Xiao-Fei Gao, Jing Kan, Hao-Yu Wu, Jing Chen, Xiang Chen, Shang-Yu Wen, Yong-Tai Gong, Qian Tong, Jun Luo, Yi-Bing Shao, Badar Ul Ahad Gill, Fazila Tun Nesa Malik, Teguh Santoso, Ramesh Daggubati, Alfredo E Rodriguez, Lavarra Francesco, Afzalur Rahman, Imad Sheiban, Sasko Kedev, Muhammad Munawar, Tak W Kwan, Yan Wang, Fei Ye, Jun-Jie Zhang, Xi-Ling Shou, Shao-Liang Chen
{"title":"Intravascular Imaging-guided versus Angiography-guided Percutaneous Coronary Intervention in Patients with Diabetes Mellitus: Rationale and design of an International, Multicenter, Randomized IVI-DIABETES Trial.","authors":"Xiao-Fei Gao, Jing Kan, Hao-Yu Wu, Jing Chen, Xiang Chen, Shang-Yu Wen, Yong-Tai Gong, Qian Tong, Jun Luo, Yi-Bing Shao, Badar Ul Ahad Gill, Fazila Tun Nesa Malik, Teguh Santoso, Ramesh Daggubati, Alfredo E Rodriguez, Lavarra Francesco, Afzalur Rahman, Imad Sheiban, Sasko Kedev, Muhammad Munawar, Tak W Kwan, Yan Wang, Fei Ye, Jun-Jie Zhang, Xi-Ling Shou, Shao-Liang Chen","doi":"10.1016/j.ahj.2025.01.017","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.01.017","url":null,"abstract":"<p><strong>Background: </strong>Intravascular imaging (IVI)- guided percutaneous coronary intervention (PCI) can improve clinical outcomes compared with angiography guidance in patients with complex lesions or acute coronary syndrome. However, the impact of this approach among diabetic patients remains unknown.</p><p><strong>Trial design: </strong>IVI-DIABETES trial is an investigator-initiated, prospective, international, multicenter, randomized trial, involving at least 30 sites, aiming to enroll 1,332 diabetic patients with obstructive coronary artery disease undergoing PCI. All enrolled patients are randomly assigned in a 1:1 fashion to undergo IVI- guided PCI or angiography- guided PCI. The choice between intravascular ultrasound or optical coherence tomography is at the discretion of the operator. The primary endpoint is target vessel failure (TVF) at 12 months, defined by the composite of cardiac death, target vessel myocardial infarction (MI), or clinically-driven target vessel revascularization. The major secondary endpoint is TVF without procedure-related MI. After hospital discharge, follow-up is conducted through clinical visits or telephone contact at 1, 6, and 12 months. The follow-up will continue annually until 5 years after the index procedure to assess the long-term outcomes.</p><p><strong>Conclusion: </strong>IVI-DIABETES trial is the first study designed to investigate the clinical efficacy and safety of IVI-guided PCI in diabetic patients compared to angiography-guided PCI.</p><p><strong>Trial registration: </strong>clinicaltrials.gov, NCT06380868.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143363488","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}
Geng Wang, Ruiyan Zhang, Shao-Liang Chen, Jian'an Wang, Yi Li, Ming Zheng, Ruifen Cao, Yitong Ma, Zhiqi Sun, Xueqi Li, Xi Su, Wen Lu, Yawei Xu, Xue Li, Yang Li, Fucheng Sun, Yaling Han
{"title":"Targeted Therapy with a Localized abluminal Groove Low-Dose Sirolimus-Eluting Bioabsorbable Polymer Coronary Stent in Chronic Total Occlusions: The TARGET CTO Non-Inferiority Randomized Trial.","authors":"Geng Wang, Ruiyan Zhang, Shao-Liang Chen, Jian'an Wang, Yi Li, Ming Zheng, Ruifen Cao, Yitong Ma, Zhiqi Sun, Xueqi Li, Xi Su, Wen Lu, Yawei Xu, Xue Li, Yang Li, Fucheng Sun, Yaling Han","doi":"10.1016/j.ahj.2025.01.018","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.01.018","url":null,"abstract":"<p><strong>Background: </strong>Our objective was to compare the efficacy and safety of a drug-eluting stent featuring an abluminal bioabsorbable sirolimus-containing polymer coating (BP-SES) with an everolimus-eluting stent with a durable polymer (DP-EES) in patients undergoing percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs).</p><p><strong>Methods: </strong>TARGET CTO is a multi-center, open-label, non-inferiority trial that randomized patients to either BP-SES or DP-EES in a 1:1 fashion following successful CTO re-canalization. The primary endpoint that was powered for non-inferiority assessment is in-stent late lumen loss (LLL) at 12 months.