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Dual antiplatelet therapy (DAPT) after percutaneous coronary intervention is necessary for preventing stent thrombosis and ensuring long-term cardiovascular protection. It is important to be thoughtful in balancing thrombotic and bleeding risk when deciding therapy regimen and duration. Revascularization randomized trials have studied many specific, at-risk populations; however, women remain underrepresented. Although there is evidence to support shortened DAPT duration in women, especially those at higher bleeding risk or on chronic oral anticoagulation, we need trials specifically enrolling and focusing on women.

IMPORTANCE: Pragmatic randomized clinical trials (RCTs) often use multiple data sources to examine clinical events, but the relative contribution of data sources to clinical end-point rates is understudied. OBJECTIVE: To assess the contribution of data sources (electronic health records [EHRs], public/private insurance claims, and/or participant-reported data) to clinical end points among ADAPTABLE participants who had available data. DESIGN, SETTING, AND PARTICIPANTS: The ADAPTABLE study was an open-label, pragmatic RCT from April 2016 through June 2019 conducted in research networks within clinical practice. Participants had existing atherosclerotic cardiovascular disease and available data to analyze. The characteristics of patients by combinations of data source availability were compared to examine the contribution of each of the data sources to end-point ascertainment. Data for this prespecified analysis were examined from January 2022 to June 2023. EXPOSURES: Randomized exposure to 81 mg or 325 mg of aspirin daily. MAIN OUTCOMES AND MEASURES: Number of events for the primary end point (composite of death, hospitalization for myocardial infarction, and hospitalization for stroke) that were contributed by EHR or claims data and then number of events contributed by each additional data source. RESULTS: Of 15 006 participants randomized with at least 1 other source of data available beyond participant-reported data, there were 8756 (58.3%) with participant-reported and EHR data; 4291 (28.6%) with participant-reported, EHR, and claims data; 1412 (9.4%) with EHR-only data; 262 (1.7%) with participant-reported and claims data; 202 (1.3%) with EHR and claims data; and 83 (0.6%) with claims-only data. Participants with EHR-only data were younger (median age, 63.7 years; IQR, 55.8-71.4) compared with the other groups (range, 65.6-71.9 years). Among participants with both EHR and claims data, with or without participant-reported data (n = 4493), for each outcome, most events (92%-100%) were identified in the EHR or in claims data. For all clinical end points, participant-reported data contributed less than 10% of events not otherwise available from claims or EHR data. CONCLUSIONS AND RELEVANCE: In this analysis of a pragmatic RCT, claims and EHR data provided the most clinical end-point data when compared with participant-reported events. These findings provide a framework for collecting end points in pragmatic clinical trials. Further work is needed to understand the data source combinations that most effectively provide clinical end-point data in RCTs.

The mechanisms, pathophysiology, and treatment of anemia in coronary artery disease (CAD) are complex. The hemodynamic changes found in the acute anemic state may contribute to progressive arterial wall and left ventricular hypertrophy if the anemic state persists chronically. We will examine the evidence for anemia as an independent risk factor for CAD events and cardiovascular mortality after percutaneous coronary intervention. We will also investigate the thresholds for appropriate blood transfusion in patients with CAD, as well as the cardiovascular outcomes associated with the utilization of a liberal versus conservative blood transfusion strategy. Although there is evidence supporting the use of intravenous iron replacement in patients with congestive heart failure, we will demonstrate the lack of evidence for iron replacement in patients with CAD. Finally, we will examine the evidence for increased cardiovascular mortality and venous thromboembolic events with the use of erythropoietin-stimulating agents in patients with CAD.

Introduction:Revascularization of coronary chronic total occlusions (CTOs) may be indicated for relief of medically refractory angina. Myocardial viability assessment by cardiac magnetic resonance (CMR) may help select patients for CTO intervention. Real-world practice is not well described.Methods:We identified patients who underwent coronary angiography between 2016-2020 at a large tertiary center and had ≥1 CTO. Patients with prior CABG were excluded. We examined rates of CMR and outcomes including revascularization and MACE. Myocardial segments were attributed to a CTO territory and adjudicated following angiographic review of coronary anatomy. Significant CMR viability was defined as <50% transmural delayed enhancement in the CTO territory.Results:We identified 1279 patients (74.1% male, 28.1% Black) who met inclusion criteria. Of these, 36.0% had type 2 diabetes mellitus and 54.9% reported angina pectoris. Over half of patients had CTO of the RCA (56.5%), and 18.5% of patients had CTO in >1 vessel. Non-invasive testing was performed in 38.4% of patients; 10.8% had CMR. Rates of CMR were higher in patients with severely reduced EF (≤35%) compared to those with normal EF (≥55%) (22.1% vs 11.1%; p<0.001). Among those who had CMR, 84.8% of patients showed significant viability in the CTO territory (Fig). CTO PCI was performed in 12.5% of patients, CABG was performed in 24.9%, and 63.2% were managed medically. Patients who had CTO PCI had higher rates of angina versus those without CTO PCI (70.0% vs 52.8%; p<0.001) and were more likely to be on ≥2 anti-anginal medications (30.6% vs 18.9%; p<0.001). CTO PCI technical success was achieved in 69.5% of patients and MACE occurred in 2.3% of cases.Conclusions:Patients with coronary CTOs demonstrate high rates of viability in CTO territories based on CMR. Rates of viability testing and CTO revascularization remain low. Further work is needed to determine the role of CMR and other non-invasive testing in CTO management.

