AIM: This study aims to use routinely collected health data and trial emulation methodology to inform the design of a pragmatic randomized controlled trial (RCT) in people requiring multivessel coronary revascularization...AIM: This study aims to use routinely collected health data and trial emulation methodology to inform the design of a pragmatic randomized controlled trial (RCT) in people requiring multivessel coronary revascularization with severe symptomatic multivessel disease and high-risk characteristics, typically underrepresented in previous RCTs. METHODS: Hospital episode statistics (HES) linked to Office for National Statistics will be the main data source. The study population is patients who require multivessel myocardial revascularization with at least one of the following high-risk characteristics: age >75 years, female, diagnosed with acute coronary syndrome, heart failure, chronic kidney disease, peripheral vascular disease, or intermediate frailty risk. The intervention procedure is coronary artery bypass grafting (CABG) and the control (reference) is percutaneous coronary intervention (PCI). Outcomes include all-cause and cardiovascular (CV) death, CV hospitalization, major adverse cardiovascular events, and major vascular complications or bleeding within 5 years of the index procedure. This study includes 3 stages of statistical analyses: (1) latent class analysis (LCA) to identify mutually exclusive patient clusters (latent classes) representing different clinical phenotypes, (2) instrumental variable analysis (IVA) to estimate the average treatment effect (ATE) in the whole population and each patient cluster; and (3) repeating stage 2 in an emulated trial population obtained by matching the HES population with individual participant data from an RCT. We will then co-design the protocol for a definitive clinical trial in partnership with patients, public, and stakeholders. DISCUSSION: This study introduces a novel, stepwise data science framework that integrates machine learning (unsupervised learning through LCA), causal inference, and trial emulation methods applied in big data, to design a future stratified and adaptive RCT of CABG versus PCI in high-risk patients. Our proposed approach fosters new collaborations among data scientists, trial methodologists, clinicians, and patient and public representatives in complex trial designs for diverse, high-risk populations. This study represents a new framework for co-production in trials of cardiovascular interventions, which offers a scalable model and has the potential to transfer to other disease areas. CLINICAL TRIAL REGISTRATION:URL: https://www. CLINICALTRIALS: gov/study/NCT05853536. Unique identifier: NCT05853536.
BACKGROUND: Whereas reperfusion benefit in ST-elevation myocardial infarction (STEMI) is time-dependent, outcome data from very early primary percutaneous coronary intervention (PPCI) are limited. The STREAM-1 and -2 tri...BACKGROUND: Whereas reperfusion benefit in ST-elevation myocardial infarction (STEMI) is time-dependent, outcome data from very early primary percutaneous coronary intervention (PPCI) are limited. The STREAM-1 and -2 trials provided a unique opportunity to assess this issue. We evaluated electrocardiographic (ECG), angiographic, and clinical outcomes of early presenting STEMI patients undergoing PPCI, focusing on those treated <60 minutes of randomization. METHODS: We analyzed STEMI patients from STREAM-1 (n = 1,892) and STREAM-2 (n = 604) trials presenting <3 hours of symptom onset who underwent PPCI. Endpoints included ECG (ST segment resolution, Q waves), angiographic (TIMI flow grade), 30-day composite of all-cause death, shock, heart failure, reinfarction, safety outcomes, and 1-year mortality. RESULTS: Patients undergoing PPCI <60 minutes of randomization (29.2%) were younger, more frequently male, and had shorter total ischemic times than those undergoing PPCI >60 minutes. ST resolution and TIMI flow outcomes were similar, but significantly fewer patients in the rapid PPCI group had Q waves on discharge ECG (58.2 vs. 71.9%, P < .001). The 30-day composite outcome was lower in the <60 minutes group (10.1 vs 14.8%, risk ratio [RR] 0.68 [95% confidence interval 0.47-0.98], P = .04), associated with a significant 62% reduction in cardiogenic shock (P = .0008), and also had lower 1-year mortality (4.0 vs 7.2%; RR 0.56 [0.31-1.01], P(logrank) = .047). After inverse probability weighted adjustment, the 30-day composite outcome and cardiogenic shock were RR 0.74 (0.50-1.08), P = .116 and RR 0.45 (0.22-0.91), P = .027, respectively, and the 1-year mortality was RR 0.70 (0.39-1.26), P = .235. Safety endpoints were similar in both groups. CONCLUSIONS: Substantial opportunity exists to improve outcomes for early-presenting STEMI patients undergoing PPCI. Establishing a first medical contact-to-PPCI time of <60 minutes provides incremental benefit. CLINICAL TRIAL REGISTRATION:URL:https://clinicaltrials.gov/study/NCT00623623, https://clinicaltrials.gov/study/NCT02777580. Unique identifiers: NCT02777580, NCT00623623.
BACKGROUND: Transcatheter edge-to-edge repair (TEER) has emerged as an important therapy for severe mitral regurgitation. Current guidelines lack evidence-based recommendations for optimal postprocedural antithrombotic s...BACKGROUND: Transcatheter edge-to-edge repair (TEER) has emerged as an important therapy for severe mitral regurgitation. Current guidelines lack evidence-based recommendations for optimal postprocedural antithrombotic strategies, leading to heterogeneous clinical practices. And there are no randomized controlled trials (RCTs) available to compare different antithrombotic strategies following TEER. METHODS: STAR-TEER trial is an investigator-initiated, multicenter, randomized, parallel controlled, open-label trial, aiming to assess the safety and efficacy of de-escalated antithrombotic strategies with monotherapy in post-TEER patients with or without indications for oral anticoagulation (OAC) respectively. This trial plans to enroll 1,912 patients stratified into 2 cohorts: patients in Cohort A (requiring long-term OAC, n = 880) will be randomized 1:1 to rivaroxaban monotherapy or rivaroxaban plus clopidogrel, and patients in Cohort B (no OAC indication, n = 1,032) will be randomized 1:1 to aspirin monotherapy or aspirin plus clopidogrel. The primary outcome is all bleeding complications within 12 months post-TEER. The 2 key secondary outcomes are nonprocedure-related bleeding within 12 months post-TEER (key secondary outcome 1) and a composite of ischemic events including all-cause mortality, stroke, systemic embolism, and myocardial infarction within 12 months post-TEER (key secondary outcome 2). A hierarchical hypothesis testing will be performed, with the primary outcome and key secondary outcome 1 tested for superiority, followed by the key secondary outcome 2 tested for noninferiority. CONCLUSION: The STAR-TEER trial is the first large randomized controlled trial (RCT) to stratify patients based on OAC indication and compare different antithrombotic strategies following TEER in these 2 distinct cohorts. TRIAL REGISTRATION:URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT06901466 (Cohort A), NCT07007143 (Cohort B).
BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP1 RA) reduce cardiovascular and kidney risk in patients with type 2 diabetes (T2D), yet real-world use rema...BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP1 RA) reduce cardiovascular and kidney risk in patients with type 2 diabetes (T2D), yet real-world use remains suboptimal. Remote care models offer a promising approach to improve access; there is limited data on the safety of and adverse events (AEs) associated with prescribing and titrating these therapies through a protocol-driven remote management program. METHODS: The DRIVE trial was a pragmatic, randomized clinical trial evaluating the safety of a remote disease management program that initiated SGLT2i and/or GLP1 RA in patients with T2D and elevated cardiovascular or kidney risk. Participants were enrolled at a large integrated health care system in Massachusetts between March 2021 and December 2022. Participants were randomized to 1 of 2 implementation strategies: a sequential approach (two months of education first followed by medication initiation) or a bundled approach (simultaneous education and medication initiation). Nonclinical navigators and clinical pharmacists, supervised by physicians, oversaw medication initiation and monitoring under a collaborative drug therapy management agreement and protocol that included algorithms for initiation and titration of SGLT2i and GLP1 RA, as well as adjustment of concurrent glucose-lowering medications to reduce the risk of hypoglycemia Safety outcomes were collected through chart review and patient report, including targeted AEs, hospitalizations, emergency department visits, and urgent care visits. Targeted AEs were prospectively collected over the first 6 months after enrollment: for SGLT2i initiators, symptoms of genital mycotic infection, urinary tract infection, or volume depletion; for GLP 1 RA initiators, nausea, vomiting, diarrhea, and abdominal pain. Hospitalizations, emergency department visits, and urgent care visits over the first 6 months after enrollment were retrospectively collected through electronic health record review. RESULTS: Of 200 participants enrolled, 106 (53%) initiated SGLT2i (n = 68) or GLP1 RA (n = 40). Among SGLT2i users, 29.4% reported an AE, most commonly genital mycotic infections (10.3%) and symptoms of volume depletion (11.8%); 10.3% discontinued due to AEs. Among GLP1 RA users, 55.0% experienced AEs, predominantly gastrointestinal; 10.0% discontinued due to AEs. No severe hypoglycemia, emergency department visits, or hospitalizations occurred. CONCLUSIONS: A remote, pharmacist- and navigator-led program safely initiated SGLT2i and GLP1 RA in a high-risk T2D population, with AE rates comparable to clinical trials and high persistence. These findings support the feasibility of remote prescribing with appropriate clinical oversight and structured AE management. TRIAL REGISTRATION: Registry: ClinicalTrials.gov; URL: https://clinicaltrials.gov/study/NCT06046560; unique identifier: NCT06046560.
