American heart journal plus : cardiology research and practice最新文献

{"title":"Magnetocardiography comes of age: From biophysical signal to clinical decision-making","authors":"Robert Takla , Mazen Awais","doi":"10.1016/j.ahjo.2026.100765","DOIUrl":"10.1016/j.ahjo.2026.100765","url":null,"abstract":"","PeriodicalId":72158,"journal":{"name":"American heart journal plus : cardiology research and practice","volume":"65 ","pages":"Article 100765"},"PeriodicalIF":1.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147803494","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":"Association of Cannabis use and Survival in patients with heart failure: A claims-based cohort study of commercially insured adults","authors":"Onyedika J. Ilonze ,&nbsp;Xiaochun Li ,&nbsp;Fangqian Ouyang ,&nbsp;Larry A. Allen ,&nbsp;Robert L. Page ,&nbsp;Sara K. Quinney ,&nbsp;Denise Christina Vidot ,&nbsp;Sarah Chuzi ,&nbsp;Khadijah Breathett","doi":"10.1016/j.ahjo.2026.100766","DOIUrl":"10.1016/j.ahjo.2026.100766","url":null,"abstract":"<div><div>We aimed to examine the prevalence of documented cannabis use and its association with survival among patients with HF using the Optum Clinoformatics dataset, large, national informatics dataset. We demonstrated low period prevalence of cannabis use among patients with heart failure and there was no statistically significant difference (<em>p</em> = 0.76) in all-cause mortality between individuals who use cannabis versus non-users.</div></div>","PeriodicalId":72158,"journal":{"name":"American heart journal plus : cardiology research and practice","volume":"64 ","pages":"Article 100766"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147599938","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":"Non-invasive estimation of coronary resistance and compliance: Prospective diagnostic study vs. angiography","authors":"Byoung-Kwon Lee ,&nbsp;Seog-San Hyeon ,&nbsp;YouSik Hong ,&nbsp;Dae-Woong Choi ,&nbsp;Sang-Suk Lee","doi":"10.1016/j.ahjo.2026.100763","DOIUrl":"10.1016/j.ahjo.2026.100763","url":null,"abstract":"<div><h3>Background</h3><div>Early identification of coronary artery disease (CAD) remains challenging, particularly in patients who cannot undergo exercise-based or contrast-dependent diagnostic testing. We evaluated a non-invasive pulse wave–based device, Coronyzer (KH-3000), designed to derive resistance and compliance indices for early screening of CAD.</div></div><div><h3>Methods</h3><div>A prospective diagnostic accuracy study was conducted in 94 patients with suspected angina who underwent coronary angiography (CAG). Significant CAD was defined as ≥50% diameter stenosis. Diagnostic performance was assessed using pre-specified thresholds for resistance (R) and compliance (C). An independent retrospective validation study was performed in 136 patients who underwent CAG and computed tomography coronary angiography (CTCA). Diagnostic performance was evaluated using predefined OR and AND decision rules (<em>R</em> &gt; 1.24 and/or C &lt; 0.8).</div></div><div><h3>Results</h3><div>In the prospective cohort, sensitivity and specificity were 81% and 89%, respectively. In the validation cohort, the OR rule demonstrated high sensitivity (0.77) with lower specificity (0.41), whereas the AND rule showed lower sensitivity (0.53) but high specificity (0.78). Receiver operating characteristic (ROC) analysis demonstrated moderate overall diagnostic accuracy (area under the curve (AUC) = 0.67).</div></div><div><h3>Conclusions</h3><div>Coronyzer demonstrated clinically meaningful diagnostic performance as a non-invasive screening and risk stratification tool for coronary artery disease. By avoiding radiation exposure, contrast agents, and exercise requirements, the device may support early clinical triage and referral for further diagnostic evaluation, particularly in patient populations for whom conventional testing is limited.