Is there really a clinical benefit to using the new drugs for HFrEF in real life?
V Martinez Mateo, L Cejudo Del Campo, E Martin Barrio, R Ibanez Leal, J M Marquez Moreno, A Gadella Fernandez, J J Portero Portaz, A J Paule SanchezAbstract
Introduction
Since 2017 new drugs that have demonstrated clinical benefit in clinical trials for patients with heart failure (HF) with reduced left ventricle ejection fraction (LVEF) have been approved for commercial use. There is little information on the benefits of these drugs in real life.
Purpose/Methods
We analyzed characteristics and prognosis of patients with heart failure with reduced left ventricle ejection fraction (HFrEF) followed prospectively in the HF Unit of a non-tertiary hospital (community-based HF unit) between periods 2010-2016 (period 1) and 2017-2025 (period 2).
Results
683 patients have completed the follow-up, 367 in period 1 (median 44 ± 20 months, 76.1% men, mean age 69.7 ± 12.5 years) and 316 in period 2 (median 41 ± 27 months, 75.6% men, mean age 68.8 ± 13.4 years). The normality of the two independent samples was verified using the Shapiro-Wilk statistical test. There were no significant differences in the baseline characteristics of patients between the two periods (most patients present with severely depressed LVEF [67.5% versus 73.4%] and functional class III [64.3% versus 59.5%], with ischemic being the main cause of dysfunction [47.4% versus 49.6%] and rates of hypertension, dyslipidaemia, diabetes mellitus and chronic renal failure of 58.9%, 49.1% and 35.3% in period 1 versus 61.4%, 50.9% and 40.0% in period 2). There were also no differences in the prescription of beta-blockers, renin-angiotensin system inhibitors and aldosterone antagonists between the two periods (90,2%, 92.9% and 58.5% respectively in period 1 versus 91,7%, 95.3% [69% sacubitril-valsartan] and 65.2% in period 2. Indeed, in period 2 sodium-glucose cotransporter type 2 (iSGLT2) inhibitors was prescribed in 75.3% of patients and vericiguat in 6.3%. Implantable electronic devices (ICD/CRT) were more frequently used in period 2 versus period 1 (28.8% vs 16.7%, p < 0.05). In the follow-up, there were not difference in mortality (73 patients [19.9%] in period 1 versus 82 patients [25.9%] in period 2, p 0.114; survival median of 75.2 +/- 2.1 versus 61.8 +/- 1.1 months, respectively [log rank, p 0.19], figure 1) or in the rate of improvement in LVEF (127 patients [34.6%] in period 1 versus 118 patients [37.3%] in period 2, p 0.41).
Conclusion
In our series of patients with HFrEF followed up at a community-based HF unit, there were no differences in baseline characteristics, survival, or improvement in EF between patients followed up before and after the approval of new drugs for the treatment of HF.For image description, please refer to the figure legend and surrounding text.