JACC advances最新文献

{"title":"Percutaneous Coronary Intervention Outcomes by 5 Major Race and Ethnic Subgroups","authors":"Arjun B. Kapoor MD ,&nbsp;Serdar Farhan MD ,&nbsp;Manish Vinayak MD ,&nbsp;Samantha Sartori PhD ,&nbsp;Yihan Feng MS ,&nbsp;Yash Prakash MD ,&nbsp;Roxana Mehran MD ,&nbsp;Annapoorna Kini MD ,&nbsp;Deepak L. Bhatt MD, MPH, MBA ,&nbsp;Samin K. Sharma MD","doi":"10.1016/j.jacadv.2025.101767","DOIUrl":"10.1016/j.jacadv.2025.101767","url":null,"abstract":"<div><h3>Background</h3><div>Racial and ethnic disparities in cardiovascular disease outcomes, including percutaneous coronary intervention (PCI), are well-documented. However, studies do not stratify certain subgroups, such as separating South Asian and East Asian patients, who exhibit varying burdens of cardiovascular disease and PCI outcomes. Additionally, socioeconomic status (SES) further complicates outcomes, with low SES serving as an independent predictor of adverse outcomes post-PCI.</div></div><div><h3>Objectives</h3><div>This study aimed to analyze PCI outcomes across 5 racial and ethnic groups—White, Black, Hispanic, South Asian, and East Asian populations—while accounting for comorbidities and SES to better understand how race and ethnicity influence cardiovascular outcomes.</div></div><div><h3>Methods</h3><div>We conducted a retrospective cohort study of patients undergoing PCI from 2012 to 2022. Patients were stratified by race/ethnicity and matched to median household income based on U.S. Census Zone Improvement Plan code data. The primary endpoint was 1-year major adverse cardiovascular events (MACE). Multivariable Cox regression models were used to assess outcomes, adjusting for comorbidities and SES.</div></div><div><h3>Results</h3><div>A total of 21,236 patients were included: 47.8% White, 11.3% Black, 18.0% Hispanic, 20.7% South Asian, and 2.2% East Asian. South Asian patients had significantly lower MACE (adjusted HR: 0.62; <em>P</em> &lt; 0.001) compared with White patients. Black patients, in contrast, had a higher risk of MACE (adjusted HR: 1.27; <em>P</em> = 0.032).</div></div><div><h3>Conclusions</h3><div>Significant racial and ethnic disparities exist in 1-year PCI outcomes, with South Asian patients exhibiting favorable outcomes compared with White patients, and Black patients experiencing worse outcomes. Baseline comorbidities and estimated SES do not fully explain these disparities, suggesting that targeted strategies are needed to address the multifactorial influences on PCI outcomes across racial and ethnic groups.</div></div>","PeriodicalId":73527,"journal":{"name":"JACC advances","volume":"4 6","pages":"Article 101767"},"PeriodicalIF":0.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143935700","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pre-Existing Pulmonary Hypertension Impact on In-Hospital Outcomes of Cardiac Implantable Electrical Device Implantation","authors":"Gilad Margolis MD ,&nbsp;Oren Mahler Hafner Bsc ,&nbsp;Mark Kazatsker MD,&nbsp;Ariel Roguin MD, PhD,&nbsp;Eran Leshem MD, MHA","doi":"10.1016/j.jacadv.2025.101768","DOIUrl":"10.1016/j.jacadv.2025.101768","url":null,"abstract":"<div><h3>Background</h3><div>Pre-existing pulmonary hypertension (PH) is associated with unfavorable in-hospital outcomes in cardiac as well as noncardiac surgeries and procedures. However, its impact on cardiac implantable electronic device (CIED) implantations is not established.</div></div><div><h3>Objectives</h3><div>The purpose of the study was to investigate the extent of pre-existing PH among patients undergoing CIED implantations and to evaluate its effect on in-hospital outcomes.</div></div><div><h3>Methods</h3><div>Using the National Inpatient Sample database, we identified patients who were hospitalized in the United States between 2016 and 2019 and underwent CIED implantation with a pre-existing diagnosis of PH. Patients with any CIED in situ were excluded. Sociodemographic and clinical data, in-hospital procedures and outcomes, and in-hospital mortality were collected. Multivariable logistic regression models were used to identify predictors of in-hospital complications.