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. 2017 Mar 29;26(143):160107. doi: 10.1183/16000617.0107-2016

TABLE 1.

Efficacy data for randomised controlled trials of targeted therapy in patients with chronic thromboembolic pulmonary hypertension

BENEFIT [39] Sildenafil study [41] CHEST-1 [38] CHEST-2 [40]
Bosentan Placebo Sildenafil Placebo Riociguat Placebo Prior riociguat Prior placebo
Patients n 77 80 9 10 173 88 155 82
Study design Multicentre, randomised, double-blind, placebo-controlled Randomised, double-blind, placebo-controlled Multicentre, randomised, double-blind, placebo-controlled Long-term, open-label extension
Primary end-point Change in PVR and 6MWD after 16 weeks Change in 6MWD after 12 weeks Change in 6MWD after 16 weeks None
6MWD m +3 (−13–19) +1 (−18–20) +18±34# +0±49# +39±79*** −6±84 +591±589 +37±69
PVR dyn·s·cm−5 −146+ (−207–−85) +30 (−25–85) −179 (245)* +18 (76) −226±248*** +23±274
mPAP mmHg −6±7# +0±6# −4±7*** +1±7
TPR dyn·s·cm−5 +
PAOP mmHg +0±3# −0±3#
mRAP mmHg −0±5# −1±6# −1±5 −1±5
PCWP mmHg +1±4 +0±4
mPa mmHg −9±12*** −0±12
Cardiac output L·min−1 +1±1*** −0±1
Cardiac index L·min−1·m−2 *** −0±1# −0±0#
SvO2 %
SaO2 % −2±4 −3±8
PaO2 mmHg −3±15 −5±12
Heart rate beats·min−1 +2±12 +1±12
NT-proBNP pg·mL−1 −200**, +400 −355±648# −77±130# −291±1717*** +76±1447 −375±1182 −505±1591
WHO FC %
 Improved 14 11 44 0 33 15 50 39
 No change 83 80 56 80 62 78 45 59
 Worsened 3 9 0 20 5 7 4 2
Clinical worsening events % 4 6 2 6 16
Borg dyspnoea score −0 (−1–0)* +0 (−0–1) −1±1# +0±2# −1±2** +0±2 −1±2 −1±2
EQ-5D score +0.06±0.28 −0.08±0.34 +0.12±0.29 +0.01±0.30
LPH score −7±19 −2±19
CAMPHOR score
 Symptoms −2±5# −0±3#
 Activity −3±2# −1±3#
 Quality of life −2±7# −0±4#

Data are presented as mean±sd or mean (95% CI), unless otherwise stated. Data represent change from baseline at 16 weeks (CHEST-1 and BENEFIT), 12 weeks (sildenafil study) or 1 year (CHEST-2). 6MWD: 6-min walking distance; PVR: pulmonary vascular resistance; mPAP: mean pulmonary arterial pressure; TPR: total pulmonary resistance; PAOP: pulmonary artery occlusion pressure; mRAP: mean right atrial pressure; PCWP: pulmonary capillary wedge pressure; mPa: mean arterial pressure; SvO2: mixed venous oxygen saturation; SaO2: arterial oxygen saturation; PaO2: arterial oxygen tension; NT-proBNP: N-terminal of the pro-brain natriuretic peptide; WHO FC: World Health Organization functional class; EQ-5D: EuroQoL 5-dimensions quality-of-life questionnaire; LPH: Living with Pulmonary Hypertension questionnaire; CAMPHOR: Cambridge Pulmonary Hypertension Outcome Review. #: mean±se; : estimated from graph. *: p<0.05; **: p<0.01; ***: p<0.001; +: p<0.0001 versus placebo.

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