Scholars@Duke
Yuliya Vladimirovna Lokhnygina

Yuliya Vladimirovna Lokhnygina

Associate Professor of Biostatistics & Bioinformatics
Biostatistics & Bioinformatics, Division of Biostatistics
yuliya.lokhnygina@duke.edu
Duke Box 3850, Durham, NC 27710
200 Morris Street, 6126 200 Morris, Durham, NC 27701

Selected Publications

Postoperative outcomes after receipt of ertapenem antimicrobial prophylaxis for colon surgery: a multicenter retrospective cohort study.

Journal Article Infection control and hospital epidemiology · October 2024 ObjectiveTo evaluate postoperative outcomes among patients undergoing colon surgery who receive perioperative prophylaxis with ertapenem compared to other antibiotic regimens.Design and settingMulticenter retrospective cohort study among ... Full text Cite

IL-6 inhibition with clazakizumab in patients receiving maintenance dialysis: a randomized phase 2b trial.

Journal Article Nat Med · August 2024 Inflammation mediated by interleukin-6 (IL-6) is strongly associated with cardiovascular risk. Here we evaluated clazakizumab, a monoclonal antibody targeting the IL-6 ligand, in a phase 2b dose-finding study. Adults with cardiovascular disease and/or diab ... Full text Link to item Cite

Baseline characteristics including blood and urine metal levels in the Trial to Assess Chelation Therapy 2 (TACT2).

Journal Article Am Heart J · July 2024 BACKGROUND: The reduction in cardiovascular disease (CVD) events with edetate disodium (EDTA) in the Trial to Assess Chelation Therapy (TACT) suggested that chelation of toxic metals might provide novel opportunities to reduce CVD in patients with diabetes ... Full text Link to item Cite

Are the cardiovascular properties of GLP-1 receptor agonists differentially modulated by sulfonylureas? Insights from post-hoc analysis of EXSCEL.

Journal Article Diabetes Res Clin Pract · June 2024 AIMS: To examine whether the cardiovascular effects of glucagon-like peptide-1 (GLP-1) receptor agonists are attenuated by concurrent sulfonylurea (SU) therapy in a post-hoc analysis of the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). METHODS ... Full text Link to item Cite

RECOVER-NEURO: study protocol for a multi-center, multi-arm, phase 2, randomized, active comparator trial evaluating three interventions for cognitive dysfunction in post-acute sequelae of SARS-CoV-2 infection (PASC).

Journal Article Trials · May 17, 2024 BACKGROUND: Post-acute sequelae of SARS-CoV-2 infection (PASC) symptoms have broad impact, and may affect individuals regardless of COVID-19 severity, socioeconomic status, race, ethnicity, or age. A prominent PASC symptom is cognitive dysfunction, colloqu ... Full text Open Access Link to item Cite

Sex Differences in Branched-chain Amino Acid and Tryptophan Metabolism and Pathogenesis of Youth-onset Type 2 Diabetes.

Journal Article J Clin Endocrinol Metab · March 15, 2024 OBJECTIVES: Insulin resistance is associated with elevations in plasma branched-chain amino acids (BCAAs). BCAAs compete with aromatic amino acids including tryptophan for uptake into β cells. To explore relationships between BCAAs and tryptophan metabolis ... Full text Link to item Cite

Trial Design with Win Statistics for Multiple Time-to-Event Endpoints with Hierarchy

Journal Article Statistics in Biopharmaceutical Research · January 1, 2024 The conventional approach to the analysis of composite endpoints is time-to-first event analysis. However, this approach has been criticized because it ignores the differences in clinical severity and may end up emphasizing the less severe time-to-event. T ... Full text Cite

Catabolism of fats and branched-chain amino acids in children with Type 1 diabetes: Association with glycaemic control and total daily insulin dose.

Journal Article Endocrinol Diabetes Metab · November 2023 OBJECTIVE: Hyperglycaemia in Type 1 diabetes (T1D) results from an absolute insulin deficiency. However, insulin resistance (IR) may exacerbate glycaemic instability in T1D and contribute to long-term cardiovascular complications. We previously showed that ... Full text Link to item Cite

Sex differences in the complications, care and clinical outcomes of patients with type 2 diabetes in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).

Journal Article Diabetes Obes Metab · June 2023 AIM: To examine sex differences in the characteristics and outcomes in participants with type 2 diabetes (T2D), with or without cardiovascular disease (CVD), randomized to once-weekly exenatide (EQW) or placebo in the Exenatide Study of Cardiovascular Even ... Full text Link to item Cite

Time-dependent event accumulation in a cardiovascular outcome trial of patients with type 2 diabetes and established atherosclerotic cardiovascular disease.

Journal Article Cardiovasc Diabetol · March 28, 2023 BACKGROUND: Estimating cardiovascular (CV) event accrual is important for outcome trial planning. Limited data exist describing event accrual patterns in patients with type 2 diabetes (T2D). We compared apparent CV event accrual patterns with true event ra ... Full text Link to item Cite

The Disproportionate Impact of Coronavirus Disease 2019 (COVID-19) Pandemic on Healthcare-Associated Infections in Community Hospitals: Need for Expanding the Infectious Disease Workforce.

Journal Article Clin Infect Dis · February 8, 2023 BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic had a considerable impact on US healthcare systems, straining hospital resources, staff, and operations. However, a comprehensive assessment of the impact on healthcare-associated infections (HAI ... Full text Link to item Cite

Evaluation of an Opt-Out Protocol for Antibiotic De-Escalation in Patients With Suspected Sepsis: A Multicenter, Randomized, Controlled Trial.

Journal Article Clin Infect Dis · February 8, 2023 BACKGROUND: Sepsis guidelines recommend daily review to de-escalate or stop antibiotics in appropriate patients. This randomized, controlled trial evaluated an opt-out protocol to decrease unnecessary antibiotics in patients with suspected sepsis. METHODS: ... Full text Link to item Cite

Effects of Long-Term Sertraline Use on Pediatric Growth and Development: The Sertraline Pediatric Registry for The Evaluation of Safety (SPRITES).

Journal Article J Child Adolesc Psychopharmacol · February 2023 Objective: To describe the results of the Sertraline Pediatric Registry for The Evaluation of Safety (SPRITES) outcome measures of cognitive, emotional, and physical development following long-term treatment with sertraline (for up to 3 years) in children ... Full text Link to item Cite

Early recognition and response to increases in surgical site infections using optimised statistical process control charts-The early 2RIS trial: A multicentre stepped wedge cluster randomised controlled trial.

Journal Article EClinicalMedicine · December 2022 BACKGROUND: Traditional approaches for surgical site infection (SSI) surveillance have deficiencies that delay detection of SSI outbreaks and other clinically important increases in SSI rates. We investigated whether use of optimised statistical process co ... Full text Open Access Link to item Cite

The Impact of Centers for Medicare & Medicaid Services SEP-1 Core Measure Implementation on Antibacterial Utilization: A Retrospective Multicenter Longitudinal Cohort Study With Interrupted Time-Series Analysis.

Journal Article Clin Infect Dis · August 31, 2022 BACKGROUND: The impact of the US Centers for Medicare & Medicaid Services (CMS) Severe Sepsis and Septic Shock: Management Bundle (SEP-1) core measure on overall antibacterial utilization is unknown. METHODS: We performed a retrospective multicenter longit ... Full text Link to item Cite

Development and validation of a model to predict cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke in patients with type 2 diabetes mellitus and established atherosclerotic cardiovascular disease.

Journal Article Cardiovasc Diabetol · August 27, 2022 BACKGROUND: Among individuals with atherosclerotic cardiovascular disease (ASCVD), type 2 diabetes mellitus (T2DM) is common and confers increased risk for morbidity and mortality. Differentiating risk is key to optimize efficiency of treatment selection. ... Full text Link to item Cite

Effect of race on cardiometabolic responses to once-weekly exenatide: insights from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).

Journal Article Cardiovasc Diabetol · June 27, 2022 BACKGROUND: To determine whether there were racial differences in short-term cardiometabolic responses to once-weekly exenatide (EQW) in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). METHODS: EXSCEL enrolled 14,752 patients with type 2 dia ... Full text Link to item Cite

Validation of the WATCH-DM and TRS-HFDM Risk Scores to Predict the Risk of Incident Hospitalization for Heart Failure Among Adults With Type 2 Diabetes: A Multicohort Analysis.

