American heart journal最新文献

{"title":"Reminders embedded in PCI reports to optimize discharge diabetes mellitus care (REMIND-DM): Rationale, design, and baseline characteristics","authors":"Safia Chatur MD ,&nbsp;Milan Seth MS ,&nbsp;Mary Casey MPA ,&nbsp;Michael P Thompson PhD, MPH ,&nbsp;M. Imran Qureshi MD ,&nbsp;Vishal Gupta MD ,&nbsp;Mansoor Qureshi MD ,&nbsp;Bashar Samman MD ,&nbsp;Annemarie Forest MS, MPH ,&nbsp;Hitinder S Gurm MD ,&nbsp;Devraj Sukul MD, MSc ,&nbsp;Muthiah Vaduganathan MD MPH","doi":"10.1016/j.ahj.2025.01.020","DOIUrl":"10.1016/j.ahj.2025.01.020","url":null,"abstract":"<div><h3>Background</h3><div>Despite the robust clinical evidence base supporting their role for high-risk patients with type 2 diabetes (T2DM) and concomitant cardiovascular disease, prescription of sodium-glucose co-transporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1RA) remains suboptimal. Clinical encounters occurring in the period post angiography may present a key opportunity to improve implementation in high-risk patients with T2DM.</div></div><div><h3>Methods</h3><div><em>R</em>eminders <em>EM</em>bedded <em>IN</em> PCI Reports to Optimize Discharge <em>D</em>iabetes <em>M</em>ellitus Care (REMIND-DM) is a pragmatic, prospective, cluster randomized quality improvement study in patients with type 2 diabetes undergoing angiography and was run as a quality improvement initiative. Following a 6 month “baseline period”, REMIND-DM randomized 23 participating percutaneous coronary intervention (PCI) sites (caring for 7,045 patients over the study period) within the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) quality improvement collaborative to either usual care or a quality improvement intervention consisting of a templated PCI report “reminder” of medication eligibility linked to a decision support tool. Sites were followed for a 6 month “evaluation period.” The primary outcome is the new prescription of SGLT2 inhibitor or GLP-1RA among eligible patients at discharge after PCI. To examine the effectiveness of the intervention, primary analyses will be conducted using a difference-in-difference design examining changes in new cardioprotective therapy prescription from baseline to the evaluation periods in both arms.</div></div><div><h3>Conclusions</h3><div>The REMIND-DM implementation trial has enrolled a large, high-risk population of patients with T2DM and will determine the effectiveness of a low touch QI intervention within BMC2 implemented in the post-PCI period to improve timely prescription of risk lowering therapies in high-risk patients with T2DM.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"285 ","pages":"Pages 12-20"},"PeriodicalIF":3.7,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482116","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":"Information for Readers","authors":"","doi":"10.1016/S0002-8703(25)00051-1","DOIUrl":"10.1016/S0002-8703(25)00051-1","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"282 ","pages":"Page iv"},"PeriodicalIF":3.7,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143453686","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":"Oral Factor XIa Inhibitor Milvexian After a Recent Acute Coronary Syndrome: Rationale and Design of the Phase 3 (Librexia ACS).","authors":"C Michael Gibson, M Cecilia Bahit, Roxana Mehran, Shamir R Mehta, Rasha Al Lamee, Shinya Goto, Jeffrey I Weitz, Jay Horrow, Elliot S Barnathan, Robert A Harrington, Kenneth W Mahaffey, Carolyn S P Lam, Karen S Pieper, S Claiborne Johnston, Graeme J Hankey, Alexei N Plotnikov, Danshi Li, Hsiaowei Deng, Philippe Gabriel Steg","doi":"10.1016/j.ahj.2025.02.011","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.02.011","url":null,"abstract":"<p><strong>Background: </strong>Despite current antiplatelet therapy, patients remain at risk of recurrent ischemic events after acute coronary syndromes (ACS), which may reflect persistently elevated thrombin generation. Factor XIa inhibition reduces thrombin generation and may improve clinical outcomes with minimal bleeding risk.