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IF 3.7 2区 医学
American heart journal Pub Date : 2025-02-01 DOI: 10.1016/S0002-8703(24)00326-0
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引用次数: 0
Novel markers of nocturnal hypoxemia in sleep apnea and heart failure with reduced ejection fraction (HFrEF) 睡眠呼吸暂停和射血分数降低性心力衰竭(HFrEF)夜间低氧血症的新标记物。
IF 3.7 2区 医学
American heart journal Pub Date : 2025-02-01 DOI: 10.1016/j.ahj.2024.08.006
Gonzalo Labarca MS, MD
{"title":"Novel markers of nocturnal hypoxemia in sleep apnea and heart failure with reduced ejection fraction (HFrEF)","authors":"Gonzalo Labarca MS, MD","doi":"10.1016/j.ahj.2024.08.006","DOIUrl":"10.1016/j.ahj.2024.08.006","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"280 ","pages":"Pages 101-103"},"PeriodicalIF":3.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999229","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}
引用次数: 0
Response to Madias Je “can currently available data on takotsubo syndrome therapies guide us to manage future cases? 对 Madias Je "关于塔克次博综合征疗法的现有数据能否指导我们管理未来的病例?
IF 3.7 2区 医学
American heart journal Pub Date : 2025-02-01 DOI: 10.1016/j.ahj.2024.11.002
Francesco Santoro MD, PhD , Luca Arcari MD , Natale Daniele Brunetti MD, PhD
{"title":"Response to Madias Je “can currently available data on takotsubo syndrome therapies guide us to manage future cases?","authors":"Francesco Santoro MD, PhD , Luca Arcari MD , Natale Daniele Brunetti MD, PhD","doi":"10.1016/j.ahj.2024.11.002","DOIUrl":"10.1016/j.ahj.2024.11.002","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"280 ","pages":"Page 100"},"PeriodicalIF":3.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142799133","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}
引用次数: 0
Heart failure and nocturnal hypoxemic burden, the connection is getting closer and closer 心力衰竭与夜间低氧负担的关系越来越密切。
IF 3.7 2区 医学
American heart journal Pub Date : 2025-02-01 DOI: 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}
引用次数: 0
Can currently available data on takotsubo syndrome therapies guide us to manage future cases? 目前可获得的takotsubo综合征治疗数据能否指导我们管理未来的病例?
IF 3.7 2区 医学
American heart journal Pub Date : 2025-02-01 DOI: 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}
引用次数: 0
Towards a person-centered after-visit summary to facilitate improved heart failure care (HF-AVS): A scoping review and call to action 以人为中心的访后总结促进改善心力衰竭护理(HF-AVS):范围回顾和行动呼吁。
IF 3.7 2区 医学
American heart journal Pub Date : 2025-01-30 DOI: 10.1016/j.ahj.2025.01.015
Judah Kreinbrook BS , Edward Rego MPH , Lindsay Schlichte MD , Stephanie Barnes MSN , Robert J. Mentz MD
{"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 ,&nbsp;Edward Rego MPH ,&nbsp;Lindsay Schlichte MD ,&nbsp;Stephanie Barnes MSN ,&nbsp;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}
引用次数: 0
Characterizing high-risk enrollment criteria and impact on clinical outcomes in a large randomized clinical trial: Insights from the TWILIGHT trial 在一项大型随机临床试验中确定高风险入组标准及其对临床结果的影响:来自TWILIGHT试验的见解
IF 3.7 2区 医学
American heart journal Pub Date : 2025-01-30 DOI: 10.1016/j.ahj.2025.01.016
Philippe Gabriel Steg MD , Johny Nicolas MD, MSc , Usman Baber MD, MS , Samantha Sartori PhD , Zhongjie Zhang MPH , Yihan Feng MS , Dominick J. Angiolillo MD, PhD , Carlo Briguori MD, PhD , David J. Cohen MD, MSc , Timothy Collier MSc , George Dangas MD,PhD , Dariusz Dudek MD, PhD , Javier Escaned MD, PhD , C. Michael Gibson MD, MSc , Ya-Ling Han MD, PhD , Kurt Huber MD , Adnan Kastrati MD , Upendra Kaul MD , Steven O. Marx MD , Ran Kornowski MD , Roxana Mehran MD
{"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 MD ,&nbsp;Johny Nicolas MD, MSc ,&nbsp;Usman Baber MD, MS ,&nbsp;Samantha Sartori PhD ,&nbsp;Zhongjie Zhang MPH ,&nbsp;Yihan Feng MS ,&nbsp;Dominick J. Angiolillo MD, PhD ,&nbsp;Carlo Briguori MD, PhD ,&nbsp;David J. Cohen MD, MSc ,&nbsp;Timothy Collier MSc ,&nbsp;George Dangas MD,PhD ,&nbsp;Dariusz Dudek MD, PhD ,&nbsp;Javier Escaned MD, PhD ,&nbsp;C. Michael Gibson MD, MSc ,&nbsp;Ya-Ling Han MD, PhD ,&nbsp;Kurt Huber MD ,&nbsp;Adnan Kastrati MD ,&nbsp;Upendra Kaul MD ,&nbsp;Steven O. Marx MD ,&nbsp;Ran Kornowski MD ,&nbsp;Roxana Mehran MD","doi":"10.1016/j.ahj.2025.01.016","DOIUrl":"10.1016/j.ahj.2025.01.016","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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 &gt; 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).</div></div><div><h3>Conclusions</h3><div>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.</div></div><div><h3>Clinical trial registration</h3><div>The trial was registered with ClinicalTrials.gov, NCT02270242.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"286 ","pages":"Pages 97-107"},"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}
引用次数: 0
Study protocol for the healthy family program on population blood pressure: A multicenter, parallel group, cluster randomized, controlled trial in rural China 健康家庭计划对人口血压的研究方案:中国农村多中心、平行组、聚类随机对照试验
IF 3.7 2区 医学
American heart journal Pub Date : 2025-01-28 DOI: 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
{"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 ,&nbsp;Chao Jiang MD ,&nbsp;Jiakun Guo MSc ,&nbsp;Yueyuan Li MAE ,&nbsp;Chi Wang PhD ,&nbsp;Shuk Han Chu MPH ,&nbsp;Zhiyan Wang MD ,&nbsp;Yanfang Wu MD ,&nbsp;Chang Hua MD ,&nbsp;Yanmei Lu PhD ,&nbsp;Shuai Zhang BS ,&nbsp;Yanna Song BS ,&nbsp;Rong Han ME ,&nbsp;Jianzeng Dong MD ,&nbsp;Changsheng Ma MD ,&nbsp;Jun Cai MD ,&nbsp;Craig S. Anderson MD PhD ,&nbsp;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}
引用次数: 0
How the COAPT trial affected the selection of patients with secondary mitral regurgitation undergoing transcatheter edge-to-edge repair: insights from the GIOTTO registry COAPT试验如何影响继发性二尖瓣返流患者接受经导管边缘到边缘修复的选择:来自GIOTTO Registry的见解。
IF 3.7 2区 医学
American heart journal Pub Date : 2025-01-27 DOI: 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
{"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 ,&nbsp;Marco Di Maio MD, PhD ,&nbsp;Luca Esposito MD ,&nbsp;Michele Bellino MD ,&nbsp;Angelo Silverio MD, PhD ,&nbsp;Marianna Adamo MD, PhD ,&nbsp;Antonio Popolo Rubbio MD ,&nbsp;Francesco De Felice MD ,&nbsp;Arturo Giordano MD ,&nbsp;Carmelo Grasso MD ,&nbsp;Paolo Denti MD ,&nbsp;Cosmo Godino MD ,&nbsp;Federico De Marco MD, PhD ,&nbsp;Fausto Castriota MD ,&nbsp;Ida Monteforte MD ,&nbsp;Annalisa Mongiardo MD ,&nbsp;Anna Sonia Petronio MD, PhD ,&nbsp;Gabriele Crimi MD ,&nbsp;Emmanuel Villa MD ,&nbsp;Antonio L. Bartorelli MD, PhD ,&nbsp;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> &lt; .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}
引用次数: 0
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 联合西罗莫司洗脱和内皮祖细胞combtm支架与生物莫司洗脱可吸收聚合物涂层BioMatrix AlphaTM支架在经皮冠状动脉介入治疗中的随机比较斯堪的纳维亚临床结果随机试验组织(SORT OUT) XI试验的基本原理和研究设计:SORT OUT XI试验设计。
IF 3.7 2区 医学
American heart journal Pub Date : 2025-01-25 DOI: 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
{"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 ,&nbsp;Evald Høj Christiansen MD PhD ,&nbsp;Jens Flensted Lassen MD PhD ,&nbsp;Bent Raungaard MD PhD ,&nbsp;Lars Jakobsen MD PhD ,&nbsp;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}
引用次数: 0
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