American heart journal最新文献

{"title":"Response to letter by Ferguson regarding article, “Revenues, costs, and contribution margins of major inpatient cardiovascular procedures within the Medicare population”","authors":"Ashwin Nathan MD","doi":"10.1016/j.ahj.2025.04.010","DOIUrl":"10.1016/j.ahj.2025.04.010","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"287 ","pages":"Page 129"},"PeriodicalIF":3.7,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143967122","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":"Letter by Ferguson regarding article, “Revenues, costs, and contribution margins of major inpatient cardiovascular procedures within the Medicare population”","authors":"Michael Ferguson PhD","doi":"10.1016/j.ahj.2025.04.009","DOIUrl":"10.1016/j.ahj.2025.04.009","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"287 ","pages":"Page 128"},"PeriodicalIF":3.7,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144061784","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":"Implementing remote patient monitoring to improve hypertension control in a primary care network: Rationale and design of the monitor-BP Cluster Randomized Trial","authors":"Nadia Liyanage-Don MD, MS ,&nbsp;Erica Phillips MD, MS ,&nbsp;Joseph E. Schwartz PhD ,&nbsp;Melinda J. Chang NP, MS ,&nbsp;Maria-Jose Lopez-Sanchez MPH ,&nbsp;Harry West PhD ,&nbsp;Brandon K. Bellows PharmD, MS ,&nbsp;Jessica Singer MD, MS ,&nbsp;Nadine Dandan PharmD ,&nbsp;Min Qian PhD ,&nbsp;Luis Blanco BFA ,&nbsp;Adina Fraser MHA ,&nbsp;Rakhi Kalra B. Tech ,&nbsp;Siqin Ye MD, MPH ,&nbsp;Ian M. Kronish MD, MPH","doi":"10.1016/j.ahj.2025.04.005","DOIUrl":"10.1016/j.ahj.2025.04.005","url":null,"abstract":"<div><h3>Background</h3><div>Home blood pressure monitoring with clinical or technological support (Supported HBPM) is an evidence-based intervention recommended by national guidelines for improving hypertension (HTN) control. However, few healthcare systems have implemented Supported HBPM because it remains unclear how best to promote uptake among patients and clinicians, and the real-world effectiveness of Supported HBPM is unknown. The Monitor-BP Trial aims to determine the impact of implementing a flexible Supported HBPM program on practice-level HTN control and to evaluate the reach, adoption, maintenance, and cost-effectiveness of the program in a socioeconomically diverse primary care network.</div></div><div><h3>Methods</h3><div>The Monitor-BP Trial takes place in 15 primary care practices affiliated with two large academic medical centers in New York City. It is a hybrid 2 effectiveness-implementation cluster randomized pre-post trial testing early implementation of a Supported HBPM program (8 practices) versus usual care (7 practices). Adult patients with diagnosed HTN and their primary care clinicians are eligible for inclusion. The intervention consists of two program options: (1) <em>MyCare Hypertension</em>, a low resource intensity option in which patients use their own BP devices to track home BP in the online patient portal with automated triage support for extreme readings and portal-delivered educational modules, (2) <em>RPM Hypertension</em>, a high resource intensity option in which patients are loaned wireless BP devices that automatically transmit home BP data to the electronic health record (EHR) with telehealth navigator onboarding and nursing support to triage extreme readings. Both options include EHR-integrated ordering and home BP data visualization for clinicians. Key features of the implementation strategy include clinician education and training via presentations, clinician prompts and reminders via e-mails and mailed postcards, detailed instructional materials for patients and clinicians via websites, and at least monthly problem-solving meetings with clinical champions to iteratively tailor implementation to individual practices. The primary effectiveness outcome is practice-level pre- to post-implementation change in the mean 12-month change in office systolic BP among patients with uncontrolled office BP at baseline. The primary implementation outcomes are reach (uptake of the Supported HBPM program by patients) and adoption (uptake of the Supported HBPM program by clinicians). Secondary outcomes include estimating the short- and long-term cost-effectiveness of the program.</div></div><div><h3>Conclusions</h3><div>The Monitor-BP Trial tests a scalable approach to implementing telemonitoring-enabled Supported HBPM interventions into real-world clinical settings. Our findings have the potential to inform how health systems can shift the paradigm of BP assessments from the office to the home.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"288 ","pages":"Pages 52-64"},"PeriodicalIF":3.7,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143900167","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":"Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease – Design and rationale of the randomized COMPLETE-NSTEMI trial","authors":"Hans-Josef Feistritzer MD, PhD ,&nbsp;Alexander Jobs MD ,&nbsp;Uwe Zeymer MD ,&nbsp;Steffen Schneider PhD ,&nbsp;Philipp Lauten MD ,&nbsp;Miroslaw Ferenc MD ,&nbsp;Maren Weferling MD ,&nbsp;Regine Brinkmann MD ,&nbsp;Sebastian Winkler MD ,&nbsp;Ulf Landmesser MD ,&nbsp;Tobias Trippel MD ,&nbsp;Christoph Stellbrink MD ,&nbsp;Harm Wienbergen MD ,&nbsp;Georg Fürnau MD ,&nbsp;Helge Möllmann MD ,&nbsp;Axel Linke MD ,&nbsp;Christian Jung MD ,&nbsp;Alexander Lauten MD ,&nbsp;Stephan Achenbach MD ,&nbsp;Tienush Rassaf MD ,&nbsp;Holger Thiele MD","doi":"10.1016/j.ahj.2025.04.007","DOIUrl":"10.1016/j.ahj.2025.04.007","url":null,"abstract":"<div><h3>Background</h3><div>Multivessel coronary artery disease (CAD) is present in 30% to 70% of patients presenting with non-ST-segment elevation myocardial infarction (NSTEMI) depending on varying age and risk profiles. In contrast to the STEMI cohort, there is only limited scientific evidence derived from randomized controlled trials directing the general decision for or against complete revascularization in the NSTEMI population.