Low-Dose Rivaroxaban Plus Aspirin in Fragile Patients After Lower Extremity Revascularization.

BACKGROUND: Rivaroxaban 2.5 mg plus aspirin reduced limb and cardiovascular events and increased bleeding in patients with symptomatic peripheral artery disease (PAD) after lower extremity revascularization in the VOYAGER PAD (Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities) study. Fragile patients are at heightened risk for ischemic and bleeding events. OBJECTIVES: The purpose of this study was to investigate the safety and efficacy of rivaroxaban 2.5 mg in fragile patients from VOYAGER PAD. METHODS: Patients were categorized as fragile based on prespecified criteria (age >75 years, weight ≤50 kg, or baseline estimated glomerular filtration rate <50 mL/min/1.73 m2). The primary efficacy outcome was the composite of acute limb ischemia, major amputation of a vascular etiology, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was TIMI major bleeding. RESULTS: Of 6,564 randomized patients, a total of 1,674 subjects were categorized as fragile at baseline. In the placebo arm, fragile patients were at higher risk of the primary outcome (HR: 1.34; 95% CI: 1.12-1.61) and TIMI major bleeding (HR: 1.57; 95% CI: 0.83-2.96), compared with nonfragile patients. The effect of rivaroxaban on the primary endpoint was not modified by frailty status (fragile HR: 0.93; 95% CI: 0.75-1.15; nonfragile HR: 0.83; 95% CI: 0.72-0.97; P interaction = 0.37). Rivaroxaban increased TIMI major bleeding in fragile (HR: 1.54; 95% CI: 0.82-2.91) and nonfragile patients (HR: 1.37; 95% CI: 0.84-2.23; P interaction = 0.65). CONCLUSIONS: Patients with PAD after lower extremity revascularization meeting fragile criteria are at higher risk of ischemic complications and bleeding. Rivaroxaban reduces ischemic risk and increases bleeding regardless of frailty status. These data may assist in personalization of antithrombotic therapy in fragile population.

Neighborhood Socioeconomic Disadvantage and 30-Day Outcomes for Common Cardiovascular Conditions.

BACKGROUND: Understanding the relationship between neighborhood environment and cardiovascular outcomes is important to achieve health equity and implement effective quality strategies. We conducted a population-based cohort study to determine the association of neighborhood socioeconomic deprivation and 30-day mortality and readmission rate for patients admitted with common cardiovascular conditions. METHODS AND RESULTS: We examined claims data from fee-for-service Medicare beneficiaries aged ≥65 years between 2017 and 2019 admitted for heart failure, valvular heart disease, ischemic heart disease, or cardiac arrhythmias. The primary exposure was the Area Deprivation Index; outcomes were 30-day all-cause death and unplanned readmission. More than 2 million admissions were included. After sequential adjustment for patient characteristics (demographics, dual eligibility, comorbidities), area health care resources (primary care clinicians, specialists, and hospital beds per capita), and admitting hospital characteristics (ownership, size, teaching status), there was a dose-dependent association between neighborhood socioeconomic deprivation and 30-day mortality rate for all conditions. In the fully adjusted model for death, estimated effect sizes of residence in the most disadvantaged versus least disadvantaged neighborhoods ranged from adjusted odds ratio 1.29 (95% CI, 1.22-1.36) for the heart failure group to adjusted odds ratio 1.63 (95% CI, 1.36-1.95) for the valvular heart disease group. Neighborhood deprivation was associated with increased adjusted 30-day readmission rates, with estimated effect sizes from adjusted odds ratio 1.09 (95% CI, 1.05-1.14) for heart failure to adjusted odds ratio 1.19 (95% CI, 1.13-1.26) for arrhythmia. CONCLUSIONS: Neighborhood socioeconomic disadvantage was associated with 30-day mortality rate and readmission for patients admitted with common cardiovascular conditions independent of individual demographics, socioeconomic status, medical risk, care access, or admitting hospital characteristics.

Feasibility of a Novel Augmented 6-Minute Incremental Step Test: A Simplified Cardiorespiratory Fitness Assessment Tool.

