Background Recent updates to the American College of Cardiology (ACC) and American Heart Association (AHA) guidelines for high blood pressure (BP) changed the risk calculator recommended, lowered the preferred treatment target, and expanded treatment recommendations for lower risk adults. We sought to quantify the clinical implications of these change among US adults. Methods Using data from the 2015–2020 National Health and Nutrition Examination Survey (NHANES), we estimated the proportion and number of US adults aged 20 years or older who were eligible for initiation or intensification of pharmacological anti-hypertensive medications under the 2017 vs the 2025 guidelines. Results Among US adults ≥20 years not being currently treated for hypertension (N = 180.0 million), using the 2017 Guideline, 18.7 % (33.6 million) were eligible for initiation of pharmacological anti-hypertensive therapy. In contrast, the 2025 Guideline would treat 18.4 % (33.2 million) with upfront medication while an additional 10.8 % (19.4 million) would be considered for medications if lifestyle modification proves insufficient. Increases in treatment eligibility were most pronounced among younger adults age 30–60 and those with obesity. Among adults currently being treated for hypertension (N = 58.0 million), most (59.8 %; 34.6 million) did not meet the recommended goal of a BP <130/80. An additional 17.6 % (5.6 million) are newly eligible for treatment intensification if pursuing the preferred BP target of <120/80. Conclusion The new 2025 AHA/ACC Hypertension Guidelines potentially expands the number of adults eligible for initiation of antihypertensives, particularly in persons who are young and/or obese, and markedly expands number eligible for intensification.
Introduction:While prior studies have documented suboptimal lipid management and low rates of low-density lipoprotein cholesterol (LDL-C) goal achievement in patients with atherosclerotic cardiovascular disease (ASCVD), the degree of variability in lipid-lowering therapy (LLT) practice patterns between clinicians is less well described. Methods:In this cohort study, we evaluated the use of LLTs and achievement of LDL-C <70 mg/dL among adults with ASCVD (coronary artery disease, peripheral arterial disease, or ischemic cerebrovascular disease) followed by a cardiology physician or advanced practice provider (APP) at a large academic medical center in north Texas from 01/01/22-06/30/24. LLT utilization and LDL-C goal achievement were modeled using mixed-effects logistic regression with clustering at the clinician level, adjusting for patient age, insurance, ASCVD type, and diabetes. We quantified clinician-level variability using the adjusted median odds ratios (aMORs) from these models. Results:Among 9098 patients with ASCVD (median age 71.0 years, 61.6% male, 70.5% White) seen across 77 cardiology clinicians (56 physicians, 21 APPs), 52.8% were on a high-intensity statin, 17.1% were on ezetimibe, 7.8% were on novel LLT (proprotein convertase subtilisin/kexin type 9 monoclonal antibody, inclisiran, or bempedoic acid). Of those with an available lipid panel in the past year (n = 7122), 48.5% achieved an LDL-C <70 mg/dL. Lipid management strategies varied substantially across clinicians. In mixed-effects models adjusting for patient-level factors, significant clinician-level variation was observed in the use of high-intensity statins (aMOR 1.44, 95% CI 1.34-1.59), ezetimibe (aMOR 1.68, 95% CI 1.52-1.91), and novel LLT (aMOR 2.21, 95% CI 1.90-2.68). Variation in achieving LDL-C <70 mg/dL was more modest (aMOR 1.31, 95% CI 1.23-1.42). Sequential adjustment for clinician prescribing patterns explained nearly half of the observed variability in LDL-C goal achievement, reducing the aMOR to 1.16 (95% CI 1.09-1.27). Conclusion:We found suboptimal rates of high-intensity statin and LDL-C control among patients with ASCVD. Even among cardiology clinicians at the same academic medical center, practice patterns varied widely in using LLT and achieving LDL-C goals for secondary prevention. Understanding the reasons for this variability and standardizing lipid management across the specialty may improve quality of care for patients with ASCVD.
