Clinical Epidemiology (Jan 2022)
Characterizing a Clinical Trial – Representative, Real-World Population with Heart Failure with Reduced Ejection Fraction
Abstract
Quinn S Wells,1,2 Eric Farber-Eger,1,2 Loren Lipworth,2,3 Paul Dluzniewski,4 Ricardo Dent,4 John Umeijiego,4 Sarah S Cohen3,5 1Division of Cardiovascular Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; 2Vanderbilt Translational and Clinical Cardiovascular Research Center (VTRACC), Vanderbilt University Medical Center, Nashville, TN, USA; 3Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; 4Center for Observational Research, Amgen, Inc., Thousand Oaks, CA, USA; 5Epidstrategies, A Division of Toxstrategies, Inc., Cary, NC, USACorrespondence: Sarah S Cohen Tel +1 919-885-0548Email [email protected]: Given known differences between real-world and clinical trial populations, we characterized demographics, clinical characteristics, and outcomes using real-world (RW) data for patients with heart failure with reduced ejection fraction (HFrEF), including those similar to subjects enrolled in an HFrEF clinical trial to better understand patient populations that could benefit from novel therapies.Patients and Methods: Using Vanderbilt University Medical Center electronic health records (2006– 2019), two RW cohorts of HFrEF patients were identified. The “Clinical Cohort” was based on a validated HFrEF algorithm and left ventricular ejection fraction (LVEF) ≤ 40%. The “GALACTIC-HF-like Cohort” mirrored enrollment requirements of the GALACTIC-HF clinical trial including hospitalizations, medications, laboratory values, and LVEF ≤ 35%.Results: Median age at index for the Clinical Cohort (N = 3954) and GALACTIC-HF-like Cohort (N = 1541) were 65 and 61 years, respectively; both were 67% male and 80% white. Over half had coronary artery disease (55% Clinical vs 64% GALACTIC-HF-like); hypercholesterolemia was common (69% Clinical vs 74% GALACTIC-HF-like). Chronic kidney disease (31 vs 21%), atrial fibrillation (32 vs 29%), and cardiac resynchronization or implantable cardioverter defibrillator (26 vs 23%) were higher in the GALACTIC-HF-like Cohort. ACE inhibitor use was high in both groups but more common in the GALACTIC-HF-like Cohort (71% and 82%, respectively). Beta-blockers or loop diuretics were used by > 90% of both cohorts. HF hospitalization rates were 261 (95% CI 224, 297) per 1000 person-years in Clinical versus 523 (484, 562) in GALACTIC-HF-like Cohort (median follow-up of 2.9 and 4.2 years, respectively).Conclusion: Approximately 40% of RW HFrEF patients met criteria for the GALACTIC-HF trial. While findings of ongoing clinical trials may be directly generalizable to this sizable proportion of patients, future trials should examine whether the majority of patients with lower prevalence of comorbidities and rate of HF hospitalization could benefit from emerging HF treatments.Keywords: heart failure, reduced ejection fraction, real-world evidence, electronic health record
