly assigned in a 1:1 fashion to undergo IVI- guided PCI or angiography- guided PCI. The choice between intravascular ultrasound or optical coherence tomography is at the discretion of the operator. The primary endpoint is target vessel failure (TVF) at 12 months, defined by the composite of cardiac death, target vessel myocardial infarction (MI), or clinically-driven target vessel revascularization. The major secondary endpoint is TVF without procedure-related MI. After hospital discharge, follow-up is conducted through clinical visits or telephone contact at 1, 6, and 12 months. The follow-up will continue annually until 5 years after the index procedure to assess the long-term outcomes.</div></div><div><h3>Conclusion</h3><div>IVI-DIABETES trial is the first study designed to investigate the clinical efficacy and safety of IVI-guided PCI in diabetic patients compared to angiography-guided PCI.</div></div><div><h3>Trial registration</h3><div>clinicaltrials.gov, NCT06380868.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"283 ","pages":"Pages 81-88"},"PeriodicalIF":3.7,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143363488","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":"Targeted therapy with a localized abluminal groove low-dose sirolimus-eluting bioabsorbable polymer coronary stent in chronic total occlusions: The TARGET CTO non-inferiority randomized trial","authors":"Geng Wang MD ,&nbsp;Ruiyan Zhang MD ,&nbsp;Shao-Liang Chen MD ,&nbsp;Jian'an Wang MD ,&nbsp;Yi Li MD ,&nbsp;Ming Zheng MD ,&nbsp;Ruifen Cao MD ,&nbsp;Yitong Ma MD ,&nbsp;Zhiqi Sun MD ,&nbsp;Xueqi Li MD ,&nbsp;Xi Su MD ,&nbsp;Wen Lu MD ,&nbsp;Yawei Xu MD ,&nbsp;Xue Li MD ,&nbsp;Yang Li MD ,&nbsp;Fucheng Sun MD ,&nbsp;Yaling Han MD, PhD ,&nbsp;TARGET CTO Investigators","doi":"10.1016/j.ahj.2025.01.018","DOIUrl":"10.1016/j.ahj.2025.01.018","url":null,"abstract":"<div><h3>Background</h3><div>Our objective was to compare the efficacy and safety of a drug-eluting stent featuring an abluminal bioabsorbable sirolimus-containing polymer coating (BP-SES) with an everolimus-eluting stent with a durable polymer (DP-EES) in patients undergoing percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs).</div></div><div><h3>Methods</h3><div>TARGET CTO is a multicenter, open-label, noninferiority trial that randomized patients to either BP-SES or DP-EES in a 1:1 fashion following successful CTO re-canalization. The primary endpoint that was powered for noninferiority assessment is in-stent late lumen loss (LLL) at 12 months.</div></div><div><h3>Results</h3><div>A total of 206 subjects underwent randomization, with 103 assigned to the BP-SES group and 103 to the DP-EES group. Baseline clinical and angiographic characteristics were comparable. The primary endpoint demonstrated noninferiority for the BP-SES group compared to the DP-EES group (0.21 ± 0.43 mm vs 0.21 ± 0.33 mm; <em>P = .</em>934, 2-sided; difference 0.01mm [BP-SES minus DP-EES]; 95% CI: -0.13 to 0.12 mm; p noninferiority &lt; .001,1-sided). No significant differences were observed in secondary angiographic or clinical endpoints. The rates of 12-month in-stent and in-segment binary restenosis in the BP-SES group and the DP-EES group were similar (6.8% vs 7.5%, <em>P = .</em>86; and 8.1% vs 8.8%; <em>P = .</em>89, respectively). Although there was a trend favoring the BP-SES group, the difference between the BP-SES group and DP-EES group at 12 months in target lesion failure (2.1% vs 8.0%, <em>P = .</em>054) and target lesion revascularization (2.1% vs 7.1%, <em>P = .</em>089) did not reach statistical significance. No definite or probable stent thromboses were reported in either group.</div></div><div><h3>Conclusions</h3><div>Compared to DP-EES, PCI of CTOs with BP-SES showed similar results in terms of late loss and binary restenosis at the 12-month follow-up.</div></div><div><h3>Clinical Trial</h3><div>ClinictalTrial.gov, number NCT03040934</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"285 ","pages":"Pages 93-104"},"PeriodicalIF":3.7,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254235","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, design and prerandomization data for a cluster randomized trial to assess the effect of a digitally enabled quality improvement intervention on LDL-C control in established atherosclerotic cardiovascular disease patients: The SAPPHIRE-LDL trial","authors":"M. Julia Machline-Carrion MD, PhD ,&nbsp;Alysson Nathan Girotto BSc ,&nbsp;Priscila Raupp MD, PhD ,&nbsp;Pedro Marton Pereira BA ,&nbsp;Frederico Monfardini MSc ,&nbsp;Raul D. Santos MD, PhD ,&nbsp;Karla Santo MD, PhD ,&nbsp;Kausik Ray MD ,&nbsp;Christopher P. Cannon MD ,&nbsp;Otávio Berwanger MD, PhD","doi":"10.1016/j.ahj.2025.01.019","DOIUrl":"10.1016/j.ahj.2025.01.019","url":null,"abstract":"<div><h3>Background</h3><div>Translating evidence into clinical practice in the management of established atherosclerotic cardiovascular disease patients is challenging. Few quality improvement interventions have successfully improved patient care.</div></div><div><h3>Objectives</h3><div>The main objectives are to evaluate the impact of a digitally enabled multifaceted quality improvement (QI) intervention on the control of LDL-cholesterol (LDL-C) in atherosclerotic cardiovascular disease (ASCVD).</div></div><div><h3>Design</h3><div>We designed a pragmatic 2-arm cluster randomized trial involving 28 clusters (outpatient clinics from public or private hospitals or private practices). Clusters are randomized to receive a digitally enabled multifaceted QI intervention or to routine practice (control). The QI intervention includes reminders, electronic clinical decision support algorithms, audit and feedback reports, and distribution of educational materials to health care providers, as well as electronic educational materials and app-based tools for drug adherence control, lipid profile control, and communication to participants. The primary endpoint is the LDL-C at 06 months after the intervention period. All analyses are performed following the intention-to-treat principle and take the cluster design into consideration by using individual-level regression modeling (generalized estimating equations-GEE).</div></div><div><h3>Summary</h3><div>If proven effective, this low-cost, digitally enabled multifaceted QI intervention would be highly useful in promoting optimal LDL-C control in ASCVD patients.</div></div><div><h3>Trial Registration</h3><div>ClinicalTrials.gov NCT05622929.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 1-10"},"PeriodicalIF":3.7,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254174","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}