American heart journal最新文献

{"title":"Cholesterol lowering therapy is highly efficacious in reducing atherosclerotic cardiovascular disease risk but grossly underutilized: How do we move the needle?","authors":"Todd M. Brown MD, MSPH","doi":"10.1016/j.ahj.2024.08.007","DOIUrl":"10.1016/j.ahj.2024.08.007","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"279 ","pages":"Pages 118-120"},"PeriodicalIF":3.7,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999228","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":"Information for Readers","authors":"","doi":"10.1016/S0002-8703(24)00191-1","DOIUrl":"10.1016/S0002-8703(24)00191-1","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"275 ","pages":"Page v"},"PeriodicalIF":3.7,"publicationDate":"2024-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141993688","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":"Safety and feasibility of triage and rapid discharge of patients with chest pain from emergency room: A pragmatic, randomized noninferiority control trial of the European Society of Cardiology (ESC) 0 to 1 hour pathway vs conventional 0 to 3 hour accelerated diagnostic protocol","authors":"Aleem Khand MD ,&nbsp;James Hatherley MBChB ,&nbsp;Ahmed Dakshi MBBCh ,&nbsp;Guy Miller BMBS ,&nbsp;Lisa Bailey PhD ,&nbsp;Michael Fisher MD, PhD ,&nbsp;Christopher Goulden MBBS ,&nbsp;Zaid Noori MBCHB ,&nbsp;Anju Rawat MSc ,&nbsp;Rachel Hornby BSC (hons) ,&nbsp;Hannah Fearon MSC ,&nbsp;Nirmol Meah MBBS ,&nbsp;Sarah Davies MChem ,&nbsp;Katarzyna Sekulska BAN ,&nbsp;Awtad Hassan BSC ,&nbsp;Angela Lambert BSC ,&nbsp;Suzannah Phillips PhD ,&nbsp;Ray Raj MRSEd ,&nbsp;Tom Wiles MBChB ,&nbsp;Paul Collinson MD","doi":"10.1016/j.ahj.2024.08.005","DOIUrl":"10.1016/j.ahj.2024.08.005","url":null,"abstract":"<div><div>Patients presenting with chest pain represent a significant proportion of Emergency Department (ED) attendances but only a minority, typically 10%, have a final diagnosis of myocardial infarction (MI). Prompt discharge of patients without MI will alleviate ED overcrowding as well as improve patient satisfaction and reduce exposure to risk of hospital acquired infections such as Covid 19.</div><div>The measurement of cardiac troponin (cTn) by a high sensitivity method is recommended by the National Institute for health and Care Excellence (NICE) for rapid categorization of patients presenting with chest pain. Strategies proposed include measurement on admission and 1 hour from admission (ESC <strong>0-1-hour pathway</strong>, the recent guideline approved pathway which has not been implemented widely), and measurement on admission and 3 hours from admission (<strong>0-3-hour pathway</strong>, which is conventional and widely adopted).</div><div>The <strong>primary objective</strong> of this study is twofold: firstly, to assess the safety, feasibility, and impact of implementing the ESC (European Society of Cardiology) 0 to 1-hour pathway in clinical practice by reference to the more established ESC 0 to 3-hour protocol. The principal outcome measure will be the safety of the ESC 0 to 1-hour protocol. However, there are concerns that the time from sample draw to result availability (typically around 60 minutes) will impact on the feasibility of the ESC 0 to 1-hour pathway. Secondly, therefore, our goal is to evaluate whether measurement of high sensitivity troponin by a bedside analyzer (point of care testing, POCT), which will produce results in 15 minutes is a feasible alternative to laboratory testing. We will compare the results produced by POCT with the laboratory results in the context of the ESC 0 to 1 hour and 0 to 3-hour pathway, as a nested controlled study in the context of a randomized controlled trial. (clinicaltrials.gov: <strong>NCT05322395).