Pub Date : 2025-02-01DOI: 10.1016/j.ahj.2024.08.012
Henrik Fox MD, FHFA
{"title":"Heart failure and nocturnal hypoxemic burden, the connection is getting closer and closer","authors":"Henrik Fox MD, FHFA","doi":"10.1016/j.ahj.2024.08.012","DOIUrl":"10.1016/j.ahj.2024.08.012","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"280 ","pages":"Pages 104-105"},"PeriodicalIF":3.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142046152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.ahj.2024.11.001
John E. Madias MD, FACC, FAHA
{"title":"Can currently available data on takotsubo syndrome therapies guide us to manage future cases?","authors":"John E. Madias MD, FACC, FAHA","doi":"10.1016/j.ahj.2024.11.001","DOIUrl":"10.1016/j.ahj.2024.11.001","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"280 ","pages":"Pages 98-99"},"PeriodicalIF":3.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142799131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-30DOI: 10.1016/j.ahj.2025.01.015
Judah Kreinbrook BS , Edward Rego MPH , Lindsay Schlichte MD , Stephanie Barnes MSN , Robert J. Mentz MD
Person-centered care (PCC) has been advanced as an optimal model for chronic heart failure management in multiple guidelines. However, fulfilling the ideal of this model requires overcoming healthcare fragmentation via effective provider-to-patient communication. One potential communication tool is the after-visit summary (AVS), a core feature of modern electronic health records (EHR); however, little is known regarding its quality from a PCC lens and whether an optimal AVS for the heart failure (HF) population has been created previously. We evaluate the history of AVS use in U.S. healthcare as well as map the extent and type of evidence on its quality, stakeholder perspectives, and attempts to perform PCC-related modifications across various healthcare settings as well as in acute-on-chronic or chronic HF specifically, evaluating if a HF-specific AVS (HF-AVS) has been reported. A search of the peer-reviewed literature was conducted of MEDLINE (via Pubmed) and SCOPUS. Select gray literature was included if cited by peer-reviewed articles. Articles were included if they were: 1) written in English, 2) discussed an EHR-generated documented intended for provider-to-patient communication, and 3) were situated within the U.S. healthcare system. Two authors screened relevant articles, with disagreements resolved by consensus. If a resolution was not found the senior author broke ties. Data were extracted by 1 abstractor and checked by at least 1 additional abstractor. This scoping review found that the AVS became a part of the modern electronic health record via legislative action. Incentives for continued use are still in place. While AVS use is widespread its quality is poor, without the necessary readability for PCC models. Patient, provider, and care partner perspectives suggest the need to reduce medical jargon and streamline workflows; however, barriers exist at the level of EHR vendors, preventing large PCC modifications. In contrast, small “embeddable” interventions appear more likely to be successful. No HF-AVS was identified; however, the modification of an existing patient-oriented discharge summary for heart failure (PODS-HF) was present, warranting exploration of embedding the document into EHRs. One potential HF specific “embeddable” intervention is free text prompting patient initiation and up titration of guideline-directed medical therapy and routing to HF nursing and pharmacist teams. If pursued, teams should secure funding, collaborate with EHR vendors, and trial these interventions with objective medication and/or exercise adherence. Limitations to this scoping review are present including the lack of a preregistered protocol. Future work is needed to increase the quality of the AVS evidence base.
{"title":"Towards a person-centered after-visit summary to facilitate improved heart failure care (HF-AVS): A scoping review and call to action","authors":"Judah Kreinbrook BS , Edward Rego MPH , Lindsay Schlichte MD , Stephanie Barnes MSN , Robert J. Mentz MD","doi":"10.1016/j.ahj.2025.01.015","DOIUrl":"10.1016/j.ahj.2025.01.015","url":null,"abstract":"<div><div>Person-centered care (PCC) has been advanced as an optimal model for chronic heart failure management in multiple guidelines. However, fulfilling the ideal of this model requires overcoming healthcare fragmentation via effective provider-to-patient communication. One potential communication tool is the after-visit summary (AVS), a core feature of modern electronic health records (EHR); however, little is known regarding its quality from a PCC lens and whether an optimal AVS for the heart failure (HF) population has been created previously. We evaluate the history of AVS use in U.S. healthcare as well as map the extent and type of evidence on its quality, stakeholder perspectives, and attempts to perform PCC-related modifications across various healthcare settings as well