Table 2.
Unadjusted and adjusted post-operative outcomes associated with aprotinin vs. no drug
| Unadjusted Results | Adjusted Results | ||||
|---|---|---|---|---|---|
| Aprotinin | No drug | p-value | Aprotinin vs. No Drug | p-value | |
| Overall | (n=7077) | (n=8644) | |||
| In-hospital mortality | 242 (3.4%) | 317 (3.7%) | 0.40 | 0.83 (0.68–1.04) | 0.15 |
| Bleeding requiring surgical invervention | 122 (1.7%) | 173 (2.0%) | 0.20 | 0.76 (0.57–1.02) | 0.07 |
| Composite* | 340 (4.8%) | 455 (5.3%) | 0.19 | 0.81 (0.68–0.97) | 0.02 |
| Dialysis | 106 (1.5%) | 102 (1.2%) | 0.08 | 1.03 (0.74–1.45) | 0.85 |
| Neurologic deficit | 113 (1.6%) | 95 (1.1%) | 0.007 | 1.18 (0.84–1.64) | 0.34 |
| Total LOS, days | 8.7 (4.0–13.0) | 7.9 (4.0–11.0) | <0.0001 | 1.02 (1.00–1.05) | 0.11 |
| ICU LOS, days | 5.1 (2.0–8.0) | 4.4 (2.0–7.0) | <0.0001 | 1.03 (0.99–1.06) | 0.12 |
| Duration of ventilation, days | 3.4 (1.0–5.0) | 3.0 (1.0–5.0) | <0.0001 | 1.04 (1.01–1.09)a | 0.02 |
| Redo Sternotomy Subgroup | (n=2819) | (n=2239) | |||
| In-hospital mortality | 64 (2.3%) | 67 (3.0%) | 0.11 | 0.57 (0.37–0.87) | 0.009 |
| Bleeding requiring surgical invervention | 45 (1.6%) | 61 (2.7%) | 0.006 | 0.50 (0.30–0.85) | 0.01 |
| Composite* | 102 (3.6%) | 118 (5.3%) | 0.004 | 0.56 (0.40–0.80) | 0.001 |
| Dialysis | 29 (1.0%) | 21 (0.9%) | 0.74 | 0.96 (0.45–2.02) | 0.91 |
| Neurologic deficit | 51 (1.8%) | 27 (1.2%) | 0.08 | 1.22 (0.68–2.20) | 0.51 |
| Total LOS, days | 7.5 (4.0–10.0) | 8.1 (5.0–11.0) | 0.001 | 0.94 (0.90–0.98)b | 0.006 |
| ICU LOS, days | 3.8 (2.0–6.0) | 4.1 (2.0–6.0) | 0.0002 | 0.90 (0.84–0.95)c | 0.0004 |
| Duration of ventilation, days | 2.3 (1.0–3.0) | 2.7 (1.0–4.0) | 0.005 | 0.93 (0.87–1.00) d | 0.04 |
| Neonate Subgroup | (n=1517) | (n=1700) | |||
| In-hospital mortality | 165 (10.9%) | 207 (12.2%) | 0.25 | 0.88 (0.66–1.17) | 0.38 |
| Bleeding requiring surgical invervention | 49 (3.2%) | 72 (4.2%) | 0.14 | 0.91 (0.56–1.49) | 0.71 |
| Composite* | 198 (13.1%) | 256 (15.1%) | 0.10 | 0.88 (0.67–1.14) | 0.32 |
| Dialysis | 70 (4.6%) | 70 (4.1%) | 0.48 | 0.95 (0.61–1.48) | 0.83 |
| Neurologic deficit | 49 (3.2%) | 38 (2.2%) | 0.08 | 1.23 (0.71–2.12) | 0.46 |
| Total LOS, days | 19.0 (9.0–29.0) | 19.2 (9.0–30.0) | 0.60 | 0.99 (0.92–1.07) | 0.85 |
| ICU LOS, days | 13.4 (6.0–20.0) | 12.8 (6.0–20.0) | 0.04 | 0.99 (0.91–1.07) | 0.80 |
| Duration of ventilation, days | 7.3 (4.0–11.0) | 7.1 (3.0–11.0) | 0.02 | 1.00 (0.92–1.09) | 0.93 |
--Unadjusted results are displayed as frequency (percent) for dichotomous variables, and 10% trimmed means (interquartile range) for continuous variables. Adjusted results (from conditional logistic regression for dichotomous variables and linear regression with center modeled as a main effect for continuous variables) are displayed as adjusted OR (95%CI) for dichotomous variables and adjusted ratio of LOS or duration of ventilation (days) between groups for continuous variables. In those groups where aprotinin was associated with a significant difference in LOS or duration of ventilation, adjusted estimates of the difference in actual days (aprotinin vs. no drug) at the median value of LOS or duration of ventilation were also calculated:
Overall group, duration of ventilation (+ 0.1 days); Reoperation subgroup,
total LOS (−0.5 days),
ICU LOS (−0.3 days),
duration of ventilation (−0.1 days).
Composite endpoint = in-hospital mortality or bleeding requiring re-operation, ICU= intensive care unit, LOS = length of stay