# Improved survival in patients with refractory variceal bleeding treated with esophageal stents: A multicenter cohort study

Delphine Weil, Morgane Clement, Charlotte Bouzbib, Jean-Paul Cervoni, Andrimalala Raoto, Grégoire Boivineau, Isabelle Ollivier, Noemi Reboux, Caroline Lemaître, Cassandra Rayer, et al.

<figure><img src="image_1.png" /></figure>

## ► To cite this version:

Delphine Weil, Morgane Clement, Charlotte Bouzbib, Jean-Paul Cervoni, Andrimalala Raoto, et al. Improved survival in patients with refractory variceal bleeding treated with esophageal stents: A multicenter cohort study. Jhep Reports, 2025, 7 (12), pp.101581. 10.1016/j.jhepr.2025.101581. hal-05417829v2

HAL Id: hal-05417829

https://hal.science/hal-05417829v2

Submitted on 15 Dec 2025

HAL is a multi-disciplinary open access archive for the deposit and dissemination of scientific research documents, whether they are published or not. The documents may come from teaching and research institutions in France or abroad, or from public or private research centers.

L'archive ouverte pluridisciplinaire HAL, est destinée au dépôt et à la diffusion de documents scientifiques de niveau recherche, publiés ou non, émanant des établissements d'enseignement et de recherche français ou étrangers, des laboratoires publics ou privés.

<figure><img src="image_2.png" /></figure>

Distributed under a Creative Commons Attribution 4.0 International License
# Improved survival in patients with refractory variceal bleeding treated with esophageal stents: A multicenter cohort study

## Authors

Delphine Weil, Morgane Clément, Charlotte Bouzbib, ..., Jean-Pierre Arpurt, Marika Rudler, Vincent Di Martino

## Correspondence

dweil@chu-besancon.fr (D. Weil).

## Graphical abstract

<figure><img src="image_3.png" /></figure>

## Highlights:

* After tamponade, all-cause mortality was 42.9% at Day 5 and 55.6% at week six.

* Both ES (rather than BT) and rTIPS improved bleeding control at day five.

* Six-week mortality was lower with ES vs. BT and in patients who underwent rTIPS.

* ES plus rTIPS provided the highest survival rate (91.7% at day five; 75.0% at week six).

## Impact and implications:

Tamponade devices are crucial in the management of refractory variceal bleeding, with balloon probes being the only option until the early 2000s. More recently, self-expanding ESs have been recommended, although their superiority over BT in terms of survival has not yet been demonstrated. Our multicenter cohort study, using propensity score analysis, found that ESs provided superior bleeding control at Day 5 and survival benefit at Week 6, regardless of severity of liver failure or use of rescue TIPS. These findings highlight ESs as the optimal tamponade device, although they might not obviate the need for prompt rescue TIPS placement.
# Improved survival in patients with refractory variceal bleeding treated with esophageal stents: A multicenter cohort study

Delphine Weil¹,²,* Morgane Clément¹, Charlotte Bouzbib³, Jean-Paul Cervoni¹, Andrimalala Raoto⁴, Grégoire Boivineau⁵, Isabelle Ollivier-Hourmand⁶, Noémi Reboux⁷, Caroline Lemaître⁸, Cassandra Rayer⁹, Marine Camus-Duboc¹⁰, Ludovic Caillo¹¹, André-Jean Remy¹², Laure Elkrief¹³, Guillaume Conroy¹⁴, Faustine Wartel¹⁵, Armand Garioud¹⁶, Maeva Guillaume¹⁷, Edouard Bardou-Jacquet⁹,¹⁸, Stéphane Koch¹⁹, Jean-Pierre Arpurt⁴, Marika Rudler³, Vincent Di Martino¹,², ANGH, CREGG, SFED, GRAPHE, CFHTP groups

JHEP Reports 2025. vol. 7 | 1–10

<figure><img src="image_4.png" /></figure>

Check for updates

**Background & Aims:** Tamponade is a bridge therapy for refractory variceal bleeding. This study compared esophageal stents (ESs) and balloon tamponade (BT) in terms of early bleeding control and mortality.

**Methods:** We analyzed a cohort of patients with cirrhosis treated with tamponade in nine French hospitals between 2002 and 2023. The primary outcome was 6-week mortality. Multivariable analyses included Cox with time-dependent covariates and logistic regression models, adjusted for model for end-stage liver disease (MELD) score, rescue transjugular intrahepatic portosystemic shunt (rTIPS), and inverse probability of treatment weighting (IPTW) for ES.

**Results:** Sixty-three patients (87.3% male; mean age 55 years; 73.0% Child-Pugh C) were included. ES was used in 30 patients, BT in 33, and rTIPS subsequently in 20. Endoscopic control was attempted in 66.1% of cases. Adverse events were more frequent with ES (56.7% vs. 27.3%, *p* = 0.018), mostly stent migrations without clinical consequence, but less severe than with BT (two esophageal ruptures). Mortality was 42.9% (n = 27) at Day 5 and 55.6% (n = 35) at 6 weeks. Univariable analysis revealed lower mortality with ES than with BT (20.0% vs. 63.6% on Day 5, *p* = 0.0005 and 36.7% vs. 72.7% on Week 6, *p* = 0.0015) and with rTIPS (10.0% vs. 58.1% on Day 5, *p* = 0.0003 and 25.5% vs. 67.5% on Week 6, *p* = 0.0009). IPTW-adjusted and IPTW-weighted time-dependent Cox and logistic models confirmed decreased 6-week mortality (hazard ratio (HR) = 0.26, *p* = 0.0078) and better 5-day bleeding control (odds ratio (OR) = 6.1, *p* = 0.020) with ES.

**Conclusions:** In patients with cirrhosis-related refractory variceal bleeding, ESs were associated with significantly better early bleeding control and reduced mortality at both Day 5 and Week 6 compared with BT. Prospective studies are warranted to confirm these findings.

