Journal of the American College of Cardiology最新文献

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To Pretreat or Not to Pretreat 预处理还是不预处理?这就是问题所在
IF 21.7 1区 医学
Journal of the American College of Cardiology Pub Date : 2024-11-04 DOI: 10.1016/j.jacc.2024.07.049
Ali Dahhan MD, Mohammad Bilal Memon DO, Zachariah Zaaza DO, Ian Jennings DO, Hanan Gruhonjic MD
{"title":"To Pretreat or Not to Pretreat","authors":"Ali Dahhan MD, Mohammad Bilal Memon DO, Zachariah Zaaza DO, Ian Jennings DO, Hanan Gruhonjic MD","doi":"10.1016/j.jacc.2024.07.049","DOIUrl":"10.1016/j.jacc.2024.07.049","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"84 20","pages":"Page e285"},"PeriodicalIF":21.7,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142574630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Gender Diversity 性别多样性
IF 21.7 1区 医学
Journal of the American College of Cardiology Pub Date : 2024-11-04 DOI: 10.1016/j.jacc.2024.07.051
Merle Myerson MD, EdD
{"title":"Gender Diversity","authors":"Merle Myerson MD, EdD","doi":"10.1016/j.jacc.2024.07.051","DOIUrl":"10.1016/j.jacc.2024.07.051","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"84 20","pages":"Page e281"},"PeriodicalIF":21.7,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142578396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Recaticimab as Add-On Therapy to Statins for Nonfamilial Hypercholesterolemia 雷西替单抗作为他汀类药物的附加疗法治疗非家族性高胆固醇血症:随机 3 期 REMAIN-2 试验
IF 21.7 1区 医学
Journal of the American College of Cardiology Pub Date : 2024-11-04 DOI: 10.1016/j.jacc.2024.09.012
Yihong Sun MD , Qiang Lv MD , Yuhan Guo MD , Zhifang Wang MB , Rongjie Huang MM , Xiaohong Gao MB , Yajun Han MD , Zhuhua Yao MD , Mingqi Zheng MD , Suxin Luo MD , Yue Li MD , Xiang Gu MD , Yumin Zhang MM , Junkui Wang MD , Lang Hong MD , Xueping Ma MD , Guohai Su MD , Jianlong Sheng MD , Chunlin Lai MD , Aidong Shen MS , Chang-Sheng Ma MD
{"title":"Recaticimab as Add-On Therapy to Statins for Nonfamilial Hypercholesterolemia","authors":"Yihong Sun MD ,&nbsp;Qiang Lv MD ,&nbsp;Yuhan Guo MD ,&nbsp;Zhifang Wang MB ,&nbsp;Rongjie Huang MM ,&nbsp;Xiaohong Gao MB ,&nbsp;Yajun Han MD ,&nbsp;Zhuhua Yao MD ,&nbsp;Mingqi Zheng MD ,&nbsp;Suxin Luo MD ,&nbsp;Yue Li MD ,&nbsp;Xiang Gu MD ,&nbsp;Yumin Zhang MM ,&nbsp;Junkui Wang MD ,&nbsp;Lang Hong MD ,&nbsp;Xueping Ma MD ,&nbsp;Guohai Su MD ,&nbsp;Jianlong Sheng MD ,&nbsp;Chunlin Lai MD ,&nbsp;Aidong Shen MS ,&nbsp;Chang-Sheng Ma MD","doi":"10.1016/j.jacc.2024.09.012","DOIUrl":"10.1016/j.jacc.2024.09.012","url":null,"abstract":"<div><h3>Background</h3><div>Currently available antiproprotein convertase subtilisin/kexin type 9 monoclonal antibodies can effectively decrease low-density lipoprotein cholesterol (LDL-C) levels, but require frequent dosing. Recaticimab is a novel humanized monoclonal antibody against proprotein convertase subtilisin/kexin type 9. In a phase 1b/2 trial, recaticimab as add-on to stable statins showed robust LDL-C reduction with a dosing interval up to every 12 weeks (Q12W) in patients with hypercholesterolemia.</div></div><div><h3>Objectives</h3><div>REMAIN-2 (REcaticiMab Add-on therapy In patients with Nonfamilial hypercholesterolemia) aimed to assess the efficacy and safety of 48-week treatment with recaticimab as add-on therapy to statins in nonfamilial hypercholesterolemia.