American heart journal最新文献

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Rationale and design of the REMBRANDT trial: A phase 3 study to evaluate the effect of obicetrapib/ezetimibe on coronary plaque characteristics. REMBRANDT试验的基本原理和设计:一项评估obicetrapib/ezetimibe对冠状动脉斑块特征影响的3期研究。
IF 3.5 2区 医学
American heart journal Pub Date : 2025-12-01 Epub Date: 2025-07-17 DOI: 10.1016/j.ahj.2025.07.012
Cian P McCarthy, Christie M Ballantyne, Ron Blankstein, Matthew J Budoff, Marc Ditmarsch, C Michael Gibson, John J P Kastelein, Ann Marie Navar, Stephen J Nicholls, Kausik K Ray, Cheerag Shirodaria, Michelle C Williams, James L Januzzi
{"title":"Rationale and design of the REMBRANDT trial: A phase 3 study to evaluate the effect of obicetrapib/ezetimibe on coronary plaque characteristics.","authors":"Cian P McCarthy, Christie M Ballantyne, Ron Blankstein, Matthew J Budoff, Marc Ditmarsch, C Michael Gibson, John J P Kastelein, Ann Marie Navar, Stephen J Nicholls, Kausik K Ray, Cheerag Shirodaria, Michelle C Williams, James L Januzzi","doi":"10.1016/j.ahj.2025.07.012","DOIUrl":"10.1016/j.ahj.2025.07.012","url":null,"abstract":"<p><strong>Background: </strong>Obicetrapib is a potent, selective cholesteryl ester transfer protein (CETP) inhibitor that significantly lowers low-density lipoprotein cholesterol (LDL-C). Additive reductions in LDL-C occur when obicetrapib is combined with ezetimibe. The impact of obicetrapib and ezetimibe fixed-dose combination (FDC) on coronary plaque burden is unknown. Favorable changes in noncalcified coronary atherosclerotic plaque volume (NCPV) may indicate a potential beneficial effect on atherosclerotic cardiovascular disease (ASCVD) events.</p><p><strong>Methods: </strong>REMBRANDT is a placebo-controlled, double-blind, randomized trial designed to assess the efficacy of obicetrapib and ezetimibe FDC on coronary plaque burden. Individuals aged 45 years or older with ASCVD (imaging evidence of vascular disease or clinically manifested ASCVD) and an LDL-C of ≥70 mg/dL despite maximally tolerated lipid-modifying therapy are eligible to participate. Eligible participants (N = 300) will be randomized in a 1:1 ratio to obicetrapib 10 mg and ezetimibe 10 mg FDC once daily or placebo tablet once daily. The primary efficacy outcome of REMBRANDT is percent change in total NCPV from baseline to 18 months as assessed by coronary computed tomographic angiography (CCTA). Secondary endpoints include absolute change in total NCPV, percent and absolute change in NCPV in the most diseased coronary segment, percent change in LDL-C, and change in perivascular fat attenuation index from baseline to 18 months.</p><p><strong>Conclusion: </strong>The REMBRANDT trial will determine whether the favorable effects of obicetrapib and ezetimibe FDC on LDL-C translate to a reduction in coronary plaque burden as a potential mechanism for ASCVD risk reduction.</p><p><strong>Clinical trial registration: </strong>NCT06305559.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"325-338"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144666899","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}
引用次数: 0
Incremental cost of complications after TAVR and SAVR in contemporary clinical practice. 当代临床TAVR和SAVR术后并发症的增量成本。
IF 3.5 2区 医学
American heart journal Pub Date : 2025-12-01 Epub Date: 2025-07-12 DOI: 10.1016/j.ahj.2025.07.001
James E Harvey, Michael Ryan, Candace Gunnarsson, Soumya Chikermane, Suzanne J Baron
