Pub Date : 2024-08-30DOI: 10.1016/j.jacc.2024.07.032
{"title":"High-Dose vs Standard-Dose Influenza Vaccine in Chronic Kidney Disease","authors":"","doi":"10.1016/j.jacc.2024.07.032","DOIUrl":"10.1016/j.jacc.2024.07.032","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0735109724080185/pdfft?md5=0234b57f150f89c7bbd5d8976d97b705&pid=1-s2.0-S0735109724080185-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108650","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}
Pub Date : 2024-08-29DOI: 10.1016/j.jacc.2024.08.026
Markus S Anker, Jan Porthun, P Christian Schulze, Tienush Rassaf, Ulf Landmesser
{"title":"Percutaneous Transcatheter Edge-To-Edge Repair for Functional Mitral Regurgitation in Heart Failure: A Meta-Analysis of 3 Randomized Controlled Trials.","authors":"Markus S Anker, Jan Porthun, P Christian Schulze, Tienush Rassaf, Ulf Landmesser","doi":"10.1016/j.jacc.2024.08.026","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.08.026","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108656","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}
Pub Date : 2024-08-29DOI: 10.1016/j.jacc.2024.08.014
Charles F Sherrod, Sara Saberi, Michael E Nassif, Brian L Claggett, Caroline J Coats, Pablo Garcia-Pavia, James L Januzzi, Gregory D Lewis, Changsheng Ma, Martin S Maron, Zi Michael Miao, Iacopo Olivotto, Josef Veselka, Michael Butzner, Daniel L Jacoby, Stephen B Heitner, Stuart Kupfer, Fady I Malik, Lisa Meng, Amy Wohltman, John A Spertus
Background: A primary goal in treating obstructive hypertrophic cardiomyopathy (oHCM) is to improve patients' health status: their symptoms, function, and quality of life. The health status benefits of aficamten, a novel cardiac myosin inhibitor, have not been comprehensively described.
Objectives: This study sought to determine the effect of aficamten on patient-reported health status, including symptoms of fatigue, shortness of breath, chest pain, physical and social limitations, and quality of life.
Methods: SEQUOIA-HCM (Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM) randomized symptomatic adults with oHCM to 24 weeks of aficamten (n = 142) or placebo (n = 140), followed by a 4-week washout. The Kansas City Cardiomyopathy Questionnaire (KCCQ) and Seattle Angina Questionnaire 7-item (SAQ7) were serially administered. Changes in mean KCCQ-Overall Summary Score (KCCQ-OSS) and SAQ7-Summary Score (SAQ7-SS) from baseline to 24 weeks and following treatment withdrawal were compared using linear regression adjusted for baseline scores and randomization strata. Proportions of patients with clinically important changes were compared.
Results: Among 282 participants, the mean age was 59 ± 13 years, 115 (41%) were female, and 223 (79%) were White. Baseline KCCQ-OSS (69.3 ± 20.1 vs 67.3 ± 18.8) and SAQ7-SS (72.0 ± 21.0 vs 72.4 ± 18.3) were similar between aficamten and placebo groups. Treatment with aficamten, compared with placebo, improved both the mean KCCQ-OSS (13.3 ± 16.3 vs 6.1 ± 12.6; mean difference: 7.9; 95% CI: 4.8-11.0; P < 0.001) and SAQ7-SS (11.6 ± 17.4 vs 3.8 ± 14.4; mean difference: 7.8; 95% CI: 4.7-11.0; P < 0.001) at 24 weeks, with benefits emerging within 4 weeks. No heterogeneity in treatment effect was found across subgroups. A much larger proportion of participants experienced a very large health status improvement (≥20 points) with aficamten vs placebo (KCCQ-OSS: 29.7% vs 12.4%, number needed to treat: 5.8; SAQ7-SS: 31.2% vs 13.9%, number needed to treat: 5.8). Participants' health status worsened significantly more after withdrawal from aficamten than placebo (KCCQ-OSS: -16.2 ± 19.0 vs -3.0 ± 9.6; P < 0.001; SAQ7-SS: -17.4 ± 21.4 vs -2.5 ± 13.3), further confirming a causal effect of aficamten.
Conclusions: In patients with symptomatic oHCM, treatment with aficamten resulted in markedly improved health status, including significant improvement in chest pain-related health status, than placebo. (Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM [SEQUOIA-HCM]; NCT05186818).