</div></div><div><h3>Methods</h3><div>REMAIN-2 was a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial. During the run-in period, patients received stable moderate or high-intensity statin, with or without cholesterol absorption inhibitors (ezetimibe) or fenofibrate, for ≥4 weeks. Patients with an LDL-C of ≥1.8 mmol/L (if with atherosclerotic cardiovascular disease [ASCVD]) or ≥2.6 mmol/L (if without ASCVD) were then randomized (2:2:2:1:1:1) to receive recaticimab 150 mg every 4 weeks (Q4W), 300 mg every 8 weeks (Q8W), or 450 mg Q12W, or matching placebo injections (Q4W, Q8W, or Q12W) for 48 weeks. The primary efficacy endpoint was percentage change from baseline to week 24 in LDL-C level.</div></div><div><h3>Results</h3><div>A total of 689 randomly assigned patients received treatment (mean age, 55.8 years; male, 64.4%; ASCVD history, 69.5%; concomitant ezetimibe, 11.2%; mean baseline LDL-C, 2.8 mmol/L). Percentage change in LDL-C from baseline to week 24 was significantly more pronounced with recaticimab vs placebo (<em>P</em> &lt; 0.0001), with least-squares mean differences of −62.2% (95% CI: −67.0% to −57.4%), −59.7% (95% CI: −65.0% to −54.4%), and −53.4% (95% CI: −58.7% to −48.2%) for the 150 mg Q4W, 300 mg Q8W, and 450 mg Q12W regimens, respectively. The decreases in LDL-C with recaticimab were maintained through week 48. Secondary lipid variables, including non–high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein(a) also favored the recaticimab groups. During the treatment period, the incidence of treatment-related adverse events (28.5% vs 26.6%) and serious treatment-related adverse events (0.4% vs 0.4%) was similarly low in both the recaticimab and placebo groups.</div></div><div><h3>Conclusions</h3><div>Recaticimab as add-on to stable statin therapy significantly decreased LDL-C levels at week 24 and sustained the decreases through week 48, providing a novel therapeutic alternative with a dosing interval of up to every 12 weeks in patients with nonfamilial hypercholesterolemia.</div></div>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"84 20","pages":"Pages 2037-2047"},"PeriodicalIF":21.7,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142574624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Artificial Intelligence in Cardiovascular Clinical Trials 人工智能在心血管临床试验中的应用
IF 21.7 1区 医学
Journal of the American College of Cardiology Pub Date : 2024-11-04 DOI: 10.1016/j.jacc.2024.08.069
Jonathan W. Cunningham MD, MPH , William T. Abraham MD , Ankeet S. Bhatt MD, MBA, ScM , Jessilyn Dunn PhD , G. Michael Felker MD, MHS , Sneha S. Jain MD, MBA , Christopher J. Lindsell PhD , Matthew Mace BS , Trejeeve Martyn MD, MS , Rashmee U. Shah MD, MS , Geoffrey H. Tison MD, MPH , Tala Fakhouri PhD, MPH , Mitchell A. Psotka MD, PhD , Harlan Krumholz MD , Mona Fiuzat PharmD , Christopher M. O’Connor MD , Scott D. Solomon MD , Heart Failure Collaboratory
{"title":"Artificial Intelligence in Cardiovascular Clinical Trials","authors":"Jonathan W. Cunningham MD, MPH ,&nbsp;William T. Abraham MD ,&nbsp;Ankeet S. Bhatt MD, MBA, ScM ,&nbsp;Jessilyn Dunn PhD ,&nbsp;G. Michael Felker MD, MHS ,&nbsp;Sneha S. Jain MD, MBA ,&nbsp;Christopher J. Lindsell PhD ,&nbsp;Matthew Mace BS ,&nbsp;Trejeeve Martyn MD, MS ,&nbsp;Rashmee U. Shah MD, MS ,&nbsp;Geoffrey H. Tison MD, MPH ,&nbsp;Tala Fakhouri PhD, MPH ,&nbsp;Mitchell A. Psotka MD, PhD ,&nbsp;Harlan Krumholz MD ,&nbsp;Mona Fiuzat PharmD ,&nbsp;Christopher M. O’Connor MD ,&nbsp;Scott D. Solomon MD ,&nbsp;Heart Failure Collaboratory","doi":"10.1016/j.jacc.2024.08.069","DOIUrl":"10.1016/j.jacc.2024.08.069","url":null,"abstract":"<div><div>Randomized clinical trials are the gold standard for establishing the efficacy and safety of cardiovascular therapies. However, current pivotal trials are