{"title":"Incremental cost of complications after TAVR and SAVR in contemporary clinical practice.","authors":"James E Harvey, Michael Ryan, Candace Gunnarsson, Soumya Chikermane, Suzanne J Baron","doi":"10.1016/j.ahj.2025.07.001","DOIUrl":"10.1016/j.ahj.2025.07.001","url":null,"abstract":"<p><strong>Background: </strong>Prior studies have demonstrated that peri-procedural complications are associated with increased healthcare costs after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). Given the technological and procedural advances that have occurred in the management of aortic valve disease over the last decade, this study aims to understand the incremental cost of specific complications after SAVR and TAVR in contemporary practice.</p><p><strong>Methods: </strong>Using the Medicare 100% standard analytic file, we identified all beneficiaries receiving SAVR or TAVR in the United States during fiscal year 2021. Specific complications were identified via ICD-10 codes. Multivariable analyses were performed to estimate the incremental cost and length of stay (LOS) for each complication. Attributable costs were calculated by adjusting the incremental cost of each complication for its incidence.</p><p><strong>Results: </strong>The cost of an uncomplicated TAVR index hospitalization was $46,257 with LOS 2.2 days, while an uncomplicated SAVR cost $58,488 with LOS 8.1 days. The presence of any complication increased costs and LOS for TAVR ($66,601; 5.9 days) and SAVR ($88,900; 13.4 days). Prolonged ventilation was associated with the highest incremental cost for TAVR ($55,742), while pacemaker implantation had the highest attributable cost ($1,270). Prolonged ventilation accounted for the highest incremental ($69,728) and attributable ($2,580) cost associated with SAVR.</p><p><strong>Conclusion: </strong>This study provides contemporary data on the incremental costs of specific peri-procedural complications associated with TAVR and SAVR. These findings can be used to develop targeted interventions to optimize healthcare resource utilization in patients undergoing aortic valve replacement.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"278-287"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144635936","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}
引用次数: 0
Active Monitoring for AtriaL FIbrillation (AMALFI): Rationale, protocol, and pilot for a pragmatic, randomized, controlled trial of remote screening for asymptomatic atrial fibrillation. 房颤主动监测(AMALFI):一项实用的、随机的、对照的无症状房颤远程筛查试验的基本原理、方案和试点。
IF 3.5 2区 医学
American heart journal Pub Date : 2025-12-01 Epub Date: 2025-07-16 DOI: 10.1016/j.ahj.2025.07.004
Rohan Wijesurendra, Guilherme Pessoa-Amorim, Georgina Buck, Charlie Harper, Richard Bulbulia, Nicholas R Jones, Christine A'Court, Rijo Kurien, Karen Taylor, Barbara Casadei, Louise Bowman
{"title":"Active Monitoring for AtriaL FIbrillation (AMALFI): Rationale, protocol, and pilot for a pragmatic, randomized, controlled trial of remote screening for asymptomatic atrial fibrillation.","authors":"Rohan Wijesurendra, Guilherme Pessoa-Amorim, Georgina Buck, Charlie Harper, Richard Bulbulia, Nicholas R Jones, Christine A'Court, Rijo Kurien, Karen Taylor, Barbara Casadei, Louise Bowman","doi":"10.1016/j.ahj.2025.07.004","DOIUrl":"10.1016/j.ahj.2025.07.004","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;Screening for asymptomatic atrial fibrillation (AF) might reduce cardioembolic strokes and screening for asymptomatic AF is recommended by some international guidelines. However, any impact of AF screening on clinical outcomes depends on a sustained increase in AF detection and anticoagulation use over time than would have occurred with routine care alone, highlighting the importance of long-term studies to generate the evidence needed to justify establishing formal screening programs. AMALFI aims to establish the long-term efficacy and cost-effectiveness of remote screening for asymptomatic AF in older individuals at increased risk of stroke using a noninvasive 14-day continuous ECG monitoring patch in UK primary care. This paper describes the study protocol and baseline characteristics of included participants.