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Randomized Controlled Trial
. 2021 Oct;8(5):4218-4227.
doi: 10.1002/ehf2.13543. Epub 2021 Aug 6.

Effect of a strategy of comprehensive vasodilation versus usual care on health-related quality of life among patients with acute heart failure

Maria Belkin  1   2   3 , Desiree Wussler  1   2   3 , Danielle Menosi Gualandro  1   3   4 , Samyut Shrestha  1   2   3 , Ivo Strebel  1 , Assen Goudev  5 , Micha T Maeder  6 , Joan Walter  1   3   7 , Dayana Flores  1   3 , Nikola Kozhuharov  1   3   8 , Pedro Lopez-Ayala  1   2   3 , Isabelle Danier  1   3 , Mucio Tavares de Oliveira Junior  4 , Richard Kobza  9 , Hans Rickli  6 , Tobias Breidthardt  1   2   3 , Paul Erne  9 , Thomas Münzel  10 , Christian Mueller  1   3
Affiliations
Randomized Controlled Trial

Effect of a strategy of comprehensive vasodilation versus usual care on health-related quality of life among patients with acute heart failure

Maria Belkin et al. ESC Heart Fail. 2021 Oct.

Abstract

Aims: We aimed to assess the long-term effect of a strategy of comprehensive vasodilation versus usual care on health-related quality of life (HRQL) among patients with acute heart failure (AHF).

Methods and results: Health-related quality of life was prospectively assessed by the generic 3-levelled EQ-5D and the disease-specific Kansas City Cardiomyopathy Questionnaire (KCCQ) among adult AHF patients enrolled in an international, multicentre, randomised, open-label blinded-end-point trial of a strategy that emphasized early intensive and sustained vasodilation using maximally tolerated doses of established oral and transdermal vasodilators according to systolic blood pressure. Changes in EQ-5D and KCCQ from admission to 180 day follow-up were individually compared between the intensive vasodilatation and the usual care group. Among 666 patients eligible for 180 day follow-up, 284 (43%, median age 79 years, 35% women) and 198 (30%, median age 77 years, 35% women) had completed the EQ-5D and KCCQ at baseline and follow-up, respectively. There was a significant improvement in HRQL as quantified by both, EQ-5D and KCCQ, from hospitalization to 180 day follow-up, with no significant differences in the change of HRQL between both treatment strategies. For instance, 39 (26%) versus 33 (25%) patients had an improvement by at least one level in at least two categories in the EQ-5D. Median increase in KCCQ overall summary score (KCCQ-OSS) was 17.6 (IQR 2.0-42.6) in the intervention group versus 18.5 (IQR 3.9-39.3) in the usual care group (P < 0.001 vs. baseline, P = 0.945 between groups).

Conclusions: Among patients with AHF, long-term HRQL quantified by EQ-5D and KCCQ improved substantially, with overall no significant differences between a strategy of comprehensive vasodilation versus usual care.

Keywords: Acute heart failure; Health-related quality of life; Sustained vasodilatation.

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Conflict of interest statement

Dr. Gualandro reported receiving personal fees from Servier. Dr. Walter has received research grants from the Swiss Heart Foundation (FF19097 and F18111) as well as the Swiss Academy of Medical Sciences and the Gottfried and Julia Bangerter‐Rhyner Foundation. Dr. Goudev reported receiving personal fees (speaking honoraria and advisory board membership) from Pfizer, Novartis, AstraZeneca, and Amge. Dr. Kozhuharov has received research grants from the Swiss National Science Foundation (P400PM‐194477), Gottfried und Julia Bangerter‐Rhyner‐Stiftung, and the European Society of Cardiology. Dr. Kobza received institutional grants from Abbott, Biosense‐Webster, Biotronik, Boston‐scientific, Medtronic and SIS‐Medical. Dr. Münzel reported being the principal investigator of the DZHK (German Center for Cardiovascular Research) Partner Site Rhine‐Main. Dr. Mueller has received research support from the Swiss National Science Foundation, the Swiss Heart Foundation, the KTI, the University Hospital Basel, Basel University, Abbott, Beckman Coulter, BRAHMS, Idorsia, LSI Medience, Norvartis, Ortho Clinical Diagnostics, Quidel, Roche, Siemens, and Singulex, as well as speaker/consulting honoraria from Acon, Amgen, Astra Zeneca, Bayer, BMS, Boehringer Ingelheim, Daiichi Sankyo, Idorsia, Osler, Novartis, Roche, and Sanofi. All other authors declare that they have no conflict of interest with this study.

Figures

Figure 1
Figure 1
HRQL at baseline and 180 day follow‐up in patients assigned to usual care versus intensive vasodilatation according to the 3‐levelled EQ‐5D. Bars indicate percentage of randomized patients (n = 134 in standard care and n = 150 in the intensive vasodilatation) reporting no, some and severe impairments regarding (A) mobility, (B) self‐care, (C) usual activities, (D) pain/discomfort, and (E) anxiety/depression; flow indicates changes from admission to follow up.
Figure 2
Figure 2
Differences in changes of HRQL between standard care and intensive vasodilatation group after 180 days of follow‐up. HRQL assessed by KCCQ. Differences in change displayed with bars intersecting vertical line representing no difference in change. Negative values indicating higher HRQL in intervention group and positive values higher change in usual care group. Calculations of change [95%‐confidence interval] was performed using empirical bootstrap method.
See this image and copyright information in PMC

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