American heart journal最新文献

{"title":"Factors associated with NT-proBNP concentration in US children and adolescents: National Health and Nutrition Examination Survey 1999-2004","authors":"Amelia S. Wallace PhD, MS ,&nbsp;Natalie Daya Malek PhD, MPH ,&nbsp;Mary R Rooney PhD, MPH ,&nbsp;Michael Fang PhD MHS ,&nbsp;Olive Tang MD, PhD ,&nbsp;Tammy M Brady MD, PhD ,&nbsp;Justin Echouffo-Tcheugui MD, PhD ,&nbsp;Robert Christenson PhD ,&nbsp;Elizabeth Selvin PhD, MPH ,&nbsp;John William McEvoy MB BCh, MHS, PhD","doi":"10.1016/j.ahj.2025.04.011","DOIUrl":"10.1016/j.ahj.2025.04.011","url":null,"abstract":"<div><h3>Background</h3><div>N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a biologically inert cleavage product of a peptide formed in response to myocardial wall stress and can be used to screen for subclinical cardiovascular disease in adults. However, associations between NT-proBNP and demographic, lifestyle, and cardiometabolic factors in youth are poorly characterized. Methods and Results: We conducted a cross-sectional analysis of youth ages &lt;20 years old in the nationally representative National Health and Nutrition Examination Survey 1999 to 2004 and measured NT-proBNP in stored serum specimens. We calculated age-and-sex-specific distributions of NT-proBNP and evaluated the associations between NT-proBNP and cardiometabolic risk factors. We found that NT-proBNP was inversely associated with BMI and most cardiometabolic risk factors in the general US population of children and adolescents.</div></div><div><h3>Conclusions</h3><div>The differences in NT-proBNP by age, sex, and race or ethnicity in younger persons mirror those seen in adults. These results suggest that as in adults, levels of NT-proBNP should be interpreted in children and adolescents based on these demographic and clinical factors.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"287 ","pages":"Pages 79-85"},"PeriodicalIF":3.7,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143886892","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":"The randomized controlled trial to compare temporary permanent pacemaker vs temporary pacemaker in patients with conduction block after transcatheter aortic valve replacement: Rationale and design of the RECOVER trial","authors":"Zhengming Jiang MD ,&nbsp;Sanshuai Chang MD ,&nbsp;Ling Tao MD ,&nbsp;Jianfang Luo MD ,&nbsp;Guosheng Fu MD ,&nbsp;Yan Wang MD ,&nbsp;Wenzhi Pan MD ,&nbsp;Lianglong Chen MD ,&nbsp;Zhenfei Fang MD ,&nbsp;Yan Li MD ,&nbsp;Ming Bai MD ,&nbsp;Bo Yu MD ,&nbsp;Xiang Cheng MD ,&nbsp;Xiaoping Peng MD ,&nbsp;Hasan Jilaihawi MD ,&nbsp;Nicolo Piazza MD ,&nbsp;Thomas Modine MD ,&nbsp;Guangyuan Song MD ,&nbsp;The RECOVER Investigators","doi":"10.1016/j.ahj.2025.04.017","DOIUrl":"10.1016/j.ahj.2025.04.017","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Rationale&lt;/h3&gt;&lt;div&gt;Current guidelines and expert consensus recommend different time thresholds of temporary pacemaker (TM) indwelling in patients with conduction block after transcatheter aortic valve replacement (TAVR). Accordingly, this lack of clinical evidence and effective strategies has resulted in extensive variations in permanent pacemaker (PPM) implantation patterns, potentially leading to over-early PPM implantation. The use of a temporary permanent pacemaker (TPPM), which involves an active fixation pacing lead and an external pulse generator secured to the skin surface, may be effective and safe in these patients. TPPM may improve postoperative mobility and facilitate early discharge, while providing prolonged and stable pacing for the recovery of conduction block, thereby reducing unnecessary PPM implantation.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Design&lt;/h3&gt;&lt;div&gt;The RECOVER trial is a prospective, multicenter, open-label, randomized controlled study comparing TPPM vs TM in patients with conduction block after TAVR. The trial will enroll 160 subjects across 13 sites in China. Inclusion criteria include patients with persistent third-degree atrioventricular block (AVB), second-degree AVB, first-degree AVB with symptoms (PR interval &gt;300 ms), alternating bundle branch block or bifascicular block with syncope/blackness related symptoms occurred during TAVR procedure or within 1 month after TAVR. Enrolled patients will be randomized 1:1 to the TPPM group for a 1-month bridge or the TM group for conventional 24 to 48 hours pacing. The primary effectiveness endpoint is the rate of PPM implantation at 6 months after the occurrence of AVB. Secondary effectiveness endpoint is the rate of PPM implantation at 1 month after the occurrence of AVB. Safety endpoints include all-cause mortality and TPPM/TM/PPM procedure-related complications during the 6-month follow-up. Key data collected will include sociodemographic information, medical history, electrocardiograph, HOLTER, echocardiography, contrast-enhanced cardiac CT, details of procedures and pacemaker interrogation. Indication for PPM implantation will be adjudicated by an independent pacing electrophysiologist committee.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;The RECOVER trial will evaluate whether TPPM is superior to conventional TM in reducing the rate of PPM implantation in patients with conduction block after TAVR, with a buffer period to distinguish whether conduction block is reversible or persistent.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Current status&lt;/h3&gt;&lt;div&gt;The trial is still enrolling participants (with 14 enrolled as of January 1, 2025).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Trial registration&lt;/h3&gt;&lt;div&gt;Randomized controlled trial to compare temporary permanent pacemaker vs temporary pacemaker in patients with conduction block after transcatheter aortic valve replacement. Chinese Clinical Trial Registry ChiCTR2400087536. Registered at July 30, 2024. &lt;span&gt;&lt;span&gt;https://www.chictr.org.cn/showproj.html?proj=227719&lt;/span&gt;&lt;","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"287 ","pages":"Pages 41-49"},"PeriodicalIF":3.7,"publicationDate":"2025-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143881328","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":"Positive outcome trials driven by reduction in nonfatal myocardial infarction: A systematic review and relevant guideline recommendations","authors":"Linjie Li MD ,&nbsp;Haonan Sun MD ,&nbsp;Zhengyang Jin MD ,&nbsp;Jingge Li MD ,&nbsp;Yiwen Fang MD ,&nbsp;Lushu Zuo MD ,&nbsp;Pengfei Sun MD, PhD ,&nbsp;Yongle Li MD, PhD ,&nbsp;Arthur Mark Richards MD ,&nbsp;Roger Sik-Yin Foo MBBS, MD ,&nbsp;Qing Yang MD, PhD ,&nbsp;Xin Zhou MD, PhD","doi":"10.1016/j.ahj.2025.04.021","DOIUrl":"10.1016/j.ahj.2025.04.021","url":null,"abstract":"<div><h3>Background</h3><div>To identify pharmacological randomized controlled trials (RCTs) with “positive” outcomes driven by nonfatal myocardial infarction (MI) reductions and assess related guideline recommendations.</div></div><div><h3>Methods</h3><div>RCTs published between 2000 and 2024 focusing on mortality and nonfatal MI were identified through searches in PubMed and Web of Science. Citation tracking was used to find trials referenced in clinical guidelines. The levels of guideline recommendations based on the supporting trials were summarized. The impact of nonfatal MI on composite outcomes was assessed by using the leave-one-out method.</div></div><div><h3>Results</h3><div>Of 21,005 records, 6 RCTs demonstrating positive outcomes due to nonfatal MI reduction were cited in current guidelines, including anti-thrombotic (3), intensive lipid-lowering (2), and anti-inflammatory (1) therapies. Intensive lipid-lowering trials (IMPROVE-IT, FOURIER; totaling 60 recommendations across 17 guidelines) were more frequently recommended in guidelines: 45% Class I, 33.3% Class IIa, and 21.7% Class IIb. Anti-thrombotic and anti-inflammatory trials had no Class I recommendations and higher Class IIb recommendations (66.7% and 100%). A meta-analysis including major intensive lipid-lowering RCTs on top of maximally tolerated statins (IMPROVE-IT, FOURIER, and ODYSSEY OUTCOMES) revealed no statistical difference in primary composite outcome after removing nonfatal MI events (relative risk 0.94, 95% confidence interval: 0.88-1.01).</div></div><div><h3>Conclusion</h3><div>In contemporary pharmacological RCTs with positive composite outcome driven by nonfatal MI reduction, intensive lipid-lowering trials are more frequently received strong guideline recommendations. This analysis underscores the need to evaluate whether these recommendations fully reflect the clinical significance of the observed benefits.