as in acute-on-chronic or chronic HF specifically, evaluating if a HF-specific AVS (HF-AVS) has been reported. A search of the peer-reviewed literature was conducted of MEDLINE (via Pubmed) and SCOPUS. Select gray literature was included if cited by peer-reviewed articles. Articles were included if they were: 1) written in English, 2) discussed an EHR-generated documented intended for provider-to-patient communication, and 3) were situated within the U.S. healthcare system. Two authors screened relevant articles, with disagreements resolved by consensus. If a resolution was not found the senior author broke ties. Data were extracted by 1 abstractor and checked by at least 1 additional abstractor. This scoping review found that the AVS became a part of the modern electronic health record via legislative action. Incentives for continued use are still in place. While AVS use is widespread its quality is poor, without the necessary readability for PCC models. Patient, provider, and care partner perspectives suggest the need to reduce medical jargon and streamline workflows; however, barriers exist at the level of EHR vendors, preventing large PCC modifications. In contrast, small “embeddable” interventions appear more likely to be successful. No HF-AVS was identified; however, the modification of an existing patient-oriented discharge summary for heart failure (PODS-HF) was present, warranting exploration of embedding the document into EHRs. One potential HF specific “embeddable” intervention is free text prompting patient initiation and up titration of guideline-directed medical therapy and routing to HF nursing and pharmacist teams. If pursued, teams should secure funding, collaborate with EHR vendors, and trial these interventions with objective medication and/or exercise adherence. Limitations to this scoping review are present including the lack of a preregistered protocol. Future work is needed to increase the quality of the AVS evidence base.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"283 ","pages":"Pages 53-69"},"PeriodicalIF":3.7,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143073162","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-30DOI: 10.1016/j.ahj.2025.01.016
Philippe Gabriel Steg, Johny Nicolas, Usman Baber, Samantha Sartori, Zhongjie Zhang, Yihan Feng, Dominick J Angiolillo, Carlo Briguori, David J Cohen, Timothy Collier, George Dangas, Dariusz Dudek, Javier Escaned, C Michael Gibson, Ya-Ling Han, Kurt Huber, Adnan Kastrati, Upendra Kaul, Steven O Marx, Ran Kornowski, Vijay Kunadian, Birgit Vogel, Angelo Oliva, Shamir R Mehta, David Moliterno, Gennaro Sardella, Mitchell Krucoff, Richard A Shlofmitz, Samin Sharma, Stuart Pocock, Roxana Mehran
Background: The TWILIGHT trial showed that, among high-risk patients who underwent percutaneous coronary intervention (PCI) and were event-free at 3 months, ticagrelor monotherapy versus ticagrelor plus aspirin reduced bleeding without increasing ischemic events.
Methods: This posthoc analysis describes the risk profiles and outcomes of patients enrolled in the TWILIGHT trial. The primary outcome was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding, and the key secondary outcome was a composite of death, myocardial infarction, or stroke within 1 year after randomization.
Results: The proportion of patients (n = 7,119) fulfilling ≤ 3, 4, 5, or ≥ 6 risk factors was 21.5%, 32.7%, 27.4%, and 18.4%, respectively. Troponin-positive acute coronary syndrome (ACS) was the most prevalent clinical criterion (64.9%), and multivessel disease (MVD) was the most prevalent angiographic criterion (66.5%). The most frequent intersection of criteria was the combination of troponin-positive ACS, atherosclerotic vascular disease, MVD, left main or proximal anterior descending lesion, and stent length > 30 mm. A stepwise increase in ischemic but not in bleeding risk was noted with an increasing number of high-risk criteria. Compared with ticagrelor plus aspirin, ticagrelor monotherapy reduced bleeding regardless of the number of risk factors (≤ 3-RF: 3.5% vs 5.8%, HR 0.59, 95% CI [0.38-0.93]; 4-RF: 3.7% vs 6.4%, HR 0.57, 95% CI [0.37-0.86]; 5-RF: 3.8% vs 8.6%, HR 0.44, 95% CI [0.29-0.66]; ≥ 6-RF: 5.3% vs 7.9%, HR 0.65, 95% CI [0.44-0.96]; p-interaction = .56) without significantly increasing the ischemic risk (≤ 3-RF: 1.6% vs 2.1%, HR 0.75, 95% CI [0.38-1.50]; 4-RF: 3.5% vs 2.2%, HR 1.58, 95% CI [0.91-2.75]; 5-RF: 4.1% vs 5.0%, HR 0.80, 95% CI [0.51-1.24]; ≥ 6-RF: 6.7% vs 6.9%, HR 0.98, 95% CI [0.67-1.43]; p-interaction = .22).
Conclusions: In the TWILIGHT trial, the high-risk features correlated more strongly with ischemic than with bleeding risk. Nonetheless, the benefits of ticagrelor compared with ticagrelor plus aspirin were consistent, irrespective of the number of high-risk features. These findings are only applicable to patients who are event-free at 3 months after PCI.
Clinical trial registration: The trial was registered with ClinicalTrials.gov, NCT02270242.