</div></div>","PeriodicalId":72158,"journal":{"name":"American heart journal plus : cardiology research and practice","volume":"64 ","pages":"Article 100763"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147599851","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":"Multicenter, randomized controlled study evaluating percutaneous and non-fluoroscopic procedure of atrial septal defects-study protocol of the PANASD randomized controlled trial","authors":"Junke Chang ,&nbsp;Jing Dong ,&nbsp;Fengwen Zhang ,&nbsp;Cheng Wang ,&nbsp;Wenbin Ouyang ,&nbsp;Fang Fang ,&nbsp;Chuangshi Wang ,&nbsp;Xiangbin Pan","doi":"10.1016/j.ahjo.2026.100747","DOIUrl":"10.1016/j.ahjo.2026.100747","url":null,"abstract":"<div><h3>Background</h3><div>Atrial septal defect (ASD) is one of the most common congenital heart diseases. Radiation exposure during transcatheter ASD closure poses cumulative risks for both patients and operators. We have pioneered a percutaneous and non-fluoroscopic procedure (PAN procedure) for a broad spectrum of cardiovascular interventional therapies, which eliminates the need for radiation and contrast. The PANASD trial is designed to compare PAN procedure with the traditional fluoroscopy procedure for transcatheter ASD closure. This article outlines the protocol of the study.</div></div><div><h3>Trial design</h3><div>PANASD is a prospective, multicenter, randomized controlled trial enrolling approximately 660 patients for elective percutaneous ASD closure from eight participating centers in China. In this RCT, patients diagnosed with secundum ASD are randomized into two groups: one undergoing echocardiography-guided percutaneous ASD closure without the use of radiation and the other following the conventional fluoroscopy-guided procedure. The primary endpoint is the success rate of occlusion, defined as no conversion to surgery, a well-positioned occluder during hospitalization, and no major adverse events. Secondary endpoints include complication rates, costs, length of hospital stay, etc. Follow-up of the last enrolled patients will be completed in early 2026, and results will be available by late 2026. Data will be collected via an electronic data capture (EDC) system, and adverse events will be systematically recorded and monitored. Adherence to ethical principles, including informed consent and confidentiality, is maintained.</div></div><div><h3>Conclusion</h3><div>This RCT protocol represents the first clinical trial to compare the safety and efficacy of percutaneous and non-fluoroscopic ASD closure with the conventional fluoroscopic method.</div></div>","PeriodicalId":72158,"journal":{"name":"American heart journal plus : cardiology research and practice","volume":"64 ","pages":"Article 100747"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147599939","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":"Heart rate circadian rhythm in patients with traumatic brain injury: A retrospective analysis of a nationwide multicenter ICU database","authors":"Yu Deng ,&nbsp;Baiyun Liu ,&nbsp;Yunfei Li ,&nbsp;Liang Wu","doi":"10.1016/j.ahjo.2026.100760","DOIUrl":"10.1016/j.ahjo.2026.100760","url":null,"abstract":"<div><h3>Objective</h3><div>This study aimed to determine whether the circadian rhythm in heart rate independently associated with in-hospital mortality among patients with TBI.</div></div><div><h3>Methods</h3><div>Data were extracted from the eICU-CRD. Heart rate circadian rhythm was characterized using three parameters: mesor, amplitude, and peak time. The prognostic association and incremental discriminatory value of these circadian variables, alongside the APACHE IV score, was assessed in relation to in-hospital mortality.</div></div><div><h3>Results</h3><div>Among 3202 patients showing a circadian rhythm in heart rate, each 10-beat/min increase in mesor was associated with a 1.18-fold higher odd of in-hospital mortality (95% CI: 1.08–1.30; <em>P</em> &lt; 0.001), while each 5-beat/min increase in amplitude corresponded to a 1.14-fold increase (95% CI: 1.03–1.25; <em>P</em> &lt; 0.001). The link between mesor and in-hospital mortality varied with comorbidities such as heart failure (<em>P</em> = 0.039), atrial fibrillation (<em>P</em> = 0.014), infection (<em>P</em> = 0.003), and fever (<em>P</em> = 0.027). Adding circadian rhythm metrics to the APACHE IV score improved model discrimination (c-index 0.795; 95% CI: 0.747–0.844) compared to APACHE IV alone (c-index 0.719; 95% CI: 0.665–0.773; <em>P</em> &lt; 0.001).</div></div><div><h3>Conclusion</h3><div>Circadian rhythm features of heart rate are independent prognostic factors associated with in-hospital mortality in TBI patients. Integrating these variables with conventional scoring systems may improve prognostic accuracy.