AIM:In patients with prior myocardial infarction (MI) on aspirin, the addition of ticagrelor reduces ischaemic risk but increases bleeding risk. The simultaneous assessment of baseline ischaemic and bleeding risk may assist clinicians in selecting patients who are most likely to have a favourable risk/benefit profile with long-term ticagrelor.METHODS AND RESULTS:PEGASUS-TIMI 54 randomized 21 162 prior MI patients, 13 956 of which to the approved 60 mg dose or placebo and who had all necessary data. The primary efficacy endpoint was cardiovascular death, MI, or stroke, and the primary safety outcome was TIMI major bleeding; differences in Kaplan-Meier event rates at 3 years are presented. Post-hoc subgroups based on predictors of bleeding and ischaemic risk were merged into a selection algorithm. Patients were divided into four groups: those with a bleeding predictor (n = 2721, 19%) and then those without a bleeding predictor and either 0-1 ischaemic risk factor (IRF; n = 3004, 22%), 2 IRF (n = 4903, 35%), or ≥3 IRF (n = 3328, 24%). In patients at high bleeding risk, ticagrelor increased bleeding [absolute risk difference (ARD) +2.3%, 95% confidence interval (CI) 0.6, 3.9] and did not reduce the primary efficacy endpoint (ARD +0.08%, 95% CI -2.4 to 2.5). In patients at low bleeding risk, the ARDs in the primary efficacy endpoint with ticagrelor were -0.5% (-2.2, 1.3), -1.5% (-3.1, 0.02), and -2.6% (-5.0, -0.24, P = 0.03) in those with ≤1, 2, and 3 risk factors, respectively (P = 0.076 for trend across groups). There were significant trends for greater absolute risk reductions for cardiovascular death (P-trend 0.018), all-cause mortality (P-trend 0.027), and net outcomes (P-trend 0.037) with ticagrelor across these risk groups.CONCLUSION:In a post-hoc exploratory analysis of patients with prior MI, long-term ticagrelor therapy appears to be best suited for those with prior MI with multiple IRFs at low bleeding risk.CLINICAL TRIAL REGISTRATION:NCT01225562 ClinicalTrials.gov.

OBJECTIVES:There are limited data on bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) with positive biomarkers of myocardial necrosis (troponin and/or creatine kinase-myocardial band isoenzyme). We sought to evaluate the safety and efficacy of bivalirudin monotherapy in patients with positive biomarkers from the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial.PATIENTS AND METHODS:We compared the net adverse clinical events [composite ischemia - (death, myocardial infarction, or unplanned ischemic revascularization) - or noncoronary artery bypass graft surgery (CABG)-related major bleeding] among patients with biomarker-positive NSTE-ACS in the ACUITY trial overall and by antithrombotic strategy.RESULTS:Among 13 819 patients with NSTE-ACS enrolled in ACUITY, 4728 patients presented with positive biomarkers and underwent an early invasive strategy. Of those, 1547 were randomized to heparin plus a glycoprotein IIb/IIIa inhibitor (GPI), 1555 to bivalirudin plus GPI, and 1626 to bivalirudin monotherapy. Compared with biomarker-negative patients, biomarker-positive patients had higher 30-day rates of net adverse clinical events (14.0 vs. 12.4%; P = 0.04), all-cause death (1.3 vs. 0.5%; P = 0.001), cardiac death (1.1 vs. 0.5%; P = 0.005), and non-CABG-related major bleeding (6.5 vs. 5.2%, P = 0.03). At 30 days, bivalirudin monotherapy was associated with significantly less non-CABG-related major bleeding (bivalirudin monotherapy 4.1% vs. bivalirudin plus GPI 8.4% vs. heparin plus GPI 7.1%) with comparable rates of composite ischemia (bivalirudin monotherapy 9.2% vs. bivalirudin plus GPI 9.9% vs. heparin plus GPI 8.4%). In a multivariable model, bivalirudin monotherapy was associated with a significant reduction in non-CABG-related major bleeding but was not associated with an increased risk of death, myocardial infarction, unplanned revascularization or stent thrombosis.CONCLUSION:Compared with heparin plus GPI or bivalirudin plus GPI, bivalirudin monotherapy provides similar protection from ischemic events with less major bleeding at 30 days among patients with NSTE-ACS and positive biomarkers.

