Heart Failure Therapy and Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction

Novartis42,494 enrolled

Overview

This was a retrospective observational cohort study using patient data from the Get With The Guideline-Heart Failure (GWTG-HF) registry linked to Medicare Fee-for-Service (FFS) claims. The main goal of the study was to compare home-time in Medicare FFS patients with heart failure with mildly reduced or preserved ejection fraction discharged with sacubitril/valsartan versus those discharged without sacubitril/valsartan.

Study Type

OBSERVATIONAL

Enrollment

42,494

Conditions

Heart Failure With Reduced Ejection Fraction Heart Failure With Preserved Ejection Fraction

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion criteria: * Hospitalized for heart failure from 01 January 2016 to 30 September 2021. * Were discharged alive (any discharge disposition other than "Expired"). * Had Mildly reduced or preserved ejection fraction (41% to 60%). * Had non-missing record of SAC/VAL use at discharge. * Continuously enrolled in Medicare Part A \& B for the 12 months following the index HF hospitalization discharge date or until death. Exclusion criteria: * Patients who left against medical advice (AMA), were transferred to an acute care facility, or discharged to hospice care. * Patients who had dialysis as an in-hospital procedure. * Patients with a medical history of chronic dialysis. * Patients with an in-hospital procedure of heart transplantation. * Patients with a medical history of heart transplantation. * Patients with an in-hospital procedure of left ventricular assist device. * Patients with a medical history of left ventricular assist device.

Locations (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Time Spent 30 Days Post-discharge by Discharge Sacubitril/Valsartan (SAC/VAL) Prescription Status

Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

Time frame: Post-discharge at Day 30

Time Spent 90 Days Post-discharge by Discharge SAC/VAL Prescription Status

Time frame: Post-discharge at Day 90

Time Spent 180 Days Post-discharge by Discharge SAC/VAL Prescription Status

Time frame: Post-discharge at Day 180

Time Spent 365 Days Post-discharge by Discharge SAC/VAL Prescription Status

Time frame: Post-discharge at Day 365

Secondary Outcomes

Data from ClinicalTrials.gov

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Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge With a Sacubitril/Valsartan (SAC/VAL) Prescription

Time frame: Post-discharge at Days 30, 90, 180, and 365

Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription

Time frame: Post-discharge at Days 30, 90, 180, and 365

Number of All-cause Mortality or Heart Failure (HF) Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge With a SAC/VAL Prescription

Time frame: Post-discharge at Days 30, 90, 180, and 365

Number of All-cause Mortality or HF Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription

Time frame: Post-discharge at Days 30, 90, 180, and 365

Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge With SAC/VAL Prescription

All-cause hospitalization was defined as any inpatient claim for post-discharge admission to an acute care hospital excluding transfers and hospitalizations for rehabilitation.

Time frame: Post-discharge at Days 30, 90, 180, and 365

Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription

All-cause hospitalization was defined as any inpatient claim for post-discharge admission to an acute care hospital excluding transfers and hospitalizations for rehabilitation.

Time frame: Post-discharge at Days 30, 90, 180, and 365

Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge With a SAC/VAL Prescription

HF hospitalization was defined as any inpatient claim with a primary diagnosis of HF (International Classification of Diseases, 10th revision, Clinical Modification \[ICD-10-CM\] diagnosis codes I098.1, I50.\*, I11.0, I13.0, I13.2) excluding transfers.

Time frame: Post-discharge at Days 30, 90, 180, and 365

Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription

Time frame: Post-discharge at Days 30, 90, 180, and 365

Number Patients Hospitalized for Dialysis or End-Stage Kidney Disease at 365 Days After Discharge With and Without a SAC/VAL Prescription

Hospitalization for dialysis or end-stage kidney disease was defined as any inpatient claim having a primary diagnosis of dialysis or end-stage kidney disease (International Classification of Diseases, 10th revision, Clinical Modification \[ICD-10-CM\] diagnosis codes Z99.2, Z49, N18.5, N18.6; or ICD.9 - 585.6, V45.11, V56.0, V56.8)

Time frame: Post-discharge at Day 365

Number Patients Hospitalized for a Metabolic/Nutritional Disorder at 365 Days After Discharge With and Without a SAC/VAL Prescription

Hospitalization for metabolic/nutritional reasons was defined as any inpatient claims with Diagnosis-related group (DRG) codes 640, 641.

Time frame: Post-discharge at Day 365

Number Patients Hospitalized for Urinary Tract Infection at 365 Days After Discharge With and Without a SAC/VAL Prescription

Hospitalization for urinary tract infection was defined as any inpatient claims with a primary diagnosis of International Classification of Diseases, 10th revision, Clinical Modification (ICD-10-CM) code N39.0.

Time frame: Post-discharge at Day 365

Number Patients Hospitalized for a Hip Fracture at 365 Days After Discharge With and Without a SAC/VAL Prescription

Hospitalization for hip fracture was defined as any inpatient claims with a primary diagnosis fracture of the neck of the femur.

Time frame: Post-discharge at Day 365

Difference in Days of Home-time Between Discharge With and Without SAC/VAL Prescription

Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility.

Time frame: Post-discharge at Days 30, 90, 180, and 365

Difference in All-cause Mortality Between Discharge With and Without SAC/VAL Prescription

Time frame: Post-discharge at Days 30, 90, 180, and 365

Difference in Composite Measure Between Discharge With and Without SAC/VAL Prescription

Composite measure: all-cause mortality or heart failure hospitalization.

Time frame: Post-discharge at Days 30, 90, 180, and 365

Difference in All-cause Re-hospitalization Between Discharge With and Without SAC/VAL Prescription

Time frame: Post-discharge at Days 30, 90, 180, and 365

Difference in HF Re-hospitalization Between Discharge With and Without SAC/VAL Prescription

Time frame: Post-discharge at Days 30, 90, 180, and 365

Difference in Hospitalization for Metabolic/Nutritional Disorder Between Discharge With and Without SAC/VAL Prescription

Hospitalization for metabolic/nutritional reasons was defined as any inpatient claims with Diagnosis-related group (DRG) codes 640, 641.

Time frame: Post-discharge at Day 365

Difference in Hospitalization for Urinary Tract Infection Between Discharge With and Without SAC/VAL Prescription

Time frame: Post-discharge at Day 365

Difference in Hospitalization for Hip Fracture Between Discharge With and Without SAC/VAL Prescription

Hospitalization for hip fracture was defined as any inpatient claims with a primary diagnosis fracture of the neck of the femur.

Time frame: Post-discharge at Day 365

Number of All-cause Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status

SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

Time frame: Post-discharge at Day 365

Number of HF Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status

SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

Time frame: Post-discharge at Day 365

All-cause Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status

SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

Time frame: Post-discharge at Day 365

All-cause HF-related Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status

SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

Time frame: Post-discharge at Day 365