Is low-risk status a surrogate outcome in pulmonary arterial hypertension? An analysis of three randomised trials.

ABSTRACT:

Background

Targeting short-term improvements in multicomponent risk scores for mortality in patients with pulmonary arterial hypertension (PAH) could result in improved long-term outcomes. We aimed to determine whether PAH risk scores were adequate surrogates for clinical worsening or mortality outcomes in PAH randomised clinical trials (RCTs).

Methods

We performed an individual participant data meta-analysis of RCTs selected from PAH trials provided by the US Food and Drug Administration (FDA). We calculated predicted risk using the COMPERA, COMPERA 2.0, non-invasive FPHR, REVEAL 2.0, and REVEAL Lite 2 risk scores. The primary outcome of interest was time to clinical worsening, a composite endpoint composed of any of the following events: all-cause death, hospitalisation fo

SUBMITTER: Blette BS 

PROVIDER: S-EPMC10592525 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature