American heart journal最新文献

{"title":"Dental procedures and associated risk of infective endocarditis.","authors":"Emil Fosbøl, Eva Havers-Borgersen, Anders Dahl, Jarl E Strange, Claus Moser, Marianne Voldstedlund, Nikolaj Ihlemann, Louise Bruun Oestergaard, Lauge Østergaard, Andrew Wang, Vivian H Chu, Morten Dahl, Søren Fanoe, Morten Schou, Trine Lauridsen, Nana Valeur, Gunnar H Gislason, Niels Eske Bruun, Henning Bundgaard, Kasper Iversen, Lars Køber","doi":"10.1016/j.ahj.2026.107552","DOIUrl":"10.1016/j.ahj.2026.107552","url":null,"abstract":"<p><strong>Background: </strong>Dental procedures may cause bacteremia, which is considered a risk factor for infective endocarditis (IE). This study sets out to examine whether dental procedures are associated with an increased risk of IE.</p><p><strong>Methods: </strong>We examined the nationwide time-dependent association between dental procedures and risk of bacteremia and IE among Danes > 18 years on January 1, 2010. Adjusted hazard ratios (HR) for bacteremia and IE were estimated by Cox regression with time-varying exposure (dental visit and three months later).</p><p><strong>Results: </strong>We examined 4,178,514 persons who had dental care (66.9% of residents, median age 44 years [IQR 30-49]). During 9 years of follow-up, 69,928 (1.7%) persons had bacteremia, and 3,754 (0.09%) had IE. Among those with bacteremia or IE in the proximity of dental care (within three months), Streptococci accounted for 16.1% and 26.9%, respectively. The adjusted HRs for bacteremia and IE associated with dental procedures were 0.94 (95% CI 0.92-0.95) and 1.00 (95% CI 0.94-1.08), respectively, compared with non-exposed time. No dose-response relationship for invasive vs non-invasive procedures was found. The IE risk associated with dental care was not different in high-risk patients (prior IE, valve prostheses, or congenital heart disease): HR 0.96 (95% CI 0.83-1.10).</p><p><strong>Conclusion: </strong>We did not find an association between dental procedures and bacteremia or IE, and this was irrespective of high-risk cardiac preconditions.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107552"},"PeriodicalIF":3.4,"publicationDate":"2026-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148721210","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":"Recurrent myocardial infarction identified by centralized troponin review: Insights from the MINT trial.","authors":"Sarang Kim, Marnie Bertolet, Bernard R Chaitman, John H Alexander, Philippe Gabriel Steg, Renato D Lopes, Tabassome Simon, Shaun G Goodman, Jordan B Strom, Pedro G M de Barros E Silva, Gregory Ducrocq, Andrew P DeFilippis, Maria M Brooks, Jeffrey Carson","doi":"10.1016/j.ahj.2026.107553","DOIUrl":"10.1016/j.ahj.2026.107553","url":null,"abstract":"<p><strong>Background: </strong>The utility of routine troponin testing to identify recurrent myocardial infarction (MI) after an incident MI is unclear. We assessed the incidence and prognosis of recurrent MIs identified from centralized troponin review in patients from the Myocardial Ischemia and Transfusion (MINT) trial.</p><p><strong>Methods: </strong>The MINT trial randomized patients with acute MI and anemia to a liberal vs restrictive red blood cell transfusion strategy. Suspected recurrent MIs were identified through both site-report and centralized review of troponin levels collected for 3 days following randomization. Differences in cardiac, noncardiac, and all-cause death at 30 and 180 days were compared across patients with any site-reported MI, only centrally identified MI, and no recurrent MI.</p><p><strong>Results: </strong>Among 3,504 patients, 275 (7.8%) had a recurrent MI within 30 days; 119 (43.3%) by site-report, and 156 (56.7%) by central troponin review only. Rates of cardiac and all-cause death at 30 and 180 days were highest for patients with site-reported MI, intermediate for centrally identified MI, and lowest for no recurrent MI; rates of noncardiac death did not vary. Patients with only centrally identified recurrent MI had an increased risk of cardiac death at 30 days (RR 1.9, 95% CI 1.0-3.4) and 180 days (RR 1.7, 95% CI 1.1-2.7) compared to those without recurrent MI.