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Alternative LDL Cholesterol-Lowering Strategy vs High-Intensity Statins in Atherosclerotic Cardiovascular Disease: A Systematic Review and Individual Patient Data Meta-Analysis. 动脉粥样硬化性心血管疾病中的替代性低密度脂蛋白胆固醇降低策略与高强度他汀类药物:系统回顾与个体患者数据元分析》。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-20 DOI: 10.1001/jamacardio.2024.3911
Yong-Joon Lee, Bum-Kee Hong, Kyeong Ho Yun, Woong Chol Kang, Soon Jun Hong, Sang-Hyup Lee, Seung-Jun Lee, Sung-Jin Hong, Chul-Min Ahn, Jung-Sun Kim, Byeong-Keuk Kim, Young-Guk Ko, Donghoon Choi, Yangsoo Jang, Myeong-Ki Hong
<p><strong>Importance: </strong>In patients with atherosclerotic cardiovascular disease (ASCVD), intensive lowering of low-density lipoprotein (LDL) cholesterol levels with high-intensity statins is generally recommended. However, alternative approaches considering statin-related adverse effects and intolerance are needed.</p><p><strong>Objective: </strong>To compare the long-term efficacy and safety of an alternative LDL cholesterol-lowering strategy vs high-intensity statin strategy in patients with ASCVD in randomized clinical trials.</p><p><strong>Data sources: </strong>PubMed, Embase, and other websites (ClinicalTrials.gov, European Society of Cardiology, tctMD) were systematically searched from inception to April 19, 2024.</p><p><strong>Study selection: </strong>Randomized clinical trials comparing an alternative LDL cholesterol-lowering strategy vs a high-intensity statin strategy in patients with ASCVD, with presence of cardiovascular events as end points.</p><p><strong>Data extraction and synthesis: </strong>Individual patient data were obtained from randomized clinical trials that met the prespecified eligibility criteria: RACING (Randomized Comparison of Efficacy and Safety of Lipid-Lowering With Statin Monotherapy vs Statin/Ezetimibe Combination for High-Risk Cardiovascular Disease) and LODESTAR (Low-Density Lipoprotein Cholesterol-Targeting Statin Therapy vs Intensity-Based Statin Therapy in Patients With Coronary Artery Disease). The moderate-intensity statin with ezetimibe combination therapy in the RACING trial and the treat-to-target strategy in the LODESTAR trial were classified as alternative LDL cholesterol-lowering strategies. The primary analysis was based on a 1-stage approach.</p><p><strong>Main outcomes and measures: </strong>The primary end point was a 3-year composite of all-cause death, myocardial infarction, stroke, or coronary revascularization. The secondary end points comprised clinical efficacy and safety end points.</p><p><strong>Results: </strong>Individual patient data from 2 trials including 8180 patients with ASCVD (mean [SD] age, 64.5 [9.8] years; 2182 [26.7%] female; 5998 male [73.3%]) were analyzed. The rate of the primary end point did not differ between the alternative strategy and high-intensity statin strategy groups (7.5% [304 of 4094] vs 7.7% [310 of 4086]; hazard ratio, 0.98; 95% CI, 0.84-1.15; P = .82). The mean (SD) LDL cholesterol level during treatment was 64.8 (19.0) mg/dL in the alternative strategy group and 68.5 (20.7) mg/dL in the high-intensity statin strategy group (P < .001). The alternative strategy group had a lower rate of new-onset diabetes (10.2% [271 of 2658] vs 11.9% [316 of 2656]; P = .047), initiation of antidiabetic medication for new-onset diabetes (6.5% [173 of 2658] vs 8.2% [217 of 2656]; P = .02), and intolerance-related discontinuation or dose reduction of assigned therapy (4.0% [163 of 4094] vs 6.7% [273 of 4086]; P < .001).</p><p><strong>Conclusions and relevance: </stro
重要性:对于动脉粥样硬化性心血管疾病(ASCVD)患者,一般建议使用高强度他汀类药物强化降低低密度脂蛋白(LDL)胆固醇水平。然而,考虑到他汀类药物相关的不良反应和不耐受性,还需要其他方法:在随机临床试验中,比较另一种降低低密度脂蛋白胆固醇策略与高强度他汀类药物策略对 ASCVD 患者的长期疗效和安全性:对PubMed、Embase和其他网站(ClinicalTrials.gov、欧洲心脏病学会、tctMD)从开始到2024年4月19日的数据进行了系统检索:随机临床试验:比较ASCVD患者的替代性低密度脂蛋白胆固醇降低策略与高强度他汀类药物策略,以是否发生心血管事件为终点:患者个体数据来自符合预设资格标准的随机临床试验:RACING(他汀单药降脂与他汀/依折麦布联合治疗高危心血管疾病的疗效和安全性随机比较)和LODESTAR(冠心病患者低密度脂蛋白胆固醇靶向他汀疗法与基于强度的他汀疗法)。RACING试验中的中等强度他汀与依折麦布联合疗法和LODESTAR试验中的靶向治疗策略被列为替代性低密度脂蛋白胆固醇降低策略。主要分析采用1阶段方法:主要终点是全因死亡、心肌梗死、中风或冠状动脉血运重建的3年复合终点。次要终点包括临床疗效和安全性终点:分析了两项试验中 8180 名 ASCVD 患者(平均 [SD] 年龄 64.5 [9.8] 岁;女性 2182 [26.7%];男性 5998 [73.3%])的个体数据。替代策略组和高强度他汀策略组的主要终点发生率没有差异(7.5% [4094 例中的 304 例] vs 7.7% [4086 例中的 310 例];危险比,0.98;95% CI,0.84-1.15;P = .82)。替代策略组治疗期间的平均(标清)低密度脂蛋白胆固醇水平为 64.8 (19.0) mg/dL,高强度他汀策略组为 68.5 (20.7) mg/dL(P 结论及意义:这项系统回顾和个体患者数据荟萃分析的结果表明,与高强度他汀类药物策略相比,替代性降低低密度脂蛋白胆固醇策略在ASCVD患者3年死亡或心血管事件方面的疗效相当,同时可降低低密度脂蛋白胆固醇水平以及新发糖尿病和不耐受风险:研究注册:PREMCOCRD42024532550。
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引用次数: 0
Palpitations After Transcatheter Atrial Septal Defect Closure. 经导管房室隔缺损闭合术后的心悸。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-20 DOI: 10.1001/jamacardio.2024.4124
Goran Medimurec, Željko Ðuric, Irena Ivanac Vranešic
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引用次数: 0
Semaglutide Eligibility Across All Current Indications for US Adults. 塞马鲁肽在美国成年人中的所有现有适应症资格。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-18 DOI: 10.1001/jamacardio.2024.4657
Ivy Shi, Sadiya S Khan, Robert W Yeh, Jennifer E Ho, Issa J Dahabreh, Dhruv S Kazi
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引用次数: 0
Early Adoption of Sodium-Glucose Cotransporter-2 Inhibitor in Patients Hospitalized With Heart Failure With Mildly Reduced or Preserved Ejection Fraction. 在射血分数轻度降低或保留的心力衰竭住院患者中尽早使用钠-葡萄糖共转运体-2 抑制剂。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-18 DOI: 10.1001/jamacardio.2024.4489
Mohammad Abdel Jawad, John A Spertus, Uchechukwu Ikeaba, Stephen J Greene, Gregg C Fonarow, Karen Chiswell, Paul S Chan