</div></div><div><h3>Results</h3><div>An estimated total of 718,980 patients underwent CIED implantation during the study period. Of them, 74,150 patients (10.3%) had a pre-existing PH diagnosis. Compared with non-PH patients, PH patients were older, had higher Charlson Comorbidity Index, and were more often implanted with implantable cardioverter defibrillators and cardiac resynchronization therapy devices. A higher rate of total complications was observed in PH patients (14.5% vs 9.9%; <em>P</em> &lt; 0.001), driven mainly by respiratory complications as well as in-hospital mortality (2.3% vs 1.2%; <em>P</em> &lt; 0.001). Multivariable analyses confirmed PH as an independent predictor for respiratory complications, total complications, and in-hospital mortality.</div></div><div><h3>Conclusions</h3><div>Pre-existing PH in patients undergoing CIED implantation was associated with increased risk for respiratory complications as well as in-hospital mortality in a nationwide, all-comer registry.</div></div>","PeriodicalId":73527,"journal":{"name":"JACC advances","volume":"4 6","pages":"Article 101768"},"PeriodicalIF":0.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143935660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A New Biomarker of Aging Derived From Electrocardiograms Improves Risk Prediction of Incident Cardiovascular Disease","authors":"Tom Wilsgaard PhD ,&nbsp;Wayne Rosamond PhD ,&nbsp;Henrik Schirmer MD, PhD ,&nbsp;Haakon Lindekleiv MD, PhD ,&nbsp;Zachi I. Attia PhD ,&nbsp;Francisco Lopez-Jimenez MD, MSc, MBA ,&nbsp;David A. Leon PhD ,&nbsp;Olena Iakunchykova PhD","doi":"10.1016/j.jacadv.2025.101764","DOIUrl":"10.1016/j.jacadv.2025.101764","url":null,"abstract":"<div><h3>Background</h3><div>A biomarker of cardiovascular aging, derived from a deep learning algorithm applied to digitized 12-lead electrocardiograms, has recently been introduced. This biomarker, δ-age, is defined as the difference between predicted electrocardiogram age and chronological age.</div></div><div><h3>Objectives</h3><div>The purpose of this study was to assess the potential value of δ-age in enhancing the performance of primary prevention models for cardiovascular disease that incorporate traditional cardiovascular risk factors.</div></div><div><h3>Methods</h3><div>In this cohort study, we included 7,108 men and women from the Norwegian Tromsø Study in 2015 to 16, with follow-up through 2021 for incident fatal and nonfatal myocardial infarction (MI) and hemorrhagic or cerebral stroke. We used Cox proportional hazards regression models, Harrell's concordance statistic (C-index), and the net reclassification improvement.</div></div><div><h3>Results</h3><div>During a median follow-up of 5.9 years, we observed 155 cases of MI and 141 strokes. In men and women combined,HR per SD increment in δ-age, after adjustment for traditional risk factors included in the Norwegian risk model for acute cerebral stroke and myocardial infarction (NORRISK 2) score, was 1.24 (95% CI: 1.09-1.41) for the combined outcome, with similar HRs for MI and stroke. In men, the HR was significant for MI and in women for stroke. The C-index increased significantly but modestly when δ-age was added to a model with traditional risk factors. The net reclassification improvement was 26.0% (95% CI: 13.3%-38.1%) for the combined outcome, 17.5% (95% CI: 0.6%-33.5%) for MI, and 37.2% (95% CI: 20.1%-53.0%) for stroke.</div></div><div><h3>Conclusions</h3><div>Incorporating δ-age into primary prevention risk prediction models significantly improved performance beyond traditional cardiovascular risk factors for the combined outcome and separately for MI and stroke.</div></div>","PeriodicalId":73527,"journal":{"name":"JACC advances","volume":"4 6","pages":"Article 101764"},"PeriodicalIF":0.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143935699","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Emergency Chest Pain Center","authors":"Marwa A. Sabe MD, MPH ,&nbsp;Frank J. Kaeberlein MD ,&nbsp;Sharif A. Sabe MD, MA ,&nbsp;Allyson Kelly BSN, MBA ,&nbsp;Tracy Summerfield ,&nbsp;Ahmed A. Sabe MD","doi":"10.1016/j.jacadv.2025.101774","DOIUrl":"10.1016/j.jacadv.2025.101774","url":null,"abstract":"<div><h3>Background</h3><div>Percutaneous coronary intervention is the preferred treatment for acute ST-segment elevation myocardial infarction (STEMI), and shorter door-to-balloon time (D2B) is associated with lower mortality. We implemented a catheterization laboratory within the emergency department (ED) as a novel strategy to reduce D2B.