Journal Article J Am Heart Assoc · June 7, 2022 Background The WATCH-DM (weight [body mass index], age, hypertension, creatinine, high-density lipoprotein cholesterol, diabetes control [fasting plasma glucose], ECG QRS duration, myocardial infarction, and coronary artery bypass grafting) and TRS-HFDM (T ... Full text Link to item Cite

Long-Term Clinical Outcomes of Severe Combined Immunodeficiency Patients Given Nonablative Marrow Transplants.

Journal Article J Allergy Clin Immunol Pract · April 2022 BACKGROUND: Severe combined immunodeficiency (SCID) is a syndrome characterized by profound T-cell deficiency that is universally fatal in infancy unless immune reconstitution is achieved by hematopoietic stem cell transplantation, gene therapy, or enzyme ... Full text Link to item Cite

Cardiovascular Events and Long-Term Risk of Sudden Death Among Stabilized Patients After Acute Coronary Syndrome: Insights From IMPROVE-IT.

Journal Article J Am Heart Assoc · February 15, 2022 Background Unlike patients with low ejection fraction after an acute coronary syndrome (ACS), little is known about the long-term incidence and influence of cardiovascular events before sudden death among stabilized patients after ACS. Methods and Results ... Full text Link to item Cite

Nonparametric Survival Analysis

Chapter · January 1, 2022 Survival or time-to-event data are ubiquitous in clinical trials research. The presence of censoring requires specialized methods for the analysis of this type of data. This chapter describes the methods for nonparametric analyses of survival data, includi ... Full text Cite

Development of an Electronic Definition for De-escalation of Antibiotics in Hospitalized Patients.

Journal Article Clin Infect Dis · December 6, 2021 BACKGROUND: Antimicrobial stewardship programs (ASPs) promote the principle of de-escalation: moving from broad- to narrow-spectrum agents and stopping antibiotics when no longer indicated. A standard, objective definition of de-escalation applied to elect ... Full text Link to item Cite

Polyvascular disease and increased risk of cardiovascular events in patients with type 2 diabetes: Insights from the EXSCEL trial.

Journal Article Atherosclerosis · December 2021 BACKGROUND AND AIMS: Polyvascular disease is an independent predictor of major adverse cardiovascular events (MACE). The relationship between the number of diseased arterial beds and MACE is unknown. How MACE risk changes in individuals with type 2 diabete ... Full text Link to item Cite

Predicting major adverse limb events in individuals with type 2 diabetes: Insights from the EXSCEL trial.

Journal Article Diabet Med · October 2021 AIMS: Although models exist to predict amputation among people with type 2 diabetes with foot ulceration or infection, we aimed to develop a prediction model for a broader range of major adverse limb events (MALE)-including gangrene, revascularization and ... Full text Link to item Cite

Effect of once-weekly exenatide on hospitalization for acute coronary syndrome or coronary revascularization in patients with type 2 diabetes mellitus.

Journal Article Am Heart J · September 2021 Cardiovascular (CV) outcome studies of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have shifted the paradigm of type 2 diabetes management given their benefits regarding a reduction in major adverse CV events. However, the relationship between GL ... Full text Link to item Cite

Sertraline Pediatric Registry for the Evaluation of Safety: Design and Clinical Characteristics of Pediatric Patients Prescribed Sertraline.

Journal Article J Child Adolesc Psychopharmacol · August 2021 Objectives: To describe the study design and clinical characteristics of patients in the Sertraline Pediatric RegIstry for The Evaluation of Safety (SPRITES). Methods: SPRITES is an open-label postmarketing study of development and safety outcomes in patie ... Full text Link to item Cite

Cardiac computed tomography improves the identification of cardiomechanical complications among patients with suspected left ventricular assist device malfunction.

Journal Article J Cardiovasc Comput Tomogr · 2021 BACKGROUND: Left ventricular assist devices (LVAD) are increasingly used for durable mechanical circulatory support in advanced heart failure. While LVAD therapy provides substantial improvement in mortality and quality of life, long-term therapy confers i ... Full text Link to item Cite

Treatment-related biomarkers in pulmonary hypertension patients on oral therapies.

Journal Article Respir Res · November 19, 2020 BACKGROUND: Multiple classes of oral therapy are available for the treatment of pulmonary arterial hypertension (PAH), but there is little to guide clinicians in choosing a specific regimen or therapeutic class. We aimed to investigate whether treatment-re ... Full text Open Access Link to item Cite

Early recognition and response to increases in surgical site infections using optimized statistical process control charts-the Early 2RIS Trial: a multicenter cluster randomized controlled trial with stepped wedge design.

Journal Article Trials · October 28, 2020 BACKGROUND: Surgical site infections (SSIs) cause significant patient suffering. Surveillance and feedback of SSI rates is an evidence-based strategy to reduce SSIs, but traditional surveillance methods are slow and prone to bias. The objective of this clu ... Full text Link to item Cite

Comparison of regression imputation methods of baseline covariates that predict survival outcomes.

Journal Article J Clin Transl Sci · September 4, 2020 INTRODUCTION: Missing data are inevitable in medical research and appropriate handling of missing data is critical for statistical estimation and making inferences. Imputation is often employed in order to maximize the amount of data available for statisti ... Full text Open Access Link to item Cite

Plasma levels of DPP4 activity and sDPP4 are dissociated from inflammation in mice and humans.

Journal Article Nat Commun · July 28, 2020 Dipeptidyl peptidase-4 (DPP4) modulates inflammation by enzymatic cleavage of immunoregulatory peptides and through its soluble form (sDPP4) that directly engages immune cells. Here we examine whether reduction of DPP4 activity alters inflammation. Prolong ... Full text Link to item Cite

Post-Discharge Bleeding and Mortality Following Acute Coronary Syndromes With or Without PCI.

Journal Article J Am Coll Cardiol · July 14, 2020 BACKGROUND: The long-term prognostic impact of post-discharge bleeding in the unique population of patients with acute coronary syndrome (ACS) treated without percutaneous coronary intervention (PCI) remains unexplored. OBJECTIVES: The aim of this study wa ... Full text Link to item Cite

Exploring the Possible Impact of Unbalanced Open-Label Drop-In of Glucose-Lowering Medications on EXSCEL Outcomes.

Journal Article Circulation · April 28, 2020 BACKGROUND: EXSCEL (Exenatide Study of Cardiovascular Event Lowering) assessed the impact of once-weekly exenatide 2 mg versus placebo in patients with type 2 diabetes mellitus, while aiming for glycemic equipoise. Consequently, greater drop-in of open-lab ... Full text Link to item Cite

Confirming the Bidirectional Nature of the Association Between Severe Hypoglycemic and Cardiovascular Events in Type 2 Diabetes: Insights From EXSCEL.

Journal Article Diabetes Care · March 2020 OBJECTIVE: We sought to confirm a bidirectional association between severe hypoglycemic events (SHEs) and cardiovascular (CV) event risk and to characterize individuals at dual risk. RESEARCH DESIGN AND METHODS: In a post hoc analysis of 14,752 Exenatide S ... Full text Link to item Cite

Microvascular and Cardiovascular Outcomes According to Renal Function in Patients Treated With Once-Weekly Exenatide: Insights From the EXSCEL Trial.

Journal Article Diabetes Care · February 2020 OBJECTIVE: To evaluate the impact of once-weekly exenatide (EQW) on microvascular and cardiovascular (CV) outcomes by baseline renal function in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). RESEARCH DESIGN AND METHODS: Least squares mean ... Full text Link to item Cite

Safety and efficacy outcomes of left atrial posterior wall isolation compared to pulmonary vein isolation and pulmonary vein isolation with linear ablation for the treatment of persistent atrial fibrillation.

Journal Article Am Heart J · February 2020 BACKGROUND: Pulmonary wall isolation (PWI) is increasingly used as an adjunctive lesion set to compliment pulmonary vein isolation (PVI), especially in patients with persistent atrial fibrillation (AF). The objective was to compare outcomes of catheter abl ... Full text Link to item Cite

Effectiveness of catheter ablation of atrial fibrillation according to heart failure etiology.

Journal Article J Arrhythm · February 2020 BACKGROUND: Catheter ablation is an important rhythm control therapy in patients with atrial fibrillation (AF) with concomitant heart failure (HF). The objective of this study was to assess the comparative efficacy of AF ablation patients with ischemic vs ... Full text Open Access Link to item Cite

Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials.

Journal Article Am Heart J · December 2019 BACKGROUND: Medicare insurance claims may provide an efficient means to ascertain follow-up of older participants in clinical research. We sought to determine the accuracy and completeness of claims- versus site-based follow-up with clinical event committe ... Full text Link to item Cite

Effect of Once-Weekly Exenatide in Patients With Type 2 Diabetes Mellitus With and Without Heart Failure and Heart Failure-Related Outcomes: Insights From the EXSCEL Trial.