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;AMALFI (ISCRTN 15544176) recruited individuals aged ≥65 years with CHA&lt;sub&gt;2&lt;/sub&gt;DS&lt;sub&gt;2&lt;/sub&gt;-VASc score ≥3 (men) or ≥4 (women) with no previous diagnosis of AF/atrial flutter from 27 UK primary care practices. Participants were randomized to ECG monitoring (Zio XT, iRhythm Technologies; intervention) or usual care (control). Those allocated to ECG monitoring were sent and returned the patch by mail. After wear, participants returned the patch to the device manufacturer where ECG data were analyzed via a deep-learned AI algorithm and confirmed by qualified cardiographic technicians. A final report was sent to study investigators, and those indicating AF or other arrhythmias considered by the study team to be clinically actionable were communicated to general practitioners (GPs) immediately by secure email. Additionally, GPs were notified by mail of the presence or absence of AF episodes ≥30 seconds, and of the burden of AF for each of their participants who wore a patch. The letter included signposting to relevant guidelines and findings were managed at the GP's discretion. Participants allocated to the control group were not required to undertake any action. The primary study outcome is the rate of new AF detection at 2.5 years, with secondary outcomes including time spent with a known AF diagnosis at 5 years of follow-up, and analyses of these outcomes by predefined age and sex subgroups. Exploratory outcomes will assess randomized assessments of time to AF detection within 2.5 and 5 years after randomization, time spent with a known AF diagnosis up to 2.5 years from randomization, and anticoagulation exposure within 2.5 and 5 years after randomization. Other exploratory long-term assessments include randomized comparisons of numbers and proportions of hospitalizations (total and cardiovascular), ischemic stroke, major bleed, and death (all-cause and cardiovascular) in both groups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Between 2019 and 2022, AMALFI randomized 5,040 people in England to screening versus usual care using mail-based invitations. Participant mean age was 77 ± 6 y","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"310-324"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144666898","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}
引用次数: 0
Defining diastolic dysfunction post-Fontan: Threshold, risk factors, and associations with outcomes. 定义fontan后舒张功能障碍:阈值、危险因素和与结果的关联。
IF 3.5 2区 医学
American heart journal Pub Date : 2025-12-01 Epub Date: 2025-07-10 DOI: 10.1016/j.ahj.2025.07.007
Tarek Alsaied, Runjia Li, Haley Grant, Mary D Schiff, Yu Li, Adam B Christopher, Jacqueline Kreutzer, Bryan H Goldstein, Jonathan H Soslow, Yue-Hin Loke, Mark A Fogel, Timothy C Slesnick, Rajesh Krishnamurthy, Vivek Muthurangu, Adam L Dorfman, Christopher Lam, Justin D Weigand, Joshua D Robinson, Laura J Olivieri, Rahul H Rathod
{"title":"Defining diastolic dysfunction post-Fontan: Threshold, risk factors, and associations with outcomes.","authors":"Tarek Alsaied, Runjia Li, Haley Grant, Mary D Schiff, Yu Li, Adam B Christopher, Jacqueline Kreutzer, Bryan H Goldstein, Jonathan H Soslow, Yue-Hin Loke, Mark A Fogel, Timothy C Slesnick, Rajesh Krishnamurthy, Vivek Muthurangu, Adam L Dorfman, Christopher Lam, Justin D Weigand, Joshua D Robinson, Laura J Olivieri, Rahul H Rathod","doi":"10.1016/j.ahj.2025.07.007","DOIUrl":"10.1016/j.ahj.2025.07.007","url":null,"abstract":"<p><strong>Background: </strong>Following the Fontan procedure, patients with single ventricle physiology are at high risk of diastolic dysfunction (DD) and elevated end-diastolic pressure (EDP).</p><p><strong>Objective: </strong>This study aims to determine (1) the optimal EDP threshold correlated with adverse outcomes post-Fontan and (2) the clinical and imaging predictors of DD.</p><p><strong>Methods: </strong>The study included patients from the Fontan Outcome Registry using CMR Examinations (FORCE) who underwent cardiac catheterization and cardiac magnetic resonance (CMR) within a 2-year window. The composite outcome was defined as all-cause mortality, sustained atrial or ventricular arrhythmia, plastic bronchitis, protein-losing enteropathy, or listing for transplantation. The EDP cutoff was determined using the lowest Brier score from Cox proportional hazard models.</p><p><strong>Results: </strong>The study included 861 patients (mean age 16.4 ± 9.3 years). Mean EDP was 9.0 ± 3.5 mm Hg, with DD defined at an optimal EDP threshold >13 mm Hg. Patients were followed for a median of 3.6 years after catheterization. By univariable analysis patients with DD were more likely to have Fontan associated liver disease (40% vs 29%, P = .03) and kidney disease (19% vs 6%, P < .001). In multivariable analyses, DD was associated with the composite outcome (HR 3.37, 95% CI: 2.03-5.59, P < .001). Ninety-seven patients (11.3%) had DD. Multivariable analysis demonstrated that older age at catheterization, greater body mass index (BMI), nonleft ventricular morphology, and higher ventricular end-diastolic volume (EDV) were associated with DD.</p><p><strong>Conclusion: </strong>DD, defined as an EDP >13 mm Hg, is linked to over 3-fold higher risk of adverse outcomes. Risk factors for DD include older age, higher BMI, nonleft ventricular morphology, and larger EDV. The presence of risk factors may warrant screening catheterization to identify DD and modify care accordingly.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"288-296"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144615794","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}
引用次数: 0
The effects of low-dose colchicine on the progression of aortic valve stenosis: Rationale, design, and baseline characteristics of the Colchicine and Inflammation in Aortic Stenosis (CHIANTI) trial. 低剂量秋水仙碱对主动脉瓣狭窄进展的影响:秋水仙碱与主动脉瓣狭窄炎症(CHIANTI)试验的基本原理、设计和基线特征
IF 3.5 2区 医学
American heart journal Pub Date : 2025-12-01 Epub Date: 2025-07-12 DOI: 10.1016/j.ahj.2025.07.010
Niekbachsh Mohammadnia, Lucas T W Vestjens, Neil J Craig, Jan G P Tijssen, Remco J J Knol, Sergiy V Lazarenko, Mariëlle G J Duffels, Jeroen Jaspers Focks, Martin E W Hemels, Iris Oving, Hanke J Schalkx, John W Eikelboom, Aysun Cetinyurek-Yavuz, Erik H J G Aarntzen, Damini Dey, Piotr J Slomka, Robin Nijveldt, Niels P Riksen, Niels van Royen, Michael C Honigberg, Marc R Dweck, Jan H Cornel, Saloua El Messaoudi
{"title":"The effects of low-dose colchicine on the progression of aortic valve stenosis: Rationale, design, and baseline characteristics of the Colchicine and Inflammation in Aortic Stenosis (CHIANTI) trial.","authors":"Niekbachsh Mohammadnia, Lucas T W Vestjens, Neil J Craig, Jan G P Tijssen, Remco J J Knol, Sergiy V Lazarenko, Mariëlle G J Duffels, Jeroen Jaspers Focks, Martin E W Hemels, Iris Oving, Hanke J Schalkx, John W Eikelboom, Aysun Cetinyurek-Yavuz, Erik H J G Aarntzen, Damini Dey, Piotr J Slomka, Robin Nijveldt, Niels P Riksen, Niels van Royen, Michael C Honigberg, Marc R Dweck, Jan H Cornel, Saloua El Messaoudi","doi":"10.1016/j.ahj.2025.07.010","DOIUrl":"10.1016/j.ahj.2025.07.010","url":null,"abstract":"<p><strong>Background: </strong>Aortic valve stenosis (AS) is one of the most common valvular heart diseases worldwide. Its prevalence increases with age and is expected to rise further as the population ages. Untreated severe AS carries a 2-year mortality rate exceeding 50%. Furthermore, surveillance and management of AS impose a significant burden on healthcare systems. Therefore, effective pharmacological strategies are urgently needed to slow or halt the progression of AS.