研究背景TWILIGHT试验显示，在接受经皮冠状动脉介入治疗（PCI）并在3个月内无事件发生的高危患者中，替卡格雷单药治疗与替卡格雷加阿司匹林治疗可减少出血而不增加缺血性事件：这项事后分析描述了 TWILIGHT 试验入组患者的风险概况和结果。主要结果是出血学术研究联合会（BARC）2、3或5型出血，关键的次要结果是随机化后一年内死亡、心肌梗死或中风的复合结果：符合≤3、4、5或≥6个危险因素的患者（人数=7119）比例分别为21.5%、32.7%、27.4%和18.4%。肌钙蛋白阳性的急性冠脉综合征（ACS）是最常见的临床标准（64.9%），多血管疾病（MVD）是最常见的血管造影标准（66.5%）。最常见的交叉标准是肌钙蛋白阳性 ACS、动脉粥样硬化性血管疾病、MVD、左主干或前降支近端病变以及支架长度大于 30 毫米的组合。随着高危标准数量的增加，缺血风险逐步增加，但出血风险并未增加。与替卡格雷加阿司匹林相比，无论风险因素的数量如何，替卡格雷单药治疗都能减少出血（≤3-RF：3.5% vs. 5.8%，HR 0.59，95% CI [0.38-0.93]；4-RF：3.5% vs. 5.8%，HR 0.59，95% CI [0.38-0.93]）。38-0.93]；4-RF：3.7% vs. 6.4%，HR 0.57，95% CI [0.37-0.86]；5-RF：3.8% vs. 8.6%，HR 0.44，95% CI [0.29-0.66]；≥6-RF：5.3% vs. 7.9%，HR 0.65，95% CI [0.44-0.96]；p-交互作用=0.56），而不会显著增加缺血风险（≤3-RF：1.6% vs. 2.1%，HR 0.75，95% CI [0.38-1.50]；4-RF：3.5% vs. 2.2%，HR 1.58，95% CI [0.91-2.75]；5-RF：4.1% vs. 5.0%，HR 0.80，95% CI [0.51-1.24]；≥6-RF：6.7% vs. 6.9%，HR 0.98，95% CI [0.67-1.43]；P-交互作用=0.22）.结论：在 TWILIGHT 试验中，高危特征与缺血风险的相关性比与出血风险的相关性更强。尽管如此，与替卡格雷加阿司匹林相比，无论高危特征有多少，替卡格雷的获益都是一致的。这些发现仅适用于PCI术后3个月无事件发生的患者：该试验已在ClinicalTrials.gov注册，编号为NCT02270242。
{"title":"Characterizing high-risk enrollment criteria and impact on clinical outcomes in a large randomized clinical trial: Insights from the TWILIGHT trial.","authors":"Philippe Gabriel Steg, Johny Nicolas, Usman Baber, Samantha Sartori, Zhongjie Zhang, Yihan Feng, Dominick J Angiolillo, Carlo Briguori, David J Cohen, Timothy Collier, George Dangas, Dariusz Dudek, Javier Escaned, C Michael Gibson, Ya-Ling Han, Kurt Huber, Adnan Kastrati, Upendra Kaul, Steven O Marx, Ran Kornowski, Vijay Kunadian, Birgit Vogel, Angelo Oliva, Shamir R Mehta, David Moliterno, Gennaro Sardella, Mitchell Krucoff, Richard A Shlofmitz, Samin Sharma, Stuart Pocock, Roxana Mehran","doi":"10.1016/j.ahj.2025.01.016","DOIUrl":"10.1016/j.ahj.2025.01.016","url":null,"abstract":"<p><strong>Background: </strong>The TWILIGHT trial showed that, among high-risk patients who underwent percutaneous coronary intervention (PCI) and were event-free at 3 months, ticagrelor monotherapy versus ticagrelor plus aspirin reduced bleeding without increasing ischemic events.</p><p><strong>Methods: </strong>This posthoc analysis describes the risk profiles and outcomes of patients enrolled in the TWILIGHT trial. The primary outcome was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding, and the key secondary outcome was a composite of death, myocardial infarction, or stroke within 1 year after randomization.</p><p><strong>Results: </strong>The proportion of patients (n = 7,119) fulfilling ≤ 3, 4, 5, or ≥ 6 risk factors was 21.5%, 32.7%, 27.4%, and 18.4%, respectively. Troponin-positive acute coronary syndrome (ACS) was the most prevalent clinical criterion (64.9%), and multivessel disease (MVD) was the most prevalent angiographic criterion (66.5%). The most frequent intersection of criteria was the combination of troponin-positive ACS, atherosclerotic vascular disease, MVD, left main or proximal anterior descending lesion, and stent length > 30 mm. A stepwise increase in ischemic but not in bleeding risk was noted with an increasing number of high-risk criteria. Compared with ticagrelor plus aspirin, ticagrelor monotherapy reduced bleeding regardless of the number of risk factors (≤ 3-RF: 3.5% vs 5.8%, HR 0.59, 95% CI [0.38-0.93]; 4-RF: 3.7% vs 6.4%, HR 0.57, 95% CI [0.37-0.86]; 5-RF: 3.8% vs 8.6%, HR 0.44, 95% CI [0.29-0.66]; ≥ 6-RF: 5.3% vs 7.9%, HR 0.65, 95% CI [0.44-0.96]; p-interaction = .56) without significantly increasing the ischemic risk (≤ 3-RF: 1.6% vs 2.1%, HR 0.75, 95% CI [0.38-1.50]; 4-RF: 3.5% vs 2.2%, HR 1.58, 95% CI [0.91-2.75]; 5-RF: 4.1% vs 5.0%, HR 0.80, 95% CI [0.51-1.24]; ≥ 6-RF: 6.7% vs 6.9%, HR 0.98, 95% CI [0.67-1.43]; p-interaction = .22).