Table 2.
BL and change from BL in haemodynamic parameters in the inoperable and persistent/recurrent PH following PEA subgroups
| Parameter | Inoperable CTEPH |
Persistent/recurrent PH after PEA |
Interaction p value for difference between inoperable and persistent/ recurrent subgroups |
||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Riociguat |
Placebo |
LS mean difference (95% CI) | Riociguat vs placebo p-value |
Riociguat |
Placebo |
LS mean difference (95% CI) | Riociguat vs placebo p value |
||||||||||
| n | BL* | Change from BL at week 16* | n | BL* | Change from BL at week 16* | n | BL* | Change from BL at week 16* | n | BL* | Change from BL at week 16* | ||||||
| PVR, dyn s/cm5 | 105 | 867 (471) | −257 (279) | 63 | 851 (423) | +33 (292) | −285 (−357 to −213) | <0.0001 | 46 | 618 (252) | −154 (127) | 19 | 540 (172) | −11 (205) | −131 (−214 to −48) | 0.0025 | 0.0089 |
| SVR, dyn s/cm5 | 106 | 1926 (692) | −537 (559) | 60 | 1887 (675) | +56 (615) | −570 (−711 to −430) | <0.0001 | 47 | 1688 (451) | −272 (484) | 17 | 1767 (529) | −121 (551) | −183 (−449 to 83) | 0.17 | 0.0080 |
| mPAP, mm Hg | 109 | 47 (13) | −4 (7) | 65 | 47 (9) | +1 (7) | −4.7 (−6.9 to −2.6) | <0.0001 | 47 | 40 (10) | −5 (6) | 19 | 37 (8) | +1 (7) | −4.8 (−8.2 to −1.5) | 0.0055 | 0.8290 |
| MAP, mm Hg | 108 | 96 (12) | −10 (13) | 61 | 96 (11) | −0.4 (11) | −9.5 (−12.7 to −6.3) | <0.0001 | 47 | 93 (12) | −7 (10) | 17 | 94 (10) | 0.1 (16) | −8.2 (−14.1 to −2.3) | 0.0076 | 0.7941 |
| RAP, mm Hg | 110 | 8.3 (5.3) | −0.8 (5.4) | 65 | 9.2 (6.1) | −0.7 (5.6) | −0.6 (−2.1 to 0.9) | 0.45 | 47 | 9.3 (5.0) | −1.6 (4.5) | 19 | 6.6 (3.4) | +0.1 (3.3) | −0.2 (−2.1 to 1.7) | 0.85 | 0.8652 |
| Cardiac output, L/min | 108 | 4.1 (1.4) | +0.8 (1.1) | 64 | 4.0 (1.4) | −0.1 (1.1) | +1.0 (0.7 to 1.3) | <0.0001 | 47 | 4.2 (0.9) | +0.7 (1.1) | 19 | 4.2 (1.1) | +0.3 (0.9) | +0.4 (−0.2 to 1.0) | 0.14 | 0.0515 |
| Cardiac index, L/min/m2 | 108 | 2.3 (0.7) | +0.5 (0.6) | 64 | 2.2 (0.7) | −0.1 (0.6) | +0.6 (0.4 to 0.7) | <0.0001 | 47 | 2.3 (0.5) | +0.4 (0.5) | 19 | 2.2 (0.5) | +0.2 (0.5) | +0.2 (−0.1 to 0.5) | 0.17 | 0.0408 |
| SvO2, % | 102 | 62 (10) | +4 (10) | 59 | 61 (9) | −1 (11) | +4.9 (1.9 to 7.9) | 0.0014 | 43 | 63 (9) | +1 (7) | 18 | 64 (10) | −0.1 (12) | +1.0 (−3.1 to 5.0) | 0.63 | 0.1336 |
| PAWP, mm Hg | 105 | 9.0 (3.2) | +0.8 (3.6) | 64 | 8.8 (3.6) | −0.1 (3.6) | +0.9 (−0.1 to 1.9) | 0.082 | 46 | 9.8 (3.3) | +0.2 (4.0) | 19 | 9.5 (3.3) | +1.0 (6.3) | −0.6 (−2.9 to 1.7) | 0.61 | 0.1162 |
| dPAP, mm Hg | 109 | 29.8 (11.0) | −3.1 (6.1) | 65 | 29.0 (7.4) | +0.9 (7.6) | – | – | 47 | 25.2 (7.0) | −3.0 (6.1) | 19 | 23.1 (4.9) | −0.2 (6.6) | – | – | – |
| DPG, mm Hg | 105 | 20.7 (10.6) | −4.0 (6.4) | 64 | 20.0 (7.5) | +0.9 (7.8) | −4.8 (−6.9 to −2.7) | <0.0001 | 46 | 15.5 (6.8) | −3.3 (6.2) | 19 | 13.6 (5.6) | −1.2 (7.7) | −1.3 (−4.7 to 2.1) | 0.45 | 0.1139 |
*Data shown are mean (SD).
BL, baseline; CTEPH, chronic thromboembolic pulmonary hypertension; dPAP, diastolic pulmonary artery pressure; DPG, diastolic pressure gradient; LS, least-squares; MAP, mean arterial pressure; mPAP, mean pulmonary artery pressure; PAWP, pulmonary artery wedge pressure; PEA, pulmonary endarterectomy; PH, pulmonary hypertension; PVR, pulmonary vascular resistance; RAP, right atrial pressure; SvO2, mixed venous oxygen saturation; SVR, systemic vascular resistance.