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Sacubitril/valsartan: what does the real-life experience tell us?
Session:
Painel 2- Insuficiencia cardiaca 4
Speaker:
Sofia Alegria
Congress:
CPC 2020
Topic:
D. Heart Failure
Theme:
10. Chronic Heart Failure
Subtheme:
10.4 Chronic Heart Failure – Treatment
Session Type:
Posters
FP Number:
---
Authors:
Sofia Alegria; Ana I. Marques; Ana Rita F. Pereira; Daniel Sebaiti; Alexandra Briosa; João Grade Santos; Débora Repolho; Ana Almeida; Otilia Ferreira Simões ; Helder Pereira
Abstract
<p><strong>Background:</strong> The PARADIGM-HF trial showed that sacubitril-valsartan, an angiotensin receptor-neprilysin inhibitor (ARNI), is more effective than enalapril for patients with heart failure (HF) and reduced ejection fraction (rEF). However, the eligibility to ARNI and the outcomes in the real-world are not well established.</p> <p><strong>Purpose: </strong>Characterize the population of patients with HFrEF under ARNI therapy, and assess the impact of this therapy.</p> <p><strong>Methods: </strong>Observational retrospective unicentric study, including all patients followed in the HF clinic of a tertiary hospital, medicated with ARNI. Cox regression analyses were used to determine predictors of mortality and the combined endpoint of mortality, heart transplantation or LVAD implantation.</p> <p><strong>Results: </strong>69 patients were identified (median age 66 years; 83% male; 49% with ischemic etiology; median follow-up 266 days). On the evaluation before starting ARNI, 52% were in class III-IV; 93% were on ACEI/ARB, 93% on beta-blocker and 58% on MRA; 42% had an ICD and 20% CRT; 12% had required perfusion of inotropes in the previous 12 months. The median NT-proBNP was 1716 pg/ml, the mean LVEF was 28±7%, and the mean peak VO<sub>2</sub> was 17±5 ml/Kg/min. Only 30% fulfilled the inclusion criteria for the PARADIGM-HF trial (Table) and 42% had an off-label indication, namely due to low systolic BP (SBP) (mean SBP 110±20 mmHg; 32% <100 mmHg). The median ARNI starting dose was 24/26 mg.</p> <p>After 3 months of follow-up, the median dose was 49/51 mg and 28% were on the maximum dose; there were no significant adverse events, and the following differences were found: improvement in functional class (class III-IV: 52 vs 35%), and reduction in NT-proBNP (1716 vs 805 pg/ml) and furosemide daily dose (20 vs 0 mg) (p<0,03 for all). In the 12 patients that performed serial cardiopulmonary exercise test (CPET) there was no significant improvement. Regarding LVEF, there was an improvement (28 vs 37%; p=0,005), although the baseline echo was not routinely performed close to starting ARNI.</p> <p>The mortality rate was 5.8%, and the combined endpoint occurred in 8.7%. The predictors of the combined end-point were inotrope use in the previous 12 months (HR 5.0) and baseline NT-proBNP >3000 pg/ml (HR 17.3), while the predictors of mortality were baseline LVEF <20% (HR 8.0) and NT-proBNP >3000 pg/ml (HR 10.2); an increase in the maximum HR in the baseline CPET was a predictor of a better outcome, for both endpoints (HR 0.92 and 0.93) (p<0.05 for all).</p> <p><strong>Conclusion:</strong> In this study of a real-world population, although the majority of patients would have been excluded from the PARADIGM-HF trial and a significant proportion were prescribed off-label, the use of ARNI was safe, even in patients with low SBP, and was associated with improvements in functional class and NT-proBNP, although there was no improvement in CPET parameters. In our study, the predictors of the outcomes were the NT-proBNP, LVEF and the maximum HR in the CPET.</p>
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