Journal Article Circulation · November 12, 2019 BACKGROUND: Once-weekly exenatide (EQW) had a neutral effect on hospitalization for heart failure (HHF) in the EXSCEL study (Exenatide Study of Cardiovascular Event Lowering), with no differential treatment effect on major adverse cardiac events by baselin ... Full text Link to item Cite

Impact of FDA black box warning on fluoroquinolone and alternative antibiotic use in southeastern US hospitals.

Journal Article Infect Control Hosp Epidemiol · November 2019 We analyzed antibiotic use data from 29 southeastern US hospitals over a 5-year period to determine changes in antibiotic use after the fluoroquinolone US Food and Drug Administration (FDA) advisory update in 2016. Fluoroquinolone use declined both before ... Full text Link to item Cite

Sitagliptin does not reduce the risk of cardiovascular death or hospitalization for heart failure following myocardial infarction in patients with diabetes: observations from TECOS.

Journal Article Cardiovasc Diabetol · September 3, 2019 BACKGROUND: To examine the effects of the DPP-4i sitagliptin on CV outcomes during and after incident MI in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). METHODS: TECOS randomized 14,671 participants with type 2 diabetes and athero ... Full text Link to item Cite

Effect of Simvastatin-Ezetimibe Compared With Simvastatin Monotherapy After Acute Coronary Syndrome Among Patients 75 Years or Older: A Secondary Analysis of a Randomized Clinical Trial.

Journal Article JAMA Cardiol · September 1, 2019 IMPORTANCE: Limited evidence is available regarding the benefit and hazard of higher-intensity treatment to lower lipid levels among patients 75 years or older. As a result, guideline recommendations differ for this age group compared with younger patients ... Full text Link to item Cite

Antithrombotic treatment gap among patients with atrial fibrillation and type 2 diabetes.

Journal Article Int J Cardiol · August 15, 2019 BACKGROUND: We investigated the use of different antithrombotic therapies at baseline among patients with a history of atrial fibrillation (AF), type 2 diabetes, and established atherosclerotic cardiovascular disease (ASCVD) enrolled in the Trial Evaluatin ... Full text Link to item Cite

Patient Phenotypes, Cardiovascular Risk, and Ezetimibe Treatment in Patients After Acute Coronary Syndromes (from IMPROVE-IT).

Journal Article Am J Cardiol · April 15, 2019 Risk prediction following acute coronary syndrome (ACS) remains challenging. Data-driven machine-learning algorithms can potentially identify patients at high risk of clinical events. The Improved Reduction of Outcomes: Vytorin Efficacy International Trial ... Full text Link to item Cite

PREPARED Study: A Study of Shared Decision-Making for Coronary Artery Disease.

Journal Article Circ Cardiovasc Qual Outcomes · February 2019 Background Guidelines recommend patient engagement in shared decision-making regarding coronary revascularization, but studies demonstrate poor patient understanding of risks, benefits, and alternatives. Effective strategies are needed to integrate informe ... Full text Link to item Cite

Medication Discontinuation in the IMPROVE-IT Trial.

Journal Article Circ Cardiovasc Qual Outcomes · January 2019 BACKGROUND: Although cholesterol-lowering medications can reduce the risk of recurrent cardiovascular events, premature discontinuation limits effectiveness. Discontinuation rates have not been systematically reported for lipid-lowering trials. METHODS AND ... Full text Link to item Cite

Natural History of Patients Postacute Coronary Syndrome Based on Heart Failure Status.

Journal Article Am J Cardiol · November 1, 2018 The natural history of patients hospitalized for acute coronary syndrome (ACS) with pre-existing versus (vs) de novo heart failure (HF) has not been previously reported over an extended duration of follow-up. The IMPROVE-IT trial enrolled 18,144 patients h ... Full text Link to item Cite

Effect of Once-Weekly Exenatide on Clinical Outcomes According to Baseline Risk in Patients With Type 2 Diabetes Mellitus: Insights From the EXSCEL Trial.

Journal Article J Am Heart Assoc · October 2, 2018 Background In the EXSCEL (Exenatide Study of Cardiovascular Event Lowering), exenatide once-weekly resulted in a nonsignificant reduction in major adverse cardiovascular events ( MACEs ) and a nominal 14% reduction in all-cause mortality in 14 752 patients ... Full text Open Access Link to item Cite

Effectiveness of targeted enhanced terminal room disinfection on hospital-wide acquisition and infection with multidrug-resistant organisms and Clostridium difficile: a secondary analysis of a multicentre cluster randomised controlled trial with crossover design (BETR Disinfection).

Journal Article Lancet Infect Dis · August 2018 BACKGROUND: The hospital environment is a source of pathogen transmission. The effect of enhanced disinfection strategies on the hospital-wide incidence of infection has not been investigated in a multicentre, randomised controlled trial. We aimed to asses ... Full text Link to item Cite

Effect of race on the glycaemic response to sitagliptin: Insights from the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS).

Journal Article Diabetes Obes Metab · June 2018 AIM: Pooled efficacy studies suggest that glycaemic responses to dipeptidyl-peptidase 4 inhibitors in type 2 diabetes are greatest in Asians, who may also respond better to alpha-glucosidase inhibitors. We assessed the glycaemic impact of sitagliptin by ra ... Full text Link to item Cite

Randomized trial of lacosamide versus fosphenytoin for nonconvulsive seizures.

Journal Article Ann Neurol · June 2018 OBJECTIVE: The optimal treatment of nonconvulsive seizures in critically ill patients is uncertain. We evaluated the comparative effectiveness of the antiseizure drugs lacosamide (LCM) and fosphenytoin (fPHT) in this population. METHODS: The TRENdS (Treatm ... Full text Link to item Cite

Denominator Matters in Estimating Antimicrobial Use: A Comparison of Days Present and Patient Days.

Journal Article Infect Control Hosp Epidemiol · May 2018 Patient days and days present were compared to directly measured person time to quantify how choice of different denominator metrics may affect antimicrobial use rates. Overall, days present were approximately one-third higher than patient days. This diffe ... Full text Link to item Cite

Cardiovascular outcomes with glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a meta-analysis.

Journal Article Lancet Diabetes Endocrinol · February 2018 BACKGROUND: Glucagon-like peptide-1 (GLP-1) receptor agonists are effective glucose-lowering drugs. Findings from cardiovascular outcome trials showed cardiovascular safety of GLP-1 receptor agonists, but results for cardiovascular efficacy were varied. We ... Full text Link to item Cite

Implementation Lessons Learned From the Benefits of Enhanced Terminal Room (BETR) Disinfection Study: Process and Perceptions of Enhanced Disinfection with Ultraviolet Disinfection Devices.

Journal Article Infect Control Hosp Epidemiol · February 2018 OBJECTIVE To summarize and discuss logistic and administrative challenges we encountered during the Benefits of Enhanced Terminal Room (BETR) Disinfection Study and lessons learned that are pertinent to future utilization of ultraviolet (UV) disinfection d ... Full text Link to item Cite

Efficacy and safety of rivaroxaban compared with warfarin in patients with carotid artery disease and nonvalvular atrial fibrillation: Insights from the ROCKET AF trial.

Journal Article Clin Cardiol · January 2018 BACKGROUND: Atrial fibrillation (AF) increases risk of stroke 5-fold. Carotid artery disease (CD) also augments the risk of stroke, yet there are limited data about the interplay of these 2 diseases and clinical outcomes in patients with comorbid AF and CD ... Full text Link to item Cite

Provocative biomarker stress test: stress-delta N-terminal pro-B type natriuretic peptide.

Journal Article Open Heart · 2018 OBJECTIVE: Stress testing is commonly performed in emergency department (ED) patients with suspected acute coronary syndrome (ACS). We hypothesised that changes in N-terminal pro-B type natriuretic peptide (NT-proBNP) concentrations from baseline to post-s ... Full text Open Access Link to item Cite

Causes of Death in a Contemporary Cohort of Patients With Type 2 Diabetes and Atherosclerotic Cardiovascular Disease: Insights From the TECOS Trial.

Journal Article Diabetes Care · December 2017 OBJECTIVE: We evaluated the specific causes of death and their associated risk factors in a contemporary cohort of patients with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD). RESEARCH DESIGN AND METHODS: We used data from the Trial Ev ... Full text Link to item Cite

Hypertension Control in Adults With Diabetes Mellitus and Recurrent Cardiovascular Events: Global Results From the Trial Evaluating Cardiovascular Outcomes With Sitagliptin.