</strong></div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"278 ","pages":"Pages 235-247"},"PeriodicalIF":3.7,"publicationDate":"2024-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995056","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":"Sex differences and long-term clinical outcomes after transcatheter aortic valve replacement: A SWEDEHEART study","authors":"Michael Dismorr MD, PhD ,&nbsp;Malin Granbom-Koski MD ,&nbsp;Emma Ellfors MD ,&nbsp;Andreas Rück MD, PhD ,&nbsp;Magnus Settergren MD, PhD ,&nbsp;Ulrik Sartipy MD, PhD ,&nbsp;Natalie Glaser MD, PhD","doi":"10.1016/j.ahj.2024.07.018","DOIUrl":"10.1016/j.ahj.2024.07.018","url":null,"abstract":"<div><h3>Background</h3><p>Previous studies on the impact of sex differences after transcatheter aortic valve replacement (TAVR) have shown conflicting results. The aim was to analyze the risk of long-term mortality, heart failure hospitalization, myocardial infarction, stroke, bleeding and aortic valve reintervention in females versus males after TAVR.</p></div><div><h3>Methods</h3><p>This nationwide, population-based cohort study included all patients who underwent TAVR in Sweden between 2008 and 2022 from the SWEDEHEART register. Additional baseline and outcome data were gathered from other national health data registers. Regression standardization was used to adjust for differences between the sexes.</p></div><div><h3>Results</h3><p>Of 10,475 patients, 4,886 (47%) were female and 5,589 (53%) were male. The mean age was 81 years. The cumulative incidence of mortality at 1, 5, and 10 years was 8% vs. 10%, 38% vs. 45%, and 75% vs. 82% for females and males, respectively. After regression standardization, the risk of all-cause mortality was lower for females (absolute difference at 10 years of 6.4%, 95% confidence interval [CI] 4.4%-8.4%). The mean follow up was 3.1 years (maximum 14.1 years). Females also had a lower risk of major bleeding than males (absolute survival difference at 10 years of 4.0%, 95% CI 1.9%-6.2%), but there was no difference in the risk of heart failure, myocardial infarction, stroke, or reintervention between the sexes.</p></div><div><h3>Conclusions</h3><p>Females had a higher survival rate and a lower bleeding risk than males after TAVR. Sex-specific factors are important to consider in the management of patients after TAVR.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"277 ","pages":"Pages 27-38"},"PeriodicalIF":3.7,"publicationDate":"2024-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324001856/pdfft?md5=5b1302f1172c5ee7cd700a4f3bab2c86&pid=1-s2.0-S0002870324001856-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141915948","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}

{"title":"Use of artificial intelligence‐guided echocardiography to detect cardiac dysfunction and heart valve disease in rural and remote areas: Rationale and design of the AGILE‐echo trial","authors":"Cheng Hwee Soh PhD ,&nbsp;Leah Wright PhD ,&nbsp;Angus Baumann MBBS ,&nbsp;Bastian Seidel PhD ,&nbsp;Christopher Yu MBBS ,&nbsp;Mark Nolan PhD ,&nbsp;Tony Mylius MBBS ,&nbsp;Thomas H. Marwick PhD, MPH, MBBS ,&nbsp;AGILE-Echo investigators in Tasmania, Western New South Wales, Northern Victoria, Western Australia, Western Queensland and Northern Territory, Australia","doi":"10.1016/j.ahj.2024.08.004","DOIUrl":"10.1016/j.ahj.2024.08.004","url":null,"abstract":"<div><h3>Background</h3><p>Transthoracic echocardiography (TTE) is essential in the diagnosis of cardiovascular diseases (CVD), including but not limited to heart failure (HF) and heart valve disease (HVD). However, its dependence on expert acquisition means that its accessibility in rural areas may be limited, leading to delayed management decisions and potential missed diagnoses. Artificial intelligence-guided (AI)-TTE offers a solution by permitting non-expert image acquisition. The impact of AI-TTE on the timing of diagnosis and early initiation of cardioprotection is undefined.