背景:治疗梗阻性肥厚型心肌病(oHCM)的首要目标是改善患者的健康状况:症状、功能和生活质量。新型心肌酶抑制剂阿非卡坦对健康状况的益处尚未得到全面描述:本研究旨在确定阿菲康坦对患者报告的健康状况的影响,包括疲劳、气短、胸痛症状、身体和社交限制以及生活质量:SEQUOIA-HCM(评估阿菲康坦与安慰剂相比在有症状oHCM成人中的疗效和安全性的3期试验)将有症状的oHCM成人患者随机分为24周的阿菲康坦(n = 142)或安慰剂(n = 140),然后进行4周的冲洗。连续进行堪萨斯城心肌病问卷(KCCQ)和西雅图心绞痛问卷7项(SAQ7)的测试。采用线性回归法比较了从基线到 24 周以及停药后平均 KCCQ 总分(KCCQ-OSS)和 SAQ7 总分(SAQ7-SS)的变化,并对基线分数和随机分层进行了调整。比较了出现临床重要变化的患者比例:在 282 名参与者中,平均年龄为 59 ± 13 岁,115 人(41%)为女性,223 人(79%)为白人。阿非卡糖与安慰剂组的基线KCCQ-OSS(69.3 ± 20.1 vs 67.3 ± 18.8)和SAQ7-SS(72.0 ± 21.0 vs 72.4 ± 18.3)相似。与安慰剂相比,使用阿非卡糖肽治疗可改善 KCCQ-OSS 平均值(13.3 ± 16.3 vs 6.1 ± 12.6;平均差异为 7.9;95% CI):7.9;95% CI:4.8-11.0;P <0.001)和 SAQ7-SS (11.6 ± 17.4 vs 3.8 ± 14.4;平均差异:7.8;95% CI:4.8-11.0;P <0.001):不同亚组的治疗效果不存在异质性。阿菲康坦与安慰剂相比,有更大比例的参与者的健康状况得到了很大改善(≥20分)(KCCQ-OSS:29.7% vs 12.4%,治疗所需人数:5.8;SAQ7-SS:31.2% vs 13.9%,治疗所需人数:5.8)。与安慰剂相比,停用阿菲康坦后参与者的健康状况明显恶化(KCCQ-OSS:-16.2 ± 19.0 vs -3.0 ± 9.6;P < 0.001;SAQ7-SS:-17.4 ± 21.4 vs -2.5 ± 13.3),进一步证实了阿菲康坦的因果效应:结论:对于有症状的 oHCM 患者,与安慰剂相比,使用阿非坎顿治疗可明显改善健康状况,包括显著改善胸痛相关的健康状况。(评估阿非卡明与安慰剂相比在症状性 oHCM 成人中的疗效和安全性的 3 期试验 [SEQUOIA-HCM];NCT05186818)。
{"title":"Effect of Aficamten on Health Status Outcomes in Obstructive Hypertrophic Cardiomyopathy: Results from SEQUOIA-HCM.","authors":"Charles F Sherrod, Sara Saberi, Michael E Nassif, Brian L Claggett, Caroline J Coats, Pablo Garcia-Pavia, James L Januzzi, Gregory D Lewis, Changsheng Ma, Martin S Maron, Zi Michael Miao, Iacopo Olivotto, Josef Veselka, Michael Butzner, Daniel L Jacoby, Stephen B Heitner, Stuart Kupfer, Fady I Malik, Lisa Meng, Amy Wohltman, John A Spertus","doi":"10.1016/j.jacc.2024.08.014","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.08.014","url":null,"abstract":"<p><strong>Background: </strong>A primary goal in treating obstructive hypertrophic cardiomyopathy (oHCM) is to improve patients' health status: their symptoms, function, and quality of life. The health status benefits of aficamten, a novel cardiac myosin inhibitor, have not been comprehensively described.</p><p><strong>Objectives: </strong>This study sought to determine the effect of aficamten on patient-reported health status, including symptoms of fatigue, shortness of breath, chest pain, physical and social limitations, and quality of life.</p><p><strong>Methods: </strong>SEQUOIA-HCM (Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM) randomized symptomatic adults with oHCM to 24 weeks of aficamten (n = 142) or placebo (n = 140), followed by a 4-week washout. The Kansas City Cardiomyopathy Questionnaire (KCCQ) and Seattle Angina Questionnaire 7-item (SAQ7) were serially administered. Changes in mean KCCQ-Overall Summary Score (KCCQ-OSS) and SAQ7-Summary Score (SAQ7-SS) from baseline to 24 weeks and following treatment withdrawal were compared using linear regression adjusted for baseline scores and randomization strata. Proportions of patients with clinically important changes were compared.</p><p><strong>Results: </strong>Among 282 participants, the mean age was 59 ± 13 years, 115 (41%) were female, and 223 (79%) were White. Baseline KCCQ-OSS (69.3 ± 20.1 vs 67.3 ± 18.8) and SAQ7-SS (72.0 ± 21.0 vs 72.4 ± 18.3) were similar between aficamten and placebo groups. Treatment with aficamten, compared with placebo, improved both the mean KCCQ-OSS (13.3 ± 16.3 vs 6.1 ± 12.6; mean difference: 7.9; 95% CI: 4.8-11.0; P < 0.001) and SAQ7-SS (11.6 ± 17.4 vs 3.8 ± 14.4; mean difference: 7.8; 95% CI: 4.7-11.0; P < 0.001) at 24 weeks, with benefits emerging within 4 weeks. No heterogeneity in treatment effect was found across subgroups. A much larger proportion of participants experienced a very large health status improvement (≥20 points) with aficamten vs placebo (KCCQ-OSS: 29.7% vs 12.4%, number needed to treat: 5.8; SAQ7-SS: 31.2% vs 13.9%, number needed to treat: 5.8). Participants' health status worsened significantly more after withdrawal from aficamten than placebo (KCCQ-OSS: -16.2 ± 19.0 vs -3.0 ± 9.6; P < 0.001; SAQ7-SS: -17.4 ± 21.4 vs -2.5 ± 13.3), further confirming a causal effect of aficamten.</p><p><strong>Conclusions: </strong>In patients with symptomatic oHCM, treatment with aficamten resulted in markedly improved health status, including significant improvement in chest pain-related health status, than placebo. (Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM [SEQUOIA-HCM]; NCT05186818).</p>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108645","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}
Pub Date : 2024-08-29DOI: 10.1016/j.jacc.2024.06.046
Daniel J Hammersley, Abbasin Zegard, Emmanuel Androulakis, Richard E Jones, Osita Okafor, Suzan Hatipoglu, Lukas Mach, Amrit S Lota, Zohya Khalique, Antonio de Marvao, Ankur Gulati, Resham Baruah, Kaushik Guha, James S Ware, Upasana Tayal, Dudley J Pennell, Brian P Halliday, Tian Qiu, Sanjay K Prasad, Francisco Leyva
Background: Myocardial fibrosis (MF) forms part of the arrhythmic substrate for ventricular arrhythmias (VAs).
Objectives: This study sought to determine whether total myocardial fibrosis (TF) and gray zone fibrosis (GZF), assessed using cardiovascular magnetic resonance, are better than left ventricular ejection fraction (LVEF) in predicting ventricular arrhythmias in patients with nonischemic cardiomyopathy (NICM).
Methods: Patients with NICM in a derivation cohort (n = 866) and a validation cohort (n = 848) underwent quantification of TF and GZF. The primary composite endpoint was sudden cardiac death or VAs (ventricular fibrillation or ventricular tachycardia).