Journal Article Hypertension · November 2017 Systolic blood pressure (SBP) treatment targets for adults with diabetes mellitus remain unclear. SBP levels among 12 275 adults with diabetes mellitus, prior cardiovascular disease, and treated hypertension were evaluated in the TECOS (Trial Evaluating Ca ... Full text Link to item Cite

Benefit of Ezetimibe Added to Simvastatin in Reduced Kidney Function.

Journal Article J Am Soc Nephrol · October 2017 Efficacy of statin-based therapies in reducing cardiovascular mortality in individuals with CKD seems to diminish as eGFR declines. The strongest evidence supporting the cardiovascular benefit of statins in individuals with CKD was shown with ezetimibe plu ... Full text Open Access Link to item Cite

The Antimicrobial Scrub Contamination and Transmission (ASCOT) Trial: A Three-Arm, Blinded, Randomized Controlled Trial With Crossover Design to Determine the Efficacy of Antimicrobial-Impregnated Scrubs in Preventing Healthcare Provider Contamination.

Journal Article Infect Control Hosp Epidemiol · October 2017 OBJECTIVE To determine whether antimicrobial-impregnated textiles decrease the acquisition of pathogens by healthcare provider (HCP) clothing. DESIGN We completed a 3-arm randomized controlled trial to test the efficacy of 2 types of antimicrobial-impregna ... Full text Link to item Cite

Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.

Journal Article N Engl J Med · September 28, 2017 BACKGROUND: The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. METHODS: We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, ... Full text Open Access Link to item Cite

Secondary Prevention of Cardiovascular Disease in Patients With Type 2 Diabetes Mellitus: International Insights From the TECOS Trial (Trial Evaluating Cardiovascular Outcomes With Sitagliptin).

Journal Article Circulation · September 26, 2017 BACKGROUND: Intensive risk factor modification significantly improves outcomes for patients with diabetes mellitus and cardiovascular disease. However, the degree to which secondary prevention treatment goals are achieved in international clinical practice ... Full text Link to item Cite

Competing Risks of Cardiovascular Versus Noncardiovascular Death During Long-Term Follow-Up After Acute Coronary Syndromes.

Journal Article J Am Heart Assoc · September 18, 2017 BACKGROUND: Understanding the relative risk of cardiovascular versus noncardiovascular death is important for designing clinical trials. These risks may differ depending on patient age, sex, and type of acute coronary syndrome (ACS). METHODS AND RESULTS: I ... Full text Link to item Cite

Efficacy and Safety of Rivaroxaban Versus Warfarin in Patients Taking Nondihydropyridine Calcium Channel Blockers for Atrial Fibrillation (from the ROCKET AF Trial).

Conference Am J Cardiol · August 15, 2017 Non-dihydropyridine calcium channel blockers (non-DHP CCBs) possess combined P-glycoprotein and moderate CYP3A4 inhibition, which may lead to increased exposure of medications that are substrates for these metabolic pathways, such as rivaroxaban. We evalua ... Full text Link to item Cite

Sample size calculations in clinical research, third edition

Book · August 15, 2017 Praise for the Second Edition:"This is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics. "This impressive book co ... Full text Cite

Efficacy and safety of rivaroxaban versus warfarin in patients from mainland China with nonvalvular atrial fibrillation: A subgroup analysis from the ROCKET AF trial.

Journal Article Thromb Res · August 2017 BACKGROUND: The ROCKET AF study evaluated once-daily rivaroxaban versus dose-adjusted warfarin for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). In this analysis, we compared rivaroxaban with warfarin in patients ... Full text Link to item Cite

Relation of Risk of Stroke in Patients With Atrial Fibrillation to Body Mass Index (from Patients Treated With Rivaroxaban and Warfarin in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation Trial).

Journal Article Am J Cardiol · June 15, 2017 We investigated stroke outcomes in normal weight (body mass index [BMI] 18.50 to 24.99 kg/m2), overweight (BMI 25.00 to 29.99 kg/m2), and obese (BMI ≥30 kg/m2) patients with atrial fibrillation treated with rivaroxaban and warfarin. We compared the inciden ... Full text Link to item Cite

Fasting glucose, NT-proBNP, treatment with eptifibatide, and outcomes in non-ST-segment elevation acute coronary syndromes: An analysis from EARLY ACS.

Conference Int J Cardiol · April 1, 2017 BACKGROUND: Higher N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels have been linked to a more favorable glucometabolic profile. Little is known about the interaction of NT-proBNP and fasting glucose in non-ST-segment elevation acute coronary s ... Full text Link to item Cite

Trade-off of myocardial infarction vs. bleeding types on mortality after acute coronary syndrome: lessons from the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) randomized trial.

Journal Article Eur Heart J · March 14, 2017 AIMS: Dual antiplatelet therapy reduces non-fatal ischaemic events after acute coronary syndrome (ACS) but increases bleeding to a similar extent. We sought to determine the prognostic impact of myocardial infarction (MI) vs. bleeding during an extended fo ... Full text Link to item Cite

Use of thienopyridine prior to presentation with non-ST-segment elevation acute coronary syndrome and association with safety and efficacy of vorapaxar: insights from the TRACER trial.

Journal Article Eur Heart J Acute Cardiovasc Care · March 2017 BACKGROUND: Vorapaxar is effective in the prevention of secondary atherothrombotic events, although the efficacy/safety balance appears less favorable in the treatment of patients with non-ST-segment elevation (NSTE) acute coronary syndrome (ACS). We hypot ... Full text Link to item Cite

Myocardial Ischemia on Exercise Stress Echocardiography Testing Is Not Associated with Changes in Troponin T Concentrations.

Journal Article J Appl Lab Med · March 1, 2017 BACKGROUND: Some posit that any amount of myocardial ischemia can be detected by high-sensitivity cardiac troponin assays. We hypothesized that patients with myocardial ischemia induced by exercise stress would have significantly higher increases in high-s ... Full text Open Access Link to item Cite

Enhanced terminal room disinfection and acquisition and infection caused by multidrug-resistant organisms and Clostridium difficile (the Benefits of Enhanced Terminal Room Disinfection study): a cluster-randomised, multicentre, crossover study.

Journal Article Lancet · February 25, 2017 BACKGROUND: Patients admitted to hospital can acquire multidrug-resistant organisms and Clostridium difficile from inadequately disinfected environmental surfaces. We determined the effect of three enhanced strategies for terminal room disinfection (disinf ... Full text Link to item Cite

Pancreatic Safety of Sitagliptin in the TECOS Study.

Journal Article Diabetes Care · February 2017 OBJECTIVE: We evaluated the incidence of acute pancreatitis and pancreatic cancer in patients with type 2 diabetes and cardiovascular disease who were treated with sitagliptin, a dipeptidyl peptidase-4 inhibitor (DPP-4i). RESEARCH DESIGN AND METHODS: In th ... Full text Link to item Cite

On-treatment analysis of the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT).

Journal Article Am Heart J · December 2016 BACKGROUND: We aimed to determine the efficacy and safety of adding ezetimibe (Ez) to simvastatin (S) in a post-acute coronary syndrome (ACS) population in a prespecified on-treatment analysis. METHODS: We evaluated 17,706 post-ACS patients from the IMPROV ... Full text Link to item Cite

Use of concomitant aspirin in patients with atrial fibrillation: Findings from the ROCKET AF trial.

Journal Article Am Heart J · September 2016 BACKGROUND: We aimed to investigate the relationship between aspirin use and clinical outcomes in patients enrolled in Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in ... Full text Link to item Cite

Albuminuria and cardiovascular events in patients with acute coronary syndromes: Results from the TRACER trial.

Journal Article Am Heart J · August 2016 BACKGROUND: Albuminuria is associated with cardiovascular (CV) outcomes. We evaluated albuminuria, alone and in combination with estimated glomerular filtration rate (eGFR), as a predictor of mortality and CV morbidity in 12,944 patients with non-ST-segmen ... Full text Link to item Cite

On-Treatment Outcomes in Patients With Worsening Renal Function With Rivaroxaban Compared With Warfarin: Insights From ROCKET AF.

Journal Article Circulation · July 5, 2016 BACKGROUND: Despite rapid clinical adoption of novel anticoagulants, it is unknown whether outcomes differ among patients with worsening renal function (WRF) taking these new drugs compared with warfarin. We aimed to determine whether the primary efficacy ... Full text Link to item Cite

Native valve disease in patients with non-valvular atrial fibrillation on warfarin or rivaroxaban.

