Journal of the American College of Cardiology最新文献

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Cardiac Biomarkers as an Early Warning System in Transthyretin Cardiac Amyloidosis 心脏生物标志物作为转甲状腺素型心脏淀粉样变性的早期预警系统
IF 22.3 1区 医学
Journal of the American College of Cardiology Pub Date : 2025-08-04 DOI: 10.1016/j.jacc.2025.05.022
Joshua D. Mitchell MD, MSCI , Nicole Nakamatsu MD , Richard K. Cheng MD, MSc
{"title":"Cardiac Biomarkers as an Early Warning System in Transthyretin Cardiac Amyloidosis","authors":"Joshua D. Mitchell MD, MSCI , Nicole Nakamatsu MD , Richard K. Cheng MD, MSc","doi":"10.1016/j.jacc.2025.05.022","DOIUrl":"10.1016/j.jacc.2025.05.022","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"86 6","pages":"Pages 476-478"},"PeriodicalIF":22.3,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144766500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Impact of Vutrisiran on Cardiac Biomarkers in Patients With Transthyretin Amyloidosis With Cardiomyopathy From HELIOS-B 乌曲西兰对HELIOS-B型转甲状腺素淀粉样变合并心肌病患者心脏生物标志物的影响
IF 22.3 1区 医学
Journal of the American College of Cardiology Pub Date : 2025-08-04 DOI: 10.1016/j.jacc.2025.04.055
Mathew S. Maurer MD , John L. Berk MD , Thibaud Damy MD, PhD , Farooq H. Sheikh MD , José González-Costello MD, PhD , Caroline Morbach MD , Diego Delgado MD , Antoine Bondue MD, PhD , Olga Azevedo MD, PhD , Steen H. Poulsen MD , Ewa A. Jankowska MD , Lili Yang PhD , Shaun Bender PhD , Satish A. Eraly MD, PhD , Patrick Y. Jay MD, PhD , John Vest MD , Marianna Fontana MD, PhD
{"title":"Impact of Vutrisiran on Cardiac Biomarkers in Patients With Transthyretin Amyloidosis With Cardiomyopathy From HELIOS-B","authors":"Mathew S. Maurer MD ,&nbsp;John L. Berk MD ,&nbsp;Thibaud Damy MD, PhD ,&nbsp;Farooq H. Sheikh MD ,&nbsp;José González-Costello MD, PhD ,&nbsp;Caroline Morbach MD ,&nbsp;Diego Delgado MD ,&nbsp;Antoine Bondue MD, PhD ,&nbsp;Olga Azevedo MD, PhD ,&nbsp;Steen H. Poulsen MD ,&nbsp;Ewa A. Jankowska MD ,&nbsp;Lili Yang PhD ,&nbsp;Shaun Bender PhD ,&nbsp;Satish A. Eraly MD, PhD ,&nbsp;Patrick Y. Jay MD, PhD ,&nbsp;John Vest MD ,&nbsp;Marianna Fontana MD, PhD","doi":"10.1016/j.jacc.2025.04.055","DOIUrl":"10.1016/j.jacc.2025.04.055","url":null,"abstract":"<div><h3>Background</h3><div>Before the development of disease-modifying therapies for transthyretin amyloidosis cardiomyopathy (ATTR-CM), N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) and troponin I/T were recognized as independent prognostic biomarkers of mortality. This study evaluated the prognostic value of these biomarkers in a contemporary patient population and the impact of vutrisiran, an RNA interference therapeutic that rapidly knocks down circulating transthyretin, on biomarker levels.</div></div><div><h3>Objectives</h3><div>This study sought to evaluate the association between risk of cardiovascular events and all-cause mortality with baseline NT-proBNP and troponin I levels and changes from baseline at month 6 in patients from HELIOS-B and explore how vutrisiran impacts biomarkers over time.</div></div><div><h3>Methods</h3><div>In HELIOS-B, a double-blind, placebo-controlled study, 655 patients with ATTR-CM were randomized 1:1 to receive vutrisiran or placebo for up to 36 months. The primary endpoint was a composite outcome of all-cause mortality and recurrent cardiovascular events. All-cause mortality through 42 months was a secondary endpoint. NT-proBNP and troponin I were assessed as prespecified exploratory endpoints.</div></div><div><h3>Results</h3><div>Baseline NT-proBNP and troponin I levels were independently associated with risks of the composite outcome and all-cause mortality (<em>P</em> &lt; 0.0001 for both biomarkers and endpoints). At month 6, increases in NT-proBNP from baseline were associated with higher risk of the composite outcome and all-cause mortality, and decreases in troponin I were associated with a lower risk of the composite outcome. At month 30, the median changes from baseline of NT-proBNP and troponin I were 753 pg/mL (Q1-Q3: −8 to 2,573 pg/mL) and 9.7 pg/mL (Q1-Q3: −6.3 to 41.2 pg/mL) in the placebo arm and 118 pg/mL (Q1-Q3: −419 to 911 pg/mL) and −5.8 pg/mL (Q1-Q3: −25.0 to 10.0 pg/mL) in the vutrisiran arm. The geometric mean fold-change ratios (vutrisiran/placebo) were 0.68 (95% CI: 0.61-0.76) for NT-proBNP and 0.68 (95% CI: 0.62-0.75) for troponin I (<em>P</em> &lt; 0.0001 for both).</div></div><div><h3>Conclusions</h3><div>Patterns of associations between biomarkers and adverse outcomes support the importance of early treatment initiation and the potential for risk reduction in patients with ATTR-CM. Vutrisiran maintained stable or reduced levels of both biomarkers consistent with the benefit of treatment in reducing the risk of cardiovascular events and all-cause mortality. (HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy; <span><span>NCT04153149</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"86 6","pages":"Pages 459-475"},"PeriodicalIF":22.3,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144766510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Audio Summary 音频的总结
IF 22.3 1区 医学
Journal of the American College of Cardiology Pub Date : 2025-08-04 DOI: 10.1016/S0735-1097(25)07054-8
{"title":"Audio Summary","authors":"","doi":"10.1016/S0735-1097(25)07054-8","DOIUrl":"10.1016/S0735-1097(25)07054-8","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"86 6","pages":"Page e53"},"PeriodicalIF":22.3,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144766502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Compression Therapy for Vasovagal Syncope 血管迷走神经性晕厥的压迫治疗
IF 22.3 1区 医学
Journal of the American College of Cardiology Pub Date : 2025-08-04 DOI: 10.1016/j.jacc.2025.06.030
Albert Y. Liu MD, MPH, Cara N. Pellegrini MD
{"title":"Compression Therapy for Vasovagal Syncope","authors":"Albert Y. Liu MD, MPH,&nbsp;Cara N. Pellegrini MD","doi":"10.1016/j.jacc.2025.06.030","DOIUrl":"10.1016/j.jacc.2025.06.030","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"86 6","pages":"Pages 423-425"},"PeriodicalIF":22.3,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144766506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Structure, Function, and Outcomes in Transthyretin Amyloid Cardiomyopathy 转甲状腺素淀粉样蛋白心肌病的结构、功能和预后
IF 22.3 1区 医学
Journal of the American College of Cardiology Pub Date : 2025-08-04 DOI: 10.1016/j.jacc.2025.06.031
Michelle M. Kittleson MD, PhD
{"title":"Structure, Function, and Outcomes in Transthyretin Amyloid Cardiomyopathy","authors":"Michelle M. Kittleson MD, PhD","doi":"10.1016/j.jacc.2025.06.031","DOIUrl":"10.1016/j.jacc.2025.06.031","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"86 6","pages":"Pages 456-458"},"PeriodicalIF":22.3,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144766509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Switching Anticoagulants and Managing Complexity in Frail Patients With Atrial Fibrillation 体弱心房颤动患者的抗凝药物转换和复杂性管理
IF 22.3 1区 医学
Journal of the American College of Cardiology Pub Date : 2025-08-04 DOI: 10.1016/j.jacc.2025.06.020
Giulio Francesco Romiti MD, PhD , Gregory Y.H. Lip MD
{"title":"Switching Anticoagulants and Managing Complexity in Frail Patients With Atrial Fibrillation","authors":"Giulio Francesco Romiti MD, PhD ,&nbsp;Gregory Y.H. Lip MD","doi":"10.1016/j.jacc.2025.06.020","DOIUrl":"10.1016/j.jacc.2025.06.020","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"86 6","pages":"Pages 440-443"},"PeriodicalIF":22.3,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144767210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Using Compression Stockings to Prevent Recurrence of Vasovagal Syncope 加压长袜预防血管迷走神经性晕厥复发
IF 22.3 1区 医学
Journal of the American College of Cardiology Pub Date : 2025-08-04 DOI: 10.1016/j.jacc.2025.05.049
Hamed Tavolinejad MD , Ali Bozorgi MD , Zahra Emkanjoo MD , Alireza Oraii MD , Javad Shahabi MD , Reza Mollazadeh MD , Mohamadreza Kiarsi MD , Somayeh Yadangi MSc , Mohammadreza Babaei MD , Saeed Oraii MD , Kaveh Hosseini MD, MPH , Saeed Sadeghian MD , Mostafa Zadkamali MD , Amin Mohsenzadeh MSc , Farshid Alaeddini MD, PhD , Satish R. Raj MD, MSCI , Artur Fedorowski MD, PhD , Masih Tajdini MD
{"title":"Using Compression Stockings to Prevent Recurrence of Vasovagal Syncope","authors":"Hamed Tavolinejad MD ,&nbsp;Ali Bozorgi MD ,&nbsp;Zahra Emkanjoo MD ,&nbsp;Alireza Oraii MD ,&nbsp;Javad Shahabi MD ,&nbsp;Reza Mollazadeh MD ,&nbsp;Mohamadreza Kiarsi MD ,&nbsp;Somayeh Yadangi MSc ,&nbsp;Mohammadreza Babaei MD ,&nbsp;Saeed Oraii MD ,&nbsp;Kaveh Hosseini MD, MPH ,&nbsp;Saeed Sadeghian MD ,&nbsp;Mostafa Zadkamali MD ,&nbsp;Amin Mohsenzadeh MSc ,&nbsp;Farshid Alaeddini MD, PhD ,&nbsp;Satish R. Raj MD, MSCI ,&nbsp;Artur Fedorowski MD, PhD ,&nbsp;Masih Tajdini MD","doi":"10.1016/j.jacc.2025.05.049","DOIUrl":"10.1016/j.jacc.2025.05.049","url":null,"abstract":"<div><h3>Background</h3><div>Vasovagal syncope (VVS) is a common yet challenging condition with limited effective treatments. Elastic compression stockings (ECS) have been proposed as a potential therapy, but their real-world effectiveness remains unclear.</div></div><div><h3>Objectives</h3><div>This study sought to compare the effectiveness of lower extremity compression with thigh-high ECS vs sham stockings for the prevention of VVS recurrence.</div></div><div><h3>Methods</h3><div>This multicenter, parallel, blinded, randomized sham-controlled trial enrolled adults 18 to 65 years of age with ≥2 VVS episodes in the past year. Participants were randomized 1:1 to receive either thigh-length, open-toe active ECS (25-30 mm Hg pressure to the leg), or identical-looking sham ECS (≤10 mm Hg pressure). All participants received standard care (education and lifestyle modifications) but no medications for preventing VVS recurrence. ECS adherence was tracked using diary booklets. The coprimary outcomes were: 1) the proportion of participants with ≥1 VVS recurrence; and 2) the time to first VVS recurrence (ie, VVS-free survival).</div></div><div><h3>Results</h3><div>Among 266 participants (mean age 39 years, 58% female), during 12 months of follow-up, VVS recurred in 29.1% (n = 39 of 134) of participants in the treatment group and 34.8% (n = 46 of 132) in the control group (absolute risk reduction: 5.7%; <em>P</em> = 0.315). VVS-free survival was not significantly different (HR: 0.81; 95% CI: 0.53-1.24; <em>P</em> = 0.333). ECS adherence was suboptimal, with discontinuation rates of 37.3% in the treatment arm vs 34.8% in the sham arm. Discontinuation rates, duration of using ECS, and adherence rates were similar between treatment groups. The median number of recurrent episodes was similar (treatment: 2.5 vs sham: 2; <em>P</em> = 0.839). However, significantly fewer VVS episodes occurred while actively wearing ECS (32.7% vs 45.1%; <em>P</em> = 0.024).</div></div><div><h3>Conclusions</h3><div>Treating syncope with thigh-high lower limb compression using ECS did not reduce the cumulative incidence of VVS recurrence, and did not change VVS-free survival. Additionally, ECS did not reduce the frequency of multiple VVS episodes. The results do not support routine use of thigh-length ECS, although it may be helpful for selected patients when added to standard care. Because our study specifically tested thigh-high ECS, future studies should aim to assess the effectiveness of more extensive compression targeting pelvic and abdominal venous pooling.</div></div>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"86 6","pages":"Pages 412-422"},"PeriodicalIF":22.3,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144766505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Effects of Vutrisiran on Cardiac Function and Outcomes in Patients With Transthyretin Amyloidosis With Cardiomyopathy 伏曲西兰对转甲状腺素淀粉样变合并心肌病患者心功能及预后的影响
IF 22.3 1区 医学
Journal of the American College of Cardiology Pub Date : 2025-08-04 DOI: 10.1016/j.jacc.2025.06.022
Karola S. Jering MD , Marianna Fontana MD, PhD , Hicham Skali MD, MSc , Bernard E. Bulwer MD , Narayana Prasad MD , Farideh Roshanali MD , Olivier Lairez MD, PhD , Simone Longhi MD, PhD , Olga Azevedo MD, PhD , Shaun Bender PhD , Patrick Y. Jay MD, PhD , John Vest MD , Scott D. Solomon MD
{"title":"Effects of Vutrisiran on Cardiac Function and Outcomes in Patients With Transthyretin Amyloidosis With Cardiomyopathy","authors":"Karola S. Jering MD ,&nbsp;Marianna Fontana MD, PhD ,&nbsp;Hicham Skali MD, MSc ,&nbsp;Bernard E. Bulwer MD ,&nbsp;Narayana Prasad MD ,&nbsp;Farideh Roshanali MD ,&nbsp;Olivier Lairez MD, PhD ,&nbsp;Simone Longhi MD, PhD ,&nbsp;Olga Azevedo MD, PhD ,&nbsp;Shaun Bender PhD ,&nbsp;Patrick Y. Jay MD, PhD ,&nbsp;John Vest MD ,&nbsp;Scott D. Solomon MD","doi":"10.1016/j.jacc.2025.06.022","DOIUrl":"10.1016/j.jacc.2025.06.022","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;Transthyretin amyloid cardiomyopathy (ATTR-CM), caused by deposition of transthyretin amyloid fibrils in the heart, is associated with high morbidity and mortality. In HELIOS-B (A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy), the RNA interference therapeutic agent vutrisiran reduced rates of the primary composite outcome of all-cause death and recurrent cardiovascular events among patients with ATTR-CM and had beneficial effects on cardiac structure and function over 30 months.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objectives&lt;/h3&gt;&lt;div&gt;The purpose of this study was to investigate associations of echocardiographic measures of cardiac structure and function with the primary outcome and to assess whether favorable changes in cardiac structure and function with vutrisiran were associated with improvements in outcomes.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;HELIOS-B randomized 655 patients with ATTR-CM to vutrisiran (25 mg subcutaneously every 12 weeks) or placebo. Echocardiograms were performed at baseline and months 12, 18, 24, and 30. Associations of baseline echocardiographic parameters with the primary outcome were analyzed using modified Andersen-Gill models adjusted for age, sex, ATTR disease type, and National Amyloidosis Centre stage, and stratified by baseline tafamidis use and treatment assignment. Changes in cardiac function from baseline to month 18 were compared between treatment arms and related to outcomes in landmark analyses.