</p><p><strong>Conclusions: </strong>In patients with acute MI and anemia, centralized troponin review identified more than half of all recurrent MI events. Patients with centrally identified MI had a higher risk of cardiac death than those with no recurrent MI.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT02981407 https://clinicaltrials.gov/study/NCT02619136.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107553"},"PeriodicalIF":3.4,"publicationDate":"2026-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148700688","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":"HPS-4/TIMI 65/ORION-4: A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease: Trial design, recruitment, and baseline characteristics.","authors":"M Mafham, M Zayed, R Collins, M Sabatine, J Armitage, D Brittain, B da Costa, F Chen, M Goonasekera, M Hill, J C Hopewell, M Landray, M Lay, A Lesogor, A Maggioni, D Morrow, M Nunn, M O'Donoghue, K K Ray, A Rizkala, G Schwartz, W Stevens, K Wallendszus, R S Wright, R Wijesurendra, E Wincott, D Preiss, L Bowman","doi":"10.1016/j.ahj.2026.107546","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107546","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Despite widespread statin use, atherosclerotic cardiovascular disease remains a leading cause of morbidity and mortality worldwide. Monoclonal antibodies targeting circulating proprotein convertase subtilisin-kexin type 9 (PCSK9) substantially reduce low-density lipoprotein cholesterol (LDL-C) levels and cardiovascular events. However, the requirement for self-administration every 2-4 weeks may limit adherence to treatment. Inclisiran, a first-in-class small interfering ribonucleic acid (siRNA) therapy targeting hepatic PCSK9 production, has several potential advantages over the anti-PCSK9 monoclonal antibodies, principally longer duration of action. To date, however, the efficacy and safety of inclisiran have not been proven in a cardiovascular outcomes trial.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The ORION-4 study is the first large-scale clinical outcomes trial of an siRNA therapy, aiming to assess the efficacy and safety of inclisiran among participants with pre-existing atherosclerotic cardiovascular disease. The primary assessment is an intention-to-treat comparison of the effect of inclisiran sodium 300 mg (equivalent to 284 mg inclisiran), given by subcutaneous injection at randomization, at approximately 3 months and then approximately every 6 months thereafter, on major adverse cardiovascular events (MACE), defined as the composite of coronary death, myocardial infarction, fatal or non-fatal ischaemic stroke, or urgent coronary revascularization. Participants will be followed until the median time since randomization is at least 5 years and at least 1700 participants have a recorded adjudicated MACE. With a planned sample size of ∼15,000 participants, ORION-4 was designed to have &gt;99% power to detect a relative reduction in the primary outcome of about one quarter, while also providing an opportunity to assess efficacy in different subgroups as well as on secondary outcomes of interest.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Between 2019 and 2023 a total of 16,124 participants were randomized in the UK and the US. The mean (SD) age was 70 (8.1) years and 30% were female. At baseline, 78% had a history of coronary heart disease, 22% of ischaemic stroke, 15% of revascularization for peripheral arterial disease, and 23% had diabetes mellitus. 85% were on statin therapy (53% high intensity statin, 29% moderate and 3% low intensity statins). Overall, baseline mean (SD) LDL-C was 96 (32) mg/dL, and was similar among participants on high- and moderate/low-intensity statin regimens (87 (27) mg/dL and 93 (26) mg/dL respectively), with higher levels in those receiving no statin therapy (133 (33) mg/dL). Follow-up will complete during 2026 and results will be available in early 2027.