</p><p><strong>Rationale and design: </strong>Inflammation plays a central role in the pathogenesis of both atherosclerosis and AS. Anti-inflammatory therapy with low-dose colchicine reduces cardiovascular events in patients with coronary artery disease, but its efficacy has not been tested in AS. Colchicine and Inflammation in Aortic Stenosis (CHIANTI) is an investigator-initiated, placebo-controlled, double-blind, multicenter, randomized trial involving 150 patients with moderate AS. After confirming tolerance during a two-week run-in phase, eligible participants underwent coronary computed tomography (CT) angiography, <sup>18</sup>F-sodium fluoride (<sup>18</sup>F-NaF) positron emission tomography (PET)-CT, and echocardiography. Thereafter, participants were randomized 1:1 to colchicine 0.5 mg once daily or a matching placebo. All baseline imaging is repeated after 24 months. The primary endpoint is the change in aortic valve calcium score on CT. Secondary endpoints are (1) the change in aortic valve <sup>18</sup>F-NaF uptake on PET-CT and corrected for target-to-background ratio, and (2) the change in peak aortic jet velocity on echocardiography.</p><p><strong>Conclusion: </strong>The CHIANTI trial evaluates whether anti-inflammatory therapy with low-dose colchicine can slow or halt the progression of moderate AS. If successful, it would offer the first effective pharmacological treatment for AS.</p><p><strong>Trial registration: </strong>Registered on ClinicalTrials.gov (https://clinicaltrials.gov/), ID: NCT05162742.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"297-309"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144635937","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}
引用次数: 0
Association of obesity subphenotypes with indices of cardiac remodeling in the Framingham Heart Study. 弗雷明汉心脏研究中肥胖亚表型与心脏重塑指数的关联
IF 3.5 2区 医学
American heart journal Pub Date : 2025-10-19 DOI: 10.1016/j.ahj.2025.107292
William J He, Brenton R Prescott, Vanessa Xanthakis, Gary F Mitchell, Susan Cheng, Ramachandran S Vasan
{"title":"Association of obesity subphenotypes with indices of cardiac remodeling in the Framingham Heart Study.","authors":"William J He, Brenton R Prescott, Vanessa Xanthakis, Gary F Mitchell, Susan Cheng, Ramachandran S Vasan","doi":"10.1016/j.ahj.2025.107292","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.107292","url":null,"abstract":"<p><strong>Background: </strong>Previous studies have reported that obesity-related metabolic abnormalities (e.g., diabetes and hypertension) lead to myocardial dysfunction and adverse cardiac remodeling. However, it is unclear whether such cardiac remodeling is from obesity or obesity-related metabolic abnormalities. We hypothesize that overweight and obesity are associated with adverse cardiac remodeling independent of associated metabolic abnormalities.</p><p><strong>Methods: </strong>We evaluated 6,639 participants from the Framingham Heart Study who underwent echocardiography and had no prevalent cardiovascular disease. Individuals were classified into six obesity sub-phenotypes based on metabolic health (metabolically healthy or metabolically unhealthy) and body mass index (normal weight, overweight, or obese). Obesity subphenotypes were related to echocardiographic measures using multivariable regression analyses.</p><p><strong>Results: </strong>Mean age was 49 years and 55% were women. Overweight and obesity were consistently associated with adverse cardiac remodeling in both metabolic healthy and unhealthy participants. Among metabolically healthy participants, compared to the normal weight group (referent), overweight and obesity were significantly associated with increased left ventricular mass (11.6 and 21.4 gm), left atrium end-systolic dimension (0.27 and 0.48 cm), global longitudinal strain (0.82 and 1.06%), and the ratio of early diastolic trans-mitral flow velocity to early diastolic mitral annulus velocity (0.35 and 0.87) (all p<0.001). Additionally, obesity was significantly associated with mitral annular plane systolic excursion (0.08 cm, p<0.001) and relative wall thickness (0.01, p=0.001) compared to the normal weight referent group.</p><p><strong>Conclusions: </strong>Increasing body weight was associated with adverse cardiac remodeling regardless of metabolic health status, which suggests that obesity may directly increase the risk of adverse cardiac remodeling.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107292"},"PeriodicalIF":3.5,"publicationDate":"2025-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145342938","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}
