The GUIDE-HF trial of pulmonary artery pressure monitoring in heart failure: impact of the COVID-19 pandemic
Why the study?
Important changes in heart failure event rates were widely reported during the COVID-19 pandemic, but few data addressed potential causes for these changes.
Does haemodynamic-guided management using pulmonary artery pressure monitoring reduce all-cause mortality and HF events in heart failure patients, and how did the COVID-19 pandemic impact this?
Structured PICO
Does haemodynamic-guided management using pulmonary artery pressure monitoring reduce all-cause mortality and HF events in heart failure patients, and how did the COVID-19 pandemic impact this?
P
Population
Heart failure patients enrolled in the GUIDE-HF study between 15 March 2018 and 20 December 2019
I
Intervention
Haemodynamic-guided management using pulmonary artery pressure monitoring for 12 months
C
Comparator
Control group
O
Outcome
Composite of all-cause mortality plus HF eventscomposite
The benefit of haemodynamic-guided management in heart failure was evident pre-COVID-19 but effaced during the pandemic due to a significant drop in event rates in the control group, likely driven by patient-dependent factors.
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“this difference in primary events almost disappeared during COVID-19, with a 21% decrease in the control group relative to pre-COVID-19, virtually no change in the treatment group, and no difference between groups.”
“The primary endpoint of GUIDE-HF—reduction in heart failure events and mortality with hemodynamic-guided management—was not statistically significant in the overall analysis, but was statistically significant in the COVID-19 impact analysis”
“Now with GUIDE-HF including Class II and patients who have not had a heart failure hospitalization but just have elevated natriuretic peptides... we can get to patients much earlier.”
Implication
Supports PA pressure monitoring in chronic HF; confirms benefit in pre-pandemic settings with active medication titration.
Abstract
AIMS: During the coronavirus disease 2019 (COVID-19) pandemic, important changes in heart failure (HF) event rates have been widely reported, but few data address potential causes for these changes; several possibilities were examined in the GUIDE-HF study. METHODS AND RESULTS: From 15 March 2018 to 20 December 2019, patients were randomized to haemodynamic-guided management (treatment) vs. control for 12 months, with a primary endpoint of all-cause mortality plus HF events. Pre-COVID-19, the primary endpoint rate was 0.553 vs. 0.682 events/patient-year in the treatment vs. control group [hazard ratio (HR) 0.81, P = 0.049]. Treatment difference was no longer evident during COVID-19 (HR 1.11, P = 0.526), with a 21% decrease in the control group (0.536 events/patient-year) and no change in the treatment group (0.597 events/patient-year). Data reflecting provider-, disease-, and patient-dependent factors that might change the primary endpoint rate during COVID-19 were examined. Subject contact frequency was similar in the treatment vs. control group before and during COVID-19. During COVID-19, the monthly rate of medication changes fell 19.2% in the treatment vs. 10.7% in the control group to levels not different between groups (P = 0.362). COVID-19 was infrequent and not different between groups. Pulmonary artery pressure area under the curve decreased -98 mmHg-days in the treatment group vs. -100 mmHg-days in the controls (P = 0.867). Patient compliance with the study protocol was maintained during COVID-19 in both groups. CONCLUSION: During COVID-19, the primary event rate decreased in the controls and remained low in the treatment group, resulting in an effacement of group differences that were present pre-COVID-19. These outcomes did not result from changes in provider- or disease-dependent factors; pulmonary artery pressure decreased despite fewer medication changes, suggesting that patient-dependent factors played an important role in these outcomes. Clinical Trials.gov: NCT03387813.
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Cite This Study
Zile et al. (2022) studied this question.