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interpretation: &lt;/strong&gt;Inclisiran potentially offers a scalable lipid-lowering treatment, either alone or in combination with other agents. ORION-4 will evaluate the clinical efficacy of inclisiran, and provide a robust assessment of","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107546"},"PeriodicalIF":3.4,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148688506","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":"Pregnancy outcomes in women with a history of myocarditis.","authors":"Jasmin M Nari, Sarah Siu, Rohan D'Souza, Birgit Pfaller, Danielle Massarella, Beatriz Fernandez-Campos, Candice K Silversides","doi":"10.1016/j.ahj.2026.107547","DOIUrl":"10.1016/j.ahj.2026.107547","url":null,"abstract":"<p><strong>Background: </strong>Myocarditis is an inflammatory cardiomyopathy with broad clinical spectrum. Pregnancy outcomes in women with a history of myocarditis are not well described.</p><p><strong>Purpose: </strong>The aim of this study is to determine maternal and fetal outcomes in pregnant women with history of myocarditis/perimyocarditis.</p><p><strong>Methods: </strong>This was a retrospective study of pregnancy outcomes in patients with prior history of myocarditis/perimyocarditis followed in a CardioObstetrics Program (1998-2025). Adverse maternal cardiac outcomes included: maternal death, heart failure, and sustained arrhythmia. Echocardiographic changes during pregnancy were examined. Fetal adverse events: fetal death, prematurity, small for gestational age (<10th percentile).</p><p><strong>Results: </strong>Thirty-six pregnancies in women (n = 27) with a history of myocarditis were included (mean age 33 ± 4.9 years, median interval between myocarditis and pregnancy 5.0 years). In 50% of cases, there was moderate/severe left ventricular (LV) systolic dysfunction at time of myocarditis presentation. In most (83%,15/18) pregnancies, with significant LV dysfunction at time of myocarditis presentation, there was full recovery of LV systolic function prior to pregnancy. No adverse maternal cardiac events were reported in 97% (35/36) of pregnancies. One patient with moderately reduced LV systolic function during myocarditis, with recovery prior to pregnancy, developed heart failure. Two patients had reduction in LV systolic function in pregnancy, from mild/normal to moderate/severely reduced. There were no maternal or fetal deaths. Thirteen percent of pregnancies had premature delivery (31-36 weeks).</p><p><strong>Conclusion: </strong>Most women with prior myocarditis do not develop adverse cardiac events. However, echocardiographic surveillance during pregnancy may still be helpful to identify decreases in LV systolic function.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107547"},"PeriodicalIF":3.4,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148688455","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":"Efficacy and safety of revascularization in patients with chronic limb-threatening ischemia by kidney function.","authors":"Jun Young Lee, Gomathy Parvathinathan, Sai Liu, Ali Etemadi, Margaret R Stedman, Shipra Arya, Tara I Chang","doi":"10.1016/j.ahj.2026.107550","DOIUrl":"10.1016/j.ahj.2026.107550","url":null,"abstract":"<p><strong>Background: </strong>The optimal revascularization strategy for patients with chronic limb-threatening ischemia (CLTI) with chronic kidney disease (CKD) remains unknown. We evaluated whether the efficacy and safety of surgical vs endovascular revascularization differ by kidney function.</p><p><strong>Methods: </strong>In this post hoc secondary analysis of BEST-CLI trial (NCT02060630), 1,704 patients with CLTI were stratified by baseline estimated glomerular filtration rate (eGFR, mL/min/1.73 m²): non-CKD (eGFR ≥ 90), mild-moderate CKD (eGFR 45-89), advanced CKD (eGFR < 45 or dialysis). The primary outcome was a composite of major adverse limb events (MALE) or death. We estimated the difference in restricted mean time lost (RMTL, in days) adjusted for inverse probability treatment weights.