| |
RCT NO. 1 |
|
|
RCT NO. 2 |
|
|
| |
EST (n = 106) |
EPCS (n = 105) |
P Value |
EPCS (n = 76) |
TIPS (n = 78) |
P Value |
| Control of bleeding, n (%) |
|
|
|
|
|
|
| Temporary during workup |
|
|
|
|
|
|
| Received vasopressin or octreotide intravenously |
95 (90) |
80 (76) |
0.012* |
60 (83) |
71 (92) |
0.13 |
| Bleeding at start of vasopressin or octreotide infusion |
47 (49) |
55 (69) |
0.014* |
40 (67) |
44 (71) |
0.59 |
| Bleeding decreased or stopped |
36 (77) |
38 (69) |
0.51 |
19 (48) |
24 (58) |
0.66 |
| Permanent by EST or EPCS (RCT No. 1) or by TIPS (RCT No. 2) |
|
|
|
|
|
|
| Indeterminate, nonbleeding death ≤14 d |
4 (4) |
12 (11) |
0.040* |
16 (21) |
8 (10) |
0.078 |
| Successful control excluding indeterminates for at least |
|
|
|
|
|
|
| 14 d |
22 (21) |
93 (100) |
<0.001* |
60 (100) |
58 (83) |
<0.001* |
| 30 d |
20 (20) |
89 (100) |
<0.001* |
57 (95) |
56 (80) |
0.017* |
| >30 d |
20 (20) |
89 (100) |
<0.001* |
57 (95) |
54 (77) |
0.005* |
| Declaration of primary therapy failure, n (%) |
81 (79) |
0 (0) |
<0.001* |
|
|
|
| Required ≥6 U PRBC in first 7 d |
15 (19) |
-- |
|
0 (0) |
9 (13) |
0.003* |
| Required ≥8 U PRBC in any 12 mo |
47 (58) |
-- |
|
2 (3) |
33 (47) |
<0.001* |
| Recurrent variceal bleeding after variceal |
|
|
|
|
|
|
| obliteration was declared |
27 (33) |
-- |
|
0 (0) |
32 (46) |
<0.001* |
| More than one criterion for failure |
8 (10) |
-- |
|
0 (0) |
19 (27) |
<0.001* |
| PRBC transfusion, U, mean/median (range) |
|
|
|
|
|
|
| Index hospitalization |
|
|
|
|
|
|
| Before primary therapy |
4.5/4 (2-12) |
5.8/5 (2-17) |
<0.001* |
5/5.6 (0-14) |
5/6.3 (0-30) |
0.83 |
| During primary therapy |
0.6/0 (0-7) |
6.3/3 (0-68) |
<0.001* |
3.5/5.4 (0-32) |
0/0.4 (0-6) |
<0.001* |
| “Catch-up” after primary therapy |
0.2/0 (0-4) |
1.2/0 (0-21) |
0.001* |
0/0.8 (0-15) |
0/0.2 (0-4) |
0.056 |
| Posttherapy bleeding |
|
|
|
|
|
|
| Variceal |
4.4/0 (0-37) |
0/0 (0-0) |
<0.001* |
0/1.1 (0-46) |
0/2.6 (0-29) |
<0.001* |
| Nonvariceal |
0.3/0 (0-11) |
1.8/0 (0-29) |
0.059 |
0/1.1 (0-21) |
0/0.1 (0-6) |
0.020* |
| Total PRBC units |
10.0/7 (2-44) |
15.0/10 (2-81) |
<0.001* |
9/14.0 (0-85) |
7/9.8 (2-42) |
0.010* |
| Readmissions for bleeding |
|
|
|
|
|
|
| Variceal bleeding |
6.8/2 (0-60) |
0.4/0 (0-26) |
<0.001* |
0/0.2 (0-14) |
6/6.6 (0-36) |
<0.001* |
| Nonvariceal bleeding |
3.8/0 (0-38) |
3.5/0 (0-33) |
0.23 |
0/0.4 (0-10) |
0/0.5 (0-11) |
0.62 |
| Total PRBC units |
10.6/7 (0-60) |
3.9/0 (0-33) |
