DIRECTION- Discontinuation versus continuation of riociguat monotherapy in chronic thromboembolic pulmonary hypertension successfully treated with balloon pulmonary angioplasty

chronic thromboembolic pulmonary hypertension

clinical worsening at the longest follow-up: a.death due to any cause, b.hospitalization due to worsening of PH, including: i.Documented right heart failure, OR ii.Need for lung transplantation, OR iii.Need for intravenous diuretics and/or inotropic support, OR iv. Need for parental prostanoids c. decline in 6MWD by ≥15% from baseline, combined with WHO functional class III or IV IV(confirmed on a second test within 7 days and both conditions met)

Change from baseline to Months 3, 6,12 and every 6 months until the last enrolled patient has completed the minimum 12-month follow-up in 6MWD, WHO FC, NT-proBNP levels, and quality of life measured by the generic EQ-5D-5L and the disease-specific EmPHasis-10., Change from baseline to Month 12 in right atrial pressure, mPAP, cardiac output and PVR., Health economic outcomes: incremental cost effectiveness ratio (difference in costs/difference in QALYS) of riociguat monotherapy withdrawal for the French public health system., Treatment burden assessed at baseline and Month 12, Occurrence at the longest follow-up (minimum 12 months) of individual components of the primary endpoint

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