Pub Date : 2024-11-18DOI: 10.1016/j.jacc.2024.06.052
Kristjan Norland, Daniel J. Schaid, Mohammadreza Naderian, Jie Na, Iftikhar J. Kullo
Background
Social determinants of health (SDOH) influence the risk of common diseases such as coronary heart disease (CHD).
Objectives
This study sought to test the associations of self-reported race/ethnicity, SDOH, and a polygenic risk score (PRS), with CHD in a large and diverse U.S. cohort.
Methods
In 67,256 All of Us (AoU) participants with available SDOH and whole-genome sequencing data, we ascertained self-reported race/ethnicity and 22 SDOH measures across 5 SDOH domains, and we calculated a PRS for CHD (PRSCHD, PGS004696). We developed an SDOH score for CHD (SDOHCHD). We tested the associations of SDOH and PRSCHD with CHD in regression models that included clinical risk factors.
Results
SDOH across 5 domains, including food insecurity, income, educational attainment, health literacy, neighborhood disorder, and loneliness, were associated with CHD. SDOHCHD was highest in self-reported Black and Hispanic people. Self-reporting as Blacks had higher odds of having CHD than Whites but not after adjustment for SDOHCHD. SDOHCHD and PRSCHD were weakly correlated. In the test set (n = 33,628), 1-SD increases in SDOHCHD and PRSCHD were associated with CHD in models that adjusted for clinical risk factors (OR: 1.32; 95% CI: 1.23-1.41 and OR: 1.36; 95% CI: 1.28-1.44, respectively). SDOHCHD and PRSCHD were associated with incident CHD events (n = 52) over a median follow-up of 214 days (Q1-Q3: 88 days).
Conclusions
Increased odds of CHD in people who self-report as Black are likely due to a higher SDOH burden. SDOH and PRS were independently associated with CHD. Our findings suggest that including both PRS and SDOH in CHD risk models could improve their accuracy.
{"title":"Associations of Self-Reported Race, Social Determinants of Health, and Polygenic Risk With Coronary Heart Disease","authors":"Kristjan Norland, Daniel J. Schaid, Mohammadreza Naderian, Jie Na, Iftikhar J. Kullo","doi":"10.1016/j.jacc.2024.06.052","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.06.052","url":null,"abstract":"<h3>Background</h3>Social determinants of health (SDOH) influence the risk of common diseases such as coronary heart disease (CHD).<h3>Objectives</h3>This study sought to test the associations of self-reported race/ethnicity, SDOH, and a polygenic risk score (PRS), with CHD in a large and diverse U.S. cohort.<h3>Methods</h3>In 67,256 All of Us (AoU) participants with available SDOH and whole-genome sequencing data, we ascertained self-reported race/ethnicity and 22 SDOH measures across 5 SDOH domains, and we calculated a PRS for CHD (PRS<sub>CHD</sub>, PGS004696). We developed an SDOH score for CHD (SDOH<sub>CHD</sub>). We tested the associations of SDOH and PRS<sub>CHD</sub> with CHD in regression models that included clinical risk factors.<h3>Results</h3>SDOH across 5 domains, including food insecurity, income, educational attainment, health literacy, neighborhood disorder, and loneliness, were associated with CHD. SDOH<sub>CHD</sub> was highest in self-reported Black and Hispanic people. Self-reporting as Blacks had higher odds of having CHD than Whites but not after adjustment for SDOH<sub>CHD</sub>. SDOH<sub>CHD</sub> and PRS<sub>CHD</sub> were weakly correlated. In the test set (n = 33,628), 1-SD increases in SDOH<sub>CHD</sub> and PRS<sub>CHD</sub> were associated with CHD in models that adjusted for clinical risk factors (OR: 1.32; 95% CI: 1.23-1.41 and OR: 1.36; 95% CI: 1.28-1.44, respectively). SDOH<sub>CHD</sub> and PRS<sub>CHD</sub> were associated with incident CHD events (n = 52) over a median follow-up of 214 days (Q1-Q3: 88 days).<h3>Conclusions</h3>Increased odds of CHD in people who self-report as Black are likely due to a higher SDOH burden. SDOH and PRS were independently associated with CHD. Our findings suggest that including both PRS and SDOH in CHD risk models could improve their accuracy.","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"38 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142665355","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 : 2024-11-18DOI: 10.1016/j.jacc.2024.07.061
