Randomised controlled trial data on the use of medical therapies in patients with chronic thromboembolic pulmonary hypertension
CHEST-1 [68] | Suntharalingam et al. [69] | MERIT-1 [70] | BENEFiT [71] | |
Patients n | 261 | 19 | 80 | 157 |
Active treatment | Riociguat | Sildenafil | Macitentan | Bosentan |
Control | Placebo | Placebo | Placebo | Placebo |
Treatment duration weeks | 16 | 12 | 24 | 16 |
Population n (%) | ||||
Inoperable | 189 (72.4) | 10 (52.6) | 80 (100) | 96 (70.1) |
Persistent/recurrent PH post-pulmonary endarterectomy | 72 (27.6) | 9 (47.4) | 0 | 41 (29.9) |
Use of PAH therapy at baseline n (%) | ||||
No | 261 (100.0) | 19 (100.0) | 31 (38.8) | 157 (100.0) |
Yes | 0 | 0 | 49 (61.3) | 0 |
Primary end-point | Change in 6MWD from baseline to week 16 | Change in 6MWD from baseline to week 12 | PVR at week 16 as a percentage of baseline | Change in PVR and 6MWD from baseline to week 16 (co-primary end-points) |
Treatment effect on 6MWD | +46 (25–67) m, p<0.001# | +18 (−24–59) m, p=ns | +34 (3–65) m, p<0.05# | +2 (−23–27) m, p=ns |
Treatment effect on PVR | −246 (−303– −190) dyn·s·cm−5, p<0.001# | −197 (−389– −6) dyn·s·cm−5, p<0.05 | 0.84¶ (0.70–0.99), p<0.05+ | −24%§ (−32– −16%), p<0.0001+ |
Treatment effect on mPAP | −5 (−7–−3) mmHg, p<0.001# | −6 (−12–0) mmHg, p=ns | −2 (−6–2) mmHg, p=ns# | −3 (−5–0) mmHg, p=ns |
Data are presented as n, n (%) or mean difference (95% CI), with p-value, between active and control groups, unless otherwise stated. PH: pulmonary hypertension; PAH: pulmonary arterial hypertension; 6MWD: 6-min walk distance; PVR: pulmonary vascular resistance; mPAP: mean pulmonary arterial pressure; ns: nonsignificant. #: treatment effect is the least-squares mean difference; ¶: corresponds to a 16% reduction, PVR decreased by 206 dyn·s·cm−5 in the macitentan group and 86 dyn·s·cm−5 in the placebo group; +: treatment effect is the ratio of geometric means; §: PVR decreased by 146 dyn·s·cm−5 in the bosentan group and increased by 30 dyn·s·cm−5 in the placebo group.