</p><p><strong>Conclusions: </strong>In the TWILIGHT trial, the high-risk features correlated more strongly with ischemic than with bleeding risk. Nonetheless, the benefits of ticagrelor compared with ticagrelor plus aspirin were consistent, irrespective of the number of high-risk features. These findings are only applicable to patients who are event-free at 3 months after PCI.</p><p><strong>Clinical trial registration: </strong>The trial was registered with ClinicalTrials.gov, NCT02270242.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143073161","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-28DOI: 10.1016/j.ahj.2025.01.014
Yangyang Tang MD , Chao Jiang MD , Jiakun Guo MSc , Yueyuan Li MAE , Chi Wang PhD , Shuk Han Chu MPH , Zhiyan Wang MD , Yanfang Wu MD , Chang Hua MD , Yanmei Lu PhD , Shuai Zhang BS , Yanna Song BS , Rong Han ME , Jianzeng Dong MD , Changsheng Ma MD , Jun Cai MD , Craig S. Anderson MD PhD , Xin Du MD PhD
Background
We aim to determine the effectiveness of a community-based, health instructor led, multifaceted family intervention, as compared with usual care, on blood pressure (BP) management among Chinese rural residents, with or without hypertension.
Methods/Design
The Healthy Family Program is a cluster randomized controlled trial being undertaken in 80 villages (each with approximately 100 residents) with a target to enroll a total of 8000 older adults (aged 40-80 years). Villages were randomly assigned in a 1:1 ratio to either an intervention group to receive multifaceted strategies or a control group to continue with usual standard of care. The main components of the multifaceted intervention strategies include: (1) Establishing a BP management team led by family health instructors, with team members including family leaders and village doctors, and (2) Implementing an intervention that focused on 6 areas: education for a healthy lifestyle, free provision of sodium substitute, weight management, physical exercise, BP monitoring, and appropriate antihypertensive treatment for individuals with hypertension. The primary outcome is change in systolic BP from baseline to 6 months in all participants, reported as the absolute difference between intervention and control groups. After the 6-month intervention, support from the study coordination center and the distribution of low-sodium salt will be withdrawn, and all participants will be followed up until 12 months. As of December 31, 2024, 24 villages in the intervention group have completed the 6-month intervention.
Conclusion
The Healthy Family Program will provide critically important data on the effectiveness of a novel BP management strategy in rural China.
Trial Registration
The study is registered at ClinicalTrials.gov (NCT06427096).
{"title":"Study protocol for the healthy family program on population blood pressure: A multicenter, parallel group, cluster randomized, controlled trial in rural China","authors":"Yangyang Tang MD , Chao Jiang MD , Jiakun Guo MSc , Yueyuan Li MAE , Chi Wang PhD , Shuk Han Chu MPH , Zhiyan Wang MD , Yanfang Wu MD , Chang Hua MD , Yanmei Lu PhD , Shuai Zhang BS , Yanna Song BS , Rong Han ME , Jianzeng Dong MD , Changsheng Ma MD , Jun Cai MD , Craig S. Anderson MD PhD , Xin Du MD PhD","doi":"10.1016/j.ahj.2025.01.014","DOIUrl":"10.1016/j.ahj.2025.01.014","url":null,"abstract":"<div><h3>Background</h3><div>We aim to determine the effectiveness of a community-based, health instructor led, multifaceted family intervention, as compared with usual care, on blood pressure (BP) management among Chinese rural residents, with or without hypertension.</div></div><div><h3>Methods/Design</h3><div>The Healthy Family Program is a cluster randomized controlled trial being undertaken in 80 villages (each with approximately 100 residents) with a target to enroll a total of 8000 older adults (aged 40-80 years). Villages were randomly assigned in a 1:1 ratio to either an intervention group to receive multifaceted strategies or a control group to continue with usual standard of care. The main components of the multifaceted intervention strategies include: (1) Establishing a BP management team led by family health instructors, with team members including family leaders and village doctors, and (2) Implementing an intervention that focused on 6 areas: education for a healthy lifestyle, free provision of sodium substitute, weight management, physical exercise, BP monitoring, and appropriate antihypertensive treatment for individuals with hypertension. The primary outcome is change in systolic BP from baseline to 6 months in all participants, reported as the absolute difference between intervention and control groups. After the 6-month intervention, support from the study coordination center and the distribution of low-sodium salt will be withdrawn, and all participants will be followed up until 12 months. As of December 31, 2024, 24 villages in the intervention group have completed the 6-month intervention.</div></div><div><h3>Conclusion</h3><div>The Healthy Family Program will provide critically important data on the effectiveness of a novel BP management strategy in rural China.</div></div><div><h3>Trial Registration</h3><div>The study is registered at ClinicalTrials.gov (NCT06427096).</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"283 ","pages":"Pages 70-80"},"PeriodicalIF":3.7,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063337","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-27DOI: 10.1016/j.ahj.2025.01.013
Cesare Baldi MD , Marco Di Maio MD, PhD , Luca Esposito MD , Michele Bellino MD , Angelo Silverio MD, PhD , Marianna Adamo MD, PhD , Antonio Popolo Rubbio MD , Francesco De Felice MD , Arturo Giordano MD , Carmelo Grasso MD , Paolo Denti MD , Cosmo Godino MD , Federico De Marco MD, PhD , Fausto Castriota MD , Ida Monteforte MD , Annalisa Mongiardo MD , Anna Sonia Petronio MD, PhD , Gabriele Crimi MD , Emmanuel Villa MD , Antonio L. Bartorelli MD, PhD , Francesco Bedogni MD
Background
The impact of the COAPT results on clinical practice has not yet been investigated in large real-world cohort study. The aim of the study is to evaluate the potential impact of the COAPT trial by analyzing the temporal trends of baseline characteristics and outcome of secondary mitral regurgitation (SMR) patients undergoing MitraClip (MC) included in the GIOTTO registry.
Methods
The study population was divided into 2 groups, considering the enrolment before or after the COAPT publication. Temporal trend analyses were performed to evaluate the changes in baseline patients’ characteristics and clinical outcome over time, and whether the COAPT publication influenced these changes. The outcome measure was the composite of hospitalization for heart failure (HF) and all-cause death at 1 year.
Results
The analysis included 1184 consecutive SMR patients treated with MC at 19 Italian centres between January 2016 and March 2020, 809 (68.3%) in the pre-COAPT group and 375 (31.7%) in the post-COAPT group. Temporal trend analyses showed a decreasing trend for New York Heart Association (NYHA) class (P = .003), hemoglobin (P = .014), and a significant upward trend for left ventricular ejection fraction (P < .001) and peripheral arterial disease (PAD, P = .046). The publication of the COAPT trial impacted only on NYHA trend. Nonsignificant differences in the composite outcome were observed between groups (P = .086).
Conclusions
The selection process of SMR patients undergoing MC changed over time, with a significant impact of the COAPT publication mainly on the trend of NYHA class. At 1-year, patients in the post-COAPT group showed a nonsignificant reduction in the incidence of hospitalization for HF and all-cause death.
{"title":"How the COAPT trial affected the selection of patients with secondary mitral regurgitation undergoing transcatheter edge-to-edge repair: insights from the GIOTTO registry","authors":"Cesare Baldi MD , Marco Di Maio MD, PhD , Luca Esposito MD , Michele Bellino MD , Angelo Silverio MD, PhD , Marianna Adamo MD, PhD , Antonio Popolo Rubbio MD , Francesco De Felice MD , Arturo Giordano MD , Carmelo Grasso MD , Paolo Denti MD , Cosmo Godino MD , Federico De Marco MD, PhD , Fausto Castriota MD , Ida Monteforte MD , Annalisa Mongiardo MD , Anna Sonia Petronio MD, PhD , Gabriele Crimi MD , Emmanuel Villa MD , Antonio L. Bartorelli MD, PhD , Francesco Bedogni MD","doi":"10.1016/j.ahj.2025.01.013","DOIUrl":"10.1016/j.ahj.2025.01.013","url":null,"abstract":"<div><h3>Background</h3><div>The impact of the COAPT results on clinical practice has not yet been investigated in large real-world cohort study. The aim of the study is to evaluate the potential impact of the COAPT trial by analyzing the temporal trends of baseline characteristics and outcome of secondary mitral regurgitation (SMR) patients undergoing MitraClip (MC) included in the GIOTTO registry.</div></div><div><h3>Methods</h3><div>The study population was divided into 2 groups, considering the enrolment before or after the COAPT publication. Temporal trend analyses were performed to evaluate the changes in baseline patients’ characteristics and clinical outcome over time, and whether the COAPT publication influenced these changes. The outcome measure was the composite of hospitalization for heart failure (HF) and all-cause death at 1 year.</div></div><div><h3>Results</h3><div>The analysis included 1184 consecutive SMR patients treated with MC at 19 Italian centres between January 2016 and March 2020, 809 (68.3%) in the pre-COAPT group and 375 (31.7%) in the post-COAPT group. Temporal trend analyses showed a decreasing trend for New York Heart Association (NYHA) class (<em>P</em> = .003), hemoglobin (<em>P</em> = .014), and a significant upward trend for left ventricular ejection fraction (<em>P</em> < .001) and peripheral arterial disease (PAD, <em>P</em> = .046). The publication of the COAPT trial impacted only on NYHA trend. Nonsignificant differences in the composite outcome were observed between groups (<em>P</em> = .086).</div></div><div><h3>Conclusions</h3><div>The selection process of SMR patients undergoing MC changed over time, with a significant impact of the COAPT publication mainly on the trend of NYHA class. At 1-year, patients in the post-COAPT group showed a nonsignificant reduction in the incidence of hospitalization for HF and all-cause death.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"283 ","pages":"Pages 43-52"},"PeriodicalIF":3.7,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-25DOI: 10.1016/j.ahj.2025.01.012
Ashkan Eftekhari MD PhD , Evald Høj Christiansen MD PhD , Jens Flensted Lassen MD PhD , Bent Raungaard MD PhD , Lars Jakobsen MD PhD , Lisette Okkels Jensen MD DMSci PhD
Rationale
The biodegradable polymer Biomatrix Alpha stent contains biolimus A9 drug which is a sirolimus derivative increased in lipophicity. The biodegradable polymer sirolimus eluting Combo stent is a dual-therapy sirolimus-eluting and CD34+ antibody coated stent capturing endothelial progenitor cells (EPCs).
Hypothesis
The main hypothesis of the SORT OUT XI trial was that the biodegradable polymer biolimus A9 Biomatrix Alpha stent is noninferior to the biodegradable polymer sirolimus eluting Combo stent in an all-comers population with coronary artery disease undergoing percutaneous coronary intervention (PCI).
Methods
The SORT OUT XI study was a randomized, multicenter, single blinded, all-comer, 2-arm, noninferiority trial comparing the biodegradable polymer biolimus A9 Biomatrix Alpha stent to the biodegradable polymer sirolimus eluting Combo stent in 3 Danish University Hospitals in Western Denmark. The composite primary endpoint was target lesion failure (TLF) within 12 months. TLF was defined as composite of cardiac death, myocardial infarction not related to other than index lesion or target lesion revascularization. Clinically driven event detection was used and no planned follow up was performed. With a sample size of 1,564 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level had a 90% power to detect noninferiority with a predetermined noninferiority margin of 2.1%.
Results
The trial ran from August 14, 2019 to March 19, 2023. A total of 3141 patients were enrolled and randomized 1:1 to Combo stent (n = 1,573) and Biomatrix Alpha stent (n = 1,568).
Conclusion
The SORT OUT XI trial will assess if the biolimus A9 eluting Biomatrix Alpha stent is noninferior to the dual-therapy Combo stent with respect to target lesion failure.
ClinicalTrials.gov
NCT03952273.