BACKGROUND: Elevated atherogenic lipoproteins increase risk of atherosclerotic cardiovascular disease (ASCVD), though long-term risk for adults without ASCVD who have low-normal levels has not been well described. METHOD...BACKGROUND: Elevated atherogenic lipoproteins increase risk of atherosclerotic cardiovascular disease (ASCVD), though long-term risk for adults without ASCVD who have low-normal levels has not been well described. METHODS: This study used pooled data from 16,384 individuals in 3 population-based prospective cohorts. At baseline all participants were without ASCVD and were not taking lipid-lowering therapy. We evaluated ASCVD events by baseline LDL-C, non-HDL-C and apoB, including low-normal values. ASCVD risk was assessed using multivariable Cox proportional hazards. RESULTS: The study cohort had a mean age of 52 (SD 18) years with 56.5% women, 64.7% of White race and 35.3% of Black race. Over a median follow-up of 18.8 years, unadjusted ASCVD event incidence was similar for adults with baseline LDL-C < 70 mg/dL and 70 to 99 mg/dL, and higher with LDL-C ≥ 100 mg/dL; trends were similar for non-HDL-C and apoB categories. Compared to having baseline LDL-C 70 to 99 mg/dL, LDL-C < 70 mg/dL was associated with similar ASCVD risk (adjusted HR 1.16 [95% Confidence Interval, 95% CI 0.90-1.50]) and LDL-C ≥ 130 mg/dL was associated with higher risk (adjusted HR 1.31 [95% CI 1.14-1.50]) after multivariable adjustment; adults with non-HDL-C ≥ 160 mg/dL or apoB ≥ 90 mg/dL also had higher risk after multivariable adjustment. CONCLUSIONS: Among adults without ASCVD not taking lipid-lowering therapy at baseline, ASCVD risk for adults with low-normal and high-normal LDL-C, non-HDL-C and apoB was similar, and their risk remained less than in adults with elevated lipoproteins. These findings emphasize the importance of achieving normal atherogenic lipoprotein levels for primary prevention of ASCVD from early adulthood through middle age.
BACKGROUND: Recent data have highlighted potential disparities in the care of children with SVT. The impact of socioeconomic factors on emergency department (ED) outcomes for pediatric SVT has not been well characterized...BACKGROUND: Recent data have highlighted potential disparities in the care of children with SVT. The impact of socioeconomic factors on emergency department (ED) outcomes for pediatric SVT has not been well characterized. METHODS: We performed a retrospective cohort study utilizing the 2006 to 2018 US Nationwide Emergency Department Sample (NEDS). Encounters for patients age 0-18 years with a primary diagnosis of SVT were evaluated, excluding those with congenital heart disease. The primary exposure was insurance payor. The primary outcome was hospital admission/transfer. Secondary outcomes included inpatient length of stay (LOS), procedures, and mortality. Multivariable logistic regression models evaluated the association of payor with outcomes, including covariates of age, hospital teaching status, hospital region, patient residence, and patient income. RESULTS: A total of 38,896 ED encounters were analyzed: median age 11.5 years (IQR 6-15); 48% male; 53% private payor, 38% public payor. Encounters with public payor had a higher rate of admit/transfer than private (24% vs 18%, P < .0001). There were no differences in LOS or procedures by payor. In multivariable analysis, public payor was an independent predictor of admission/transfer (OR 1.6, 95% CI 1.2-2.2). Patient age was also associated with admission/transfer, with all age groups less likely to undergo admission/transfer compared to age < 1 year. CONCLUSIONS: Public insurance payor is associated with higher rates of hospital admission/transfer for pediatric SVT, independent of age. Further studies are needed to identify whether differential access to preventative care underlies this observation, as this may be a target for intervention.
BACKGROUND: The role of N-terminal pro-B-type natriuretic peptide (NT-proBNP) risk stratification in adults with congenital heart disease (CHD) is not well defined because of paucity of data. The purpose of this study wa...BACKGROUND: The role of N-terminal pro-B-type natriuretic peptide (NT-proBNP) risk stratification in adults with congenital heart disease (CHD) is not well defined because of paucity of data. The purpose of this study was to assess the prognostic role of baseline and follow-up NT-proBNP levels in a large well-characterized cohort of CHD patients (derivation cohort), and to evaluate derived prognostic thresholds in another sample of CHD patients (validation cohort). METHOD: Retrospective cohort study of adults with CHD with ≥2 NT-proBNP measurements (2003-2023). Temporal change in NT-proBNP was calculated as relative change from baseline levels (relative ∆_NT-proBNP). RESULTS: We studied 4307 patients (derivation cohort [n = 2154, 50%] and validation cohort [n = 2153, 50%]). In the derivation cohort, baseline and follow-up NT-proBNP levels were 189 (77, 538) pg/mL and 285 (127, 852) pg/mL, and 1481 (69%) had temporal increase in NT-proBNP levels (relative ∆_NT-proBNP >0). Higher baseline NT-proBNP levels correlated with older age, atrial fibrillation, hepatorenal dysfunction, biventricular systolic dysfunction, and elevated biventricular filling pressures. Higher baseline NT-proBNP levels and temporal increase in NT-proBNP levels were associated with mortality, and serial NT-proBNP levels had superior prognostic value compared to single (baseline) NT-proBNP measurements. The prognostic performance of NT proBNP was comparable to cardiac catheterization and exercise test indices, both in the derivation and validation cohorts. CONCLUSIONS: NT-proBNP assay is inexpensive, readily available, and noninvasive, making it ideal for longitudinal monitoring. Further studies are required to determine whether interventions that modify the correlates of NT-proBNP level would improve clinical outcomes in this population.
BACKGROUND: Electrical storm (ES) is a clinical syndrome characterized by densely clustered ventricular arrhythmias and associated with substantial morbidity and mortality. Autonomic dysfunction is thought to play key ro...BACKGROUND: Electrical storm (ES) is a clinical syndrome characterized by densely clustered ventricular arrhythmias and associated with substantial morbidity and mortality. Autonomic dysfunction is thought to play key role in the pathophysiology of ES, with sympathetic blockade considered a therapeutic target. However, robust data supporting this treatment strategy remain limited. The objective of the SEDATE trial is to evaluate the effectiveness and safety of dexmedetomidine in the acute management of ES. METHODS AND DESIGN: SEDATE is a multicenter, double-blinded, randomized trial comparing dexmedetomidine to placebo in the acute treatment of patients with ES. A total of 192 participants admitted to an intensive care unit with ES will be randomized in a 1:1 fashion to receive either dexmedetomidine or placebo. Participants will undergo a study drug titration phase, followed by a 48-hour maintenance period and a subsequent study drug weaning phase. The primary outcome is a composite of all-cause in-hospital mortality and/or recurrent ventricular arrhythmia prompting intervention. All participants will be followed for the duration of their hospitalization. IMPLICATION: The SEDATE clinical trial aims to determine whether early use of dexmedetomidine improves in-hospital outcomes in patients with ES. TRIAL REGISTRATION: clinicaltrials.gov NCT06281977.