Adam Hartley, Nasser Alshahrani, Ramzi Y. Khamis
No Abstract
无摘要
{"title":"Reply: Answering the Call: Enhancing Telemedicine Reach With Artificial intelligence Integration","authors":"Adam Hartley, Nasser Alshahrani, Ramzi Y. Khamis","doi":"10.1016/j.jacc.2024.07.061","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.07.061","url":null,"abstract":"No Abstract","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"248 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142665358","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 : 2024-11-18DOI: 10.1016/j.jacc.2024.06.051
Ioannis Skalidis, Niccolo Maurizi, George Dangas, Yiannis S. Chatzizisis
No Abstract
无摘要
{"title":"Answering the Call: Enhancing Telemedicine Reach With Artificial intelligence Integration","authors":"Ioannis Skalidis, Niccolo Maurizi, George Dangas, Yiannis S. Chatzizisis","doi":"10.1016/j.jacc.2024.06.051","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.06.051","url":null,"abstract":"No Abstract","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"99 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142665356","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 : 2024-11-18DOI: 10.1016/j.jacc.2024.10.101
Dhanunjaya Lakkireddy, Christopher R. Ellis, David Thaler, Vijendra Swarup, Alok Gambhir, James Hermiller, Jens Erik Nielsen-Kudsk, Stephen Worthley, Devi Nair, Boris Schmidt, Rodney Horton, Nigel Gupta, Jordan A. Anderson, Hong Zhao, Mohamad Alkhouli, Stephan Windecker
Background
The Amulet IDE trial (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial) evaluated the safety and effectiveness of the Amulet occluder (Abbott) in patients with nonvalvular atrial fibrillation. The Amulet IDE trial is the largest randomized LAAO trial, comparing the Amulet occluder with the Watchman 2.5 device (Boston Scientific).
Objectives
This analysis presents the 5-year results from the trial comparing the 2 devices head to head.
Methods
Patients enrolled in the Amulet IDE trial were at a high risk of stroke or systemic embolism defined as a CHADS2 score ≥2 or CHA2DS2-VASc score ≥3. Oral anticoagulation (OAC) use and key clinical outcomes are presented through 5 years.
Results
A total of 1,878 patients were randomized, with 1,833 undergoing a device implantation attempt (n = 917, Amulet occluder; and n = 916, Watchman device). A significantly higher percentage of patients were free of OAC in the Amulet occluder group at each follow-up visit, with 94.0% and 90.9% free of OAC at the last 5-year follow-up visit in the Amulet and Watchman device groups, respectively (P = 0.009). The 5-year clinical outcomes were similar between the Amulet and Watchman devices, including the composite of ischemic stroke or systemic embolism (7.4% vs 7.1%; P = 0.851), the composite of stroke, systemic embolism, or cardiovascular death (20.3% vs 20.7%; P = 0.666), major bleeding (20.1% vs 20.0%; P = 0.882), cardiovascular (CV) death (14.3% vs 15.4%; P = 0.429), and all-cause death (28.7% vs 31.1%; P = 0.217). Annualized ischemic stroke rates at 5 years were low and the same for Amulet (1.6%/y) and Watchman (1.6%/y) devices. Strokes in patients with the Amulet occluder were less severe (n = 38, nondisabling; n = 11, disabling; n = 11, fatal; n = 12, unknown) than strokes in patients with the Watchman device (n = 19, nondisabling; n = 22, disabling; n = 17, fatal; n = 10, unknown). Moreover, device factors (device-related thrombus or peridevice leak ≥3 mm) preceded stroke events and CV deaths more frequently in patients with the Watchman device (n = 63) compared with patients with the Amulet occluder (n = 31).