</p><p><strong>Results: </strong>Surgical revascularization was significantly associated with fewer days with MALE or death in non-CKD (RMTL difference: -127.8 days; 95% CI -176.1, -79.6) and mild-moderate CKD (-63.2 days; 95% CI -104.7, -21.8) but not in advanced CKD (-16.4 days; 95% CI -78.8, 46.0; P interaction = .02). This attenuation reflected a diminishing mortality benefit with more severe CKD (P interaction = .01), whereas the association with fewer days with MALE remained consistent across CKD strata (P interaction = .34). Major adverse cardiovascular events and serious adverse events were more common with more severe CKD but did not differ significantly by treatment.</p><p><strong>Conclusions: </strong>Surgical vs endovascular revascularization was consistently associated with fewer days with MALE across CKD strata. However, its association with mortality varied by kidney function, attenuating the overall benefit for the composite endpoint of MALE or death. These results support individualized revascularization strategies, but require prospective confirmation.</p><p><strong>Trial registration: </strong>The BEST CLI trial is registered at ClinicalTrials.gov (NCT02060630).</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107550"},"PeriodicalIF":3.4,"publicationDate":"2026-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148676872","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":"Exercise treadmill testing for efficacy evaluation in randomized, controlled trials","authors":"Andrew Morrow PhD ,&nbsp;Robin Young PhD ,&nbsp;George R. Abraham BMBCh ,&nbsp;Stephen Hoole DM ,&nbsp;Joana Maria Gomes Oliveira MSc ,&nbsp;John P. Greenwood MBChB, PhD ,&nbsp;Jayanth Ranjit Arnold BMBCh, MA, DPhil ,&nbsp;Vanessa Ferreira SB, MD, DPhil ,&nbsp;Roby Rakhit BSc(Hons), MBBS MD ,&nbsp;Gavin Galasko BA, BM, MA, DM ,&nbsp;Aish Sinha BSc, MRCP ,&nbsp;Divaka Perera MD, FRCP ,&nbsp;Rasha Al-Lamee MBBS, PhD ,&nbsp;Ioakim Spyridopoulos MD ,&nbsp;Ashish Kotecha MBBS ,&nbsp;Gerald Clesham MA, PhD ,&nbsp;Thomas J. Ford MBChB(Hons), PhD ,&nbsp;Anthony Davenport MA, PhD ,&nbsp;Sandosh Padmanabhan MBBS, PhD ,&nbsp;Juan Carlos Kaski MD, DSc ,&nbsp;Colin Berry BSc, MBChB, PhD","doi":"10.1016/j.ahj.2026.107379","DOIUrl":"10.1016/j.ahj.2026.107379","url":null,"abstract":"<div><div>Exercise treadmill testing measures functional capacity and inducible myocardial ischemia and has historically served as an endpoint in phase 2 trials. The Precision Medicine with Zibotentan in Microvascular Angina trial evaluated the selective endothelin-A receptor antagonist zibotentan as a potential disease-modifying therapy for microvascular angina. The trial had a randomized, double-blind, cross-over design and the primary outcome was exercise duration. Compared with placebo, zibotentan at a dose of 10-mg daily for 12-weeks did not improve exercise duration or angina symptoms. In this prespecified analysis, exercise duration was compared across four sequential study visits and the factors associated with within-trial changes were evaluated. Exercise test duration increased progressively in all participants during sequential trial phases, independent of treatment with either zibotentan or placebo. This improvement in exercise duration was associated with female sex (interaction <em>p</em>-value = .0213; effect estimate [95% confidence interval]) 34.95 [13.99, 55.78] seconds, <em>P</em> = .002). In conclusion, the exercise test has limitations as an objective endpoint of efficacy in randomized trials.</div><div>PRIZE; <span><span>https://clinicaltrials.gov/study/NCT04097314</span><svg><path></path></svg></span></div><div>Clinicaltrials.gov Registration: NCT04097314.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"297 ","pages":"Article 107379"},"PeriodicalIF":3.