6/28/23, 12:08 AM CHEST-1 Pathway Feedback Search Clinical Topics Home Studies CHEST 1 CHEST 1 Disease Chronic thromboembolic pulmo Trial question What is the role of riociguat, a soluble guanylate cyclase stimulator, in patients with chronic thromboembolic pulmonary hypertension? Study design Multi-center Double blinded RCT Population Characteristics of study participants 66.0% female N = 261 34.0% male 261 patients (172 female, 89 male) Inclusion criteria: patients with inoperable chronic thromboembolic pulmonary hypertension, or persistent or recurrent pulmonary hypertension after pulmonary endarterectomy Key exclusion criteria: receipt of an endothelin-receptor antagonist, prostacyclin analogue, phosphodiesterase type 5 inhibitor, or nitric oxide donor within the 3 months before study entry Interventions N=173 riociguat (an oral dose of 1-2.5 mg TID for 16 weeks) N=88 placebo (matching placebo TID for 16 weeks) Primary outcome Significant increase in improvement in 6-minute walk distance at week 16 (39 m vs. -6 m; MD 46, 95% CI 25 to 67) t https://web.pathway.md/studies/rectBS9P9bWgihKa0 S d 1/2 6/28/23, 12:08 AM CHEST-1 Pathway Secondary outcomes Significant decrease in elevation of pulmonary vascular resistance at week 16 (-226 dyn s/cm vs. 23 dyn s/cm ; MD -246, 95% CI -303 to -190) Significant decrease in improvement in N-terminal pro-BNP level at week 16 (-291 pg/mL vs. 76 pg/mL; MD -444, 95% CI -843 to -45) Significant increase in quality of life as measured by the EuroQol-5D questionnaire (0.06 vs. -0.08; MD 0.13, 95% CI 0.06 to 0.21) Safety outcomes No significant differences in clinical worsening, RV failure, syncope, other adverse events. Conclusion In patients with inoperable chronic thromboembolic pulmonary hypertension, or persistent or recurrent pulmonary hypertension after pulmonary endarterectomy, riociguat was superior to placebo with respect to improvement in 6-minute walk distance at week 16. Reference Hossein-Ardeschir Ghofrani, Andrea M D'Armini, Friedrich Grimminger et al. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med. 2013 Jul 25;369(4):319-29. Open reference URL https://web.pathway.md/studies/rectBS9P9bWgihKa0 2/2