</div></div>","PeriodicalId":72158,"journal":{"name":"American heart journal plus : cardiology research and practice","volume":"64 ","pages":"Article 100760"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147599937","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":"Impact of influenza vaccination on in-hospital outcomes among patients with heart failure and acute respiratory illness","authors":"Aimen Shafiq ,&nbsp;Syed Sarmad Javaid ,&nbsp;Apurva Popat ,&nbsp;Hamza Asif ,&nbsp;Mahlika Ahmad ,&nbsp;Rehan Ali ,&nbsp;Irfa Zaheer ,&nbsp;Usama Arshad ,&nbsp;Dua Jabeen ,&nbsp;Alishba Karim Mandokhail ,&nbsp;Danaish Kumar ,&nbsp;Saeeda Khanam ,&nbsp;F.N.U. Sagar ,&nbsp;Muhammad Shariq Usman ,&nbsp;Ali Hasan ,&nbsp;Raheel Ahmed","doi":"10.1016/j.ahjo.2026.100757","DOIUrl":"10.1016/j.ahjo.2026.100757","url":null,"abstract":"<div><h3>Background</h3><div>Influenza vaccination is recommended to patients with heart failure (HF), who are vulnerable to severe complications from respiratory infections. However, data on its impacts on in-hospital outcomes remain limited.</div></div><div><h3>Methods</h3><div>We analyzed the National Inpatient Sample (2018 to 2020), including adults (≥ 18 years) hospitalized with acute respiratory infection (ARI) and HF, identified using ICD-10 CM Codes(ARI: J09.x–J11.x, J12.x–J18.x, J20.x, J21.x; HF: I50.x, I0981, I110, I130, I132, I97130, I97131, O29121–O29129, Z95811, Z95812). The primary outcome was in-hospital mortality. Secondary outcomes included mechanical ventilation use, sepsis, length of stay (LOS) in hospital, and inflation-adjusted total hospital charges. Multivariable logistic and linear regression models assessed associations between influenza vaccination and outcomes, adjusting for demographic, clinical, socioeconomic and hospital-level factors.</div></div><div><h3>Results</h3><div>Among 491,210 hospitalizations for patients with HF and ARI, 28% (137,538) received influenza vaccination. Vaccinated patients with HF had significantly lower odds of in-hospital mortality (OR: 0.32; 95% CI, 0.23–0.46; <em>p</em> &lt; 0.001), mechanical ventilation (OR: 0.67; 95% CI, 0.54–0.83; p &lt; 0.001), and sepsis (OR: 0.63; 95% CI, 0.45–0.88; <em>p</em> = 0.006). They also had lower total hospital charges (β = −$3181; 95% CI, −$5264 to –$1098; <em>p</em> = 0.003). No significant difference was found in LOS (β = −0.05; 95% CI, −0.21 to 0.12; <em>p</em> = 0.6).</div></div><div><h3>Conclusion</h3><div>Influenza vaccination for ARI is linked to lower mortality, fewer complications, and reduced health care costs. These findings support the promotion of inpatient vaccination to improve outcomes and reduce burden in the high-risk population.</div></div>","PeriodicalId":72158,"journal":{"name":"American heart journal plus : cardiology research and practice","volume":"64 ","pages":"Article 100757"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147599852","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":"Colchicine in addition to usual care for acute pericarditis with classical ECG changes after catheter ablation for cardiac arrhythmias","authors":"Mauro Toniolo ,&nbsp;Luca Rebellato ,&nbsp;Massimo Imazio","doi":"10.1016/j.ahjo.2026.100761","DOIUrl":"10.1016/j.ahjo.2026.100761","url":null,"abstract":"<div><h3>Background</h3><div>Acute pericarditis is a complication associated with radiofrequency or cryo-energy catheter ablation (CA) for arrhythmias and may be accompany pericardial effusion. A frequent complication of acute pericarditis is the onset of arrhythmias. While colchicine has demonstrated both anti-inflammatory and anti-arrhythmic effects in acute pericarditis, its efficacy in cases specifically developing post-CA remains unknown.</div><div>The purpose of this study is to determine whether colchicine administration after the diagnosis of acute pericarditis due to CA is associated with a reduction in the recurrence rate of arrhythmias.</div></div><div><h3>Methods</h3><div>Patients who developed acute pericarditis after CA for arrhythmias were retrospectively included in this study. Following the CA procedure, a group of patients was prescribed 0.5 mg of colchicine twice daily for 14 days at the operator's discretion, in addition to usual care. The primary outcome was freedom from arrhythmias within 12 months. Secondary outcomes included signs of pericarditis, recurrence of pericardial effusion, and the incidence of constrictive pericarditis.