Enhanced Versus Standard Dermatologic Management With Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC: The COCOON Global Randomized Controlled Trial.

Introduction: Amivantamab plus lazertinib significantly improved progression-free and overall survival versus osimertinib in patients with previously untreated, EGFR-mutant advanced NSCLC. EGFR-targeted therapies are associated with dermatologic adverse events (AEs), which can affect quality of life (QoL). COCOON was conducted to assess prophylactic management and improve treatment experience.

Achievement and quality measure attainment in patients hospitalized with atrial fibrillation: Results from The Get With The Guidelines - Atrial Fibrillation (GWTG-AFIB) registry.

Background: The Get With The Guidelines - Atrial Fibrillation (GWTG-AFIB) Registry uses achievement and quality measures to improve the care of patients with atrial fibrillation (AF). We sought to evaluate overall and site-level variation in attainment of these measures among sites participating in the GWTG-AFIB Registry.

Methods: From the GWTG-AFIB registry, we included patients with AF admitted between 1/3/2013 and 6/30/2019.

Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in acute and early HIV-1 infection: a DIAMOND subgroup analysis.

Background: Treatment during acute or early human immunodeficiency virus (HIV)-1 infection is associated with immunologic and virologic benefits.

Objective: To evaluate darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) efficacy/safety among patients with acute or early HIV-1 infection who rapidly initiate treatment.

Methods: DIAMOND (ClinicalTrials.

Home Health Care Use and Post-Discharge Outcomes After Heart Failure Hospitalizations.

Objectives: This study compared the characteristics of Medicare beneficiaries who were hospitalized for heart failure (HF) and then discharged home who received home health care (HHC) to the characteristics of those who did not, and examined associations among HHC and readmission and mortality rates.

Background: After hospitalization for HF, some patients receive HHC. However, the use of HHC over time, the factors associated with its use, and the post-discharge outcomes after receiving it are not well studied.

Strict Versus Lenient Versus Poor Rate Control Among Patients With Atrial Fibrillation and Heart Failure (from the Get With The Guidelines - Heart Failure Program).

Randomized data suggest lenient rate control (resting heart rate <110 beats/min) is noninferior to strict rate control (resting heart rate <80 beats/min) in patients with atrial fibrillation (AF). However, the optimal rate control strategy in patients with AF and heart failure (HF) remains unknown. Accordingly, we performed an observational analysis using data from the Get With The Guidelines-HF Program linked with Medicare data from July 1, 2011, to September 30, 2014.

Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF.

Objectives: This study sought to determine the degree to which U.S. patients enrolled in a heart failure (HF) trial represent patients in routine U.

Thrombolysis in young adults with stroke: Findings from Get With The Guidelines-Stroke.

Objective: To determine whether young adults (≤40 years old) with acute ischemic stroke are less likely to receive IV tissue plasminogen activator (tPA) and more likely to have longer times to brain imaging and treatment.

Methods: We analyzed data from the Get With The Guidelines-Stroke registry for patients with acute ischemic stroke hospitalized between January 2009 and September 2015. We used multivariable models with generalized estimating equations to evaluate tPA treatment and outcomes between younger (age 18-40 years) and older (age >40 years) patients with acute ischemic stroke.

Effect of Catheter Ablation vs Medical Therapy on Quality of Life Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial.

Importance: Catheter ablation is more effective than drug therapy in restoring sinus rhythm in patients with atrial fibrillation (AF), but its incremental effect on long-term quality of life (QOL) is uncertain.

Objective: To determine whether catheter ablation is more beneficial than conventional drug therapy for improving QOL in patients with AF.

Design, Setting, And Participants: An open-label randomized clinical trial of catheter ablation vs drug therapy in 2204 symptomatic patients with AF older than 65 years or 65 years or younger with at least 1 risk factor for stroke.

Use, Temporal Trends, and Outcomes of Endovascular Therapy After Interhospital Transfer in the United States.

Background: The use of endovascular therapy (EVT) in patients with acute ischemic stroke who have large vessel occlusion has rapidly increased in the United States following pivotal trials demonstrating its benefit. Information about the contribution of interhospital transfer in improving access to EVT will help organize regional systems of stroke care.

Methods: We analyzed trends of transfer-in EVT from a cohort of 1 863 693 patients with ischemic stroke admitted to 2143 Get With The Guidelines-Stroke participating hospitals between January 2012 and December 2017.

Characteristics of Acute Heart Failure Hospitalizations Based on Presenting Severity.