</p><p><strong>Design: </strong>Librexia ACS (ClinicalTrials.gov NCT05754957) is a Phase 3, randomized, double-blind, placebo-controlled, event-driven trial to test the efficacy and safety of milvexian, an oral, selective factor XIa inhibitor, in addition to conventional antiplatelet therapy after a recent ACS. Eligibility criteria include symptoms of spontaneous ischemia, a diagnosis of ACS and cardiac biomarker elevation indicative of myonecrosis within 7 days before randomization, along with at least two risk-enhancing factors. Participants are randomly assigned to oral milvexian (25 mg twice daily) or a matched placebo. Randomization is stratified according to the planned duration and type of antiplatelet therapy. The primary efficacy endpoint is the time to first occurrence of the composite of cardiovascular death, myocardial infarction (MI), or ischemic stroke that will enroll approximately 16,000 patients with follow-up until 875 events are accrued. The first major secondary endpoint is time to the first occurrence of cardiovascular death, MI, ischemic stroke, major adverse limb events, and symptomatic venous thromboembolism. The principal safety endpoint is Bleeding Academic Research Consortium 3c or 5 bleeding.</p><p><strong>Summary: </strong>The Librexia-ACS trial will determine the efficacy and safety of milvexian after ACS and will be the first trial to test whether factor XIa inhibition in addition to standard-of-care antiplatelet therapy reduces major adverse cardiovascular events without an increased risk of significant bleeding.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476208","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":"Encouraging the prescribing of SGLT2i and GLP-1RA medications to reduce cardiovascular and renal risk in patients with type 2 diabetes: rationale and design of a randomized controlled trial.","authors":"Nancy Haff, Daniel M Horn, Gauri Bhatkhande, Meekang Sung, Caitlin Colling, Wendy Wood, Ted Robertson, Daniel Gaposchkin, Leigh Simmons, Judy Yang, James Yeh, Katherine L Crum, Kaitlin E Hanken, Julie C Lauffenburger, Niteesh K Choudhry","doi":"10.1016/j.ahj.2025.02.007","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.02.007","url":null,"abstract":"<p><strong>Background: </strong>Sodium-glucose cotransporter-2 inhibitor (SGLT2i) and glucagon-like peptide-1 receptor agonist (GLP-1RA) medications reduce the risk of cardiovascular and renal complications among patients with type 2 diabetes but are underutilized. There are numerous barriers to prescribing including insurance coverage, medication availability, comfort with prescribing, and diffusion of responsibility of prescribing across specialists. Methods are needed to support prescribing in primary care.</p><p><strong>Methods: </strong>This was a pragmatic, randomized controlled trial testing interventions to increase appropriate SGLT2i and GLP-1RA prescribing. Primary care providers (PCPs) were randomized to one of three arms: 1) peer champion support 2) peer champion support and information on insurance coverage, or 3) usual care (no intervention). PCPs in both intervention arms received a welcome email and electronic health record (EHR) messages before visits with patients who had sub-optimally controlled diabetes and an indication for one of these medications. In the peer champion support only arm the EHR messages included prescribing tips. In the arm that provided peer champion support and information on insurance coverage, EHR messages contained information on medications in each class that would be most affordable for the patient based on their insurance coverage and offered support for prior authorizations if needed. The primary outcome was prescriptions for an SGLT2i or GLP-1RA medication, beginning 3 days before the targeted visit and continuing through 28 days, in each intervention arm compared to control.</p><p><strong>Results: </strong>191 primary care providers were included in the study. 1389 patients had at least one visit scheduled with their PCP during the 6-month intervention period; of these 1079 patients attended at least one of these visits and will be included in the primary outcome analysis. 66 providers (484 patients) received the peer champion intervention alone, 63 providers (446 patients) received the peer champion intervention and information on insurance coverage, and 62 providers (459 patients) received usual care. On average, patients were 66 years old, 46% were female, 61% were white, and 16% were Hispanic. There were small differences between groups with regards to patient sex, race, ethnicity, partner status, and percent with Medicare insurance.