Journal Article Heart · July 1, 2016 OBJECTIVE: To compare the characteristics and outcomes of patients with atrial fibrillation (AF) and aortic stenosis (AS) with patients with AF with mitral regurgitation (MR) or aortic regurgitation (AR) and patients without significant valve disease (no S ... Full text Link to item Cite

An evaluation of constrained randomization for the design and analysis of group-randomized trials.

Journal Article Stat Med · May 10, 2016 In group-randomized trials, a frequent practical limitation to adopting rigorous research designs is that only a small number of groups may be available, and therefore, simple randomization cannot be relied upon to balance key group-level prognostic factor ... Full text Link to item Cite

Association Between Sitagliptin Use and Heart Failure Hospitalization and Related Outcomes in Type 2 Diabetes Mellitus: Secondary Analysis of a Randomized Clinical Trial.

Journal Article JAMA Cardiol · May 1, 2016 IMPORTANCE: Previous trial results have suggested that dipeptidyl peptidase 4 inhibitor (DPP4i) use might increase heart failure (HF) risk in type 2 diabetes mellitus (T2DM). The DPP4i sitagliptin has been shown to be noninferior to placebo with regard to ... Full text Link to item Cite

Implantable Neurostimulation for Headache Disorders: Effect on Healthcare Utilization and Expenditures.

Journal Article Neuromodulation · April 2016 OBJECTIVES: Chronic daily headache is a considerable source of morbidity for patients and also carries an enormous economic burden. Patients who fail standard medication regimens lack well-defined therapies, and neurostimulation is an emerging option for t ... Full text Link to item Cite

Sudden Cardiac Death After Non-ST-Segment Elevation Acute Coronary Syndrome.

Journal Article JAMA Cardiol · April 1, 2016 IMPORTANCE: In the current therapeutic era, the risk for sudden cardiac death (SCD) after non-ST-segment elevation acute coronary syndrome (NSTE ACS) has not been characterized completely. OBJECTIVE: To determine the cumulative incidence of SCD during long ... Full text Link to item Cite

Reduction in Total Cardiovascular Events With Ezetimibe/Simvastatin Post-Acute Coronary Syndrome: The IMPROVE-IT Trial.

Journal Article J Am Coll Cardiol · February 2, 2016 BACKGROUND: Intensive low-density lipoprotein cholesterol therapy with ezetimibe/simvastatin in IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial) significantly reduced the first primary endpoint (PEP) in patients post-acute ... Full text Link to item Cite

Frequency, clinical and angiographic characteristics, and outcomes of high-risk non-ST-segment elevation acute coronary syndromes patients with left circumflex culprit lesions.

Journal Article Int J Cardiol · January 15, 2016 BACKGROUND: The relationship between culprit vessel, infarct size, and outcomes in non-ST-segment elevation acute coronary syndromes (NSTE ACS) is unclear. In some reports, the left circumflex artery (LCX) was more often the culprit at angiography than the ... Full text Link to item Cite

Comparison of Bilateral vs. Staged Unilateral Deep Brain Stimulation (DBS) in Parkinson's Disease in Patients Under 70 Years of Age.

Journal Article Neuromodulation · January 2016 OBJECTIVE: The most popular surgical method for deep brain stimulation (DBS) in Parkinson's disease (PD) is simultaneous bilateral DBS. However, some centers conduct a staged unilateral approach advocating that reduced continuous intraoperative time reduce ... Full text Link to item Cite

Statin intolerance in a referral lipid clinic.

Journal Article J Clin Lipidol · 2016 BACKGROUND: Statins effectively prevent atherosclerotic cardiovascular disease, but rates of statin discontinuation after adverse events are high. OBJECTIVE: Describe the range and relative frequencies of adverse events potentially attributable to statins ... Full text Link to item Cite

Concomitant proton-pump inhibitor use, platelet activity, and clinical outcomes in patients with acute coronary syndromes treated with prasugrel versus clopidogrel and managed without revascularization: insights from the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial.

Journal Article Am Heart J · October 2015 UNLABELLED: Concomitant use of proton-pump inhibitors (PPIs) has been implicated in diminished antiplatelet response to clopidogrel and an increased risk of ischemic events, but primarily among patients undergoing percutaneous coronary intervention. We sou ... Full text Link to item Cite

Efficacy and safety of rivaroxaban in patients with diabetes and nonvalvular atrial fibrillation: the Rivaroxaban Once-daily, Oral, Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF Trial).

Journal Article Am Heart J · October 2015 BACKGROUND: The prevalence of both atrial fibrillation (AF) and diabetes mellitus (DM) are rising, and these conditions often occur together. Also, DM is an independent risk factor for stroke in patients with AF. We aimed to examine the safety and efficacy ... Full text Link to item Cite

Comparison of 2-Year Outcomes of Extended Criteria Cardiac Transplantation Versus Destination Left Ventricular Assist Device Therapy Using Continuous Flow.

Journal Article Am J Cardiol · August 15, 2015 Alternatives have emerged for patients ineligible for cardiac transplantation under standard criteria. The purpose of our study was to compare outcomes in patients ineligible for cardiac transplantation under standard criteria, treated either with extended ... Full text Link to item Cite

Evaluation of Selvester QRS score for use in presence of conduction abnormalities in a broad population.

Journal Article Am Heart J · August 2015 BACKGROUND: The Selvester QRS score is an electrocardiographic tool designed to quantify myocardial scar. It was updated in 2009 to expand its usefulness in patients with conduction abnormalities such as bundle-branch and fascicular blocks. There is need t ... Full text Link to item Cite

Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes.

Journal Article N Engl J Med · July 16, 2015 BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease. METHODS: In this randomized, double-blind st ... Full text Link to item Cite

Digoxin use in patients with atrial fibrillation and adverse cardiovascular outcomes: a retrospective analysis of the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF).

Journal Article Lancet · June 13, 2015 BACKGROUND: Digoxin is a widely used drug for ventricular rate control in patients with atrial fibrillation (AF), despite a scarcity of randomised trial data. We studied the use and outcomes of digoxin in patients in the Rivaroxaban Once Daily Oral Direct ... Full text Link to item Cite

Magnitude of troponin elevation and long-term clinical outcomes in acute coronary syndrome patients treated with and without revascularization.

Journal Article Circ Cardiovasc Interv · June 2015 BACKGROUND: In patients with non-ST-segment-elevation acute coronary syndrome (NSTE ACS), elevated troponin levels identify patients at high risk for adverse outcomes; however, it is unknown whether the magnitude of troponin elevation during hospitalizatio ... Full text Link to item Cite

Glycoprotein IIb/IIIa Receptor Inhibitors in Combination With Vorapaxar, a Platelet Thrombin Receptor Antagonist, Among Patients With Non-ST-Segment Elevation Acute Coronary Syndromes (from the TRACER Trial).

Journal Article Am J Cardiol · May 15, 2015 We evaluated the interaction between protease-activated receptor-1 antagonist vorapaxar and concomitant glycoprotein (GP) IIb/IIIa receptor inhibitors in patients with non-ST-segment elevation acute coronary syndromes who underwent PCI. In Thrombin Recepto ... Full text Link to item Cite

Impact of advancing age on post-operative complications of deep brain stimulation surgery for essential tremor.

Journal Article J Clin Neurosci · May 2015 Essential tremor (ET) was the original indication for deep brain stimulation (DBS), with USA Food and Drug Administration approval since 1997. Despite the efficacy of DBS, it is associated with surgical complications that cause sub-optimal clinical outcome ... Full text Link to item Cite

Alternative calculations of individual patient time in therapeutic range while taking warfarin: results from the ROCKET AF trial.

Journal Article J Am Heart Assoc · March 3, 2015 BACKGROUND: In the 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) trial, marked regional differences in control of warfarin anticoa ... Full text Link to item Cite

Applying novel methods to assess clinical outcomes: insights from the TRILOGY ACS trial.

Journal Article Eur Heart J · February 7, 2015 AIMS: Several methods provide new insights into understanding clinical trial composite endpoints, using both conventional and novel methods. The TRILOGY ACS trial is used as a contemporary example to prospectively compare these methods side by side. METHOD ... Full text Link to item Cite

A national survey of spinal cord stimulation trial-to-permanent conversion rates.

Journal Article Neuromodulation · February 2015 OBJECTIVES: Conversion rates from trial leads to permanent spinal cord stimulation (SCS) systems have recently come under scrutiny. Our goal was to examine the rate of conversion from trial lead to permanent system placement as well as identify factors ass ... Full text Link to item Cite

Higher risk of death and stroke in patients with persistent vs. paroxysmal atrial fibrillation: results from the ROCKET-AF Trial.

Journal Article Eur Heart J · February 1, 2015 AIM: Anticoagulation prophylaxis for stroke is recommended for at-risk patients with either persistent or paroxysmal atrial fibrillation (AF). We compared outcomes in patients with persistent vs. paroxysmal AF receiving oral anticoagulation. METHODS AND RE ... Full text Link to item Cite

Effects of left ventricular assist device support on biomarkers of cardiovascular stress, fibrosis, fluid homeostasis, inflammation, and renal injury.

Journal Article JACC Heart Fail · January 2015 OBJECTIVES: The purpose of this study was to examine changes in a broad panel of biomarkers following left ventricular assist device (LVAD) support in advanced heart failure (HF). BACKGROUND: LVAD therapy mechanically unloads the failing heart and may resu ... Full text Link to item Cite

Clinical characteristics and outcomes with rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation but underlying native mitral and aortic valve disease participating in the ROCKET AF trial.

Journal Article Eur Heart J · December 14, 2014 AIMS: We investigated clinical characteristics and outcomes of patients with significant valvular disease (SVD) in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in ... Full text Link to item Cite

Vorapaxar with or without clopidogrel after non-ST-segment elevation acute coronary syndromes: results from the thrombin receptor antagonist for clinical event reduction in acute coronary syndrome trial.

Journal Article Am Heart J · December 2014 BACKGROUND: Protease-activated receptor 1 antagonism with vorapaxar represents a novel strategy for platelet inhibition. In TRACER, vorapaxar was compared with placebo plus standard of care among 12,944 patients with non-ST-segment elevation acute coronary ... Full text Link to item Cite

Morbidity, mortality, and health care costs for patients undergoing spine surgery following the ACGME resident duty-hour reform: Clinical article.

Journal Article J Neurosurg Spine · October 2014 OBJECT: The Accreditation Council for Graduate Medical Education (ACGME) implemented resident duty-hour restrictions on July 1, 2003, in concern for patient and resident safety. Whereas studies have shown that duty-hour restrictions have increased resident ... Full text Link to item Cite

Effect of advancing age on outcomes of deep brain stimulation for Parkinson disease.

Journal Article JAMA Neurol · October 2014 IMPORTANCE: Deep brain stimulation (DBS) is a well-established modality for the treatment of advanced Parkinson disease (PD). Recent studies have found DBS plus best medical therapy to be superior to best medical therapy alone for patients with PD and earl ... Full text Link to item Cite

Randomized, double-blind, placebo-controlled trial of the efficacy and safety of rilonacept in the treatment of systemic juvenile idiopathic arthritis.

Conference Arthritis Rheumatol · September 2014 OBJECTIVE: To assess the efficacy and safety of rilonacept, an interleukin-1 inhibitor, in a randomized, double-blind, placebo-controlled trial. METHODS: An initial 4-week double-blind placebo phase was incorporated into a 24-week randomized multicenter de ... Full text Link to item Cite

Comparison of safety of sotalol versus amiodarone in patients with atrial fibrillation and coronary artery disease.

Journal Article Am J Cardiol · September 1, 2014 Sotalol is a commonly prescribed antiarrhythmic drug (AAD) used for maintaining sinus rhythm in patients with atrial fibrillation (AF). Although randomized studies have found that sotalol can significantly delay time to AF recurrence, its association with ... Full text Link to item Cite

Usefulness and safety of vorapaxar in patients with non-ST-segment elevation acute coronary syndrome undergoing percutaneous coronary intervention (from the TRACER Trial).

Journal Article Am J Cardiol · September 1, 2014 The therapeutic potential of vorapaxar in patients with non-ST-segment elevation acute coronary syndrome undergoing percutaneous coronary intervention (PCI) is unknown. This prespecified analysis of a postrandomization subgroup evaluated the effects of vor ... Full text Link to item Cite

Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial.

Journal Article Eur Heart J · July 21, 2014 AIMS: There are no data regarding management and outcomes of major bleeding events in patients treated with oral factor Xa inhibitors. METHODS AND RESULTS: Using data from ROCKET AF, we analysed the management and outcomes of major bleeding overall and acc ... Full text Link to item Cite

Reduction in overall occurrences of ischemic events with vorapaxar: results from TRACER.

Journal Article J Am Heart Assoc · July 10, 2014 BACKGROUND: Clinical trials traditionally use time-to-first-event analysis embedded within the composite endpoint of cardiovascular death (CVD), myocardial infarction (MI), or stroke. However, many patients have >1 event, and this approach may not reflect ... Full text Link to item Cite

Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF).

Journal Article Circulation · July 8, 2014 BACKGROUND: Nonvalvular atrial fibrillation is common in elderly patients, who face an elevated risk of stroke but difficulty sustaining warfarin treatment. The oral factor Xa inhibitor rivaroxaban was noninferior to warfarin in the Rivaroxaban Once Daily, ... Full text Link to item Cite

Use and outcomes of antiarrhythmic therapy in patients with atrial fibrillation receiving oral anticoagulation: results from the ROCKET AF trial.

Journal Article Heart Rhythm · June 2014 BACKGROUND: Antiarrhythmic drugs (AADs) and anticoagulation are mainstays of atrial fibrillation (AF) treatment. OBJECTIVE: To study the use and outcomes of AAD therapy in anticoagulated patients with AF. METHODS: Patients in the Rivaroxaban Once Daily Ora ... Full text Link to item Cite

Outcomes of temporary interruption of rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: results from the rivaroxaban once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation (ROCKET AF).

Journal Article Circulation · May 6, 2014 BACKGROUND: During long-term anticoagulation in atrial fibrillation, temporary interruptions (TIs) of therapy are common, but the relationship between patient outcomes and TIs has not been well studied. We sought to determine reasons for TI, the characteri ... Full text Link to item Cite

Intracranial hemorrhage among patients with atrial fibrillation anticoagulated with warfarin or rivaroxaban: the rivaroxaban once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation.

Journal Article Stroke · May 2014 BACKGROUND AND PURPOSE: Intracranial hemorrhage (ICH) is a life-threatening complication of anticoagulation. METHODS: We investigated the rate, outcomes, and predictors of ICH in 14 264 patients with atrial fibrillation from Rivaroxaban Once Daily, Oral, D ... Full text Link to item Cite

Use Of Rate And Rhythm Control Drugs In Patients Younger Than 65 Years With Atrial Fibrillation.

Journal Article J Atr Fibrillation · 2014 Little is known about the use of pharmacologic rhythm or rate control in younger atrial fibrillation (AF) patients in clinical practice. Using commercial health data from 2006 through 2010, patients aged <65 years with an initial AF encounter were categori ... Link to item Cite

Relationship between time in therapeutic range and comparative treatment effect of rivaroxaban and warfarin: Results from the ROCKET AF trial

Conference Journal of the American Heart Association · January 1, 2014 Background: Time in therapeutic range (TTR) is a standard quality measure of the use of warfarin. We assessed the relative effects of rivaroxaban versus warfarin at the level of trial center TTR (cTTR) since such analysis preserves randomized comparisons. ... Full text Cite

A blood-based biomarker panel to detect acute stroke.

Journal Article J Stroke Cerebrovasc Dis · 2014 BACKGROUND: The aim of this study was to develop an adjunctive, peripheral biomarker test to differentiate ischemic strokes, intracranial hemorrhages (ICHs), and stroke mimics in the acute setting. METHODS: Serum samples were collected from 167 patients wh ... Full text Link to item Cite

Adherence to guideline recommendations for antiarrhythmic drugs in atrial fibrillation.

Journal Article Am Heart J · November 2013 BACKGROUND: Atrial fibrillation (AF) guideline recommendations for antiarrhythmic drugs (AADs) are based on the effectiveness and safety of the AAD in patients with selected, concomitant heart disease. It is unknown to what extent these recommendations are ... Full text Link to item Cite

Routine early eptifibatide versus delayed provisional use at percutaneous coronary intervention in high-risk non-ST-segment elevation acute coronary syndromes patients: an analysis from the Early Glycoprotein IIb/IIIa Inhibition in Non-ST-Segment Elevation Acute Coronary Syndrome trial.

Journal Article Am Heart J · September 2013 AIMS: In the EARLY ACS trial, routine early eptifibatide was not superior to delayed provisional use at percutaneous coronary intervention (PCI); however, among PCI-treated patients, numerically fewer ischemic end points occurred in the upstream eptifibati ... Full text Link to item Cite

Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography: a secondary, prespecified analysis of the TRILOGY ACS trial.