Results: The primary endpoint was met by 52 of 866 (6.0%) patients in the derivation cohort (median follow-up: 7.5 years; Q1-Q3: 5.2-9.3 years). In competing-risks analyses, MF on visual assessment (MFVA) predicted the primary endpoint (HR: 5.83; 95% CI: 3.15-10.8). Quantified MF measures permitted categorization into 3 risk groups: a TF of >0 g and ≤10 g was associated with an intermediate risk (HR: 4.03; 95% CI: 1.99-8.16), and a TF of >10 g was associated with the highest risk (HR: 9.17; 95% CI: 4.64-18.1) compared to patients with no MFVA (lowest risk). Similar trends were observed in the validation cohort. Categorization into these 3 risk groups was achievable using TF or GZF in combination or in isolation. In contrast, LVEF of <35% was a poor predictor of the primary endpoint (validation cohort HR: 1.99; 95% CI: 0.99-4.01).
Conclusions: MFVA is a strong predictor of sudden cardiac death and VAs in NICM. TF and GZF mass added incremental value to MFVA. In contrast, LVEF was a poor discriminator of arrhythmic risk.
{"title":"Arrhythmic Risk Stratification by Cardiovascular Magnetic Resonance Imaging in Patients With Nonischemic Cardiomyopathy.","authors":"Daniel J Hammersley, Abbasin Zegard, Emmanuel Androulakis, Richard E Jones, Osita Okafor, Suzan Hatipoglu, Lukas Mach, Amrit S Lota, Zohya Khalique, Antonio de Marvao, Ankur Gulati, Resham Baruah, Kaushik Guha, James S Ware, Upasana Tayal, Dudley J Pennell, Brian P Halliday, Tian Qiu, Sanjay K Prasad, Francisco Leyva","doi":"10.1016/j.jacc.2024.06.046","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.06.046","url":null,"abstract":"<p><strong>Background: </strong>Myocardial fibrosis (MF) forms part of the arrhythmic substrate for ventricular arrhythmias (VAs).</p><p><strong>Objectives: </strong>This study sought to determine whether total myocardial fibrosis (TF) and gray zone fibrosis (GZF), assessed using cardiovascular magnetic resonance, are better than left ventricular ejection fraction (LVEF) in predicting ventricular arrhythmias in patients with nonischemic cardiomyopathy (NICM).</p><p><strong>Methods: </strong>Patients with NICM in a derivation cohort (n = 866) and a validation cohort (n = 848) underwent quantification of TF and GZF. The primary composite endpoint was sudden cardiac death or VAs (ventricular fibrillation or ventricular tachycardia).</p><p><strong>Results: </strong>The primary endpoint was met by 52 of 866 (6.0%) patients in the derivation cohort (median follow-up: 7.5 years; Q1-Q3: 5.2-9.3 years). In competing-risks analyses, MF on visual assessment (MF<sub>VA</sub>) predicted the primary endpoint (HR: 5.83; 95% CI: 3.15-10.8). Quantified MF measures permitted categorization into 3 risk groups: a TF of >0 g and ≤10 g was associated with an intermediate risk (HR: 4.03; 95% CI: 1.99-8.16), and a TF of >10 g was associated with the highest risk (HR: 9.17; 95% CI: 4.64-18.1) compared to patients with no MF<sub>VA</sub> (lowest risk). Similar trends were observed in the validation cohort. Categorization into these 3 risk groups was achievable using TF or GZF in combination or in isolation. In contrast, LVEF of <35% was a poor predictor of the primary endpoint (validation cohort HR: 1.99; 95% CI: 0.99-4.01).</p><p><strong>Conclusions: </strong>MF<sub>VA</sub> is a strong predictor of sudden cardiac death and VAs in NICM. TF and GZF mass added incremental value to MF<sub>VA</sub>. In contrast, LVEF was a poor discriminator of arrhythmic risk.</p>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108639","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}
Pub Date : 2024-08-29DOI: 10.1016/j.jacc.2024.08.021
Scott D Solomon, John W Ostrominski, Xiaowen Wang, Sanjiv J Shah, Barry A Borlaug, Javed Butler, Melanie J Davies, Dalane W Kitzman, Subodh Verma, Steen Z Abildstrøm, Mette Nygaard Einfeldt, Søren Rasmussen, Walter P Abhayaratna, Fozia Z Ahmed, Tuvia Ben-Gal, Vijay Chopra, Hiroshi Ito, Bela Merkely, Julio Núñez, Michele Senni, Peter van der Meer, Dennis Wolf, Mark C Petrie, Mikhail N Kosiborod
<p><strong>Background: </strong>Obesity is associated with adverse cardiac remodeling and is a key driver for the development and progression of heart failure (HF). Once-weekly semaglutide (2.4 mg) has been shown to improve HF-related symptoms and physical limitations, body weight, and exercise function in patients with obesity-related heart failure with preserved ejection fraction (HFpEF), but the effects of semaglutide on cardiac structure and function in this population remain unknown.</p><p><strong>Objectives: </strong>In this echocardiography substudy of the STEP-HFpEF Program, we evaluated treatment effects of once-weekly semaglutide (2.4 mg) vs placebo on cardiac structure and function.</p><p><strong>Methods: </strong>Echocardiography at randomization and 52 weeks was performed in 491 of 1,145 participants (43%) in the STEP-HFpEF Program (pooled STEP-HFpEF [Semaglutide Treatment Effect in People with Obesity and HFpEF] and STEP-HFpEF DM [Semaglutide Treatment Effect in People with Obesity, HFpEF, and Type 2 Diabetes] trials). The prespecified primary outcome was change in left atrial (LA) volume, with changes in other echocardiography parameters evaluated as secondary outcomes. Treatment effects of semaglutide vs placebo were assessed using analysis of covariance stratified by trial and body mass index, with adjustment for baseline parameter values.