Conclusions
The 5-year outcomes from the largest randomized LAAO clinical trial demonstrated the long-term safety and effectiveness of the Amulet occluder and Watchman 2.5 devices. The dual-seal Amulet occluder reduces atrial fibrillation–related thromboembolic events while eliminating the need for long-term OAC. (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial [Amulet IDE trial]; NCT02879448)
背景Amulet IDE 试验（AMPLATZER Amulet 左心房阑尾封堵器[LAAO] 研究性设备豁免[IDE] 试验）评估了 Amulet 封堵器（雅培）在非瓣膜性心房颤动患者中的安全性和有效性。Amulet IDE 试验是最大的 LAAO 随机试验，比较了 Amulet 封堵器和 Watchman 2.5 设备（波士顿科学公司）。方法Amulet IDE 试验的入组患者为中风或全身性栓塞的高危人群，定义为 CHADS2 评分≥2 或 CHA2DS2-VASc 评分≥3。结果 共有1878名患者接受了随机治疗，其中1833名接受了装置植入尝试（n = 917，Amulet闭塞器；n = 916，Watchman装置）。在每次随访中，Amulet 封堵器组患者无 OAC 的比例明显更高，在最后一次 5 年随访中，Amulet 和 Watchman 装置组无 OAC 的比例分别为 94.0% 和 90.9%（P = 0.009）。Amulet 装置组和 Watchman 装置组的 5 年临床结果相似，包括缺血性卒中或全身性栓塞的复合死亡率（7.4% vs 7.1%；P = 0.851）、卒中、全身性栓塞或心血管死亡的复合死亡率（20.3% vs 20.7%; P = 0.666）、大出血（20.1% vs 20.0%; P = 0.882）、心血管（CV）死亡（14.3% vs 15.4%; P = 0.429）和全因死亡（28.7% vs 31.1%; P = 0.217）。5 年的年化缺血性脑卒中发生率较低，Amulet（1.6%/年）和 Watchman（1.6%/年）装置的发生率相同。与使用 Watchman 装置的患者相比，使用 Amulet 闭塞器的患者中风的严重程度较低（n = 38，非致残；n = 11，致残；n = 11，致命；n = 12，未知）（n = 19，非致残；n = 22，致残；n = 17，致命；n = 10，未知）。此外，与使用 Amulet 封堵器的患者（n = 31）相比，使用 Watchman 设备的患者（n = 63）在发生脑卒中事件和心血管疾病死亡之前更常出现设备因素（设备相关血栓或设备周围泄漏≥3 mm）。结论最大的 LAAO 随机临床试验的 5 年结果表明，Amulet 封堵器和 Watchman 2.5 设备具有长期安全性和有效性。双密封 Amulet 封堵器可减少与心房颤动相关的血栓栓塞事件，同时无需长期使用 OAC。(AMPLATZER Amulet 左心房阑尾封堵器[LAAO]研究性设备豁免[IDE]试验[Amulet IDE 试验]；NCT02879448）。
{"title":"5-Year Results From the AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial","authors":"Dhanunjaya Lakkireddy, Christopher R. Ellis, David Thaler, Vijendra Swarup, Alok Gambhir, James Hermiller, Jens Erik Nielsen-Kudsk, Stephen Worthley, Devi Nair, Boris Schmidt, Rodney Horton, Nigel Gupta, Jordan A. Anderson, Hong Zhao, Mohamad Alkhouli, Stephan Windecker","doi":"10.1016/j.jacc.2024.10.101","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.10.101","url":null,"abstract":"<h3>Background</h3>The Amulet IDE trial (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial) evaluated the safety and effectiveness of the Amulet occluder (Abbott) in patients with nonvalvular atrial fibrillation. The Amulet IDE trial is the largest randomized LAAO trial, comparing the Amulet occluder with the Watchman 2.5 device (Boston Scientific).<h3>Objectives</h3>This analysis presents the 5-year results from the trial comparing the 2 devices head to head.<h3>Methods</h3>Patients enrolled in the Amulet IDE trial were at a high risk of stroke or systemic embolism defined as a CHADS2 score ≥2 or CHA2DS2-VASc score ≥3. Oral anticoagulation (OAC) use and key clinical outcomes are presented through 5 years.