</p><p><strong>Conclusions: </strong>These medication classes have the potential to reduce cardiovascular and kidney disease among patients with type 2 diabetes. This study tests interventions to support prescribing of these medications in primary care.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476207","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":"Functional coronary angiography to indicate and guide revascularization in STEMI patients with multivessel disease: Rationale and design of the AIR-STEMI trial","authors":"Andrea Erriquez MD ,&nbsp;Iginio Colaiori MD ,&nbsp;Abdul Hakeem MD ,&nbsp;Vincenzo Guiducci MD ,&nbsp;Mila Menozzi MD ,&nbsp;Marco Barbierato MD ,&nbsp;Manfredi Arioti MD ,&nbsp;Domenico D'Amario MD ,&nbsp;Gianni Casella MD ,&nbsp;Roberto Scarsini MD ,&nbsp;Alberto Polimeni MD ,&nbsp;Luca Donazzan MD ,&nbsp;Giorgio Benatti MD ,&nbsp;Gabriele Venturi MD ,&nbsp;Marco Ruozzi MD ,&nbsp;Massimo Giordan MD ,&nbsp;Alberto Monello MD ,&nbsp;Francesco Moretti MD ,&nbsp;Francesco Versaci MD ,&nbsp;Jehangir Ali Shah MD ,&nbsp;Simone Biscaglia MD","doi":"10.1016/j.ahj.2025.02.012","DOIUrl":"10.1016/j.ahj.2025.02.012","url":null,"abstract":"<div><h3>Background</h3><div>Complete revascularization has been shown to be superior to culprit-only treatment in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. However, it remains unclear whether complete revascularization should be guided by coronary physiology or conventional angiography. Angiography-derived physiology may allow functional assessment and procedural guidance using angiograms from primary percutaneous coronary intervention (PCI), potentially maximizing the benefits of a physiology-guided approach. We present the design of a dedicated study that will address this research gap.</div></div><div><h3>Methods and Design</h3><div>The Functional Coronary Angiography to Indicate and Guide Revascularization in STEMI Patients with Multivessel Disease (AIR-STEMI) trial is a prospective, randomized, international, multicenter, open-label study with blinded adjudicated evaluation of outcomes. After successful treatment of the culprit lesion, patients will be randomized to receive PCI of the nonculprit lesions guided by conventional angiography or by angiography-derived fractional flow reserve (FFR). The primary endpoint is the composite endpoint of all-cause death, any myocardial infarction (MI), any cerebrovascular accident, or any revascularization. It will be censored once the last enrolled patient reaches 1-year follow-up. The secondary endpoint will be the composite of cardiovascular death or MI and each single component of the primary endpoint. All endpoints will be tested also at 3 and 5 years. The sample size for the study is a minimum of 1,800 patients.</div></div><div><h3>Implications</h3><div>The AIR-STEMI trial will provide novel evidence on whether a specific complete revascularization strategy should be applied to patients with STEMI and multivessel disease to improve their clinical outcomes.</div></div><div><h3>Trial Registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> NCT05818475.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 71-80"},"PeriodicalIF":3.7,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143472061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ventricular-Arterial Coupling is associated with Clinical Outcomes in Patients with Systemic Right Ventricle.","authors":"Giulia Pasqualin, Amrit Misra, Kimberlee Gauvreau, Stephen P Sanders, Akshay S Desai, Alex Alexander, Ashwin Prakash, Michael M Givertz, Anne Marie Valente","doi":"10.1016/j.ahj.2025.02.013","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.02.013","url":null,"abstract":"<p><strong>Background: </strong>Adults with transposition of the great arteries (TGA) and systemic right ventricle (SRV) are at risk for heart failure (HF) and decreased survival. Ventricular-arterial coupling (VAC) quantifies the interaction between myocardial contractile function and the load imposed by the arterial circulation and may be valuable in identifying subclinical SRV dysfunction. The purpose of our study is to determine the association of VAC with adverse clinical outcomes in adults with TGA and SRV.</p><p><strong>Methods: </strong>A single center, retrospective cohort study of subjects ≥ 16 years of age with TGA and SRV who underwent a cardiac magnetic resonance (CMR) examination. VAC was calculated as the ratio between CMR-derived SRV end-systolic volume and stroke volume. Cox proportional hazards regression analysis was performed to assess the association of VAC with clinical outcomes.