Importance: Sodium-glucose cotransporter-2 inhibitors (SGLT2is) are the first therapy shown to improve clinical outcomes for patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) greater than 40%. Nationwide adoption of SGLT2is in the US since publication of the Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction (EMPEROR-Preserved) in August 2021 is unknown.

Objective: To examine trends and hospital-level variation in SGLT2i adoption.

Design, setting, and participants: This cohort study included patients with LVEF greater than 40% who were hospitalized for decompensated HF at 1 of 557 sites in the US between July 1, 2021, and September 30, 2023, from the Get With The Guidelines-Heart Failure registry.

Main outcomes and measures: Patient-level trends and site-level variation in prescription rates of SGLT2i at hospital discharge. Site-level variation was quantified using the median odds ratio, which describes the average odds that a patient being treated at one vs another randomly selected hospital would receive SGLT2i therapy at discharge.

Results: Of 158 849 patients (median [IQR] age, 76 [66-85] years; 89 816 females [56.5%]), 22 126 eligible patients (13.9%) with HF and an LVEF greater than 40% were prescribed an SGLT2i at hospital discharge. Quarterly prescription rates increased from 4.2% in July to September 2021 to 23.5% in July to September 2023 (P for trend < .001). SGLT2i prescription was more likely among patients with HF with mildly reduced LVEF (41%-49%) than in those with preserved LVEF (≥50%; 5127 of 27 712 patients [18.5%] vs 16 999 of 131 137 patients [13.0%]; absolute standardized difference, 16.7%). After adjustment for patient characteristics, there was a high variance between hospitals in the rate of SGLT2i prescription (median odds ratio, 2.12; 95% CI, 2.02-2.25). Among 518 hospitals with 10 or more eligible discharges, 11 hospitals (2.1%) discharged 50% or more of their patients with an SGLT2i prescription, while 232 (44.8%) discharged fewer than 10% of eligible patients with an SGLT2i prescription.

Conclusion and relevance: For patients with HF and an LVEF greater than 40%, discharge prescription of SGLT2is increased from 4.2% to 23.5% during the first 2 years after the EMPEROR-Preserved trial demonstrating treatment benefits; however, these rates varied across US hospitals.

重要性:钠-葡萄糖共转运体-2抑制剂(SGLT2is)是第一种被证明可改善左心室射血分数(LVEF)大于40%的心力衰竭(HF)患者临床疗效的疗法。自 2021 年 8 月发表 Empagliflozin Outcome Trial in Patients With Preserved Ejection Fraction(EMPEROR-Preserved)慢性心衰患者射血分数保留率试验以来,SGLT2is 在美国全国范围内的应用情况尚不清楚:研究采用 SGLT2i 的趋势和医院层面的差异:这项队列研究纳入了 2021 年 7 月 1 日至 2023 年 9 月 30 日期间在美国 557 个地点中的一个地点因失代偿性心力衰竭住院的 LVEF 大于 40% 的患者,这些患者来自 "Get With The Guidelines-Heart Failure "登记处:出院时 SGLT2i 处方率在患者层面的趋势和地点层面的变化。使用中位数几率比来量化医院层面的差异,中位数几率比描述了在一家医院接受治疗的患者与在另一家随机选择的医院接受治疗的患者在出院时接受 SGLT2i 治疗的平均几率:在 158 849 名患者(中位数[IQR]年龄为 76 [66-85] 岁;89 816 名女性[56.5%])中,22 126 名符合条件的 HF 患者(13.9%)在出院时接受了 SGLT2i 治疗。季度处方率从 2021 年 7 月至 9 月的 4.2% 增加到 2023 年 7 月至 9 月的 23.5%(P 为趋势结论和相关性):对于 LVEF 超过 40% 的心房颤动患者,在 EMPEROR-Preserved 试验证明治疗效果后的头两年,出院时 SGLT2i 的处方率从 4.2% 增加到 23.5%;然而,美国各家医院的处方率各不相同。
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引用次数: 0
Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Secondary Analysis of the FINEARTS-HF Randomized Clinical Trial. 非格列酮治疗射血分数轻度降低或保留的女性和男性心力衰竭患者:FINEARTS-HF随机临床试验的二次分析。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-17 DOI: 10.1001/jamacardio.2024.4613
Misato Chimura, Xiaowen Wang, Pardeep S Jhund, Alasdair D Henderson, Brian L Claggett, Akshay S Desai, Cândida Fonseca, Eva Goncalvesova, Tzvetana Katova, Katharina Mueller, Andrea Glasauer, Katja Rohwedder, Prabhakar Viswanathan, Savina Nodari, Carolyn S P Lam, Clara Inés Saldarriaga, Michele Senni, Kavita Sharma, Adriaan A Voors, Faiez Zannad, Bertram Pitt, Orly Vardeny, Muthiah Vaduganathan, Scott D Solomon, John J V McMurray

Importance: Sex is associated with the clinical presentation, outcomes, and response to treatment in patients with heart failure (HF). However, little is known about the safety and efficacy of treatment with finerenone according to sex.

Objective: To estimate the efficacy and safety of finerenone compared with placebo in both women and men.

Design, setting, and participants: Prespecified analyses were conducted in the phase 3 randomized clinical trial Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure (FINEARTS-HF). The trial was conducted across 653 sites in 37 countries. Participants were adults aged 40 years and older with symptomatic HF and left ventricular ejection fraction (LVEF) of 40% or greater randomized between September 2020 and January 2023.

Intervention: Finerenone (titrated to 20 mg or 40 mg) or placebo.

Main outcomes and measures: The primary outcome was a composite of cardiovascular death and total (first and recurrent) HF events (unplanned HF hospitalizations or urgent HF visits).

Results: A total of 6001 patients were randomized in FINEARTS-HF, of whom 2732 were women (45.5%), with a mean (SD) age of 73.6 (9.1) years. Women had higher rates of any obesity, higher LVEF (54.6 [7.6%] vs 50.9 [7.6] for men), lower mean (SD) estimated glomerular filtration rate than men (59.7 [19.1] vs 64.1 [20.0] for men; P<.001) , worse New York Heart Association functional class, and lower Kansas City Cardiomyopathy Questionnaire-Total Symptom Scores (KCCQ-TSS) (mean [SD] 62.3 [24.0] vs 71.0 [23.1]). The incident rate of the primary outcome was slightly lower in women (15.7; 95% CI, 14.3-17.3) than in men (16.8; 95% CI, 15.4-18.3) per 100 person-years. Compared with placebo, finerenone reduced the risk of the primary end point similarly in women and men: rate ratio 0.78 (95% CI, 0.65-0.95) in women and 0.88 (95% CI, 0.74-1.04) in men (P = .41 for interaction). Consistent effects were observed for the components of the primary outcome and all-cause mortality. The mean increase (improvement) in KCCQ-TSS from baseline to 12 months was greater with finerenone, regardless of sex (P = .73 for interaction). Finerenone had similar tolerability in women and men.

Conclusions and relevance: In FINEARTS-HF, finerenone reduced the risk of the primary end point similarly in women and men with heart failure with mildly reduced or preserved ejection fraction. Finerenone had similar tolerability in women and men.

Trial registration: ClinicalTrials.gov Identifier: NCT04435626.

重要性:性别与心力衰竭(HF)患者的临床表现、预后和对治疗的反应有关。然而,人们对根据性别使用非格列酮治疗的安全性和有效性知之甚少:目的:评估非格列酮与安慰剂相比对女性和男性的疗效和安全性:在心力衰竭患者非奈酮疗效和安全性优于安慰剂的3期随机临床试验(FINEARTS-HF)中进行了预设分析。该试验在 37 个国家的 653 个地点进行。参与者为年龄在40岁及以上、患有症状性心力衰竭且左心室射血分数(LVEF)大于或等于40%的成年人,在2020年9月至2023年1月期间进行随机分组:非格列酮(滴定至 20 毫克或 40 毫克)或安慰剂:主要结果和测量指标:主要结果是心血管死亡和全部(首次和复发)HF事件(非计划性HF住院或紧急HF就诊)的复合结果:FINEARTS-HF共有6001名患者接受了随机治疗,其中2732人为女性(45.5%),平均(标清)年龄为73.6(9.1)岁。女性肥胖率较高,LVEF(54.6 [7.6%] vs 50.9 [7.6])较高,估计肾小球滤过率的平均值(标度)低于男性(59.7 [19.1] vs 64.1 [20.0];结论与意义:在FINEARTS-HF中,非格列酮能降低射血分数轻度降低或保留的女性和男性心力衰竭患者的主要终点风险。非格列酮对女性和男性的耐受性相似:试验注册:ClinicalTrials.gov Identifier:试验注册:ClinicalTrials.gov Identifier:NCT04435626。
{"title":"Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Secondary Analysis of the FINEARTS-HF Randomized Clinical Trial.","authors":"Misato Chimura, Xiaowen Wang, Pardeep S Jhund, Alasdair D Henderson, Brian L Claggett, Akshay S Desai, Cândida Fonseca, Eva Goncalvesova, Tzvetana Katova, Katharina Mueller, Andrea Glasauer, Katja Rohwedder, Prabhakar Viswanathan, Savina Nodari, Carolyn S P Lam, Clara Inés Saldarriaga, Michele Senni, Kavita Sharma, Adriaan A Voors, Faiez Zannad, Bertram Pitt, Orly Vardeny, Muthiah Vaduganathan, Scott D Solomon, John J V McMurray","doi":"10.1001/jamacardio.2024.4613","DOIUrl":"10.1001/jamacardio.2024.4613","url":null,"abstract":"<p><strong>Importance: </strong>Sex is associated with the clinical presentation, outcomes, and response to treatment in patients with heart failure (HF). However, little is known about the safety and efficacy of treatment with finerenone according to sex.</p><p><strong>Objective: </strong>To estimate the efficacy and safety of finerenone compared with placebo in both women and men.</p><p><strong>Design, setting, and participants: </strong>Prespecified analyses were conducted in the phase 3 randomized clinical trial Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure (FINEARTS-HF). The trial was conducted across 653 sites in 37 countries. Participants were adults aged 40 years and older with symptomatic HF and left ventricular ejection fraction (LVEF) of 40% or greater randomized between September 2020 and January 2023.</p><p><strong>Intervention: </strong>Finerenone (titrated to 20 mg or 40 mg) or placebo.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was a composite of cardiovascular death and total (first and recurrent) HF events (unplanned HF hospitalizations or urgent HF visits).</p><p><strong>Results: </strong>A total of 6001 patients were randomized in FINEARTS-HF, of whom 2732 were women (45.5%), with a mean (SD) age of 73.6 (9.1) years. Women had higher rates of any obesity, higher LVEF (54.6 [7.6%] vs 50.9 [7.6] for men), lower mean (SD) estimated glomerular filtration rate than men (59.7 [19.1] vs 64.1 [20.0] for men; P<.001) , worse New York Heart Association functional class, and lower Kansas City Cardiomyopathy Questionnaire-Total Symptom Scores (KCCQ-TSS) (mean [SD] 62.3 [24.0] vs 71.0 [23.1]). The incident rate of the primary outcome was slightly lower in women (15.7; 95% CI, 14.3-17.3) than in men (16.8; 95% CI, 15.4-18.3) per 100 person-years. Compared with placebo, finerenone reduced the risk of the primary end point similarly in women and men: rate ratio 0.78 (95% CI, 0.65-0.95) in women and 0.88 (95% CI, 0.74-1.04) in men (P = .41 for interaction). Consistent effects were observed for the components of the primary outcome and all-cause mortality. The mean increase (improvement) in KCCQ-TSS from baseline to 12 months was greater with finerenone, regardless of sex (P = .73 for interaction). Finerenone had similar tolerability in women and men.</p><p><strong>Conclusions and relevance: </strong>In FINEARTS-HF, finerenone reduced the risk of the primary end point similarly in women and men with heart failure with mildly reduced or preserved ejection fraction. Finerenone had similar tolerability in women and men.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04435626.</p>","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":""},"PeriodicalIF":14.8,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11571069/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Power of Digital Nudges to Boost Influenza Vaccination Rates. 利用数字提示提高流感疫苗接种率。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-17 DOI: 10.1001/jamacardio.2024.4692
Mohammad Madjid, Payam Safavi-Naeini
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引用次数: 0
Electronic Nudges and Influenza Vaccination Among Patients With a History of Myocardial Infarction: Insights From 3 Nationwide Randomized Clinical Trials. 心肌梗死病史患者的电子提示和流感疫苗接种:三项全国性随机临床试验的启示。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-17 DOI: 10.1001/jamacardio.2024.4648
Ankeet S Bhatt, Niklas Dyrby Johansen, Muthiah Vaduganathan, Daniel Modin, Manan Pareek, Safia Chatur, Brian L Claggett, Kira Hyldekær Janstrup, Carsten Schade Larsen, Lykke Larsen, Lothar Wiese, Michael Dalager-Pedersen, Erica L Dueger, Sandrine Samson, Matthew M Loiacono, Rebecca C Harris, Lars Køber, Scott D Solomon, Cyril Jean-Marie Martel, Pradeesh Sivapalan, Jens Ulrik Stæhr Jensen, Tor Biering-Sørensen
<p><strong>Importance: </strong>Influenza vaccination in patients with acute myocardial infarction (AMI) reduces major adverse cardiac events and is strongly recommended in clinical practice guidelines. Effective strategies to improve vaccination are needed in these high-risk patients.</p><p><strong>Objective: </strong>To evaluate whether electronically delivered behavioral nudges improve influenza vaccine uptake in patients with AMI across 3 nationwide implementation randomized clinical trials (RCTs).</p><p><strong>Design, setting, and participants: </strong>Nationwide Utilization of Danish Government Electronic Letter System for Increasing Influenza Vaccine Uptake (NUDGE-FLU), Nationwide Utilization of Danish Government Electronic Letter System for Confirming the Effectiveness of Behavioral Nudges in Increasing Influenza Vaccine Uptake Among Older Adults (NUDGE-FLU-2), and Nationwide Utilization of Danish Government Electronic Letter System for Increasing Influenza Vaccine Uptake Among Adults With Chronic Disease (NUDGE-FLU-CHRONIC) were RCTs conducted during the 2022 to 2023 and 2023 to 2024 influenza seasons in Denmark. Participants were randomized to either usual care or various behaviorally informed, electronically delivered, letter-based nudges. In a prespecified participant-level pooled meta-analysis, interaction of AMI status on the effects of letter-based nudges vs usual care was examined. Pooled treatment effects were estimated using binomial regression models with identity link, adjustment for trial, and 2-way clustered SEs at the household and participant levels. Effect modification by recency of AMI as a continuous variable was assessed using restricted cubic spline modeling in NUDGE-FLU-CHRONIC.</p><p><strong>Interventions: </strong>Behaviorally informed, electronically delivered, letter-based nudges or usual care.</p><p><strong>Main outcome and measures: </strong>The primary end point was influenza vaccination receipt.</p><p><strong>Results: </strong>Of 2 146 124 individual randomizations (mean [SD] age, 71.1 [11.6] years; 1 114 725 female [51.9%]) across all 3 trials, 59 458 (2.8%) had a history of AMI. Improvement in vaccine uptake was similar in patients with vs without a history of AMI who received any nudge letter compared with usual care (+1.81 vs +1.32 percentage points; P for interaction by AMI status = .09). A letter highlighting the cardiovascular benefits of vaccination (ie, cardiovascular-gain frame) resulted in larger improvements in vaccine uptake among patients with (vs without) a history of AMI (+3.91 vs +2.03 percentage points; P for interaction by AMI status = .002). Among patients with AMI, the benefits of the cardiovascular-gain frame letter were more pronounced in those not vaccinated in the prior season (+13.7 vs +1.48 percentage points; P for interaction <.001). Among younger participants with chronic disease, the cardiovascular-gain frame letter was particularly effective in patients with more recent AMI (P
重要性:急性心肌梗死(AMI)患者接种流感疫苗可减少重大心脏不良事件的发生,临床实践指南强烈推荐接种流感疫苗。我们需要有效的策略来提高这些高危患者的疫苗接种率:评估在 3 项全国范围内实施的随机临床试验 (RCT) 中,通过电子方式提供的行为指导是否能提高急性心肌梗死患者的流感疫苗接种率:全国范围内利用丹麦政府电子信件系统提高流感疫苗接种率(NUDGE-FLU)、全国范围内利用丹麦政府电子信件系统确认行为引导对提高老年人流感疫苗接种率的效果(NUDGE-FLU-2)以及全国范围内利用丹麦政府电子信件系统提高流感疫苗接种率(NUDGE-FLU-3)、和 "全国范围内利用丹麦政府电子信件系统提高慢性病成人流感疫苗接种率"(NUDGE-FLU-CHRONIC)是在丹麦2022年至2023年和2023年至2024年流感季节期间进行的研究。参与者被随机分配到常规护理或各种行为知情、电子递送、基于信件的劝导。在一项预设的参与者水平汇总荟萃分析中,考察了AMI状态对基于信件的劝导与常规护理效果的交互作用。采用二项回归模型估算汇总治疗效果,该模型具有身份链接、试验调整以及家庭和参与者层面的双向聚类 SE。使用 NUDGE-FLU-CHRONIC 中的限制性立方样条模型评估了作为连续变量的 AMI 复发率对治疗效果的影响:主要结果和测量指标:主要终点是流感疫苗接种率:在所有 3 项试验的 2 146 124 名随机参与者(平均 [SD] 年龄 71.1 [11.6] 岁;1 114 725 名女性 [51.9%])中,59 458 人(2.8%)有 AMI 病史。与常规护理相比,接受任何提示函的有 AMI 病史和无 AMI 病史患者的疫苗接种率提高幅度相似(+1.81 vs +1.32 个百分点;与 AMI 状态交互作用的 P = .09)。一封强调疫苗接种对心血管益处的信件(即心血管增益框架)使有(与没有)急性心肌梗塞病史的患者的疫苗接种率有了更大的提高(+3.91 vs +2.03个百分点;与急性心肌梗塞状态的交互作用P = .002)。在急性心肌梗塞患者中,心血管增益框架信对上一季未接种疫苗的患者的益处更为明显(+13.7 vs +1.48个百分点;P为交互作用结论和相关性:在对丹麦公民进行的 3 项全国性 RCT 研究中,强调接种疫苗对心血管有益的信息提高了流感疫苗的接种率,在有急性心肌梗死病史的患者中观察到更大的益处。应考虑采用这种低成本、可扩展的实施策略来鼓励高危患者接种流感疫苗:试验注册:ClinicalTrials.gov Identifiers:NCT05542004、NCT06030726、NCT06030739。
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引用次数: 0
Sex-Specific Efficacy and Safety in HF Trials: Inclusion Is Only the First Step. 高血压试验中的性别特异性疗效和安全性:纳入只是第一步
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-17 DOI: 10.1001/jamacardio.2024.4624
Sadiya Khan, Clyde W Yancy, Gregg C Fonarow
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引用次数: 0
Finerenone, Serum Potassium, and Clinical Outcomes in Heart Failure With Mildly Reduced or Preserved Ejection Fraction. 射血分数轻度降低或保留的心力衰竭患者的非格列酮、血清钾和临床疗效。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-17 DOI: 10.1001/jamacardio.2024.4539
Orly Vardeny, Muthiah Vaduganathan, Brian L Claggett, Akshay S Desai, Pardeep S Jhund, Carolyn S P Lam, Michele Senni, Sanjiv J Shah, Adriaan A Voors, Faiez Zannad, Bertram Pitt, Shingo Matsumoto, Béla Merkely, Shelley Zieroth, Mehmet Birhan Yilmaz, James Lay-Flurrie, Prabhakar Viswanathan, Andrea Horvat-Broecker, Andrea Scalise, John J V McMurray, Scott D Solomon

