Table 4.
PREVENTT secondary and safety endpoints
| Placebo (n=243) | Intravenous iron (n=244) | Iron vs placebo (95% CI) | ||
|---|---|---|---|---|
| Units of blood*transfused from randomisation to 30 days after operation (excluding LBT) | ||||
| Mean | 0·65 (1·3) | 0·61 (1·3) | 0·98 (0·65 to 1·47)† | |
| Patients with ≥1 transfusion | 64/237 (27%) | 66/237 (28%) | .. | |
| Total units transfused | 155 | 145 | .. | |
| Units of blood*transfused from randomisation to 6 months after operation (excluding LBT) | ||||
| Mean | 0·94 (2·0) | 0·79 (1·6) | 0·89 (0·60 to 1·32)† | |
| Patients with ≥1 transfusion | 73/224 (33%) | 72/220 (33%) | .. | |
| Total units transfused | 212 | 174 | .. | |
| Days alive and out of hospital within 30 days | ||||
| Mean | 19·8 (7·5) | 19·7 (7·0) | −0·1 (−1·5 to 1·2) | |
| Postoperative complications | ||||
| CD grade III or above to discharge | 24/227 (11%) | 22/233 (9%) | 0·89 (0·52 to 1·55)‡ | |
| MFI questionnaire | ||||
| 10-day assessment | 50·5 (18·9) | 53·2 (18·4) | 1·2 (−1·1 to 3·4) | |
| 8-week assessment | 53·9 (17·7) | 52·9 (17·1) | −1·7 (−4·7 to 1·3) | |
| 6-month assessment | 47·4 (19·1) | 48·8 (18·9) | −0·1 (−3·5 to 3·2) | |
| EQ-5D-5L questionnaire | ||||
| Utility score | ||||
| 10-day assessment | 0·81 (0·21) | 0·80 (0·20) | 0·01 (−0·02 to 0·03) | |
| 8-week assessment | 0·77 (0·21) | 0·79 (0·20) | 0·02 (−0·01 to 0·05) | |
| 6-month assessment | 0·82 (0·21) | 0·82 (0·22) | 0·02 (−0·02 to 0·05) | |
| Health score | ||||
| 10-day assessment | 73·8 (19·6) | 70·6 (20·5) | −0·8 (−3·5 to 1·9) | |
| 8-week assessment | 71·1 (19·5) | 70·7 (19·4) | 0·3 (−3·2 to 3·9) | |
| 6-month assessment | 76·2 (19·2) | 75·0 (18·4) | 0·2 (−3·4 to 3·8) | |
| ICU length of stay (days) | ||||
| Median (IQR) | 1 (0–3) | 2 (0–3) | .. | |
| Range | 0–23 | 0–33 | .. | |
| Hospital length of stay (days) | ||||
| Median (IQR) | 9 (5–14) | 9 (7–14) | .. | |
| Range | 1–46 | 1–118 | .. | |
| All-cause mortality | ||||
| 30 days | 2/241 (1%) | 2/239 (1%) | 1·01 (0·14 to 7·10)‡ | |
| 6 months | 10/236 (4%) | 12/238 (5%) | 1·19 (0·52 to 2·70)‡ | |
| Readmission to hospital for complications | ||||
| Discharge to 8 weeks | ||||
| Any readmission | 51/234 (22%) | 31/234 (13%) | 0·61 (0·40 to 0·91)‡ | |
| Total number of readmissions | 71 | 38 | 0·54 (0·34 to 0·85)† | |
| Discharge to 6 months | ||||
| Any readmission | 73/223 (32%) | 58/227 (26%) | 0·78 (0·58 to 1·04)‡ | |
| Total number of readmissions | 130 | 84 | 0·64 (0·44 to 0·92)† | |
| Safety outcomes to 6 months§ | ||||
| SAEs and SUSARs | 23/240 (10%) | 22/240 (9%) | 0·96 (0·55 to 1·67)‡ | |
| Adverse reaction to trial therapy | 5/240 (2%) | 11/240 (5%) | 2·20 (0·78 to 6·24)‡ | |
| Development of perioperative AKI | 13/122 (11%) | 11/137 (8%) | 0·75 (0·35 to 1·62)‡ | |
Data are mean (SD), n/N (%), n, median (IQR), range, or treatment effect (95% CI). LBT=large blood transfusion, defined as 4 or more units of blood transfused in a single transfusion episode (there were 9 LBTs in total). CD=Clavien–Dindo. ICU=intensive care unit. MFI=Multidimensional Fatigue Inventory. EQ-5D-5L=European Quality of Life: 5 Dimensions 5 Levels. SAE=serious adverse event. SUSAR=suspected unexpected serious adverse event. AKI=acute kidney injury.
*
Total number of units of blood or blood products transfused. Treatment effect is either difference in mean or rate ratio (†) or risk ratio (‡).
§
Safety outcomes measured in the safety population.