Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia: A Randomized Clinical Trial.

Importance: Immune dysregulation contributes to poorer outcomes in COVID-19.

Objective: To investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to standard care for COVID-19 pneumonia.

Design, Setting, And Participants: Randomized, double-masked, placebo-controlled clinical trial using a master protocol to investigate immunomodulators added to standard care for treatment of participants hospitalized with COVID-19 pneumonia.

Rationale and design of a multicenter randomized clinical trial of vestibulodynia: understanding pathophysiology and determining appropriate treatments (vestibulodynia: UPDATe).

Background: Limited data are available to establish evidence-based management protocols for vestibulodynia (VBD), a chronic vulvar pain condition that affects approximately 14 million women in the U.S. For the purposes of the study, our group subdivided VBD subtypes that may benefit from different types of treatment: 1) VBD peripheral (VBD-p), characterized by pain localized to the vulvar vestibule and 2) VBD central (VBD-c), characterized by VBD alongside one or more other chronic overlapping pain conditions (e.

Abatacept for Treatment of Adults Hospitalized with Moderate or Severe Covid-19.

Background: We investigated whether abatacept, a selective costimulation modulator, provides additional benefit when added to standard-of-care for patients hospitalized with Covid-19.

Methods: We conducted a master protocol to investigate immunomodulators for potential benefit treating patients hospitalized with Covid-19 and report results for abatacept. Intravenous abatacept (one-time dose 10 mg/kg, maximum dose 1000 mg) plus standard of care (SOC) was compared with shared placebo plus SOC.

Infliximab for Treatment of Adults Hospitalized with Moderate or Severe Covid-19.

Background: Immune dysregulation contributes to poorer outcomes in severe Covid-19. Immunomodulators targeting various pathways have improved outcomes. We investigated whether infliximab provides benefit over standard of care.

Prophylactic Mechanical Circulatory Support Use in Elective Percutaneous Coronary Intervention for Patients With Stable Coronary Artery Disease.

Background: Mechanical circulatory support (MCS) devices can be used in high-risk percutaneous coronary intervention (PCI). Our objective was to describe trends and outcomes of prophylactic MCS use in elective PCI for patients with stable coronary artery disease in the American College of Cardiology National Cardiovascular Data Registry's CathPCI registry.

Methods: Among 2 108 715 consecutive patients with stable coronary artery disease undergoing elective PCI in the CathPCI registry between 2009 and 2018, we examined patterns of prophylactic use of MCS.

Differential Longitudinal Outcomes Following Percutaneous Coronary Intervention to the Left Internal Mammary Artery and Other Bypass Grafts of the LAD: Findings From the NCDR.

Objectives: Limited studies of percutaneous coronary intervention (PCI) of the left internal mammary artery (LIMA) graft exist. We compared outcomes of different bypass grafts to the left anterior descending (LAD) coronary artery.

Methods: Participants ≥65 years old in the CathPCI Registry who underwent PCI of a bypass graft to the LAD between 2009 and 2014 were included.

Establishment of normative ranges of the healthy human immune system with comprehensive polychromatic flow cytometry profiling.

Existing normative flow cytometry data have several limitations including small sample sizes, incompletely described study populations, variable flow cytometry methodology, and limited depth for defining lymphocyte subpopulations. To overcome these issues, we defined high-dimensional flow cytometry reference ranges for the healthy human immune system using Human Immunology Project Consortium methodologies after carefully screening 127 subjects deemed healthy through clinical and laboratory testing. We enrolled subjects in the following age cohorts: 18-29 years, 30-39, 40-49, and 50-66 and enrolled cohorts to ensure an even gender distribution and at least 30% non-Caucasians.

Association of Physician Variation in Use of Manual Aspiration Thrombectomy With Outcomes Following Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction: The National Cardiovascular Data Registry CathPCI Registry.

Importance: Following negative randomized clinical trials, US guidelines downgraded support for routine manual aspiration thrombectomy (AT) during primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction (STEMI). However, some PCI operators continue to endorse a clinical benefit with AT use despite the lack of supportive data.