引用次数: 0
Distal versus conventional radial large-bore access for percutaneous coronary intervention of complex coronary lesions: Rationale and design of the DISCO COMPLEX randomized superiority trial. 复杂冠状动脉病变经皮冠状动脉介入治疗的远端与传统桡骨大口径通道:DISCO complex随机优势试验的基本原理和设计。
IF 3.5 2区 医学
American heart journal Pub Date : 2025-10-18 DOI: 10.1016/j.ahj.2025.107291
Juan F Iglesias, Gregor Leibundgut, Dik Heg, Gabriele L Gasparini, Grigorios Tsigkas, Claudiu Ungureanu, Giuseppe Colletti, Sophie Degrauwe, Panagiotis Xaplanteris, Karsten Schenke, Alexandru Achim, Maarten Ah van Leeuwen, Maia Muresan, Shigeru Saito, Gregory A Sgueglia, Adel Aminian
{"title":"Distal versus conventional radial large-bore access for percutaneous coronary intervention of complex coronary lesions: Rationale and design of the DISCO COMPLEX randomized superiority trial.","authors":"Juan F Iglesias, Gregor Leibundgut, Dik Heg, Gabriele L Gasparini, Grigorios Tsigkas, Claudiu Ungureanu, Giuseppe Colletti, Sophie Degrauwe, Panagiotis Xaplanteris, Karsten Schenke, Alexandru Achim, Maarten Ah van Leeuwen, Maia Muresan, Shigeru Saito, Gregory A Sgueglia, Adel Aminian","doi":"10.1016/j.ahj.2025.107291","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.107291","url":null,"abstract":"<p><strong>Rationale: </strong>Distal radial access (DRA) has emerged as a promising alternative to conventional transradial access (TRA) for coronary angiography and percutaneous coronary intervention (PCI). However, existing randomized evidence on DRA primarily involves low-risk patients undergoing diagnostic angiography or non-complex PCI using ≤6 French (Fr) introducer sheaths. The clinical benefits of DRA among patients undergoing PCI for complex coronary lesions using large-bore guide catheters remain therefore uncertain.</p><p><strong>Design: </strong>DISCO COMPLEX is an investigator-initiated, prospective, multicenter, international, open-label, randomized, controlled trial with a blinded outcome assessment and superiority design. The trial will compare in a 1:1 ratio large-bore DRA versus conventional TRA using a 7-Fr introducer sheath in 708 patients undergoing PCI for complex coronary lesions (chronic total occlusions, left main disease, heavily calcified lesions, or complex bifurcations) with a 7-Fr guide catheter. The primary hypothesis is that large-bore DRA is superior to conventional TRA with respect to the incidence of forearm radial artery occlusion (RAO) assessed by Doppler ultrasound at hospital discharge. The prespecified DISCOPHILE COMPLEX hand function substudy is a non-inferiority trial evaluating whether large-bore DRA is not inferior to conventional TRA with respect to change in full-Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire score from baseline to 12 months in participants of the DISCO COMPLEX trial.</p><p><strong>Enrolment status: </strong>The trial aims to recruit a total of 708 patients from 10 to 15 participating centers across Europe. The first patient was enrolled on August 31, 2023. As of August 20, 2025, 385 patients have been included.</p><p><strong>Conclusion: </strong>DISCO COMPLEX is the first randomized clinical trial designed to test the superiority of large-bore DRA over conventional TRA in reducing RAO rates among patients undergoing complex PCI with 7-Fr guide catheters.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107291"},"PeriodicalIF":3.5,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145336263","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}
引用次数: 0
Worsening Heart Failure Events in Adults with Mild-to-Moderate Chronic Kidney Disease. 成人轻中度慢性肾病患者心衰事件加重
IF 3.5 2区 医学
American heart journal Pub Date : 2025-10-17 DOI: 10.1016/j.ahj.2025.107290