{"title":"Randomized comparison of the combined Sirolimus eluting and endothelial progenitor cell combo Stent vs. biolimus eluting absorbable polymer coated biomatrix alpha stent in patients undergoing percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for randomized trials with clinical outcome (SORT OUT) XI trial","authors":"Ashkan Eftekhari MD PhD , Evald Høj Christiansen MD PhD , Jens Flensted Lassen MD PhD , Bent Raungaard MD PhD , Lars Jakobsen MD PhD , Lisette Okkels Jensen MD DMSci PhD","doi":"10.1016/j.ahj.2025.01.012","DOIUrl":"10.1016/j.ahj.2025.01.012","url":null,"abstract":"<div><h3>Rationale</h3><div>The biodegradable polymer Biomatrix Alpha stent contains biolimus A9 drug which is a sirolimus derivative increased in lipophicity. The biodegradable polymer sirolimus eluting Combo stent is a dual-therapy sirolimus-eluting and CD34+ antibody coated stent capturing endothelial progenitor cells (EPCs).</div></div><div><h3>Hypothesis</h3><div>The main hypothesis of the SORT OUT XI trial was that the biodegradable polymer biolimus A9 Biomatrix Alpha stent is noninferior to the biodegradable polymer sirolimus eluting Combo stent in an all-comers population with coronary artery disease undergoing percutaneous coronary intervention (PCI).</div></div><div><h3>Methods</h3><div>The SORT OUT XI study was a randomized, multicenter, single blinded, all-comer, 2-arm, noninferiority trial comparing the biodegradable polymer biolimus A9 Biomatrix Alpha stent to the biodegradable polymer sirolimus eluting Combo stent in 3 Danish University Hospitals in Western Denmark. The composite primary endpoint was target lesion failure (TLF) within 12 months. TLF was defined as composite of cardiac death, myocardial infarction not related to other than index lesion or target lesion revascularization. Clinically driven event detection was used and no planned follow up was performed. With a sample size of 1,564 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level had a 90% power to detect noninferiority with a predetermined noninferiority margin of 2.1%.</div></div><div><h3>Results</h3><div>The trial ran from August 14, 2019 to March 19, 2023. A total of 3141 patients were enrolled and randomized 1:1 to Combo stent (n = 1,573) and Biomatrix Alpha stent (n = 1,568).</div></div><div><h3>Conclusion</h3><div>The SORT OUT XI trial will assess if the biolimus A9 eluting Biomatrix Alpha stent is noninferior to the dual-therapy Combo stent with respect to target lesion failure.</div></div><div><h3>ClinicalTrials.gov</h3><div>NCT03952273.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"283 ","pages":"Pages 37-42"},"PeriodicalIF":3.7,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-25DOI: 10.1016/j.ahj.2025.01.011
Thanat Chaikijurajai MD , Horng H. Chen MBBCh , W.H. Wilson Tang MD
Background
We aim to validate NT-proBNP nonresponse score (NNRS) previously derived from the PROTECT and BATTLESCARRED studies in comparison with standard health status measures in predicting natriuretic peptide responses in patients with heart failure with reduced ejection fraction.
Methods
Data on the GUIDE-IT trial were used to derive the NNRS based on 4 predictors including baseline NT-proBNP, heart rate, NYHA functional class, and history of atrial fibrillation. The discriminative capacity of the NNRS and health status measures for having NT-proBNP >1,000 pg/mL at 12 months was assessed and compared with baseline or follow-up health status measures including Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS), Duke Activity Status Index (DASI), and 6-minute walk distance. Multivariable logistic regression analysis was used to determine the predictive value of the score and health status measures greater than the median values for NT-proBNP response with adjustment for age, sex, body mass index, comorbidities, baseline creatinine and NT-proBNP levels.
Results
Among 877 patients, 252 (28.7%) patients had NT-proBNP >1,000 pg/mL at 12 months. The discriminative capacity of the NT-proBNP nonresponse score was 0.72 (95% CI, 0.67-0.77). After adjusting for covariates, only NNRS (P = .044) and KCCQ-OSS (P = .002) remained predictive for NT-proBNP nonresponse at 12 months.
Conclusion
NT-proBNP nonresponse score and KCCQ-OSS was associated with persistently elevated NT-proBNP 12 months independently of baseline NT-proBNP levels.
{"title":"Baseline NT-proBNP nonresponse score and health status measures in assessing treatment responses in heart failure with reduced ejection fraction","authors":"Thanat Chaikijurajai MD , Horng H. Chen MBBCh , W.H. Wilson Tang MD","doi":"10.1016/j.ahj.2025.01.011","DOIUrl":"10.1016/j.ahj.2025.01.011","url":null,"abstract":"<div><h3>Background</h3><div>We aim to validate NT-proBNP nonresponse score (NNRS) previously derived from the PROTECT and BATTLESCARRED studies in comparison with standard health status measures in predicting natriuretic peptide responses in patients with heart failure with reduced ejection fraction.</div></div><div><h3>Methods</h3><div>Data on the GUIDE-IT trial were used to derive the NNRS based on 4 predictors including baseline NT-proBNP, heart rate, NYHA functional class, and history of atrial fibrillation. The discriminative capacity of the NNRS and health status measures for having NT-proBNP >1,000 pg/mL at 12 months was assessed and compared with baseline or follow-up health status measures including Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS), Duke Activity Status Index (DASI), and 6-minute walk distance. Multivariable logistic regression analysis was used to determine the predictive value of the score and health status measures greater than the median values for NT-proBNP response with adjustment for age, sex, body mass index, comorbidities, baseline creatinine and NT-proBNP levels.</div></div><div><h3>Results</h3><div>Among 877 patients, 252 (28.7%) patients had NT-proBNP >1,000 pg/mL at 12 months. The discriminative capacity of the NT-proBNP nonresponse score was 0.72 (95% CI, 0.67-0.77). After adjusting for covariates, only NNRS (<em>P</em> = .044) and KCCQ-OSS (<em>P</em> = .002) remained predictive for NT-proBNP nonresponse at 12 months.</div></div><div><h3>Conclusion</h3><div>NT-proBNP nonresponse score and KCCQ-OSS was associated with persistently elevated NT-proBNP 12 months independently of baseline NT-proBNP levels.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"283 ","pages":"Pages 17-25"},"PeriodicalIF":3.7,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-23DOI: 10.1016/j.ahj.2025.01.010
David E. Kandzari MD , Azeem Latib MD , Darren Mylotte MD, PhD , Ziad A. Ali MD, DPhil , Azfar Zaman MD , Sandeep Brar MD , Maria Parke MS , Bruno Scheller MD
Background and Rationale
In-stent restenosis (ISR) remains the leading cause of treatment failure following percutaneous coronary intervention (PCI) with contemporary drug-eluting stents. Especially in small caliber coronary arteries, restenosis is common following PCI and represents a treatment challenge. Drug-coated balloons (DCB) are an attractive alternative to stents for treatment of both ISR and small vessel disease. The safety and efficacy of the Prevail DCB will be assessed for (1) the treatment of ISR and (2) de novo lesions in small vessels.
