Age (years), mean ± SD
|
2,508 |
49.3 ± 15.9 |
46.3 ± 16.0 |
50.5 ± 15.6 |
47.8 ± 16.3 |
Sex (Female), n (%)
|
2,508 |
1,956 (78.0) |
497 (80.6) |
1,361 (77.1) |
98 (78.4) |
Race, n (%)
|
2,508 |
|
|
|
|
White |
|
1,704 (67.9) |
388 (62.9) |
1,226 (69.4) |
90 (72.0) |
Asian |
|
463 (18.5) |
148 (24.0) |
294 (16.6) |
21 (16.8) |
Black |
|
86 (3.4) |
19 (3.1) |
63 (3.6) |
4 (3.2) |
Multiple / Other |
|
31 (1.2) |
18 (2.9) |
13 (0.7) |
0 (0.0) |
Unknown |
|
224 (8.9) |
44 (7.1) |
170 (9.6) |
10 (8.0) |
Ethnicity, n (%)
|
2,508 |
|
|
|
|
Not Hispanic/Latino |
|
2,227 (88.8) |
561 (90.9) |
1,551 (87.8) |
115 (92.0) |
Hispanic/Latino |
|
280 (11.2) |
56 (9.1) |
214 (12.1) |
10 (8.0) |
Unknown |
|
1 (0.0) |
0 (0.0) |
1 (0.1) |
0 (0.0) |
Body mass index (kg/m
2
), mean ± SD
|
2,508 |
26.9 ± 5.7 |
26.0 ± 5.0 |
27.2 ± 5.9 |
27.1 ± 5.3 |
PAH etiology, n (%)
|
2,503 |
|
|
|
|
Idiopathic |
|
1,388 (55.5) |
292 (47.5) |
1,013 (57.5) |
83 (66.4) |
Associated with connective tissue disease |
|
776 (31.0) |
233 (37.9) |
509 (28.9) |
34 (27.2) |
Associated with congenital heart disease |
|
181 (7.2) |
56 (9.1) |
122 (6.9) |
3 (2.4) |
Drug and toxin-induced |
|
72 (2.9) |
15 (2.4) |
56 (3.2) |
1 (0.8) |
Heritable/familial |
|
56 (2.2) |
13 (2.1) |
40 (2.3) |
3 (2.4) |
Associated with HIV infection |
|
30 (1.2) |
6 (1.0) |
23 (1.3) |
1 (0.8) |
Background PAH therapy, n (%)
|
2,508 |
|
|
|
|
None |
|
1,348 (53.7) |
344 (55.8) |
946 (53.6) |
58 (46.4) |
Phosphodiesterase type 5 |
|
736 (29.3) |
184 (29.8) |
510 (28.9) |
42 (33.6) |
inhibitor alone |
|
|
|
|
|
Phosphodiesterase type 5 |
|
227 (9.1) |
43 (7.0) |
171 (9.7) |
13 (10.4) |
inhibitor and Endothelin receptor |
|
|
|
|
|
antagonist |
|
|
|
|
|
Endothelin receptor antagonist alone |
|
156 (6.2) |
33 (5.3) |
113 (6.4) |
10 (8.0) |
Phosphodiesterase type 5 inhibitor and Prostacyclin analogue |
|
24 (1.0) |
9 (1.5) |
13 (0.7) |
2 (1.6) |
Prostacyclin analogue alone |
|
17 (0.7) |
4 (0.6) |
13 (0.7) |
0 (0.0) |
WHO functional class, n (%)
|
2,507 |
|
|
|
|
I |
|
10 (0.4) |
5 (0.8) |
5 (0.3) |
0 (0.0) |
II |
|
1,110 (44.3) |
485 (78.6) |
622 (35.2) |
3 (2.4) |
III |
|
1,361 (54.3) |
127 (20.6) |
1,125 (63.7) |
109 (87.9) |
IV |
|
26 (1.0) |
0 (0.0) |
14 (0.8) |
12 (9.7) |
Six-minute walk distance (m), mean ± SD
|
2,506 |
353.3 ± 89.5 |
400.0 ± 78.2 |
342.5 ± 84.7 |
275.0 ± 103.5 |
NT-proBNP (pg/mL)
|
1,744 |
365 [208, 1,750] |
156 [81, 268] |
939 [365, 1,924] |
2,527 [1,880, 3,486] |
Mean right atrial pressure (mmHg), median [IQR]
|
2,332 |
8.0 [5.0, 11.0] |
5.0 [4.0, 7.0] |
8.0 [6.0, 12.0] |
16.0 [15.0, 20.0] |
Mean pulmonary artery pressure (mmHg), median [IQR]
|
2,503 |
51 [41, 60] |
44 [36, 54] |
52 [43, 62] |
58 [51, 65] |
Cardiac output (L/min), median [IQR]
|
2,423 |
4.2 [3.4, 5.1] |
5.0 [4.4, 6.0] |
4.0 [3.2, 4.8] |
2.9 [2.4, 3.4] |
Cardi ac index (L/min/m
2
), median [IQR]
|
2,431 |
2.4 [1.9, 2.9] |
2.9 [2.6, 3.4] |
2.2 [1.9, 2.6] |
1.7 [1.4, 1.9] |
Pulmonary vascular resistance (Wood units), median [IQR]
|
2,445 |
10 [7, 14] |
7 [5, 9] |
11 [7, 15] |
17 [13, 21] |
Pulmonary artery wedge pressure (mmHg), median [IQR]
|
2,387 |
9.0 [7.0, 12.0] |
9.0 [6.0, 11.0] |
10.0 [7.0, 12.0] |
10.0 [7.0, 11.5] |
Treatment assignment
|
2,508 |
|
|
|
|
Experimental |
|
1,372 (54.7) |
326 (52.8) |
982 (55.6) |
64 (51.2) |
Control |
|
1,136 (45.3) |
291 (47.2) |
784 (44.4) |
61 (48.8) |