© 2025 The Authors. Published by Elsevier B.V. on behalf of European Association for the Study of the Liver (EASL). This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

## Introduction

Tamponade devices are used as a temporary measure in the event of refractory variceal bleeding, either massive at the outset or recurrent within the first 5 days, pending the availability of a more efficacious treatment of bleeding and/or portal hypertension.¹,² Currently, two types of device are available: single (Linton) or double (Blakemore) balloon probes³⁻⁵ and, more recently, expansive esophageal stents (ESs).⁶⁻⁹

In its most recent report, the Baveno Consortium suggested that the use of ESs was the optimal option, although it acknowledged that there were insufficient studies comparing the two categories of tamponade device.¹⁰ Indeed, the literature reports only one randomized trial that included a very small number of patients, which was unable to demonstrate the superiority of either device in terms of immediate bleeding control or short- or mid-term survival.¹¹ The main arguments in favor of the use of ESs over balloons are their ease of

placement, longer maintenance period, favorable safety profile, and the absence of esophageal lumen obstruction.²,¹²

Therefore, we conducted a comparative study to assess whether one device (balloon tamponade [BT] vs. ES) is superior to another in terms of short- and mid-term survival and bleeding control.

## Patients and methods

### Study design

This was a French multicenter cohort study that considered for inclusion patients from six general hospitals and nine university hospitals. A questionnaire was made available online to all French hepato-gastroenterologists from March 2021 to June 2023 by five French scientific societies involved in portal hypertension and digestive endoscopy, which promoted this study. Inclusions were both retrospective and prospective to

<footnote>* Corresponding author. Address: Service d'Hépatologie et de Soins Intensifs Digestifs, CHU Jean Minjoz, 3 Bld Fleming, 25000 Besançon, France. Tel.: +33 381668421; fax: +33 381668417.</footnote>

<footnote>E-mail address: dweil@chu-besancon.fr (D. Weil).
https://doi.org/10.1016/j.jhepr.2025.101581</footnote>
ensure a sufficient number of patients and to enable compar-
ison of tamponade devices, covering a period from January
2002 to April 2023.

Ethics statement

The research was conducted in accordance with the Decla-
rations of Helsinki and Istanbul, and the French Regulatory
Authority for clinical studies. The Institutional Board ‘Clinical
Research and Innovation Department’ and the Human Pro-
tection Committee East Area II Besancon, France, approved
this study. A certificate from the President of the Human
Protection Committee East Area II Besancon, France indicates
that, according to the French Regulatory Authority for Clinical
Studies, prospective and retrospective observational studies
are not evaluated by Human Protection Committees. No
informed consent was required for this study based on French
Regulatory Authority guidance.

Outcome measures

Mortality at Week 6 was the primary endpoint. The secondary
endpoints were 5-day mortality, 5-day bleeding control,
bleeding recurrence, and tamponade device-related adverse
events (AEs). Failure to control the initial bleeding is defined as
massive bleeding or early rebleeding within the first 5 days
after the index bleeding.¹⁰ Therefore, we defined recurrent
bleeding as occurring after Day 5 and collected these data on
Day 7 and Week 6. Device-related AEs were recorded during
insertion and after removal. Owing to the variable length of
device maintenance, data were collected on Day 7.

Population

All patients who underwent tamponade for variceal bleeding between March 2021 and April 2023 and met the inclusion criteria were prospectively included in the study. The inclusion criteria were as follows: age >18 years; esophageal variceal bleeding requiring hospitalization and refractory to conventional treatment, and use of tamponade with a balloon catheter or covered self-expanding ES. Patients included in a center reporting the use of a single tamponade device were excluded from the study. Additional exclusion criteria included the existence of gastric varices, non-cirrhotic portal hypertension, or hepatocellular carcinoma. To increase the number of patients, investigators were encouraged to retrospectively include additional consecutive patients who had been hospitalized at their center between 2002 and 2021 based on data from the French National Uniform Hospital Discharge Data Set Database (PMSI) (International Classification of Diseases (ICD)-10 code: EHBDO01). However, the timeframe used for the retrospective inclusion was based on the judgment of each investigator. The diagnosis of cirrhosis was based on conventional clinical, biochemical, radiological, or histological criteria. The severity of cirrhosis at the time of bleeding was assessed using the Child-Pugh and model for end-stage liver disease (MELD) scores.

Data collection

The questionnaire included 177 variables, of which 101 were
collected on admission, 49 on Day 7, and 27 at Week six.
Three variables were demographic, 18 were related to history
of portal hypertension, 53 to characteristics and management

of bleeding before tamponade, 23 to tamponade modalities,
and 80 to outcome after tamponade. Of the post-tamponade
follow-up data, 10 variables were related to AEs associated
with the tamponade device, four to bleeding recurrence, and
six to mortality. In the event of death, the investigator reported
the cause. The use of rescue transjugular intrahepatic porto-
systemic shunt (rTIPS), defined as TIPS placement within the
first 5 days to control bleeding, was also recorded and
included four variables.

Statistical analysis

Results were compared between the BT and ES groups. Quantitative variables were expressed as mean ± SD when normally distributed, and qualitative variables as absolute numbers and percentages. Univariable comparisons were performed using the Student's t test or Mann-Whitney U test for quantitative variables, and the Chi-square or Fisher's exact test for qualitative variables, as appropriate. Survival analyses were conducted using the Kaplan-Meier method, with group comparisons assessed by the Log-rank test.

To adjust for baseline differences and minimize confounding
factors, we used multivariable Cox and logistic regression
models with inverse probability of treatment weighting (IPTW),
derived from a selected propensity score (PS) model (PS3;
Materials and methods S1A, S1B, S1C, Table S1, Table S2).
The primary analyses were based on a stabilized and truncated
IPTW (stIPTW3), applied directly to the models to improve co-
variate balance while limiting variance inflation. In addition,
stIPTW3 was also incorporated as a covariate in separate
sensitivity models to explore the consistency of results across
alternative adjustment strategies. A time-dependent Cox model
was used to account for the immortal time bias introduced by
rTIPS placement when analyzing 6-week survival. Variables
included in the multivariable models were chosen based on
clinical relevance, univariable associations, and the absence of
collinearity, adhering to the 10 events per variable rule.

In addition to models using different adjustment strategies (unadjusted, PS-adjusted, and alternative IPTW specifications; Tables S2 and S6), sensitivity analyses were conducted in two contexts. First, the analysis was restricted to patients included during the period when ESs were available (December 2010 to April 2023) to ensure treatment equipoise across centers (Fig. S2 and Table S5A). Second, to address immortal time bias related to delayed transjugular intrahepatic portosystemic shunt (TIPS) placement, a landmark analysis was performed that excluded all patients who died before Day 2 (Fig. S3 and Table S5B). All analyses were performed using NCSS 2019 (Kaysville, UT, USA) and R software, version 4.5.0.

