Key result
In real-world heart failure patients, sacubitril/valsartan initiation improved NYHA class and daily activity, but did not significantly change VO2max (14.1 vs 14.7 mL/kg/min; p=0.237).
Why the study?
Sacubitril/valsartan reduced HF hospitalizations and mortality in PARADIGM-HF, but real-world data on symptomatic and functional improvement were lacking.
Does sacubitril/valsartan improve functional status and exercise capacity in real-world patients with heart failure?
Observational (n=201)
Does sacubitril/valsartan improve functional status and exercise capacity in real-world patients with heart failure?
Absolute Event Rate: 14.1% vs 14.7%
p-value: p=0.237
In a real-world setting, sacubitril/valsartan initiation was associated with significant improvements in NYHA functional class and daily activity levels, though maximal exercise performance on CPET did not significantly change.
Should not yet change practice on subjective gains alone; leaves open randomized confirmation of effects on exercise capacity.
Background: Sacubitril/valsartan significantly reduced heart failure(HF) hospitalisations and mortality in the PARADIGM-HF-trial. However real-world data on symptomatic and functional improvement are lacking.Methods: Between December 2016 and January 2018, we retrospectively collected baseline and follow-up data including New York Heart Association (NYHA)-functional class and Cardio-pulmonary exercise data(CPET) in all HF-patients receiving sacubitril/valsartan. Additionally, in patients with an implantable electric cardiovascular device (IECD) enrolled in remote telemonitoring, we quantified patient level activity before and after initiation.Results: A total of 201 patients (82% males) were identified. NYHA-functional class was reassessed after an average of 221 ± 114 days. Overall, 3.3% of patients improved 2 NYHA classes, 28.7% improved 1 NYHA class, 64% remained stable and 4% deteriorated 1 NYHA class. Patients with symptomatic improvement exhibited a larger reduction in Left Ventricular End Systolic Volume(LVESV) and a larger increase in Left Ventricular Ejection Fraction(LVEF[p-value both <.05]). In total, 110 patients (55%) were equipped with an IECD capable of quantifying outpatient activity-level. On an average of 364 days before sacubitril/valsartan, an activity expressed as %-of-the-day was 13 ± 2%, vs. 18 ± 3% the 364 days following sacubitril/valsartan initiation. Signifying a 38% improvement in the out-patient activity level. CPET-data was obtained in paired-fashion in 45 patients (22%). VO2max at baseline (14.7 ± 3.8 mL/kg/min) did not significantly change at follow-up (14.1 ± 4.7 mL/min/kg; p = .237).Conclusion: Real-world patients exhibit significant symptomatic and functional improvement following the initiation of sacubitril/valsartan. However, larger prospective studies are necessary to assess the impact of sacubitril/valsartan on indices of maximal exercise performance measured during CPET.
No takes yet. Share an insight, caveat, or question.
Lau et al. (2018) conducted an observational in Heart failure (n=201). Sacubitril/valsartan vs. Baseline (before initiation) was evaluated on VO2max (mL/kg/min) (p=0.237). In real-world heart failure patients, sacubitril/valsartan initiation improved NYHA class and daily activity, but did not significantly change VO2max (14.1 vs 14.7 mL/kg/min; p=0.237).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: