Table 5.
Effects of ferric derisomaltose compared to usual care for patients classified by transferrin saturation
| TSAT | ≤10 | >10 to ≤15 | >15 to <20 | ≥ 20%* | P for interaction | ||||
|---|---|---|---|---|---|---|---|---|---|
| Usual care | FDI | Usual care | FDI | Usual care | FDI | Usual care | FDI | ||
| 142 | 130 | 142 | 156 | 144 | 127 | 128 | 141 | ||
| Haemoglobin (g/dL) | |||||||||
| Value at 4 months | 12.1 (1.6) | 13.4 (1.4) | 12.3 (1.3) | 12.7 (1.4) | 12.1 (1.4) | 12.5 (1.3) | 12.4 (1.4) | 12.7 (1.1) | |
| Difference in change from baseline | 1.4 (1.0 to 1.8) | 0.4 (0.1 to 0.7) | 0.5 (0.2 to 0.8) | 0.3 (0.1 to 0.6) | <.001 | ||||
| MLwHF score overall (n) | |||||||||
| Value at 4 months | 44 (29) | 41 (30) | 41 (26) | 38 (28) | 40 (26) | 37 (27) | 35 (25) | 33 (24) | |
| Difference at 4 months | −3 (−11 to +5) | −3 (−10 to +4) | −3 (−10 to +4) | −2 (−8 to +4) | 1.0 | ||||
| MLwHF score physical | |||||||||
| Value at 4 months | 22 (12) | 19 (13) | 20 (11) | 18 (12) | 20 (11) | 18 (12) | 18 (11) | 17 (11) | |
| Difference at 4 months | −3 (−6 to +0) | −2 (−5 to +1) | −2 (−5 to +1) | −1 (−4 to +2) | .85 | ||||
| MLwHF score emotional | |||||||||
| Value at 4 months | 9 (8) | 10 (9) | 9 (8) | 8 (8) | 9 (7) | 8 (8) | 8 (8) | 7 (7) | |
| Difference at 4 months | +0 (−2 to +3) | −1 (−2 to +2) | −1 (−3 to +2) | −1 (−3 to +1) | .90 | ||||
| 6-Minute walk test (n) | 51 | 50 | 52 | 65 | 59 | 58 | 61 | 79 | |
| Distance at 4 months (m) | 256 (125) | 265 (116) | 283 (145) | 295 (142) | 262 (124) | 264 (127) | 324 (121) | 297 (134) | |
| Difference usual care vs. FDI | +9 (−39 to +57) | +12 (−41 to +65) | +1 (−45 to +47) | −27 [−71 to +16] | .61 | ||||
| Primary endpoint | |||||||||
| Rate per 100 patient-years | 32.1 | 25.4 | 24.1 | 24.3 | 32.6 | 21.4 | 20.3 | 17.8 | |
| Rate ratio | 0.80 (0.53 to 1.21) | 0.99 (0.64 to 1.54) | 0.65 (0.42 to 1.01) | 0.96 (0.60 to 1.52) | .58 | ||||
| Absolute difference in rate | 6.7 lower with FDI | 0.2 higher with FDI | 11.2 lower with FDI | 2.5 lower with FDI | |||||
| Primary endpoint (COVID sensitivity) | |||||||||
| Rate per 100 patient-years | 30.1 | 29.1 | 28.5 | 20.7 | 36.5 | 20.3 | 18.8 | 17.4 | |
| Rate ratio | 0.95 (0.58 to 1.55) | 0.72 (0.42 to 1.22) | 0.55 (0.31 to 0.98) | 0.96 (0.55 to 1.68) | .50 | ||||
| Absolute difference in rate | 1.0 lower with FDI | 7.8 lower with FDI | 16.2 lower with FDI | 1.4 lower with FDI | |||||
| CV mortality | |||||||||
| Percentage (%) | 26.8 | 23.8 | 21.8 | 21.8 | 27.8 | 18.9 | 18.8 | 17.7 | |
| Hazard ratio | 0.90 (0.56 to 1.45) | 1.05 (0.64 to 1.70) | 0.63 (0.38 to 1.05) | 1.03 (0.59 to 1.82) | .46 | ||||
| Absolute difference in percentages (%) | 3.0 lower with FDI | No difference | 8.9 lower with FDI | 1.0 lower with FDI | |||||
| CV mortality (COVID sensitivity) | |||||||||
| Percentage (%) | 14.4 | 15.7 | 14.6 | 11.7 | 20.4 | 9.2 | 11.9 | 11.9 | |
| Hazard ratio | 1.06 (0.55 to 2.01) | 0.80 (0.42 to 1.53) | 0.42 (0.21 to 0.84) | 1.12 (0.54 to 2.29) | .18 | ||||
| Absolute difference in percentages (%) | 1.3 higher with FDI | 2.9 lower with FDI | 11.2 lower with FDI | No change | |||||
| All-cause mortality | |||||||||
| Percentage (%) | 40.8 | 38.5 | 29.6 | 32.1 | 36.8 | 27.6 | 25.8 | 30.5 | |
| Hazard ratio | 0.96 (0.66 to 1.40) | 1.13 (0.75 to 1.70) | 0.69 (0.45 to 1.06) | 1.30 (0.82 to 2.05) | .21 | ||||
| Absolute difference in percentages (%) | 2.3 lower with FDI | 2.5 higher with FDI | 9.2 lower with FDI | 4.7 higher with FDI | |||||
| All-cause mortality (COVID sensitivity) | |||||||||
| Percentage (%) | 24.2 | 24.3 | 19.0 | 16.6 | 24.8 | 16.0 | 14.4 | 20.0 | |
| Hazard ratio | 0.99 (0.60 to 1.64) | 0.88 (0.50 to 1.53) | 0.58 (0.33 to 1.02) | 1.56 (0.85 to 2.87) | .15 | ||||
| Absolute difference in percentages (%) | 0.1 higher with FDI | 2.4 lower with FDI | 8.8 lower with FDI | 5.6 higher with FDI | |||||
Substantial differences in rates are highlighted in bold. MLwHF, Minnesota Living with Heart Failure.
*Ferritin <100 μg/L required if TSAT ≥20%.