expensive, lengthy, and insufficiently diverse. Emerging artificial intelligence (AI) technologies can potentially automate and streamline clinical trial operations. This review describes opportunities to integrate AI throughout a trial’s life cycle, including designing the trial, identifying eligible patients, obtaining informed consent, ascertaining physiological and clinical event outcomes, interpreting imaging, and analyzing or disseminating the results. Nevertheless, AI poses risks, including generating inaccurate results, amplifying biases against underrepresented groups, and violating patient privacy. Medical journals and regulators are developing new frameworks to evaluate AI research tools and the data they generate. Given the high-stakes role of randomized trials in medical decision making, AI must be integrated carefully and transparently to protect the validity of trial results.</div></div>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"84 20","pages":"Pages 2051-2062"},"PeriodicalIF":21.7,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142574672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Hypertensive Disorders of Pregnancy Increase the Risk for Myocardial Infarction: A Population-Based Study. 妊娠期高血压疾病增加心肌梗死风险:一项基于人群的研究。
IF 21.7 1区 医学
Journal of the American College of Cardiology Pub Date : 2024-11-02 DOI: 10.1016/j.jacc.2024.06.049
Lisa E Vaughan, Yoshihisa Kanaji, Sonja Suvakov, Santosh Parashuram, Yvonne S Butler Tobah, Alanna M Chamberlain, Suzette J Bielinski, Natasa Milic, Rajiv Gulati, Karl A Nath, Amir Lerman, Vesna D Garovic
{"title":"Hypertensive Disorders of Pregnancy Increase the Risk for Myocardial Infarction: A Population-Based Study.","authors":"Lisa E Vaughan, Yoshihisa Kanaji, Sonja Suvakov, Santosh Parashuram, Yvonne S Butler Tobah, Alanna M Chamberlain, Suzette J Bielinski, Natasa Milic, Rajiv Gulati, Karl A Nath, Amir Lerman, Vesna D Garovic","doi":"10.1016/j.jacc.2024.06.049","DOIUrl":"10.1016/j.jacc.2024.06.049","url":null,"abstract":"<p><strong>Background: </strong>Angiographic evidence of the anatomy of coronary arteries and the type of coronary artery lesions in women with a history of hypertensive disorders of pregnancy (HDP) are poorly documented.</p><p><strong>Objectives: </strong>This study sought to determine the role of a history of HDP as a unique risk factor for early coronary artery disease (CAD) and type of acute coronary syndrome (ACS) (ie, atherosclerotic vs myocardial infarction with nonobstructive coronary arteries [MINOCA]) in women who underwent coronary angiography.</p><p><strong>Methods: </strong>This study used a population-based cohort of parous female patients with incident CAD who underwent coronary angiography and age-matched control subjects. The SYNTAX (Synergy between PCI [percutaneous coronary intervention] with TAXUS [Boston Scientific] and Cardiac Surgery) score was assessed to determine the complexity and degree of CAD; MINOCA was diagnosed in the presence of clinical acute myocardial infarction in the absence of obstructive coronary disease.</p><p><strong>Results: </strong>A total of 506 parous female Olmsted County, Minnesota (USA) residents had incident CAD and angiographic data from November 7, 2002 to December 31, 2016. Women with HDP were younger than normotensive women at the time of the event (median: 64.8 years vs 71.8 years; P = 0.030). There was a strong association between HDP and ACS (unadjusted P = 0.018). Women with HDP compared with women with normotensive pregnancies were more likely to have a higher SYNTAX score (OR: 2.28; 95% CI: 1.02-5.12; P = 0.046), and MINOCA (OR: 2.08; 95% CI: 1.02-4.25; P = 0.044).</p><p><strong>Conclusions: </strong>A history of HDP is associated with CAD earlier in life and with a future risk for myocardial infarction with both obstructive and nonobstructive coronary arteries. This study underscores the need for timely detection and treatment of nonobstructive disease, in addition to traditional risk factors.</p>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":" ","pages":""},"PeriodicalIF":21.7,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Classification of Myocardial Infarction in Women With Hypertensive Disorders of Pregnancy. 妊娠高血压妇女心肌梗塞的分类。
IF 21.7 1区 医学
Journal of the American College of Cardiology Pub Date : 2024-11-01 DOI: 10.1016/j.jacc.2024.07.058
Michael C Honigberg
{"title":"Classification of Myocardial Infarction in Women With Hypertensive Disorders of Pregnancy.","authors":"Michael C Honigberg","doi":"10.1016/j.jacc.2024.07.058","DOIUrl":"10.1016/j.jacc.2024.07.058","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":" ","pages":""},"PeriodicalIF":21.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Beyond Prognosis: The Vital Role of Quality of Life after Transcatheter Tricuspid Valve Replacement 超越预后:经导管三尖瓣置换术后生活质量的重要作用
IF 24 1区 医学
Journal of the American College of Cardiology Pub Date : 2024-10-30 DOI: 10.1016/j.jacc.2024.10.087
Domenico Angellotti, Fabien Praz, Stephan Windecker
{"title":"Beyond Prognosis: The Vital Role of Quality of Life after Transcatheter Tricuspid Valve Replacement","authors":"Domenico Angellotti, Fabien Praz, Stephan Windecker","doi":"10.1016/j.jacc.2024.10.087","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.10.087","url":null,"abstract":"No Abstract","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"130 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142541570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results From TRISCEND II Pivotal Trial 经导管三尖瓣置换术后的生活质量:TRISCEND II 关键性试验的 1 年结果
IF 24 1区 医学
Journal of the American College of Cardiology Pub Date : 2024-10-30 DOI: 10.1016/j.jacc.2024.10.067
Suzanne V. Arnold, Rebecca T. Hahn, Vinod H. Thourani, Raj Makkar, Moody Makar, Rahul P. Sharma, Christiane Haeffele, Charles J. Davidson, Akhil Narang, Brian O’Neill, James Lee, Pradeep Yadav, Firas Zahr, Scott Chadderdon, Mackram Eleid, Sorin Pislaru, Robert Smith, Molly Szerlip, Brian Whisenant, Nishant Sekaran, David J. Cohen
{"title":"Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results From TRISCEND II Pivotal Trial","authors":"Suzanne V. Arnold, Rebecca T. Hahn, Vinod H. Thourani, Raj Makkar, Moody Makar, Rahul P. Sharma, Christiane Haeffele, Charles J. Davidson, Akhil Narang, Brian O’Neill, James Lee, Pradeep Yadav, Firas Zahr, Scott Chadderdon, Mackram Eleid, Sorin Pislaru, Robert Smith, Molly Szerlip, Brian Whisenant, Nishant Sekaran, David J. Cohen","doi":"10.1016/j.jacc.2024.10.067","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.10.067","url":null,"abstract":"<h3>Background</h3>Severe tricuspid regurgitation (TR) often causes substantial impairment in patient-reported health status (ie, symptoms, physical and social function, and quality of life), which may improve with transcatheter tricuspid valve replacement (TTVR).<h3>Objectives</h3>We performed an in-depth analysis of health status of patients enrolled in the TRISCEND (Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device) II pivotal trial to help quantify the benefit of intervention to patients.<h3>Methods</h3>The TRISCEND II pivotal trial randomized 400 patients with symptomatic and severe or greater TR 2:1 to TTVR with the EVOQUE tricuspid valve replacement system plus optimal medical therapy (OMT) or OMT alone. Health status was assessed with the Kansas City Cardiomyopathy Questionnaire and the 36-Item Short Form Health Survey. Changes in health status over 1 year were compared between treatment groups using mixed-effects repeated-measures models.<h3>Results</h3>The analysis cohort included 392 patients, of whom 259 underwent attempted TTVR and 133 received OMT alone (mean age 79.2 ± 7.6 years, 75.5% women, 56.1% with massive or torrential TR). Patients had substantially impaired health status at baseline (mean Kansas City Cardiomyopathy Questionnaire Overall Summary Score [KCCQ-OS] 52.1 ± 22.8; mean 36-Item Short Form Health Survey physical component summary score 35.2 ± 8.4). TTVR+OMT patients reported significantly greater improvement in both disease-specific and generic health status at each follow-up time point. Mean between-group differences in the KCCQ-OS favored TTVR+OMT at each time point: 11.8 points (95% CI: 7.4-16.3 points) at 30 days, 20.8 points (95% CI: 16.1-25.5 points) at 6 months, and 17.8 points (95% CI: 13.0-22.5 points) at 1 year. In subgroup analyses, TTVR+OMT improved health status to a greater extent among patients with torrential or massive TR vs severe TR (treatment effect 23.3 vs 22.6 vs 11.3; interaction <em>P</em> = 0.049). At 1 year, 64.6% of TTVR+OMT patients were alive and well (KCCQ-OS ≥60 points and no decline of ≥10 points from baseline) compared with 31.0% with OMT alone.<h3>Conclusions</h3>Compared with OMT alone, treatment of patients with symptomatic and severe or greater TR with TTVR+OMT resulted in substantial improvement in patients’ symptoms, function, and quality of life. These benefits were evident 30 days after TTVR, continued to increase through 6 months, and remained durable through 1 year. (TRISCEND II Pivotal Trial [Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device]; <span><span>NCT04482062</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>)","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"38 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142541626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Randomized Comparison of Novel Low-Dose Sirolimus-Eluting Biodegradable Polymer Stent vs Second-Generation DES: TARGET-IV NA Trial 新型低剂量西罗莫司洗脱生物可降解聚合物支架与第二代 DES 的随机比较:TARGET-IV NA 试验
IF 24 1区 医学
Journal of the American College of Cardiology Pub Date : 2024-10-30 DOI: 10.1016/j.jacc.2024.10.074
Robert W. Yeh, Olivier F. Bertrand, Ehtisham Mahmud, Emanuele Barbato, Batla Falah, Melek Ozgu Issever, Björn Redfors, Alexandra Popma, Michael Curtis, Niels van Royen, Jean-Francois Tanguay, Luc Janssens, William N. Newman, Koen Teeuwen, James W. Choi, Maurits T. Dirksen, Akiko Maehara, Martin B. Leon
{"title":"Randomized Comparison of Novel Low-Dose Sirolimus-Eluting Biodegradable Polymer Stent vs Second-Generation DES: TARGET-IV NA Trial","authors":"Robert W. Yeh, Olivier F. Bertrand, Ehtisham Mahmud, Emanuele Barbato, Batla Falah, Melek Ozgu Issever, Björn Redfors, Alexandra Popma, Michael Curtis, Niels van Royen, Jean-Francois Tanguay, Luc Janssens, William N. Newman, Koen Teeuwen, James W. Choi, Maurits T. Dirksen, Akiko Maehara, Martin B. Leon","doi":"10.1016/j.jacc.2024.10.074","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.10.074","url":null,"abstract":"&lt;h3&gt;Background&lt;/h3&gt;Drug-eluting stents (DESs) with controlled antiproliferative drug release reduce restenosis risk, but durable polymers can delay healing and inhibit reendothelialization. The Firehawk biodegradable polymer sirolimus-eluting stent (BP-SES) has a fully biodegradable sirolimus-containing polymer coating localized to recessed abluminal grooves on the stent surface and delivers roughly one-third the drug dose of other DESs.