</div></div><div><h3>Primary hypothesis</h3><div>The COMPLETE-NSTEMI trial aims to investigate whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with NSTEMI and multivessel CAD.</div></div><div><h3>Design</h3><div>COMPLETE-NSTEMI is a prospective, randomized, controlled, multicenter, parallel group, open-label trial. It will enroll 3390 NSTEMI patients with multivessel CAD at 65 to 70 sites in Germany and Austria. Patients will be randomized 1:1 to either complete revascularization with PCI or culprit lesion-only PCI.</div></div><div><h3>Endpoints</h3><div>The primary efficacy endpoint is a composite of cardiovascular death or rehospitalization for nonfatal myocardial infarction during follow-up. The trial is event-driven and will be stopped as soon as 578 primary endpoint events and a minimal follow-up duration of 12 months for each patient are reached.</div></div><div><h3>Current status</h3><div>The first patient was enrolled at October 27, 2023. By April 2025, 51 sites have been activated and &gt;500 patients have been randomized. Completion of recruitment is expected for the first half of 2027. The final results of the primary endpoint are expected in 2028.</div></div><div><h3>Outlook</h3><div>COMPLETE NSTEMI will be the first dedicated trial to answer the question about the optimal revascularization strategy in patients with NSTEMI and multivessel CAD.</div></div><div><h3>Trial registration: ClinicalTrials.gov</h3><div>NCT05786131</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"287 ","pages":"Pages 94-106"},"PeriodicalIF":3.7,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143894404","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":"Design and rationale of the drug-coated balloon coronary angioplasty versus stenting for treatment of disease adjacent to a chronic total occlusion (Co-CTO) trial","authors":"Yvemarie B.O. Somsen MD ,&nbsp;Ruben W. de Winter MD ,&nbsp;Jiawei Wu MD ,&nbsp;Roel Hoek MD ,&nbsp;Ralf W. Sprengers MD, PhD ,&nbsp;Niels J. Verouden MD, PhD ,&nbsp;Bimmer E.P.M. Claessen MD, PhD ,&nbsp;Sebastiaan A. Kleijn MD, PhD ,&nbsp;Jos W.R. Twisk PhD ,&nbsp;José P. Henriques MD, PhD ,&nbsp;James C. Spratt MD, PhD ,&nbsp;Tuomas T. Rissanen MD, PhD ,&nbsp;Margaret B. McEntegart MD, PhD ,&nbsp;Akiko Maehara MD, PhD ,&nbsp;Alexander Nap MD, PhD ,&nbsp;Paul Knaapen MD, PhD","doi":"10.1016/j.ahj.2025.03.023","DOIUrl":"10.1016/j.ahj.2025.03.023","url":null,"abstract":"<div><h3>Background</h3><div>Percutaneous coronary intervention (PCI) of chronic total coronary occlusions (CTOs) typically involves extensive drug-eluting stent (DES) implantation. As a result, patients undergoing CTO PCI are exposed to a relatively high risk of in-stent restenosis and target lesion revascularization. While the application of drug-coated balloons (DCBs) may improve patient outcome by reducing stent burden, randomized controlled trials investigating the use of DCB in CTO PCI are lacking.</div></div><div><h3>Methods</h3><div>The Co-CTO trial (NCT04881812) is a single-blind, noninferiority randomized controlled trial enrolling 144 patients undergoing CTO PCI. A hybrid strategy (stenting of the CTO body and DCB treatment of adjacent disease) will be compared to a complete stenting strategy. The primary study endpoint is in-segment percentage diameter stenosis at 1 year follow-up determined by intravascular ultrasound. Secondary endpoints include major adverse cardiovascular events (a composite of cardiac death, nonfatal myocardial infarction, and ischemia-driven target lesion revascularization) at 1 year, angiographic outcomes, and cardiac symptoms (Canadian Cardiovascular Society Grading Scale, New York Heart Association Classification of Dyspnea).</div></div><div><h3>Conclusion</h3><div>The Co-CTO trial is the first randomized controlled trial exploring a hybrid strategy (DES + DCB) in patients undergoing CTO PCI.</div></div><div><h3>Trial registration</h3><div>Registered at ClinicalTrials.Gov under registration number: NCT04881812 (<span><span>https://clinicaltrials.gov/study/NCT04881812?cond=cto&amp;intr=drug-coated%20balloon&amp;rank=1</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"288 ","pages":"Pages 65-76"},"PeriodicalIF":3.7,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143904018","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 MD ,&nbsp;Charlotte Helene Wichmand MD ,&nbsp;Sarah Louise Duus Holle MD ,&nbsp;Alexander Christian Falkentoft MD, PhD ,&nbsp;Louise Bruun Østergaard MD, PhD ,&nbsp;Christian Torp-Pedersen MD, DMSc ,&nbsp;Sidsel Gamborg Møller MD, PhD ,&nbsp;Trine Kiilerich Lauridsen MD, PhD ,&nbsp;Gunnar Gislason MD, PhD ,&nbsp;Lauge Østergaard MD, PhD ,&nbsp;Emil Fosbøl MD, PhD ,&nbsp;Niels Eske Bruun MD, DMSc ,&nbsp;Anne-Christine Ruwald MD, PhD","doi":"10.1016/j.ahj.2025.04.003","DOIUrl":"10.1016/j.ahj.2025.04.003","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>By cross-linking Danish nationwide registers, we identified all Danish residents above 30 years of age, from January 1, 2007 through December 31, 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.</div></div><div><h3>Results</h3><div>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 to 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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"287 ","pages":"Pages 119-127"},"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}