SESSION TITLE: Pulmonary Vascular Disease Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: October 18-21, 2020 PURPOSE: The Registry to Evaluate Early and Long-term Pulmonary Arterial Hypertension (PAH) Disease Management (REVEAL) risk score (RRS) 1.0 and refined RRS 2.0 were developed to predict survival in patients with PAH. To facilitate clinical use, the abridged RRS Lite 1, excluding invasive variables, was developed. This was further refined, excluding non-modifiable variables, to RRS Lite 2. This post hoc analysis compared the four RRS in the 12-week placebo-controlled PATENT-1 study of riociguat (NCT00810693) and assessed predictive accuracy for 1-year long-term outcomes in PATENT-2, the long-term open-label follow-up (NCT00863681). METHODS: RRS 1.0, RRS 2.0, RRS Lite 1, and RRS Lite 2 were calculated for patients receiving either riociguat 2.5 mg three times a day (tid) , 1.5 mg tid–maximum, or placebo at PATENT-1 baseline (BL) and Week 12 (Wk 12). Only patients enrolled in PATENT-2 were included. Predictive accuracy of each RRS for mortality and clinical worsening (CW) at 1 year were compared using receiver operator curve analyses and estimates of C-indices. RESULTS: Data were available for 396 patients who entered PATENT-2. At BL, the four RRS showed almost complete overlap, with most patients having RRS between 4–9. At Wk 12, RRS still overlapped, but were skewed toward lower risk scores due to a reduction of risk in patients treated with riociguat. The majority of RRS were between 3–7. One year after starting PATENT-2, 12 (3%) patients had died. There were few differences between the RRS in prediction of a mortality event. Using BL RRS, C-indices (95% confidence interval) were: RRS 1.0, 0.61 (0.46–0.77); RRS 2.0, 0.58 (0.44–0.72); RRS Lite 1, 0.57 (0.42–0.71); and RRS Lite 2, 0.57 (0.41–0.72). Using Wk 12 RRS, the C-indices were: RRS 1.0, 0.64 (0.51–0.78); RRS 2.0, 0.67 (0.54–0.80); RRS Lite 1, 0.66 (0.53–0.79); and RRS Lite 2, 0.67 (0.54–0.80). After 1 year in PATENT-2, 45 patients (11%) experienced CW. Using BL RRS, C-indices for the four RRS showed similar predictive accuracy: RRS 1.0, 0.67 (0.59–0.76); RRS 2.0, 0.67 (0.58–0.75); RRS Lite 1, 0.66 (0.57–0.75); and RRS Lite 2, 0.67 (0.58–0.76). Using Wk 12 RRS, predictive accuracy was also comparable: RRS 1.0, 0.73 (0.64–0.81); RRS 2.0, 0.75 (0.67–0.83); RRS Lite 1, 0.73 (0.65–0.81); and RRS Lite 2, 0.74 (0.66–0.82). CONCLUSIONS: All RRS confirmed risk decreased from BL to Wk 12 in patients treated with riociguat in PATENT-1. Increased predictive accuracy of Wk 12 RRS highlights the importance of follow-up risk evaluations throughout patient management. Prediction of risk of death or CW was similar across calculators, although further analyses are required in larger patient cohorts with more events. CLINICAL IMPLICATIONS: Despite having fewer variables and excluding invasive variables, the Lite calculators appear to have similar utility in risk prediction compared with the full RRS calculators. DISCLOSURES: Employee relationship with Bayer US LLC Please note: >$100000 Added 06/01/2020 by Sameer Bansilal, source=Web Response, value=Salary No relevant relationships by Raymond Benza, source=Web Response No relevant relationships by Athénaïs Boucly, source=Web Response Advisory Committee Member relationship with Actelion Please note: $1001 - $5000 by Harrison Farber, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Actelion Please note: $1001 - $5000 by Harrison Farber, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Bayer Please note: $5001 - $20000 by Harrison Farber, source=Web Response, value=Honoraria Advisory Committee Member relationship with Arena Please note: $5001 - $20000 by Harrison Farber, source=Web Response, value=Consulting fee Removed 04/28/2020 by Harrison Farber, source=Web Response Advisory Committee Member relationship with United Therapeutics Please note: $5001 - $20000 by Harrison Farber, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Bellerophon Please note: $1-$1000 by Harrison Farber, source=Web Response, value=Consulting fee Removed 04/28/2020 by Harrison Farber, source=Web Response Advisory Committee Member relationship with Boehringer-Ingelheim Please note: $1001 - $5000 by Harrison Farber, source=Web Response, value=Consulting fee Consultant relationship with Bristol-Myers Squibb Please note: $1001 - $5000 by Harrison Farber, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Acceleron Please note: $1001 - $5000 Added 04/28/2020 by Harrison Farber, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Altavant Please note: $1001 - $5000 Added 04/28/2020 by Harrison Farber, source=Web Response, value=Consulting fee Scientific Medical Advisor relationship with PhaseBio Please note: $5001 - $20000 Added 06/01/2020 by Adaani Frost, source=Web Response, value=Honoraria DMC member for two studies relationship with Actelion Please note: $5001 - $20000 Added 06/01/2020 by Adaani Frost, source=Web Response, value=Honoraria End point adjudication committee chair relationship with United Therapeutics Please note: $1-$1000 Added 06/01/2020 by Adaani Frost, source=Web Response, value=nothing yet Consultant relationship with Acceleron Please note: $1001 - $5000 Added 06/01/2020 by Marius Hoeper, source=Web Response, value=Honoraria Consultant relationship with Actelion Please note: $5001 - $20000 Added 06/01/2020 by Marius Hoeper, source=Web Response, value=Honoraria Consultant relationship with Bayer AG Please note: $1001 - $5000 Added 06/01/2020 by Marius Hoeper, source=Web Response, value=Honoraria Consultant relationship with Janssen-Cilag Please note: $1001 - $5000 Added 06/01/2020 by Marius Hoeper, source=Web Response, value=Honoraria Consultant relationship with MSD Please note: $5001 - $20000 Added 06/01/2020 by Marius Hoeper, source=Web Response, value=Honoraria Consultant relationship with Pfizer Please note: $1001 - $5000 Added 06/01/2020 by Marius Hoeper, source=Web Response, value=Honoraria Employee relationship with Bayer AG Please note: >$100000 Added 06/02/2020 by Christian Meier, source=Web Response, value=Salary No relevant relationships by Claudia Rahner, source=Web Response

