BACKGROUND: Individuals with lower extremity peripheral artery disease (LE PAD) represent a subset of patients with atherosclerotic cardiovascular disease that are among the highest risk for major adverse cardiovascular...BACKGROUND: Individuals with lower extremity peripheral artery disease (LE PAD) represent a subset of patients with atherosclerotic cardiovascular disease that are among the highest risk for major adverse cardiovascular and limb events. Despite this, LE PAD is frequently under diagnosed, and an individual patient's risk for cardiovascular morbidity and limb loss is often underestimated and undertreated. OBJECTIVE: This narrative review aims to explore mechanisms and evidence for secondary prevention therapies to change the course of PAD disease progression. SUMMARY: The cornerstone of secondary prevention is centered on symptom control, lifestyle and behavioural interventions that include exercise therapy, smoking cessation, healthy nutrition and weight management. Individuals with high-risk concomitant comorbidities, such as ongoing smoking, diabetes, and chronic kidney disease, represent an even higher risk population that warrant stringent monitoring and may benefit the most from pharmacological therapies. Guideline-recommended pharmacological therapies include antiplatelet and anticoagulant medications, lipid lowering therapies, diabetes medications, and cilostazol. Despite guideline recommendations, these medical therapies remain under-utilized in patients with PAD. CONCLUSION: Based on the elevated risk profile of individuals with LE PAD undergoing lower extremity revascularization, increased efforts are required to initiate and escalate secondary prevention therapies. To achieve this, the development of effective, patient-centered and scalable implementation strategies remains a priority.
BACKGROUND: Drug-eluting stents (DES) are associated with a 2% annual failure rate and have worse outcomes at coronary bifurcations. Recent randomized control data have shown the noninferiority of drug-coated balloons (D...BACKGROUND: Drug-eluting stents (DES) are associated with a 2% annual failure rate and have worse outcomes at coronary bifurcations. Recent randomized control data have shown the noninferiority of drug-coated balloons (DCB) vs stents at 1 year. Possible benefits of DCBs include the lack of a metal prosthesis, absence of stent malapposition, lack of obligate antiplatelet treatment, and maintenance of vessel geometry and function. HYPOTHESIS: The use of DCBs in the treatment of nonleft main bifurcation disease is noninferior to a DES strategy for Target Bifurcation Failure at 1 year. STRATEGY DESIGN: The EBC DCB trial is a nonblinded, investigator-initiated, randomized control trial that will recruit 750 patients with nonleft main bifurcations requiring revascularization. Both main vessel and side branch must have significant atheroma. Subacute (NSTEMI and unstable angina) and elective presentations will be eligible for inclusion. Patients will be randomized to either a step-wise provisional DES or a DCB strategy. Major exclusion criteria include STEMI in the previous 48 hours, chronic total occlusions, and in-stent restenosis. The primary endpoint of Target Bifurcation Failure is a composite of cardiovascular death, target bifurcation myocardial infarction, or target bifurcation revascularization. Patients will be followed up at 6 months, 1, 3, 5, and 8 years. If noninferiority is met, superiority will be tested. SUMMARY: EBC DCB is an open-label, multicenter, international randomized control trial comparing the use of DCB and DES in the treatment of coronary artery bifurcation disease. The trial is registered at clinicaltrials.gov (NCT06822322).
Woelders ECI, Yosofi B, Peeters DAM
… +13 more, von Birgelen C, van Rees JB, Heestermans AACM, Claessen BEPM, van den Oord SCH, Dirksen MT, van Vliet D, Konijnenberg LSF, Cetinyurek-Yavuz A, van Royen N, van Geuns RM, Nijveldt R, Damman P
BACKGROUND: Ticagrelor monotherapy after a short period of dual antiplatelet therapy (DAPT) has shown to be safe and effective after percutaneous coronary intervention (PCI), including primary PCI in ST-elevation myocard...BACKGROUND: Ticagrelor monotherapy after a short period of dual antiplatelet therapy (DAPT) has shown to be safe and effective after percutaneous coronary intervention (PCI), including primary PCI in ST-elevation myocardial infarction (STEMI). However, direct omission of aspirin could further reduce bleeding risk. We aimed to assess the safety of ticagrelor monotherapy directly after primary PCI regarding ischemic events, and to investigate the effect on clinical bleeding events. METHODS: In this multicenter open-label pilot study, 200 STEMI patients were 1:1 randomized to ticagrelor monotherapy versus ticagrelor plus aspirin, directly after primary PCI. Major adverse cardiac and cerebral events (MACCE) and bleeding were assessed at 3 months. RESULTS: At 3 months, major adverse cardiac and cerebral events occurred in 3.1% of the experimental group (n = 99) vs 2.0% in the control group (n = 101) (HR: 1.54; 95% CI: 0.26-9.24), clinically relevant bleeding was observed in 4.2% vs 8.9% (HR: 0.46, 95% CI: 0.14-1.48), and clinically relevant non-access site bleeding in 2.0% vs 7.9% (HR: 0.25, 95% CI: 0.05-1.19). CONCLUSIONS: Although no significant difference in ischemic events was observed between the novel concept of ticagrelor monotherapy and DAPT, safety cannot be confirmed given the small number of events. Additionally, there was a tendency for a reduction in clinically relevant non-access site bleeding events.
BACKGROUND: The periprocedural management of elective invasive coronary angiography (ICA) or percutaneous coronary intervention (PCI) of patients using direct oral anticoagulation (DOAC) remains debated. This trial aims...BACKGROUND: The periprocedural management of elective invasive coronary angiography (ICA) or percutaneous coronary intervention (PCI) of patients using direct oral anticoagulation (DOAC) remains debated. This trial aims to evaluate whether continuing DOAC therapy is as safe as temporary interruption, by comparing in-hospital and 30-day bleeding and ischemic outcomes. METHODS: The South Limburg Myocardial Infarction 2 (SLIM-2) trial (NCT04977076) is an investigator-initiated, multicenter, randomized controlled trial. A total of 1,270 patients using DOAC and scheduled for elective ICA or PCI will be randomized in a 1:1 ratio to uninterrupted or interrupted therapy. The primary endpoint is in-hospital bleeding, classified as type 2, 3, or 5 according to the Bleeding Academic Research Consortium (BARC). Secondary endpoints are 30-day bleedings, major adverse cardiac and cerebrovascular events (MACCE), and net adverse clinical events (NACE, MACCE plus bleeding events). CONCLUSION: The SLIM-2 trial is the first large-scale randomized controlled trial to evaluate the safety of uninterrupted DOAC therapy in elective ICA and PCI. Its results will provide critical evidence to guide periprocedural anticoagulation management and may inform future clinical practice guidelines. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov with the number NCT04977076. https://clinicaltrials.gov/study/NCT04977076?term=NCT04977076&viewType=Card&rank=1.
BACKGROUND: Acute heart failure is the leading cause of hospitalization in older adults and carries a high risk of short-term death or readmission. Initial treatment involves intravenous loop diuretics, often combined wi...BACKGROUND: Acute heart failure is the leading cause of hospitalization in older adults and carries a high risk of short-term death or readmission. Initial treatment involves intravenous loop diuretics, often combined with vasodilators, despite limited evidence. The individual and combined effects of loop diuretics and vasodilators have never been directly compared during the initial emergency phase, as previous studies have included patients after early stabilization, leaving the optimal first-line treatment unknown. STUDY DESIGN: DECONGEST-AHF is a pragmatic, multicenter, randomized, double-blinded, placebo-controlled trial evaluating early treatment strategies in patients with suspected acute heart failure. Patients are included no later than 3 hours after emergency department arrival. Inclusion criteria are acute dyspnea, clinical signs of congestion, oxygen saturation <94% or need for oxygen therapy, and systolic blood pressure ≥100 mmHg. Patients are randomized (1:1:1) to receive intravenous furosemide, intravenous isosorbide dinitrate, or both as initial in-hospital treatment. The primary outcome is days alive and outside of the hospital at 30 days. The trial will enroll 1,041 patients across 5 Danish hospitals. DISCUSSION: By initiating treatment during the hyperacute phase and applying a blinded and placebo-controlled design, we aim to clarify the individual and combined effects of 2 widely used therapies. The use of emergency consent procedures enables the inclusion of a real-world patient population, including patients who are often excluded from clinical trials. This approach ensures broad generalizability and reflects routine emergency care. Findings from DECONGEST-AHF may improve early management of patients with acute heart failure. TRIAL REGISTRATION: ClinicalTrials.gov identifier:(NCT05276219).