Background: Hospitalizations for acute heart failure (HF) are significant events with downstream implications for patients, as well as healthcare systems and payers. However, from anecdotal experience, both hospitalization and postdischarge courses vary significantly based on severity of presenting decompensation.

Methods And Results: We compared patient and hospitalization characteristics, resource utilization, and associated outcomes, among modern era acute HF patients enrolled in the GWTG-HF (Get With the Guidelines-Heart Failure) registry between 2011 and 2016, by varying severity of their acute HF.

Association of Kidney Function With 30-Day and 1-Year Poststroke Mortality and Hospital Readmission.

Background and Purpose- Kidney dysfunction is common among patients hospitalized for ischemic stroke. Understanding the association of kidney disease with poststroke outcomes is important to properly adjust for case mix in outcome studies, payment models and risk-standardized hospital readmission rates. Methods- In this cohort study of fee-for-service Medicare patients admitted with ischemic stroke to 1579 Get With The Guidelines-Stroke participating hospitals between 2009 and 2014, adjusted multivariable Cox proportional hazards models were used to determine the independent associations of estimated glomerular filtration rate (eGFR) and dialysis status with 30-day and 1-year postdischarge mortality and rehospitalizations.

Glycated Hemoglobin and Outcomes of Heart Failure (from Get With the Guidelines-Heart Failure).

Glycated hemoglobin (HbA) is a risk factor for new onset heart failure (HF). There is however a paucity of data evaluating its association with outcomes in patients with established HF. We assessed the relation of HbA with outcomes among hospitalized HF patients.

Economic and Quality-of-Life Outcomes of Natriuretic Peptide-Guided Therapy for Heart Failure.

Background: The GUIDE-IT (GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) trial prospectively compared the efficacy of an N-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided heart failure treatment strategy (target NT-proBNP level <1,000 pg/ml) with optimal medical therapy alone in high-risk patients with heart failure and reduced ejection fraction. When the study was stopped for futility, 894 patients had been enrolled.

Objectives: The purpose of this study was to assess treatment-related quality-of-life (QOL) and economic outcomes in the GUIDE-IT trial.

Shock Index Predicts Patient-Related Clinical Outcomes in Stroke.

Background The prognostic value of shock index ( SI ), heart rate divided by systolic blood pressure, in stroke for clinical outcomes other than mortality is not well understood. Methods and Results We examined the Get With The Guidelines-Stroke ( GWTG -Stroke) data to explore the usefulness of SI in predicting in-hospital outcomes in 425 808 acute stroke cases (mean age: 71.0±14.

Dofetilide dose reductions and discontinuations in women compared with men.

Background: Compared with men, women have longer corrected QT (QTc) intervals, lower clearance of dofetilide, and higher rates of drug-induced torsades de pointes, but the dofetilide dosing algorithm is the same for men and women.

Objective: The purpose of this study was to evaluate the tolerability of the 500 μg twice daily dose of dofetilide for men and women.

Methods: Men and women admitted to Duke University Medical Center (January 1, 2006, to October 19, 2012) for the initiation of dofetilide 500 μg twice daily were matched 1:1 on age and estimated creatinine clearance.

Association of Electronic Health Record Use With Quality of Care and Outcomes in Heart Failure: An Analysis of Get With The Guidelines-Heart Failure.

Background: Adoption of electronic health record (EHR) systems has increased significantly across the nation. Whether EHR use has translated into improved quality of care and outcomes in heart failure (HF) is not well studied.

Methods And Results: We examined participants from the Get With The Guidelines-HF registry who were admitted with HF in 2008 (N=21 222), using various degrees of EHR implementation (no EHR, partial EHR, and full EHR).

Economic Analysis of Apixaban Therapy for Patients With Atrial Fibrillation From a US Perspective: Results From the ARISTOTLE Randomized Clinical Trial.

Importance: The Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial reported that apixaban therapy was superior to warfarin therapy in preventing stroke and all-cause death while causing significantly fewer major bleeds. To establish the value proposition of substituting apixiban therapy for warfarin therapy in patients with atrial fibrillation, we performed a cost-effectiveness analysis using patient-level data from the ARISTOTLE trial.

Objective: To assess the cost and cost-effectiveness of apixaban therapy compared with warfarin therapy in patients with atrial fibrillation from the perspective of the US health care system.

Delays in Door-to-Needle Times and Their Impact on Treatment Time and Outcomes in Get With The Guidelines-Stroke.

Background And Purpose: Despite quality improvement programs such as the American Heart Association/American Stroke Association Target Stroke initiative, a substantial portion of acute ischemic stroke patients are still treated with tissue-type plasminogen activator (alteplase) later than 60 minutes from arrival. This study aims to describe the documented reasons for delays and the associations between reasons for delays and patient outcomes.