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;Among the 654 participants with available echocardiographic data (median age 77 years, 93% male, 88% wild-type transthyretin), baseline left and right ventricular systolic and diastolic function were independently associated with the primary outcome (HR per unit increase, left ventricular ejection fraction, 0.90 per 5% increase, 95% CI: 0.86-0.95; absolute global longitudinal strain, 0.92 per 1% increase, 95% CI: 0.89-0.96; tricuspid annular systolic myocardial velocity, 0.94 per 1-cm/s increase, 95% CI: 0.90-0.98; average E/e’, 1.03 per 1-U increase, 95% CI: 1.01-1.04). At 18 months, vutrisiran attenuated declines in left ventricular and right ventricular systolic function (least squares mean difference: left ventricular ejection fraction, 1.6%, 95% CI: 0.1-3.2; absolute global longitudinal strain, 0.7%, 95% CI: 0.3-1.2; tricuspid annular systolic myocardial velocity, 0.5 cm/s, 95% CI: 0.1-0.9). Worsening in these parameters at 18 months was associated with a heightened risk of the primary outcome.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;&lt;div&gt;Echocardiographic measures of biventricular systolic and diastolic function provide important prognostic information beyond National Amyloidosis Centre stage in patients with ATTR-CM. Vutrisiran improved diastolic function and attenuated declines in left ventricular and right ventricular systolic function over 18 months. The benefits on cardiac function with vutrisiran may partly under","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"86 6","pages":"Pages 444-455"},"PeriodicalIF":22.3,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144766508","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Outcomes in Older Patients After Switching to a Newer Anticoagulant or Remaining on Warfarin 老年患者改用新型抗凝剂或继续使用华法林后的预后
IF 22.3 1区 医学
Journal of the American College of Cardiology Pub Date : 2025-08-04 DOI: 10.1016/j.jacc.2025.05.060
Andre M. Nicolau MD , Robert P. Giugliano MD, SM , Andre Zimerman MD, PhD , Jonathan Afilalo MD, MSc , Baris Gencer MD, MPH , Jan Steffel MD , Michael G. Palazzolo MS , John W. Eikelboom MBBS , Christopher B. Granger MD , Manesh R. Patel MD , Renato D. Lopes MD, PhD , Bernard J. Gersh MD , Belal Suleiman MD , Joris R. de Groot MD , Mauricio I. Scanavacca MD , Christian T. Ruff MD, MPH , Elliott M. Antman MD , Eugene Braunwald MD , Lars Wallentin MD
{"title":"Outcomes in Older Patients After Switching to a Newer Anticoagulant or Remaining on Warfarin","authors":"Andre M. Nicolau MD ,&nbsp;Robert P. Giugliano MD, SM ,&nbsp;Andre Zimerman MD, PhD ,&nbsp;Jonathan Afilalo MD, MSc ,&nbsp;Baris Gencer MD, MPH ,&nbsp;Jan Steffel MD ,&nbsp;Michael G. Palazzolo MS ,&nbsp;John W. Eikelboom MBBS ,&nbsp;Christopher B. Granger MD ,&nbsp;Manesh R. Patel MD ,&nbsp;Renato D. Lopes MD, PhD ,&nbsp;Bernard J. Gersh MD ,&nbsp;Belal Suleiman MD ,&nbsp;Joris R. de Groot MD ,&nbsp;Mauricio I. Scanavacca MD ,&nbsp;Christian T. Ruff MD, MPH ,&nbsp;Elliott M. Antman MD ,&nbsp;Eugene Braunwald MD ,&nbsp;Lars Wallentin MD","doi":"10.1016/j.jacc.2025.05.060","DOIUrl":"10.1016/j.jacc.2025.05.060","url":null,"abstract":"<div><h3>Background</h3><div>Whether frail, elderly patients with atrial fibrillation (AF) on a vitamin K antagonist (VKA) should switch to a direct-acting oral anticoagulant (DOAC) was studied in the FRAIL-AF trial and remains controversial.