<0.001* |
0/06.9 (0-14) |
6/7.0 (0-36) |
<0.001* |
| Total PRBC units for variceal bleeding |
15.8/14 (2-64) |
13.6/10 (2-73) |
0.037* |
8/11.7 (0-85) |
14/15 (3-47) |
<0.001* |
| Overall survival (Pr/95% Cl) |
|
|
<0.001* |
|
|
<0.001* |
| 30-d |
0.88 (0.81, 0.94) |
0.87 (0.80, 0.93) |
|
0.77 (0.68, 0.87) |
0.78 (0.70, 0.88) |
0.96 |
| 1-yr |
0.72 (0.64, 0.81) |
0.81 (0.74, 0.89) |
|
0.75 (0.65, 0.85) |
0.55 (0.45, 0.67) |
0.022* |
| 2-yr |
0.54 (0.45, 0.64) |
0.77 (0.70, 0.86) |
|
0.68 (0.58, 0.79) |
0.49 (0.39, 0.61) |
0.022* |
| 3-yr |
0.44 (0.36, 0.55) |
0.75 (0.67, 0.84) |
|
0.65 (0.55, 0.77) |
0.36 (0.27, 0.48) |
0.001* |
| 4-yr |
0.35 (0.27, 0.45) |
0.74 (0.66, 0.83) |
|
0.63 (0.53, 0.75) |
0.23 (0.15, 0.35) |
<0.001* |
| 5-yr |
0.21 (0.14, 0.30) |
0.73 (0.65, 0.82) |
|
0.61 (0.51, 0.73) |
0.20 (0.13, 0.31) |
<0.001* |
| 7-yr |
|
|
|
0.52 (0.41, 0.66) |
0.15 (0.09, 0.28) |
<0.001* |
| 10-yr |
0.09 (0.05, 0.17) |
0.46 (0.37, 0.56) |
|
-- |
-- |
|
| 15-yr |
0.09 (0.05, 0.17) |
0.46 (0.37, 0.56) |
|
-- |
-- |
|
| Median survival, yr (95% Cl) |
2.48 (1.58, 3.76) |
6.17 (5.60, 10.37) |
|
>10 (5.1 >10) |
1.99 (0.52, 2.8) |
|
| Survival by Child risk class (Pr/95% Cl) |
|
|
|
|
|
|
| 5-yr Child class (PR/95% Cl) |
|
|
|
|
|
|
| A |
0.38 (0.24, 0.59) |
0.89 (0.83, 1.00) |
0.003* |
0.85 (0.68, 1) |
0.38 (0.20, 0.71) |
0.006* |
| B |
0.15 (0.08, 0.30) |
0.76 (0.64, 0.89) |
<0.001* |
0.65 (0.51, 0.82) |
0.22 (0.12, 0.41) |
<0.002* |
| C |
0.11 (0.04, 0.31) |
0.57 (0.41, 0.78) |
0.005* |
0.42 (0.26, 0.67) |
0.04 (0.01, 0.30) |
0.016* |
| 10-yr Child class (PR/95% Cl) |
|
|
|
|
|
|
| A |
0.18, (0.08, 0.38) |
0.62 (0.45, 0.83) |
0.003* |
0.76 (0.55, 1) |
0.30 (0.20, 0.71) |
0.008* |
| B |
0.07 (0.02, 0.20) |
0.45 (0.33, 0.61) |
<0.001* |
0.51 (0.36, 0.71) |
0.15 (0.06, 0.41) |
0.003* |
| C |
0.04 (0.01, 0.25) |
0.33 (0.20, 0.55) |
0.005* |
0.42 (0.26, 0.67) |
0.04 (0.01, 0.30) |
0.016* |
| Median survival, yr (95% Cl) |
|
|
|
|
|
|
| A |
4.62 (4.08, 6.34) |
10.43 (>5.92) |
0.003* |
>9.37 (>9.37 >9.37) |
3.46 (0.51, 8.05) |
0.008* |
| B |
2.61 (1.65, 3.96) |
6.19 (>5.44) |
<0.001* |
>9.80 (5.09 >9.80) |
2.12 (1.03, 3.00) |
<0.001* |
| C |
0.58 (0.12, 2.36) |
5.30 (0.70, 10.16) |
0.005* |
1.25 (0.06 >9.66) |
0.08 (0.04, 1.99 |
0.016* |
| Survival by direct UCSD admission versus transfer from |
|
|
|
|
|
0.13 |
| outside UCSD (Pr/95% Cl) |
|
|
0.48 |
|
|
|
| Direct UCSD admission |
|
|
|
|
|
|
| 5 yr |
0.17 (0.08, 0.36) |
0.58 (0.42, 0.80) |
|
