Table 2.
Demographic and clinical variables in the overall series of patients according to per protocol analysis.
| Variable | Pre-emptive TIPS (n = 9) | Standard of care (n = 12) | p value∗ |
|---|---|---|---|
| Age, years† | 59 ± 12 | 63 ± 7 | 0.42 |
| Sex (male/female), n | 6/3 | 10/2 | 0.37 |
| Etiology of cirrhosis, n (HCV/alcohol/HCV + alcohol/NASH/other) | 1/3/1/2/2 | 3/6/1/2/0 | 0.46 |
| Cause of bleeding (IGV1/GOV2), n | 4/5 | 8/4 | 0.31 |
| Shock at admission (yes/no), n | 6/3 | 6/6 | 0.44 |
| Child-Pugh class (A/BC) at admission, n | 3/6 | 5/7 | 0.69 |
| Child-Pugh score at admission† | 7.2 ± 1.6 | 7.8 ± 1.3 | 0.42 |
| Haematocrit at admission† | 26 ± 7 | 28 ± 7 | 0.55 |
| 5-day failure (yes/no), n | 0/9 | 3/9 | 0.10 |
| Rescue therapy (yes/no), n | 0/9 | 2/10 | 0.19 |
| 6-week death (yes/no), n | 0/9 | 3/9 | 0.105 |
| Outcome at 6-week, n: Died or OLT Alive w/o OLT |
0 9 |
3 9 |
0.105 |
| Follow-up (months)† | 17 ± 11 | 12 ± 13 | 0.38 |
| Rebleeding at follow-up (yes/no), n | 0/9 | 5/7 | 0.027 |
| Outcome follow-up, n: Rebleeding or death Uneventful |
0 9 |
6 6 |
0.017 |
| Patients with SAE (yes/no), n | 4/5 | 5/7 | 0.89 |
| SAE (description), n: ACLF HE Portopulmonary syndrome |
2 1 1 |
1 4 0 |
0.30 |
Quantitative data were analyzed by Student’s t test and qualitative data using Chi-square tests except for the outcome follow-up, for which a Fischer exact test was used.
ACLF, acute-on-chronic liver failure; AVB, acute variceal bleeding; GOV2, gastroesophageal varices type 2; HE, hepatic encephalopathy requiring admission; IGV1, isolated gastric varices type 1; NASH, non-alcoholic steatohepatitis; OLT, orthotopic liver transplantation; SAE, serious adverse event; TIPS, transjugular intrahepatic portosystemic shunt.
Excluding one patient who died before the 5-day period.
∗
Levels of significance: p <0.05.
†
Mean ± SD.