Karen Lin, Henry P Foote, Michael Camitta, Beiyu Liu, Elizabeth Lydon, Hwanhee Hong, Autumn Peterson, Neeta Sethi, Erin V Shea, Jennifer Turi, Kevin D Hill
{"title":"Outcomes in infants with restrictive atrial septum and pre-stage 1 palliation septal intervention.","authors":"Karen Lin, Henry P Foote, Michael Camitta, Beiyu Liu, Elizabeth Lydon, Hwanhee Hong, Autumn Peterson, Neeta Sethi, Erin V Shea, Jennifer Turi, Kevin D Hill","doi":"10.1016/j.ahj.2026.107620","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107620","url":null,"abstract":"<p><strong>Background: </strong>Infants diagnosed with hypoplastic left heart syndrome (HLHS) who have a restrictive or intact atrial septum (RAS) have worse outcomes in single center analyses. Multi-center studies are lacking, and optimal identification and management of atrial restriction remains unclear.</p><p><strong>Methods: </strong>Multicenter retrospective cohort study of infants undergoing stage 1 palliation (S1P) from 2016 to 2024 and included in the National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC). Infants were classified based on atrial septal anatomy and intervention as follows: RAS with pre-S1P intervention, RAS without pre-S1P intervention, and no RAS. Primary analysis compared outcomes between infants with RAS and pre-S1P intervention versus infants without RAS. Primary outcomes included operative survival, post-S1P length of stay (LOS), and one-year mortality. Secondary outcomes included peri-operative and S1P discharge characteristics. Analyses were adjusted for demographic and clinical factors through multivariable regression.</p><p><strong>Results: </strong>Among 3644 infants who underwent S1P at 70 centers, 5% (n=164) had RAS with pre-S1P septal intervention, 10% (n=369) had RAS without intervention, and 85% (n=3111) did not have RAS. Compared to infants without RAS, those with RAS and pre-S1P septal intervention had greater pre-operative instability with increased inotrope use (43% vs 15%), mechanical ventilation (57% vs 19%), and persistent shock (18% vs 7%), all p<0.001, and were more likely to undergo hybrid S1P (23% vs 10%, p<0.001). In risk-adjusted analysis, infants with RAS and pre-S1P septal intervention had higher operative mortality (aOR 2.01 [95% CI 1.22-3.33] p=0.007) and one-year mortality (aOR 2.2 [1.44,3.38] p<0.001) than infants without RAS.</p><p><strong>Conclusion: </strong>RAS identifies a high-risk phenotype with early instability and excess early and one-year mortality. These findings highlight the need for improved risk stratification and more effective, standardized atrial decompression strategies for infants with clinically significant atrial restriction.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107620"},"PeriodicalIF":3.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149102950","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}
Daehoon Kim, Kyung-Yeon Lee, Hanjin Park, Hee Tae Yu, Tae-Hoon Kim, Seung-Young Roh, Jae-Sun Uhm, Boyoung Joung, Dae-In Lee, Young-Hoon Kim, Hui-Nam Pak
{"title":"Rationale and design of a multicenter randomized trial of adjunctive non-pulmonary vein trigger ablation in persistent atrial fibrillation: The EXPORT trial.","authors":"Daehoon Kim, Kyung-Yeon Lee, Hanjin Park, Hee Tae Yu, Tae-Hoon Kim, Seung-Young Roh, Jae-Sun Uhm, Boyoung Joung, Dae-In Lee, Young-Hoon Kim, Hui-Nam Pak","doi":"10.1016/j.ahj.2026.107624","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107624","url":null,"abstract":"<p><strong>Background: </strong>Pulmonary vein (PV) isolation in paroxysmal atrial fibrillation (AF) is strongly endorsed with a class IA recommendation for those with symptomatic AF who are refractory to antiarrhythmic drug (AAD) therapy to reduce symptoms, recurrence, and disease progression. However, in persistent AF, the efficacy of PV isolation alone is less pronounced than in paroxysmal AF, underscoring the necessity of adjunctive ablation strategies. Whether ablation of non-PV triggers after PV isolation improves the long-term procedure outcome is unknown. The EXPORT trial aims to evaluate the effects of systematic non-PV trigger ablation over PV isolation alone on freedom from atrial tachyarrhythmia recurrence among participants with persistent AF.