Table 1.
Primary (Weeks 0–16) and sensitivity (Weeks 4–16) analyses
| Death | CP Hospitalization | 6MWD Decline | Clinical Improvement | Total | |
|---|---|---|---|---|---|
| Primary win ratio analysis | |||||
| Algorithm 1 | |||||
| iTre wins | 1,642 (11%) | 2,796 (19%) | 2,489 (17%) | 2,182 (15%) | 9,109 (61%) |
| Placebo wins | 1,479 (10%) | 2,484 (17%) | 1,185 (8%) | 726 (5%) | 5,874 (39%) |
| Total | 3,121 (21%) | 5,280 (35%) | 3,674 (25%) | 2,908 (19%) | 14,983 (100%) |
| Win ratio | 1.551 (CI, 1.068–2.252, P = 0.021) | ||||
| Algorithm 2 | |||||
| iTre wins | 1,836 (12%) | 2,756 (18%) | 2,938 (19%) | 2,121 (14%) | 9,651 (62%) |
| Placebo wins | 1,510 (10%) | 2,370 (15%) | 1,229 (8%) | 721 (5%) | 5,830 (38%) |
| Total | 3,346 (22%) | 5,126 (33%) | 4,167 (27%) | 2,842 (18%) | 15,481 (100%) |
| Win ratio | 1.655 (CI, 1.131–2.422, P = 0.010) | ||||
| Sensitivity analysis | |||||
| Algorithm 1 | |||||
| iTre wins | 1,483 (11%) | 2,282 (18%) | 2,555 (20%) | 2,140 (16%) | 8,460 (65%) |
| Placebo wins | 1,154 (9%) | 1,445 (11%) | 1,204 (9%) | 761 (6%) | 4,673 (35%) |
| Total | 2,637 (20%) | 3,727 (29%) | 3,759 (29%) | 2,901 (22%) | 13,024 (100%) |
| Win ratio | 1.854 (CI, 1.241–2.769, P = 0.003) | ||||
| Algorithm 2 | |||||
| iTre wins | 1,661 (12%) | 2,282 (17%) | 3,017 (22%) | 2,079 (15%) | 9,039 (67%) |
| Placebo wins | 1,160 (9%) | 1,427 (11%) | 1,191 (9%) | 756 (6%) | 4,534 (33%) |
| Total | 2,821 (21%) | 3,709 (27%) | 4,208 (27%) | 2,835 (21%) | 13,573 (100%) |
| Win ratio | 1.994 (CI, 1.326–2.997, P = 0.001) | ||||
Definition of abbreviations: 6MWD = 6-minute-walk distance; CI = confidence interval; CP = cardiopulmonary; iTre = inhaled treprostinil; NT-proBNP = N-terminal pro–B-type natriuretic peptide.
The event hierarchy was ordered as follows: death, cardiopulmonary hospitalization, ⩾15% 6MWD decrease from baseline, and clinical improvement (⩾15% increase in 6MWD together with a ⩾30% reduction in NT-proBNP).