Background: The cardiopulmonary exercise test (CPET) is considered a gold standard in assessing cardiorespiratory fitness (CRF) but has limited accessibility due to competency requirements and cost. Incorporating portable sensor devices into a simple bedside test of CRF could improve diagnostic and prognostic value. Objectives: The authors sought to evaluate the association of an augmented 6-minute incremental step test (6MIST) with standard CPET. Methods: We enrolled patients undergoing clinically indicated supine cycle ergometry CPET with invasive hemodynamics (iCPET) for the same-day 6MIST. CRF-related variables were simultaneously recorded using a signal morphology-based impedance cardiograph (PhysioFlow Enduro) and a portable metabolic analyzer (VO2 Master Pro) during incremental pace stationary stepping. The correlation between CPET and hemodynamic parameters from both tests was assessed using the intraclass correlation coefficient (ICC). Results: Fifteen patients (mean age 60 ± 14 years, 40% female, 27% Black) were included. All patients who agreed to undergo 6MIST completed the study without any test-related adverse events. We observed good to excellent correlation between iCPET- and 6MIST-measured CPET parameters: peak heart rate (ICC = 0.60; 95% CI: 0.15-0.85), absolute peak O2 consumption (VO2) (ICC = 0.77; 95% CI: 0.44-0.92), relative peak VO2 (ICC = 0.64; 95% CI: 0.20-0.86), maximum ventilation (ICC = 0.59; 95% CI: 0.13-0.84), O2 pulse (ICC = 0.71; 95% CI: 0.33-0.89), and cardiorespiratory optimal point (ICC = 0.82; 95% CI: 0.52-0.94). No significant correlation was determined between iCPET and 6MIST in measuring cardiac index at rest (ICC = 0.19; 95% CI: -0.34 to 0.63) or at peak exercise (ICC = 0.36; 95% CI: -0.17 to 0.73). Conclusions: We demonstrate the feasibility of a novel augmented 6MIST with wearable devices for simultaneous CPET and hemodynamic assessment. 6MIST-measured CPET parameters were strongly correlated with the iCPET-derived measurements. Additional studies are needed to confirm the validity of the 6MIST compared to standard upright CPET.

Left Ventricular Unloading Using Intra-Aortic Entrainment Pumping Before Reperfusion Reduces Post-AMI Infarct Size.

BACKGROUND: Anterior myocardial infarction standard of care prioritizes swift coronary reperfusion. Recent studies show left ventricular (LV) unloading with transvalvular axial-flow pumps for 30 minutes before reperfusion (versus immediate reperfusion) reduces 28-day infarct size. Intra-aortic entrainment pumping, using hardware located away from the heart to provide support throughout the cardiac cycle, reduce effective systemic vascular resistance, and augment visceral blood flow and pressure, may reproduce this benefit with reduced risk. This study characterized hemodynamic effects of unloading before and during reperfusion using intra-aortic entrainment pumping and investigated whether unloading reduced anterior myocardial infarction (AMI) scar size. METHODS AND RESULTS: Yorkshire swine were subjected to 90 minutes of left anterior descending artery balloon occlusion and randomly assigned to immediate reperfusion (n=6) versus 30 minutes unloading before reperfusion followed by 120 minutes further unloading (n=7). Unloading was achieved using percutaneous entrainment pumping in the descending aorta. The AMI model matches that used in recent transvalvular pumping studies. Mortality before randomization was 22%. After randomization, mortality was 36% for immediate reperfusion and 0% for unloading. Unloading showed immediate hemodynamic benefit that increased through reperfusion and continued support, leading to distinct differences in cardiac function between groups after 30 minutes of reperfusion. Unloading increased stroke volume and cardiac efficiency at this timepoint relative to pre-occlusion baseline and reduced 28-day LV scar size by 37-45%. CONCLUSIONS: We present the first preclinical data showing extra-cardiac LV unloading before coronary reperfusion using intra-aortic entrainment pumping decreases 28-day infarct size. Extra-cardiac unloading to reduce LV scar size may provide an alternative to transvalvular pumping with potential advantages including reduced risk.