Trial Design
Prevail Global is a prospective, international, dual cohort clinical study enrolling (1) patients undergoing PCI for ISR in a randomized controlled trial (1:1) design comparing the Prevail DCB versus an FDA-approved DCB (AgentTM, Boston Scientific Corporation, Natick MA), and (2) patients with de novo small vessel disease undergoing PCI with the Prevail DCB as part of a single-arm study compared with a historical control. The primary endpoint is target lesion failure, defined as a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization at 12 months post procedure. Patient follow-up is planned for 1 month, 6 months, and yearly through 5 years. Enrollment is expected to start in early 2025.
Conclusions
The Prevail Global study will directly assess the safety and efficacy of the Prevail DCB for the treatment of ISR and de novo small vessel lesions.
Trial Registration
Prevail Global, NCT06535854, is registered at https://clinicaltrials.gov/study/NCT06535854.
{"title":"Rationale and design of the prevail global trial program evaluating the prevail drug-coated balloon in patients with in-stent restenosis and de novo small vessel disease","authors":"David E. Kandzari MD , Azeem Latib MD , Darren Mylotte MD, PhD , Ziad A. Ali MD, DPhil , Azfar Zaman MD , Sandeep Brar MD , Maria Parke MS , Bruno Scheller MD","doi":"10.1016/j.ahj.2025.01.010","DOIUrl":"10.1016/j.ahj.2025.01.010","url":null,"abstract":"<div><h3>Background and Rationale</h3><div>In-stent restenosis (ISR) remains the leading cause of treatment failure following percutaneous coronary intervention (PCI) with contemporary drug-eluting stents. Especially in small caliber coronary arteries, restenosis is common following PCI and represents a treatment challenge. Drug-coated balloons (DCB) are an attractive alternative to stents for treatment of both ISR and small vessel disease. The safety and efficacy of the Prevail DCB will be assessed for (1) the treatment of ISR and (2) <em>de novo</em> lesions in small vessels.</div></div><div><h3>Trial Design</h3><div>Prevail Global is a prospective, international, dual cohort clinical study enrolling (1) patients undergoing PCI for ISR in a randomized controlled trial (1:1) design comparing the Prevail DCB versus an FDA-approved DCB (Agent<sup>TM</sup>, Boston Scientific Corporation, Natick MA), and (2) patients with <em>de novo</em> small vessel disease undergoing PCI with the Prevail DCB as part of a single-arm study compared with a historical control. The primary endpoint is target lesion failure, defined as a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization at 12 months post procedure. Patient follow-up is planned for 1 month, 6 months, and yearly through 5 years. Enrollment is expected to start in early 2025.</div></div><div><h3>Conclusions</h3><div>The Prevail Global study will directly assess the safety and efficacy of the Prevail DCB for the treatment of ISR and <em>de novo</em> small vessel lesions.</div></div><div><h3>Trial Registration</h3><div>Prevail Global, NCT06535854, is registered at <span><span>https://clinicaltrials.gov/study/NCT06535854</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"283 ","pages":"Pages 26-36"},"PeriodicalIF":3.7,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143035976","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-23DOI: 10.1016/j.ahj.2025.01.008
Moein Ebrahimi MD , Gregg C. Fonarow MD
{"title":"Higher levels of glucose within the normal range and cardiovascular risk: A landscape beyond diabetes and prediabetes","authors":"Moein Ebrahimi MD , Gregg C. Fonarow MD","doi":"10.1016/j.ahj.2025.01.008","DOIUrl":"10.1016/j.ahj.2025.01.008","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"283 ","pages":"Pages 1-4"},"PeriodicalIF":3.7,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143035975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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