Background The incidence of cardiovascular (CV) risk factors is increasing globally, with a disproportionate burden in the low and low-middle income countries (L/LMICs). Peer support, as a low-cost lifestyle intervention, has succeeded in managing chronic illness. For global CV risk reduction, limited data exists in LMICs. Aim The GHP-CHANGE was designed as a community-based randomized trial to test the effectiveness of peer support strategy for CV risk reduction in the island of Grenada, a LMIC. Methods We recruited 402 adults from the Grenada Heart Project (GHP) Cohort Study of 2827 subjects with at least two CV risk factors. Subjects were randomized in a 1:1 fashion to a peer-group based intervention group (n = 206) or a self-management control group (n = 196) for 12 months. The primary outcome was the change from baseline in a composite score related to Blood pressure, Exercise, Weight, Alimentation and Tobacco (FBS, Fuster-BEWAT Score), ranging from 0 to 15 (ideal health = 15). Linear mixed-effects models were used to test for intervention effects. Results Participants mean age was 51.4 years (SD 14.5) years, two-thirds were female, and baseline mean FBS was 8.9 (SD 2.6) and 8.5 (SD 2.6) in the intervention and control group, respectively (P = .152). At post intervention, the mean FBS was higher in the intervention group compared to the control group [9.1 (SD 2.7) vs 8.5 (SD 2.6), P = .028]. When balancing baseline health profile, the between-group difference (intervention vs. control) in the change of FBS was 0.31 points (95% CI: -0.12 to 0.75; P = .154). Conclusions The GHP-CHANGE trial showed that a peer-support lifestyle intervention program was feasible; however, it did not demonstrate a significant improvement in the FBS as compared to the control group. Further studies should assess the effects of low-cost lifestyle interventions in LMICs.

To investigate the use of prasugrel after percutaneous coronary intervention (PCI) in African American (AA) patients presenting with acute coronary syndrome (ACS).