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146193978","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":"Effect of age on restrictive and liberal transfusion outcomes in patients with anemia and myocardial infarction","authors":"Andrew M. Goldsweig MD, MS ,&nbsp;Colleen M. Ballantyne MPH ,&nbsp;Harvey D. White MD ,&nbsp;Jinnette Dawn Abbott MD ,&nbsp;Dean A. Fergusson PhD ,&nbsp;Brandon M. Herbert MPH, PhD ,&nbsp;Shaun G. Goodman MD, MSc ,&nbsp;Jeffrey L. Carson MD ,&nbsp;Maria M. Brooks PhD ,&nbsp;MINT Investigators","doi":"10.1016/j.ahj.2026.107381","DOIUrl":"10.1016/j.ahj.2026.107381","url":null,"abstract":"<div><div>For patients with anemia and myocardial infarction (MI), the randomized, 3,504-patient MINT trial found that a liberal transfusion threshold (10 g/dL) may be preferable to a restrictive threshold (8 g/dL) in terms of death or MI. The relative effects of liberal versus restrictive transfusion in younger and older patients are unknown. The present prespecified MINT substudy found no significant interaction between age and transfusion strategy for death or MI, heart failure, revascularization procedures, cardiac death, pulmonary embolism or deep vein thrombosis, bacteremia or pneumonia, and death at 30 and 180 days. A liberal transfusion approach appears to be safe and may be the preferred transfusion strategy in anemic patients with MI, regardless of age.</div><div>MINT Trial, ClinicalTrials.gov Number NCT02981407, <span><span>https://www.minttrial.org/</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"297 ","pages":"Article 107381"},"PeriodicalIF":3.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146775918","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":"Rationale and design of a pragmatic randomized clinical trial assessing a smartphone-based digital health intervention in hypertension: The ELFIE-HYPERTENSION trial","authors":"Eduardo Martins MD, PhD ,&nbsp;Caio A.M. Tavares MD, PhD ,&nbsp;Leandro Favaro MD ,&nbsp;Frederico Monfardini ,&nbsp;Jean-Jacques Mourad MD, PhD ,&nbsp;Kamlesh Khunti MD, PhD ,&nbsp;Gianluigi Savarese MD, PhD ,&nbsp;Otávio Berwanger MD, PhD ,&nbsp;Karla Santo MD, PhD","doi":"10.1016/j.ahj.2026.107380","DOIUrl":"10.1016/j.ahj.2026.107380","url":null,"abstract":"<div><h3>Background</h3><div>Hypertension represents a major contributor to the global cardiovascular (CV) disease burden, yet it remains inadequately controlled largely due to poor treatment adherence. Emerging digital health technologies hold promise for improving blood pressure (BP) management and CV outcomes, but the lack of evidence, unavailability in most countries, and out-of-pocket costs have hindered the widespread use of these technologies in clinical practice.</div></div><div><h3>Objectives</h3><div>To assess in a randomized controlled trial whether a digital health intervention (DHI) based on the free Elfie solution compared to usual care will reduce systolic blood pressure (SBP) in adults with uncontrolled hypertension (SBP ≥ 140 mmHg).</div></div><div><h3>Methods</h3><div>This is a pragmatic, open-label, randomized parallel arm, international, multicenter clinical trial. Adult individuals with hypertension are randomly assigned to usual care or a DHI based on the Elfie solution. Elfie offers a comprehensive set of features designed to enhance self-monitoring, adherence and education, complemented with a gamification feature to boost engagement. The primary outcome is office SBP measured at 6 months. Secondary outcomes include medication adherence, diastolic BP, BP control achievement, hypertension knowledge, self-care, health-related quality of life and process outcomes assessing app usage and engagement.</div></div><div><h3>Conclusions</h3><div>The ELFIE-HYPERTENSION trial is an international multicenter pragmatic randomized clinical trial, investigating the effects of an innovative, free and scalable DHI to improve BP control. If proven effective, this intervention can be easily and widely implemented in the management of hypertension in a variety of clinical settings globally.</div></div><div><h3>Trial registration number</h3><div>The trial is registered at the Clinicaltrials.gov (NCT06242483).</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"297 ","pages":"Article 107380"},"PeriodicalIF":3.