</div></div><div><h3>Objectives</h3><div>The purpose of this paper was to compare D2B and mortality in STEMI patients presenting to ED vs standard catheterization labs at a community hospital.</div></div><div><h3>Methods</h3><div>We prospectively reviewed consecutive patients presenting with STEMI to our institution between 1998 and 2011 and treated with primary percutaneous coronary intervention. The primary endpoints were D2B and time to death. A multivariable linear regression model was used to assess the relationship between catheterization lab location and D2B. The relationship between D2B and mortality was examined using a Cox proportional hazards model.</div></div><div><h3>Results</h3><div>We included 1,053 STEMI patients (553 in ED vs 500 in standard catheterization labs). Both groups had similar age, sex, race, diabetes, left main disease, and Killip class on presentation. Standard catheterization lab patients were more likely to have left ventricular ejection fraction &lt;40% (11% vs 6.5%). D2B was shorter in ED vs standard cath lab patients (54 vs 83 minutes, <em>P</em> &lt; 0.001). ED catheterization lab patients were more likely to have &lt;30-minute D2B (17% vs &lt;1%, <em>P</em> &lt; 0.001). After covariate adjustment, ED catheterization lab patients had lower 30-day (adjusted hazard ratio [adj HR]: 0.54, 95% confidence interval [CI] 0.29-0.99), 1-year (adj HR: 0.58, 95% CI: 0.37-0.91), and 10-year mortality (adj HR: 0.39, 95% CI: 0.29-0.53) than standard catheterization lab patients.</div></div><div><h3>Conclusions</h3><div>Implementation of an ED catheterization lab is a feasible strategy which may reduce D2B and STEMI mortality.</div></div>","PeriodicalId":73527,"journal":{"name":"JACC advances","volume":"4 6","pages":"Article 101774"},"PeriodicalIF":0.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143935698","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Integrating Community-Based Participatory Research Into Cardiac Clinical Trials","authors":"Aminah Sallam MD ,&nbsp;Niurka Suero-Tejeda MS, MA, CHES ,&nbsp;Stephanie Niño de Rivera BA ,&nbsp;Rhonda Monroe MBA ,&nbsp;Patrick O. Gee PhD, JLC ,&nbsp;John A. Spertus MD, MPH ,&nbsp;Ruth Masterson Creber PhD, RN","doi":"10.1016/j.jacadv.2025.101799","DOIUrl":"10.1016/j.jacadv.2025.101799","url":null,"abstract":"","PeriodicalId":73527,"journal":{"name":"JACC advances","volume":"4 6","pages":"Article 101799"},"PeriodicalIF":0.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143935931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Mixed Hemodynamic Profile in Shock","authors":"Ashraf E.G. Roshdy MBBCh, MSc, PhD","doi":"10.1016/j.jacadv.2025.101796","DOIUrl":"10.1016/j.jacadv.2025.101796","url":null,"abstract":"","PeriodicalId":73527,"journal":{"name":"JACC advances","volume":"4 6","pages":"Article 101796"},"PeriodicalIF":0.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143935932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Perinatal Exercise and Cardiovascular Disease Risk","authors":"Marnie K. McLean MS ,&nbsp;Bradley J. Petek MD ,&nbsp;Lidija McGrath MD ,&nbsp;Emily McGill BS ,&nbsp;Abbi D. Lane PhD","doi":"10.1016/j.jacadv.2025.101776","DOIUrl":"10.1016/j.jacadv.2025.101776","url":null,"abstract":"<div><div>The purpose of this narrative review was to summarize perinatal exercise guidelines and associations of perinatal physical activity and/or exercise with cardiovascular disease (CVD) risk. Observational studies, randomized controlled trials, systematic reviews, and meta-analyses were included. Gaps in literature and suggestions for future studies were identified. Despite concordant international guidelines, data to support nuanced activity advice for some subgroups are limited. Perinatal physical activity and exercise are consistently recommended to combat traditional CVD risk factors during the perinatal period, like excessive gestational weight gain, high blood pressure, and high blood glucose. Physical activity and exercise appear to improve nontraditional risk factors such as poor sleep and depression. Data are emerging regarding associations with some pregnancy-specific factors, such as placental characteristics. Further research investigating associations with pregnancy-specific CVD risk factors and associations in the longer term, as well as data to support uptake, adherence, and resistance exercise prescription is warranted.