The complexity and costs associated with traditional randomized, controlled trials have increased exponentially over time, and now threaten to stifle the development of new drugs and devices. Nevertheless, the growing use of electronic health records, mobile applications, and wearable devices offers significant promise for transforming clinical trials, making them more pragmatic and efficient. However, many challenges must be overcome before these innovations can be implemented routinely in randomized, controlled trial operations. In October of 2018, a diverse stakeholder group convened in Washington, DC, to examine how electronic health record, mobile, and wearable technologies could be applied to clinical trials. The group specifically examined how these technologies might streamline the execution of clinical trial components, delineated innovative trial designs facilitated by technological developments, identified barriers to implementation, and determined the optimal frameworks needed for regulatory oversight. The group concluded that the application of novel technologies to clinical trials provided enormous potential, yet these changes needed to be iterative and facilitated by continuous learning and pilot studies.

BACKGROUND:Preschool-based interventions offer promise to instill healthy behaviors in children, which can be a strategy to reduce the burden of cardiovascular disease later. However, their efficacy in underserved communities is not well established. OBJECTIVES:The purpose of this study was to assess the impact of a preschool-based health promotion educational intervention in an underserved community. METHODS:This cluster-randomized controlled study involved 15 Head Start preschools in Harlem, New York. Schools and their children were randomized 3:2 to receive either a 4-month (50 h) educational intervention to instill healthy behaviors in relation to diet, physical activity, body/heart awareness, and emotion management; or their standard curriculum (control). The primary outcome was the change from baseline in the overall knowledge, attitudes, and habits (KAH) score of the children at 5 months. As secondary outcomes, we evaluated the changes in KAH subcomponents and emotion comprehension. Linear mixed-effects models were used to test for intervention effects. RESULTS:The authors enrolled 562 preschool children age 3 to 5 years, 51% female, 54% Hispanic/Latino, and 37% African-American. Compared with the control group, the mean relative change from baseline in the overall KAH score was ∼2.2 fold higher in the intervention group (average absolute difference of 2.86 points; 95% confidence interval: 0.58 to 5.14; p = 0.014). The maximal effect was observed in children who received >75% of the curriculum. Physical activity and body/heart awareness components, and knowledge and attitudes domains, were the main drivers of the effect (p values <0.05). Changes in emotion comprehension trended toward favoring intervened children. CONCLUSIONS:This multidimensional school-based educational intervention may be an effective strategy for establishing healthy behaviors among preschoolers from a diverse and socioeconomically disadvantaged community. Early primordial prevention strategies may contribute to reducing the global burden of cardiovascular disease. (Family-Based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health [FAMILIA]; NCT02343341).

ISS Fro C Ma Ne fun Inn Fe BACKGROUND Preschool-based interventions offer promise to instill healthy behaviors in children, which can be a strategy to reduce the burden of cardiovascular disease later. However, their efficacy in underserved communities is not

The complexity and costs associated with traditional randomized, controlled trials have increased exponentially over time, and now threaten to stifle the development of new drugs and devices. Nevertheless, the growing use of electronic health records, mobile applications, and wearable devices offers significant promise for transforming clinical trials, making them more pragmatic and efficient. However, many challenges must be overcome before these innovations can be implemented routinely in randomized, controlled trial operations. In October of 2018, a diverse stakeholder group convened in Washington, DC, to examine how electronic health record, mobile, and wearable technologies could be applied to clinical trials. The group specifically examined how these technologies might streamline the execution of clinical trial components, delineated innovative trial designs facilitated by technological developments, identified barriers to implementation, and determined the optimal frameworks needed for regulatory oversight. The group concluded that the application of novel technologies to clinical trials provided enormous potential, yet these changes needed to be iterative and facilitated by continuous learning and pilot studies.

