Table 2.
Clinical outcomes
| Outcome | SonR (N=649) | Echo (N=318) | Mean % difference (95% CI) |
P-value |
|
|---|---|---|---|---|---|
| % (n) | Non-inferiority | Superiority | |||
| Clinical respondersa | 75.0 (487) | 70.4 (224) | 4.6 (−1.4, 10.6) | <0.001 | 0.13 |
| NYHA improved | 65.6 (426) | 61.9 (197) | |||
| Stable NYHA, improved quality of life | 9.4 (61) | 8.5 (27) | |||
| Clinical non-respondersb | 25.0 (162) | 29.6 (94) | |||
| Clinically stable | 4.0 (26) | 4.4 (14) | |||
| Clinically worsened: secondary endpoint | 21.0 (136) | 25.2 (80) | 4.2 (−1.5, 9.9) | <0.001 | 0.15 |
| Death from any cause | 5.5 (36) | 6.0 (19) | |||
| If no death, HF-related event | 10.2 (66) | 12.9 (41) | |||
| Worsened NYHA class | 0.9 (6) | 0.3 (1) | |||
| Worsened quality of life; stable NYHA stable | 4.3 (28) | 6.0 (19) | |||
| Death or HF hospitalization | 14.2 (92) | 17.6 (56) | 3.4 (−1.5, 8.4) | <0.001 | 0.18 |
P-value for non-inferiority is based on one-sided Z-test of two binomial proportions at 0.025 alpha level with 10.0% non-inferiority margin; P-value for superiority is based on two-sided Z-test.
CI, confidence interval; HF, heart failure; NYHA, New York Heart Association functional class.
a
Patients who are clinically improved according to the primary efficacy endpoint.
b
Patients who are either stable or deteriorated according to the primary efficacy endpoint.