</p></div><div><h3>Methods</h3><p>AGILE-Echo (use of Artificial intelligence-Guided echocardiography to assIst cardiovascuLar patient managEment) is a randomized-controlled trial conducted in 5 rural and remote areas around Australia. Adults with CV risk factors and exercise intolerance, or concerns regarding HVD are randomized into AI-TTE or usual care (UC). AI-TTE participants may have a cardiovascular problem excluded, identified (leading to AI-guided interventions) or unresolved (leading to conventional TTE). UC participants undergo usual management, including referral for standard TTE. The primary endpoint is a composite of HVD or HF diagnosis at 12-months. Subgroup analysis, stratified based on age range and sex, will be conducted. All statistical analyses will be conducted using R.</p></div><div><h3>Results</h3><p>Of the first 157 participants, 78 have been randomized into AI-TTE (median age 68 [IQR 17]) and 79 to UC (median age 65 [IQR 17], <em>P</em> = .034). HVD was the primary concern in 37 participants (23.6%) while 84.7% (n = 133) experienced exercise intolerance. The overall 10-year HF incidence risk was 13.4% and 20.0% (<em>P</em> = .089) for UC and AI-TTE arm respectively. Atrial remodeling, left ventricular remodeling and valvular regurgitation were the most common findings. Thirty-three patients (42.3%) showed no abnormalities.</p></div><div><h3>Conclusions</h3><p>This randomized-controlled trial of AI-TTE will provide proof-of-concept for the role of AI-TTE in identifying pre-symptomatic HF or HVD when access to TTE is limited. Additionally, this could promote the usage of AI-TTE in rural or remote areas, ultimately improving health and quality of life of community dwelling adults with risks, signs or symptoms of cardiac dysfunction.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"277 ","pages":"Pages 11-19"},"PeriodicalIF":3.7,"publicationDate":"2024-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324001984/pdfft?md5=acf4880d1aa01bfb21665e274da1a066&pid=1-s2.0-S0002870324001984-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141915949","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}

{"title":"The pathophysiology of patent foramen ovale and its related complications","authors":"Ashish H. Shah MD, MD-Res, FRCP ,&nbsp;Eric M. Horlick MDDM ,&nbsp;Malek Kass MD ,&nbsp;John D. Carroll MD ,&nbsp;Richard A. Krasuski MD","doi":"10.1016/j.ahj.2024.08.001","DOIUrl":"10.1016/j.ahj.2024.08.001","url":null,"abstract":"<div><p>The foramen ovale plays a vital role in sustaining life in-utero; however, a patent foramen ovale (PFO) after birth has been associated with pathologic sequelae in the systemic circulation including stroke/transient ischemic attack (TIA), migraine, high altitude pulmonary edema, decompression illness, platypnea–orthodeoxia syndrome (POS) and worsened severity of obstructive sleep apnea. Importantly, each of these conditions is most commonly observed among specific age groups: migraine in the 20 to 40s, stroke/TIA in the 30-50s and POS in patients &gt;50 years of age. The common and central pathophysiologic mechanism in each of these conditions is PFO-mediated shunting of blood and its contents from the right to the left atrium. PFO-associated pathologies can therefore be divided into (1) paradoxical systemic embolization and (2) right to left shunting (RLS) of blood through the PFO. Missing in the extensive literature on these clinical syndromes are mechanistic explanations for the occurrence of RLS, including timing and the volume of blood shunted, the impact of age on RLS, and the specific anatomical pathway that blood takes from the venous system to the left atrium. Visualization of the flow pattern graphically illustrates the underlying RLS and provides a greater understanding of the critical flow dynamics that determine the frequency, volume, and pathway of flow. In the present review, we describe the important role of foramen ovale in in-utero physiology, flow visualization in patients with PFO, as well as contributing factors that work in concert with PFO to result in the diverse pathophysiological sequelae.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"277 ","pages":"Pages 76-92"},"PeriodicalIF":3.7,"publicationDate":"2024-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324001868/pdfft?md5=a9b1185019c75a26732edc3a124a271d&pid=1-s2.0-S0002870324001868-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141970493","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}

{"title":"A randomized comparison of the treatment sequence of percutaneous coronary intervention and transcatheter aortic valve implantation: Rationale and design of the TAVI PCI trial","authors":"Barbara E. Stähli MD, MPH, MBA ,&nbsp;Axel Linke MD ,&nbsp;Dirk Westermann MD ,&nbsp;Nicolas M. Van Mieghem MD ,&nbsp;David M. Leistner MD ,&nbsp;Steffen Massberg MD ,&nbsp;Hannes Alber MD ,&nbsp;Andreas Mügge MD ,&nbsp;Giuseppe Musumeci MD ,&nbsp;Rahel Kesterke PhD ,&nbsp;Steffen Schneider PhD ,&nbsp;Adnan Kastrati MD ,&nbsp;Ian Ford PhD ,&nbsp;Frank Ruschitzka MD ,&nbsp;Markus A. Kasel MD ,&nbsp;TAVI PCI Investigators,&nbsp;Barbara E. Stähli ,&nbsp;Markus Kasel ,&nbsp;Frank Ruschitzka ,&nbsp;Axel Linke ,&nbsp;Aldo Maggioni","doi":"10.1016/j.ahj.2024.07.019","DOIUrl":"10.1016/j.ahj.2024.07.019","url":null,"abstract":"<div><h3>Background</h3><p>About half of patients with severe aortic stenosis present with concomitant coronary artery disease. The optimal timing of percutaneous coronary intervention (PCI) and transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and concomitant coronary artery disease remains unknown.</p></div><div><h3>Study design</h3><p>The TAVI PCI trial is a prospective, international, multicenter, randomized, 2-arm, open-label study planning to enroll a total of 986 patients. It is designed to investigate whether the strategy “angiography-guided complete revascularization after (within 1-45 days) TAVI” is noninferior to the strategy “angiography-guided complete revascularization before (within 1-45 days) TAVI” using the Edwards SAPIEN 3 or 3 Ultra Transcatheter Heart Valve in patients with severe aortic stenosis and concomitant coronary artery disease. Patients are randomized in a 1:1 ratio to one of the 2 treatment strategies. The primary end point is a composite of all-cause death, nonfatal myocardial infarction, ischemia-driven revascularization, rehospitalization (valve- or procedure-related including heart failure), or life-threatening/disabling or major bleeding at 1 year.</p></div><div><h3>Conclusions</h3><p>The TAVI PCI trial tests the hypothesis that the strategy “PCI after TAVI” is noninferior to the strategy “PCI before TAVI” in patients with severe aortic stenosis and concomitant coronary artery disease.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"277 ","pages":"Pages 104-113"},"PeriodicalIF":3.7,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141911375","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":"Impact of sex on outcomes associated with polyvascular disease in patients after PCI","authors":"Birgit Vogel MD ,&nbsp;Stephanie Jou MD ,&nbsp;Samantha Sartori PhD,&nbsp;Serdar Farhan MD,&nbsp;Kenneth Smith MPH,&nbsp;Clayton Snyder MPH,&nbsp;Alessandro Spirito MD,&nbsp;Mashal Nathani MD,&nbsp;Katie Kenny Byrne MB BCh BAO,&nbsp;Raman Sharma MD,&nbsp;Prakash Krishnan MD,&nbsp;George Dangas MD, PhD,&nbsp;Annapoorna Kini MD,&nbsp;Samin Sharma MD,&nbsp;Roxana Mehran MD","doi":"10.1016/j.ahj.2024.08.002","DOIUrl":"10.1016/j.ahj.2024.08.002","url":null,"abstract":"<div><h3>Background</h3><p>Atherosclerosis in more than 1 vs. 1 arterial bed is associated with increased risk for major adverse cardiovascular events (MACE). This study aimed to determine whether the risk of post percutaneous coronary intervention (PCI) MACE associated with polyvascular disease (PVD) differs by sex.</p></div><div><h3>Methods</h3><p>We analyzed 18,721 patients undergoing PCI at a tertiary-care center between 2012 and 2019. Polyvascular disease was defined as history of peripheral artery and/or cerebrovascular disease. The primary endpoint was MACE, a composite of all-cause death, myocardial infarction, or stroke at 1 year. Multivariate Cox regression was used to adjust for differences in baseline risk between patients with PVD vs. coronary artery disease (CAD) alone and interaction testing was used to assess risk modification by sex.</p></div><div><h3>Results</h3><p>Women represented 29.2% (N = 5,467) of the cohort and were more likely to have PVD than men (21.7% vs. 16.1%; <em>P</em> &lt; .001). Among both sexes, patients with PVD were older with higher prevalence of comorbidities and cardiovascular risk factors. Women with PVD had the highest MACE rate (10.0%), followed by men with PVD (7.2%), women with CAD alone (5.0%), and men with CAD alone (3.6%). Adjusted analyses revealed similar relative MACE risk associated with PVD vs. CAD alone in women and men (adjusted hazard ratio [aHR] 1.54, 95% confidence interval [CI] 1.20-1.99; <em>P</em> &lt; .001 and aHR 1.31, 95% CI 1.06-1.62; <em>P</em> = .014, respectively; p-interaction = 0.460).</p></div><div><h3>Conclusion</h3><p>Women and men derive similar excess risk of MACE from PVD after PCI. The heightened risk associated with PVD needs to be addressed with maximized use of secondary prevention in both sexes.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"277 ","pages":"Pages 39-46"},"PeriodicalIF":3.7,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141911376","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":"Pathological evaluation of predictors for delayed endothelial coverage after currently available drug-eluting stent implantation in coronary arteries: Impact of lesions with acute and chronic coronary syndromes","authors":"Kazuki Aihara MD ,&nbsp;Sho Torii MD, PhD ,&nbsp;Norihito Nakamura MD, PhD ,&nbsp;Hideki Hozumi MD ,&nbsp;Manabu Shiozaki MD ,&nbsp;Yu Sato MD ,&nbsp;Marie Yoshikawa MD ,&nbsp;Norihiko Kamioka MD ,&nbsp;Takeshi Ijichi MD, PhD ,&nbsp;Makoto Natsumeda MD ,&nbsp;Yohei Ohno MD, PhD ,&nbsp;Takahide Kodama MD, PhD ,&nbsp;Tomoya Onodera MD, PhD ,&nbsp;Yoshiaki Mibiki MD, PhD ,&nbsp;Hayato Ohtani MD, PhD ,&nbsp;Ryosuke Kametani MD, PhD ,&nbsp;Ayako Yoshikawa RN ,&nbsp;Naoya Nakamura MD, PhD ,&nbsp;Yuji Ikari MD, PhD ,&nbsp;Gaku Nakazawa MD, PhD","doi":"10.1016/j.ahj.2024.08.003","DOIUrl":"10.1016/j.ahj.2024.08.003","url":null,"abstract":"<div><h3>Background</h3><p>The optimal duration of dual antiplatelet therapy after currently available drug-eluting stent (DES) implantation to prevent stent thrombosis (ST) remains controversial. Delayed healing is frequently identified as a leading cause of ST in the early phase. However, a thorough pathological investigation into strut coverage after currently available DES implantation is lacking—a gap addressed in the current study.</p></div><div><h3>Methods</h3><p>From our autopsy registry of 199 stented lesions, 4,713 struts from 66 currently available DES-stented lesions with an implant duration ≤370 days were histologically evaluated. Endothelial coverage was defined as the presence of luminal endothelial cells overlying struts and an underlying smooth muscle cell layer. The stented lesions were classified into acute coronary syndrome (ACS) (n = 40) and chronic coronary syndrome (CCS) (n = 26) groups and were compared. Endothelial coverage predictors were identified through logistic analysis.</p></div><div><h3>Results</h3><p>Although ACS and CCS lesions presented comparable clinical characteristics, including age, sex, and cause of death, the latter exhibited a significantly higher prevalence of chronic kidney disease and hemodialysis than the former (33.3% vs. 65.2%; <em>P</em> = .02, 7.7% vs. 30.4%; <em>P</em> = .02). The poststent implant median duration was significantly shorter in ACS lesions than in CCS lesions (13 [IQR 5-26 days] vs. 40 [IQR 16-233 days]; <em>P</em> &lt; .01). The endothelial coverage percentage was 3.5% at 30 days and 27.7% at 90 days after currently available DES implantation. Multivariable logistic regression analysis implicated implant duration of ≤90 days (odds ratio [OR], 0.009; 95% confidence interval [CI], 0.006-0.012; <em>P</em> &lt; .01), superficial calcification (OR, 0.11; 95% CI, 0.07-0.17; <em>P</em> &lt; .01), ACS culprit site (OR, 0.29; 95% CI, 0.09-0.94; <em>P</em> = .039), and circumferentially durable polymer-coated DES (OR, 0.32; 95% CI, 0.24-0.41; <em>P</em> &lt; .01) as delayed endothelial coverage predictors.</p></div><div><h3>Conclusions</h3><p>Endothelial coverage was limited at 90 days after currently available DES implantation, and the ACS culprit site and circumferentially durable polymer-coated DES were identified as independent predictors of delayed endothelial coverage. Our findings suggest the importance of underlying plaque morphology and stent technology for vessel healing after such implantation.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"277 ","pages":"Pages 114-124"},"PeriodicalIF":3.7,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324001972/pdfft?md5=a6d96a92c2b7b068b125c59613afe3dc&pid=1-s2.0-S0002870324001972-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141911377","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}

{"title":"Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent","authors":"David Erlinge MD, PhD ,&nbsp;Jonas Andersson MD, PhD ,&nbsp;Ole Fröbert MD, PhD ,&nbsp;Mattias Törnerud MD ,&nbsp;Felix Böhm MD, PhD ,&nbsp;Claes Held MD, PhD ,&nbsp;Candace Elek MS ,&nbsp;Motasim Sirhan MS ,&nbsp;Jonas Oldgren MD, PhD ,&nbsp;Stefan James MD, PhD","doi":"10.1016/j.ahj.2024.07.016","DOIUrl":"10.1016/j.ahj.2024.07.016","url":null,"abstract":"<div><h3>Background</h3><p>Modern drug-eluting stents have seen significant improvements, yet still create a rigid cage within the coronary artery. There is a 2% to 4% annual incidence of target lesion failure (TLF) beyond 1 year, and half of the patients experience angina after 5 years. The DynamX bioadaptor is a sirolimus-eluting, thin (71 µm) cobalt-chromium platform with helical strands that unlock and separate after in vivo degradation of the bioresorbable polymer coating. This allows the vessel to return to normal physiological function and motion, along with compensatory adaptive remodeling, which may reduce the need for reintervention and alleviate angina following percutaneous coronary intervention (PCI).</p></div><div><h3>Methods</h3><p>The INFINITY-SWEDEHEART trial is a single-blind, registry-based randomized clinical trial (R-RCT) to evaluate the safety and effectiveness of the DynamX bioadaptor compared to the Resolute Onyx stent in the treatment of patients with ischemic heart disease with de novo native coronary artery lesions. The R-RCT framework allows for recruitment, randomization, and pragmatic data collection of baseline demographics, medications, and clinical outcomes using existing national clinical registries integrated with the trial database. The primary objective is to demonstrate noninferiority in terms of freedom from TLF (cardiovascular death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Powered secondary endpoints will be tested sequentially for superiority from 6 months to the end of follow-up (5 years) for the following: 1) TLF in all subjects, 2) target vessel failure in all subjects, and 3) TLF in subjects with acute coronary syndrome (ACS). Subsequent superiority testing will be performed at a time determined depending on the number of events, ensuring sufficient statistical power. Change in angina-related symptoms, function and quality of life will be assessed using the Seattle Angina Questionnaire-short version. Predefined sub-groups will be analyzed. In total, 2400 patients have been randomized at 20 sites in Sweden. Available baseline characteristic reveal relatively old age (68 years) and a large proportion of ACS patients including 25% STEMI and 37% NSTEMI patients.</p></div><div><h3>Summary</h3><p>The INFINITY-SWEDEHEART study is designed to evaluate the long-term safety and efficacy of the DynamX bioadaptor compared to the Resolute Onyx stent in a general PCI patient population.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"277 ","pages":"Pages 1-10"},"PeriodicalIF":3.7,"publicationDate":"2024-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324001820/pdfft?md5=6b5e99d55ecc656d9e5d5489f23f47c1&pid=1-s2.0-S0002870324001820-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141888211","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}