</p><p><strong>Results: </strong>A total of 206 subjects underwent randomization, with 103 assigned to the BP-SES group and 103 to the DP-EES group. Baseline clinical and angiographic characteristics were comparable. The primary endpoint demonstrated non-inferiority for the BP-SES group compared to the DP-EES group (0.21±0.43 mm vs. 0.21±0.33 mm; p=0.934, 2-sided; difference 0.01mm [BP-SES minus DP-EES]; 95% CI: -0.13 to 0.12 mm; p non-inferiority <0.001,1-sided). No significant differences were observed in secondary angiographic or clinical endpoints. The rates of 12-month in-stent and in-segment binary restenosis in the BP-SES group and the DP-EES group were similar (6.8% vs. 7.5%, p=0.86; and 8.1% vs. 8.8%; p=0.89, respectively). Although there was a trend favoring the BP-SES group, the difference between the BP-SES group and DP-EES group at 12 months in target lesion failure (2.1% vs. 8.0%, p=0.054) and target lesion revascularization (2.1% vs. 7.1%, p=0.089) did not reach statistical significance. No definite or probable stent thromboses were reported in either group.</p><p><strong>Conclusions: </strong>Compared to DP-EES, PCI of CTOs with BP-SES showed similar results in terms of late loss and binary restenosis at the 12-month follow-up.</p><p><strong>Clinical trial: </strong>ClinictalTrial.gov, number NCT03040934.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254235","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}
M Julia Machline-Carrion, Alysson Nathan Girotto, Priscila Raupp, Pedro Marton Pereira, Frederico Monfardini, Raul D Santos, Karla Santo, Kausik Ray, Christopher P Cannon, Otávio Berwanger
{"title":"Rationale, design and pre-randomization data for a cluster randomized trial to assess the effect of a digitally enabled quality improvement intervention on LDL-C control in established atherosclerotic cardiovascular disease patients: The SAPPHIRE-LDL Trial.","authors":"M Julia Machline-Carrion, Alysson Nathan Girotto, Priscila Raupp, Pedro Marton Pereira, Frederico Monfardini, Raul D Santos, Karla Santo, Kausik Ray, Christopher P Cannon, Otávio Berwanger","doi":"10.1016/j.ahj.2025.01.019","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.01.019","url":null,"abstract":"<p><strong>Background: </strong>Translating evidence into clinical practice in the management of established atherosclerotic cardiovascular disease patients is challenging. Few quality improvement interventions have successfully improved patient care.</p><p><strong>Objectives: </strong>The main objectives are to evaluate the impact of a digitally enabled multifaceted quality improvement (QI) intervention on the control of LDL-cholesterol (LDL-C) in atherosclerotic cardiovascular disease (ASCVD).</p><p><strong>Design: </strong>We designed a pragmatic two-arm cluster randomized trial involving 28 clusters (outpatient clinics from public or private hospitals or private practices). Clusters are randomized to receive a digitally enabled multifaceted QI intervention or to routine practice (control). The QI intervention includes reminders, electronic clinical decision support algorithms, audit and feedback reports, and distribution of educational materials to health care providers, as well as electronic educational materials and app-based tools for drug adherence control, lipid profile control, and communication to participants. The primary endpoint is the LDL-C at 06 months after the intervention period. All analyses are performed following the intention-to-treat principle and take the cluster design into consideration by using individual-level regression modeling (generalized estimating equations-GEE).</p><p><strong>Summary: </strong>If proven effective, this low-cost, digitally enabled multifaceted QI intervention would be highly useful in promoting optimal LDL-C control in ASCVD patients.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05622929.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254174","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}
{"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}
{"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}
{"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}
Judah Kreinbrook, Edward Rego, Lindsay Schlichte, Stephanie Barnes, Robert J Mentz
{"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, Edward Rego, Lindsay Schlichte, Stephanie Barnes, Robert J Mentz","doi":"10.1016/j.ahj.2025.01.015","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.01.015","url":null,"abstract":"<p><p>Person-centered care (PCC) has been advanced as an optimal model of 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 via MEDLINE (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, & 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 one abstractor and checked by at least one 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 reduction and streamlining workflows; however, barriers exist 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 pre-registered protocol. Future work is needed to increase the quality of the AVS evidence base.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-01-29","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}