Introduction:Chronic limb-threatening ischemia (CLTI) affects 1-2 million Americans yet remains understudied. Existing CLTI trials focus on endovascular procedures and surgeries, maintain strict inclusion criteria, and may not fully capture the breadth of the CLTI population. We aimed to build a robust understanding of current treatments, outcomes, quality of life, and healthcare utilization among a diverse cohort of CLTI patients from across the United States.Methods:Designed as a companion to the BEST-CLI randomized trial, the BEST-Registry will prospectively enroll >1,000 CLTI patients at 40 U.S. BEST-CLI sites and follow their clinical courses for 12 months. Though initially, only patients ineligible for BEST-CLI were to be enrolled, BEST-Registry enrollment did not begin until after BEST-CLI enrollment ended. Baseline data including demographics, medications, and available hemodynamic data are collected as well as wound care regimens, interventions, and quality of life (VASCUQOL-6, EQ-5D, and SF-12). The primary adjudicated endpoint is major adverse limb events (MALE) defined as above-ankle amputation or major revascularization. Secondary endpoints include mortality, hospitalizations, MALE-free survival, and quality of life.Results:We will present 6-month adjudicated outcomes of 534 participants. The median age is 70.0 years [IQR 62.0, 77.0] and 35% are female (Table). Documented rates of hypertension (89%), diabetes (67%) and hyperlipidemia (78%) are high at baseline. Only 46.6% of patients had hemoglobin A1c and 38.8% LDL-c lab values available within a year. However, control of these two lab values was relatively good (Table).Conclusions:Patients with CLTI enrolled in the BEST-Registry are diverse, have complex disease, many comorbidities, and receive a variety of treatments. Registry data at 6 and 12 months will provide important context for the BEST-CLI trial results and characterize contemporary management and outcomes in CLTI.

Introduction:Pragmatic randomized controlled trials (RCT) often use multiple data sources to examine clinical events, but the relative contribution of data sources (patient-reported, electronic health records (EHR), private/public claims data) to clinical endpoint rates is often not examined.Hypothesis:We hypothesized that claims data would contribute the highest number of events relative to other data sources.Methods:The ADAPTABLE study was an open-label, pragmatic RCT that demonstrated no significant difference in major cardiovascular or bleeding events among patients with CV disease randomized to an aspirin dose of 81vs. 325 mg/daily. We assessed the clinical endpoint rates and contribution of clinical endpoints by data source among patients who had EHR, public and private insurance claims data, and/or patient-reported (portal) data.Results:Of 15,076 patients randomized, there were 1,412 patients with EHR-only data; 8,756 with portal and EHR data; and 4,291 patients with portal, EHR, and claims data (Medicare or private). Patients with EHR-only data were younger (63.7 years) compared to the other groups (65.6-71.1 years); and were more likely Black (10.6%) vs. the other groups (6.3%-9.7%), p<0.001. The table demonstrates trial clinical event rates by data source among patients with available portal, EHR, and claims data. Among patients with available portal, EHR, and claims data, Medicare claims data contributed the most events for the composite endpoint (77.5%) and all-cause death (97.3%), while EHR data contributed the most events for MI (74.3%), stroke (74.3%), and major bleed (73.3%).Conclusions:In a large pragmatic trial, Medicare claims data contributed the most clinical events for the primary composite outcome and all-cause death, when compared with other available data sources. Further work is needed to understand the data source combinations that most effectively provide clinical endpoint data in RCTs.