Results

Study population

Characteristics

The study included 63 patients (33 in the BT group and 30 in
the ES group) who were selected from 99 patients recorded
from 15 centers (Fig. 1). All of the included patients came from
the nine centers that reported using both ES and BT for tam-
ponade (Fig. S1 shows inclusion timeline by center and device
availability). The patients had cirrhosis-related portal
<figure><img src="image_5.png" /><figcaption>**Fig. 1.** Study flow chart. Flow chart showing the selection process for inclusion in the nationwide multicenter cohort. Among 99 patients with tamponade for variceal bleeding identified across 15 centers, 63 patients fulfilled the eligibility criteria and were included in the analysis. Reasons for exclusion are detailed, including patients from centers reporting the use of only one type of tamponade device, non-cirrhotic portal hypertension, gastric varices, and hepatocellular carcinoma.</figcaption></figure>

hypertension and no gastric varices or hepatocellular carcinoma (Fig. 1). The baseline characteristics of the study population are shown in Table 1. Three centers were able to use ES

before March, 2021 (in 11 patients). The other centers used ES after they became eligible for reimbursement in 2021. Of the 63 patients, 31 were enrolled prospectively (19 ES vs. 12 BT) and 32 retrospectively (11 ES vs. 21 BT). The proportion of patients receiving ES was higher among those enrolled prospectively vs. those enrolled retrospectively (61.3% vs. 38.7%, respectively; $p = 0.032$). Most patients were men (87.3%), with a mean age of 55 ± 13 years. Cirrhosis was alcohol related in 57 patients (90.5%). Most patients (73.0%) had Child-Pugh class C cirrhosis. The mean MELD score was 22.1 ± 9.0. Esophageal varices were documented in 61.9% of patients before the index bleeding episode. Thirty-one patients (49.2%) had previously experienced at least one variceal bleeding event. Of these patients, 15 met the criteria for pre-emptive (p)TIPS¹³ at the time of previous bleeding, and five received TIPS. Of these five patients, three had clinical ascites despite TIPS and one had TIPS thrombosis. The median time between the two bleeding episodes was 13 days for patients with pTIPS criteria during the first episode vs. 133 days for other patients. No patient received anticoagulant treatment, whereas only two patients in each group received antiplatelet agents. Baseline hemodynamic parameters were comparable between the two groups. A mean arterial pressure (MAP) <60 mmHg was observed in 31.6% of cases. Mean hemoglobin concentration was 7.1 ± 2.2 g/dl, and mean creatinine was 113 ± 88 µmol/L.

The baseline characteristics of patients in both groups served as the basis for constructing multiple PS models to predict the probability of receiving ES vs. BT and to select the model that best balanced covariates between groups (Materials and methods S1). The effectiveness of the final weighting strategy, based on stIPTW3, is illustrated in Fig. 2.

## First-line management of the bleeding episode

Management before tamponade is summarized in Table 2. More than half of the patients (52.4%) were admitted directly to

<table><caption>**Table 1.** Baseline characteristics.</caption><thead><tr><th>Variable</th><th>BT (n = 33)</th><th>ES (n = 30)</th><th>Total (n = 63)</th><th>p value</th></tr></thead><tbody><tr><td>Male sex</td><td>28 (84.8%)</td><td>27 (90.0%)</td><td>55 (87.3%)</td><td>0.540</td></tr><tr><td>Age (years)</td><td>55.1 ± 12.5</td><td>55.3 ± 12.8</td><td>55.2 ± 12.6</td><td>0.940</td></tr><tr><td>Prospective enrollment</td><td>12 (36.4%)</td><td>19 (63.3%)</td><td>31 (49.2%)</td><td>0.032</td></tr><tr><td>Alcohol-related cirrhosis</td><td>27 (90.9%)</td><td>30 (90.0%)</td><td>57 (90.5%)</td><td>0.902</td></tr><tr><td>MELD score</td><td>20.6 ± 8.9</td><td>23.7 ± 8.9</td><td>22.1 ± 9.0</td><td>0.172</td></tr><tr><td>Child-Pugh A stage</td><td>2 (6.1%)</td><td>0 (0.0%)</td><td>2 (3.2%)</td><td>0.270</td></tr><tr><td>Child-Pugh B stage</td><td>5 (15.1%)</td><td>10 (33.3%)</td><td>15 (23.8%)</td><td>0.091</td></tr><tr><td>Child-Pugh C stage</td><td>26 (78.8%)</td><td>20 (66.7%)</td><td>46 (73.0%)</td><td>0.279</td></tr><tr><td>Known esophageal varices</td><td>19 (57.6%)</td><td>20 (66.7%)</td><td>39 (61.9%)</td><td>0.458</td></tr><tr><td>Known previous decompensation</td><td>19 (57.6%)</td><td>24 (80.0%)</td><td>43 (68.2%)</td><td>0.056</td></tr><tr><td>History of variceal bleeding</td><td>15 (45.4%)</td><td>16 (53.3%)</td><td>31 (49.2%)</td><td>0.532</td></tr><tr><td>Previous TIPS</td><td>1 (3.0%)</td><td>4 (13.3%)</td><td>5 (7.9%)</td><td>0.131</td></tr><tr><td>Non-selective beta blockers</td><td>8 (24.2%)</td><td>10 (33.3%)</td><td>18 (28.6%)</td><td>0.425</td></tr><tr><td>Diuretics</td><td>7 (21.2%)</td><td>10 (33.3%)</td><td>17 (27.0%)</td><td>0.279</td></tr><tr><td>Antiplatelet agents</td><td>2 (6.1%)</td><td>2 (6.7%)</td><td>4 (6.3%)</td><td>0.921</td></tr><tr><td>Ascites</td><td>18/32 (56.2%)</td><td>19 (63.3%)</td><td>37/62 (56.4%)</td><td>0.569</td></tr><tr><td>Hepatic encephalopathy</td><td>18/32 (56.2%)</td><td>17 (56.7%)</td><td>35/62 (51.0%)</td><td>0.535</td></tr><tr><td>Mean arterial pressure (mmHg)</td><td>64.1 ± 21.8</td><td>65.7 ± 24.6</td><td>68.4 ± 18.0</td><td>0.790</td></tr><tr><td>Hemoglobin (g/dl)</td><td>7.7 ± 2.4</td><td>6.6 ± 1.9</td><td>7.1 ± 2.2</td><td>0.051</td></tr><tr><td>Prothrombin time (%)</td><td>38.9 ± 18.0</td><td>33.6 ± 16.3</td><td>36.3 ± 17.3</td><td>0.222</td></tr><tr><td>Bilirubin (µmol/L)</td><td>92.6 ± 101.0</td><td>121.2 ± 170.1</td><td>106.7 ± 138.9</td><td>0.425</td></tr><tr><td>Albumin (g/L)</td><td>25.0 ± 6.8</td><td>24.7 ± 4.9</td><td>24.8 ± 5.9</td><td>0.834</td></tr><tr><td>Creatinine (µmol/L)</td><td>105.7 ± 73.1</td><td>121.2 ± 102.7</td><td>113.3 ± 88.5</td><td>0.499</td></tr></tbody></table>

Statistical differences were assessed using Chi-squared or Fisher's exact tests for percentages and Student t test for mean differences. BT, balloon tamponade; ES, esophageal stent; MELD, model for end-stage liver disease; TIPS, transjugular portosystemic shunt.
Esophageal stent for refractory variceal bleeding

<figure><img src="image_6.png" /><figcaption>**Fig. 2.** Covariate balance before and after IPTW derived from PS model 3. Love plot showing SMDs for 36 baseline covariates before weighting (red), after crude IPTW using PS3 (yellow), and after stabilized/truncated IPTW using PS3 (blue). SMDs were calculated as mean or proportion differences divided by pooled standard deviation. While crude IPTW failed to correct baseline imbalances, the final weighting strategy substantially improved covariate balance (SMD <0.2 for 23/36 variables; only two variables had SMD >0.5), including key factors, such as year of inclusion and prospective enrollment. The choice of PS3 among 11 PS models is detailed in Table S1. Full balance metrics are provided in Table S2. APA, antiplatelet agent; EV, esophageal varices; GI, gastrointestinal; ICU, intensive care unit; IPTW, inverse probability of treatment weighting; MAP, mean arterial pressure; MASLD, metabolic dysfunction-associated steatotic liver disease; MELD, model for end-stage liver disease; PH, portal hypertension; PS, propensity score; RBC, red blood cell; SMD, standardized mean difference; TIPS, transjugular intrahepatic portosystemic shunt.</figcaption></figure>

the intensive care unit (ICU). Most patients (90.5%) required blood transfusion, with a mean number of packed red cells of 5.0 units. Antibiotic prophylaxis was prescribed to 57 of 63 patients. On admission, 57 patients underwent endoscopy. This procedure was performed in sufficiently stable patients, and more frequently in the ES group than in the BT group (100.0% vs. 81.8%, *p* = 0.014). Endoscopic findings confirmed the presence of grade II (42.5%) or III (55.3%) esophageal varices. Endoscopy performed before tamponade confirmed the esophageal origin of bleeding in all patients. Endoscopic hemostasis was attempted in 70.4% of patients in the BT group compared with 62.1% of patients in the ES group (*p* = 0.512). The most common method of hemostasis was band ligation, used in 32 patients. Post-banding ulcers were

diagnosed in 11 patients, with a higher prevalence in the ES group than in the BT group (31.0% vs. 7.4%, respectively; *p* = 0.026). The proportion of patients with persistent bleeding despite endoscopic and pharmacological treatment (rather than massive bleeding) did not significantly differ between the ES and BT groups (56.7% vs. 45.2%, respectively; *p* = 0.369). The interval between the onset of variceal bleeding and placement of the tamponade device was 14 ± 28 h in the ES group and 12 ± 22 h in the BT group (*p* = 0.661). The time required to place the tamponade device (data available from only 14 patients) was longer in the ES group than in the BT group (16 ± 7 min vs. 8 ± 3 min; *p* = 0.021). The technical success rate of tamponade was 93.9% in the BT group and 93.3% in the ES group (*p* = 0.922). Technical difficulties with
<table><caption>Table 2. Initial management of bleeding before tamponade.</caption><thead><tr><td>Variables</td><td>BT</td><td>ES</td><td>Total</td><td>p value</td></tr></thead><tbody><tr><td>Care in a university hospital</td><td>30 (90.9%)</td><td>17 (56.7%)</td><td>47 (74.6%)</td><td>0.002</td></tr><tr><td>Intensive Care Unit admission</td><td>16 (48.5%)</td><td>17 (56.7%)</td><td>33 (52.4%)</td><td>0.516</td></tr><tr><td>Blood transfusion</td><td>30 (90.9%)</td><td>27 (90.0%)</td><td>57 (90.5%)</td><td>0.903</td></tr><tr><td>Number of red blood cell packs (mean ± SD)</td><td>5.2 ± 4.5</td><td>4.7 ± 3.0</td><td>5.0 ± 3.8</td><td>0.613</td></tr><tr><td>Vasopressive amines</td><td>16 (48.5%)</td><td>15 (50.0%)</td><td>31 (49.2%)</td><td>0.904</td></tr><tr><td>Vasoactive drugs for portal hypertension</td><td>30 (90.9%)</td><td>28 (93.3%)</td><td>58 (92.1%)</td><td>0.722</td></tr><tr><td>Antibiotic prophylaxis</td><td>28 (84.8%)</td><td>29 (96.7%)</td><td>57 (90.5%)</td><td>0.111</td></tr><tr><td>Intubation</td><td>17 (51.5%)</td><td>15 (50.0%)</td><td>32 (50.8%)</td><td>0.904</td></tr><tr><td>Endoscopy at day 0</td><td>27 (81.8%)</td><td>30 (100.0%)</td><td>57 (90.5%)</td><td>0.014</td></tr><tr><td>Esophageal varices stage III*</td><td>15 (55.5%)</td><td>16 (55.1%)</td><td>31 (55.3%)</td><td>0.977</td></tr><tr><td>Active bleeding*</td><td>25 (92.6%)</td><td>23 (79.3%)</td><td>48 (85.7%)</td><td>0.156</td></tr><tr><td>Adherent clot*</td><td>6 (22.2%)</td><td>4 (13.8%)</td><td>10 (17.9%)</td><td>0.410</td></tr><tr><td>Platelet clot*</td><td>3 (11.1%)</td><td>7 (24.1%)</td><td>10 (17.9%)</td><td>0.203</td></tr><tr><td>Post banding ulcer*</td><td>2 (7.4%)</td><td>9 (31.0%)</td><td>11 (19.6%)</td><td>0.026</td></tr><tr><td>Gastropathy*</td><td>2 (7.4%)</td><td>7 (24.1%)</td><td>9 (16.1%)</td><td>0.088</td></tr><tr><td>Endoscopic hemostasis attempt*</td><td>19 (70.4%)</td><td>18 (62.1%)</td><td>37 (66.1%)</td><td>0.512</td></tr><tr><td>Band ligation*</td><td>17 (63.0%)</td><td>15 (51.7%)</td><td>32 (57.1%)</td><td>0.396</td></tr><tr><td>Glue obliteration*</td><td>0 (0.0%)</td><td>1 (3.4%)</td><td>1 (1.8%)</td><td>0.834</td></tr><tr><td>Sclerosis*</td><td>5 (18.5%)</td><td>1 (3.4%)</td><td>6 (10.7%)</td><td>0.068</td></tr></tbody></table>