Importance:The use of audiovisual aids in the consent process may improve comprehension and willingness to participate in research. However, data supporting this hypothesis are lacking. Objective:To determine the impact of audiovisual augmentation of the consent process on willingness to participate in research and on consent comprehension. Design, Setting, and Participants:The Personalizing Cardiovascular Health: A Population Approach to Promoting Cardiovascular Disease Resistance and Resilience Among Individuals With Obesity (RESILIENCE) nonrandomized cohort study embedded this multiarm randomized clinical trial to test different participant consent modalities. RESILIENCE recruited participants between September 2019 and March 2022, with the analysis for this randomized substudy conducted from July to December 2025. No follow-up was undertaken for this study. This component of the study was conducted exclusively virtually and completed online within a single large US academic health system. Interventions:Potential participants were randomized for this trial in a 1:1:1:1 allocation to receive consent information via (1) text-only (2) text and physician-featured video, (3) text and patient-featured video, or (4) text and animated video. Main Outcomes and Measures:The primary outcome was provision of consent to participate in the cohort clinical study. The secondary outcome was consent comprehension, based on a score of at least 5 of 7 on a follow-up comprehension survey. Robust log-linear Poisson regression was used to determine the relative risks (RRs) of outcomes in comparison with the text-only arm. Analyses were conducted with the evaluable population. Results:Of 1535 participants (968 [63.1%] female; 658 [42.9%] ≥60 years of age; 380 randomized to text-only, 386 to text and physician-featured video, 383 to text and patient-featured video, and 386 to text and animated video) who began the consent process, 888 (57.9%) overall gave consent to participate in the study. Patient consent rates were similar across the 4 consent delivery strategies (text only [comparator], 221 of 380 [58.2%]; text and physician video, 241 of 386 [62.4%]; RR, 1.07 [96% CI, 0.95-1.21]; text and patient video, 203 of 383 [53.0%]; RR, 0.91 [96% CI, 0.8-1.04]; and text and animated video, 223 of 386 [57.8%]; RR, 0.99 [96% CI, 0.88-1.13]). Among 884 individuals who consented and completed the consent comprehension survey, the rate of comprehension of the consent process was high 86.4% (n = 764) and did not vary among the intervention delivery strategies (text only, 193 of 221 [87.3%]; text and physician video, 207 of 241 [85.9%]; text and patient video, 177 of 203 [87.2%]; and text and animated video, 187 of 223 [83.9%]). Compared with the text-only arm, the RRs of consent comprehension were not different for the text and physician-featured video arm (RR, 1.00; [95% CI, 0.93-1.07]), the text and patient-featured video arm (RR, 1.00 [95% CI, 0.93-1.07]) and the text and animated video arm (RR, 0.96 [95% CI, 0.89-1.04]). Conclusions and Relevance:In this randomized clinical trial of virtual consent delivery, the rates of patient consent and consent comprehension were similar regardless of whether they were delivered by text only or text augmented by physician, patient, or animated videos. Further evaluation of these consent delivery processes across different study types and patient populations is suggested to optimize the recruitment of diverse, informed populations. Trial Registration:ClinicalTrials.gov Identifier: NCT04551872.
Antiplatelet medications have been fundamental to the management of atherosclerotic cardiovascular disease (ASCVD); however, recommendations for their use have evolved over the past decade. Aspirin remains the most widely used antiplatelet drug. Recent data do not support a benefit for primary prevention of ASCVD in unselected populations with routine aspirin use; consideration should be reserved for those at highest ischemic risk. Similarly, the evolution of drug-eluting stents, antiplatelet medications, and research on the optimal regimen and duration of dual antiplatelet therapy have altered evidence-based recommendations for use of antiplatelets in managing patients diagnosed with ASCVD. Antiplatelet medications remain powerful tools to prevent ischemic events, particularly for those who have experienced an acute coronary syndrome, but the balance between the risk of ischemia and the risk of bleeding poses a perpetual challenge and requires individualized treatment. This scientific statement provides a detailed overview of current evidence for the use of antiplatelets in the management of ASCVD. This includes a comparison of current clinical practice guideline-based recommendations, summary of pivotal trials, and discussion of antiplatelet use in patients with elevated bleeding risk or those undergoing surgery. Considerations for use of antiplatelets in those with different phenotypes of ASCVD and those with indications for concurrent use of antithrombotic medications, as well as long-term monitoring and adherence, are addressed.
