Quality not quantity. Why not both? It is established that sacubitril/valsartan is superior to enalapril (or dose-equivalent ACE-I) when it comes to mortality and morbidity in HFrEF. But what about quality of life (QoL)? Patients enrolled in PARADIGM-HF had increased quality of life when randomized to sacubitril/valsartan.
In the 8399 HFrEF patients of the PARADIGM-HF study, 7623 patients completed the Kansas City Cardiomyopathy Questionnaire (KCCQ) at multiple time points. This well-validated tool measures health related quality of life. The KCCQ assessment reflected improved in quality of life for patients on sacubitril/valsartan compared to dose-equivalent ACE-I. Worth mentioning, the first KCCQ was administered 5-10 weeks after randomization, following the “run-in” period after which patients were randomized in a blinded fashion to either enalapril BID or sacubitril/valsartan.
Changes in the clinical summary score (KCCQ-CS) and overall score (KCCQ-OS) were assessed between randomization and 8 months. In a multivariable model, randomization to sacubitril/valsartan remained an independent predictor of QoL improvement.
QoL scores were high in this study. The higher scores may reflect the unique study schedule of the PARADIGM-HF in that the first KCCQ survey was given following the run-in phase. Further, it is known that health related QoL perceptions can improve in the setting of a clinical trial.
In a heartbeat…
HFrEF patients treated with Sacubitril/Valsartan reported higher QoL score compared to patients randomized to enalapril.
A young Latin American female patient walks into clinic with signs and symptoms of HF, a right bundle branch block on 12-lead EKG, and reduced EF on echo. She has Chagas disease and HFrEF, but what is her prognosis?
Despite its high prevalence in South America, reports of morbidity and mortality of this disease have been variant. Using post-hoc analysis, McMurray et al evaluated outcomes in 2552 Latin American patients from the PARADIGM-HF and ATMOSPHERE trials where 195 (7.6%) had Chagasic HFrEF. The authors discovered that despite younger age and fewer comorbidities, the Chagasic HFrEF cohort had higher CV death and hospitalization when compared to ischemic and non-ischemic groups. Chagasic HFrEF patients had worse quality of life compared to the non-ischemic group, measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Chagasic HFrEF patients had higher rates of thromboembolic events and higher prevalence of renal failure, yet similar NT-proBNP levels.
No study is perfect. The study was post-hoc, it included a relatively small number of Chagasic HFrEF patients, and selection bias created by the PARADIGM-HF and ATMOSPHERE trial inclusion criteria was present.
In a heartbeat…
In the setting of guideline-based pharmacologic therapy, patients with Chagasic-HFrEF have worse QoL, higher hospitalization rates, and higher incidence of CV death.