Effect of Peripheral Interventions in Patients with Peripheral Artery Disease Receiving Rivaroxaban and Aspirin: Analyses from the XATOA Registry.

OBJECTIVE: To assess the characteristics and clinical outcomes of patients with lower extremity peripheral artery disease (PAD) in XATOA receiving dual pathway inhibition (DPI) with rivaroxaban 2.5 mg twice daily plus aspirin according to lower extremity revascularisation (LER) history. METHODS: XATOA is an international, multicentre, prospective, single arm registry study. This subanalysis investigated patients with lower extremity PAD according to LER history. Patients with coronary artery disease, PAD, or both, receiving DPI were followed for 12 or more months. Baseline characteristics and clinical outcomes were assessed according to LER history. A time dependency analysis assessed outcomes by time between the most recent LER procedure and the start of DPI. A multivariate analysis assessed the influence of patient characteristics on clinical outcomes. RESULTS: In XATOA (n = 5 532), 2 820 (51.0%) patients had lower extremity PAD, of whom 1 736 (61.6%) had prior LER and 1 084 (38.4%) had no prior LER. Baseline characteristics were generally similar between patients with or without prior LER. A higher proportion of patients with prior LER experienced any treatment emergent clinical events compared with those without prior LER (15.0% vs. 9.4%, respectively), with greater differences observed between incidence rates of limb events, including major adverse limb events (9.06 vs. 4.09 events per 100 patient years, respectively). Similar rates of myocardial infarction, stroke, and major bleeding were observed in both subgroups. Clinical event rates were generally higher in patients who had previous LER for six months or less compared with patients who had previous LET for more than six months before starting DPI, regardless of LER type. Multivariate analyses showed that prior LER was predictive of limb events. CONCLUSION: This subanalysis of XATOA found that prior LER was associated with increased rates of limb events, consistent with results of COMPASS and VOYAGER PAD. Rates of bleeding were also low regardless of LER history and consistent with the findings from these trials.

Completeness of revascularization by FFRCT in stable angina: Association to adverse cardiovascular outcomes.

BACKGROUND: The prognostic impact of complete coronary revascularization relative to non-invasive testing methods is unknown. OBJECTIVES: To assess the association between completeness of revascularization defined by CTA-derived fractional flow reserve (FFRCT) and cardiovascular outcomes in patients with stable angina. METHODS: Multicenter 3-year follow-up study of patients with new onset stable angina and ≥ 30% stenosis by CTA. The lesion-specific FFRCT value (two cm-distal-to-stenosis) was registered in all vessels with stenosis and considered abnormal when ≤ 0.80. Patients with FFRCT ≤ 0.80 were categorized as: Completely revascularized (CR-FFRCT), all vessels with FFRCT ≤ 0.80 revascularized; incompletely revascularized (IR-FFRCT), ≥ 1 vessels with FFRCT ≤ 0.80 non-revascularized. Early revascularization (< 90 days from index CTA) categorized vessels as revascularized. The primary endpoint comprised cardiovascular death and non-fatal myocardial infarction; the secondary endpoint vessel-specific late revascularization and non-fatal myocardial infarction. RESULTS: Amongst 900 patients and 1759 vessels, FFRCT was ≤ 0.80 in 377 (42%) patients, 536 (30%) vessels; revascularization was performed in 244 (27%) patients, 340 (19%) vessels. Risk of the primary endpoint was higher for IR-FFRCT (15/210 [7.1%]) compared to CR-FFRCT (4/167 [2.4%]), RR: 2.98; 95% CI: 1.01-8.8, p â€‹= â€‹0.036, and to normal FFRCT (3/523 [0.6%]), RR: 12.45; 95% CI: 3.6-42.6, p â€‹< â€‹0.001. Incidence of the secondary endpoint was higher in non-revascularized vessels with FFRCT ≤ 0.80 (29/250 [12%]) compared to revascularized vessels with FFRCT ≤ 0.80 (5/286 [1.7%]), p â€‹= â€‹0.001, and to vessels with FFRCT > 0.80 (10/1223 [0.8%]), p â€‹< â€‹0.001. CONCLUSION: Incomplete revascularization of patients with lesion-specific FFRCT ≤ 0.80 is associated to unfavorable cardiovascular outcomes compared to those with complete revascularization or FFRCT > 0.80.

Diagnostic Performance of Coronary Angiography Derived Computational Fractional Flow Reserve.

BACKGROUND: Computational fluid dynamics can compute fractional flow reserve (FFR) accurately. However, existing models are limited by either the intravascular hemodynamic phenomarkers that can be captured or the fidelity of geometries that can be modeled. METHODS AND RESULTS: This study aimed to validate a new coronary angiography-based FFR framework, FFRHARVEY, and examine intravascular hemodynamics to identify new biomarkers that could augment FFR in discerning unrevascularized patients requiring intervention. A 2-center cohort was used to examine diagnostic performance of FFRHARVEY compared with reference wire-based FFR (FFRINVASIVE). Additional biomarkers, longitudinal vorticity, velocity, and wall shear stress, were evaluated for their ability to augment FFR and indicate major adverse cardiac events. A total of 160 patients with 166 lesions were investigated. FFRHARVEY was compared with FFRINVASIVE by investigators blinded to the invasive FFR results with a per-stenosis area under the curve of 0.91, positive predictive value of 90.2%, negative predictive value of 89.6%, sensitivity of 79.3%, and specificity of 95.4%. The percentage ofdiscrepancy for continuous values of FFR was 6.63%. We identified a hemodynamic phenomarker, longitudinal vorticity, as a metric indicative of major adverse cardiac events in unrevascularized gray-zone cases. CONCLUSIONS: FFRHARVEY had high performance (area under the curve: 0.91, positive predictive value: 90.2%, negative predictive value: 89.6%) compared with FFRINVASIVE. The proposed framework provides a robust and accurate way to compute a complete set of intravascular phenomarkers, in which longitudinal vorticity was specifically shown to differentiate vessels predisposed to major adverse cardiac events.

Empowering US healthcare delivery organizations: Cultivating a community of practice to harness AI and advance health equity.

Healthcare delivery organizations (HDOs) in the US must contend with the potential for AI to worsen health inequities. But there is no standard set of procedures for HDOs to adopt to navigate these challenges. There is an urgent need for HDOs to present a unified approach to proactively address the potential for AI to worsen health inequities. Amidst this background, Health AI Partnership (HAIP) launched a community of practice to convene stakeholders from across HDOs to tackle challenges related to the use of AI. On February 15, 2023, HAIP hosted an inaugural workshop focused on the question, "Our health care delivery setting is considering adopting a new solution that uses AI. How do we assess the potential future impact on health inequities?" This topic emerged as a common challenge faced by all HDOs participating in HAIP. The workshop had 2 main goals. First, we wanted to ensure participants could talk openly without reservations about challenging topics such as health equity. The second goal was to develop an actionable, generalizable framework that could be immediately put into practice. The workshop engaged 77 participants with 100% representation from all 10 HDOs and invited ecosystem partners. In an accompanying Research Article, we share the Health Equity Across the AI Lifecycle (HEAAL) framework. We invite and encourage HDOs to test the HEAAL framework internally and share feedback so that we can continue to refine and maintain the set of procedures. The HEAAL framework reveals the challenges associated with rigorously assessing the potential for AI to worsen health inequities. Significant investment in personnel, capabilities, and data infrastructure is required, and the level of investment needed could be beyond reach for most HDOs. We look forward to expanding our community of practice to assist HDOs around the world.

Assessment of Days Alive Out of Hospital as a Possible End Point in Trials of Stroke Prevention for Atrial Fibrillation: A ROCKET AF Analysis.