<h3>Results</h3>A total of 1,878 patients were randomized, with 1,833 undergoing a device implantation attempt (n = 917, Amulet occluder; and n = 916, Watchman device). A significantly higher percentage of patients were free of OAC in the Amulet occluder group at each follow-up visit, with 94.0% and 90.9% free of OAC at the last 5-year follow-up visit in the Amulet and Watchman device groups, respectively (<em>P</em> = 0.009). The 5-year clinical outcomes were similar between the Amulet and Watchman devices, including the composite of ischemic stroke or systemic embolism (7.4% vs 7.1%; <em>P</em> = 0.851), the composite of stroke, systemic embolism, or cardiovascular death (20.3% vs 20.7%; <em>P</em> = 0.666), major bleeding (20.1% vs 20.0%; <em>P</em> = 0.882), cardiovascular (CV) death (14.3% vs 15.4%; <em>P</em> = 0.429), and all-cause death (28.7% vs 31.1%; <em>P</em> = 0.217). Annualized ischemic stroke rates at 5 years were low and the same for Amulet (1.6%/y) and Watchman (1.6%/y) devices. Strokes in patients with the Amulet occluder were less severe (n = 38, nondisabling; n = 11, disabling; n = 11, fatal; n = 12, unknown) than strokes in patients with the Watchman device (n = 19, nondisabling; n = 22, disabling; n = 17, fatal; n = 10, unknown). Moreover, device factors (device-related thrombus or peridevice leak ≥3 mm) preceded stroke events and CV deaths more frequently in patients with the Watchman device (n = 63) compared with patients with the Amulet occluder (n = 31).<h3>Conclusions</h3>The 5-year outcomes from the largest randomized LAAO clinical trial demonstrated the long-term safety and effectiveness of the Amulet occluder and Watchman 2.5 devices. The dual-seal Amulet occluder reduces atrial fibrillation–related thromboembolic events while eliminating the need for long-term OAC. (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial [Amulet IDE trial]; <span><span>NCT02879448</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>)","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"45 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142670672","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 : 2024-11-18DOI: 10.1016/j.jacc.2024.11.005
Daniel J. Friedman, James V. Freeman
No Abstract
无摘要
{"title":"Amulet LAAO 5-year Outcomes: Best in Class or Class Effect?","authors":"Daniel J. Friedman, James V. Freeman","doi":"10.1016/j.jacc.2024.11.005","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.11.005","url":null,"abstract":"No Abstract","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"173 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142670676","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 : 2024-11-18DOI: 10.1016/j.jacc.2024.11.006
Philippe Généreux, Marko Banovic, Duk-Hyun Kang, Gennaro Giustino, Bernard D. Prendergast, Brian R. Lindman, David E. Newby, Philippe Pibarot, Björn Redfors, Neil J. Craig, Jozef Bartunek, Allan Schwartz, Roxanna Seyedin, David J. Cohen, Bernard Iung, Martin B. Leon, Marc R. Dweck
Background
Current guidelines recommend a strategy of clinical surveillance (CS) for patients with asymptomatic severe aortic stenosis (AS) and normal left ventricular ejection fraction.
Objectives
To conduct a study-level meta-analysis of randomized controlled trials (RCTs) evaluating the effect of early aortic valve replacement (AVR) compared with CS in patients with asymptomatic severe AS.