</p><p><strong>Results: </strong>Overall, baseline clinical and echocardiographic characteristics were balanced among those receiving semaglutide (n = 253) and placebo (n = 238). Between baseline and 52 weeks, semaglutide attenuated progression of LA remodeling (estimated mean difference [EMD] in LA volume, -6.13 mL; 95% CI: -9.85 to -2.41 mL; P = 0.0013) and right ventricular (RV) enlargement (EMD in RV end-diastolic area: -1.99 cm<sup>2</sup>; 95% CI: -3.60 to -0.38 cm<sup>2</sup>; P = 0.016; EMD in RV end-systolic area: -1.41 cm<sup>2</sup>; 95% CI: -2.42 to -0.40] cm<sup>2</sup>; P = 0.0064) compared with placebo. Semaglutide additionally improved E-wave velocity (EMD: -5.63 cm/s; 95% CI: -9.42 to -1.84 cm/s; P = 0.0037), E/A (early/late mitral inflow velocity) ratio (EMD: -0.14; 95% CI: -0.24 to -0.04; P = 0.0075), and E/e' (early mitral inflow velocity/early diastolic mitral annular velocity) average (EMD: -0.79; 95% CI: -1.60 to 0.01; P = 0.05). These associations were not modified by diabetes or atrial fibrillation status. Semaglutide did not significantly affect left ventricular dimensions, mass, or systolic function. Greater weight loss with semaglutide was associated with greater reduction in LA volume (P<sub>interaction</sub> = 0.033) but not with changes in E-wave velocity, E/e' average, or RV end-diastolic area.</p><p><strong>Conclusions: </strong>In the STEP-HFpEF Program echocardiography substudy, semaglutide appeared to improve adverse cardiac remodeling compared with placebo, further suggesting that treatment with semaglutide may be disease modifying among patients with obesity
{"title":"Effect of Semaglutide on Cardiac Structure and Function in Patients With Obesity-Related Heart Failure.","authors":"Scott D Solomon, John W Ostrominski, Xiaowen Wang, Sanjiv J Shah, Barry A Borlaug, Javed Butler, Melanie J Davies, Dalane W Kitzman, Subodh Verma, Steen Z Abildstrøm, Mette Nygaard Einfeldt, Søren Rasmussen, Walter P Abhayaratna, Fozia Z Ahmed, Tuvia Ben-Gal, Vijay Chopra, Hiroshi Ito, Bela Merkely, Julio Núñez, Michele Senni, Peter van der Meer, Dennis Wolf, Mark C Petrie, Mikhail N Kosiborod","doi":"10.1016/j.jacc.2024.08.021","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.08.021","url":null,"abstract":"<p><strong>Background: </strong>Obesity is associated with adverse cardiac remodeling and is a key driver for the development and progression of heart failure (HF). Once-weekly semaglutide (2.4 mg) has been shown to improve HF-related symptoms and physical limitations, body weight, and exercise function in patients with obesity-related heart failure with preserved ejection fraction (HFpEF), but the effects of semaglutide on cardiac structure and function in this population remain unknown.</p><p><strong>Objectives: </strong>In this echocardiography substudy of the STEP-HFpEF Program, we evaluated treatment effects of once-weekly semaglutide (2.4 mg) vs placebo on cardiac structure and function.</p><p><strong>Methods: </strong>Echocardiography at randomization and 52 weeks was performed in 491 of 1,145 participants (43%) in the STEP-HFpEF Program (pooled STEP-HFpEF [Semaglutide Treatment Effect in People with Obesity and HFpEF] and STEP-HFpEF DM [Semaglutide Treatment Effect in People with Obesity, HFpEF, and Type 2 Diabetes] trials). The prespecified primary outcome was change in left atrial (LA) volume, with changes in other echocardiography parameters evaluated as secondary outcomes. Treatment effects of semaglutide vs placebo were assessed using analysis of covariance stratified by trial and body mass index, with adjustment for baseline parameter values.</p><p><strong>Results: </strong>Overall, baseline clinical and echocardiographic characteristics were balanced among those receiving semaglutide (n = 253) and placebo (n = 238). Between baseline and 52 weeks, semaglutide attenuated progression of LA remodeling (estimated mean difference [EMD] in LA volume, -6.13 mL; 95% CI: -9.85 to -2.41 mL; P = 0.0013) and right ventricular (RV) enlargement (EMD in RV end-diastolic area: -1.99 cm<sup>2</sup>; 95% CI: -3.60 to -0.38 cm<sup>2</sup>; P = 0.016; EMD in RV end-systolic area: -1.41 cm<sup>2</sup>; 95% CI: -2.42 to -0.40] cm<sup>2</sup>; P = 0.0064) compared with placebo. Semaglutide additionally improved E-wave velocity (EMD: -5.63 cm/s; 95% CI: -9.42 to -1.84 cm/s; P = 0.0037), E/A (early/late mitral inflow velocity) ratio (EMD: -0.14; 95% CI: -0.24 to -0.04; P = 0.0075), and E/e' (early mitral inflow velocity/early diastolic mitral annular velocity) average (EMD: -0.79; 95% CI: -1.60 to 0.01; P = 0.05). These associations were not modified by diabetes or atrial fibrillation status. Semaglutide did not significantly affect left ventricular dimensions, mass, or systolic function. Greater weight loss with semaglutide was associated with greater reduction in LA volume (P<sub>interaction</sub> = 0.033) but not with changes in E-wave velocity, E/e' average, or RV end-diastolic area.</p><p><strong>Conclusions: </strong>In the STEP-HFpEF Program echocardiography substudy, semaglutide appeared to improve adverse cardiac remodeling compared with placebo, further suggesting that treatment with semaglutide may be disease modifying among patients with obesity","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108646","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}
Pub Date : 2024-08-29DOI: 10.1016/j.jacc.2024.08.024
Do-Yoon Kang, Sang-Hyup Lee, Se-Whan Lee, Cheol Hyun Lee, Choongki Kim, Ji-Yong Jang, Nihar Mehta, Jun-Hyok Oh, Young Rak Cho, Kyung Ho Yoon, Sung Gyun Ahn, Jung-Hee Lee, Deok-Kyu Cho, Yongcheol Kim, Jeongsu Kim, Gyeong Hun Cho, Kyu-Sup Lee, Hanbit Park, Mutlu Vural, Young-Hyo Lim, Kyoung-Ha Park, Bong-Ki Lee, Jong-Young Lee, Hyun-Woo Park, Yong-Hoon Yoon, Jae-Hwan Lee, Seung-Yul Lee, Kyung Woo Park, Jeehoon Kang, Hyun Kuk Kim, Si-Hyuck Kang, Jae-Hyoung Park, In-Cheol Choi, Chang Sik Yu, Sung-Cheol Yun, Duk-Woo Park, Myeong-Ki Hong, Seung-Jung Park, Jung-Sun Kim, Jung-Min Ahn
Background: Current guidelines recommend the perioperative continuation of aspirin in patients with coronary drug-eluting stents (DES) undergoing noncardiac surgery. However, supporting evidence is limited.