</div></div><div><h3>Results</h3><div>Among the 75 consecutively enrolled patients, acute pericarditis occurred after: pulmonary vein isolation (<em>n</em> = 50), endocardial ventricular tachycardia ablation (<em>n</em> = 18), right outflow premature ventricular contraction ablation (<em>n</em> = 5), and atrioventricular nodal re-entrant tachycardia ablation (<em>n</em> = 2). During a median follow-up of 365.0 days (IQR 333.0–420.0 days), freedom from any arrhythmia (regardless of anti-arrhythmic drug use) was similar between groups (76.2% in the colchicine group vs. 74.1% in the usual care group; log-rank <em>p</em> = 0.93). Univariate analysis showed that colchicine use was not associated with a lower risk of arrhythmia recurrence. No cases of recurrent pericarditis or constrictive pericarditis were observed in either group during the follow-up period.</div></div><div><h3>Conclusion</h3><div>Colchicine, when added to usual care, doesn't appear associated with improved clinical outcomes in patients who developed acute pericarditis following CA for arrhythmias.</div><div>Clinical trial number: UD5684993756.</div></div>","PeriodicalId":72158,"journal":{"name":"American heart journal plus : cardiology research and practice","volume":"64 ","pages":"Article 100761"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147599940","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":"Lived experience of people with hypertension in Ethiopia: A phenomenological study, 2025","authors":"Ousman Adal ,&nbsp;Mekides Misganaw ,&nbsp;Asnake Gashaw Belayneh ,&nbsp;Destaw Endeshaw ,&nbsp;Abebu Tegenaw Delie ,&nbsp;Yeshimebet Tamir Tsehay ,&nbsp;Tadele Fentabel Anagaw ,&nbsp;Eyob Ketema Bogale","doi":"10.1016/j.ahjo.2026.100729","DOIUrl":"10.1016/j.ahjo.2026.100729","url":null,"abstract":"<div><h3>Background</h3><div>Hypertension poses a substantial and growing public health challenge in Ethiopia. Despite its increasing prevalence, significant knowledge gaps remain regarding how patients experience and manage the condition within their social, cultural, and economic contexts. This study aimed to explore the lived experiences of patients with hypertension in Ethiopia using a qualitative approach, contributing to improved understanding and supporting sustainable, equitable, and patient-centered care.</div></div><div><h3>Methods</h3><div>Data were collected from adults living with hypertension who were receiving treatment in tertiary hospitals in northwest Amhara, Ethiopia, in July 2025. Participants were selected using purposive and heterogeneous sampling to include both males and females across all age groups above 18 years. Data were collected in the local language (Amharic), translated into English, and imported into ATLAS.ti v7 for coding and analysis. A thematic analysis was conducted, and rigor was ensured by considering credibility, dependability, confirmability, and transferability.</div></div><div><h3>Results</h3><div>Eight themes emerged from the analysis: (1) emotional and cognitive responses to diagnosis; (2) health provider interaction and communication; (3) adaptation and self-management; (4) treatment challenges and complications; (5) social and family support; (6) impact on daily life; (7) perception and control of hypertension; and (8) healthcare system and access barriers. Participants highlighted the importance of tailored patient education, effective provider communication, and community engagement for improving adherence and health outcomes. While most participants accepted their condition calmly, prior knowledge and interactions with healthcare providers shaped understanding and coping strategies. Adaptation included lifestyle modification, dietary adherence, and treatment compliance, with some challenges such as transportation issues, medication shortages, and long waiting times noted.</div></div><div><h3>Conclusion</h3><div>Understanding patients lived experiences provides insights for designing culturally appropriate interventions, improving adherence, and enhancing overall management of hypertension in Ethiopia.</div></div>","PeriodicalId":72158,"journal":{"name":"American heart journal plus : cardiology research and practice","volume":"63 ","pages":"Article 100729"},"PeriodicalIF":1.8,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146081271","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":"Effects of pericardial incision on circulation and body oxygenation in pediatric patients with congenital heart disease","authors":"Takashi Sakamoto ,&nbsp;Naoki Matsumoto ,&nbsp;Satoko Yamazaki ,&nbsp;Ryota Mitsumori ,&nbsp;Takashi Suto ,&nbsp;Shigeru Saito","doi":"10.1016/j.ahjo.2026.100738","DOIUrl":"10.1016/j.ahjo.2026.100738","url":null,"abstract":"<div><h3>Study objective</h3><div>To evaluate the influence of pericardial incision (PI) on circulation and body oxygenation and identify factors influencing them in pediatric patients undergoing surgery for congenital heart disease (CHD).