Methods
Studies were quantitatively assessed in a meta-analysis using random effects modeling. Prespecified outcomes included all-cause and cardiovascular mortality, unplanned cardiovascular or heart failure (HF) hospitalization, and stroke. The meta-analysis is registered on the International Platform of Registered Systematic Review and Meta-analysis Protocols (INPLASY 202490002).
Results
Four RCTs were identified, including a total of 1427 patients (719 in the early AVR group and 708 in the CS group). At an average follow-up time of 4.1 years, early AVR was associated with a significant reduction in unplanned cardiovascular or HF hospitalization (pooled rates, 14.6% vs. 31.9%; HR 0.28; 95% CI, (0.17-0.47); I2=0%; p<0.01) and stroke (pooled rates 4.5% vs. 7.2%; HR, 0.62; 95% CI, 0.40-0.97; I2=0%; p=0.03). No differences in all-cause mortality (pooled rates 9.7% vs. 13.7%; HR, 0.68; 95% CI, 0.40-1.17; I2=61%; p=0.17) and cardiovascular mortality (pooled rates 5.1% vs. 8.3%; HR, 0.67; 95% CI, 0.35-1.29; I2=50%; p=0.23) were observed with early AVR compared with CS, although there was a high degree of heterogeneity between studies.
Conclusions
In this pooled meta-analysis of 4 RCTs, early AVR was associated with a significant reduction in unplanned cardiovascular or HF hospitalization and stroke, and no differences in all-cause and cardiovascular mortality compared with CS.
{"title":"Aortic Valve Replacement Versus Clinical Surveillance in Asymptomatic Severe Aortic Stenosis: A Systematic Review and Meta-Analysis","authors":"Philippe Généreux, Marko Banovic, Duk-Hyun Kang, Gennaro Giustino, Bernard D. Prendergast, Brian R. Lindman, David E. Newby, Philippe Pibarot, Björn Redfors, Neil J. Craig, Jozef Bartunek, Allan Schwartz, Roxanna Seyedin, David J. Cohen, Bernard Iung, Martin B. Leon, Marc R. Dweck","doi":"10.1016/j.jacc.2024.11.006","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.11.006","url":null,"abstract":"<h3>Background</h3>Current guidelines recommend a strategy of clinical surveillance (CS) for patients with asymptomatic severe aortic stenosis (AS) and normal left ventricular ejection fraction.<h3>Objectives</h3>To conduct a study-level meta-analysis of randomized controlled trials (RCTs) evaluating the effect of early aortic valve replacement (AVR) compared with CS in patients with asymptomatic severe AS.<h3>Methods</h3>Studies were quantitatively assessed in a meta-analysis using random effects modeling. Prespecified outcomes included all-cause and cardiovascular mortality, unplanned cardiovascular or heart failure (HF) hospitalization, and stroke. The meta-analysis is registered on the International Platform of Registered Systematic Review and Meta-analysis Protocols (INPLASY 202490002).<h3>Results</h3>Four RCTs were identified, including a total of 1427 patients (719 in the early AVR group and 708 in the CS group). At an average follow-up time of 4.1 years, early AVR was associated with a significant reduction in unplanned cardiovascular or HF hospitalization (pooled rates, 14.6% vs. 31.9%; HR 0.28; 95% CI, (0.17-0.47); I<sup>2</sup>=0%; p<0.01) and stroke (pooled rates 4.5% vs. 7.2%; HR, 0.62; 95% CI, 0.40-0.97; I<sup>2</sup>=0%; p=0.03). No differences in all-cause mortality (pooled rates 9.7% vs. 13.7%; HR, 0.68; 95% CI, 0.40-1.17; I<sup>2</sup>=61%; p=0.17) and cardiovascular mortality (pooled rates 5.1% vs. 8.3%; HR, 0.67; 95% CI, 0.35-1.29; I<sup>2</sup>=50%; p=0.23) were observed with early AVR compared with CS, although there was a high degree of heterogeneity between studies.<h3>Conclusions</h3>In this pooled meta-analysis of 4 RCTs, early AVR was associated with a significant reduction in unplanned cardiovascular or HF hospitalization and stroke, and no differences in all-cause and cardiovascular mortality compared with CS.","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"6 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142670718","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 : 2024-11-18DOI: 10.1016/j.jacc.2024.08.081