</p><p><strong>Results: </strong>One hundred sixty-seven subjects (mean age 32 ± 10 years, 59% males) were evaluated. VAC predicted the composite outcome of death, cardiac arrest and HF hospitalizations (hazard ratio (HR) 2.09; 95% CI: 1.12-3.92, p = 0.02), as well as other cardiovascular hospitalizations including device implantation and percutaneous or surgical structural intervention (HR 1.65, 95% CI: 1.09-2.49, p = 0.02) after adjustment for age, sex, and the presence of significant tricuspid regurgitation.</p><p><strong>Conclusions: </strong>VAC is associated with major clinical adverse outcomes in patients with TGA and SRV, and may improve risk stratification of this complex population.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143472063","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":"Implementing depression treatment for cardiac populations in rapidly changing contexts: Design of the hybrid effectiveness-implementation iHeart DepCare trial.","authors":"Andrea T Duran, Jennifer Mizhquiri Barbecho, Kaitlin Shaw, Siqin Ye, Nohora Ospina, Samantha Simantiris, Joseph E Schwartz, Nathalie Moise","doi":"10.1016/j.ahj.2025.02.009","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.02.009","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Rationale: &lt;/strong&gt;Few coronary heart disease (CHD) patients engage in evidence-based depression treatments (i.e., antidepressants, therapy, exercise). We present the protocol and analysis plan for a hybrid type II effectiveness-implementation trial evaluating the impact of a theory-informed, multi-level implementation strategy centered around an electronic shared decision making (eSDM)/patient activation tool.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design: &lt;/strong&gt;The iHeart DepCare Trial uses a pre-post single group, open label design with 4 sites (each with a cluster of cardiology clinics and a cluster of primary care clinics, 8 clusters in total) introduced to the multi-level strategy (i.e., single arm) in random order with patients (a pre-implementation cohort and nonoverlapping post-implementation cohort) nested within clinicians, nested within clusters. All primary care and cardiology clinicians at participating clinics are included. The patient sample includes English- and Spanish-speaking CHD patients ≥ 21 years of age with screen-detected elevated depressive symptoms (i.e., Patient Health Questionnaire-9 score ≥10) and a scheduled visit during the relevant time period. In the pre-implementation period, CHD patients receive usual care. At the start of each implementation period, a site's behavioral health providers (BHPs) and clinic administrators are invited to problem solving meetings; patients receive an eSDM and patient activation tool that includes psychoeducation, patient activation, and treatment selection support; and clinicians/BHPs receive a summary report of patients' preferences (implementation strategy). During pre- and post-implementation periods, patients are assessed at baseline and 6 months for depressive symptoms, depression treatment intensification, health-related quality of life years, and (at baseline only) patient activation and decisional conflict. The primary effectiveness outcome is change in depressive symptoms from baseline to follow-up during the post-implementation period compared to pre-implementation period. Key trial design changes, relative to our initial pre-COVID-19 trial protocol, include transition from a stepped wedge design to a single pre-post design randomized to strategy timing, reduction of exclusion criteria, options to bypass clinicians for direct BHP referrals (vs. reliance on referrals) and addressing multiplicity in our statistical analysis plan. The trial was launched in April 2019 and is estimated to conclude by July 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;The iHeart DepCare Trial is the first hybrid type II effectiveness-implementation trial to examine the effect of a brief, theory-informed eSDM and patient activation tool strategy on depression treatment uptake and symptoms in CHD patients. Our protocol advances the field of implementation science by incorporating a multi-level (vs. single-level) implementation strategy to address depression, highlighting unique challenges of stepped wedge