Elbenawi H, Hassan I, Abdelgalil MS
… +19 more, Hanna M, Almotawally S, Fayed M, Mohamed KA, Elnaggar H, Abouainain L, Hamed BM, Ibrahim A, Khatib AA, Elhelw M, Hassan E, Eisa M, Zaaya M, Ibrahim R, Goldsweig AM, Saad M, Alfonso F, Alkhouli M, Elgendy IY
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is associated with periprocedural stroke risk due to embolic debris. The efficacy and safety of cerebral embolic protection devices (CEPDs) remain uncertain, with...BACKGROUND: Transcatheter aortic valve replacement (TAVR) is associated with periprocedural stroke risk due to embolic debris. The efficacy and safety of cerebral embolic protection devices (CEPDs) remain uncertain, with conflicting results between trials. We performed a meta-analysis of randomized controlled trials (RCTs) of current-generation CEPDs for TAVR. METHODS: Electronic databases were searched for RCTs comparing clinical outcomes with routine CEPD use vs no CEPD use. Outcomes of interest included any stroke, disabling stroke, and all-cause mortality. Risk ratios (RR) or mean differences with 95% confidence intervals (CIs) were pooled using random-effects models. The analysis was complemented by meta-regression and trial sequential analyses. RESULTS: The meta-analysis included 8 RCTs (5 filter-based and 3 shield-based) with 11,596 patients. CEPD use was not associated with a lower incidence of any stroke (RR 0.92; 95% CI 0.75-1.14), disabling stroke (RR 0.80; 95% CI 0.55-1.15), new magnetic resonance imaging-detected lesions (RR 1.00; 95% CI 0.93-1.07), or all-cause mortality (RR 1.04; 95% CI 0.71-1.51). Trial sequential analysis provided conclusive meta-analytic evidence and affirmed the absence of CEPD benefit. Meta‑regression showed no significant association between stroke risk and patient-level covariates, including age, sex, or the presence of diabetes, prior stroke, or atrial fibrillation (all P > .05). CONCLUSIONS: Current-generation CEPD devices during TAVR did not significantly reduce the risk of any stroke, disabling stroke, or all-cause mortality. Trial sequential analysis indicates that, at least with available data, cumulative evidence appears sufficient to question the predefined benefit thresholds for existing systems. These findings suggest the lack of routine use of current-generation CEPD in TAVR.
BACKGROUND: This retrospective, cross-sectional study describes using community mailings followed by ankle brachial index (ABI) testing to identify participants for clinical trials of interventions to improve walking per...BACKGROUND: This retrospective, cross-sectional study describes using community mailings followed by ankle brachial index (ABI) testing to identify participants for clinical trials of interventions to improve walking performance in people with peripheral artery disease (PAD). Clinical characteristics of clinical trial participants were compared between PAD participants identified with community-based recruitment vs PAD participants recruited from the medical center. METHODS: Between January 09, 2012, and October 31, 2025, approximately 10,000 to 60,000 postcards/month were mailed to residents aged 50 and older in Chicago or New Orleans, to recruit PAD participants for clinical trials testing therapies for walking impairment. Respondents with PAD risk factors and walking difficulty were invited to undergo ABI testing. Additional participants were identified from patients with PAD in medical centers in Chicago and New Orleans. The 6-minute walk and questionnaires were administered. RESULTS: Of 2,856 people (49.9% women, 55.8% Black) who responded to a postcard and underwent ABI testing, 669 (23.4%) had ABI < 0.90, consistent with PAD. Compared to 275 PAD patients from a medical center, PAD participants from the community included a higher proportion of people who were Black (65.5% vs 48.7%, P < .001), with household income < $50,000 (36.7% vs 28.5%, P = .015), and without a college degree (67.6% vs 58.1%, P = .016). Compared to PAD participants identified from a medical center, those identified from the community had poorer 6-minute walk distance (308 vs 334 m, P = .002). CONCLUSIONS: Approximately 23% of people living in the community who underwent ABI testing as part of a clinical trial recruitment method had PAD. Compared to PAD participants from the medical center, those identified from the community included more people traditionally underrepresented in clinical trials and had greater walking impairment TRIAL REGISTRATION: ClinicalTrials.gov identifier: (NCT03743636, NCT04794530, NCT05624125, NCT02593110, NCT03054519, NCT06032065, NCT06165016, NCT03363165, NCT03871075, NCT06399900, NCT02538900, NCT01408901, NCT04228978, NCT06657976).
Namba HF, de Jong EAM, Boerhout CKM
… +16 more, Mechroubi A, Nijkamp T, Damman P, Dimitriu-Leen AC, Meuwissen M, Heestermans TACM, den Haan MC, Beijk MAM, Vos NS, Escaned J, den Ruijter HM, Appelman Y, Eringa EC, Delewi R, Piek JJ, van de Hoef TP
BACKGROUND: Coronary vasospasm is highly prevalent in patients with angina and no obstructive coronary arteries (ANOCA). In the pathophysiology of coronary vasospasm, endothelial dysfunction and vascular smooth muscle ce...BACKGROUND: Coronary vasospasm is highly prevalent in patients with angina and no obstructive coronary arteries (ANOCA). In the pathophysiology of coronary vasospasm, endothelial dysfunction and vascular smooth muscle cell hyperreactivity may cause an imbalance between vasodilation and vasoconstriction. Within this pathophysiology, nitric oxide is crucial. Nitric oxide activates soluble guanylate cyclase, which through the nitric oxide-soluble guanylate cyclase-cyclic guanosine monophosphate pathway, reduces intracellular calcium levels in vascular smooth muscle cells, resulting in vasodilation. sGC stimulators, such as vericiguat, enhance the sensitivity of soluble guanylate cyclase to nitric oxide. Vericiguat was shown to be well tolerated, safe, and clinically effective in both heart failure patients as well as in patients with coronary artery disease. We hypothesize that vericiguat restores the balance between vasodilation and vasoconstriction and thereby reduces coronary spasm episodes in ANOCA patients. METHODS: In the Vericiguat in Vasospastic Angina trial, we will assess the impact of vericiguat on endothelial function and microvascular vasodilator responses, angina and quality of life. Additionally, we will evaluate the tolerability and safety of vericiguat in patients with coronary vasospasm as the pathophysiological substrate of ANOCA. 50 patients will be included in the trial, and will be randomized in a 1:1 ratio to placebo treatment first, followed by vericiguat treatment, or vericiguat treatment first, followed by placebo treatment. TRIAL REGISTRATION: The Vericiguat in Vasospastic Angina trial is registered at ClinicalTrials.gov ID NCT06415227.
BACKGROUND: Hospital ownership type may influence acute cardiovascular (CV) disease disparities that persist across the U.S. We examined associations between hospital ownership type and in-hospital and readmission outcom...BACKGROUND: Hospital ownership type may influence acute cardiovascular (CV) disease disparities that persist across the U.S. We examined associations between hospital ownership type and in-hospital and readmission outcomes for ST-elevation myocardial infarction (STEMI) hospitalizations. METHODS: We performed a retrospective cohort study of hospitalizations for STEMI using the National Readmissions Database (2016-2022). Hospitals were categorized as nonprofit, for-profit, or public. Outcomes included in-hospital mortality and 90-day readmission for acute coronary syndrome, heart failure (HF), CV, and all causes. Associations were assessed using multivariable logistic and Cox proportional hazards regression, adjusting for patient, hospitalization, and hospital-level characteristics. RESULTS: Of 610,427 STEMI hospitalizations, 460,451 (75.4%) were at nonprofit, 88,965 (14.6%) at for-profit, and 61,011 (10.0%) at public hospitals. Compared with nonprofit hospitals, for-profit hospitals (adjusted odds ratio [OR] 1.09, 95% confidence interval [CI] 1.05-1.13) and public hospitals (aOR 1.17, 95% CI 1.12-1.22) were each associated with higher odds of in-hospital mortality. For-profit hospitals were associated with higher risk of 90-day readmission for acute coronary syndrome (adjusted hazards ratio [HR] 1.15, 95% CI 1.10-1.21), HF (aHR 1.08, 95% CI 1.03-1.13), CV (aHR 1.08, 95% CI 1.05-1.12), and all causes (aHR 1.13, 95% CI 1.10-1.16) relative to nonprofit hospitals. Public hospitals were associated with higher risk of 90-day readmission for HF (aHR 1.08, 95% CI 1.02-1.13) relative to nonprofit hospitals. CONCLUSIONS: For-profit and public hospitals were associated with higher in-hospital mortality and 90-day readmission for various causes compared with nonprofit hospitals. These findings suggest that hospital-level factors may contribute to disparities in STEMI outcomes and warrant further investigation.
BACKGROUND: International Classification of Diseases, Tenth Revision (ICD-10) codes are commonly used for identifying myocardial infarction (MI) in clinical research and increasingly used to capture events in clinical tr...BACKGROUND: International Classification of Diseases, Tenth Revision (ICD-10) codes are commonly used for identifying myocardial infarction (MI) in clinical research and increasingly used to capture events in clinical trials; however, their accuracy for distinguishing MI subtypes is uncertain. METHODS: In this secondary analysis of a single-center prospective cohort study, consecutive individuals who underwent highsensitivity cardiac troponin testing between October 2023 and February 2025 were adjudicated by physicians as either an MI subtype, myocardial injury, or non-elevated troponin. Clinician adjudicated diagnoses were compared to ICD-10 codes attributable to type 1 MI, type 2 MI, and type 3-5 MI. RESULTS: In a study of 24,524 individuals undergoing troponin testing, type 1 MI ICD-10 codes showed moderate sensitivity (53%) but high specificity (99%), whereas the ICD-10 codes for type 2 MI and types 3-5 MI demonstrated extremely low sensitivities (3% and 0%, respectively) despite high sepificitiy (99%). CONCLUSIONS: These data suggest the ICD-10 codes for each individual MI subtype have such low sensitivity that they may not reliably and accurately identify these MI subtypes in clinical research or in quality metrics and value-based programs.
BACKGROUND: The organ perfusion pressure (OPP) is a surrogate for end-organ hypoperfusion and was shown to predict outcomes in a multicenter cohort of cardiogenic shock (CS) patients. This investigation was conducted to...BACKGROUND: The organ perfusion pressure (OPP) is a surrogate for end-organ hypoperfusion and was shown to predict outcomes in a multicenter cohort of cardiogenic shock (CS) patients. This investigation was conducted to externally validate the independent prognostic efficacy of admission OPP in predicting in-hospital mortality in CS. METHODS: This was a retrospective analysis of a Multicenter International Registry that enrolled consecutive patients admitted for CS from July 2023 to October 2024. Only patients with CS related to heart failure (HF) or acute myocardial infarction (AMI) were included. Admission OPP was calculated as the difference between mean arterial pressure and central venous pressure. The primary outcome was in-hospital all-cause death. RESULTS: About 621 patients were considered (mean age 62 ± 13 years; 138 [22.2%] female): 518 (83.4%) patients presented with SCAI stage ≥ C severity. In-hospital all-cause death occurred in 247 (39.8%) individuals. As compared to survivors, nonsurvivors had significantly lower OPP (59 mmHg [IQR 49-69 mmHg] vs 70 mmHg [60-80 mmHg], P-value < .001). In univariable analysis, low OPP (<57 mmHg) was associated with significantly higher in-hospital all-cause mortality (OR 3.20 [95% CI 2.25-4.56], P-value < .001); this result was consistent across both AMI-CS and HF-CS cohorts. In a multivariable logistic regression analysis including age, diabetes, SCAI stage, Sequential Organ Failure Assessment Score, creatinine, lactates, Vasoactive Inotropic Score, OPP, central venous pressure and cardiac arrest, lower OPP significantly predicted the primary outcome (OR per mmHg decrease: 1.03 [95% CI 1.01-1.06], P-value = .020). The C-index for OPP as a predictor of in-hospital mortality was 0.691 (slope = 1.01; intercept = 0.01). CONCLUSIONS: In this multicenter CS cohort, admission OPP was an independent prognostic marker of in-hospital mortality, irrespective of underlying CS etiology. Its inherent simplicity and demonstrated clinical robustness may support its integration into risk stratification and CS protocols.
Zhao J, Hong H, Fanaroff AC
… +16 more, Zhong S, Bush KNV, Granger C, Huber N, Jackevicius CA, Kindipan I, Li S, Lewis P, Osho A, Sather J, Sigal SL, Thomas K, Ni Z, Hall JL, Jacobs AK, Goyal A
BACKGROUND: Cardiovascular disease remains the leading cause of mortality worldwide, with acute myocardial infarction (AMI) contributing to over 100,000 deaths annually in the United States. Accurate risk stratification...BACKGROUND: Cardiovascular disease remains the leading cause of mortality worldwide, with acute myocardial infarction (AMI) contributing to over 100,000 deaths annually in the United States. Accurate risk stratification for in-hospital mortality is essential for guiding clinical decisions, improving outcomes, and optimizing hospital resources. However, existing models often rely on limited predictor sets, outdated data, and linear methods that may not reflect current clinical practice. OBJECTIVE: To develop and validate a contemporary in-hospital mortality risk model for AMI patients, incorporating clinical, demographic, and social determinants of health, and to compare performance against the legacy ACTION Registry-GWTG model. METHODS: We utilized data from the American Heart Association (AHA) Get with The Guidelines-Coronary Artery Disease (GWTG-CAD) Registry. Patients with AMI admitted between October 1, 2019, and December 31, 2022 (201,191 patients from 605 hospitals) were used to develop the in-hospital mortality prediction model. A total number of 70,302 patients admitted in 2023 served as an independent validation cohort. We incorporated 27 predictors and benchmarked against the legacy ACTION Registry-GWTG model. Subgroup and sensitivity analyses assessed model performance across sex, race/ethnicity, ST-elevation myocardial infarction status, and time period. RESULTS: The Light Gradient Boosting Machine (LightGBM)-based GWTG-CAD model achieved the highest discrimination (area under the receiver operating characteristic curve [AUROC] 0.874, 95% confidence intervals, 0.867-0.880) and superior calibration across subgroups, outperforming the ACTION Registry-GWTG model (AUROC 0.859, 95% confidence intervals, 0.852-0.867). Comorbidities, transportation method, and community-level socioeconomic factors contributed meaningful predictive value beyond traditional predictors. The generalized linear mixed model (AUROC 0.865) provided interpretable odds ratios and calibrated probability estimates suitable for risk-adjusted benchmarking and quality improvement. CONCLUSION: The GWTG-CAD model suite advances AMI mortality prediction through 2 complementary approaches: the LightGBM model offers superior discrimination for identifying high-risk patients across diverse subgroups, while the generalized linear mixed model provides a transparent tool for institutional benchmarking and quality improvement. Broader external validation is needed before clinical deployment.
RATIONALE: Radial artery occlusion (RAO) and bleeding are the principal complications of transradial cardiac catheterization. Although unfractionated heparin (UFH) reduces RAO, it may increase bleeding risk; thus, the op...RATIONALE: Radial artery occlusion (RAO) and bleeding are the principal complications of transradial cardiac catheterization. Although unfractionated heparin (UFH) reduces RAO, it may increase bleeding risk; thus, the optimal balance between efficacy and safety remains uncertain. PRIMARY HYPOTHESIS: Among patients undergoing transradial coronary angiography, UFH (high-dose 50 U/kg or low-dose 25 U/kg) compared with placebo reduces RAO, assessed by Doppler ultrasound prior to discharge. DESIGN: Multicenter, randomized, controlled trial comparing high-dose UFH, low-dose UFH, and placebo. Patients undergo standardized radial hemostasis (30-minute compression followed by stepwise 20-minute release). Net clinical benefit defined as composite of RAO and hematoma ≥5 cm. CLINICAL TRIAL REGISTRATION:URL: www. CLINICALTRIALS: gov; Unique identifier: NCT04374799.
Derval N, Tixier R, Duchateau J
… +22 more, Georget A, Albenque JP, Combes S, Massoullié G, Zhao A, Cauchemez B, Knecht S, Duytschaever M, Escande W, Lepillier A, Denis A, Chauvel R, Bortone A, Maury P, Sacristan B, Charton J, Sacher F, Hocini M, Haïssaguerre M, Jaïs P, Bénard A, Pambrun T
BACKGROUND: Beyond pulmonary veins isolation (PVI), the ablation strategy that has prevailed over the past two decades remains controversial: (1) the left atrium partition using linear lesions ("cox-maze" strategy); (2)...BACKGROUND: Beyond pulmonary veins isolation (PVI), the ablation strategy that has prevailed over the past two decades remains controversial: (1) the left atrium partition using linear lesions ("cox-maze" strategy); (2) the mapping of the left atrium in atrial fibrillation (AF) to identify and localize the arrhythmia sources. Both methods have failed to demonstrate superiority compared to PVI alone. Whether the addition of a systematic vein of Marshall (VOM) ethanol infusion and empirical linear ablation to PVI (Marshall-Plan) improves outcomes in patients with persistent AF remains to be demonstrated. OBJECTIVES: To compare the 2-year freedom from any atrial arrhythmia (atrial fibrillation [AF]/atrial tachycardia [AT]) between the Marshall-Plan approach and the PVI approach in patients with persistent AF. METHODS: The Marshall Plan is a multicenter, prospective, randomized, parallel- group, controlled clinical trial of superiority conducted in nine tertiary care centers across Europe (8 centers in France, 1 center in Belgium). A total of 262 patients will be randomized in two arms: Marshall-Plan, consisting of PVI with additional ablation, including vein of Marshall ethanol infusion, and lines of block at the mitral, dome, and cavotricuspid isthmuses versus PVI alone. The main outcome will be the 2-year freedom from any arrhythmia AF/AT <30 seconds) after a single ablation procedure with or without antiarrhythmic medication. CONCLUSIONS: This randomized trial aims to determine the success and safety of adjunctive VOM ethanol infusion and linear ablation to PVI in patients with persistent AF. REGISTRATION:URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04681872.
BACKGROUND: Systemic inflammation (SI), detected via high-sensitivity C-reactive protein (hsCRP) testing, has a recognized role in the pathogenesis and long-term outcomes in cardiovascular disease. However, SI in patient...BACKGROUND: Systemic inflammation (SI), detected via high-sensitivity C-reactive protein (hsCRP) testing, has a recognized role in the pathogenesis and long-term outcomes in cardiovascular disease. However, SI in patients with heart failure (HF) with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) is less characterized. This study aimed to evaluate the impact of SI on real-world healthcare resource utilization (HCRU) and costs. METHODS: This retrospective cohort study included patients within the Komodo Healthcare Map database between January 2016 and April 2024. HFmrEF/HFpEF was classified using a validated claims-based algorithm. Patients with a valid hsCRP test were classified as with SI (hsCRP 2-10 mg/L) or without SI (hsCRP <2 mg/L). Inverse probability of treatment weighting was used to balance patients based on demographic and clinical covariates. During the follow-up period (minimum 12 months following hsCRP test and HF diagnosis), HCRU was summarized descriptively, and per-patient per-year costs (adjusted to April 2024 USD) were estimated using generalized linear models or two-part models. RESULTS: Among 7,242 propensity-weighted patients with HFmrEF/HFpEF and an eligible hsCRP test, HCRU and costs were greater among those with SI (n = 3,299) vs without SI (n = 3,943). SI was associated with higher mean per-patient per-year costs; the total medical cost difference between groups was $3,329 (95% confidence interval [CI]: 1,802-4,857), including all-cause outpatient visits ($1,175 [95% CI: 302-2,049]) and hospitalizations ($1,666 [95% CI: 845-2,488]). CONCLUSIONS: SI was associated with increased economic and resource burden among patients with HFmrEF/HFpEF. SI testing may have a potential role in identifying those likely to have higher HCRU.