Sarah Crook, Brett R. Anderson
No Abstract
无摘要
{"title":"Reply: Revealing the Hidden Layers: Focus on Social and Psychological Determinants in Congenital Heart Surgery Prognosis","authors":"Sarah Crook, Brett R. Anderson","doi":"10.1016/j.jacc.2024.08.081","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.08.081","url":null,"abstract":"No Abstract","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"12 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142665362","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 : 2024-11-18DOI: 10.1016/s0735-1097(24)10255-0
No Abstract
无摘要
{"title":"Audio Summary","authors":"","doi":"10.1016/s0735-1097(24)10255-0","DOIUrl":"https://doi.org/10.1016/s0735-1097(24)10255-0","url":null,"abstract":"No Abstract","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"55 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142665564","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 : 2024-11-18DOI: 10.1016/j.jacc.2024.08.080
Irene Santos-Pardo, Mikael Andersson Franko, Thomas Nyström
No Abstract
无摘要
{"title":"Reply: Glycemic Control and Coronary Stent Failure in Patients With Type 2 Diabetes Mellitus","authors":"Irene Santos-Pardo, Mikael Andersson Franko, Thomas Nyström","doi":"10.1016/j.jacc.2024.08.080","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.08.080","url":null,"abstract":"No Abstract","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"1 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142665577","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 : 2024-11-18DOI: 10.1016/j.jacc.2024.11.014
Mikhail N. Kosiborod, David Z.I. Cherney, Akshay S. Desai, Jeffrey M. Testani, Subodh Verma, Khaja Chinnakondepalli, David Dolling, Shachi Patel, Magnus Dahl, James M. Eudicone, Lovisa Friberg, Mario Ouwens, Murillo O. Antunes, Kim A. Connelly, Vagner Madrini, Luca Kuthi, Anuradha Lala, Miguel Lorenzo, Patrícia O. Guimarães, Marta Cobo Marcos, Mark C. Petrie
Background
Mineralocorticoid receptor antagonists (MRA) improve outcomes in patients with heart failure and reduced ejection fraction (HFrEF) but are underused in clinical practice. Observational data suggest that hyperkalemia is the leading obstacle for the suboptimal use of MRA.
Objectives
We evaluated the effects of sodium zirconium cyclosilicate (SZC) in optimizing use of spironolactone among participants with HFrEF and hyperkalemia.
Methods
REALIZE-K (NCT04676646) was a prospective, double-blind, randomized- withdrawal trial in participants with HFrEF (NYHA II–IV; left ventricular ejection fraction ≤40%), optimal guideline-directed therapy (except MRA), and prevalent or incident MRA- induced hyperkalemia. During open-label run-in, participants underwent spironolactone titration (target: 50 mg/daily); those with hyperkalemia started SZC. Participants with normokalemia (potassium 3.5–5.0 mEq/L) on SZC and spironolactone ≥25 mg/daily were randomized to continued SZC or placebo for 6 months. The primary endpoint was optimal treatment response (normokalemia on spironolactone ≥25 mg/daily without rescue therapy for hyperkalemia [months 1–6]). The five key secondary endpoints were tested hierarchically. Exploratory endpoints included a composite of adjudicated cardiovascular death or worsening HF events (hospitalizations and urgent visits).