0.46 (0.26, 0.83) |
0.20 (0.06, 0.69) |
|
| 7 yr |
-- |
-- |
|
0.31 (0.14, 0.70) |
0.10 (0.02, 0.64) |
|
| 10 yr |
0.11 (0.05, 0.29) |
0.52 (0.27, 0.66) |
|
-- |
-- |
|
| Transfer from outside UCSD |
|
|
|
|
|
|
| 5 yr |
0.24 (0.16, 0.36) |
0.79 (0.70, 0.88) |
|
0.64 (0.53, 0.77) |
0.20 (0.12, 0.32) |
|
| 7 yr |
-- |
-- |
|
0.57 (0.46, 0.72) |
0.17 (0.10, 0.30) |
|
| 10 yr |
0.08 (0.03, 0.18) |
0.45 (0.36, 0.58) |
|
|
|
|
| Mean survival, yr (95% Cl) |
|
|
|
|
|
|
| Direct UCSD admission |
2.71 (0.72, 4.51) |
5.28 (>2.80) |
|
1.25 (0.04 >9.79) |
1.03 (0.49 >7.13) |
|
| Transfer from outside UCSD |
2.45 (1.59, 3.76) |
6.25 (5.81, 11.03) |
|
>10 (5.18 >10) |
1.99 (0.51, 3.0) |
|
| Rescue portacaval shunt in EST group – effect on median |
|
|
|
|
|
|
| survival, yr (95% Cl) and rescue portacaval shunt in TIPS group |
|
|
|
|
|
|
| Successful EST (n = 21) or TIPS (n = 15) |
2.76 (1.52, 7.35) |
-- |
0.48 |
-- |
3.75 (1.15 >7.18) |
0.95 |
| Failed EST (n = 81) or failed TIPS (n = 55) |
2.71 (1.65, 3.92) |
-- |
|
|
|
|
| Rescue shunt-failed EST (n = 50) or rescue shunt in failed TIPS (n=8) |
3.01 (1.65, 4.34) |
-- |
0.098 |
-- |
2.04 (0.92, 2.88) |
0.98 |
| No rescue shunt-failed EST (n = 31) or failed TIPS (n = 39) |
2.36 (0.72, 4.34) |
-- |
|
-- |
>8.06 (3.93 >8.06) |
|
| Overall survival: rescue shunt (n = 50) versus primary |
|
|
|
|
1.03 (0.50, 2.67) |
|
| EPCS (n = 105) in RCT No. 1 and rescue shunt (n=8) versus |
3.01 (1.65, 4.34) |
6.18 (5.61, 10.38) |
<0.001* |
>10 (5.1 >10) |
>8.06 (3.93 >8.06) |
0.98 |
| Primary EPCS (n = 64) in RCT No. 2 |
|
|
|
|
|
|
| Postoperative survival: rescue shunt (n = 50) versus |
1.99 (1.34, 3.73) |
6.18 (5.61, 10.38) |
<0.001* |
>10 (5.1 >10) |
>8.04 (3.08 >8.04) |
0.67 |
| primary EPCS (n = 105) |
|
|
|
|
|
|
| 10-yr Child class (Pr/95% Cl) |
|
|
|
|
|
|
| A |
0.18 (0.08, 0.38) |
0.62 (0.45, 0.83) |
0.003* |
|
|
|
| B |
0.07 (0.02, 0.20) |
0.45 (0.33, 0.61) |
<0.001* |
|
|
|
| C |
0.04 (0.01, 0.25) |
0.33 (0.20, 0.55) |
0.005* |
|
|
|
| Median survival, yr (95% Cl) |
|
|
|
|
|
|
| A |
4.62 (4.08, 6.34) |
10.43 (>5.92) |
0.003* |
>9.37 (>9.37 >9.37) |
3.46 (0.51, 8.05) |
0.008* |
| B |
2.61 (1.65, 3.96) |
6.19 (>5.44) |
<0.001* |
>9.80 (5.09 >9.80) |
2.12 (1.03, 3.00) |
<0.001* |
| C |
0.58 (0.12, 2.36) |
5.30 (0.70, 10.16) |
0.005* |
1.25 (0.06 >9.66) |
0.08 (0.04, 1.99) |
0.016* |
Pr-probability; PRBC, Packed Red Blood Cells; UCSD-University of California-San Diego.
*Statistically significant difference |