INTRODUCTION: Atrial fibrillation (AF) is the most common arrhythmia in older people, with an increasing prevalence of various geriatric conditions, such as multimorbidity, and frailty. A contemporary integrated approach...INTRODUCTION: Atrial fibrillation (AF) is the most common arrhythmia in older people, with an increasing prevalence of various geriatric conditions, such as multimorbidity, and frailty. A contemporary integrated approach is effective in reducing the risk of clinical adverse events, particularly when streamlined through the application of the Atrial Fibrillation Better Care (ABC) pathway, as proven in 2 non-European trials. METHODS: The atrial fibrillation integrated approach in frail, multimorbid and polymedicated older people (AFFIRMO) trial, a European multicenter, open-label, cluster-randomized study, will examine whether a mobile-health integrated care approach based on the ABC pathway combined with a multidimensional Comprehensive Geriatric Assessment (CGA) can reduce the 12-month risk of unplanned all-cause hospitalizations in patients with AF ≥65 years with ≥1 concomitant chronic condition(s). RESULTS: The AFFIRMO trial enrolled 1,260 patients with AF (mean age 74 [SD 6] years; 44.4% female) across 6 European countries (Bulgaria, Denmark, Italy, Romania, Serbia, and Spain). At baseline, the median (IQR) CHADS-VASc score was 4 (3-5), and the median (IQR) HAS-BLED score was 1 (1-2). Hypertension was reported in 992 (78.7%) patients, and diabetes mellitus in 369 (29.3%) patients. Among the enrolled patients, 507 (40.5%) were prefrail, and 171 (13.7%) were frail. Oral anticoagulants (OACs) were prescribed for 1,225 (97.2%) patients, with 1,149 (91.2%) patients receiving non-VKAs oral anticoagulants (NOACs). Follow-up is ongoing and planned to be completed in January 2026. CONCLUSIONS: The AFFIRMO trial will provide evidence on the efficacy of the ABC pathway in conjunction with the CGA approach in reducing the risk of unplanned all-cause hospitalizations and other clinical adverse events in older, multimorbid patients with AF. REGISTRATION: ClinicalTrials.gov identifier: NCT06775028.
Vekstein AM, Salah HM, Stebbins A
… +11 more, Wegermann Z, Yankey GS, Kosinski A, Wang A, Arnold S, Cohen D, Sorajja P, Kaneko T, Batchelor W, Thourani V, Vemulapalli S
BACKGROUND: Transcatheter tricuspid valve interventions (TTVI) have expanded with the recent FDA approval of both replacement transcatheter tricuspid valve replacement (TTVR) and edge-to-edge repair (T-TEER) devices. How...BACKGROUND: Transcatheter tricuspid valve interventions (TTVI) have expanded with the recent FDA approval of both replacement transcatheter tricuspid valve replacement (TTVR) and edge-to-edge repair (T-TEER) devices. However, the volume and outcomes of commercial, off-label TTVR and T-TEER procedures are unknown. Herein, we describe institutional volume and patient characteristics for commercial, off-label TTVR and T-TEER procedures in the STS/ACC transcatheter valve therapies (TVT) registry, and assess 30-day and 1-year outcomes, including quality of life. METHODS: Patients undergoing isolated TTVR or T-TEER for tricuspid regurgitation (TR) without stenosis were identified. The primary outcomes were residual TR severity and change in KCCQ-OS at 30 days. Secondary outcomes included 30-day mortality, vascular/bleeding complications, heart failure readmission, tricuspid reintervention, and 1-year Kaplan-Meier estimated mortality. RESULTS: A total of 995 tricuspid procedures were performed at 142 sites from January, 2021 to December, 2023, including 238 TTVR (primarily valve-in-valve or valve-in-ring) and 757 T-TEER. 72% of sites performed 5 or fewer procedures, while 4 high-volume centers performed 49, 81, 94, and 120 procedures, respectively. Among TTVR patients (median age 60), 97% had ≤ moderate residual TR at 30 days; 61% had substantial improvement and 14% had moderate improvement in KCCQ-OS. 30-day and 1-year estimated mortality were 3.9% and 19% respectively. Among T-TEER patients (median age 78), 74% had ≤ moderate residual TR; 54% had substantial improvement and 17% moderate improvement in KCCQ-OS. 30-day and 1-year estimated mortality were 3.0% and 18%, respectively. CONCLUSIONS: Off-label use of transcatheter tricuspid valve interventions was highly variable across institutions, with the majority of institutions performing <5 procedures, while others performed >100. Both T-TEER and TTVR reduced residual TR to ≤ moderate in the majority of cases and were associated with substantial improvements in quality of life.