Importance: Treatment with finerenone, a nonsteroidal mineralocorticoid receptor antagonist (MRA), improved outcomes in patients with heart failure with mildly reduced or preserved ejection fraction in FINEARTS-HF, but was associated with increased levels of serum potassium in follow-up.

Objective: To investigate the frequency and predictors of serum potassium level greater than 5.5 mmol/L and less than 3.5 mmol/L and examine the treatment effect associated with finerenone, relative to placebo, on clinical outcomes based on postrandomization potassium levels.

Design, setting, and participants: Secondary analysis of the FINEARTS-HF multicenter, randomized clinical trial, performed between September 14, 2020, and January 10, 2023, with a median follow-up of 32 months (final date of follow-up: June 14, 2024). Patients with heart failure and left ventricular ejection fraction greater than or equal to 40%, New York Heart Association class II to IV symptoms, and elevated natriuretic peptides were included.

Intervention: Participants received finerenone or placebo.

Main outcomes and measures: The primary outcome was a composite of total worsening heart failure events or cardiovascular death.

Results: A total of 6001 participants were included (3003 randomized to receive finerenone and 2998 randomized to receive placebo). The increase in serum potassium was greater in the finerenone group than the placebo group at 1 month (median [IQR] difference, 0.19 [0.17-0.21] mmol/L) and 3 months (median [IQR] difference, 0.23 [0.21-0.25] mmol/L), which persisted for the remainder of trial follow-up. Finerenone increased the risks of potassium level increasing to greater than 5.5 mmol/L (hazard ratio [HR], 2.16 [95% CI, 1.83-2.56]; P < .001) and decreased the risks for potassium level decreasing to less than 3.5 mmol/L (HR, 0.46 [95% CI, 0.38-0.56]; P < .001). Both low (< 3.5 mmol/L; HR, 2.49 [95% CI, 1.8-3.43]) and high (>5.5 mmol/L; HR, 1.64 [95% CI, 1.04-2.58]) potassium levels were associated with higher subsequent risks of the primary outcome in both treatment groups. Nevertheless, the risk of the primary outcome was generally lower in patients treated with finerenone compared with placebo, even in those whose potassium level increased to greater than 5.5 mmol/L.

Conclusions and relevance: In patients with heart failure with mildly reduced or preserved ejection fraction, finerenone resulted in more frequent hyperkalemia and less frequent hypokalemia. However, with protocol-directed surveillance and dose adjustment, clinical benefit associated with finerenone relative to placebo was maintained even in those whose potassium level increased to greater than 5.5 mmol/L.

Trial registration: ClinicalTrials.gov Identifier: NCT04435626.