</div></div>","PeriodicalId":73527,"journal":{"name":"JACC advances","volume":"4 6","pages":"Article 101776"},"PeriodicalIF":0.0,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143935661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Short-Term Results of Early Detection of Critical Congenital Heart Disease","authors":"Julissa Carhuayo-Chura MD ,&nbsp;Felipe E. Terpin-Ayvar ,&nbsp;Anthony Bautista-Pariona MD ,&nbsp;J. Pierre Zila-Velasque MD ,&nbsp;Luis S. Velarde-Zegarra MD ,&nbsp;Carmen Davila-Aliaga MD ,&nbsp;Katia Bravo-Jaimes MD","doi":"10.1016/j.jacadv.2025.101775","DOIUrl":"10.1016/j.jacadv.2025.101775","url":null,"abstract":"<div><h3>Background</h3><div>Critical congenital heart disease (CCHD) affects 1 in 400 newborns and requires early intervention to prevent neonatal mortality. In Peru, neonatal CCHD screening is primarily implemented in the capital, but its impact on patient outcomes remains unclear.</div></div><div><h3>Objectives</h3><div>The purpose of this study was to evaluate the short-term outcomes of an early CCHD-detection program at the National Maternal Perinatal Institute in Lima, Peru.</div></div><div><h3>Methods</h3><div>A retrospective cohort study included all newborns diagnosed with CCHD at National Maternal Perinatal Institute between January 2022 and December 2023. Data were extracted from medical records, including maternal demographics, neonatal characteristics, and referral times to the 2 existing surgical congenital heart disease centers in Lima. Survival status was assessed through national identification registry records. Time to transfer, delays, and survival rates were analyzed using descriptive statistics, Kaplan-Meier survival curves, and multivariable models.</div></div><div><h3>Results</h3><div>A total of 34 neonates were diagnosed with CCHD. The most common conditions were hypoplastic left heart syndrome (18%) and pulmonary atresia (18%). Median time from birth to transfer was 8 days for EsSalud and 16 days for Ministry of Health (MINSA) surgical centers. The main causes of delay were lack of bed availability and administrative barriers. One-year survival rates were 36.7% for MINSA referrals and 85.7% for EsSalud referrals.</div></div><div><h3>Conclusions</h3><div>Despite early CCHD detection, neonatal mortality remains high, particularly for patients referred to MINSA centers. These findings highlight the urgent need to optimize referral pathways and expand surgical capacity to improve survival outcomes.</div></div>","PeriodicalId":73527,"journal":{"name":"JACC advances","volume":"4 6","pages":"Article 101775"},"PeriodicalIF":0.0,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143935696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Diagnostic and Prognostic Value of the 12-Lead ECG in Arrhythmogenic Left Ventricular Cardiomyopathy","authors":"Leonardo Calò MD ,&nbsp;Cinzia Crescenzi MD ,&nbsp;Andrea Di Marco MD, PhD ,&nbsp;Francesca Fanisio MD ,&nbsp;Fabiana Romeo MD ,&nbsp;Alessio Gargaro MSc ,&nbsp;Annamaria Martino MD, PhD ,&nbsp;Chiara Cappelletto MD ,&nbsp;Marco Merlo MD ,&nbsp;Mattia Targetti MD ,&nbsp;Elisabetta Toso MD ,&nbsp;Federica Toto MD ,&nbsp;Maria Beatrice Musumeci MD ,&nbsp;Giacomo Tini MD ,&nbsp;Michele Ciabatti MD ,&nbsp;Matteo Stefanini MD ,&nbsp;Stefano Canestrelli MD ,&nbsp;Elisa Fedele MD ,&nbsp;Chiara Lanzillo MD, PhD ,&nbsp;Armando Fusco MD, PhD ,&nbsp;Giuseppe Novelli MD, PhD","doi":"10.1016/j.jacadv.2025.101766","DOIUrl":"10.1016/j.jacadv.2025.101766","url":null,"abstract":"<div><h3>Background</h3><div>Electrocardiographic findings in arrhythmogenic left ventricular cardiomyopathy (ALVC) have been limited to small studies.</div></div><div><h3>Objectives</h3><div>The authors aimed to analyze the electrocardiogram (ECG) characteristics of ALVC, to correlate ECG with cardiac magnetic resonance and genetic data, and to evaluate its prognostic value.</div></div><div><h3>Methods</h3><div>We reviewed data of 125 consecutive patients with ALVC (81.5% <em>desmoplakin</em> pathogenic/likely pathogenic variants). The composite endpoint of major arrhythmic events (MAEs) included sudden cardiac death, aborted sudden cardiac death, and appropriate implantable cardioverter-defibrillator shock. Predictors of MAE were evaluated with logistic regression.