</p><p><strong>Study design: </strong>The EXPORT trial is a multicenter, prospective, superiority, single-blinded, blinded-endpoint, clinical trial. Participants with persistent AF refractory to AAD therapy undergoing first-time AF ablation will be randomly assigned to either PV isolation with non-PV trigger provocation, mapping, and ablation or PV isolation alone. The primary endpoint is any documented atrial arrhythmia lasting ≥30 s after a 3-month blanking period following ablation with or without the use of AADs. Key secondary endpoints are freedom from atrial arrhythmia recurrence without AAD use, periprocedural complications, and total procedure time. The estimated total sample size is 430 participants, with 215 participants in each group.</p><p><strong>Conclusion: </strong>The EXPORT trial will assess the effect of non-PV trigger mapping and ablation with PV isolation on freedom from atrial tachyarrhythmia recurrence in participants with persistent AF.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov; NCT07197931.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107624"},"PeriodicalIF":3.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149103034","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}
Han Zhang, Daniel Munhoz, Ward Heggermont, Paul Vermeersch, Peter Sinnaeve, Kazumasa Ikeda, Takuya Mizukami, Mitsuaki Matsumura, Jeroen Sonck, Hitoshi Matsuo, Tetsuya Amano, Hirohiko Ando, Masahiro Hada, Brian Ko, Simone Biscaglia, Fernando Rivero, Thomas Engstrøm, Antonio Maria Leone, Lokien X van Nunen, William F Fearon, Evald Høj Christiansen, Stephane Fournier, Liyew Desta, Toshiro Shinke, Andy Yong, Julien Adjedj, Javier Escaned, Masafumi Nakayama, Ashkan Eftekhari, Danielle Keulards, Frederik M Zimmermann, Ethan Korngold, Gianluca Campo, Frédéric Bouisset, Adriaan Wilgenof, Colin Berry, Damien Collison, Thomas W Johnson, Divaka Perera, Allen Jeremias, David Cohen, Ziad Ali, Gary S Mintz, Ajay J Kirtane, Margaret B McEntegart, Alexandra Popma, Jeff Popma, Ovidiu Dressler, Yader Sandoval, Bernard De Bruyne, Nils Johnson, Carlos Collet
{"title":"Periprocedural Myocardial Infarction and Clinical Outcomes in Diffuse versus Focal Coronary Artery Disease.","authors":"Han Zhang, Daniel Munhoz, Ward Heggermont, Paul Vermeersch, Peter Sinnaeve, Kazumasa Ikeda, Takuya Mizukami, Mitsuaki Matsumura, Jeroen Sonck, Hitoshi Matsuo, Tetsuya Amano, Hirohiko Ando, Masahiro Hada, Brian Ko, Simone Biscaglia, Fernando Rivero, Thomas Engstrøm, Antonio Maria Leone, Lokien X van Nunen, William F Fearon, Evald Høj Christiansen, Stephane Fournier, Liyew Desta, Toshiro Shinke, Andy Yong, Julien Adjedj, Javier Escaned, Masafumi Nakayama, Ashkan Eftekhari, Danielle Keulards, Frederik M Zimmermann, Ethan Korngold, Gianluca Campo, Frédéric Bouisset, Adriaan Wilgenof, Colin Berry, Damien Collison, Thomas W Johnson, Divaka Perera, Allen Jeremias, David Cohen, Ziad Ali, Gary S Mintz, Ajay J Kirtane, Margaret B McEntegart, Alexandra Popma, Jeff Popma, Ovidiu Dressler, Yader Sandoval, Bernard De Bruyne, Nils Johnson, Carlos Collet","doi":"10.1016/j.ahj.2026.107617","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107617","url":null,"abstract":"<p><strong>Background: </strong>Whether periprocedural myocardial infarction (PMI) differs between focal and diffuse coronary physiology in the treated vessel remains unclear.</p><p><strong>Objectives: </strong>To compare the incidence and prognostic impact of PMI after PCI for vessels with focal versus diffuse diseases defined by pullback pressure gradient (PPG).</p><p><strong>Methods: </strong>We analyzed 855 patients undergoing PCI in the PPG Global registry. Physiological patterns of treated vessels were classified as focal or diffuse using PPG. PMI in the original registry was defined according to the Fourth Universal Definition of Myocardial Infarction (UDMI). The primary outcome of the current analysis was 1-year target vessel failure (TVF), a composite of cardiac death, spontaneous target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization.</p><p><strong>Results: </strong>Fourth UDMI PMI was higher in patients with diffuse compared with focal physiology in the treated vessel (9.8% vs 5.9%; p=0.048). Troponin elevation ≥70 × URL(8.5% vs 4.8%; p=0.041) and PMI with flow-limiting angiographic complications (2.0% vs 0.2%; p=0.015) occurred more frequently after PCI for vessels with diffuse disease, whereas PMI with ischemic electrocardiographic changes was infrequent and similar between groups (0.8% vs 0.7%; p=1.000). 