Table 3.

Unadjusted and adjusted post-operative outcomes associated with TXA, ACA, and aprotinin

	Unadjusted Results				Adjusted Results
	Aprotinin	TXA	ACA	p-value	TXA vs. aprotinin	p-value	ACA vs. aprotinin	p-value
Overall	(n=2247)	(n=1140)	(n=1478)
In-hospital mortality	89 (4.0%)	23 (2.0%)	57 (3.9%)	0.009	0.39 (0.21–0.71)	0.002	1.30 (0.82–2.08)	0.27
Bleeding requiring surgical invervention	52 (2.3%)	18 (1.6%)	38 (2.6%)	0.21	0.42 (0.22–0.77)	0.005	1.62 (0.91–2.88)	0.10
Composite*	132 (5.9%)	41 (3.6%)	79 (5.4%)	0.02	0.47 (0.30–0.74)	0.001	1.13 (0.77–1.67)	0.53
Dialysis	38 (1.7%)	9 (0.8%)	23 (1.6%)	0.10	0.23 (0.10–0.55)	0.0008	1.01 (0.51–1.98)	0.99
Neurologic deficit	56 (2.5%)	29 (2.5%)	25 (1.7%)	0.21	0.92 (0.51–1.65)	0.78	0.97 (0.54–1.74)	0.91
Total LOS, days	8.9 (4.0–14.0)	7.6 (4.0–11.0)	9.3 (5.0–14.0)	<0.0001	0.95 (0.89–1.01)	0.09	0.95 (0.90–1.01)	0.10
ICU LOS, days	5.2 (2.0–8.0)	4.3 (2.0–7.0)	5.3 (2.0–8.0)	<0.0001	0.92 (0.85–1.00)a	0.04	0.99 (0.92–1.06)	0.68
Duration of ventilation, days	3.3 (1.0–5.0)	2.7 (1.0–4.0)	3.3 (1.0–5.0)	<0.0001	0.80 (0.73–0.88)b	<0.0001	1.00 (0.92–1.08)	0.98
Redo Sternotomy Subgroup	(n=953)	(n=469)	(n=573)
In-hospital mortality	18 (1.9%)	7 (1.5%)	19 (3.3%)	0.09	0.50 (0.16–1.57)	0.24	2.59 (1.04–6.45)	0.04
Bleeding requiring surgical invervention	20 (2.1%)	6 (1.3%)	12 (2.1%)	0.51	0.40 (0.14–1.10)	0.08	1.42 (0.58–3.47)	0.44
Composite*	35 (3.7%)	13 (2.8%)	26 (4.5%)	0.32	0.63 (0.28–1.42)	0.26	1.31 (0.67–2.54)	0.43
Dialysis	8 (0.8%)	4 (0.9%)	4 (0.7%)	0.95	NA		NA
Neurologic deficit	21 (2.2%)	18 (3.8%)	9 (1.6%)	0.05	1.57 (0.66–3.73)	0.31	1.12 (0.40–3.10)	0.83
Total LOS, days	7.5 (4.0–11.0)	7.1 (4.0–10.0)	8.2 (5.0–11.0)	0.0004	1.02 (0.94–1.12)	0.62	0.99 (0.91–1.08)	0.85
ICU LOS, days	3.9 (2.0–6.0)	3.3 (2.0–5.0)	4.3 (2.0–7.0)	<0.0001	1.02 (0.91–1.14)	0.76	1.03 (0.93–1.15)	0.55
Duration of ventilation, days	2.2 (1.0–3.0)	2.2 (1.0–3.0)	2.4 (1.0–4.0)	0.58	0.91 (0.80–1.04)	0.18	1.10 (0.97–1.25)	0.13
Neonate Subgroup	(n=481)	(n=206)	(n=271)
In-hospital mortality	67 (13.9%)	13 (6.3%)	32 (11.8%)	0.02	0.31 (0.14–0.69)	0.004	1.13 (0.59–2.18)	0.71
Bleeding requiring surgical invervention	25 (5.2%)	6 (2.9%)	19 (7.0%)	0.14	0.30 (0.11–0.84)	0.02	2.81 (1.12–7.09)	0.03
Composite*	86 (17.9%)	19 (9.2%)	42 (15.5%)	0.02	0.30 (0.15–0.58)	0.0004	1.31 (0.73–2.34)	0.37
Dialysis	27 (5.6%)	4 (1.9%)	15 (5.5%)	0.09	0.12 (0.04–0.41)	0.0006	0.73 (0.30–1.77)	0.49
Neurologic deficit	29 (6.0%)	8 (3.9%)	10 (3.7%)	0.26	0.55 (0.20–1.51)	0.25	0.83 (0.30–2.27)	0.72
Total LOS, days	20.2 (9.0–32.0)	16.3 (9.0–23.0)	22.3 (11.0–36.0)	0.002	0.87 (0.75–1.01)	0.07	0.96 (0.83–1.11)	0.61
ICU LOS, days	14.3 (6.0–22.0)	12.2 (6.0–18.0)	14.6 (6.0–24.0)	0.18	0.82 (0.69–0.98)c	0.03	0.99 (0.84–1.17)	0.94
Duration of ventilation, days	7.0 (3.0–10.0)	5.5 (3.0–8.0)	8.3 (4.0–12.0)	0.0002	0.62 (0.52–0.74)d	<0.0001	0.92 (0.78–1.10)	0.37

--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 at the median value of LOS or duration of ventilation were also calculated: Overall group:

^aICU LOS, TXA vs. aprotinin (−0.3 days);

^bduration of ventilation, TXA vs. aprotinin (−0.4 days). Neonate subgroup:

^cICU LOS, TXA vs. aprotinin (−1.8 days);

^dduration of ventilation, TXA vs. aprotinin (−2.3 days).

^*Composite endpoint=in-hospital mortality or bleeding requiring re-operation. NA=not enough events to model, ICU=intensive care unit, LOS=length of stay