Importance:Optimizing participant recruitment is critical to the success and generalizability of clinical research, yet there is limited randomized clinical trial evidence comparing the effects of digital recruitment strategies and message framing on participant engagement. Objective:To determine the impact of various recruitment strategies on engagement with potential research participants. Design, Setting, and Participants:This randomized clinical trial was embedded within the Research for Personalized Cardiovascular Disease Prevention (RESILIENCE) study and had a 2 × 2 factorial design. This component of the RESILIENCE study was exclusively virtual and completed online within a single large academic health system in the United States. Potential research participants were identified through electronic health records. The study recruited participants between September 2019 and March 2022, with the analysis undertaken in July to December 2025. No follow-up was undertaken for this study. Interventions:Participants were randomized to a recruitment modality (email vs patient portal) and to a type of message content (altruistic vs individualistic). Main Outcomes and Measures:The primary outcome was participant interest, defined as logging onto the study website by clicking the link in the message within 6 months. A robust log-linear Poisson model was used to estimate the relative risk (RR) of the primary outcome based on modality and message content. Results:Of 15 376 potential research participants (9309 [60.5%] female) identified through the electronic health records, 7737 (50.3%) were randomized to the email recruitment modality and 7639 (49.7%) were randomized to the patient portal modality; 7682 (50.0%) received an altruistic recruitment message and 7694 (50.0%) received an individualistic recruitment message. The primary outcome occurred in 1220 participants (7.9%). The email recruitment modality led to a higher likelihood of the primary outcome than patient portal messages (768 [9.9%] vs 452 [5.9%]; RR, 1.68; 99% CI, 1.45-1.95), while no difference was observed by message content type (634 [8.3%] altruistic vs 586 [7.6%] individualistic; RR, 1.08; 99% CI, 0.94-1.25). There was no significant interaction between message modality and content. Exploratory interactions by age and risk phenotype were observed, with altruistic messaging more effective than individualistic messaging in those aged 60 years and younger and email more effective than patient portal in those older than 60 years and in individuals with obesity. Conclusions and Relevance:In this randomized clinical trial of recruitment strategies, email messaging led to higher participant interest than patient portal messaging, particularly in older individuals. Message content did not significantly impact engagement overall, but altruistic messaging was more effective in younger participants. These results can inform recruitment strategies for future trials. Trial Registration:ClinicalTrials.gov Identifier: NCT04551872.
BACKGROUND:The bidirectional association between worsening kidney function (WKF) and cardiovascular outcomes in type 2 diabetes (T2D) patients with atherosclerotic cardiovascular disease (ASCVD) is unclear. OBJECTIVES:This study aimed to evaluate the bidirectional association between: 1) nonfatal cardiovascular events and WKF; and 2) severe hypoglycemia and WKF. METHODS:We analyzed data from TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin), enrolling 14,671 patients with T2D and ASCVD randomized to sitagliptin or placebo. The primary outcome was a 4-component major adverse cardiovascular event (MACE4) comprising nonfatal myocardial infarction, stroke, cardiovascular death, or unstable angina hospitalization. We also examined hospitalization for heart failure (hHF). WKF was defined as a glomerular filtration rate decline of ≥40% (per the Modification of Diet in Renal Disease formula) or initiation of renal replacement therapy. Cox proportional hazards models assessed associations between WKF and subsequent MACE4 and hHF. RESULTS:Over a median 3-year follow-up, 1,030 (7.0%) experienced WKF. Overall, WKF risk increased after nonfatal myocardial infarction, stroke, or unstable angina (adjusted HR [HRadj]: 2.0; 95% CI: 1.6-2.5) and was higher after hHF (HRadj: 6.1; 95% CI: 4.8-7.9). Median estimated glomerular filtration rate declines before MACE4 and hHF were -3.8% (IQR: -17.4, 9.4) and -9.2% (IQR: -22.7, 6.6), respectively. WKF was associated with increased risks of MACE4 (HRadj: 1.9; 95% CI: 1.5-2.4), hHF (HRadj: 3.2; 95% CI: 2.2-4.6), and severe hypoglycemia (HRadj: 2.8; 95% CI: 1.8-4.4). CONCLUSIONS:In patients with T2D and ASCVD, WKF is common and linked to adverse cardiovascular outcomes and severe hypoglycemia, highlighting the need for early cardiorenal therapies.