design","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143466843","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":"Impact of a clinical atrial fibrillation risk estimation tool on cardiac rhythm monitor utilization following acute ischemic stroke: A prepost clinical trial","authors":"Jeffrey M. Ashburner PhD, MPH ,&nbsp;Reinier W.P. Tack MD ,&nbsp;Shaan Khurshid MD, MPH ,&nbsp;Ashby C. Turner MD ,&nbsp;Steven J. Atlas MD, MPH ,&nbsp;Daniel E. Singer MD ,&nbsp;Patrick T. Ellinor MD, PhD ,&nbsp;Emelia J. Benjamin MD, ScM ,&nbsp;Ludovic Trinquart PhD ,&nbsp;Steven A. Lubitz MD, MPH ,&nbsp;Christopher D. Anderson MD, MMSc","doi":"10.1016/j.ahj.2025.02.010","DOIUrl":"10.1016/j.ahj.2025.02.010","url":null,"abstract":"<div><h3>Background</h3><div>Detection of undiagnosed atrial fibrillation (AF) after ischemic stroke through extended cardiac monitoring is important for preventing recurrent stroke. We evaluated whether a tool that displays clinically predicted AF risk to clinicians caring for stroke patients was associated with the use of extended cardiac monitoring.</div></div><div><h3>Methods</h3><div>We prospectively included hospitalized ischemic stroke patients without known AF in a preintervention (October 2018 - June 2019) and intervention period (March 11, 2021 - March 10, 2022). The intervention consisted of an electronic health record (EHR)-based best-practice advisory (BPA) alert which calculated and displayed 5-year risk of AF. We used a multivariable Fine and Gray model to test for an interaction between predicted AF risk and period (preintervention vs intervention) with regards to incidence of extended cardiac monitoring. We compared the incidence of extended cardiac monitoring within 6-months of discharge between periods, stratified by BPA completion.</div></div><div><h3>Results</h3><div>We included 805 patients: 493 in the preintervention cohort and 312 in the intervention cohort. In the intervention cohort, the BPA was completed for 180 (58%) patients. The association between predicted clinical risk of AF and incidence of 6-month extended cardiac monitoring was not different by time period (interaction HR = 1.00 [95% Confidence Interval (CI) 0.98; 1.02]). The intervention period was associated with an increased cumulative incidence of cardiac monitoring (adjusted HR = 1.32 [95% CI 1.03-1.69]).</div></div><div><h3>Conclusions</h3><div>An embedded EHR tool displaying predicted AF risk in a poststroke setting had limited clinician engagement and predicted risk was not associated with the use of extended cardiac monitoring.</div></div><div><h3>Clinical Trial Registration</h3><div>NCT04637087</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 57-66"},"PeriodicalIF":3.7,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143466758","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":"Lipoprotein(a) immunoassays and their associations with coronary artery calcification and aortic valve calcification","authors":"Maarten J.G. Leening MD, PhD, FESC ,&nbsp;Ching F. Khan MD, MSc ,&nbsp;Fang Zhu MPH, PhD ,&nbsp;Sunny S. Singh MD, PhD ,&nbsp;Maryam Kavousi MD, PhD, FESC ,&nbsp;Eric J.G. Sijbrands MD PhD ,&nbsp;Yolanda B. de Rijke PhD ,&nbsp;Daniel Bos MD, PhD","doi":"10.1016/j.ahj.2025.02.008","DOIUrl":"10.1016/j.ahj.2025.02.008","url":null,"abstract":"<div><h3>Background</h3><div>Lp(a) causes atherosclerosis and degenerative aortic valve disease, but concerns have risen that mass-based assays may beaffected by isoform sizes and provide inaccurate estimates of Lp(a) exposure.</div></div><div><h3>Methods</h3><div>We compared contemporary immunoturbidimetric assays reporting either mass-based (Randox) or molar-based (Roche) using data from 5,129 unselected participants from the prospective population-based Rotterdam Study cohort. We studied the association of both Lp(a) measurements with the burden of coronary artery calcium (CAC) and aortic valve calcification (AVC) in a random subset of participants who underwent cardiac CT.</div></div><div><h3>Results</h3><div>There was a near perfect linear correlation between Lp(a) concentrations from both immunoassays (R² 98.8%) with most pronounced differences apparent only at very high Lp(a) concentrations. Lp(a) concentrations were related with natural logtransformed Agatston scores (Randox standardized linear β 0.1003, <em>P</em> = 5.6·10⁻⁸; Roche standardized linear β 0.1004, <em>P</em> = 5.4·10⁻⁸). Lp(a) concentrations were strongly but similarly related to natural log-transformed AVC Agatston scores (Randox standardized linear β 0.1525, <em>P</em> = 9.2·10⁻¹⁶; Roche standardized linear β 0.1539, <em>P</em> = 4.8·10⁻¹⁶).</div></div><div><h3>Conclusion</h3><div>We demonstrate that these immunoassays provide interchangeable Lp(a) measurements, and that associations with CAC and AVC were near-identical. This provides opportunities to directly compare findings from research done with either immunoassay.</div></div><div><h3>Trial Registration</h3><div>The Rotterdam Study has been entered in the Netherlands National Trial Register and the WHO International Clinical Trials Registry Platform under shared catalog number NTR6831.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 42-46"},"PeriodicalIF":3.7,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143466784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Occult cancer in patients with unprovoked venous thromboembolism: Rationale, design, and methods of the VaLRIETEs study and the SOME-RIETE trial","authors":"Maria Barca-Hernando MD, PhD ,&nbsp;Sonia Otalora-Valderrama MD, PhD ,&nbsp;Juan Jose Lopez-Nuñez MD, PhD ,&nbsp;Jose Portillo-Sanchez MD, PhD ,&nbsp;Javier Pagan-Escribano MD, PhD ,&nbsp;Patricia Lopez-Miguel MD ,&nbsp;Isabelle Mahe MD, PhD ,&nbsp;Elisabeth Mena-Muñoz MD ,&nbsp;Ines Jou-Segovia MD ,&nbsp;Egidio Imbalzano MD ,&nbsp;Paloma Agudo-de Blas MD, PhD ,&nbsp;Alicia Lorenzo-Hernandez MD, PhD ,&nbsp;Carmen Diaz-Pedroche MD, PhD ,&nbsp;Jesus Aibar-Gallizo MD, PhD ,&nbsp;Gloria de la Red-Bellvis MD ,&nbsp;Fatima del Molino-Sanz MD ,&nbsp;Cristina Amado-Fernandez MD ,&nbsp;Jose Luis Fernandez-Reyes MD ,&nbsp;Aurora Villalobos-Sanchez MD, PhD ,&nbsp;Juan Bosco Lopez-Saez MD, PhD ,&nbsp;Luis Jara-Palomares MD, PhD","doi":"10.1016/j.ahj.2025.02.004","DOIUrl":"10.1016/j.ahj.2025.02.004","url":null,"abstract":"<div><h3>Background</h3><div>Unprovoked venous thromboembolism (VTE) is considered when no clear major provoking factor for VTE is identified. Although the 1-year risk of diagnosing new cancer in these patients can be as high as 5%, the benefits of extensive screening remain uncertain. It is possible that in a risk-enriched population of patients, screening yields benefit. Recently, the RIETE score, a composite score including sex, age, chronic pulmonary disease, anemia, platelet count and previous VTE, was found to improve risk prediction for identification of occult cancer in patients with unprovoked VTE. As for screening tests, whole body 18F-fluorodeoxyglucose Positron Emission/Computed Tomography (18F-FDG PET/CT) is a promising and sensitive tool for occult cancer screening.</div></div><div><h3>Methods</h3><div>This manuscript summarizes the rationale and design of 2 prospective studies in patients with unprovoked symptomatic VTE: (1) ValRIETE is an international, multicenter, prospective, adaptative, cohort study that plans to include 1,550 patients; the adaptive design permits a sample size increase depending on the results of the predefined interim analysis. This study will enable the external validation of the RIETE score, with several ancillary aims related to additional clinical and biomarker predictors. Recruitment began in December 2022. (2) SOME-RIETE is an open-label, randomized, multicenter clinical trial that plans to enroll 650 patients with a RIETE score ≥3 to compare limited screening with limited screening plus whole body 18F-FDG PET/CT. The primary outcome is cancer diagnosis within 3 months after VTE event. Secondary outcomes include cancer diagnosis and mortality at 12 months.</div></div><div><h3>Conclusions</h3><div>This study provides clinically meaningful data on and the utility of extended screening of cancer by 18F-FDG PET/CT.</div></div><div><h3>Study Registration</h3><div>VaLRIETE study: ethics committee of the Virgen del Rocio University Hospital, Sevilla (Spain). <span><span>https://www.juntadeandalucia.es/salud/portaldeetica/xhtml/inicio/inicio.iface</span><svg><path></path></svg></span> (1687-N-22).</div></div><div><h3>Trial Registration</h3><div><em>SOME-RIETE:</em> <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (NCT03937583).</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 81-93"},"PeriodicalIF":3.7,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143456673","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}