重要性:在FINEARTS-HF研究中,非格列酮(一种非甾体类矿物质皮质激素受体拮抗剂(MRA))可改善射血分数轻度降低或保留的心力衰竭患者的预后,但在随访中与血清钾水平升高有关:调查血清钾水平大于 5.5 mmol/L 和小于 3.5 mmol/L 的频率和预测因素,并根据随机化后的血钾水平,研究非格列酮(相对于安慰剂)对临床预后的治疗效果:2020年9月14日至2023年1月10日期间进行的FINEARTS-HF多中心随机临床试验的二次分析,中位随访时间为32个月(最终随访日期:2024年6月14日)。研究对象包括心力衰竭、左心室射血分数大于或等于40%、纽约心脏协会II级至IV级症状以及钠尿肽升高的患者:干预措施:参与者接受非格列酮或安慰剂治疗:主要结果和测量指标:主要结果是心衰恶化事件总数或心血管死亡的复合结果:共纳入 6001 名参与者(3003 人随机接受非格列酮治疗,2998 人随机接受安慰剂治疗)。在1个月(中位数[IQR]差异为0.19[0.17-0.21]mmol/L)和3个月(中位数[IQR]差异为0.23[0.21-0.25]mmol/L)时,非格列酮组血清钾的升高幅度大于安慰剂组,这种情况在试验随访的剩余时间内持续存在。非格列酮会增加血钾水平升高至大于 5.5 mmol/L 的风险(危险比 [HR],2.16 [95% CI,1.83-2.56];P 5.5 mmol/L;HR,1.64 [95% CI,1.04-2.58]),在两个治疗组中,血钾水平都与较高的主要结局后续风险相关。尽管如此,与安慰剂相比,使用非格列酮治疗的患者发生主要结局的风险普遍较低,即使是血钾水平升高至 5.5 mmol/L 以上的患者也是如此:在射血分数轻度降低或保留的心衰患者中,非格列酮会导致更频繁的高钾血症,而低钾血症的发生率较低。然而,通过方案指导下的监测和剂量调整,即使在血钾水平升高到 5.5 mmol/L 以上的患者中,非格列酮相对于安慰剂的临床益处仍能保持:试验注册:ClinicalTrials.gov Identifier:试验注册:ClinicalTrials.gov Identifier:NCT04435626。
{"title":"Finerenone, Serum Potassium, and Clinical Outcomes in Heart Failure With Mildly Reduced or Preserved Ejection Fraction.","authors":"Orly Vardeny, Muthiah Vaduganathan, Brian L Claggett, Akshay S Desai, Pardeep S Jhund, Carolyn S P Lam, Michele Senni, Sanjiv J Shah, Adriaan A Voors, Faiez Zannad, Bertram Pitt, Shingo Matsumoto, Béla Merkely, Shelley Zieroth, Mehmet Birhan Yilmaz, James Lay-Flurrie, Prabhakar Viswanathan, Andrea Horvat-Broecker, Andrea Scalise, John J V McMurray, Scott D Solomon","doi":"10.1001/jamacardio.2024.4539","DOIUrl":"10.1001/jamacardio.2024.4539","url":null,"abstract":"<p><strong>Importance: </strong>Treatment with finerenone, a nonsteroidal mineralocorticoid receptor antagonist (MRA), improved outcomes in patients with heart failure with mildly reduced or preserved ejection fraction in FINEARTS-HF, but was associated with increased levels of serum potassium in follow-up.</p><p><strong>Objective: </strong>To investigate the frequency and predictors of serum potassium level greater than 5.5 mmol/L and less than 3.5 mmol/L and examine the treatment effect associated with finerenone, relative to placebo, on clinical outcomes based on postrandomization potassium levels.</p><p><strong>Design, setting, and participants: </strong>Secondary analysis of the FINEARTS-HF multicenter, randomized clinical trial, performed between September 14, 2020, and January 10, 2023, with a median follow-up of 32 months (final date of follow-up: June 14, 2024). Patients with heart failure and left ventricular ejection fraction greater than or equal to 40%, New York Heart Association class II to IV symptoms, and elevated natriuretic peptides were included.</p><p><strong>Intervention: </strong>Participants received finerenone or placebo.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was a composite of total worsening heart failure events or cardiovascular death.</p><p><strong>Results: </strong>A total of 6001 participants were included (3003 randomized to receive finerenone and 2998 randomized to receive placebo). The increase in serum potassium was greater in the finerenone group than the placebo group at 1 month (median [IQR] difference, 0.19 [0.17-0.21] mmol/L) and 3 months (median [IQR] difference, 0.23 [0.21-0.25] mmol/L), which persisted for the remainder of trial follow-up. Finerenone increased the risks of potassium level increasing to greater than 5.5 mmol/L (hazard ratio [HR], 2.16 [95% CI, 1.83-2.56]; P < .001) and decreased the risks for potassium level decreasing to less than 3.5 mmol/L (HR, 0.46 [95% CI, 0.38-0.56]; P < .001). Both low (< 3.5 mmol/L; HR, 2.49 [95% CI, 1.8-3.43]) and high (>5.5 mmol/L; HR, 1.64 [95% CI, 1.04-2.58]) potassium levels were associated with higher subsequent risks of the primary outcome in both treatment groups. Nevertheless, the risk of the primary outcome was generally lower in patients treated with finerenone compared with placebo, even in those whose potassium level increased to greater than 5.5 mmol/L.</p><p><strong>Conclusions and relevance: </strong>In patients with heart failure with mildly reduced or preserved ejection fraction, finerenone resulted in more frequent hyperkalemia and less frequent hypokalemia. However, with protocol-directed surveillance and dose adjustment, clinical benefit associated with finerenone relative to placebo was maintained even in those whose potassium level increased to greater than 5.5 mmol/L.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04435626.</p>","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":""},"PeriodicalIF":14.8,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11571067/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644129","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Partial Cardiac Denervation to Prevent Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: The pCAD-POAF Randomized Clinical Trial. 部分心脏去神经化预防冠状动脉旁路移植术后心房颤动:pCAD-POAF 随机临床试验。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-17 DOI: 10.1001/jamacardio.2024.4639
Ziang Yang, Xieraili Tiemuerniyazi, Fei Xu, Yang Wang, Yang Sun, Peng Yan, Liangxin Tian, Chao Han, Yan Zhang, Shiwei Pan, Zhan Hu, Xi Li, Wei Zhao, Wei Feng