BACKGROUND: Days alive out of hospital (DAOH) is an objective and patient-centered net benefit end point. There are no assessments of DAOH in clinical trials of interventions for atrial fibrillation (AF), and it is not known whether this end point is of clinical utility in these populations. METHODS AND RESULTS: ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) was an international double-blind, double-dummy randomized clinical trial that compared rivaroxaban with warfarin in patients with atrial fibrillation at increased risk for stroke. We assessed DAOH using investigator-reported event data for up to 12 months after randomization in ROCKET AF. We assessed DAOH overall, by treatment group, and by subgroup, including age, sex, and comorbidities, using Poisson regression. The mean±SD number of days dead was 7.3±41.2, days hospitalized was 1.2±7.2, and mean DAOH was 350.7±56.2, with notable left skew. Patients with comorbidities had fewer DAOH overall. There were no differences in DAOH by treatment arm, with mean DAOH of 350.6±56.5 for those randomized to rivaroxaban and 350.7±55.8 for those randomized to warfarin (P=0.86). A sensitivity analysis found no difference in DAOH not disabled with rivaroxaban versus warfarin (DAOH not disabled, 349.2±59.5 days and 349.1 days±59.3 days, respectively, P=0.88). CONCLUSIONS: DAOH did not identify a treatment difference between patients randomized to rivaroxaban versus warfarin. This may be driven in part by the low overall event rates in atrial fibrillation anticoagulation trials, which leads to substantial left skew in measures of DAOH.

Development and preliminary testing of Health Equity Across the AI Lifecycle (HEAAL): A framework for healthcare delivery organizations to mitigate the risk of AI solutions worsening health inequities.

The use of data-driven technologies such as Artificial Intelligence (AI) and Machine Learning (ML) is growing in healthcare. However, the proliferation of healthcare AI tools has outpaced regulatory frameworks, accountability measures, and governance standards to ensure safe, effective, and equitable use. To address these gaps and tackle a common challenge faced by healthcare delivery organizations, a case-based workshop was organized, and a framework was developed to evaluate the potential impact of implementing an AI solution on health equity. The Health Equity Across the AI Lifecycle (HEAAL) is co-designed with extensive engagement of clinical, operational, technical, and regulatory leaders across healthcare delivery organizations and ecosystem partners in the US. It assesses 5 equity assessment domains-accountability, fairness, fitness for purpose, reliability and validity, and transparency-across the span of eight key decision points in the AI adoption lifecycle. It is a process-oriented framework containing 37 step-by-step procedures for evaluating an existing AI solution and 34 procedures for evaluating a new AI solution in total. Within each procedure, it identifies relevant key stakeholders and data sources used to conduct the procedure. HEAAL guides how healthcare delivery organizations may mitigate the potential risk of AI solutions worsening health inequities. It also informs how much resources and support are required to assess the potential impact of AI solutions on health inequities.

Framework of the strengths and challenges of clinically integrated trials: An expert panel report.

The limitations of the explanatory clinical trial framework include the high expense of implementing explanatory trials, restrictive entry criteria for participants, and redundant logistical processes. These limitations can result in slow evidence generation that is not responsive to population health needs, yielding evidence that is not generalizable. Clinically integrated trials, which integrate clinical research into routine care, represent a potential solution to this challenge and an opportunity to support learning health systems. The operational and design features of clinically integrated trials include a focused scope, simplicity in design and requirements, the leveraging of existing data structures, and patient participation in the entire trial process. These features are designed to minimize barriers to participation and trial execution and reduce additional research burdens for participants and clinicians alike. Broad adoption and scalability of clinically integrated trials are dependent, in part, on continuing regulatory, healthcare system, and payer support. This analysis presents a framework of the strengths and challenges of clinically integrated trials and is based on a multidisciplinary expert "Think Tank" panel discussion that included representatives from patient populations, academia, non-profit funding agencies, the U.S. Food and Drug Administration, and industry.

LXR signaling pathways link cholesterol metabolism with risk for prediabetes and diabetes.