Objectives: This study aimed to compare continuing aspirin monotherapy vs temporarily holding all antiplatelet therapy before noncardiac surgery in patients with previous DES implantation.
Methods: We randomly assigned patients who had received a DES >1 year previously and were undergoing elective noncardiac surgery either to continue aspirin or to discontinue all antiplatelet agents 5 days before noncardiac surgery. Antiplatelet therapy was recommended to be resumed no later than 48 hours after surgery, unless contraindicated. The primary outcome was a composite of death from any cause, myocardial infarction, stent thrombosis, or stroke between 5 days before and 30 days after noncardiac surgery.
Results: A total of 1,010 patients underwent randomization. Among 926 patients in the modified intention-to-treat population (462 patients in aspirin monotherapy group and 464 patients in the no-antiplatelet therapy group), the primary composite outcome occurred in 3 patients (0.6%) in the aspirin monotherapy group and 4 patients (0.9%) in the no antiplatelet group (difference, -0.2 percentage points; 95% CI: -1.3 to 0.9; P > 0.99). There was no stent thrombosis in either group. The incidence of major bleeding did not differ significantly between groups (6.5% vs 5.2%; P = 0.39), whereas minor bleeding was significantly more frequent in the aspirin group (14.9% vs 10.1%; P = 0.027).
Conclusions: Among patients undergoing low-to-intermediate risk noncardiac surgery >1 year after stent implantation primarily with a DES, in the setting of lower-than-expected event rates, we failed to identify a significant difference between perioperative aspirin monotherapy and no antiplatelet therapy with respect to ischemic outcomes or major bleeding. (Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery [ASSURE-DES]; NCT02797548).
背景:目前的指南建议接受非心脏手术的冠状动脉药物洗脱支架(DES)患者围术期继续服用阿司匹林。然而,支持性证据有限:本研究旨在比较既往接受过 DES 植入术的患者在接受非心脏手术前继续使用阿司匹林单药治疗与暂时停止所有抗血小板治疗的差异:我们随机分配了接受 DES >1年且正在接受择期非心脏手术的患者,让他们在非心脏手术前5天继续服用阿司匹林或停用所有抗血小板药物。除非有禁忌症,否则建议在手术后 48 小时内恢复抗血小板治疗。主要结果是非心脏手术前5天至手术后30天内因任何原因死亡、心肌梗死、支架血栓或中风的综合结果:共有 1,010 名患者接受了随机分组。在改良意向治疗人群的926名患者中(阿司匹林单药治疗组462名患者,无抗血小板治疗组464名患者),阿司匹林单药治疗组有3名患者(0.6%)出现主要综合结果,无抗血小板治疗组有4名患者(0.9%)出现主要综合结果(差异,-0.2个百分点;95% CI:-1.3至0.9;P > 0.99)。两组均未出现支架血栓。两组大出血的发生率无显著差异(6.5% vs 5.2%;P = 0.39),而阿司匹林组轻微出血的发生率明显更高(14.9% vs 10.1%;P = 0.027):结论:在以DES为主的支架植入术后1年以上接受中低风险非心脏手术的患者中,在事件发生率低于预期的情况下,我们未能发现围手术期阿司匹林单药治疗与不进行抗血小板治疗在缺血性结果或大出血方面存在显著差异。(接受非心脏手术的药物洗脱支架患者围手术期抗血小板疗法[ASSURE-DES];NCT02797548)。
{"title":"Aspirin Monotherapy vs No Antiplatelet Therapy in Stable Patients With Coronary Stents Undergoing Low-to-Intermediate Risk Noncardiac Surgery.","authors":"Do-Yoon Kang, Sang-Hyup Lee, Se-Whan Lee, Cheol Hyun Lee, Choongki Kim, Ji-Yong Jang, Nihar Mehta, Jun-Hyok Oh, Young Rak Cho, Kyung Ho Yoon, Sung Gyun Ahn, Jung-Hee Lee, Deok-Kyu Cho, Yongcheol Kim, Jeongsu Kim, Gyeong Hun Cho, Kyu-Sup Lee, Hanbit Park, Mutlu Vural, Young-Hyo Lim, Kyoung-Ha Park, Bong-Ki Lee, Jong-Young Lee, Hyun-Woo Park, Yong-Hoon Yoon, Jae-Hwan Lee, Seung-Yul Lee, Kyung Woo Park, Jeehoon Kang, Hyun Kuk Kim, Si-Hyuck Kang, Jae-Hyoung Park, In-Cheol Choi, Chang Sik Yu, Sung-Cheol Yun, Duk-Woo Park, Myeong-Ki Hong, Seung-Jung Park, Jung-Sun Kim, Jung-Min Ahn","doi":"10.1016/j.jacc.2024.08.024","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.08.024","url":null,"abstract":"<p><strong>Background: </strong>Current guidelines recommend the perioperative continuation of aspirin in patients with coronary drug-eluting stents (DES) undergoing noncardiac surgery. However, supporting evidence is limited.</p><p><strong>Objectives: </strong>This study aimed to compare continuing aspirin monotherapy vs temporarily holding all antiplatelet therapy before noncardiac surgery in patients with previous DES implantation.</p><p><strong>Methods: </strong>We randomly assigned patients who had received a DES >1 year previously and were undergoing elective noncardiac surgery either to continue aspirin or to discontinue all antiplatelet agents 5 days before noncardiac surgery. Antiplatelet therapy was recommended to be resumed no later than 48 hours after surgery, unless contraindicated. The primary outcome was a composite of death from any cause, myocardial infarction, stent thrombosis, or stroke between 5 days before and 30 days after noncardiac surgery.</p><p><strong>Results: </strong>A total of 1,010 patients underwent randomization. Among 926 patients in the modified intention-to-treat population (462 patients in aspirin monotherapy group and 464 patients in the no-antiplatelet therapy group), the primary composite outcome occurred in 3 patients (0.6%) in the aspirin monotherapy group and 4 patients (0.9%) in the no antiplatelet group (difference, -0.2 percentage points; 95% CI: -1.3 to 0.9; P > 0.99). There was no stent thrombosis in either group. The incidence of major bleeding did not differ significantly between groups (6.5% vs 5.2%; P = 0.39), whereas minor bleeding was significantly more frequent in the aspirin group (14.9% vs 10.1%; P = 0.027).</p><p><strong>Conclusions: </strong>Among patients undergoing low-to-intermediate risk noncardiac surgery >1 year after stent implantation primarily with a DES, in the setting of lower-than-expected event rates, we failed to identify a significant difference between perioperative aspirin monotherapy and no antiplatelet therapy with respect to ischemic outcomes or major bleeding. (Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery [ASSURE-DES]; NCT02797548).</p>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108640","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}
Pub Date : 2024-08-29DOI: 10.1016/j.jacc.2024.08.022
Subodh Verma, Helen M Colhoun, Dror Dicker, G Kees Hovingh, Steven E Kahn, Alexandra Kautzky-Willer, Ildiko Lingvay, Jorge Plutzky, Søren Rasmussen, Naveen Rathor, Søren Tetens Hoff, A Michael Lincoff
{"title":"Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity (SELECT): Outcomes by Sex.","authors":"Subodh Verma, Helen M Colhoun, Dror Dicker, G Kees Hovingh, Steven E Kahn, Alexandra Kautzky-Willer, Ildiko Lingvay, Jorge Plutzky, Søren Rasmussen, Naveen Rathor, Søren Tetens Hoff, A Michael Lincoff","doi":"10.1016/j.jacc.2024.08.022","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.08.022","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108660","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}
Pub Date : 2024-08-29DOI: 10.1016/j.jacc.2024.08.019