BACKGROUND:Dapagliflozin is a sodium-glucose co-transporter-2 (SGLT-2) inhibitor that reduces blood glucose in patients with type 2 diabetes mellitus (T2DM) by promoting glycosuria via inhibiting urinary glucose reabsorption. In addition to improving blood glucose control, treatment with dapagliflozin results in glucose-induced osmotic diuresis, weight loss, and blood pressure lowering. Previous trials of SGLT-2 inhibitors showed reductions in cardiovascular (CV) events, including CV death and hospitalization for heart failure, and ischemic events in patients with atherosclerotic cardiovascular disease (ASCVD). RESEARCH DESIGN AND METHODS:DECLARE-TIMI 58 (NCT01730534) is a phase 3b randomized, double-blind, placebo-controlled trial designed to evaluate the CV safety and efficacy of dapagliflozin that has completed randomization of 17,160 patients with T2DM and a history of either established ASCVD (n=6,971) or multiple risk factors for ASCVD (n=10,189). Patients were randomized in a 1:1 fashion to dapagliflozin 10 mg or matching placebo. The primary safety outcome is the time to the first event of the composite of CV death, myocardial infarction, or ischemic stroke (major adverse cardiovascular events; MACEs). The co-primary efficacy outcomes are the composite of CV death, myocardial infarction, or ischemic stroke and the composite of CV death or hospitalization for heart failure. This event-driven trial will continue until at least 1,390 subjects have a MACE outcome, thereby providing >99% power to test for the primary outcome of safety of dapagliflozin measured by rejecting the hypothesis that the upper bound of the CI >1.3 for the primary outcome of MACE, as well as 85% power to detect a 15% relative risk reduction in MACE and an estimated 87% power to detect a 20% reduction in the composite of CV death or hospitalization for heart failure at a 1-sided α level of .0231. CONCLUSION:The DECLARE-TIMI 58 trial is testing the hypotheses that dapagliflozin is safe (does not increase) and may reduce the occurrence of major CV events. DECLARE-TIMI 58 is the largest study to address this question with an SGLT-2 inhibitor in patients with T2DM and with established CV disease and without CV disease but with multiple risk factors.

Background: Although bradyarrhythmias have been observed with ticagrelor and its use with advanced atrioventricular block is not recommended, questions arise regarding its use in patients with mild conduction abnormalities. The objectives were to compare rates of clinically relevant arrhythmias in relation to any mild baseline conduction abnormality in patients with acute coronary syndrome randomized to ticagrelor versus clopidogrel. Methods: We included all subjects in the electrocardiographic (ECG) substudy of the Platelet Inhibition and Patient Outcomes trial, excluding those with missing baseline ECG or with a pacemaker at baseline (N = 15,460). Conduction abnormality was defined as sinus bradycardia, first-degree atrioventricular block, hemiblock, or bundle-branch block. The primary arrhythmic outcome was the composite of any symptomatic brady-or tachyarrhythmia, permanent pacemaker placement, or cardiac arrest through 12 months. Results: Patients with baseline conduction abnormalities (n = 4,256, 27.5%) were older and more likely to experience the primary arrhythmic outcome. There were no differences by ticagrelor versus clopidogrel in the composite arrhythmic end point in those with baseline conduction disease (1-year cumulative incidence rate: 17% for both study arms; hazard ratio: 0.99 [0.86-1.15]) or without baseline conduction disease (1-year cumulative incidence rate: clopidogrel 12.8% vs ticagrelor 12.4%; hazard ratio: 0.98 (0.88-1.09). There were also no statistically significant differences between ticagrelor and clopidogrel in the rates of bradycardic (or any individual arrhythmic) events in patients with baseline conduction abnormalities. Conclusions: Ticagrelor compared to clopidogrel did not increase arrhythmic events even in subjects with acute coronary syndrome who present with mild conduction abnormalities on their baseline ECG. (C) 2018 Published by Elsevier Inc.

Introduction: African-Americans are at a greater risk of cardiovascular (CV) events. Differential race vulnerability to early subclinical atherosclerosis disease is likely, and yet few studies have...