</div></div><div><h3>Design</h3><div>Prospective observational study.</div></div><div><h3>Setting</h3><div>Gunma Children's Medical Center from August 4, 2022 to May 30, 2025.</div></div><div><h3>Participants</h3><div>We evaluated 63 patients aged 0–18 years with CHD undergoing elective cardiovascular surgery.</div></div><div><h3>Main outcome measures</h3><div>Blood pressure (BP), central venous pressure (CVP), and tissue oxygenation index (TOI), representing systemic oxygenation, were measured before and after PI during surgery and compared between the pre- and post-incision periods. Univariate (logistic) regression analysis was performed with the age and type of disease set as explanatory variables.</div></div><div><h3>Results</h3><div>Systolic (sBP), diastolic (dBP), and mean blood pressure (mBP) significantly decreased after PI. CVP significantly increased from 4.93 (1.96) to 6.08 (2.47), <em>P</em> = 0.00005, CI = −1.6733 to −0.5889, ES = 0.53 (medium). TOI significantly decreased from 71.22 (7.25) to 70.41 (7.79), <em>P</em> = 0.00631, CI = 0.403–1.56, ES = 0.37 (small to medium). Age was the only significant explanatory variable to decrease the TOI value (coefficient (coef) = 0.0004, <em>P</em> = 0.0301, CI = 0.000113 to 0.0.000797).</div></div><div><h3>Conclusion</h3><div>PI increases venous congestion and reduces arterial pressure, leading to a decline in systemic oxygenation in patients with CHD. Therefore, age exhibits the most detrimental effect on this pathological condition.</div></div>","PeriodicalId":72158,"journal":{"name":"American heart journal plus : cardiology research and practice","volume":"63 ","pages":"Article 100738"},"PeriodicalIF":1.8,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147313155","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":"Novel cholesterol lowering drugs: Can phase 2/3 clinical trial safety assessments predict cardiovascular event outcome trial efficacy?","authors":"Charles Shear ,&nbsp;Michael H. Davidson ,&nbsp;Marc Ditmarsch ,&nbsp;John J.P. Kastelein ,&nbsp;Michael Szarek","doi":"10.1016/j.ahjo.2026.100728","DOIUrl":"10.1016/j.ahjo.2026.100728","url":null,"abstract":"<div><h3>Setting</h3><div>Prior to a cardiovascular outcomes trial (CVOT), novel cholesterol-lowering therapies undergo phase 2/3 studies for their lipid and atherosclerotic effects and safety (non-CVOTs). Since the occurrence of major adverse cardiovascular events (MACE) is part of the safety assessment, nominal reductions or increases may be observed prior to definitive testing of the effect in a CVOT.</div></div><div><h3>Study objective</h3><div>To investigate if the observed MACE treatment effect in non-CVOT lipid-lowering registration studies holds value in predicting the outcome in a CVOT trial, typically reported later than the initial lipid-lowering studies.</div></div><div><h3>Design/participants/interventions</h3><div>We reviewed recent development programs for cholesterol-lowering drugs that had completed non-CVOT and CVOT studies. MACE data were compared for phase 2/3 non-CVOT versus pivotal CVOT results.</div></div><div><h3>Main outcome measures</h3><div>Our primary outcome was a qualitative comparison for directionally concordant consistency in MACE risk ratio treatment effects (harm, neutrality, or benefit). Correlation analysis was also performed.</div></div><div><h3>Results</h3><div>Seven drugs were reviewed in 3 cholesterol-lowering classes: CETP inhibitors, bempedoic acid, and PCSK9 inhibitors. Concordance in non-CVOT vs CVOT results was seen in 6 of 7 drugs. One drug (dalcetrapib) had a trend for benefit observed, albeit with very small numbers, in early development, but showed a neutral CVOT. There was a moderate correlation between the risk reductions or increases from the non-CVOTs and CVOTs: <em>r</em> = 0.69, <em>p</em> = 0.0893.</div></div><div><h3>Conclusion</h3><div>Within the limitations of the drugs studied and the variability in MACE definitions, there is value in the results of non-CVOTs to predict the CVOT outcome.</div></div>","PeriodicalId":72158,"journal":{"name":"American heart journal plus : cardiology research and practice","volume":"63 ","pages":"Article 100728"},"PeriodicalIF":1.8,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146174399","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}