Renato D Lopes, Steven J Atlas, Alan S Go, Steven A Lubitz, David D McManus, Rowena J Dolor, Ranee Chatterjee, Michael B Rothberg, David R Rushlow, Lori A Crosson, Ronald S Aronson, Michael Patlakh, Dianne Gallup, Donna J Mills, Emily C O'Brien, Daniel E Singer
Background: Atrial fibrillation (AF) often remains undiagnosed, and it independently raises the risk of ischemic stroke, which is largely reversible by oral anticoagulation. Although randomized trials using longer term screening approaches increase identification of AF, no studies have established that AF screening lowers stroke rates.
Objectives: To address this knowledge gap, the GUARD-AF (Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals) trial screened participants in primary care practices using a 14-day continuous electrocardiographic monitor to determine whether screening for AF coupled with physician/patient decision-making to use oral anticoagulation reduces stroke and provides a net clinical benefit compared with usual care.
Methods: GUARD-AF was a prospective, parallel-group, randomized controlled trial designed to test whether screening for AF in people aged ≥70 years using a 14-day single-lead continuous electrocardiographic patch monitor could identify patients with undiagnosed AF and reduce stroke. Participants were randomized 1:1 to screening or usual care. The primary efficacy and safety outcomes were hospitalization due to all-cause stroke and bleeding, respectively. Analyses used the intention-to-treat population.
Results: Enrollment began on December 17, 2019, and involved 149 primary care sites across the United States. The COVID-19 pandemic led to premature termination of enrollment, with 11,905 participants in the intention-to-treat population. Median follow-up was 15.3 months (Q1-Q3: 13.8-17.6 months). Median age was 75 years (Q1-Q3: 72-79 years), and 56.6% were female. The risk of stroke in the screening group was 0.7% vs 0.6% in the usual care group (HR: 1.10; 95% CI: 0.69-1.75). The risk of bleeding was 1.0% in the screening group vs 1.1% in the usual care group (HR: 0.87; 95% CI: 0.60-1.26). Diagnosis of AF was 5% in the screening group and 3.3% in the usual care group, and initiation of oral anticoagulation after randomization was 4.2% and 2.8%, respectively.
Conclusions: In this trial, there was no evidence that screening for AF using a 14-day continuous electrocardiographic monitor in people ≥70 years of age seen in primary care practice reduces stroke hospitalizations. Event rates were low, however, and the trial did not enroll the planned sample size.(Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals [GUARD-AF]; NCT04126486).
{"title":"Effect of Screening for Undiagnosed Atrial Fibrillation on Stroke Prevention.","authors":"Renato D Lopes, Steven J Atlas, Alan S Go, Steven A Lubitz, David D McManus, Rowena J Dolor, Ranee Chatterjee, Michael B Rothberg, David R Rushlow, Lori A Crosson, Ronald S Aronson, Michael Patlakh, Dianne Gallup, Donna J Mills, Emily C O'Brien, Daniel E Singer","doi":"10.1016/j.jacc.2024.08.019","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.08.019","url":null,"abstract":"<p><strong>Background: </strong>Atrial fibrillation (AF) often remains undiagnosed, and it independently raises the risk of ischemic stroke, which is largely reversible by oral anticoagulation. Although randomized trials using longer term screening approaches increase identification of AF, no studies have established that AF screening lowers stroke rates.</p><p><strong>Objectives: </strong>To address this knowledge gap, the GUARD-AF (Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals) trial screened participants in primary care practices using a 14-day continuous electrocardiographic monitor to determine whether screening for AF coupled with physician/patient decision-making to use oral anticoagulation reduces stroke and provides a net clinical benefit compared with usual care.</p><p><strong>Methods: </strong>GUARD-AF was a prospective, parallel-group, randomized controlled trial designed to test whether screening for AF in people aged ≥70 years using a 14-day single-lead continuous electrocardiographic patch monitor could identify patients with undiagnosed AF and reduce stroke. Participants were randomized 1:1 to screening or usual care. The primary efficacy and safety outcomes were hospitalization due to all-cause stroke and bleeding, respectively. Analyses used the intention-to-treat population.</p><p><strong>Results: </strong>Enrollment began on December 17, 2019, and involved 149 primary care sites across the United States. The COVID-19 pandemic led to premature termination of enrollment, with 11,905 participants in the intention-to-treat population. Median follow-up was 15.3 months (Q1-Q3: 13.8-17.6 months). Median age was 75 years (Q1-Q3: 72-79 years), and 56.6% were female. The risk of stroke in the screening group was 0.7% vs 0.6% in the usual care group (HR: 1.10; 95% CI: 0.69-1.75). The risk of bleeding was 1.0% in the screening group vs 1.1% in the usual care group (HR: 0.87; 95% CI: 0.60-1.26). Diagnosis of AF was 5% in the screening group and 3.3% in the usual care group, and initiation of oral anticoagulation after randomization was 4.2% and 2.8%, respectively.</p><p><strong>Conclusions: </strong>In this trial, there was no evidence that screening for AF using a 14-day continuous electrocardiographic monitor in people ≥70 years of age seen in primary care practice reduces stroke hospitalizations. Event rates were low, however, and the trial did not enroll the planned sample size.(Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals [GUARD-AF]; NCT04126486).</p>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142126073","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}
Pub Date : 2024-08-29DOI: 10.1016/j.jacc.2024.08.023
Subodh Verma, Javed Butler, Barry A Borlaug, Melanie J Davies, Dalane W Kitzman, Mark C Petrie, Sanjiv J Shah, Thomas Jon Jensen, Søren Rasmussen, Cecilia Rönnbäck, Bela Merkely, Evan O'Keefe, Mikhail N Kosiborod