Results
Overall, 203 participants were randomized (SZC 102, placebo 101). Higher percentage of SZC- versus placebo-treated participants had optimal response (71% vs 36%; OR 4.45 [95% CI 2.89–6.86]; p<0.001). SZC (versus placebo) improved the first four key secondary endpoints: normokalemia on randomization dose of spironolactone and without rescue therapy (58% vs 23%; OR 4.58 [2.78–7.55]; p<0.001), receiving spironolactone ≥25 mg/daily (81% vs 50%; OR 4.33 [2.50–7.52]; p<0.001), time to hyperkalemia (HR 0.51 [0.37–0.71]; p<0.001), time to decrease/discontinuation of spironolactone due to hyperkalemia (HR 0.37 [0.17–0.73]; p=0.006). There was no between-group difference in KCCQ-CSS at 6 months (-1.01 points [-6.64–4.63]; p=0.72). Adverse events (64% vs 63%) and serious adverse events (23% vs 22%) were balanced between SZC and placebo, respectively. Composite of CV death or worsening HF occurred in 11 (11%) participants in the SZC group (1 with CV death, 10 with HF events) and 3 (3%) participants in the placebo group (1 with CV death, 2 with HF events; log-rank nominal p=0.034).
Conclusions
In participants with HFrEF and hyperkalemia, SZC led to large improvements in the percentage of participants with normokalemia while on optimal spironolactone dose, and reduced risk of hyperkalaemia and down-titration/discontinuation of spironolactone.Although underpowered for clinical outcomes, more participants had HF events with SZC than placebo, which should be factored into the clinical decision making.
背景矿物皮质激素受体拮抗剂（MRA）可改善射血分数降低型心力衰竭（HFrEF）患者的预后，但在临床实践中使用不足。目的 我们评估了环硅酸锆钠（SZC）在优化 HFrEF 和高钾血症患者使用螺内酯方面的效果。方法REALIZE-K（NCT04676646）是一项前瞻性、双盲、随机撤消试验，参加者均为高频低氧血症患者（NYHA II-IV；左心室射血分数≤40%），接受过最佳指南指导治疗（MRA除外），并存在或发生过由 MRA 引起的高钾血症。在开放标签试运行期间，参与者接受螺内酯滴定（目标值：50 毫克/天）；出现高钾血症者开始服用 SZC。服用 SZC 且螺内酯≥25 毫克/天的正常血钾患者（血钾 3.5-5.0 mEq/L）被随机分配至继续服用 SZC 或安慰剂，为期 6 个月。主要终点是最佳治疗反应（服用螺内酯≥25 毫克/天后无高钾血症抢救治疗的正常血钾[第 1-6 个月]）。对五个关键次要终点进行了分层测试。探索性终点包括判定的心血管死亡或HF恶化事件（住院和急诊）的复合终点。与安慰剂相比，SZC治疗参与者中获得最佳应答的比例更高（71% vs 36%；OR 4.45 [95% CI 2.89-6.86]；p<0.001）。SZC（与安慰剂相比）改善了前四个关键次要终点：服用随机剂量螺内酯且未接受抢救治疗的正常血钾（58% vs 23%；OR 4.58 [2.78-7.55]；p<0.001）、接受螺内酯≥25 mg/天（81% vs 50%；OR 4.33 [2.50-7.52]；p<0.001）、高钾血症发生时间（HR 0.51 [0.37-0.71]；p<0.001）、因高钾血症减少/停止使用螺内酯时间（HR 0.37 [0.17-0.73]；p=0.006）。6个月时的KCCQ-CSS没有组间差异（-1.01分[-6.64-4.63]；P=0.72）。SZC和安慰剂的不良事件发生率（64% vs 63%）和严重不良事件发生率（23% vs 22%）分别均衡。SZC组有11人（11%）发生冠心病死亡或HF恶化（1人发生冠心病死亡，10人发生HF事件），安慰剂组有3人（3%）发生冠心病死亡或HF恶化（1人发生冠心病死亡，2人发生HF事件；log-rank名义P=0.034）。结论 在患有高频低氧血症和高钾血症的参与者中，SZC可大幅提高在服用最佳螺内酯剂量时出现正常血钾的参与者比例，并降低高钾血症和螺内酯降量/停药的风险。虽然临床结果的馈源不足，但使用SZC发生高频事件的参与者多于使用安慰剂的参与者，临床决策时应考虑到这一点。
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