17 TVF occurred within 1 year; only troponin elevation ≥35 × URL accompanied by angiographic complications was associated with 1-year TVF.</p><p><strong>Conclusions: </strong>PMI occurred more frequently after PCI for vessels with diffuse than focal coronary physiology, particularly phenotypes with higher troponin elevation or angiographic complications. Associations with 1-year TVF were observed only for PMI phenotypes incorporating angiographic complications; however, findings should be interpreted cautiously because TVF events were sparse.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107617"},"PeriodicalIF":3.4,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149079442","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}
Zaidon S Al-Falahi, Todd T Schlegel, Vivian Lee, Clara K Chow, Rebecca Kozor, Thomas Lindow, Martin Ugander
{"title":"Study protocol for The Heart Watch Study - Prognostic performance of smartwatch 12-lead ECG with advanced ECG analysis in consumer self-screening for cardiovascular disease.","authors":"Zaidon S Al-Falahi, Todd T Schlegel, Vivian Lee, Clara K Chow, Rebecca Kozor, Thomas Lindow, Martin Ugander","doi":"10.1016/j.ahj.2026.107619","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107619","url":null,"abstract":"<p><strong>Background: </strong>It is now possible to acquire a fully diagnostic standard 12-lead electrocardiography (ECG) using a smartwatch, a smartphone app, and no additional hardware. This study aims to evaluate the predictive performance of advanced ECG (A-ECG) analysis applied to a smartwatch 12-lead ECG (SWECG) acquired using an Apple Watch in identifying cardiovascular risks among asymptomatic adults performing consumer self-screening in the general population.</p><p><strong>Methods and design: </strong>The Heart Watch Study is a prospective, Australia-wide observational cohort study. The study will recruit 30,000 participants aged 20-79 years without prior known cardiovascular disease. Participants will enrol and consent electronically, and download a dedicated study iPhone app that enables a directed 12-lead SWECG acquisition using an Apple Watch. The recordings will undergo both conventional and A-ECG analysis. Follow-up will be performed through linkage with administrative health datasets in Australia, including hospital visits and mortality. The primary combined endpoint is all-cause mortality, hospitalization for cardiovascular causes, and incident cardiovascular disease (arrythmia, ischemic heart disease, heart failure) as predicted by existing A-ECG analyses.</p><p><strong>Conclusion: </strong>This study evaluates the feasibility of performing a fully diagnostic standard 12-lead SWECG using only a smartwatch and a smartphone application, and addresses the prognostic value of A-ECG machine-learning based analysis in consumer self-screening in a large, diverse and apparently healthy population.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107619"},"PeriodicalIF":3.4,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149073431","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}
Mouhamed Djahoum Moussa, Osama Abou Arab, Julien Labreuche, Emmanuel Besnier, Pierre-Gregoire Guinot, Fanette Denis, Benoit Dervaux, Yazine Mahjoub, Thibault Duburcq, Saad Nseir, Alain Duhamel, Francis Juthier, Emmanuel Robin, André Vincentelli
{"title":"Individualized Or Conventional Transfusion Strategy During Veno-Arterial Extracorporeal Membrane Oxygenation Support (ICONE Study): Rationale and Design of a Prospective Multicenter Randomized Controlled Trial.","authors":"Mouhamed Djahoum Moussa, Osama Abou Arab, Julien Labreuche, Emmanuel Besnier, Pierre-Gregoire Guinot, Fanette Denis, Benoit Dervaux, Yazine Mahjoub, Thibault Duburcq, Saad Nseir, Alain Duhamel, Francis Juthier, Emmanuel Robin, André Vincentelli","doi":"10.1016/j.ahj.2026.107616","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107616","url":null,"abstract":"<p><strong>Background: </strong>Red blood cell (RBC) transfusion practices during veno-arterial extracorporeal membrane oxygenation (VA-ECMO) are heterogeneous, and the benefit - harm balance remains uncertain. Current recommendations rely on predefined hemoglobin thresholds and do not provide criteria for individualized transfusion. As the primary goal of RBC transfusion is to optimize oxygen delivery (DO₂) to meet oxygen consumption (VO₂), a strategy guided by a surrogate of DO₂/VO₂ mismatch - central venous oxygen saturation (ScvO₂)- may be more appropriate than fixed liberal transfusion thresholds.