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AF and Dapagliflozin Efficacy in Preserved or Mildly Reduced EF
Quick Takes
- The beneficial effects of dapagliflozin, compared with placebo, on clinical events and symptoms were not modified by AF at baseline, irrespective of definition or type of AF.
- These data provide further support for dapagliflozin as a new treatment option for patients with HF across the range of LVEF regardless of AF status.
Study Questions:
What are the effects of dapagliflozin according to the presence or not of atrial fibrillation (AF) in the DELIVER (Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure) trial?
Methods:
DELIVER was an event-driven, randomized, double-blind, controlled trial in patients with heart failure (HF) and mildly reduced and preserved left ventricular ejection fraction (LVEF) that compared the efficacy and safety of dapagliflozin 10 mg once daily compared with matching placebo. A total of 6,263 patients with HF with New York Heart Association functional class II-IV, LVEF >40%, evidence of structural heart disease, and elevated N-terminal pro–B-type natriuretic peptide (NT-proBNP) levels were randomized to dapagliflozin or placebo. The investigators examined clinical outcomes, and the effect of dapagliflozin, according to AF status. The primary outcome was a composite of cardiovascular death or a worsening HF. To compare the effects of dapagliflozin versus placebo, time-to-event data and total (first and recurrent) events were evaluated with Cox proportional-hazards models and semiparametric proportional-rates models, respectively.
Results:
Of the 6,261 patients with data on baseline AF, 43.3% had no AF, 18.0% paroxysmal AF, and 38.7% persistent/permanent AF. The risk of the primary endpoint was higher in patients with AF, especially paroxysmal AF, driven by a higher rate of HF hospitalization: no AF, HF hospitalization rate per 100 person-years (95% confidence interval [CI]), 4.5 (4.0-5.1); paroxysmal AF 7.5 (6.4-8.7); persistent/permanent AF 6.4 (5.7-7.1) (p < 0.001). The benefit of dapagliflozin on the primary outcome was consistent across AF types: no AF, HR (95% CI) 0.89 (0.74-1.08); paroxysmal AF, 0.75 (0.58-0.97); persistent AF, 0.79 (0.66-0.95) (pinteraction = 0.49). Consistent effects were observed for HF hospitalization, cardiovascular death, all-cause mortality, and improvement in the Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS).
Conclusions:
The authors concluded that the beneficial effects of dapagliflozin, compared with placebo, on clinical events and symptoms were consistent, irrespective of presence or type of AF at baseline.
Perspective:
This study reports that the beneficial effects of dapagliflozin, compared with placebo, on clinical events and symptoms were not modified by AF at baseline, irrespective of definition or type of AF. These data provide further support for dapagliflozin as a new treatment option for patients with HF across the range of LVEF regardless of AF status. There is a need for additional prospective mechanistic studies to better understand the effects of diastolic ventricular function and atrial arrhythmias on the clinical response to sodium-glucose cotransporter-2 (SGLT-2) inhibition in patients with HF of various etiologies.
Clinical Topics: Arrhythmias and Clinical EP, Diabetes and Cardiometabolic Disease, Dyslipidemia, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Lipid Metabolism, Acute Heart Failure, Heart Failure and Cardiac Biomarkers
Keywords: Arrhythmias, Cardiac, Atrial Fibrillation, Geriatrics, Heart Failure, Metabolic Syndrome, Natriuretic Peptide, Brain, Primary Prevention, Sodium-Glucose Transporter 2, Stroke Volume, Ventricular Function, Left
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