AIM: Proof-of-concept study evaluating the effect of a 12-week, predominantly plant-based online dietary intervention compared to usual diet on change in glycated hemoglobin (HbA1c) and estimated cardiovascular disease (...AIM: Proof-of-concept study evaluating the effect of a 12-week, predominantly plant-based online dietary intervention compared to usual diet on change in glycated hemoglobin (HbA1c) and estimated cardiovascular disease (CVD) risk in people with type 2 diabetes (T2D). METHODS: People with T2D on stable medication were randomized to usual diet or a 12-week, predominantly plant-based online dietary intervention. Coprimary outcomes were change in HbA1c and estimated relative CVD risk calculated from change in HbA1c, low-density lipoprotein cholesterol (LDL-c), and systolic blood pressure (SBP). RESULTS: In total, 49 people were randomized, with 48 completing the trial. Mean age was 64 ± 9 years, and 50% were male. There was a nonsignificant 3 (95% CI -7, 2) mmol/mol reduction in HbA1c and a 16% (95% CI -29, 1%) estimated relative CVD risk reduction in the plant-based compared to the usual diet group. Plant-based to total protein intake increased by 35% (95% CI 21, 49%), saturated fat intake decreased by 4 energy-percent (95% CI -6, -1), weight decreased by 2.0 kg (95% CI -3.6; -0.5) and LDL-c by 0.3 mmol/L (95% CI -0.6; -0.0) in the plant-based compared to the usual diet group. There was no effect on SBP (-3 mmHg) (95% CI -10, 4). Medication use remained stable. No people experienced clinically important hypoglycemia. Mild gastrointestinal complaints in the plant-based group were generally well tolerated. CONCLUSIONS: An online plant-based dietary intervention did not significantly reduce HbA1c and resulted in a trend toward a 16% estimated reduction in relative CVD risk. Several secondary outcomes, including dietary components, weight, and LDL-c improved. TRIAL REGISTRATION: This trial was registered at clinicaltrials.gov under NCT05777746.
Peng AW, Plott CF, Zahid S
… +11 more, Kassamali AA, Jones LK, Campbell-Salome G, Davis E, Head L, Kalich BA, Spitz JA, Farbaniec M, Schott SL, Martin SS, Marvel FA
RATIONALE: Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of morbidity and mortality worldwide. Lowering low-density lipoprotein cholesterol (LDL-C) with statins and nonstatin therapies has been demo...RATIONALE: Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of morbidity and mortality worldwide. Lowering low-density lipoprotein cholesterol (LDL-C) with statins and nonstatin therapies has been demonstrated to reduce cardiovascular events. However, real-world evidence consistently reveals large treatment gaps, including underprescribing of lipid-lowering therapy, limited intensification, and poor patient adherence. Observational registries describe these treatment gaps, and randomized trials demonstrate therapy efficacy under controlled conditions, but interventions translating these findings into routine clinical practice remain limited. The Corrie Lipids Program is a digital health initiative designed to address these critical gaps in lipid-lowering as a component of ASCVD treatment by delivering an intervention that combines a patient-facing smartphone app, clinician education and coaching, and seamless incorporation into clinical workflows. PRIMARY HYPOTHESIS: The Corrie Lipids Program will increase the proportion of high-risk patients achieving guideline-directed LDL-C goals at 6 and 12 months, and improve both patient and clinician engagement with lipid management through utilizing a digital health platform. DESIGN: This is a prospective, multicenter, implementation science study. Participants receive a patient-facing smartphone app with features including lipid tracking, medication reminders, educational content, and engagement tools. Clinicians receive virtual coaching, decision support, and workflow integration to optimize guideline-directed therapy. The study uses the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to evaluate effectiveness, adoption, and implementation outcomes. Qualitative interviews with patients and clinicians will explore barriers and facilitators to program adoption. No randomization or control group is included. SITES: This study will initially enroll at 3 academic medical centers: Johns Hopkins Medicine, Inova Schar Heart and Vascular, and Penn State Health, with plans for future expansion to additional sites. ESTIMATED ENROLLMENT: A total of 1,000 adult patients with uncontrolled LDL-C and at high risk for ASCVD, defined as known or subclinical ASCVD diagnosed by imaging, familial hypercholesterolemia or LDL-C ≥190 mg/dL, diabetes mellitus, individuals who meet criteria for lipid-lowering therapy based on ASCVD risk assessment in the most up-to-date guidelines, or statin-intolerance. ENROLLMENT DATES: Initiated in June 2025 with estimated completion of follow-up by early 2027. CURRENT STATUS: Currently enrolling, with 124 patients enrolled as of March 1, 2026. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT07478887.