Chen X, Li S, Wang B
… +20 more, Chen G, Yao Y, He Y, Wu X, Yang Y, Kang H, Ding L, Cheng Y, Shen Q, Guo H, Wang J, Wen S, Zhu L, Xing Y, Tong Q, Li P, Liu Y, Peng X, Chen SL, Wang Y
BACKGROUND: Complete revascularization (CR) has been shown to reduce the risk of adverse cardiovascular events compared with culprit-only revascularization (COR) in acute ST-segment elevation myocardial infarction (STEMI...BACKGROUND: Complete revascularization (CR) has been shown to reduce the risk of adverse cardiovascular events compared with culprit-only revascularization (COR) in acute ST-segment elevation myocardial infarction (STEMI) patients with multivessel disease (MVD). However, the optimal timing of staged complete revascularization (SCR) after primary percutaneous coronary intervention (PCI) remains unclear. TRIAL DESIGN: The STAGED trial is an investigator-initiated, multicenter, randomized study involving 37 sites, aiming to include 1,586 acute STEMI patients with MVD undergoing successful primary PCI of the culprit lesion followed by SCR. Eligible patients will be assigned to two groups based on the timing of SCR: early-staged PCI and delayed-staged PCI. The primary endpoint is major adverse cardiac event (MACE), including cardiovascular death, myocardial infarction, or ischemia-driven revascularization for both culprit and nonculprit vessels at 12 months since the randomization. The secondary endpoint is individual components of primary endpoint, all-cause death, heart failure-related rehospitalization, stroke, contrast-induced nephropathy, and radiation exposure dose. Follow-up will be conducted through clinic visits or telephone interviews at 1, 3, and 12 months after the index procedure. CONCLUSION: The STAGED trial is the first randomized controlled study specifically designed to evaluate the clinical efficacy and safety of different timing strategies for SCR in acute STEMI patients with MVD. TRIAL REGISTRATION: clinicaltrials.gov, NCT04918030.
An accurate interpretation of hemodynamics measured by right heart catheterization (RHC) is crucial for guiding the management of heart failure and pulmonary hypertension. We evaluated the concordance and variability bet...An accurate interpretation of hemodynamics measured by right heart catheterization (RHC) is crucial for guiding the management of heart failure and pulmonary hypertension. We evaluated the concordance and variability between site-reported and core laboratory-adjudicated interpretations of invasive hemodynamic measurements.
Artificial intelligence (AI) is becoming increasingly prevalent in medical practice and has demonstrated sufficient clinical acumen to pass several licensing examinations. We tested the ability of 3 popular large-languag...Artificial intelligence (AI) is becoming increasingly prevalent in medical practice and has demonstrated sufficient clinical acumen to pass several licensing examinations. We tested the ability of 3 popular large-language models, ChatGPT-4.0 (OpenAI), Gemini (Google), and Bing AI (Microsoft), to pass a cardiovascular medicine board-style exam. Of these AI platforms, only ChatGPT-4.0 was able to achieve a score similar to human participants.
Ahn HJ, Lee SR, Kwon S
… +18 more, Rhee TM, Lee YS, Han SJ, Kang KW, Shim J, Yu HT, Oh IY, Park HS, Park JK, Jang SW, Lee SH, Roh SY, Chun KJ, Park HW, Lee KY, Oh S, Choi EK, GUARD-OAC Trial Investigators
BACKGROUND: Direct oral anticoagulants (DOACs) are the cornerstone of thromboembolic prevention in patients with atrial fibrillation, venous thromboembolism, or other cardiovascular conditions. However, DOAC use is assoc...BACKGROUND: Direct oral anticoagulants (DOACs) are the cornerstone of thromboembolic prevention in patients with atrial fibrillation, venous thromboembolism, or other cardiovascular conditions. However, DOAC use is associated with an increased risk of bleeding, with gastrointestinal (GI) bleeding being the most common site of major bleeding. Proton pump inhibitors (PPIs) are reasonably used during combined antithrombotic therapy or based on individual bleeding risk; nonetheless, evidence supporting their benefit in patients receiving DOAC therapy remains limited. METHODS: The Gastrointestinal protection Using proton-pump inhibitor in pAtients who RequireD Oral AntiCoagulants (GUARD-OAC) trial is a prospective, multicenter, open-label, randomized controlled trial evaluating the GI protective effect of PPI coadministration with DOAC. Eligible participants are patients with cardio- or cerebrovascular disease requiring long-term anticoagulation (≥1 year), who are currently receiving or initiating DOAC therapy, and have a HAS-BLED score of ≥1. The primary outcome is a composite of upper GI clinical events, including bleeding, symptomatic gastroduodenal ulcer, persistent pain of presumed GI origin with underlying multiple erosive disease, obstruction, or perforation. The secondary outcomes are the individual components of the primary outcome, GI symptoms or signs, cardiovascular or all bleeding events, and all-cause mortality. Assuming a 40% relative risk reduction of the primary outcome in the PPI plus DOAC group compared to the DOAC alone group, a total of 3,846 patients will be enrolled and followed for one year. A Clinical Events Committee will adjudicate clinical outcomes and adverse events for causality and attribution, and an independent Data Safety Monitoring Board will oversee the study. The GUARD-OAC trial is funded by the Ministry of Health & Welfare, Republic of Korea. CONCLUSIONS: The GUARD-OAC trial is the first randomized controlled trial exploring the efficacy of PPI cotherapy in patients receiving DOACs, providing evidence that may inform future guidelines on GI protection in this population. TRIAL REGISTRATION: Clinical Research Information Service, Identifier KCT0006848.