Linda Ye, Michael P Girouard, Alan S Go, Jane Y Liu, Rishi V Parikh, Thida C Tan, Emily S Lee, Grace Sun, Rami Halaseh, Ankeet S Bhatt, Leonid Pravoverov, Sijie Zheng, Jana Svetlichnaya, Jesse K Fitzpatrick, Harshith R Avula, Keane K Lee, Sirtaz Adatya, David Ouyang, Parag Goyal, Alexander T Sandhu, Andrew P Ambrosy
{"title":"Worsening Heart Failure Events in Adults with Mild-to-Moderate Chronic Kidney Disease.","authors":"Linda Ye, Michael P Girouard, Alan S Go, Jane Y Liu, Rishi V Parikh, Thida C Tan, Emily S Lee, Grace Sun, Rami Halaseh, Ankeet S Bhatt, Leonid Pravoverov, Sijie Zheng, Jana Svetlichnaya, Jesse K Fitzpatrick, Harshith R Avula, Keane K Lee, Sirtaz Adatya, David Ouyang, Parag Goyal, Alexander T Sandhu, Andrew P Ambrosy","doi":"10.1016/j.ahj.2025.107290","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.107290","url":null,"abstract":"<p><strong>Background: </strong>Chronic kidney disease (CKD) is a major risk factor for heart failure (HF). However, the burden of worsening HF (WHF) events among adults with mild-to-moderate CKD has not been well described.</p><p><strong>Objectives: </strong>This study assessed the burden of WHF in a contemporary cohort of adults with mild-to-moderate CKD.</p><p><strong>Methods: </strong>We identified adults with mild-to-moderate CKD (eGFR 30-59 ml/min/1.73m² or eGFR ≥60 ml/min/1.73m² with albuminuria) within a large, integrated healthcare delivery system from 2012-2021. Outcomes included hospitalizations, emergency department visits, and outpatient encounters for WHF, stratified by HF status and level of CKD.</p><p><strong>Results: </strong>Among 375,495 adults with mild-to-moderate CKD, mean age was 64 ±16 years, 54% were women, mean eGFR was 76 ± 26 ml/min/1.73m², and 6.5% had prior known HF. CKD stages G1A2 (31.6%), G2A2 (24.9%), and G3aA1 (25.1%) were most prevalent. Rates (95% CI) per 100 person-years for WHF events were 1.85 (1.83-1.87) for hospitalizations, 0.85 (0.84-0.86) for emergency department visits, and 0.83 (0.81-0.84) for outpatient encounters, resulting in a cumulative rate of 2.42 (2.40-2.44). Event rates were higher at lower eGFR and higher albuminuria levels.</p><p><strong>Conclusions: </strong>WHF is a common source of morbidity in adults with earlier stage CKD, and particularly high in those with lower eGFR and greater albuminuria. These findings underscore the importance of implementing available and emerging cardioprotective and renoprotective therapies in this high-risk population.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107290"},"PeriodicalIF":3.5,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145328176","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}
引用次数: 0
Information for Readers 读者资讯
IF 3.5 2区 医学
American heart journal Pub Date : 2025-10-07 DOI: 10.1016/S0002-8703(25)00343-6
{"title":"Information for Readers","authors":"","doi":"10.1016/S0002-8703(25)00343-6","DOIUrl":"10.1016/S0002-8703(25)00343-6","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Page iv"},"PeriodicalIF":3.5,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145262518","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}
引用次数: 0
Statistical methodological limitations and improvement suggestions in the study of vitamin D deficiency and cardiovascular mortality after heart transplantation 维生素D缺乏与心脏移植后心血管死亡率研究的统计方法局限性及改进建议。
IF 3.5 2区 医学
American heart journal Pub Date : 2025-10-07 DOI: 10.1016/j.ahj.2025.08.015
Haiying Hu BSc, Linjun Wang BSc
{"title":"Statistical methodological limitations and improvement suggestions in the study of vitamin D deficiency and cardiovascular mortality after heart transplantation","authors":"Haiying Hu BSc,&nbsp;Linjun Wang BSc","doi":"10.1016/j.ahj.2025.08.015","DOIUrl":"10.1016/j.ahj.2025.08.015","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 216-217"},"PeriodicalIF":3.5,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145257132","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}
引用次数: 0
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