</p><p><strong>Methods: </strong>ICONE is a multicenter, randomized, controlled trial comparing two transfusion strategies in adult patients supported by VA-ECMO for refractory cardiogenic shock. Patients are randomized 1:1 and stratified according to postcardiotomy versus medical etiology to either individualized or conventional transfusion strategy. In the individualized group, transfusion is triggered by ScvO<sub>2</sub> <65% despite optimization of VO₂ determinants. In the conventional group, transfusion was triggered by hemoglobin <9 g/dL. The primary endpoint is the number of RBCs units transfused per day of ECMO support. Secondary outcomes include 28-day composite of major adverse outcomes (key secondary endpoint), 90-days all-cause mortality, rate of organ failure, transfusion-related immune and non-immune complications (including human leucocyte antigen allosensitization) and cost effectiveness. A total of 236 patients provides 80% power to detect a 25% reduction in the primary endpoint and in key secondary outcomes using a two-sided test at 0.05 significance level (considering hierarchical testing framework) and considering 5% drop out. The study was registered in April 2020 (NCT05699005; IDRCB 2021-A01925-36) and is currently recruiting.</p><p><strong>Conclusion: </strong>The ICONE trial may contribute to changing transfusion practice in VA-ECMO.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107616"},"PeriodicalIF":3.4,"publicationDate":"2026-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149073392","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}
Jiawei Han, Xiao Ma, Qu Chen, Hongyan Zhou, Fangzhou Li, Huajie Li, Lili Liu, Jianfang Cai, Juan Du, Heng Zhang, Sheng Liu
{"title":"Efficacy of perioperative recombinant human brain natriuretic peptide for preventing acute kidney injury after cardiac surgery: Rationale, design, and study protocol for a multicenter, double-blind, randomized controlled trial (PROTECT-CS).","authors":"Jiawei Han, Xiao Ma, Qu Chen, Hongyan Zhou, Fangzhou Li, Huajie Li, Lili Liu, Jianfang Cai, Juan Du, Heng Zhang, Sheng Liu","doi":"10.1016/j.ahj.2026.107615","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107615","url":null,"abstract":"<p><strong>Background: </strong>Acute kidney injury (AKI) is one of the most common and consequential complications after cardiac surgery. Despite improvements in perioperative care, no pharmacological intervention has been definitively shown to prevent AKI following cardiac surgery. Recombinant human brain natriuretic peptide (rhBNP) shares structural and biological activity with endogenous brain natriuretic peptide and has demonstrated favorable natriuretic, diuretic, and renal hemodynamic effects in prior studies. However, robust randomized evidence on whether perioperative rhBNP can prevent AKI is lacking.</p><p><strong>Design: </strong>This is an investigator-initiated, multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-group trial comparing perioperative rhBNP with placebo in high-risk patients undergoing elective on-pump cardiac surgery. A total of 694 participants will be randomized 1:1 to receive a continuous intravenous infusion of rhBNP (0.01 µg/kg/min) or matched normal-saline placebo, initiated between anesthesia induction and the onset of cardiopulmonary bypass and continued for 48 ± 2 hours. The primary efficacy endpoint is the incidence of AKI within 7 postoperative days defined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Secondary endpoints include AKI severity and duration, renal replacement therapy during the index hospitalization, major adverse kidney events at 30 and 90 days (MAKE-30, MAKE-90), 30-day all-cause mortality, intensive care unit and total length of stay.</p><p><strong>Conclusions: </strong>To our knowledge, PROTECT-CS is the first adequately powered, multicenter, double-blind randomized trial designed to evaluate whether perioperative rhBNP prevents AKI after high-risk cardiac surgery. The study is intended to provide high-quality evidence to inform clinical practice and future guideline recommendations on pharmacological renal protection in cardiac surgery patients.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, identifier NCT07617675.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107615"},"PeriodicalIF":3.4,"publicationDate":"2026-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149057133","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}