Statistical differences were assessed using Chi-squared or Fisher's exact tests for percentages and Student t test for mean differences. BT, balloon tamponade; ES, esophageal stent; ICU, intensive care unit.

the self-expanding stent were reported in three cases: one probe was deemed too rigid to pass through the esophageal lumen, one migrated immediately during insertion, and another could not be released because of a lack of gastric balloon expansion. Two instances of failed balloon probe insertion were reported, including one case of esophageal rupture. Overall, two patients in whom the ES procedure failed received a Blakemore probe, and one patient in whom the BT procedure failed received an ES. Given that conversion was performed immediately, assignment to the ES or BT group was based on the most recent device placed. The tamponade device was maintained for an average of 1.5 ± 2.0 days in the BT group, compared with 6.7 ± 4.3 days in the ES group ($p = 0.001$).

### Rescue TIPS placement

The decision to implant rTIPS was made at the discretion of the referring physician. None of the available baseline variables, including indicators of severity (i.e. high MELD score, ICU admission, intubation, renal replacement therapy, mean arterial pressure, use of vasopressor amines, and volume of blood transfusion at Day 0), could discriminate subsequent use of rTIPS. In addition, the date and site of enrollment did not affect access to rTIPS, which was implanted in patients from the nine participating centers. Within the first 5 days, 12 patients in the ES group and eight patients in the BT group underwent rTIPS placement (including two bare stents in the BT group). There was no significant difference in rate of use of rTIPS between groups (ES: 19.1% vs. BT: 12.7%; $p = 0.180$), period (prospective enrollment or not: 38.7% vs. 25.0%, respectively; $p = 0.242$) or time taken to place the rTIPS (1.3 ± 0.5 days in the BT group vs. 1.9 ± 1.4 days in the ES group; $p = 0.339$). No TIPS was placed between Day 5 and Week 6.

### Mortality

The overall mortality rate on Day 5 was 42.9% (n = 27). Eight additional patients died between Day 5 and Week 6 (Table 3). Refractory hemorrhagic shock was the primary cause of mortality on Day 5 (79.2% of cases), whereas multiorgan failure

accounted for 8.3% of deaths. The 6-week mortality rate was 55.6%. Recurrent bleeding was the cause of death in 37.5% of cases between Day 5 and Week 6, whereas sepsis was involved in 25.0% of cases and multiorgan failure in 37.5%.

### Impact of the tamponade device

Six-week mortality was significantly lower in the ES group compared with the BT group (36.7% vs. 72.7%, respectively; $p = 0.0015$; Table 3 and Fig. 3; Figs S4 and S5), with a similar difference already present at Day 5 (20.0% vs. 63.6%, respectively; $p = 0.0005$). Early mortality within the first 2 days was also significantly lower in the ES group (13.3% vs. 51.2%, respectively, $p = 0.0013$). This survival difference remained significant in a sensitivity analysis restricted to the period during which ES was available (December 2010 to April 2023; Fig. S2). Time-dependent Cox models adjusted for MELD score, rTIPS, and stPTW3 confirmed that ES was independently associated with improved 6-week survival (Table 4; Table S3). A landmark analysis restricted to patients alive on Day 2 yielded consistent results (Table S5B). When further restricted to patients alive on Day 5, the association was no longer statistically significant.

### Impact of rescue TIPS

Among patients who survived for 6 weeks, 47.4% (9/19) in the ES group and 66.7% (6/9) in the BT group had undergone rTIPS. Regardless of the tamponade device used, the 6-week mortality was significantly lower in patients who underwent rTIPS (25.5% vs. 67.5% in patients who did not undergo rTIPS; $p = 0.0009$, Fig S3A, S5). This association is further illustrated in Fig S3B which confirms the protective effect of rTIPS on 6-week survival in a landmark sensitivity analysis restricted to patients who survived the first 2 days. The Day 5 mortality was also significantly lower in patients who underwent rTIPS than in those who did not (10.0% vs. 58.1%, respectively; $p = 0.0003$). In the ES group, Day 5 and Week 6 mortality rates were 8.3% and 25.0%, respectively, with rTIPS, and 27.8% and 44.4%, respectively, without rTIPS (Log-rank test; $p = 0.248$). In the BT

<footnote>*Data reported for 56 patients (27 in BT group; 29 in ES group).</footnote>
Esophageal stent for refractory variceal bleeding

