What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Pulmonary Arterial Hypertension (n=3263). Intervention: Changes in hemodynamic indices (mPAP, PVR, RAP, CI). Primary outcome: Change in 6-minute walk distance (Δ6MWD) associated with change in mPAP (Coefficient -7.1067, p=<0.0001).

April 30, 2021Open Access

The Prognostic Significance of the Alterations of Cardiovascular Hemodynamics in Patients With Pulmonary Arterial Hypertension: A Meta-regression Analysis of Randomized Controlled Trials

Q: What are the key findings of this study?

Changes in mean pulmonary artery pressure (mPAP) after treatment were significantly associated with changes in 6-minute walk distance (coefficient -7.1067, p<0.0001) and had the highest explanatory power for adverse clinical events (R2 analog=0.911).

Resultado clave

Changes in mean pulmonary artery pressure (mPAP) after treatment were significantly associated with changes in 6-minute walk distance (coefficient -7.1067, p<0.0001) and had the highest explanatory power for adverse clinical events (R2 analog=0.911).

Diseño del estudio

Tipo

Meta-Analysis (n=3,263)

PICO estructurado

Do changes in hemodynamic indices (mPAP, PVR, RAP, CI) after treatment predict changes in 6MWD and adverse clinical events in patients with pulmonary arterial hypertension?

Población

3,263 adult patients with pulmonary arterial hypertension from 20 randomized controlled trials, analyzed to determine the prognostic significance of changes in cardiovascular hemodynamics.

Exposición

Active pharmacological treatment for PAH (any of 9 drug classes: ERA, PDE5, PDGFR, Prostacyclin, Prostacyclin plus ERA, Rho-kinase, TXSI/TXRA, sGC)

Comparador

Placebo or another active PAH drug class

Resultado

Association between changes in hemodynamic indices (mPAP, PVR, RAP, CI) and change in 6-minute walk distance (∆6MWD), adverse clinical events, hospitalization for PAH, death due to PAH, and total mortalitysurrogate

Changes in hemodynamic parameters after treatment, particularly mean pulmonary artery pressure and pulmonary vascular resistance, are significantly associated with clinical outcomes and mortality in PAH patients, supporting their use in risk assessment.

Resultado numérico

Estimación del efecto: Coefficient -7.1067

valor p: p=<0.0001

Limitaciones

The long-term prognostic values of hemodynamic changes haven't been evaluated in large cohorts yet.
Variances of baseline characteristics, study designs, and background therapies across the enrolled RCTs can cause biased study findings.
Inclusion of subjects with distinct pathophysiology (e.g., connective tissue disease) may influence the findings.
Based on published RCTs, in some of which currently available PAH drugs were not commercially available.

Resumen

Abstract Background: Hemodynamic assessment in patients with pulmonary arterial hypertension (PAH) is essential for risk stratification and pharmacological management. However, the prognostic value of the hemodynamic changes after treatment is less well established. Objectives: We investigated the prognostic impacts of the changes in hemodynamic indices, including mean pulmonary artery pressure (mPAP), pulmonary vascular resistance (PVR), right atrial pressure (RAP) and cardiac output index (CI). We conducted this systematic review with meta-regression analysis on existing clinical trials. Methods: We searched and identified all relevant randomized controlled trials from multiple databases. An analogous R 2 index was used to quantify the proportion of variance explained by each predictor in the association with PAH patients’ prognosis. A total of 20 trials and 3,263 individuals were enrolled. Results: The changes in mPAP, PVR, RAP and CI were all significantly associated with the change in 6MWD (∆6MWD). The change in mPAP was with the highest explanatory power for ∆6MWD (R 2 analog=0.739). Additionally, the changes in mPAP, PVR and CI were independently predictive of adverse clinical events. The change in mPAP had the highest explanatory power for the clinical events (R 2 analog =0.911). Furthermore, the change in PVR was with the highest explanatory power for total mortality of PAH patients (R 2 analog =0.594). Conclusion: Hemodynamic changes after treatment, including mPAP, PVR, CI and RAP, were significantly associated with adverse clinical events or mortality in treated PAH patients. It is recommended that further studies be conducted to evaluate the changes in hemodynamic indices to guide drug titration. Trial registration number: PROSPERO; No.: CRD42019125157; URL: https://www.crd.york.ac.uk/PROSPERO/ (Date of registration: 14/03/2019)

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