Abstract
Background
PEA is the recommended treatment for CTEPH as it is potentially curative in the majority of patients (pts). However, some pts have persistent/recurrent pulmonary hypertension (PH) following PEA.
Aims
This subgroup analysis of the CHEST study assessed the long-term effects of riociguat in pts with persistent/recurrent PH following PEA.
Methods
In CHEST-1, 72 pts with persistent/recurrent PH following PEA were randomized to riociguat (up to 2.5 mg tid) or placebo (pbo) for 16 wks. After CHEST-1 completion, eligible pts could enter the long-term extension study CHEST-2, where all pts received riociguat. The results of an interim analysis (censored Mar 2013) are reported.
Results
At the end of CHEST-1, 6MWD and several secondary endpoints had improved in the riociguat group vs pbo. Of the 72 pts with persistent/recurrent PH following PEA in CHEST-1, 65 entered CHEST-2 (mean age 58±15 yrs, mean time since PEA 3.3 yrs). At censor date, 86% (n=56) of pts were ongoing, 69% (n=45) attended the 1-yr visit, and 14% (n=9) had discontinued, of whom 8% (n=5) had died. Riociguat was well tolerated; 2% (n=1) of pts withdrew due to adverse events. Improvements in 6MWD at Wk 12 of CHEST-2 vs CHEST-1 baseline (ex-riociguat 40±75 m; ex-pbo 44±43 m) were sustained for 1 yr in the overall cohort (44±64 m; n=42). WHO functional class improved/stabilized/worsened in 42/53/4% and 42/58/0% of the ex-riociguat and ex-pbo pts, respectively, at Wk 12 of CHEST-2, and 49/51/0% of pts at 1 yr (n=43).
Conclusions
Long-term riociguat was well tolerated in pts with persistent/recurrent PH following PEA and improved 6MWD and secondary endpoints for up to 1 yr.
- © 2014 ERS