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"288 ","pages":"Pages 15-25"},"PeriodicalIF":3.7,"publicationDate":"2025-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143891289","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 the anticoagulant therapy after left atrial appendage closure (ATLAAC) trial","authors":"Kristina Gosvig ,&nbsp;Julie Goller ,&nbsp;Nils Henrik Hansson ,&nbsp;Axel Brandes ,&nbsp;Ivy Modrau ,&nbsp;Louise Feilberg Rasmussen ,&nbsp;Kristian Eskesen ,&nbsp;Aksel Karl Georg Jensen ,&nbsp;Emilie Belley-Côté ,&nbsp;Richard Whitlock ,&nbsp;Lars Peter Schødt Riber","doi":"10.1016/j.ahj.2025.04.015","DOIUrl":"10.1016/j.ahj.2025.04.015","url":null,"abstract":"<div><h3>Introduction</h3><div>Left atrial appendage closure (LAAC) has become a recommended addition to oral anticoagulation for patients with atrial fibrillation, who undergo cardiac surgery. The procedure significantly reduces the risk of stroke and systemic arterial embolism, potentially making oral anticoagulation (OAC) unnecessary or even harmful, when considering the associated increased risk of bleeding. This publication describes the rationale and design of a randomized trial, testing the hypothesis that stopping OAC is noninferior to continuing OAC after surgical LAAC in terms of the primary endpoint.</div></div><div><h3>Methods</h3><div>The ATLAAC trial is a multicenter, randomized, controlled trial, aiming to enroll 1,220 patients with atrial fibrillation, who have undergone surgical LAAC and remain on OAC. A cardiac CT scan is performed to confirm success of the LAAC. Patients with successful closure are randomized to stop or continue OAC. The primary endpoint is the first occurrence of ischemic stroke, systemic arterial embolism, or major bleeding over an expected mean follow-up of 4 years. Secondary endpoints include all-cause mortality, cardiovascular mortality, any bleeding leading to hospitalization, blood transfusion, venous thromboembolism, myocardial infarction, and quality of life measures.</div></div><div><h3>Trial status</h3><div>Enrollment for the ATLAAC trial began in March 2024. As of January 18th, 2025, 554 patients have been enrolled in the study and 319 patients have been randomized. Recruitment is expected to continue for approximately 12 months. Follow-up will be stopped once 128 primary endpoints have occurred.</div></div><div><h3>Conclusions</h3><div>The ATLAAC trial will evaluate the safety of stopping OAC after surgical LAAC.</div></div><div><h3>Trial registration number</h3><div>EU-CT: 2022-502986-92-00, clinicaltrials.gov ID: NCT06401616.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"287 ","pages":"Pages 86-93"},"PeriodicalIF":3.7,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143891257","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":"Racial and ethnic disparities in longitudinal trajectories of hospitalizations in patients diagnosed with heart failure","authors":"Matthew E. Dupre PhD ,&nbsp;Radha Dhingra MD, PhD ,&nbsp;Hanzhang Xu PhD, RN ,&nbsp;Bradley G. Hammill DrPH ,&nbsp;Scott M. Lynch PhD ,&nbsp;Jessica S. West PhD ,&nbsp;Michael D. Green BA ,&nbsp;Lesley H. Curtis PhD ,&nbsp;Eric D. Peterson MD, MPH","doi":"10.1016/j.ahj.2025.04.006","DOIUrl":"10.1016/j.ahj.2025.04.006","url":null,"abstract":"<div><h3>Background</h3><div>Racial and ethnic disparities in hospitalizations among heart failure (HF) patients have been well documented. However, little is known about racial and ethnic differences in the long-term trajectories of hospital admissions that follow the diagnosis of HF.</div></div><div><h3>Methods</h3><div>We used electronic health records (EHR) of 5,606 patients with newly-diagnosed HF between January 1, 2015 and July 28, 2018 in the Duke University Health System. Patients were followed for up to 5 years (until July 28, 2023) to identify all-cause hospital admissions after their initial diagnosis of HF. Group-based trajectory models were used to identify major trajectories of hospitalization, and multinomial logistic regression models were used to identify patients’ clinical and nonclinical characteristics associated with the trajectories of admissions.