Implementation of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction (OpTIMa-HF Registry)

Abstract

Aims: The last released European guidelines on the management of heart failure (HF) recommend in patients with chronic HF with reduced ejection fraction (HFrEF) a pharmacological approach based on four fundamental drugs to be rapidly implemented and then uptitrated to modify disease progression. The aim of the Optimization of Therapy in the Italian Management of Heart Failure (OPTIMA-HF) registry is to collect data on chronic HF outpatients in different settings of care. In the present analysis, we report the first analysis of the OPTIMA-HF registry, focusing on the real-life use of guideline-directed medical therapy in patients affected by HFrEF.

Methods: OPTIMA-HF is an observational, cross-sectional, multicentre, real-life Italian registry conducted in two different clinical settings: HF outpatients' clinics of Italian hospitals and community HF outpatients' services. The study comprises a T0 phase-retrospective data collection, in which data of consecutive HF outpatients seen between January and October 2022 were collected; an educational activity phase; and a T1 phase-prospective data collection, in which data of consecutive HF outpatients seen between September 2023 and November 2023 were collected. In the present analysis, we describe the T0 phase focusing on HFrEF drug prescription rates, types, doses, combination therapy, the presence of contraindications and reasons of non-optimized treatment.

Results: Twenty-nine centres enrolled 2110 HF patients, of which 1390 (65.9%) had HFrEF [69.5 ± 11.9 years, 76.2% males, 4.1 years since HF diagnosis, median ejection fraction (EF) 33%]. Among HFrEF patients, 89.1% were on treatment with renin-angiotensin-aldosterone system inhibitor (RAASi)/angiotensin receptor neprilysin inhibitor (ARNI) (72% ARNI and 17.1% RAASi), 95.1% with beta-blockers, 75.8% with mineralocorticoid receptor antagonists (MRA) and 63.2% with sodium/glucose cotransporter 2 inhibitors (SGLT2i). Despite high prescription rates, a non-negligible number of patients with no contraindications were not treated with each specific drug. Patients taking all four drug classes, as recommended by guidelines, were mere 46.9%. Regarding doses, a still low number of patients on RAASi/ARNI and beta-blockers were treated with a dose ≥50% of the target doses recommended by the European guidelines.

Conclusions: The OPTIMA-HF registry reported that HFrEF fundamental drugs are prescribed in most Italian patients; however, <50% of patients receive optimal combination therapy, and still not a satisfying number of patients receive target doses. Strategies to improve implementation of guideline-directed medical therapy are needed to improve HF prognosis.

Keywords: HFrEF; disease‐modifying drugs; guideline‐directed medical therapy; heart failure; pharmacotherapy.

Figure 1

Prescription rates of heart failure with reduced ejection fraction (HFrEF) drugs. Red bars refer to on‐treatment patients; blue bars refer to non‐treated patients without specific contraindications; and orange bars refer to non‐treated patients with specific contraindications. For more details, please consult the main text. ACEi, angiotensin‐converting enzyme inhibitor; ARB, angiotensin receptor blocker; ARNI, angiotensin receptor neprilysin inhibitor; MRA, mineralocorticoid receptor antagonist; SGLT2i, sodium/glucose cotransporter 2 inhibitor.

Figure 2

Rate of absence of main contraindications in patients not on treatment with angiotensin receptor neprilysin inhibitor (ARNI) or sodium/glucose cotransporter 2 inhibitor (SGLT2i). Red bars refer to the absence of reported specific condition in patients not on ARNI; blue bars refer to the absence of reported specific condition in patients not on SGLT2i. Hyperkalaemia is not reported for SGLT2i because this condition does not represent a contraindication for a SGLT2i prescription. For more details, please consult the main text. eGFR, estimated glomerular filtration rate; SBP, systolic blood pressure.

Figure 3

Prescription rates of heart failure with reduced ejection fraction (HFrEF) combination treatment. HFrEF patients taking all four drug classes were 46.9% [40.6% on angiotensin receptor neprilysin inhibitor (ARNI) and 6.3% on angiotensin‐converting enzyme inhibitor (ACEi)/angiotensin receptor blocker (ARB) combined with the other three recommended drug classes]; the remaining patients were treated with one, two or three out of four drugs. The four‐drug combinations and the three‐drug combinations including renin–angiotensin–aldosterone system inhibitor/ARNI + beta‐blocker (BB) and mineralocorticoid receptor antagonist (MRA) or sodium/glucose cotransporter 2 inhibitor (SGLT2i) are reported in Figure 3. For more details, please consult the main text.

Figure 4

Prescription rates of heart failure with reduced ejection fraction drug doses. According to the European Society of Cardiology guidelines recommendations, we divided the reported doses into two groups: low dose (<50% of target dose) and intermediate–high dose (≥50% of target dose). For more details, please consult the main text. ACEi, angiotensin‐converting enzyme inhibitor; ARB, angiotensin receptor blocker; ARNI, angiotensin receptor neprilysin inhibitor; BB, beta‐blocker; MRA, mineralocorticoid receptor antagonist; SGLT2i, sodium/glucose cotransporter 2 inhibitor.