Introduction: Preschool-based interventions offer promise to instill healthy behaviors in children. However, its efficacy in underserved communities is not well established. Objective: To assess the impact of a preschool-based health promotion education intervention in an underserved community. Methods: We performed the cluster-randomized controlled “Family-Based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health” (FAMILIA) trial involving 15 Head Start preschools in Harlem, New York. Schools and their children were 3:2 randomized to either receive the usual curriculum (control); or a 4-month educational intervention for a total of 50 hours to instill healthy behaviors in relation to diet, physical activity, understanding how the human body and heart work, and emotion management. The primary outcome was the change from baseline in the overall knowledge, attitudes, and habits (KAH) score of the child. As secondary outcomes, we evaluated the changes in KAH subcomponents and in the test of emotion comprehension. Linear mixed-effects models were used to test for intervention effects. Results: We enrolled 562 children 3 to 5 years old, 51% female, 54% Hispanic/Latino and 37% African-American. The mean % relative change from baseline in the overall KAH score was 5.5% and 11.8% in control and intervention groups, respectively. The average between-group absolute difference in overall KAH was 2.89 points (95% CI: 0.61 to 5.17; p = 0.013; Figure). Physical activity and understanding of the human body and heart components, and knowledge and attitudes domains, were the main drivers of the effect. Changes in emotion comprehension trended to favor intervened children as compared to controls. Conclusions: The FAMILIA trial demonstrates that a multidimensional school-based education intervention is an effective strategy for instilling healthy behaviors among preschoolers from a diverse and socially/economically disadvantaged community. As part of our long-term vision, we are conducting a long-term follow-up of the children to assess the sustainability of the intervention effects.

BACKGROUND Patients with prior myocardial infarction (MI) and multivessel coronary disease (MVD) are at high risk for recurrent coronary events. OBJECTIVES The authors investigated the efficacy and safety of ticagrelor versus placebo in patients with MVD in the PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis In Myocardial Infarction 54) trial. METHODS Patients with a history of MI 1 to 3 years before inclusion in the PEGASUS-TIMI 54 trial were stratified in a pre-specified analysis based on the presence of MVD. The effect of ticagrelor (60 mg and 90 mg) on the composite of cardiovascular death, MI, or stroke (major adverse cardiovascular events [MACE]), as well as the composite of coronary death, MI, or stent thrombosis (coronary events), and on TIMI major bleeding, intracranial hemorrhage (ICH), and fatal bleeding were evaluated over a median of 33 months. RESULTS A total of 12,558 patients (59.4%) had MVD. In the placebo arm, compared with patients without MVD, those with MVD were at higher risk for MACE (9.37% vs. 8.57%, adjusted hazard ratio [HRadj]: 1.24; p = 0.026) and for coronary events (7.67% vs. 5.34%, HRadj: 1.49; p = 0.0005). In patients with MVD, ticagrelor reduced the risk of MACE (7.94% vs. 9.37%, HR: 0.82; p = 0.004) and coronary events (6.02% vs. 7.67%, HR: 0.76; p < 0.0001), including a 36% reduction in coronary death (HR: 0.64; 95% confidence interval: 0.48 to 0.85; p = 0.002). In this subgroup, ticagrelor increased the risk of TIMI major bleeding (2.52% vs. 1.08%, HR: 2.67; p < 0.0001), but not ICH or fatal bleeds. CONCLUSIONS Patients with prior MI and MVD are at increased risk of MACE and coronary events, and experience substantial relative and absolute risk reductions in both outcomes with long-term ticagrelor treatment relative to those without MVD. Ticagrelor increases the risk of TIMI major bleeding, but not ICH or fatal bleeding. For patients with prior MI and MVD, ticagrelor is an effective option for long-term antiplatelet therapy. (Prevention of Cardiovascular Events [e.g., Death From Heart or Vascular Disease, Heart Attack, or Stroke] in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin [PEGASUS]; NCT01225562) (c) 2018 by the American College of Cardiology Foundation.

American College of Cardiology 67th Annual Scientific Session 2018. Orlando, USA. March 10-12, 2018.

Introduction: Obesity and dyslipidemia are increasingly prevalent, disproportionately affecting low-income families. We studied the presence of metabolic syndrome (MetS) by ethnicity among caregivers of preschool children in Harlem, New York. Methods: We analyzed 553 Hispanic and non-Hispanic black caregivers of children in Head Start preschools at their baseline assessment enrolling in a community-based lifestyle intervention. MetS was defined by at least 3 of the following: waist circumference >102/88 cm for men/women respectively, systolic/diastolic blood pressure ≥130/85 mm Hg, serum glucose > 100 mg/dL, triglycerides >150 mg/dL, or HDL < 40/50 mg/dL for men/women. Univariate logistic regression was used to determine significant predictors of MetS, and a multivariable logistic regression model was constructed to predict MetS among participants. Results: The mean age of participants was 37.5±11.3 years old. 34.4% Hispanic and 24.6% non-Hispanic black participants had MetS (p=0.015). This difference in ...