<p><strong>Background: </strong>Obesity is a key factor in the development and progression of both heart failure with preserved ejection fraction (HFpEF) and atrial fibrillation (AF). In the STEP-HFpEF Program (comprising the STEP-HFpEF [Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity] and STEP-HFpEF DM [Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes] trials), once-weekly semaglutide 2.4 mg improved HF-related symptoms, physical limitations, and exercise function and reduced body weight in patients with obesity-related HFpEF. Whether the effects of semaglutide in this patient group differ in participants with and without AF (and across various AF types) has not been fully examined.</p><p><strong>Objectives: </strong>The goals of this study were: 1) to evaluate baseline characteristics and clinical features of patients with obesity-related HFpEF with and without a history of AF; and 2) to determine if the efficacy of semaglutide across all key trial outcomes are influenced by baseline history of AF (and AF types) in the STEP-HFpEF Program.</p><p><strong>Methods: </strong>This was a secondary analysis of pooled data from the STEP-HFpEF and STEP-HFpEF DM trials. Patients with heart failure, left ventricular ejection fraction ≥45%, body mass index ≥30 kg/m<sup>2</sup>, and Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) <90 points were randomized 1:1 to receive once-weekly semaglutide 2.4 mg or matching placebo for 52 weeks. Dual primary endpoints (change in KCCQ-CSS and percent change in body weight), confirmatory secondary endpoints (change in 6-minute walk distance; hierarchical composite endpoint comprising all-cause death, HF events, thresholds of change in KCCQ-CSS, and 6-minute walk distance; and C-reactive protein [CRP]), and exploratory endpoint (change in N-terminal pro-B-type natriuretic peptide [NT-proBNP]) were examined according to investigator-reported history of AF (yes/no). Responder analyses examined the proportions of patients who experienced a ≥5-, ≥10, ≥15, and ≥20-point improvement in KCCQ-CSS per history of AF.</p><p><strong>Results: </strong>Of the 1,145 participants, 518 (45%) had a history of AF (40% paroxysmal, 24% persistent AF, and 35% permanent AF) and 627 (55%) did not. Participants with (vs without) AF were older, more often male, had higher NT-proBNP levels, included a higher proportion of those with NYHA functional class III symptoms, and used more antithrombotic therapies, beta-blockers, and diuretics. Semaglutide led to larger improvements in KCCQ-CSS (11.5 points [95% CI: 8.3-14.8] vs 4.3 points [95% CI: 1.3-7.2]; P interaction = 0.001) and the hierarchal composite endpoint (win ratio of 2.25 [95% CI: 1.79-2.83] vs 1.30 [95% CI: 1.06-1.59]; P interaction < 0.001) in participants with AF vs without AF, respectively. The proportions of patients receiving semagluti
{"title":"Atrial Fibrillation and Semaglutide Effects in Obesity-Related Heart Failure With Preserved Ejection Fraction: STEP-HFpEF Program.","authors":"Subodh Verma, Javed Butler, Barry A Borlaug, Melanie J Davies, Dalane W Kitzman, Mark C Petrie, Sanjiv J Shah, Thomas Jon Jensen, Søren Rasmussen, Cecilia Rönnbäck, Bela Merkely, Evan O'Keefe, Mikhail N Kosiborod","doi":"10.1016/j.jacc.2024.08.023","DOIUrl":"10.1016/j.jacc.2024.08.023","url":null,"abstract":"<p><strong>Background: </strong>Obesity is a key factor in the development and progression of both heart failure with preserved ejection fraction (HFpEF) and atrial fibrillation (AF). In the STEP-HFpEF Program (comprising the STEP-HFpEF [Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity] and STEP-HFpEF DM [Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes] trials), once-weekly semaglutide 2.4 mg improved HF-related symptoms, physical limitations, and exercise function and reduced body weight in patients with obesity-related HFpEF. Whether the effects of semaglutide in this patient group differ in participants with and without AF (and across various AF types) has not been fully examined.</p><p><strong>Objectives: </strong>The goals of this study were: 1) to evaluate baseline characteristics and clinical features of patients with obesity-related HFpEF with and without a history of AF; and 2) to determine if the efficacy of semaglutide across all key trial outcomes are influenced by baseline history of AF (and AF types) in the STEP-HFpEF Program.</p><p><strong>Methods: </strong>This was a secondary analysis of pooled data from the STEP-HFpEF and STEP-HFpEF DM trials. Patients with heart failure, left ventricular ejection fraction ≥45%, body mass index ≥30 kg/m<sup>2</sup>, and Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) <90 points were randomized 1:1 to receive once-weekly semaglutide 2.4 mg or matching placebo for 52 weeks. Dual primary endpoints (change in KCCQ-CSS and percent change in body weight), confirmatory secondary endpoints (change in 6-minute walk distance; hierarchical composite endpoint comprising all-cause death, HF events, thresholds of change in KCCQ-CSS, and 6-minute walk distance; and C-reactive protein [CRP]), and exploratory endpoint (change in N-terminal pro-B-type natriuretic peptide [NT-proBNP]) were examined according to investigator-reported history of AF (yes/no). Responder analyses examined the proportions of patients who experienced a ≥5-, ≥10, ≥15, and ≥20-point improvement in KCCQ-CSS per history of AF.</p><p><strong>Results: </strong>Of the 1,145 participants, 518 (45%) had a history of AF (40% paroxysmal, 24% persistent AF, and 35% permanent AF) and 627 (55%) did not. Participants with (vs without) AF were older, more often male, had higher NT-proBNP levels, included a higher proportion of those with NYHA functional class III symptoms, and used more antithrombotic therapies, beta-blockers, and diuretics. Semaglutide led to larger improvements in KCCQ-CSS (11.5 points [95% CI: 8.3-14.8] vs 4.3 points [95% CI: 1.3-7.2]; P interaction = 0.001) and the hierarchal composite endpoint (win ratio of 2.25 [95% CI: 1.79-2.83] vs 1.30 [95% CI: 1.06-1.59]; P interaction < 0.001) in participants with AF vs without AF, respectively. The proportions of patients receiving semagluti","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108641","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}
Pub Date : 2024-08-28DOI: 10.1016/j.jacc.2024.08.048
Daniel Modin, Brian Claggett, Niklas Dyrby Johansen, Scott D Solomon, Ramona Trebbien, Thyra Grove Krause, Jens-Ulrik Stæhr Jensen, Mikkel Porsborg Andersen, Gunnar Gislason, Tor Biering-Sørensen
Background: Influenza virus may cause severe infection in patients with heart failure. It is known that influenza infection is associated with increased morbidity and mortality in patients with heart failure. However, less is known about the excess burden of morbidity and mortality caused by influenza infection in patients with heart failure at a population level.