</div></div><div><h3>Results</h3><div>ALVC showed distinct ECG signs, including left posterior fascicular block (LPFB) (13.6%), pathological Q waves (26.4%), R/S ratio in V₁ ≥0.5 (26.4%), and SV1 + RV6 ≤12 mm and RI + RII ≤8 mm (44%). Fifteen (12%) patients had a normal ECG. MAE occurred in 35 patients (28%). In multivariable analysis, LPFB (OR: 4.7; 95% CI: 1.2-18.3), syncope (OR: 84.95; 95% CI: 14-496), transmural late gadolinium enhancement (OR: 9.95; 95% CI: 2.3-36), and right ventricular ejection fraction (OR: 0.92; 95% CI: 0.87-0.97) were the independent predictors of MAE. The model including these 4 variables achieved a remarkable predictive capability (area under the curve: 0.9). In the primary prevention scenario, with Cox regression, LPFB (HR: 3.98; 95% CI: 1.3-12.0), syncope (HR: 19.13; 95% CI: 5.8-63.0), and transmural late gadolinium enhancement (HR: 10.57; 95% CI: 2.9-38.0) were independent predictors of MAE.</div></div><div><h3>Conclusions</h3><div>In ALVC, ECG is a valuable diagnostic tool and may have a relevant prognostic role, since LFPB is a strong and independent predictor of MAE.</div></div>","PeriodicalId":73527,"journal":{"name":"JACC advances","volume":"4 6","pages":"Article 101766"},"PeriodicalIF":0.0,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143935695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preserving Trial Endpoint Specificity and Cause of Death Attribution in Cardiovascular Trials","authors":"Shea E. Hogan MD, MSCS ,&nbsp;Mario Enrico Canonico MD, PhD ,&nbsp;Robert W. King MD ,&nbsp;Cecilia C. Low Wang MD ,&nbsp;Mark R. Nehler MD ,&nbsp;Jessica Parr MD ,&nbsp;R. Kevin Rogers MD, MSc ,&nbsp;Wentao Lu PhD ,&nbsp;John Albanese ,&nbsp;Elliot S. Barnathan MD ,&nbsp;Alex C. Spyropoulos MD ,&nbsp;James D. Douketis MD ,&nbsp;Marc P. Bonaca MD, MPH ,&nbsp;Warren H. Capell MD","doi":"10.1016/j.jacadv.2025.101763","DOIUrl":"10.1016/j.jacadv.2025.101763","url":null,"abstract":"<div><h3>Background</h3><div>The MARINER (Medically Ill Patient Assessment of Rivaroxaban vs Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk) trial examined the efficacy of rivaroxaban on venous thromboembolism (VTE) following discharge in high-risk medical inpatients. The trial did not meet its primary endpoint, in part due to a lesser effect of rivaroxaban on “VTE-related death” than on nonfatal VTE.</div></div><div><h3>Objectives</h3><div>The objective of this exploratory research was to examine the impact of more specific fatal VTE definitions on trial outcome HRs through readjudication of death endpoints.</div></div><div><h3>Methods</h3><div>Primary source documents for the 241 deaths in the MARINER trial were reviewed by blinded adjudicators not involved with the original trial. Prespecified definitions for VTE-related death were used, and “Death of Unknown Etiology” was allowed instead of the original endpoint “Cannot rule out pulmonary embolism.” Original event determinations for nonfatal events were used in this analysis. HRs and 95% CIs for rivaroxaban vs placebo were calculated for prespecified cardiovascular outcome composites.</div></div><div><h3>Results</h3><div>Rereviewed death cases showed strong concordance with original results, except deaths originally categorized as “Cannot rule out pulmonary embolism” were redistributed, largely to undetermined death (60%). The readjudicated MARINER primary endpoint using only confirmed fatal VTE events revealed a HR of 0.46 (95% CI: 0.23-0.91) vs the original HR of 0.76 (95% CI: 0.52-1.1).</div></div><div><h3>Conclusions</h3><div>This post-hoc, exploratory analysis of endpoint design demonstrates that designing specific trial endpoints can minimize the risk of type II error. In the trial design stage, it is important to preserve endpoint specificity to allow accurate hypothesis testing. Using standardized endpoint definitions, such as for VTE-related death, across trials can help achieve this goal.</div></div>","PeriodicalId":73527,"journal":{"name":"JACC advances","volume":"4 6","pages":"Article 101763"},"PeriodicalIF":0.0,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143935697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}