BACKGROUNDPreclinical studies suggest that cholesterol accumulation leads to insulin resistance. We previously reported that alterations in a monocyte cholesterol metabolism transcriptional network (CMTN) - suggestive of cellular cholesterol accumulation - were cross-sectionally associated with obesity and type 2 diabetes (T2D). Here, we sought to determine whether the CMTN alterations independently predict incident prediabetes/T2D risk, and correlate with cellular cholesterol accumulation.METHODSMonocyte mRNA expression of 11 CMTN genes was quantified among 934 Multi-Ethnic Study of Atherosclerosis (MESA) participants free of prediabetes/T2D; cellular cholesterol was measured in a subset of 24 monocyte samples.RESULTSDuring a median 6-year follow-up, lower expression of 3 highly correlated LXR target genes - ABCG1 and ABCA1 (cholesterol efflux) and MYLIP (cholesterol uptake suppression) - and not other CMTN genes, was significantly associated with higher risk of incident prediabetes/T2D. Lower expression of the LXR target genes correlated with higher cellular cholesterol levels (e.g., 47% of variance in cellular total cholesterol explained by ABCG1 expression). Further, adding the LXR target genes to overweight/obesity and other known predictors significantly improved prediction of incident prediabetes/T2D.CONCLUSIONThese data suggest that the aberrant LXR/ABCG1-ABCA1-MYLIP pathway (LAAMP) is a major T2D risk factor and support a potential role for aberrant LAAMP and cellular cholesterol accumulation in diabetogenesis.FUNDINGThe MESA Epigenomics and Transcriptomics Studies were funded by NIH grants 1R01HL101250, 1RF1AG054474, R01HL126477, R01DK101921, and R01HL135009. This work was supported by funding from NIDDK R01DK103531 and NHLBI R01HL119962.

Frameworks for procurement, integration, monitoring, and evaluation of artificial intelligence tools in clinical settings: A systematic review.

Research on the applications of artificial intelligence (AI) tools in medicine has increased exponentially over the last few years but its implementation in clinical practice has not seen a commensurate increase with a lack of consensus on implementing and maintaining such tools. This systematic review aims to summarize frameworks focusing on procuring, implementing, monitoring, and evaluating AI tools in clinical practice. A comprehensive literature search, following PRSIMA guidelines was performed on MEDLINE, Wiley Cochrane, Scopus, and EBSCO databases, to identify and include articles recommending practices, frameworks or guidelines for AI procurement, integration, monitoring, and evaluation. From the included articles, data regarding study aim, use of a framework, rationale of the framework, details regarding AI implementation involving procurement, integration, monitoring, and evaluation were extracted. The extracted details were then mapped on to the Donabedian Plan, Do, Study, Act cycle domains. The search yielded 17,537 unique articles, out of which 47 were evaluated for inclusion based on their full texts and 25 articles were included in the review. Common themes extracted included transparency, feasibility of operation within existing workflows, integrating into existing workflows, validation of the tool using predefined performance indicators and improving the algorithm and/or adjusting the tool to improve performance. Among the four domains (Plan, Do, Study, Act) the most common domain was Plan (84%, n = 21), followed by Study (60%, n = 15), Do (52%, n = 13), & Act (24%, n = 6). Among 172 authors, only 1 (0.6%) was from a low-income country (LIC) and 2 (1.2%) were from lower-middle-income countries (LMICs). Healthcare professionals cite the implementation of AI tools within clinical settings as challenging owing to low levels of evidence focusing on integration in the Do and Act domains. The current healthcare AI landscape calls for increased data sharing and knowledge translation to facilitate common goals and reap maximum clinical benefit.

The algorithm journey map: a tangible approach to implementing AI solutions in healthcare.

When integrating AI tools in healthcare settings, complex interactions between technologies and primary users are not always fully understood or visible. This deficient and ambiguous understanding hampers attempts by healthcare organizations to adopt AI/ML, and it also creates new challenges for researchers to identify opportunities for simplifying adoption and developing best practices for the use of AI-based solutions. Our study fills this gap by documenting the process of designing, building, and maintaining an AI solution called SepsisWatch at Duke University Health System. We conducted 20 interviews with the team of engineers and scientists that led the multi-year effort to build the tool, integrate it into practice, and maintain the solution. This "Algorithm Journey Map" enumerates all social and technical activities throughout the AI solution's procurement, development, integration, and full lifecycle management. In addition to mapping the "who?" and "what?" of the adoption of the AI tool, we also show several 'lessons learned' throughout the algorithm journey maps including modeling assumptions, stakeholder inclusion, and organizational structure. In doing so, we identify generalizable insights about how to recognize and navigate barriers to AI/ML adoption in healthcare settings. We expect that this effort will further the development of best practices for operationalizing and sustaining ethical principles-in algorithmic systems.