BACKGROUND AND OBJECTIVES:We sought to determine the frequency of use and association between prasugrel and outcomes in acute coronary syndrome patients undergoing percutaneous coronary intervention (PCI) in clinical practice.METHODS:PROMETHEUS was a multicenter observational registry of acute coronary syndrome patients undergoing PCI from 8 centers in the United States that maintained a prospective PCI registry for patient outcomes. The primary end points were major adverse cardiovascular events at 90days, a composite of all-cause death, nonfatal myocardial infarction, stroke, or unplanned revascularization. Major bleeding was defined as any bleeding requiring hospitalization or blood transfusion. Hazard ratios (HRs) were generated using multivariable Cox regression and stratified by the propensity to treat with prasugrel.RESULTS:Of 19,914 patients (mean age 64.4years, 32% female), 4,058 received prasugrel (20%) and 15,856 received clopidogrel (80%). Prasugrel-treated patients were younger with fewer comorbid risk factors compared with their counterparts receiving clopidogrel. At 90days, there was a significant association between prasugrel use and lower major adverse cardiovascular event (5.7% vs 9.6%, HR 0.58, 95% CI 0.50-0.67, P<.0001) and bleeding (1.9% vs 2.9%, HR 0.65, 95% CI 0.51-0.83, P<.001). After propensity stratification, associations were attenuated and no longer significant for either outcome. Results remained consistent using different approaches to adjusting for potential confounders.CONCLUSIONS:In contemporary clinical practice, patients receiving prasugrel tend to have a lower-risk profile compared with those receiving clopidogrel. The lower ischemic and bleeding events associated with prasugrel use were no longer evident after accounting for these baseline differences.

The nonvitamin K antagonist oral anticoagulants (NOACs) dabigatran, rivaroxaban, apixaban, and edoxaban are used for the reduction of the risk of stroke or systemic embolism (SEE) in patients with nonvalvular atrial fibrillation (NVAF). The purpose of this review is to highlight the safety and efficacy results of the pivotal NOAC clinical trials for use in NVAF, discuss some of the unique management challenges in the use of NOACs in special populations, summarize data on emerging and novel indications, and address potential future directions.MethodsA literature search was conducted and to identify relevant clinical trials and studies regarding the use of NOACs for the prevention of stroke or SEE in patients with atrial fibrillation.ResultsRelative to warfarin, NOACs are as effective or superior in the prevention of stroke or SEE, and are associated with similar or lower rates of major bleeding and significantly decreased rates of intracranial bleeding, but may be associated with a slightly increased risk of gastrointestinal bleeding in patients with AF. The NOACs are not indicated for use and have not been widely tested in AF patients with other cardiovascular conditions. Additional ongoing and planned clinical trials will provide additional information regarding the use of NOACs in these patients. In situations requiring rapid reversal of anticoagulation, the availability of specific antidotes will improve safety and facilitate NOAC use.ConclusionsUse of NOACs in clinical practice requires consideration of patient characteristics as well as potentially required procedures.

Objective Heart rate volatility (HRVO) is a physiological parameter that is believed to reflect the sympathetic activity of the autonomic nervous system. We explored the utility of HRVO as a predictive tool for declining physiological states, hypothesising that patients admitted from the resuscitation area of the ED to a high dependency unit (HDU) experience low HRVO compared with patients who did not.Methods We retrospectively reviewed HR data recordings, medical charts and disposition decisions from the ED of patients who were admitted to the five resuscitation beds in our adult ED between 29 April 2014 and 30 May 2015. HRVO was calculated for each 5 min interval; it was measured as the SD of all HRs within that interval. Logistic regression was used to model the odds of admission to a HDU given low HRVO during ED stay.Results HR data from 2051 patients was collected and approximately 7 million HR data points were analysed. 402 patients experienced low HRVO. Patients who experienced low HRVO during their ED stay were twice as likely to be admitted to a HDU from the ED (OR=2.07, 95% CI 1.64 to 2.60; p<0.001).Conclusions Our result provides additional evidence supporting previously published data indicating that autonomic nervous system measures such as HRVO could serve as important and useful clinical tools in the early triage of critically ill patients in the ED.