</div></div><div><h3>Results</h3><div>In our study cohort (mean age 74.8 ± 5.8 years), we identified 4 distinct trajectories of hospitalization during follow up: 45.6% (Group 1: <em>N</em> = 2,556) had “low risks” of hospitalization, 36.6% (Group 2: <em>N</em> = 2,052) had elevated risks of admission shortly after diagnosis (“early risk” group), 9.9% (Group 3: <em>N</em> = 553) had elevated risks at later stages of illness (“late risk” group), and 7.9% (Group 4: <em>N</em> = 445) had consistently “high risks” of hospitalization. Non-Hispanic Black patients were more likely to exhibit early risks of hospitalization (odds ratio [OR], 1.33; 95% confidence interval [CI], 1.16-1.52; <em>P</em> &lt; .001), late risks of hospitalization (OR = 1.92; 95% CI, 1.58-2.34; <em>P</em> &lt; .001), or consistently high risks of hospitalization (OR = 1.89; 95% CI, 1.52-2.35; <em>P</em> &lt; .001) compared with non-Hispanic White patients. Diabetes, chronic kidney disease, and residence in a disadvantaged neighborhood significantly contributed to the excess risks of admissions among non-Hispanic Black patients. We found no significant differences in patterns of admissions between patients from other racial and ethnic groups compared with non-Hispanic White patients.</div></div><div><h3>Conclusions</h3><div>Non-Hispanic Black patients had early, late, and consistently high risks of hospitalization following the diagnosis of HF compared with non-Hispanic White patients. These findings have important implications for targeting interventions to reduce hospitalizations during the course of HF management.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"287 ","pages":"Pages 32-40"},"PeriodicalIF":3.7,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143882043","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)00113-9","DOIUrl":"10.1016/S0002-8703(25)00113-9","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"285 ","pages":"Page iv"},"PeriodicalIF":3.7,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143785883","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":"Infective endocarditis and the association to income as a proxy for socioeconomic position - A Danish nationwide register-based cohort study.","authors":"Kasper Høtoft Bengtsen, Charlotte Helene Wichmand, Sarah Louise Duus Holle, Alexander Christian Falkentoft, Louise Bruun Østergaard, Christian Torp-Pedersen, Sidsel Gamborg Møller, Trine Kiilerich Lauridsen, Gunnar Gislason, Lauge Østergaard, Emil Fosbøl, Niels Eske Bruun, Anne-Christine Ruwald","doi":"10.1016/j.ahj.2025.04.003","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.04.003","url":null,"abstract":"<p><strong>Aims: </strong>Despite continued focus on infective endocarditis morbidity and mortality remains high. Socioeconomic position is known to influence the risk of multiple diseases but the impact on the occurrence of infective endocarditis is unknown. We aimed to investigate the association between available income as a proxy for socioeconomic position and infective endocarditis in an unselected nationwide population.</p><p><strong>Methods and results: </strong>By cross-linking Danish nationwide registers, we identified all Danish residents above 30 years of age, from January 1^st, 2007 through December 31^st, 2017. Information on income, comorbidities and the primary outcome of infective endocarditis was obtained through the registers. Socioeconomic position was defined according to quintiles of disposable income. The association between socioeconomic position and infective endocarditis was examined using multivariate Poisson Regression analyses, incorporating time-updated estimates of disposable income. The study included 3,524,314 individuals (median age = 47 years) with a median follow-up of 11 years. Declining level of income was associated with increasing incidence rates of infective endocarditis, spanning from 7-20 events/100.000 person-years. Individuals with low income had higher incidence rate ratio (IRR) of infective endocarditis compared to individuals with high income (lowest vs. highest income group, IRR = 1.58 [1.43-1.75]). The association between decreasing income and increasing IRR of infective endocarditis was present across all age groups, although the association was strongest in the young population.</p><p><strong>Conclusion: </strong>In a nationwide population, a significant association between low income and increasing incidence of infective endocarditis was observed. The association was most evident in younger individuals.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143802244","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":"Novel automated electronic medical record-based VEST (virtual echocardiography screening tool) algorithm for pulmonary arterial hypertension","authors":"Suneesh Chembiparambil Anand MD ,&nbsp;Gabriela Narowska MD ,&nbsp;Chethan Gangireddy MD, MPH, MBA ,&nbsp;John Enevoldsen ,&nbsp;Martin Gerard Keane MD ,&nbsp;Daniel Edmundowicz MD, MBA ,&nbsp;Paul Robert Forfia MD ,&nbsp;Anjali Vaidya MD","doi":"10.1016/j.ahj.2025.03.020","DOIUrl":"10.1016/j.ahj.2025.03.020","url":null,"abstract":"<div><h3>Background</h3><div>Pulmonary arterial hypertension (PAH) remains underrecognized and life-threatening due to limited awareness, nonspecific symptoms, and late referral to accredited pulmonary hypertension (PH) centers. The previously validated virtual echocardiography screening tool (VEST) predicts PAH hemodynamics. The objectives of the present study were to determine if the novel automated electronic medical record (EMR)-based algorithm could accurately calculate VEST scores to identify PAH hemodynamics and aid referral to PH specialty care.</div></div><div><h3>Methods</h3><div>This study is a retrospective analysis of 4,952 patients who underwent transthoracic echocardiogram (TTE) with tricuspid regurgitation velocity (TRV) ≥2.9 m/s in a hospital with an accredited PH Center of Comprehensive Care. Using the automated EMR-based algorithm, EMR-calculated VEST scores were calculated and compared to manually calculated VEST scores. Automated EMR VEST scores were used to identify those with highest risk for PAH (+3 score). Patients with +3 score were analyzed to determine whether they were evaluated within the accredited PH center or undergone right heart catheterization (RHC), the gold standard for PH diagnosis.</div></div><div><h3>Results</h3><div>Automated EMR VEST scores were validated with 100% correlation to 60 manual scores. Of 354 patients with +3 score, those that underwent RHC had severe PH, with mean pulmonary artery pressure 48 mm Hg and pulmonary vascular resistance 8.5 Wood units. One hundred and four patients (29.4%) were never referred for specialty PH care, and of these, only 37.5% underwent RHC. In the 250 patients referred to subspecialty PH care, 237 (94.8%) underwent RHC.</div></div><div><h3>Conclusions</h3><div>This novel EMR-based automated VEST calculator is a powerful yet simple scoring tool that can capture patients at high risk for PAH, prompting earlier diagnosis and referrals to accredited PH centers to allow for earlier expert care and implementation of medical therapies.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"287 ","pages":"Pages 24-31"},"PeriodicalIF":3.7,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143802269","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":"Potassium-competitive acid blocker versus proton-pump inhibitor in patients receiving antithrombotic therapy who are at high risk for gastrointestinal bleeding: Rationale and design of the randomized PROTECT- HBR trial","authors":"Jinho Lee MD ,&nbsp;Han-Su Park MD ,&nbsp;Junghoon Lee MD ,&nbsp;Kee Don Choi MD ,&nbsp;Do-Yoon Kang MD ,&nbsp;Jung-Min Ahn MD ,&nbsp;Weon Kim MD ,&nbsp;Jong-Young Lee MD ,&nbsp;Young-Hyo Lim MD ,&nbsp;Se Hun Kang MD ,&nbsp;Sung Uk Kwon MD ,&nbsp;Hanbit Park MD ,&nbsp;Eue-Keun Choi MD ,&nbsp;Soon Jun Hong MD ,&nbsp;Byeong-Keuk Kim MD ,&nbsp;Eun-Sun Jin MD ,&nbsp;Jin-Ok Jeong MD ,&nbsp;Chang-Wook Nam MD ,&nbsp;Wang Soo Lee MD ,&nbsp;Sang Min Kim MD ,&nbsp;Duk-Woo Park MD","doi":"10.1016/j.ahj.2025.04.001","DOIUrl":"10.1016/j.ahj.2025.04.001","url":null,"abstract":"<div><h3>Background</h3><div>Concomitant use of proton pump inhibitor (PPI) is recommended in patients receiving chronic antithrombotic therapy who are at high risk of gastrointestinal (GI) bleeding. However, long-term safety and efficacy of chronic PPI use have been concerned. Potassium-competitive acid blocker (P-CAB) is a novel class of acid suppressants, providing more acid stability, rapid onset of action, less variability with CYP2C19 polymorphisms, and longer duration of action than PPI.