Importance: Efficient approaches to prevent postoperative atrial fibrillation (POAF) after coronary artery bypass grafting (CABG) are still needed.

Objective: To investigate whether partial cardiac denervation, achieved by cutting off the ligament of Marshall (LOM) and resecting the fat pad along the Waterston groove, can reduce the risk of POAF following CABG.

Design, setting and participants: This single-center, randomized clinical trial enrolled adult patients scheduled for isolated CABG in China. Enrollment was from August 15, 2022, to December 13, 2023; follow-up visits were 30 days after discharge.

Interventions: Participants were randomized into the intervention group (CABG plus partial cardiac denervation) and the control group (CABG only) in a 1:1 pattern. All participants were continuously monitored for the incidence of POAF until day 6 after the operation.

Main outcome and measures: The primary end point was the incidence of POAF in 6 days, defined as a supraventricular arrhythmia lasting for more than 30 seconds.

Results: The trial enrolled 430 patients (79 [18.4%] female; mean [SD] age, 61.9 [7.8] years). Compared with the control group, the 6-day incidence of POAF was significantly lower in the intervention group (18.1% vs 31.6%; P = .001; risk ratio, 0.57 [95% CI, 0.41-0.81]). To further support these results, a sensitivity analysis performed with Kaplan-Meier survival curves also showed a significant reduction in the occurrence of POAF in the intervention group (hazard ratio, 0.53 [95% CI, 0.36-0.79]; P = .002). Safety assessments showed no difference between the 2 groups, while postoperative medical cost was reduced in the intervention group.

Conclusions and relevance: This randomized clinical trial found that partial cardiac denervation was an effective procedure to reduce the occurrence of POAF after isolated CABG without additional postoperative complications. These results suggest that partial cardiac denervation may be a good option for cardiac surgeons to consider for preventing POAF after CABG.

Trial registration: ClinicalTrials.gov Identifier: NCT05009914.

重要性:目前仍需要有效的方法来预防冠状动脉旁路移植术(CABG)术后心房颤动(POAF):目的:研究通过切断马歇尔韧带(LOM)并沿沃特斯顿沟切除脂肪垫来实现部分心脏去神经化是否能降低冠状动脉旁路移植术后发生心房颤动的风险:这项单中心随机临床试验招募了中国计划接受孤立CABG的成年患者。入组时间为 2022 年 8 月 15 日至 2023 年 12 月 13 日;随访时间为出院后 30 天:干预措施:以 1:1 的模式将参与者随机分为干预组(CABG 加部分心脏去神经)和对照组(仅 CABG)。所有参与者在术后第6天之前均接受POAF发生率的持续监测:主要终点是 6 天内 POAF 的发生率,定义为持续 30 秒以上的室上性心律失常:试验共招募了 430 名患者(女性 79 [18.4%];平均 [SD] 年龄 61.9 [7.8] 岁)。与对照组相比,干预组的 POAF 6 天发病率明显降低(18.1% vs 31.6%;P = .001;风险比为 0.57 [95% CI, 0.41-0.81])。为了进一步支持这些结果,利用卡普兰-梅耶生存曲线进行的敏感性分析也显示,干预组的 POAF 发生率显著降低(危险比为 0.53 [95% CI, 0.36-0.79]; P = .002)。安全性评估显示两组之间没有差异,而干预组的术后医疗费用有所降低:这项随机临床试验发现,心脏部分去神经化手术能有效减少孤立的心血管成形术后 POAF 的发生,且不会增加术后并发症。这些结果表明,对于心脏外科医生来说,部分心脏去神经化可能是预防 CABG 术后 POAF 的一个不错选择:试验注册:ClinicalTrials.gov Identifier:试验注册:ClinicalTrials.gov Identifier:NCT05009914。
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引用次数: 0
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JAMA cardiology
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