<table><caption>Table 3. Outcome events.</caption><thead><tr><th>Variable</th><th>BT</th><th>ES</th><th>Total</th><th>p values</th></tr></thead><tbody><tr><td>Mortality at Week 6</td><td>24 (72.7%)</td><td>11 (36.7%)</td><td>35 (55.6%)</td><td>0.0015</td></tr><tr><td>Mortality at Day 5</td><td>21 (63.6%)</td><td>6 (20.0%)</td><td>27 (42.9%)</td><td>0.0005</td></tr><tr><td>Control of bleeding at Day 5</td><td>10 (30.3%)</td><td>21 (70.0%)</td><td>31 (49.2%)</td><td>0.002</td></tr><tr><td>Recurrent bleeding at Day 7*</td><td>1/12 (8.3%)</td><td>2/23 (8.3%)</td><td>3/36 (8.3%)</td><td>1.000</td></tr><tr><td>Recurrent bleeding at Week 6*</td><td>1/10 (10.0%)</td><td>2/23 (8.7%)</td><td>3/33 (9.1%)</td><td>0.905</td></tr><tr><td><strong>Device-related AEs</strong></td><td></td><td></td><td></td><td></td></tr><tr><td>At least one device-related AE</td><td>9 (27.3%)</td><td>17 (56.7%)</td><td>26 (41.3%)</td><td>0.018</td></tr><tr><td>Esophageal rupture</td><td>2 (6.1%)</td><td>0 (0.0%)</td><td>2 (3.2%)</td><td>0.493</td></tr><tr><td>Inhalation pneumonia</td><td>5 (15.2%)</td><td>3 (10.0%)</td><td>8 (12.7%)</td><td>0.539</td></tr><tr><td>Placement-related esophageal injury</td><td>4 (12.1%)</td><td>7 (23.3%)</td><td>11 (17.5%)</td><td>0.242</td></tr><tr><td>Chest pain</td><td>2 (6.1%)</td><td>2 (6.7%)</td><td>4 (6.4%)</td><td>0.921</td></tr><tr><td>Device migration</td><td>0 (0.0%)</td><td>8 (26.7%)</td><td>8 (12.7%)</td><td>0.0015</td></tr><tr><td>Early withdrawal</td><td>2 (6.1%)</td><td>2 (6.7%)</td><td>4 (6.4%)</td><td>0.921</td></tr><tr><td>Bleeding after removal</td><td>0/7 (0.0%)</td><td>4/11 (36.4%)</td><td>4/18 (22.2%)</td><td>0.070</td></tr><tr><td>Ischemia after removal</td><td>0/11 (0.0%)</td><td>3/22 (13.7%)</td><td>3/33 (9.1%)</td><td>0.199</td></tr><tr><td><strong>Other OEs</strong></td><td></td><td></td><td></td><td></td></tr><tr><td>Hepatic encephalopathy</td><td>10 (30.3%)</td><td>17 (56.7%)</td><td>27 (42.9%)</td><td>0.035</td></tr><tr><td>Infection</td><td>8 (24.2%)</td><td>9 (30.0%)</td><td>17 (27.0%)</td><td>0.607</td></tr><tr><td>Hepatorenal syndrome</td><td>1 (3.3%)</td><td>7 (23.3%)</td><td>8 (13.3%)</td><td>0.023</td></tr><tr><td>Cardiac arrest</td><td>4 (12.1%)</td><td>0 (0.0%)</td><td>4 (6.4%)</td><td>0.115</td></tr></tbody></table>

Figures are given for 33 patients in the BT group and 30 in the ES group. If data are missing for some variables, the denominators are given. Statistical differences were assessed using Chi-squared or Fisher's exact test.

AE, adverse event; BT, balloon tamponade; ES, esophageal stent; OE, outcome event.

*Analysis excludes patients with uncontrolled bleeding on Day 5.

<figure><img src="image_7.png" /><figcaption>**Fig. 3.** Survival up to 6 weeks according to the type of tamponade device used. Unadjusted overall survival at Day 42 (Week 6) was significantly higher in patients treated with an ES compared with PT (Log-rank test, *p* = 0.0015). This survival analysis shows a significant survival benefit in favor of ESs, with early and sustained divergence of the curves, emphasizing the impact of Ess on early mortality reduction. BT, balloon tamponade; ES, esophageal stent.</figcaption></figure>

group, the mortality rates on Day 5 and Week 6 were 12.5% and 25.0%, respectively, with rTIPS and 80.0% and 84.0%, respectively, without rTIPS (Log-rank test; *p* = 0.0013).

## Multivariable analysis

In the stIPTW3-adjusted time-dependent multivariable Cox model on mortality at Week 6, high MELD scores were associated with a significantly increased risk of death (hazard ratio [HR] = 1.056, 95% CI 1.018–1.094, *p* = 0.0035), whereas the

use of ES (HR = 0.261; 95% CI 0.097–0.702, *p* = 0.0078) and rTIPS (HR = 0.211; 95% CI 0.059–0.752, *p* = 0.0165) were both found to be independent protective factors (Table S3). The robustness of these findings was tested in multivariable models weighted by stIPTW3 or incorporating stIPTW3 as a covariate, and multiple sensitivity analyses with alternative adjustment strategies (unadjusted, PS3-adjusted, adjusted with crude IPTW3, and stIPTW3 Cox models with no time-dependent covariates) (Table 4; Table S6). All models consistently supported the beneficial effects of ES on survival (Table 4).
<table><caption>Table 4. Impact of ES on Week-6 mortality and early bleeding control across univariable and multivariable models.</caption><thead><tr><th>Analysis</th><th>HR</th><th>95% CI</th><th>p values</th></tr></thead><tbody><tr><td colspan="4"><strong>Impact of esophageal stent on Week-6 mortality</strong></td></tr><tr><td>Univariable Cox regression</td><td>0.328</td><td>0.159-0.674</td><td>0.0024</td></tr><tr><td>Multivariable time-dependent Cox (ES + MELD* + rTIPS<sup>†</sup>) without PS-derived adjustment</td><td>0.229</td><td>0.105-0.498</td><td>0.0002</td></tr><tr><td>Multivariable time-dependent Cox (ES + MELD* + rTIPS<sup>†</sup> + stIPTW3 as covariate)</td><td>0.261</td><td>0.097-0.702</td><td>0.0078</td></tr><tr><td>Multivariable time-dependent Cox (ES + MELD* + rTIPS<sup>†</sup>) weighted by stIPTW3</td><td>0.269</td><td>0.119-0.605</td><td>0.0015</td></tr><tr><td colspan="4"><strong>Impact of ES on early bleeding control</strong></td></tr><tr><td>Univariable analysis (Chi-squared)</td><td>5.367</td><td>1.827-15.763</td><td>0.0016</td></tr><tr><td>Multivariable logistic regression (ES + MELD* + rTIPS<sup>†</sup>) without PS-derived adjustment</td><td>8.999</td><td>2.623-30.873</td><td>0.0005</td></tr><tr><td>Multivariable logistic regression (ES + MELD* + rTIPS<sup>†</sup> + stIPTW3* as covariate)</td><td>6.127</td><td>1.323-28.376</td><td>0.0205</td></tr><tr><td>Multivariable logistic regression (ES + MELD* + rTIPS<sup>†</sup>) weighted by stIPTW3</td><td>14.716</td><td>3.145-68.865</td><td>0.0006</td></tr></tbody></table>

The use of ESs was consistently associated with improved outcomes in patients with refractory variceal bleeding. Across all models, their use resulted in a reduction in Week-6 mortality of at least 65%, and an ~five fold increase in the likelihood of achieving early bleeding control compared with BT. The magnitude and consistency of these effects across univariable and multivariable models underscore the robustness of this therapeutic benefit.

