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BACKGROUND: The prevalence of heart failure with mildly reduced or preserved ejection fraction markedly increases with age, with older individuals disproportionately facing excess risk for mortality and hospitalization. METHODS: The DELIVER trial (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure) randomized patients with New York Heart Association functional class II-IV and left ventricular ejection fraction >40% to either dapagliflozin or placebo for a median follow-up period of 2.3 years. We examined efficacy and safety outcomes by age categories (<55, 55-64, 65-74, and ≥75 years) and across age as a continuous measure. RESULTS: Among 6263 randomized patients (aged 40-99 years, mean age 71.7±9.6 years), 338 (5.4%) were <55 years, 1007 (16.1%) were 55-64 years, 2326 (37.1%) were 65 to 74 years, and 2592 (41.4%) were ≥75 years. Dapagliflozin reduced the risk of the primary composite outcome compared with placebo in all age categories (Pinteraction=0.95) and across the age spectrum as a continuous function (Pinteraction=0.76). Similar benefits were observed for the components of the primary outcome, with no significant interaction between randomized treatment and age category. Adverse events occurred more frequently with increasing age, but there were no significant differences in predefined safety outcomes between patients randomized to dapagliflozin and placebo across all age categories. CONCLUSIONS: In patients with heart failure and mildly reduced or preserved ejection fraction enrolled in DELIVER, dapagliflozin reduced the combined risk of cardiovascular death or worsening heart failure events across the spectrum of age, with a consistent safety profile, including among the traditionally under-treated older segment of patients ≥75 years. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03619213.

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OBJECTIVES: This report describes the baseline clinical profiles and management of DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure) trial participants and how these compare with those in other contemporary heart failure with preserved ejection fraction trials. BACKGROUND: The DELIVER trial was designed to evaluate the effects of the sodium-glucose cotransporter-2 inhibitor dapagliflozin on cardiovascular death, heart failure (HF) hospitalization, or urgent HF visits in patients with HF with mildly reduced and preserved left ventricular ejection fraction (LVEF). METHODS: Adults with symptomatic HF and LVEF >40%, with or without type 2 diabetes mellitus, elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, and evidence of structural heart disease were randomized to dapagliflozin 10 mg once daily or matching placebo. RESULTS: A total of 6,263 patients were randomized (mean age: 72 ± 10 years; 44% women; 45% type 2 diabetes mellitus; 45% with body mass index ≥30 kg/m2; and 57% with history of atrial fibrillation or flutter). Most participants had New York Heart Association functional class II symptoms (75%). Baseline mean LVEF was 54.2 ± 8.8% and median NT-proBNP of 1,399 pg/mL (IQR: 962 to 2,210 pg/mL) for patients in atrial fibrillation/flutter compared with 716 pg/mL (IQR: 469 to 1,281 pg/mL) in those who were not. Patients in both hospitalized and ambulatory settings were enrolled, including 10% enrolled in-hospital or within 30 days of a hospitalization for HF. Eighteen percent of participants had HF with improved LVEF. CONCLUSIONS: DELIVER is the largest and broadest clinical trial of this population to date and enrolled high-risk, well-treated patients with HF with mildly reduced and preserved LVEF. (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure [NCT03619213]).

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The objective of this study is to determine if flow-mediated endothelial-dependent vasodilatation (FMD) performed after stress electrocardiogram (ECG) test has an additive value for the diagnosis of significant coronary artery disease (CAD). We studied 322 patients who underwent stress ECG test, coronary arteriography (CAG), and FMD evaluation. The pretest probability (preTP) for the presence of significant CAD (>or=50% stenosis) was 73%. The probability for the disease after positive or negative ECG test (postTP) was 75% and 62%, respectively. A positive FMD response after a positive stress test resulted in 86% postTP with prevalence of advanced CAD in this subgroup -70.4%. A negative FMD response after a positive treadmill test decreased the postTP to 50% (prevalence of significant CAD 25.5%) and could change clinical behavior--additional tests before proceeding to CAG. After negative stress test the postTP increased to 78% when FMD was positive (prevalence of the disease 50%), necessitating the performance of CAG. It decreased to 36% after a negative FMD (prevalence of the disease 11.5%), directing to conservative behavior. In a group with a high pretest probability for the presence of advanced coronary atherosclerosis, FMD has an additive value to stress ECG for the diagnosis of significant CAD and could guide clinical behavior.

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Our purpose was to determine and compare the diagnostic accuracy of flow-mediated dilatation (FMD) and intima-media thickness (IMT). Included were 543 patients. FMD was performed in 543 patients, IMT in 233, and coronary arteriography (CAG) in 442. Analyzing ROC (receiver operating characteristic) curves, FMD /=0.788 mm had 71% sensitivity, 62% specificity, PPV 60%, and NPV 73% for the presence of advanced coronary atherosclerosis. FMD >8% or IMT <0.614 mm distinguished a group of patients with a low probability of advanced CAD (95% sensitivity for both and 91% and 81% NPV for FMD and IMT, respectively), whereas FMD /=1.09 mm indicated a high probability for significant coronary stenosis (specificity 95% and NPV 71 and 67%, respectively). FMD and IMT have a clinically applicable diagnostic accuracy for the presence of angiographically significant CAD with a better performance for FMD. FMD and IMT values help us define zones with high and low probability for the presence of advanced coronary atherosclerosis.