Journal Article Lancet · August 17, 2013 BACKGROUND: Treatment with prasugrel and aspirin improves outcomes compared with clopidogrel and aspirin for patients with acute coronary syndrome who have had angiography and percutaneous coronary intervention; however, no clear benefit has been shown for ... Full text Link to item Cite

Trends in clinical trials of non-ST-segment elevation acute coronary syndromes over 15 years.

Journal Article Int J Cardiol · July 31, 2013 BACKGROUND: Data are limited on whether clinical trials have randomized higher-risk patients over time and how trends in risk profiles and evidence-based pharmacotherapies have influenced trial outcomes. We quantified changes in baseline risk, treatment, a ... Full text Link to item Cite

Quantification of the effect of clopidogrel on enzymatic infarct size related to a percutaneous coronary intervention in patients with acute coronary syndromes: insights from the CHAMPION percutaneous coronary intervention trial.

Journal Article Coron Artery Dis · June 2013 OBJECTIVES: Using data from the CHAMPION percutaneous coronary intervention (PCI), we determined the relationship between clopidogrel started at least 5 days before PCI (maintenance of clopidogrel) and PCI-related enzymatic infarct size. BACKGROUND: Clopid ... Full text Link to item Cite

Automatic cone photoreceptor segmentation using graph theory and dynamic programming.

Journal Article Biomed Opt Express · June 1, 2013 Geometrical analysis of the photoreceptor mosaic can reveal subclinical ocular pathologies. In this paper, we describe a fully automatic algorithm to identify and segment photoreceptors in adaptive optics ophthalmoscope images of the photoreceptor mosaic. ... Full text Link to item Cite

Outcomes after cardioversion and atrial fibrillation ablation in patients treated with rivaroxaban and warfarin in the ROCKET AF trial.

Journal Article J Am Coll Cardiol · May 14, 2013 OBJECTIVES: This study sought to investigate the outcomes following cardioversion or catheter ablation in patients with atrial fibrillation (AF) treated with warfarin or rivaroxaban. BACKGROUND: There are limited data on outcomes following cardioversion or ... Full text Link to item Cite

Methods of creatine kinase-MB analysis to predict mortality in patients with myocardial infarction treated with reperfusion therapy.

Journal Article Trials · May 2, 2013 BACKGROUND: Larger infarct size measured by creatine kinase (CK)-MB release is associated with higher mortality and has been used as an important surrogate endpoint in the evaluation of new treatments for ST-segment elevation myocardial infarction (STEMI). ... Full text Open Access Link to item Cite

Transfusion-related biologic effects and free hemoglobin, heme, and iron.

Journal Article Transfusion · April 2013 BACKGROUND: Red blood cell (RBC) transfusion is common in intensive care unit (ICU) patients and is associated with complications that appear related to the duration of blood storage. We hypothesize that hemolysis of stored RBCs results in increases in the ... Full text Link to item Cite

Impact of global geographic region on time in therapeutic range on warfarin anticoagulant therapy: data from the ROCKET AF clinical trial.

Journal Article J Am Heart Assoc · February 19, 2013 BACKGROUND: Vitamin K antagonist (VKA) therapy remains the most common method of stroke prevention in patients with atrial fibrillation. Time in therapeutic range (TTR) is a widely cited measure of the quality of VKA therapy. We sought to identify factors ... Full text Link to item Cite

Outcomes of discontinuing rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: analysis from the ROCKET AF trial (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation).

Journal Article J Am Coll Cardiol · February 12, 2013 OBJECTIVES: The purpose of this study was to understand the possible risk of discontinuation in the context of clinical care. BACKGROUND: Rivaroxaban is noninferior to warfarin for preventing stroke in atrial fibrillation patients. Concerns exist regarding ... Full text Link to item Cite

Buprenorphine/Naloxone and methadone effects on laboratory indices of liver health: a randomized trial.

Journal Article Drug Alcohol Depend · February 1, 2013 BACKGROUND: Buprenorphine/naloxone (BUP) and methadone (MET) are efficacious treatments for opioid dependence, although concerns about a link between BUP and drug-induced hepatitis have been raised. This study compares the effects of BUP and MET on liver h ... Full text Link to item Cite

Renal dysfunction as a predictor of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: validation of the R(2)CHADS(2) index in the 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) and ATRIA (AnTicoagulation and Risk factors In Atrial fibrillation) study cohorts.

Journal Article Circulation · January 15, 2013 BACKGROUND: We sought to define the factors associated with the occurrence of stroke and systemic embolism in a large, international atrial fibrillation (AF) trial. METHODS AND RESULTS: In ROCKET AF (Rivaroxaban Once-daily, oral, direct factor Xa inhibitio ... Full text Link to item Cite

Racial/ethnic differences in the rates and correlates of HIV risk behaviors among drug abusers.

Journal Article Am J Addict · 2013 BACKGROUND: HIV infection disproportionately impacts minorities; yet research on racial/ethnic differences in the prevalence and correlates of HIV risk behaviors is limited. OBJECTIVE: This study examined racial/ethnic differences in the rates of HIV risk ... Full text Link to item Cite

Longitudinal reproducibility of optical coherence tomography measurements in children.

Journal Article J AAPOS · December 2012 PURPOSE: To evaluate the longitudinal reproducibility of optical coherence tomography (OCT) measurements in normal and glaucomatous eyes of children. METHODS: In this 2-setting prospective study, OCT-3 was used to obtain fast retinal nerve fiber layer (RNF ... Full text Link to item Cite

Prasugrel versus clopidogrel for acute coronary syndromes without revascularization.

Journal Article N Engl J Med · October 4, 2012 BACKGROUND: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated. METHODS: In this double-blind, randomized trial, ... Full text Link to item Cite

Sustained ventricular tachycardia and ventricular fibrillation complicating non-ST-segment-elevation acute coronary syndromes.

Journal Article Circulation · July 3, 2012 BACKGROUND: Ventricular arrhythmias remain a lethal complication of acute coronary syndromes (ACS). However, the incidence and prognosis of sustained ventricular tachycardia/ventricular fibrillation (VT/VF) in contemporary non-ST-segment-elevation (NSTE) A ... Full text Link to item Cite

Regional patterns of use of a medical management strategy for patients with non-ST-segment elevation acute coronary syndromes: insights from the EARLY ACS Trial.

Journal Article Circ Cardiovasc Qual Outcomes · March 1, 2012 BACKGROUND: Regional differences in the profile and prognosis of non-ST-segment elevation acute coronary syndrome (NSTE ACS) patients treated with medical management after angiography remain uncertain. METHODS AND RESULTS: Using data from the Early Glycopr ... Full text Link to item Cite

Prediction of enzymatic infarct size in ST-segment elevation myocardial infarction.

Journal Article Coron Artery Dis · March 2012 OBJECTIVES: Predictors of adverse outcomes following myocardial infarction (MI) are well established; however, little is known about what predicts enzymatically estimated infarct size in patients with acute ST-elevation MI. The Complement And Reduction of ... Full text Link to item Cite

Percutaneous coronary interventions and cardiovascular outcomes for patients with chronic total occlusions.

Journal Article Catheter Cardiovasc Interv · March 1, 2012 OBJECTIVES: This study sought to assess the benefits of a coronary chronic total occlusion CTO recanalization after adjusting for the case-mix and the propensity to undergo the CTO intervention in a population of patients with stable coronary artery diseas ... Full text Link to item Cite

Thrombin-receptor antagonist vorapaxar in acute coronary syndromes.

Journal Article N Engl J Med · January 5, 2012 BACKGROUND: Vorapaxar is a new oral protease-activated-receptor 1 (PAR-1) antagonist that inhibits thrombin-induced platelet activation. METHODS: In this multinational, double-blind, randomized trial, we compared vorapaxar with placebo in 12,944 patients w ... Full text Link to item Cite

The impact of postrandomization crossover of therapy in acute coronary syndromes care.

Journal Article Circ Cardiovasc Qual Outcomes · March 2011 BACKGROUND: In the Superior Yield of the New Strategy of Enoxaparin, Revascularization, and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) study, patients assigned enoxaparin or unfractionated heparin (UFH) were treated with alternative anticoagulant therapy a ... Full text Link to item Cite

Gender differences in the rates and correlates of HIV risk behaviors among drug abusers.