Objectives: To estimate the excess burden of morbidity and mortality as determined by annual excess number of deaths and hospitalizations associated with influenza infection in patients with heart failure in Denmark.
Methods: We collected nationwide data on weekly number of deaths and hospitalizations among patients with heart failure in Denmark and weekly estimates of influenza circulation as determined by the proportion of positive influenza samples analyzed at all Danish Hospitals. These data were correlated in a time series linear regression model and this model was used to estimate the annual excess number of deaths and hospitalizations attributable to influenza circulation among patients with heart failure in Denmark. The model also included data on weekly mean temperature and restricted cubic spline terms to account for seasonality and trends over time.
Results: Data were available from 2010 to 2018 encompassing 8 influenza seasons with an annual mean of 25180 samples tested for influenza at Danish hospitals. Among an annual mean of 70570 patients with heart failure, our model estimated that influenza activity was associated with an annual excess of 250 all cause deaths (95%CI 144-489) corresponding to 2.6% of all all-cause deaths (95%CI 1.5% - 5.1%) in patients with heart failure. Similarly, influenza activity was associated with an annual excess of 115 cardiovascular deaths (95%CI 62-244) corresponding to 2.9% of all cardiovascular deaths (95%CI 1.5% - 6.1%). Influenza activity was also associated with an annual excess of 251 hospitalizations for pneumonia or influenza (95%CI 107-533) corresponding to 5.0% of all hospitalizations for pneumonia or influenza.
Conclusions: Our results indicate that influenza activity likely causes substantial morbidity and mortality among patients with heart failure. Notably, our study suggests that approximately 2.6% of all deaths and 5.0% of all hospitalizations with influenza or pneumonia may be attributed to influenza in patients with heart failure.
{"title":"Excess mortality and hospitalizations associated with seasonal influenza in patients with heart failure.","authors":"Daniel Modin, Brian Claggett, Niklas Dyrby Johansen, Scott D Solomon, Ramona Trebbien, Thyra Grove Krause, Jens-Ulrik Stæhr Jensen, Mikkel Porsborg Andersen, Gunnar Gislason, Tor Biering-Sørensen","doi":"10.1016/j.jacc.2024.08.048","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.08.048","url":null,"abstract":"<p><strong>Background: </strong>Influenza virus may cause severe infection in patients with heart failure. It is known that influenza infection is associated with increased morbidity and mortality in patients with heart failure. However, less is known about the excess burden of morbidity and mortality caused by influenza infection in patients with heart failure at a population level.</p><p><strong>Objectives: </strong>To estimate the excess burden of morbidity and mortality as determined by annual excess number of deaths and hospitalizations associated with influenza infection in patients with heart failure in Denmark.</p><p><strong>Methods: </strong>We collected nationwide data on weekly number of deaths and hospitalizations among patients with heart failure in Denmark and weekly estimates of influenza circulation as determined by the proportion of positive influenza samples analyzed at all Danish Hospitals. These data were correlated in a time series linear regression model and this model was used to estimate the annual excess number of deaths and hospitalizations attributable to influenza circulation among patients with heart failure in Denmark. The model also included data on weekly mean temperature and restricted cubic spline terms to account for seasonality and trends over time.</p><p><strong>Results: </strong>Data were available from 2010 to 2018 encompassing 8 influenza seasons with an annual mean of 25180 samples tested for influenza at Danish hospitals. Among an annual mean of 70570 patients with heart failure, our model estimated that influenza activity was associated with an annual excess of 250 all cause deaths (95%CI 144-489) corresponding to 2.6% of all all-cause deaths (95%CI 1.5% - 5.1%) in patients with heart failure. Similarly, influenza activity was associated with an annual excess of 115 cardiovascular deaths (95%CI 62-244) corresponding to 2.9% of all cardiovascular deaths (95%CI 1.5% - 6.1%). Influenza activity was also associated with an annual excess of 251 hospitalizations for pneumonia or influenza (95%CI 107-533) corresponding to 5.0% of all hospitalizations for pneumonia or influenza.</p><p><strong>Conclusions: </strong>Our results indicate that influenza activity likely causes substantial morbidity and mortality among patients with heart failure. Notably, our study suggests that approximately 2.6% of all deaths and 5.0% of all hospitalizations with influenza or pneumonia may be attributed to influenza in patients with heart failure.</p>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142120140","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}