Introduction:Patients with peripheral artery disease (PAD) are at high risk for adverse cardiovascular events, including acute myocardial infarction (AMI). Though AMI care has improved, in-hospital outcomes for patients experiencing an AMI with comorbid PAD are not well described in recent practice. We hypothesized that patients with PAD would have higher rates of bleeding and mortality during AMI hospitalization.Methods:We assessed clinical characteristics and in-hospital major bleeding and mortality rates of patients admitted with AMI and comorbid PAD at 646 hospitals in the NCDR Chest Pain MI Registry from 1/2019 to 9/2021. Major bleeding and mortality were compared for patients with vs. without PAD using multivariable logistic regression.Results:Compared with patients admitted for AMI without PAD (n = 307,550), those with PAD (n = 24,585) were older, had more comorbidities including tobacco use, diabetes, prior AMI and heart failure, and more frequently presented with NSTEMI vs. STEMI. Patients with PAD had higher crude rates of in-hospital major bleeding (9.7% vs. 6.3%) and mortality (8.1% vs. 4.7%); in exploratory analyses, rates of other adverse in-hospital events were also higher (Figure). After multivariable adjustment, PAD was associated with an increased risk of major bleeding (adjusted OR [aOR] 1.23 [95% CI 1.17-1.30]). PAD was also associated with greater risk of in-hospital mortality (aOR 1.28 [95% CI 1.21-1.37]), particularly among patients over age 65 (aOR 1.32 [95% CI 1.23-1.42] for ≥65 years vs. 1.06 [95% CI 0.96-1.18] for patients <65 years; interaction p = 0.02).Conclusions:Among patients hospitalized with AMI, those with PAD have greater comorbidity burden and increased risk of major bleeding. Patients with PAD, particularly those who are ≥65 years, also have increased risk of in-hospital death. These findings highlight a need for improved preventive efforts, tailored care pathways, and greater focus on AMI management in PAD patients.

Introduction:Reduced doses of direct oral anticoagulants (DOACs) are approved to prevent bleeding complications in specified populations of patients with non-valvular atrial fibrillation (NVAF). Little is known about the accuracy of DOAC dosing in patients with renal dysfunction.Hypothesis:We hypothesized that NVAF patients with renal dysfunction would be more likely to receive an inappropriate dose of a DOAC compared with patients with normal renal function.Methods:We examined all patients who had at least two claims for NVAF between 2015 and 2017 in the Symphony Health claims dataset. We defined under-dosing as patients treated with a reduced dose without meeting label specified criteria for dose reduction, and excess dosing as patients treated with a full dose despite meeting criteria for dose reduction. We performed a logistic regression model to measure the effect of CrCl on DOAC dosing.Results:Among 86,919 patients with NVAF and CHA2DS2-VASc>2, 12.3% were underdosed and 5.0% were excess dosed. Patients who received excess-dosed or under-dosed DOACs were older and more likely to have comorbidities such as heart failure or history of prior stroke (all p<0.001), compared with patients who were appropriately dosed. Among patients with CrCl > 60 ml/min, under-dosing occurred in 9% of patients, highest among patients treated with edoxaban (18%) and rivaroxaban (10.4%). Under-dosing rates were higher among patients with CrCl 30-59 ml/min, especially for apixaban and dabigatran (Table). Excess dosing occurred in approximately 1 in 5 patients with CrCl <30 ml/min. For every 10 unit decrease in CrCl, the odds of the patient receiving an inappropriately dosed DOAC increased by 27%.Conclusions:Incorrect DOAC dosing was observed in a substantial number of patients with NVAF in this large national study. Dosing errors occurred more frequently in patients with lower renal function, suggesting the need for efforts to improve effective and safe dosing of DOACs.

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Background:Patients with PAD have a high risk of future cardiovascular (CVD) events and mortality. Little is known about the changes in clinical disease stage over time in PAD patients, and the association of changes in clinical disease stage with subsequent CVD events.Methods:In this analysis of the EUCLID (Examining Use of Ticagrelor in Symptomatic PAD) trial, we examined the changes in Rutherford classification* of 12,759 trial patients over 12 months. We examined the baseline characteristics of patients by change in classification at 12 months (?improved?=decreased Rutherford classification, ?no change?, or ?worsened?=increased Rutherford classification), as well as the association between clinical disease stage changes at 12 months and subsequent CVD events**.Results:Among 12,759 trial patients, 3,240 patients were classified as improved by Rutherford classification at 12 months, 8,132 as no change, and 1,387 as worsened. At 12 months, the majority of patients who were asymptomatic or had mild/moderate claudication at enrollment had no change in clinical disease stage, while over half of patients with severe claudication/pain at rest had improved clinical disease stage. Patients who worsened over 12 months were more likely to have comorbidities (diabetes, prior PCI or MI) and more events (MI, amputation, and major bleeding) by 12 months post-randomization, all p<0.001. Worsened clinical stage of disease was associated with an increased risk of all-cause death, major amputation, and a composite of CV death, MI or stroke, p<0.05 after 12 months post-randomization (Table).Discussion:Patients with comorbid conditions and prior history of CVD events at baseline and within the first 12 months of the trial were more likely to have worsening clinical disease stage at 12 months. Worsening clinical disease stage is associated with an increased risk of all-cause death, amputation, and a composite of CV death, MI, or stroke from 12 months post randomization.

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Background:Anticoagulation rates remain suboptimal for patients with atrial fibrillation (AF). Although these rates could potentially be improved with performance measures, there is no universal algorithm for identifying AF patients at risk for stroke using the electronic medical record.

Background:While academic hospitals are more likely to apply evidence-based therapies in-hospital for patients with non-ST elevation myocardial infarction (NSTEMI) than non-academic hospitals, differences in post-discharge persistence of evidence-based medications have never been evaluated.