BACKGROUND:The American College of Cardiology and American Heart Association recently updated their guidelines for dyslipidemia, which included recommending new risk calculators and thresholds, treatment targets, and treatment recommendations based on long-term risk. OBJECTIVES:The purpose of this study was to quantify the population-level implications of the 2026 Dyslipidemia Guideline. METHODS:Using data across 4 survey cycles from the 2011-2020 NHANES (National Health and Nutrition Examination Survey), we estimated the proportion and number of U.S. adults aged 20 years or older who were eligible for initiation of lipid-lowering therapy (LLT) under the 2026 vs 2018 guideline recommendations and the proportion meeting their 2026 treatment targets RESULTS: Among U.S. adults ≥20 years of age without atherosclerotic cardiovascular disease (ASCVD), with a low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL, and not on LLT (n = 165.4 million), 40.5% were eligible per the 2026 guideline vs 25.7% per the 2018 guideline, representing an additional 24.5 million adults. The largest contributor to the increase was the recommendation to consider statins in adults aged 30 to 59 years with a 30-year ASCVD risk ≥10% despite a 10-year risk <3%, based on which 15.6 million more adults would be eligible. In this age group, nearly twice as many qualify based on a 30-year ASCVD ≥10% vs 10-year ASCVD risk ≥3% (15.6 million vs 7.9 million). Among 39.1 million adults receiving LLT for a Class 1 indication, most (79.0%) had LDL-C above goal, including 91.1% of adults with ASCVD having LDL-C ≥55 mg/dL and 74.5% with LDL-C ≥70 mg/dL. CONCLUSIONS:Compared with the 2018 guideline, the 2026 American College of Cardiology/American Heart Association Multisociety Dyslipidemia Guideline substantially expanded the proportion of U.S. adults for whom statin therapy should be considered by extending recommendations to adults at high 30-year risk. Among those already on treatment, the vast majority remain above new guideline goals. Significant population-level shifts in statin initiation and therapy intensification will be needed to reach guideline goals at a national level.
BACKGROUND:Obesity is a growing epidemic associated with cardiovascular disease (CVD). The RESILIENCE study aimed to understand the factors underlying heterogeneity in CVD development among individuals with obesity as well as the variability in response to weight loss interventions in this population, with a focus on branched-chain amino acids (BCAA). METHODS:Four cohorts were recruited: individuals with obesity (BMI ≥ 30 kg/m2) and either high (≥20%) or low (<7.5%) 10-year atherosclerotic CVD (ASCVD) risk (calculated by the Pooled Cohorts Equation), and individuals with normal weight (BMI 18-25 kg/m2) and either high or low ASCVD risk. Clinical, behavioral, and molecular characteristics were collected at baseline between the four groups to assess heterogeneity between obesity and risk for CVD. Participants with obesity then participated in a 6-month remote weight loss intervention to evaluating predictors of response to the weight loss intervention. Our primary hypothesis was that BCAA are associated with CVD risk and obesity and that similarly, BCAA will predict response to weight loss interventions. RESULTS:598 participants were recruited between 2019 and 2022 within the Duke University Health System. 100 had normal weight and low ASCVD risk, 103 had normal weight and high ASCVD risk, 196 patients had obesity and low ASCVD risk, and 199 patients had obesity and high ASCVD risk. CONCLUSIONS:This two-stage design (stratified baseline cohort with nested intervention) enables independent evaluation of the mechanisms linking obesity, CVD risk, and BCAA, among other variables. This approach will clarify how these factors influence cardiovascular disease variability and weight loss outcomes. TRIAL REGISTRATION:ClinicalTrials.gov (https://clinicaltrials.gov), NCT04551872.
Background Triptan medications are proposed as an association of cerebral ischemic stroke in patients with migraine, but population‐based data on this are lacking. Methods A retrospective, observational, cohort study was performed using computerized claims data from a proprietary, insurance‐based registry—Marketscan (by Merative). Patients with at least 1 claim related to a migraine diagnosis were included. The primary exposure was initiation of any triptan medication defined by at least 1 prescription fill. The primary end point was time to cerebral ischemic stroke. Secondary end points included time to retinal stroke (central retinal artery occlusion, other retinal artery occlusion), intracranial hemorrhage, and myocardial infarction. The association between triptan initiation and study end points was modeled using a propensity score‐overlap weighted Cox model. Adjusted hazard ratios (HR) and corresponding 95% CIs were computed. Results In total, 869 092 patients (median age 40.0 years [Q1–Q3, 30.0–50.0]; 77.5% female) met study selection criteria of whom 287 629 initiated a triptan and 581 463 did not. Median follow‐up was 2555 days in the entire cohort. Initiation of a triptan was associated with higher hazard of cerebral ischemic stroke (adjusted HR, 2.37 [95% CI, 1.65–3.51]; absolute risk difference of 0.17% per year). Of 4 secondary end points, 2 were associated with triptan use: intracranial hemorrhage (adjusted HR, 2.37 [95% CI, 1.65–3.41]) and myocardial infarction (adjusted HR, 2.06 [95% CI, 1.60–2.66]). Conclusions In a population‐based cohort study, initiation of a triptan was independently associated with risk of subsequent cerebral ischemic stroke.
BACKGROUND:Patients with heart failure (HF) with socioeconomic hardship have poor medication adherence and worse patient outcomes. Whether an early postdischarge financial support intervention can improve care behaviors and outcomes among socioeconomically disadvantaged populations is unclear. OBJECTIVES:To describe the design, socioeconomic eligibility framework, therapeutic drug monitoring methodology, and baseline characteristics of the FUND-HF trial, a pilot randomized controlled trial evaluating the feasibility and effect of early postdischarge financial support among low-income patients with HF with reduced ejection fraction. The primary clinical outcomes are reported in a companion Brief Report. METHODS:In this pilot randomized controlled trial (NCT05928026), adults hospitalized for acute HF with income <130% federal poverty limit and difficulty paying bills with ≥1 additional socioeconomic need were randomized within 14 days of discharge 1:1 to early financial support ($500 debit card) vs control ($500 at 30-day follow-up). Key outcomes were medication adherence assessed by therapeutic drug monitoring, expressed as percent of tested cardiac drugs with detectable serum levels and categorized as complete/partial/none, assessed overall and for HF guideline-directed medical therapy with available assays (metoprolol, spironolactone) and the Kansas City Cardiomyopathy Questionnaire at 1 month. Data on 30-day all-cause hospitalizations and outpatient visit attendance were also collected. RESULTS:Of the 153 randomized participants (n = 76 financial support; n = 77 control; mean 53 y, 76% male, 73% Black; mean ejection fraction 26 ± 9%), 140 completed 1-month follow-up. Participants had median monthly income of $600 (IQR 0-1179), with 76% reporting cost-related medication non-adherence at baseline. On average, participants had 5 identified socioeconomic domain needs. Housing instability was reported by 50% of participants, while 85% reported food insecurity and 65% reported transportation barriers. 81% of participants were unemployed or retired. Baseline characteristics were well balanced between groups except for numerically higher median monthly income and lower mineralocorticoid receptor antagonist/sodium-glucose cotransporter-2 inhibitor prescription in the financial support group. CONCLUSIONS:The FUND-HF pilot trial successfully enrolled a deeply socioeconomically disadvantaged HF with reduced ejection fraction population using a multidomain social determinants of health eligibility framework with comprehensive socioeconomic phenotyping across multiple domains. This pilot design and implementation framework provides a practical template for future larger trials targeting economic barriers in cardiovascular populations. The clinical findings of this pilot trial are presented in the companion report.
BACKGROUND:Although the effectiveness of Lp(a) (lipoprotein[a])-lowering therapies remains under study, lipid guidelines now recommend Lp(a) testing in all adults to identify individuals who need more aggressive risk factor modification. Therefore, we evaluate contemporary patterns of Lp(a) testing and the impact of testing on LDL-C (low-density lipoprotein cholesterol) management. METHODS:Electronic health record patient data from 13 US health systems from January 1, 2021 to January 1, 2025, were utilized to assess the annual proportion of patients with atherosclerotic cardiovascular disease who underwent Lp(a) testing. Multivariable logistic regression was used to identify factors associated with (1) Lp(a) testing and (2) high Lp(a) (≥125 nmol/L or ≥50 mg/dL). Changes in lipid-lowering therapy after Lp(a) testing were evaluated, stratified by Lp(a) level. RESULTS:Among 1 948 540 patients with atherosclerotic cardiovascular disease (44% female sex; mean age, 70.9±12.8 years), 36 410 (1.9%) had an Lp(a) test. Testing increased slightly over time but remained low: from 0.2% in 2021 to 0.8% in 2024. Among tested patients, 31.1% had elevated Lp(a). Although female sex (odds ratio, 0.95 [95% CI, 0.93-0.98]) and non-Hispanic Black patients (0.79 [95% CI, 0.76-0.82]) were less likely to undergo testing, these groups had higher odds of elevated Lp(a) (1.19 [95% CI, 1.14-1.25] and 2.83 [95% CI, 2.63-3.05], respectively). Intensification of lipid-lowering therapy in those with LDL-C≥55 mg/dL increased with higher Lp(a) levels: 32.7% with Lp(a) 125 to <200 nmol or 50 to <80 mg/dL, and 38.2% with Lp(a)≥200 nmol or ≥80 mg/dL had lipid-lowering therapy intensification (Ptrend<0.001). CONCLUSIONS:Lp(a) testing remains low despite guideline recommendations. Although those with elevated Lp(a) were more likely to undergo lipid-lowering therapy intensification, over half of those with Lp(a)≥200 nmol/L or ≥ 80 mg/dL had no change in therapy. These results highlight a significant gap in clinical care and an opportunity to improve the use of Lp(a) testing to guide LDL-C management.
Importance Low-quality dietary intake is associated with adverse heart failure (HF) outcomes, yet evidence evaluating food-as-medicine interventions that supply high-quality dietary content is limited. Objective To determine the feasibility of providing food supplementation with medically tailored meals or fresh produce and explore the association of food supplementation vs usual care with clinical outcomes in patients recently hospitalized with HF and whether it differs by conditioning food supplementation to health care engagement. Design, Setting, and Participants This open-label factorial randomized clinical trial was conducted between April 2024 and October 2025 at 2 hospitals in Dallas, Texas. The study included patients who were hospitalized for HF and enrolled within 14 days of discharge, excluding those with prior heart transplant, a left ventricular assist device, or inotropic support at discharge; current enrollment in meal delivery programs; and inability to receive home deliveries. Participants were followed up with for 12 weeks. Of 150 participants enrolled, 2 were withdrawn due to clinical deterioration, 1 died, and 6 were lost to follow-up; all were included in the intention-to-treat analysis. Interventions Participants were randomized 1:1:1 to medically tailored meals, fresh produce, or usual care. Those receiving food supplementation underwent secondary 1:1 randomization to conditional (linked to clinic attendance and medication fills) vs unconditional delivery. Main Outcomes and Measures Implementation outcomes included delivery completion, adherence, and acceptability and exploratory clinical outcomes. The primary clinical outcome was defined as readmission for HF or emergency department (ED) visits for HF over 90-day follow-up. Secondary clinical outcomes included a win-ratio–based hierarchical composite (all-cause death, total HF hospitalizations or ED visits, and ≥10-point Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score [KCCQ-CSS] improvement). Results Among 150 participants (median [IQR] age, 59.5 [52.0-66.0] years; 91 [60.7%] male), the baseline median (IQR) left ventricular ejection fraction was 35% (25.0-54.0), the baseline median (IQR) KCCQ-CSS was 56.6 (36.8-72.9), and 79 (52.7%) had food insecurity. Food delivery completion was 93.6% with a mean (SD) reported consumption adherence of 4.7 (2.4) days per week (medically tailored meals) and 5.5 (2.3) days per week (fresh produce), with high retention (96.0%). Fresh produce demonstrated superior acceptability compared with medically tailored meals (Net Promoter Score: 8.6 vs 7.3; P = .02). There was no significant difference in the primary clinical outcome (HF readmission or ED visit) between food supplementation (23 events among 100 participants) vs usual care (9 events among 50 participants) (adjusted rate ratio, 1.09; 95% CI, 0.49-2.43; P = .83). The hierarchical composite favored food supplementation vs usual care (win ratio, 1.21; 95% CI, 1.14-1.29; P < .001). Among participants receiving food supplementation, conditional delivery (vs unconditional) was not associated with risk of HF events. Conclusions and Relevance In this randomized clinical trial, 90-day food supplementation was feasible and well accepted in individuals with recent HF. Food supplementation was not associated with an improvement in the primary clinical outcome and there was no difference when conditioning food supplementation on health care engagement. Trial Registration ClinicalTrials.gov Identifier: NCT06115369