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146177376","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":"A comprehensive set of per-protocol analyses of the myocardial ischemia and transfusion (MINT) trial","authors":"Brandon M. Herbert PhD, MPH ,&nbsp;Jeffrey L. Carson MD ,&nbsp;Marnie Bertolet PhD ,&nbsp;John H. Alexander MD, MHS ,&nbsp;Shaun G. Goodman MD, MSc ,&nbsp;Dean A. Fergusson PhD ,&nbsp;Gregory Ducrocq MD ,&nbsp;Renato D. Lopes MD, PhD ,&nbsp;Tabassome Simon MD, PhD ,&nbsp;Philippe Gabriel Steg MD ,&nbsp;Paul C. Hebert MD, MHSc ,&nbsp;Maria Mori Brooks PhD ,&nbsp;MINT Investigators","doi":"10.1016/j.ahj.2026.107382","DOIUrl":"10.1016/j.ahj.2026.107382","url":null,"abstract":"<div><div>We conducted a series of analyses to estimate the per-protocol effect of restrictive versus liberal transfusion strategies on 30-day death and death or recurrent myocardial infarction (MI) among patients from the Myocardial Ischemia and Transfusion (MINT) trial. Multiple analytic approaches were used to estimate the per-protocol effect, including analyses based on different definitions of adherence (site-reported, time-based, transfusion delay) and an instrumental variable analysis. Analyses based on adherence definitions found a restrictive strategy was associated with a substantially greater risk of 30-day death or recurrent MI, while the instrumental variable analysis estimated a moderate treatment effect similar to the original ITT result.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"297 ","pages":"Article 107382"},"PeriodicalIF":3.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146257192","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":"Cardiovascular Regulatory Science: Accelerating the Path from Bench to Bedside.","authors":"Serge Korjian, C Michael Gibson, Jonathan Seltzer, Kenneth W Mahaffey, Norman Stockbridge, Patrick R Lawler, Krishna Pundi, Brian A Bergmark, Mark C Petrie, Christopher R deFilippi, Stephen J Nicholls, A Michael Lincoff, Carolyn S P Lam, Kazuhiro Sase, Sanjeev P Bhavnani, Marc P Bonaca, Sanket S Dhruva, Roxana Mehran, Renato D Lopes, Eri Kato, Nicholas A Marston","doi":"10.1016/j.ahj.2026.107487","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107487","url":null,"abstract":"<p><p>Regulatory science (RS) is a field dedicated to developing and applying scientific methods, tools, standards, and evidence-based frameworks to improve regulatory policies and decision-making related to medical and device products. The acceleration of cardiovascular innovations over the past two decades has underscored the need for efficient evidence generation and streamlined regulatory pathways for new drugs and devices. RS seeks to address these challenges by strengthening the evidence base that informs policy and guidance, enhancing transparency, expediting approval processes, and enabling more agile responses to emerging public health needs. By evaluating innovative trial designs and employing advanced statistical methods, RS can reduce resource demands of clinical trials while preserving scientific integrity. RS also facilitates the standardization of biomarker evaluations and surrogate endpoints, supporting advancements in precision medicine. In addition to clinical evaluation, RS can enhance post-marketing surveillance by utilizing real-world evidence and advanced analytics to promptly identify safety signals, ensuring patient safety and continuous product monitoring. RS also supports global regulatory harmonization efforts, reducing redundancies and accelerating access to therapies across regions. RS aims to guide the development of regulatory policies, refine communication strategies to optimize the use of medical products, and maintain efficient, transparent, and scientifically rigorous regulatory frameworks. Continued investment in RS is essential for improving patient outcomes in cardiovascular medicine by safeguarding safety while accelerating innovation and access to therapies.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107487"},"PeriodicalIF":3.5,"publicationDate":"2026-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147961938","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}