Ji Hae Lee, Fred Wu, Anais Marenco, Olivia D Miller, Vedang Diwanji, Minmin Lu, Ava Conklin, Lynn A Sleeper, Tal Geva, Anne Marie Valente
{"title":"The evolving clinical profile of patients with repaired tetralogy of Fallot undergoing pulmonary valve replacement.","authors":"Ji Hae Lee, Fred Wu, Anais Marenco, Olivia D Miller, Vedang Diwanji, Minmin Lu, Ava Conklin, Lynn A Sleeper, Tal Geva, Anne Marie Valente","doi":"10.1016/j.ahj.2026.107614","DOIUrl":"10.1016/j.ahj.2026.107614","url":null,"abstract":"<p><strong>Background: </strong>Timely pulmonary valve replacement (PVR) is increasingly used to treat right ventricular outflow dysfunction in patients with repaired tetralogy of Fallot (rTOF). Although PVR procedural volume has increased over the last decade, the evolution of the clinical profiles of patients referred for surgical or transcatheter PVR (sPVR, tPVR) has not been clearly elucidated.</p><p><strong>Objectives: </strong>To evaluate the clinical characteristics of rTOF patients referred for PVR and to compare trends over time in patients undergoing sPVR vs tPVR.</p><p><strong>Methods: </strong>This was a retrospective, single-center cohort study conducted at Boston Children's Hospital that analyzed clinical, arrhythmia, imaging, and exercise data from patients with rTOF who had undergone PVR, comparing it with data from matched controls without PVR, stratified by era (1995-2003 vs 2004-2012 vs 2013-2021). We also compared time trends in referral patterns for sPVR vs tPVR.</p><p><strong>Results: </strong>Over time, patients underwent TOF repair at a younger age. Among patients referred for PVR, age at the time of PVR remained stable, but the burden of heart failure symptoms and arrhythmias decreased, as did the severity of right ventricular dilation and dysfunction. The percentage of tPVR increased from 0% in Era 1 to 21% in Era 2 to 38% in Era 3 (P < .001). The increase in tPVR was particularly pronounced among patients with TOF and pulmonary stenosis, as well as among those with a transannular patch repair (from 0% to 27% to 47% across eras; P < .001). In contrast, the frequency of sPVR in patients with a right ventricle-to-pulmonary artery conduit decreased from 20% to 12% to 5% across eras (P < .001).</p><p><strong>Conclusions: </strong>This study highlights more proactive referral to PVR in rTOF and increasing use of tPVR. Further study is required to determine whether these evolving practices improve clinical outcomes.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107614"},"PeriodicalIF":3.4,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149029644","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}
Wojciech Wanha, Sylwia Iwanczyk, Jose Maria de la Torre Hernandez, Antoine Khoury, Stefano De Servi, Manel Sabatè, Dario Gattuso, Armando Perez de Prado, Bernardo Cortese
{"title":"Single vs. dual antiplatelet therapy in elderly or HBR patients undergoing percutaneous interventions with drug-coated balloons: design and rationale of PICCOLETO IV-EPIC 38 study.","authors":"Wojciech Wanha, Sylwia Iwanczyk, Jose Maria de la Torre Hernandez, Antoine Khoury, Stefano De Servi, Manel Sabatè, Dario Gattuso, Armando Perez de Prado, Bernardo Cortese","doi":"10.1016/j.ahj.2026.107606","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107606","url":null,"abstract":"<p><strong>Rationale: </strong>Elderly patients with obstructive coronary artery disease (CAD) frequently present a high bleeding risk (HBR). In this category of patients, percutaneous coronary intervention (PCI) is also associated with a higher risk of periprocedural and long-term ischemic and bleeding complications. PCI with drug-coated balloons (DCB) with short dual antiplatelet therapy (DAPT) is a valid alternative to stenting in this group of elderly or HBR patients. To date, no dedicated trial has prospectively evaluated the safety and efficacy of a PCI with solo-DCB followed by single antiplatelet therapy (SAPT).