BACKGROUND:While health systems have implemented resources to improve lipid management in people with atherosclerotic cardiovascular disease, the population-level effectiveness is unclear. METHODS:Electronic health record data from patients with atherosclerotic cardiovascular disease between January 1, 2021, and December 31, 2023, across 16 US academic health systems were analyzed. Atherosclerotic cardiovascular disease (defined by diagnosis and procedure codes) was established on or before the index date defined as the date of the most recent LDL-C (low-density lipoprotein-cholesterol) or the last day of the study period for those without an LDL-C available. Systems were surveyed to identify lipid management programs (eg, prevention/lipid clinic, electronic health record-based tools, and lipid management algorithms). Sequential multilevel multivariable logistic regression modeling was used to (1) assess the system-level association between an LDL-C <70 mg/dL and the presence of lipid management programs, adjusting for patient-level demographic and clinical characteristics, and (2) whether system-level uptake of statin or nonstatin lipid-lowering therapy was associated with an LDL-C <70 mg/dL. RESULTS:We included 1 738 042 patients with atherosclerotic cardiovascular disease (median, 88 365 per system; range, 17 086-2 48 371). About 81% of the health systems had prevention or lipid clinics. The proportion of those on statins ranged from 31.0% to 60.4% across health systems (median, 46.3%). Lower proportions were observed in the use of high-intensity statins (16.2%-33.1%), nonstatins (2.6%-8.1%), and combination lipid-lowering therapy (1.7%-6.3%). Among those with an LDL-C level available (n=890 521), 42.5% had an LDL-C <70 mg/dL, ranging 35.8% to 49.4% across systems. There was no association between the odds of achieving LDL-C <70 mg/dL and health system lipid management algorithm, prevention clinics/lipid clinics, or electronic health record-based tools. Neither system-level high-intensity statin utilization nor nonstatin use was associated with an LDL-C <70 mg/dL. CONCLUSIONS:Despite variability in lipid management resources and lipid-lowering therapy use across systems, many did not reach an LDL-C <70 mg/dL, and there was low uptake of lipid-lowering therapy. Innovative implementation strategies are needed for system-level lipid management.
Background Long-term control of low-density lipoprotein cholesterol (LDL-C) is key to reducing the risk of atherosclerotic cardiovascular disease (ASCVD), yet most large-scale evaluations have been cross-sectional. Objectives This study aimed to characterize the long-term trends in LDL-C among patients with ASCVD and to identify factors associated with reaching LDL-C goals. Methods Using data from the cvMOBIUS-2 (Cardiovascular Multicenter Observational Investigation of Lipid Care in the United States-2) registry, which pools electronic health record data from 17 U.S. health systems, we identified adults with ASCVD and a baseline LDL-C ≥70 mg/dL. We used generalized estimating equations to model LDL-C trends and multivariable logistic regression to identify clinical factors associated with: 1) achieving an LDL-C <70 mg/dL at 12 months; and 2) therapeutic intensification, defined as statin initiation/increase or nonstatin addition, within 1 year. Results Among 1,033,703 patients (median age 67.9 years; 49.2% women) with a median follow-up of 2.2 years (IQR: 1.1-3.8 years), LDL-C demonstrated a “drop-and-plateau” pattern: following an initial decline, mean LDL-C stalled well above 80 mg/dL and remained elevated throughout the remaining follow-up. A recurrent ASCVD event was strongly associated with both achieving LDL-C <70 mg/dL (OR: 2.18; 95% CI: 1.98-2.40) and therapeutic intensification (OR: 2.77; 95% CI: 2.34-3.27). Conversely, peripheral artery disease was associated with lower odds of goal attainment (OR: 0.70; 95% CI: 0.68-0.72) and intensification (OR: 0.73; 95% CI: 0.70-0.75). Conclusions In ASCVD patients, LDL-C levels plateau well above guideline targets following an initial decline. Because lipid management remains predominantly event-driven, proactive, system-level monitoring and timely intervention are urgently needed to reduce cumulative above-goal LDL-C exposure.
BACKGROUND Digital health technologies can potentially improve clinical research efficiency and increase participant diversity but have challenges with long-term participant engagement. OBJECTIVES The Heartline Study evaluated the impact of a mobile app-based heart health engagement program with the Irregular Rhythm Notification (IRN) and electrocardiogram features of the Apple Watch on diagnosis, treatment, and outcomes of atrial fibrillation in U.S. participants aged >= 65 years. METHODS Participants were randomized 3:1 to the watch group (vs no watch control group), stratified by prevalent atrial fibrillation. Participants interfaced with the study via a custom, app-based engagement program designed to facilitate participant enrollment, post-IRN follow-up, and electronic patient-reported outcome (ePRO) collection. To ensure users would respond to app-based reminders to complete ePROs and follow-up with providers after a potential IRN, targeted engagement strategies based on behavioral science principles were incorporated, including human-centered design, curated health education, and points-based incentives. RESULTS Of 34,244 enrolled Heartline participants, 32,299 (94%) started the program. High, longitudinal participant engagement was seen, with 93% actively engaged with the app at least weekly after 1 year, and 86% after 2 years. ePRO completion rates were 82% at 1 year and 76% at 2 years. Upon study completion, participants reported high satisfaction with the study and their personal investment. CONCLUSIONS Study adherence in Heartline was high and sustained through 2-year follow-up, using a purposely designed engagement program delivered by a mobile app. Participants in this older population remotely and regularly submitted study information through the app and reported high study satisfaction (A Study to Investigate if Early Atrial Fibrillation [AF] Diagnosis Reduces Risk of Events Like Stroke in the Real-World; NCT04276441) (JACC Adv. 2025;4:102072) (c) 2025 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
BACKGROUND:While International Classification of Diseases, Tenth Revision codes suffice for identifying stroke events in surveillance, accurately classifying stroke types and subtypes using electronic health records remains challenging due to limitations in structured data. This often necessitates manual review of clinical documentation. This study evaluated whether a large language model, Generative Pre-Trained Transformer 4 Omni (GPT-4o), can accurately identify stroke types and subtypes from unstructured clinical notes. METHODS:We implemented a retrieval-augmented generation framework with GPT-4o to classify stroke types (ischemic versus hemorrhagic) and ischemic stroke subtypes using electronic health records data. The American Heart Association Get With The Guidelines-Stroke registry served as the gold standard. Model development used a 20% subset of Get With The Guidelines-Stroke-linked data from UT Southwestern Medical Center (UTSW), with the remaining 80% reserved for testing. External validation used data from the Parkland Health and Hospital System (PHHS). A total of 4123 stroke hospitalizations from January 2019 to August 2023 were included (UTSW: n=2047; PHHS: n=2076). Three prompting strategies-zero-shot chain-of-thought, expert-guided, and instruction-based-were evaluated. Predictions of GPT-4os were compared with classifications made by trained abstractors contributing to the Get With The Guidelines-Stroke registry. RESULTS:In the external validation set, 79.6% of patients had ischemic stroke and 20.4% hemorrhagic. GPT-4o achieved 98% accuracy (95% CI, 0.97-0.99) in classifying stroke type, where accuracy reflects the overall proportion of correctly classified patients. Sensitivity was 0.98 (95% CI, 0.97-0.99), and specificity was 0.97 (95% CI, 0.96-0.98). For ischemic stroke subtypes, sensitivity ranged from 0.40 (95% CI, 0.31-0.49) for cryptogenic to 0.95 (95% CI, 0.93-0.97) for small-vessel occlusion. Specificity ranged from 0.94 (95% CI, 0.92-0.96) for large-artery atherosclerosis to 0.98 (95% CI, 0.97-0.99) for cardioembolism. Zero-shot chain-of-thought prompting-requiring minimal human input-performed comparably to more labor-intensive strategies. Consistency analysis revealed >99% agreement across repeated queries. CONCLUSIONS:GPT-4o demonstrated strong accuracy in classifying stroke types but faced challenges with ischemic subtypes.