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Changes in health-related quality of life and treatment effects in chronic heart failure: a meta-analysis
Session:
Comunicações Orais - Sessão 18 - Insuficiência cardíaca: tratamento
Speaker:
António Afonso Angélico Gonçalves
Congress:
CPC 2023
Topic:
D. Heart Failure
Theme:
10. Chronic Heart Failure
Subtheme:
10.4 Chronic Heart Failure – Treatment
Session Type:
Comunicações Orais
FP Number:
---
Authors:
António Afonso Angélico Gonçalves; Ana Rita Ferreira Leite; João Sérgio Neves; Francisca Saraiva; Liliana Brochado; Javed Butler; Milton Packer; Faiez Zannad; Francisco Vasques Nóvoa; Adelino Leite-Moreira; João Pedro Ferreira
Abstract
<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:"Times New Roman",serif"><strong>Background:</strong> Heart failure (HF) is associated with poor health status, high morbidity and mortality. A recent FDA guidance draft proposes patient-centered outcomes, such as health status, as acceptable endpoints for clinical trials. However, it is not well-established how health status changes correlate with treatment effects on “hard” clinical outcomes.</span></span></p> <p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:"Times New Roman",serif"><strong>Purpose:</strong> To study the association between treatment-induced changes in health status, assessed by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23), and “hard” clinical outcomes in chronic HF.</span></span></p> <p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:"Times New Roman",serif"><strong>Methods:</strong> Systematic search of phase III-IV RCTs in chronic HF, where the impact of pharmacological treatments on KCCQ-23 score and clinical outcomes throughout follow-up were evaluated. We studied the association between treatment-induced changes in KCCQ-23 and the corresponding treatment effect on clinical outcomes (composite of HF hospitalization or cardiovascular death, HF hospitalization, cardiovascular death, and all-cause death) using weighted, random effects meta-regression.</span></span></p> <p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:"Times New Roman",serif"><strong>Results:</strong> Sixteen HF trials, published between 2009 and 2022, were included, enrolling a total of 65,664 participants. Treatment-induced KCCQ-23 changes were moderately correlated with treatment effects on HF hospitalization or cardiovascular mortality (regression coefficient (RC)=<span style="background-color:white"><span style="color:black">−</span></span>0.047, 95%CI: <span style="background-color:white"><span style="color:black">−</span></span>0.085 to <span style="background-color:white"><span style="color:black">−</span></span>0.009, p=0.016; R<sup>2</sup>=49%), a correlation that was mainly driven by HF hospitalization (RC=<span style="background-color:white"><span style="color:black">−0.076, 95%CI: −0.124 to −0.029,</span></span> p=0.002; R<sup>2</sup>=56%). The correlations between treatment-induced KCCQ-23 changes and cardiovascular death (RC=<span style="background-color:white"><span style="color:black">−0.029; 95%CI: −0.073 to 0.015;</span></span> p=0.20; R<sup>2</sup>=10%) and all-cause death (RC=<span style="background-color:white"><span style="color:black">−0.019, 95%CI: −0.057 to 0.019,</span></span> p=0.32; R<sup>2</sup>=0%) were weak and statistically non-significant. </span></span></p> <p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:"Times New Roman",serif"><strong>Conclusions: </strong>Treatment-induced changes in KCCQ-23 were moderately correlated with treatment effects on HF hospitalizations but were not correlated with the effects on cardiovascular and all-cause mortality. Changes in patient-centered outcomes (i.e., KCCQ-23) may reflect symptomatic changes in the clinical course of HF that may lead to hospitalization, but do not appear to be strongly correlated with mortality. Large outcome trials should continue to assess HF hospitalization and mortality as a robust mean of evaluating treatment effects.</span></span></p>
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