Journal Article Subst Use Misuse · December 2010 This study examined gender differences in the rates and correlates of HIV risk behaviors among 1,429 clients participating in multi-site trials throughout the United States between 2001 and 2005 as part of the National Institute on Drug Abuse-funded Clinic ... Full text Link to item Cite

A polymorphism near IL28B is associated with spontaneous clearance of acute hepatitis C virus and jaundice.

Journal Article Gastroenterology · November 2010 BACKGROUND & AIMS: A single nucleotide polymorphism (SNP) upstream of the IL28B gene has been associated with response of patients with chronic hepatitis C to therapy with pegylated interferon and ribavirin and also with spontaneous clearance of acute hepa ... Full text Link to item Cite

Platelet factor 4/heparin antibodies in blood bank donors.

Journal Article Am J Clin Pathol · November 2010 Platelet factor 4 (PF4)/heparin antibody, typically associated with heparin therapy, is reported in some heparin-naive people. Seroprevalence in the general population, however, remains unclear. We prospectively evaluated PF4/heparin antibody in approximat ... Full text Link to item Cite

Study design and rationale of a comparison of prasugrel and clopidogrel in medically managed patients with unstable angina/non-ST-segment elevation myocardial infarction: the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) trial.

Journal Article Am Heart J · July 2010 Practice guidelines recommend dual antiplatelet therapy with aspirin and clopidogrel for patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) regardless of in-hospital management strategy. Prasugrel-a thienopyridine adenosine diphosph ... Full text Link to item Cite

Inpatient medication reconciliation at admission and discharge: A retrospective cohort study of age and other risk factors for medication discrepancies.

Journal Article Am J Geriatr Pharmacother · April 2010 BACKGROUND: Medication discrepancies are unintended differences between medication regimens (ie, between a patient's home regimen and medications prescribed on admission to the hospital). OBJECTIVE: The goal of this study was to describe the incidence, dru ... Full text Link to item Cite

Body image and body satisfaction differ by race in overweight postpartum mothers.

Journal Article J Womens Health (Larchmt) · February 2010 BACKGROUND: Body image (BI) and body satisfaction may be important in understanding weight loss behaviors, particularly during the postpartum period. We assessed these constructs among African American and white overweight postpartum women. METHODS: The sa ... Full text Open Access Link to item Cite

Long-term clinical outcome of patients with severe combined immunodeficiency who received related donor bone marrow transplants without pretransplant chemotherapy or post-transplant GVHD prophylaxis.

Journal Article J Pediatr · December 2009 OBJECTIVE: To determine long-term health benefits of nonablative bone marrow transplantation for severe combined immunodeficiency (SCID), we investigated our cohort of 161 related donor bone marrow-transplanted patients with SCID. Only 16 (10%) had HLA-ide ... Full text Link to item Cite

Safety of a peanut oral immunotherapy protocol in children with peanut allergy.

Journal Article J Allergy Clin Immunol · August 2009 Featured Publication BACKGROUND: Oral immunotherapy (OIT) offers a promising therapeutic option for peanut allergy. Given that during OIT an allergic patient ingests an allergen that could potentially cause a serious reaction, the safety of OIT is of particular concern. OBJECT ... Full text Link to item Cite

Usefulness of beta blockers in high-risk patients after myocardial infarction in conjunction with captopril and/or valsartan (from the VALsartan In Acute Myocardial Infarction [VALIANT] trial).

Journal Article Am J Cardiol · July 15, 2009 Featured Publication Concern has been raised about combining beta blockers with angiotensin-receptor blockers in patients with heart failure. The VALsartan In Acute myocardial infarction (VALIANT) trial enrolled 14,703 patients with myocardial infarction complicated by heart f ... Full text Link to item Cite

Clinical and angiographic outcomes with sirolimus-eluting stents in total coronary occlusions: the ACROSS/TOSCA-4 (Approaches to Chronic Occlusions With Sirolimus-Eluting Stents/Total Occlusion Study of Coronary Arteries-4) trial.

Journal Article JACC Cardiovasc Interv · February 2009 Featured Publication OBJECTIVES: We sought to examine angiographic and clinical outcomes with sirolimus-eluting stents (SES) in total coronary occlusion (TCO) revascularization. BACKGROUND: Despite evaluation of drug-eluting stents beyond approved indications, few studies have ... Full text Link to item Cite

Optimal two-stage group-sequential designs

Journal Article Journal of Statistical Planning and Inference · February 1, 2008 We derive optimal two-stage adaptive group-sequential designs for normally distributed data which achieve the minimum of a mixture of expected sample sizes at the range of plausible values of a normal mean. Unlike standard group-sequential tests, our metho ... Full text Cite

Amiodarone use after acute myocardial infarction complicated by heart failure and/or left ventricular dysfunction may be associated with excess mortality.

Journal Article Am Heart J · January 2008 Featured Publication BACKGROUND: We sought to assess the association of amiodarone use with mortality during consecutive periods in patients with post-acute myocardial infarction with left ventricular systolic dysfunction and/or HF treated with a contemporary medical regimen. ... Full text Link to item Cite

Time to coronary angiography and outcomes among patients with high-risk non ST-segment elevation acute coronary syndromes: results from the SYNERGY trial.

Journal Article Circulation · December 4, 2007 Featured Publication BACKGROUND: Optimal timing for an early invasive strategy in patients with non-ST-segment-elevation acute coronary syndrome remains unclear. We evaluated the relationship between time from hospital admission to coronary angiography and outcomes in high-ris ... Full text Link to item Cite

Timing of death and myocardial infarction in patients with non-ST elevation acute coronary syndromes: insights from randomized clinical trials.

Journal Article J Interv Cardiol · October 2007 Featured Publication BACKGROUND: Adverse events occur following non-ST elevation acute coronary syndromes (NSTE ACS). However, the timing of these events in relation to index event is less clear. METHODS: Accordingly, we evaluated 26,466 NSTE ACS patients from the Global Use o ... Full text Link to item Cite

Relation between dose of loop diuretics and outcomes in a heart failure population: results of the ESCAPE trial.

Journal Article Eur J Heart Fail · October 2007 Featured Publication BACKGROUND: We examined the relation of maximal in-hospital diuretic dose to weight loss, changes in renal function, and mortality in hospitalised heart failure (HF) patients. METHODS: In ESCAPE, 395 patients received diuretics in-hospital. Weight was meas ... Full text Link to item Cite

Cox regression methods for two-stage randomization designs.

Journal Article Biometrics · June 2007 Featured Publication Two-stage randomization designs (TSRD) are becoming increasingly common in oncology and AIDS clinical trials as they make more efficient use of study participants to examine therapeutic regimens. In these designs patients are initially randomized to an ind ... Full text Link to item Cite

Predictors of stroke in high-risk patients after acute myocardial infarction: insights from the VALIANT Trial.

Journal Article Eur Heart J · March 2007 Featured Publication AIMS: We sought to determine risk models for predicting early and late stroke in a large cohort of high-risk post-myocardial infarction (MI) patients. METHODS AND RESULTS: We prospectively analysed data from 14 703 patients in the VALIANT trial with acute ... Full text Link to item Cite

Risk indexes for exacerbations and hospitalizations due to COPD.

Journal Article Chest · January 2007 Featured Publication OBJECTIVE: The ability to predict exacerbations in patients with COPD might permit more rational use of preventive interventions. Our objective was to develop risk indexes for exacerbations and hospitalizations due to exacerbations that might be applied to ... Full text Link to item Cite

Comparison of concordance correlation coefficient and coefficient of individual agreement in assessing agreement.

Journal Article J Biopharm Stat · 2007 Featured Publication In method comparison and reliability studies, it is often important to assess agreement between multiple measurements made by different methods, devices, laboratories, observers, or instruments. For continuous data, the concordance correlation coefficient ... Full text Link to item Cite

Tests for 2 × 2 tables in clinical trials

Journal Article Journal of Modern Applied Statistical Methods · January 1, 2007 Five standard tests are compared: chi-squared, Fisher's exact, Yates' correction, Fisher's exact mid-p, and Barnard's. Yates' is always inferior to Fisher's exact. Fisher's exact is so conservative that one should look for alternatives. For certain sample ... Full text Cite

Efficacy and safety of enoxaparin compared with unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndrome undergoing percutaneous coronary intervention in the Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial.

Journal Article Am Heart J · December 2006 Featured Publication BACKGROUND: Enoxaparin reduces ischemic events more effectively than unfractionated heparin (UFH) in patients treated conservatively for non-ST-segment elevation acute coronary syndrome. The SYNERGY trial compared these agents in high-risk patients undergo ... Full text Link to item Cite