</div></div><div><h3>Design</h3><div>The PROTECT-HBR trial is a multicenter, randomized, double-blind, double-dummy, parallel-group clinical trial. Approximately 3320 patients with known cardiac or vascular disease receiving antithrombotic drugs (either antiplatelet or anticoagulant agents) and who are at high risk of GI bleeding will be randomized to P-CAB (tegoprazan 50mg once daily) or PPI (rabeprazole 20mg once daily) for up to 12 months. The primary endpoint is a composite outcome of upper GI clinical events, including overt or occult GI bleeding, symptomatic gastroduodenal ulcers or erosions, obstruction, or perforation, at 12 months. Secondary endpoints also included cardiovascular events and safety outcomes.</div></div><div><h3>Results</h3><div>As of December 2024, approximately 1460 patients were enrolled from 32 participating sites in South Korea. The complete enrollment is anticipated at the mid- or late-term of 2025, and the primary results will be available by 2027.</div></div><div><h3>Conclusion</h3><div>PROTECT-HBR is a large-scale, multicenter, clinical trial, which will provide a pivotal comparison of the efficacy and safety of novel P-CAB, tegoprazan with those of PPI, rabeprazole in patients with documented cardiac or vascular disease receiving chronic antithrombotic drugs and at high risk of GI bleeding.</div></div><div><h3>Clinical Trial Registration</h3><div>Potassium-Competitive Acid Blocker versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High GastroIntestinal Bleeding Risk Receiving Antithrombotic Therapy (PROTECT-HBR): NCT04416581.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"287 ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794470","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 VICAD-RISK study: Visualization of coronary artery disease for modification of risk factors","authors":"Archana Kulasingam MD ,&nbsp;Sussie Laustsen MSN, PhD ,&nbsp;Martin Busk MD, PhD ,&nbsp;Niels-Peter Rønnow Sand MD, PhD ,&nbsp;Simon Winther MD, PhD, DMSci ,&nbsp;Kristian Kragholm MD, PhD ,&nbsp;Osama Hammid MD ,&nbsp;Kamilla Bech Pedersen ,&nbsp;Peter Vedsted MD, PhD ,&nbsp;Helle Kanstrup MD, PhD ,&nbsp;Martin Bødtker Mortensen MD, PhD ,&nbsp;Erik Lerkevang Grove MD, PhD ,&nbsp;Jesper Møller Jensen MD, PhD ,&nbsp;Bjarne Linde Nørgaard MD, PhD, DMSci","doi":"10.1016/j.ahj.2025.04.002","DOIUrl":"10.1016/j.ahj.2025.04.002","url":null,"abstract":"<div><h3>Background</h3><div>With the increasing use of coronary computed tomography angiography (CTA), the prevalence of patients with nonobstructive atherosclerotic coronary artery disease (NOCAD) is growing. Presence of NOCAD is associated with an increased risk of an unfavorable clinical outcome. Therefore, guideline-directed preventive strategies such as lipid-lowering therapy with statins are important. This study aims to assess whether visualization of personal CTA images to patients with a new diagnosis of NOCAD facilitates reduction of low-density lipoprotein (LDL) cholesterol (primary endpoint), improves statin adherence, influences the perception of statin-associated side effects, and modifies the coronary atherosclerotic phenotype.</div></div><div><h3>Methods</h3><div>The VICAD-RISK study is a Danish multicenter randomized trial including statin naïve patients suspected of chronic coronary syndrome with a new diagnosis of NOCAD determined by first-line coronary CTA. A total of 273 patients will be randomized 1:1:1 into; (1) usual care; representing current clinical practice of general practitioner follow-up; (2) low-intensity intervention; specialized nurse consultation, or (3) high-intensity intervention; similar to group 2 and presentation of the personal CTA-images. All participants, including the intervention groups, will be followed at the discretion of their general practitioner. Research follow-up including biochemistry measurements, and coronary CTA investigation will be repeated for all participants after 12 months.</div></div><div><h3>Conclusion</h3><div>The VICAD-RISK study evaluates whether personal CTA image visualization in patients with a new diagnosis of NOCAD improves reduction of LDL cholesterol.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov, NCT06413641, <span><span>www.clinicaltrials.gov</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"287 ","pages":"Pages 16-23"},"PeriodicalIF":3.7,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787552","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}