Objective: To examine temporal trends and comparative outcomes of AT use during pPCI for STEMI.

Relationship Between Operator Volume and Long-Term Outcomes After Percutaneous Coronary Intervention.

Background: Although many studies show an inverse association between operator procedural volume and short-term adverse outcomes after percutaneous coronary intervention (PCI), the association between procedural volume and longer-term outcomes is unknown.

Methods: Using the National Cardiovascular Data Registry CathPCI registry data linked with Medicare claims data, we examined the association between operator PCI volume and long-term outcomes among patients ≥65 years of age. Operators were stratified by average annual PCI volume (counting PCIs performed in patients of all ages): low- (<50 PCIs), intermediate- (50-100), and high- (>100) volume operators.

Usefulness of Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Myocardial Infarction.

To examine patterns of preadmission and discharge antithrombotic therapies in coronary artery disease (CAD) and atrial fibrillation (AF) patients admitted for acute myocardial infarction (AMI), we performed a retrospective analysis of the Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines (ACTION Registry-GWTG), which captures consecutive AMI patients treated at participating US hospitals. We included patients with CAD, AF, and CHADS-VASc score ≥2 admitted for AMI (07/01/2013-09/30/2016). In the 15,034 AMI patients with previous AF and CAD, median age was 75; 32% were female.

Association of Patient Perceptions of Cardiovascular Risk and Beliefs on Statin Drugs With Racial Differences in Statin Use: Insights From the Patient and Provider Assessment of Lipid Management Registry.

Importance: African American individuals face higher atherosclerotic cardiovascular disease risk than white individuals; reasons for these differences, including potential differences in patient beliefs regarding preventive care, remain unknown.

Objective: To evaluate differences in statin use between white and African American patients and identify the potential causes for any observed differences.

Design, Setting, And Participants: Using the 2015 Patient and Provider Assessment of Lipid Management (PALM) Registry data, we compared statin use and dosing between African American and white outpatient adults who were potentially eligible for primary or secondary prevention statins.

Appropriateness and Outcomes of Percutaneous Coronary Intervention at Top-Ranked and Nonranked Hospitals in the United States.

Objectives: This study sought to compare the appropriate use and outcomes of percutaneous coronary intervention (PCI) between top-ranked and nonranked hospitals.

Background: The U.S.

Outcomes of PCI in Relation to Procedural Characteristics and Operator Volumes in the United States.

Background: Professional guidelines have reduced the recommended minimum number to an average of 50 percutaneous coronary intervention (PCI) procedures performed annually by each operator. Operator volume patterns and associated outcomes since this change are unknown.

Objectives: The authors describe herein PCI operator procedure volumes; characteristics of low-, intermediate-, and high-volume operators; and the relationship between operator volume and clinical outcomes in a large, contemporary, nationwide sample.

Metformin for Treatment of Overweight Induced by Atypical Antipsychotic Medication in Young People With Autism Spectrum Disorder: A Randomized Clinical Trial.

Importance: Atypical antipsychotic medications are indicated for the treatment of irritability and agitation symptoms in children with autism spectrum disorder (ASD). Unfortunately, these medications are associated with weight gain and metabolic complications that are especially troubling in children and with long-term use.

Objective: To evaluate the efficacy of metformin for weight gain associated with atypical antipsychotic medications in children and adolescents with ASD (defined in the protocol as DSM-IV diagnosis of autistic disorder, Asperger disorder, or pervasive developmental disorder not otherwise specified), aged 6 to 17 years.

Coronary CT Angiography Versus Standard Emergency Department Evaluation for Acute Chest Pain and Diabetic Patients: Is There Benefit With Early Coronary CT Angiography? Results of the Randomized Comparative Effectiveness ROMICAT II Trial.