Hypertension, microvascular obstruction and infarct size in patients with STEMI undergoing PCI: Pooled analysis from 7 cardiac magnetic resonance imaging studies.

BACKGROUND: Mortality after ST-segment elevation myocardial infarction (STEMI) is increased in patients with hypertension. The mechanisms underlying this association are uncertain. We sought to investigate whether patients with STEMI and prior hypertension have greater microvascular obstruction (MVO) and infarct size (IS) compared with those without hypertension. METHODS: We pooled individual patient data from 7 randomized trials of patients with STEMI undergoing primary percutaneous coronary intervention (PCI) in whom cardiac magnetic resonance imaging was performed within 1 month after reperfusion. The associations between hypertension and MVO, IS, and mortality were assessed in multivariable adjusted models. RESULTS: Among 2174 patients (61.3 ± 12.6 years, 76% male), 1196 (55.0%) had hypertension. Patients with hypertension were older, more frequently diabetic and had more extensive coronary artery disease than those without hypertension. MVO and IS measured as percent LV mass were not significantly different in patients with and without hypertension (adjusted differences 0.1, 95% CI -0.3 to 0.6, P = .61 and -0.2, 95% CI -1.5 to 1.2, P = .80, respectively). Hypertension was associated with a higher unadjusted risk of 1-year death (hazard ratio [HR] 2.28, 95% CI 1.44-3.60, P < .001), but was not independently associated with higher mortality after multivariable adjustment (adjusted HR 1.04, 95% CI 0.60-1.79, P = .90). CONCLUSION: In this large-scale individual patient data pooled analysis, hypertension was not associated with larger IS or MVO after primary PCI for STEMI.

Impact of Smoking on Coronary Volume-to-Myocardial Mass Ratio: An ADVANCE Registry Substudy.

Purpose To examine the relationship between smoking status and coronary volume-to-myocardial mass ratio (V/M) among individuals with coronary artery disease (CAD) undergoing CT fractional flow reserve (CT-FFR) analysis. Materials and Methods In this secondary analysis, participants from the ADVANCE registry evaluated for suspected CAD from July 15, 2015, to October 20, 2017, who were found to have coronary stenosis of 30% or greater at coronary CT angiography (CCTA) were included if they had known smoking status and underwent CT-FFR and V/M analysis. CCTA images were segmented to calculate coronary volume and myocardial mass. V/M was compared between smoking groups, and predictors of low V/M were determined. Results The sample for analysis included 503 current smokers, 1060 former smokers, and 1311 never-smokers (2874 participants; 1906 male participants). After adjustment for demographic and clinical factors, former smokers had greater coronary volume than never-smokers (former smokers, 3021.7 mm3 ± 934.0 [SD]; never-smokers, 2967.6 mm3 ± 978.0; P = .002), while current smokers had increased myocardial mass compared with never-smokers (current smokers, 127.8 g ± 32.9; never-smokers, 118.0 g ± 32.5; P = .02). However, both current and former smokers had lower V/M than never-smokers (current smokers, 24.1 mm3/g ± 7.9; former smokers, 24.9 mm3/g ± 7.1; never-smokers, 25.8 mm3/g ± 7.4; P < .001 [unadjusted] and P = .002 [unadjusted], respectively). Current smoking status (odds ratio [OR], 0.74 [95% CI: 0.59, 0.93]; P = .009), former smoking status (OR, 0.81 [95% CI: 0.68, 0.97]; P = .02), stenosis of 50% or greater (OR, 0.62 [95% CI: 0.52, 0.74]; P < .001), and diabetes (OR, 0.67 [95% CI: 0.56, 0.82]; P < .001) were independent predictors of low V/M. Conclusion Both current and former smoking status were independently associated with low V/M. Keywords: CT Angiography, Cardiac, Heart, Ischemia/Infarction Clinical trial registration no. NCT02499679 Supplemental material is available for this article. © RSNA, 2024.