BACKGROUND: Improved survival of individuals with congenital heart disease (CHD) into adulthood has made reproductive health a crucial aspect of CHD care. Despite existing guidelines on heritability, contraception, pregn...BACKGROUND: Improved survival of individuals with congenital heart disease (CHD) into adulthood has made reproductive health a crucial aspect of CHD care. Despite existing guidelines on heritability, contraception, pregnancy, and postpartum care, little is known about CHD survivors' experiences and attitudes toward reproductive health. This study aimed to examine reproductive health outcomes and experiences among adults with CHD, with a focus on female survivors. METHODS: Data were drawn from the CHD PULSE (Project to Understand Lifelong Survivor Experience) study, a cross-sectional survey conducted from September 2021 to April 2023. Participants were adults (≥18 years) with at least 1 CHD intervention at 1 of 11 U.S. Pediatric Cardiac Care Consortium centers. CHD severity was categorized based on initial diagnosis and intervention. Categorical and continuous variables were analyzed using Chi-square and Kruskal-Wallis tests, respectively. RESULTS: Among 3,073 respondents (1,704 females, 1,369 males), 48% of female participants reported receiving no reproductive counseling. Factors significantly associated with receiving counseling included older age, later age at last surgery, marital history, severe CHD, higher income, government insurance, and more comorbidities (P < .001). Women were significantly more likely to have biological children than men (40.4% vs 37.5%, P < .0001). CONCLUSION: Reproductive counseling is infrequent among women with CHD, especially among younger, unmarried, low-income individuals with less severe CHD and fewer comorbidities. Significant gender disparities in reproductive outcomes emphasize the need for tailored, gender-specific reproductive health counseling for CHD survivors.
Diletti R, Daemen J, Faurie B
… +26 more, Barbierato M, Tchetche D, Hovasse T, Teeuwen K, Oemrawsingh RM, Allali A, Campo G, Bennett J, Alfonso F, Mashayekhi K, Moreno R, Abdelwahed YS, Dedic A, de la Torre Hernandez JM, Murphy JC, Amat-Santos I, Dens J, Franzé A, Leistner D, Ghattas A, Spratt JC, Banning AP, Tijssen JGP, Spitzer E, Van Mieghem NM, IVUS CHIP investigators
BACKGROUND: Intravascular ultrasound (IVUS) guidance for percutaneous coronary intervention (PCI) has been associated with a reduction in clinical events. Whereas most evidence is generated in Asian-Pacific populations,...BACKGROUND: Intravascular ultrasound (IVUS) guidance for percutaneous coronary intervention (PCI) has been associated with a reduction in clinical events. Whereas most evidence is generated in Asian-Pacific populations, its global adoption remains low. METHODS: The IVUS complex high-risk indicated procedures (CHIP) trial is a multicenter, international, event-driven, randomized superiority trial comparing IVUS-guided PCI with angio-guided PCI during complex high-risk indicated procedures. The primary endpoint is target vessel failure, defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target vessel revascularization. The IVUS CHIP trial utilizes an event-driven approach. The outcomes for the primary endpoint are first reported when at least 169 patients with a primary endpoint have been confirmed. A total of 2020 patients will be enrolled in 37 European sites. CONCLUSIONS: The aim of the IVUS CHIP trial is to assess the superiority of an IVUS-guided approach vs an angio-guided approach in patients undergoing complex high-risk indicated procedures in terms of the study primary endpoint of target vessel failure. TRIAL REGISTRATION: The IVUS CHIP trial is registered at ClinicalTrial.gov and assigned the identifier NCT04854070.