Background: Cardiac computed tomography angiography (CCTA) reduces emergency department length of stay compared with standard evaluation in patients with low- and intermediate-risk acute chest pain. Whether diabetic patients have similar benefits is unknown.

Methods And Results: In this prespecified analysis of the Rule Out Myocardial Ischemia/Infarction by Computer Assisted Tomography (ROMICAT II) multicenter trial, we randomized 1000 patients (17% diabetic) with symptoms suggestive of acute coronary syndrome to CCTA or standard evaluation.

Use of Coronary Computed Tomographic Angiography Findings to Modify Statin and Aspirin Prescription in Patients With Acute Chest Pain.

Coronary CT angiography (CCTA) is used in patients with low-intermediate chest pain presenting to the emergency department for its reliability in excluding acute coronary syndrome (ACS). However, its influence on medication modification in this setting is unclear. We sought to determine whether knowledge of CCTA-based coronary artery disease (CAD) was associated with change in statin and aspirin prescription.

Potential for coronary CT angiography to tailor medical therapy beyond preventive guideline-based recommendations: insights from the ROMICAT I trial.

Background: Coronary CT angiography (CCTA) is used in the emergency department to rule out acute coronary syndrome in low-intermediate risk patients.

Objectives: We evaluated the potential of CCTA to tailor aspirin (ASA) and statin therapy in acute chest pain patients.

Methods: We included all patients in the ROMICAT I trial who underwent CCTA before admission.

An electronic surveillance tool for catheter-associated urinary tract infection in intensive care units.

Background: Traditional methods of surveillance of catheter-associated urinary tract infections (CAUTIs) are error-prone and resource-intensive. To resolve these issues, we developed a highly sensitive electronic surveillance tool.

Objective: To develop an electronic surveillance tool for CAUTIs and assess its performance.

Sensitive troponin assays in patients with suspected acute coronary syndrome: Results from the multicenter rule out myocardial infarction using computer assisted tomography II trial.

Background: Sensitive troponin (Tn) assays have been developed for the evaluation of patients with suspected acute coronary syndrome (ACS). We sought to compare the performance of a commercially available sensitive Tn I (sTnI) and precommercial highly sTnI (hsTnI) method to conventional Tn (cTn) assays.

Methods: Among patients with acute chest pain but normal cTn in the emergency department of 6 centers, sTnI and hsTnI were measured at baseline, 2 and 4 hours after presentation.

Use of coronary artery calcium scanning beyond coronary computed tomographic angiography in the emergency department evaluation for acute chest pain: the ROMICAT II trial.

Background: Whether a coronary artery calcium (CAC) scan provides added value to coronary computed tomographic angiography (CCTA) in emergency department patients with acute chest pain remains unsettled. We sought to determine the value of CAC scan in patients with acute chest pain undergoing CCTA.

Methods And Results: In the multicenter Rule Out Myocardial Infarction using Computer-Assisted Tomography (ROMICAT) II trial, we enrolled low-intermediate risk emergency department patients with symptoms suggesting acute coronary syndrome (ACS).

Steroid exposure, acute coronary syndrome, and inflammatory bowel disease: insights into the inflammatory milieu.

Background: Steroids are anti-inflammatory agents commonly used to treat inflammatory bowel disease. Inflammation plays a critical role in the pathophysiology of both inflammatory bowel disease and acute coronary syndrome. We examined the relationship between steroid use in patients with inflammatory bowel disease and acute coronary syndrome.

Coronary CT angiography versus standard evaluation in acute chest pain.

Background: It is unclear whether an evaluation incorporating coronary computed tomographic angiography (CCTA) is more effective than standard evaluation in the emergency department in patients with symptoms suggestive of acute coronary syndromes.

Methods: In this multicenter trial, we randomly assigned patients 40 to 74 years of age with symptoms suggestive of acute coronary syndromes but without ischemic electrocardiographic changes or an initial positive troponin test to early CCTA or to standard evaluation in the emergency department on weekdays during daylight hours between April 2010 and January 2012. The primary end point was length of stay in the hospital.