BT, ballon tamponade; CI, confidence interval; ES, esophageal stent; HR, hazard ratio; IPTW, inverse probability of treatment (ES) weighting; MELD, model for end stage liver disease; OR, odds ratio; TIPS, transjugular portosystemic shunt.

*Expressed as continuous variables.

†rTIPS was included as a time-dependent variable in the Cox model.

## Bleeding

### Control of initial bleeding

Control of initial bleeding was observed in 31 patients (49.2%), more frequently in the ES group than in the BT group (70.0% vs. 30.3%, respectively; *p* = 0.002; Table 3). Control of initial bleeding was also more frequent in the 20 patients who underwent rTIPS placement compared with those who did not (70.0% vs. 39.5%, respectively; *p* = 0.024). In patients who underwent rTIPS, control of initial bleeding did not differ between the ES and BT groups (75.0% vs. 62.5%, respectively; *p* = 0.550). Conversely, in the 43 patients who did not undergo rTIPS, bleeding control was observed more frequently in the ES group than in the BT group (66.7% vs. 20.0%, respectively; *p* = 0.002).

In the stIPTW3-adjusted logistic regression analysis, low MELD score (odds ratio [OR] = 1.088, 95% CI 1.031–1.148, *p* = 0.040), rTIPS (OR = 3.955, 95% CI 1.065–14.689, *p* = 0.0145), and ES (OR = 6.127, 95% CI 1.323–28.376, *p* = 0.0205) were independently associated with bleeding control at Day 5 (Table S4). Similar conclusions were reached in the stIPTW3-weighted logistic regression analysis, except for rTIPS, which had no independent effect (Table S4). Multivariable models that explored different adjustment strategies reinforced the robustness of the observed benefits of ES in achieving early bleeding control (Table 4, Table S6).

### Recurrent bleeding

Of the 36 patients who survived to Day five (11 in the ES group with rTIPS, 13 in the ES group without rTIPS, seven in the BT group with rTIPS, and five in the BT group without rTIPS), two patients experienced recurrent bleeding on Day 7 in the ES group and one in the BT group. Two of these three had received rTIPS (one after ES, one after BT). Three additional episodes of recurrent bleeding were observed at Week 6. These episodes occurred in two patients in the ES group and one in the BT group. No significant differences were observed for recurrent bleeding between the groups.

## Other outcome events

Table 3 presents the outcomes observed throughout the follow-up period. No patient underwent liver transplantation

within the first 6 weeks following the index variceal bleeding. With regard to device-related AEs, the available records indicate that four cases of esophageal bleeding and three cases of ischemia on stent removal were reported in the ES group. By contrast, no such complications occurred in the BT group. Two cases of esophageal rupture and eight cases of stent migration were observed in the BT and ES groups, respectively. The occurrence of esophageal ulcers, inhalation pneumonia, chest pain, and early withdrawal did not differ between the two groups. Overall, 17 patients in the ES group and nine patients in the BT group (56.7% vs. 27.3%, respectively; *p* = 0.018) experienced at least one device-related AE. Most of these events involved stent migration (Table 3) without clinical consequences. The occurrence of hepatic encephalopathy or hepatorenal syndrome at Week 6 was more frequent in the ES group than in the BT group (Table 3), but the differences were not significant when considering only patients alive at Day 5.

## Discussion

Refractory variceal bleeding, defined as bleeding that persists despite pharmacological and endoscopic treatments, is a rare but serious complication of cirrhosis. It accounts for an estimated 15–20% of variceal bleeding cases.¹⁴,¹⁵ Despite the use of rTIPS, mortality rates in different studies range from 20% to 50%.⁵,¹² In this context, any contribution to improving survival would be welcome.

In this nationwide multicenter cohort study of patients with refractory variceal bleeding, self-expanding ESs were associated with significantly improved early bleeding control and reduced mortality on Day 5 and Week 6, compared with BT. To the best of our knowledge, this is the first comparative study to document the superiority of ES in this setting. These associations remained consistent following rigorous adjustment using stIPTW3, based on a well-performing PS model that included 23 pretreatment covariates. Notably, the 5-day mortality rate decreased from 63.6% with BT to 20.0% with ES, and the 6-week mortality rate decreased from 72.7% to 36.7%. This dramatic reduction in early mortality further underscores the protective role of ESs during the acute phase of bleeding (Fig. 3). The highest survival rates were observed in patients who received both ES and rTIPS, with 91.7% of patients alive at Day 5 and 75% alive at Week 6. The benefit of ES
Esophageal stent for refractory variceal bleeding

observed was not only statistically robust, but also clinically meaningful, especially considering the severity of illness in this cohort (MELD 22.1 and 73.0% Child-Pugh C). The impact on bleeding control persisted as a significant factor in fully adjusted models (OR = 6.127, *p* = 0.0205; Table 4; Table S4). In addition, the ES was found to be independently associated with decreased 6-week mortality (HR = 0.261, *p* = 0.0078; Table 4; Table S3). The survival benefit resulting from ES was noteworthy and somewhat unexpected in its magnitude. Despite the frequent use of rTIPS during the study period, which did not differ between groups, and the significant impact of liver failure, an unlikely influence of a tamponade device,¹⁶ the survival benefit associated with ES remained unaffected. rTIPS likewise provided protection in most cases, although its statistical significance varied depending on the modeling strategy. Taken together, these findings support a sequential strategy in which tamponade ensures immediate mechanical compression to stop bleeding, and rTIPS offers definitive treatment for portal hypertension. While the best outcomes were seen with a combination of ES and rTIPS, ES alone was also associated with improved survival.

