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EXPLORATORY ENDPOINT: CHANGE IN NUMBER OF LOW-RISK CRITERIA1

Two sets of parameters were assessed and the thresholds used to define low-risk were updated post hoc to align with those recommended in the (ESC)/(ERS) guidelines. Low-risk criteria: invasive and non-invasive variables defined as FC I/II, 6MWD >440 m, mRAP <8 mmHg, and cardiac index >2.5 L·min−1·m−2, Lowrisk criteria: non-invasive variables defined as FC I/II, 6MWD >440 m, and NT-proBNP <300 ng·L−1.1

References:

[1] Sibton O, Cottin V, Canuet M, et al. initial combination therapy of macitentan and tadalafil in pulmonary arterial hypertension. Eur Respir J. 2020 Sep 3;56 (3):2000673.

CP-263144