</p><p><strong>Objectives: </strong>The study aims to evaluate the incidence of ischemic and bleeding adverse events following SAPT after only-DCB PCI in elderly patients or those with high bleeding risk, either with chronic or acute coronary syndromes.</p><p><strong>Design: </strong>PICCOLETO IV-EPIC38 study (clinicaltrial.gov: NCT06535568) is a prospective, international, multicenter, investigator-driven, open-label, randomized (1:1), superiority clinical trial. The study will enroll elderly patients aged 75 years or older (≥75 years) or HBR patients, as defined by the Academic Research Consortium criteria, who are undergoing successful DCB-only PCI for native coronary artery disease in vessels with a diameter between 2.0 and 4.0 mm. Participants will be randomized in a 1:1 ratio between two treatment groups: the experimental arm receiving SAPT and the comparative arm receiving DAPT. Patients in the experimental arm will receive either aspirin or clopidogrel. In the comparative arm, patients will receive standard care. The primary endpoint of this study is the incidence of Net Adverse Clinical Events (NACE), defined as the composite of major adverse cardiac events (MACE), including total mortality, target vessel revascularization, and spontaneous myocardial infarction, and clinically relevant bleeding events (BARC 2, 3, or 5), assessed over 12 months. A superiority hypothesis will be tested. A total of 576 patients will be enrolled in the study, with primary analysis conducted on an intention-to-treat basis and secondary analysis performed on an as-treated basis. Randomization will take place after successful intervention.</p><p><strong>Summary: </strong>The PICCOLETO IV-EPIC38 study is a randomized trial assessing the safety and efficacy of SAPT post-PCI with DCB treatment, which could significantly impact treatment for elderly or HBR patients with CAD.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107606"},"PeriodicalIF":3.4,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149029595","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":"Letter to the Editor regarding \"Association between atherosclerosis and atrial fibrillation progression in patients with paroxysmal atrial fibrillation: Data from the RACE V study\".","authors":"Hui-Hui Wang, Qian-Qian Hu, Kun Ren","doi":"10.1016/j.ahj.2026.107610","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107610","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107610"},"PeriodicalIF":3.4,"publicationDate":"2026-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149001064","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}
American heart journalPub Date : 2026-07-01Epub Date: 2026-02-11DOI: 10.1016/j.ahj.2026.107379
Andrew Morrow PhD , Robin Young PhD , George R. Abraham BMBCh , Stephen Hoole DM , Joana Maria Gomes Oliveira MSc , John P. Greenwood MBChB, PhD , Jayanth Ranjit Arnold BMBCh, MA, DPhil , Vanessa Ferreira SB, MD, DPhil , Roby Rakhit BSc(Hons), MBBS MD , Gavin Galasko BA, BM, MA, DM , Aish Sinha BSc, MRCP , Divaka Perera MD, FRCP , Rasha Al-Lamee MBBS, PhD , Ioakim Spyridopoulos MD , Ashish Kotecha MBBS , Gerald Clesham MA, PhD , Thomas J. Ford MBChB(Hons), PhD , Anthony Davenport MA, PhD , Sandosh Padmanabhan MBBS, PhD , Juan Carlos Kaski MD, DSc , Colin Berry BSc, MBChB, PhD
{"title":"Exercise treadmill testing for efficacy evaluation in randomized, controlled trials","authors":"Andrew Morrow PhD , Robin Young PhD , George R. Abraham BMBCh , Stephen Hoole DM , Joana Maria Gomes Oliveira MSc , John P. Greenwood MBChB, PhD , Jayanth Ranjit Arnold BMBCh, MA, DPhil , Vanessa Ferreira SB, MD, DPhil , Roby Rakhit BSc(Hons), MBBS MD , Gavin Galasko BA, BM, MA, DM , Aish Sinha BSc, MRCP , Divaka Perera MD, FRCP , Rasha Al-Lamee MBBS, PhD , Ioakim Spyridopoulos MD , Ashish Kotecha MBBS , Gerald Clesham MA, PhD , Thomas J. Ford MBChB(Hons), PhD , Anthony Davenport MA, PhD , Sandosh Padmanabhan MBBS, PhD , Juan Carlos Kaski MD, DSc , 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}