&lt;h3&gt;Objectives&lt;/h3&gt;We report the primary results of the TARGET-IV NA (Firehawk Rapamycin Target Eluting Coronary Stent North American Trial) randomized controlled trial comparing clinical outcomes with BP-SES vs currently used second-generation DESs.&lt;h3&gt;Methods&lt;/h3&gt;The TARGET-IV NA study was a prospective, multicenter, single-blind, 1:1 randomized noninferiority trial comparing the BP-SES with control in North America and Europe among patients undergoing percutaneous coronary intervention for chronic or acute coronary syndromes. The primary endpoint was target lesion failure (TLF) at 12 months (composite of cardiac death, target vessel–related myocardial infarction, or ischemia-driven target lesion revascularization). The primary analysis (intention-to-treat) tested noninferiority of BP-SES vs control using an absolute margin of 3.85% and 1-sided α of 0.025. Noninferiority-powered secondary endpoints were tested in an optical coherence tomography substudy (endpoint: mean neointimal hyperplasia thickness) and an angiography substudy (endpoint: in-stent late lumen loss).&lt;h3&gt;Results&lt;/h3&gt;A total of 1,720 patients (mean age 66 years; 74% male) with 2,159 lesions were randomly allocated to receive either BP-SES (860 patients, 1,057 lesions) or control second-generation DES (860 patients, 1,084 lesions). A total of 61% of patients presented with stable coronary disease, 32% had unstable angina, and 7% had non-ST-segment elevation myocardial infarction (NSTEMI) or recent ST-segment elevation myocardial infarction. The rate of TLF with BP-SES was noninferior to control at 12 months (3.4% vs 3.3%, absolute risk difference 0.13%, upper bound 97.5% CI: 2.03, &lt;em&gt;P&lt;/em&gt;&lt;sub&gt;noninferiority&lt;/sub&gt; &lt; 0.0001). Cardiac death, myocardial infarction, and stent thrombosis rates were similar between groups. Angiographic follow-up was available in 104 patients (97.2% of those enrolled in the angiographic substudy) and 128 (94.1%) lesions. At 13 months, the powered secondary endpoint of mean in-stent late lumen loss was 0.149 ± 0.263 mm for BP-SES and 0.327 ± 0.463 mm for control (least squares mean difference: −0.178; 90% CI: −0.2943 to −0.0632; &lt;em&gt;P&lt;/em&gt;&lt;sub&gt;noninferiority&lt;/sub&gt; &lt; 0.0001). The optical coherence tomography substudy included 37 patients (42 lesions) with no difference in mean neointimal hyperplasia thickness between groups at 13 months (&lt;em&gt;P&lt;/em&gt;&lt;sub&gt;noninferiority&lt;/sub&gt; = 0.01).&lt;h3&gt;Conclusions&lt;/h3&gt;The biodegradable polymer sirolimus-eluting stent was noninferior to currently used second-generation DES with regard","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"28 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142541627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Transcatheter Interventions in Tricuspid Regurgitation: Shifting the focus beyond Quantity of Life to Quality of Life 三尖瓣反流的经导管介入治疗:将重点从 "生活数量 "转移到 "生活质量 "上来
IF 24 1区 医学
Journal of the American College of Cardiology Pub Date : 2024-10-30 DOI: 10.1016/j.jacc.2024.10.085
Aakriti Gupta, Celina Yong, Rasha Al-Lamee
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