BACKGROUND: Over 50% of women evaluated for suspected ischemia have no obstructive coronary artery disease (INOCA). Statins, angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) are effe...BACKGROUND: Over 50% of women evaluated for suspected ischemia have no obstructive coronary artery disease (INOCA). Statins, angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) are effective in intermediate outcome trials; however, impact on coronary plaque has not been well characterized. OBJECTIVES: The Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD (WARRIOR NCT03417388) trial testing intensive medical therapy (IMT) (high intensity statin, ACEI or ARB and low dose aspirin) vs usual care (UC) in women with suspected INOCA offers the opportunity to evaluate the impact of IMT vs UC on plaque composition, and chest pain symptoms by coronary CT angiography (CCTA). We hypothesize that IMT provides beneficial data on plaque composition impacting flow reserve and trial outcomes. METHODS: This WARRIOR ancillary study will consecutively enroll 200 eligible participants randomized to IMT vs UC by baseline and exit CCTA. Changes in plaque and peri‑coronary artery adipose tissue attenuation (PCAT) characteristics will be quantified. RESULTS: Results will address: (1) Changes in coronary plaque characteristics and their hemodynamic significance using AI-enabled quantification of CCTA; (2) Changes in plaque inflammatory characteristics through pericoronary adipose tissue (PCAT) density analysis; (3) Plaque burden, composition and PCAT density changes related to angina score (Seattle Angina Questionnaire [SAQ]), (4) Derive a quantitative machine learning risk score (MLRS) using CCTA-derived variables for prediction of change in angina. CONCLUSIONS: The ancillary study will be the first to quantify the impact of IMT vs UC on plaque composition, and outcomes in women with suspected INOCA. TRIAL REGISTRATION: WARRIOR Ancillary Study for CCTA Analysis, NCT05035056.
BACKGROUND: Early structural heart disease (SHD) detection is crucial for improving prognostic outcomes, but widely accessible screening methods are lacking. The advent of artificial intelligence-enabled electrocardiogra...BACKGROUND: Early structural heart disease (SHD) detection is crucial for improving prognostic outcomes, but widely accessible screening methods are lacking. The advent of artificial intelligence-enabled electrocardiograms (AI-ECG) and point-of-care cardiac-ultrasonography (POCCUS) offers promising new approaches for patient screening. We explored the feasibility and potential of integrating these innovative technologies into a practical SHD screening framework. METHODS: Outpatients undergoing ECG at the Mayo Clinic ECG laboratory between November 2023 and February 2024 were pragmatically offered POCCUS, performed by novice operators and reviewed by expert echocardiographers. AI-ECG and POCCUS findings were integrated to assess SHD, including reduced left ventricular systolic function (ejection-fraction<50%), aortic stenosis, and increased left ventricular wall thickness suggestive of cardiac amyloidosis or hypertrophic cardiomyopathy. Operators were blinded to patients' comorbidities and formal echocardiogram results. RESULTS: Of 486 patients (median-age 64 years; 49% women), 286 had available formal echocardiography, with 17.5% having SHD. AI-ECG had a 32% positive predictive value (PPV) and a 94% negative predictive value (NPV) to detect any SHD. Adding POCCUS increased the overall PPV to 64% with an NPV of 93%, with an increase in diagnostic accuracy from 67% to 88%. Notably, 89.5% (17/19) of the "false positives" by AI-ECG + POCCUS had less-than-moderate-SHD. Applying the AI-ECG + POCCUS screening workflow on the entire cohort resulted in a number-needed-to-screen of 8 to identify 1 patient requiring formal echocardiography. CONCLUSIONS: The integration of AI-ECG and POCCUS holds promise as a potentially effective screening method for SHD, facilitating improved patient selection for formal echocardiography.