</div></div><div><h3>Objectives</h3><div>The purpose of this study was to evaluate, in the COMBINE-AF data set, the impact on clinical outcomes of switching frail, elderly AF patients from VKA to DOAC.</div></div><div><h3>Methods</h3><div>COMBINE-AF consists of individual patient-level data from 71,683 patients with AF in 4 randomized clinical trials comparing DOAC vs warfarin. Frailty was evaluated using a frailty index derived from a modified Rockwood’s Accumulation Model including 18 age-related conditions. Patients with a frailty index score above the median were considered frail. Prespecified outcomes were stroke or systemic embolic events, bleeding events, death, and a net clinical outcome combining these events.</div></div><div><h3>Results</h3><div>We identified 5,913 patients who were frail, elderly (age ≥75 years), and VKA-experienced and 52,721 patients who did not meet all 3 of these criteria. Patients were randomized to a standard-dose (SD) DOAC or warfarin. After 27 months median follow-up, there was no heterogeneity in treatment effect with SD-DOAC vs warfarin among those who met all 3 criteria vs those who did not for the endpoints of stroke or systemic embolic events (HR: 0.83 vs 0.81; <em>P</em><sub><em>int</em></sub> = 0.75) or for death (HR: 0.95 vs 0.91; <em>P</em><sub><em>int</em></sub> = 0.54). Major bleeding was similar with SD-DOAC vs warfarin in frail, elderly, VKA-experienced patients (HR: 1.06 [95% CI: 0.90-1.25]), while it was significantly reduced with SD-DOAC in patients without all 3 criteria (HR: 0.82 [95% CI: 0.76-0.89]; <em>P</em><sub><em>int</em></sub> = 0.007). Likewise, the net clinical outcome was similar in the frail, elderly, VKA-experienced patients with SD-DOAC vs warfarin (HR: 1.01 [95% CI: 0.91-1.13]), while significantly reduced with SD-DOAC patients without all 3 criteria (HR: 0.89 [95% CI: 0.85-0.93]; <em>P</em><sub><em>int</em></sub> = 0.028). Fatal and intracranial bleeding were significantly reduced with SD-DOAC in both subgroups to a similar degree (both <em>P</em><sub><em>int</em></sub> &gt; 0.05), while gastrointestinal bleeding with SD-DOAC was increased to a greater degree in frail, elderly, VKA-experienced patients (HR: 1.83 [95% CI: 1.42-2.36]) compared with those without all 3 criteria (HR: 1.23 [95% CI: 1.09-1.39]; <em>P</em><sub><em>int</em></sub> = 0.006).</div></div><div><h3>Conclusions</h3><div>Frail, elderly, VKA-experienced patients with AF switched to SD-DOAC experienced significant reductions in stroke or systemic embolism, fatal and intracranial bleeding, and death. Gastrointestinal bleeding was increased with SD-DOAC, while major bleeding and the primary net clinical outcome were similar. Based on these findings, SD-DOAC is a reasonable choi","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"86 6","pages":"Pages 426-439"},"PeriodicalIF":22.3,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144766507","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
A Breakthrough With a Burden 有负担的突破
IF 22.3 1区 医学
Journal of the American College of Cardiology Pub Date : 2025-08-04 DOI: 10.1016/j.jacc.2025.07.001
Harlan M. Krumholz MD, SM, FACC, FAHA (Editor-in-Chief, JACC; Harold H. Hines, Jr Professor), Michelle M. Kittleson MD, PhD, Kushal T. Kadakia MD, MSc
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