Methods: We analyzed the characteristics of 55 296 patients who received intravenous alteplase in 1422 hospitals participating in Get With The Guidelines-Stroke from October 2012 to April 2015, excluding transferred patients and inpatient strokes.

Prescription of Guideline-Recommended Implantable Cardioverter Defibrillator and Cardiac Resynchronization Therapy Among Patients Hospitalized With Heart Failure and Varying Degrees of Renal Function.

Implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) reduce mortality in many patients with heart failure (HF), but the current use and effectiveness of ICD/CRT in patients with chronic kidney disease (CKD) are uncertain. We examined associations between kidney function and guideline-recommended prescription of ICD/CRT in the Get With The Guidelines-Heart Failure registry, a performance improvement program for hospitalized patients with HF. We compared differences in ICD and CRT prescription between the following categories of estimated glomerular filtration rate (eGFR; mL/min/1.

Factors Associated With and Prognostic Implications of Cardiac Troponin Elevation in Decompensated Heart Failure With Preserved Ejection Fraction: Findings From the American Heart Association Get With The Guidelines-Heart Failure Program.

Importance: Elevated levels of cardiac troponins are associated with adverse clinical outcomes among patients with heart failure (HF) and reduced ejection fraction. However, the clinical significance of troponin elevation in the setting of decompensated HF with preserved ejection fraction (HFpEF) is not well established.

Objective: To determine the clinical predictors of troponin elevation and its association with in-hospital and long-term outcomes among patients with decompensated HFpEF.

Heart failure medications prescribed at discharge for patients with left ventricular assist devices.

Background: Real-world use of traditional heart failure (HF) medications for patients with left ventricular assist devices (LVADs) is not well known.

Methods: We conducted a retrospective, observational analysis of 1,887 advanced HF patients with and without LVADs from 32 LVAD hospitals participating in the Get With The Guidelines-Heart Failure registry from January 2009 to March 2015. We examined HF medication prescription at discharge, temporal trends, and predictors of prescription among patients with an in-hospital (n = 258) or prior (n = 171) LVAD implant, and those with advanced HF but no LVAD, as defined by a left ventricular ejection fraction ≤25% and in-hospital receipt of intravenous inotropes or vasopressin receptor antagonists (n = 1,458).

Quality-of-Life Outcomes With Anatomic Versus Functional Diagnostic Testing Strategies in Symptomatic Patients With Suspected Coronary Artery Disease: Results From the PROMISE Randomized Trial.

Background: The Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial found that initial use of ≥64 detector-row computed tomography angiography versus standard functional testing strategies (exercise ECG, stress nuclear methods, or stress echocardiography) did not improve clinical outcomes in 10 003 stable symptomatic patients with suspected coronary artery disease requiring noninvasive testing. Symptom burden and quality of life (QOL) were major secondary outcomes.

Methods And Results: We prospectively collected a battery of QOL instruments in 5985 patients at baseline and 6, 12, and 24 months postrandomization.

Association of Hospital and Physician Characteristics and Care Processes With Racial Disparities in Procedural Outcomes Among Contemporary Patients Undergoing Coronary Artery Bypass Grafting Surgery.

Background: Previous studies have reported that black patients undergoing coronary artery bypass surgery had worse outcomes than white patients, even after accounting for patient factors. The degree to which clinician, hospital, and care factors account for these outcome differences remains unclear.

Methods And Results: We evaluated procedural outcomes in 11,697 blacks and 136,362 whites undergoing isolated coronary artery bypass surgery at 663 Society of Thoracic Surgery Database participating sites (January 1, 2010 to June 30, 2011) adjusted for patients' clinical and socioeconomic features, hospital and surgeon effects, and care processes (internal mammary artery graft and perioperative medications use).

Comparison of quality-of-life measures after radial versus femoral artery access for cardiac catheterization in women: Results of the Study of Access Site for Enhancement of Percutaneous Coronary Intervention for Women quality-of-life substudy.

Background: In the SAFE-PCI for Women trial, patient preference for radial access for future procedures was greater than for femoral access. We sought to assess whether radial or femoral access impacts formal measures of quality-of-life (QOL) among women undergoing cardiac catheterization.

Methods: We assessed QOL using European quality of life-5 dimensions (EQ-5D) and EQ visual analog scale (EQ-VAS) scores among 304 women randomized to radial or femoral arteriotomy in the SAFE-PCI for Women trial at sites with QOL substudy approval.