The credibility of these results is bolstered by several fac-
tors. The cohort included patients from nine centers, encom-
passing the main configurations of care delivery, including
university and non-university hospitals, with or without ICUs,
and with or without local TIPS availability. Although it was not
possible to formally confirm strict consecutive inclusion
because of potential limitations in ICD-based retrospective
identification, the pragmatic design and efforts made to
include as many patients as possible through national hep-
atology networks suggest good representativeness. Thirty-one
patients were prospectively enrolled in the study, and the
remainder were included retrospectively based on consistent
diagnostic coding. The duration of inclusion varied across
centers. However, a centralized methodology and standard-
ized data collection processes minimized heterogeneity. Two
additional methodological strengths should be noted. First, the
study was restricted to centers that had used both tamponade
devices during the inclusion period, which limited the risk of
center-level confounding. Second, rigorous eligibility criteria
were implemented to ensure a homogeneous population
(Fig. 1). Only patients with cirrhosis were included, and all
patients with hepatocellular carcinoma were excluded
because it can compromise the optimal management of vari-
ceal bleeding, particularly access to ICUs. Any patient with
gastric varices, even if presumed non-bleeding, was also
excluded to avoid introducing confusion in the analysis of
esophageal compression efficacy on survival outcomes. The
third PS model exhibited remarkable discrimination, as evi-
denced by an AUROC of 0.935 (Materials and methods S1B).
In addition, substantial covariate balance was attained
following the implementation of a weighting scheme. Sensi-
tivity analyses using various adjustment methods (PS covari-
ate, crude IPTW, and stIPTW3) consistently reproduced the
effects of ES on both endpoints (Table S6).

However, the present study had several limitations. The
study was observational in nature, and unmeasured con-
founding cannot be fully excluded despite the robust meth-
odology used. The impact of rTIPS on survival appears to be
less significant than that of ES, with varying levels of

significance across multivariable models (Tables S3 and S4). Among the time-dependent Cox models, only the model that included stIPTW3 as a covariate showed a statistically significant protective effect of rTIPS. By contrast, the model weighted by stIPTW3 did not (Table S3). This discrepancy is likely the result of the temporal overlap between rTIPS timing and early mortality. Notably, 42.4% of deaths occurred within the first 2 days, during which >90% of rTIPS procedures were performed. Consequently, patients who died early were inherently excluded from the rTIPS group, thereby introducing immortal time bias in non-time-dependent analyses. Although time-dependent modeling addresses immortal time bias, it can yield unstable estimates in this context because of the high concentration of events within a narrow time window. This makes the analysis highly sensitive to minor imbalances between groups. Notably, all non-corrected models including unadjusted, IPTW-adjusted, and landmark analyses excluding early deaths, consistently demonstrated a survival benefit of rTIPS. The variability observed in the effect of rTIPS, as revealed by the analyses, is hypothesized to be driven primarily by analytic constraints rather than by true clinical inefficacy. Indeed, the protective effect of rTIPS was confirmed by a sensitivity analysis that excluded all patients who died before Day 2.

It is noteworthy that early deaths before Day 2 were considerably more prevalent in the BT group (51.2% vs. 13.3% in the ES group; *p* = 0.0013). However, the survival benefit associated with ES remained significant in the landmark analysis restricted to patients who survived at least 48 h (Table S5B). This finding reinforces the robustness of the ES effect and suggests that its protective association cannot be explained solely by a lead-time advantage or an imbalance in early deaths. Conversely, in analyses restricted to the prospectively enrolled subset, the beneficial effect of ES was no longer statistically significant, most likely because of insufficient power rather than an absence of effect.

In addition, there are certain contextual and methodological
aspects that merit attention. First, access to ESs was initiated
in December 2010 in a limited number of centers and subse-
quently became universal after 2021. This raises the possibility
of a period effect (Fig. S1). However, the stIPTW3 model
effectively neutralized differences in the year of inclusion and
prospective enrollment between groups. This is evident from
the standardized mean difference of <0.2 for both covariates
(Fig. 2; Table S2). Furthermore, a sensitivity analysis restricted
to the broader period from December 2010 to April 2023,
corresponding to the period of potential ES availability,
confirmed the observed benefit (Fig. S2 and Table S5A), thereby
mitigating this concern. Second, the determination of causes of
death was not centrally adjudicated, and decisions about rTIPS
placement were not based on predefined criteria. This might
indicate center-specific practices or implicit assessments of
futility in critically ill patients,¹⁷ which could introduce selection
bias. Third, a randomized controlled trial would be the most
robust design for validating these findings; however, such an
approach is unlikely to be feasible. Refractory variceal bleeding
requiring tamponade is a rare occurrence, and the French ICD
records estimated that only 1.4% of variceal bleeding cases per
year involved tamponade.¹⁸ Furthermore, recent data from
French and international registries indicate that tamponade was
used in only 103 (3.4%) of 3,019 patients enrolled over 5 years in 87 European centers.¹⁹ The low incidence of the condition in question poses significant logistical and ethical challenges to implementing of large-scale randomized trials within a reasonable timeframe.

Another consideration is that ESs might create more favorable conditions for rTIPS placement by allowing for a longer tamponade duration and maintaining luminal patency. This was not directly measurable in the present study. This hypothesis is supported by the finding that an ES can remain in place for several days, ensuring hemodynamic stabilization and facilitating transfer to a tertiary care facility. Although the number of transfers was limited in this cohort, this effect might be underestimated because of the retrospective nature of some of the data. Consequently, the function of the ES might extend beyond achieving hemostasis immediately, thereby

contributing to the success of subsequent therapeutic interventions.

In summary, the use of tamponade with a self-expanding stent should not be considered merely an interim measure while awaiting definitive therapy. Rather, it should be recognized as a crucial component of initial management. The substantial decrease in early mortality, especially when ES is used with timely rTIPS, supports a two-step therapeutic approach that could transform outcomes in this high-risk population. These findings should inform updates to international practice guidelines, including the Baveno Consensus, by recognizing the therapeutic value of ESs as integral interventions, rather than only bridges. Further prospective data are necessary to validate these findings and to optimize care pathways. This includes facilitating prompt access to specialized centers for TIPS placement.

## Affiliations

¹Service d'Hépatologie et Soins Intensifs Digestifs, CHU Jean Minjoz, Besançon, France; ²Université Marie et Louis Pasteur, EFS, INSERM UMR1098 RIGHT, Besançon, F-25000, France; ³Unité de Soins Intensifs d'Hépatologie et Gastro-Entérologie, Hôpital Pitié-Salpêtrière, APHP, Paris, France; ⁴Service d'Hépato-Gastroentérologie, CH d'Avignon, Avignon, France; ⁵Service de Gastroentérologie, Hôpital Nord, AP-HM, Hôpital Nord AP-HM, Marseille, France; ⁶Service d'Hépatologie, CHU Côte de Nacre, Caen, France; ⁷Service d'Hépato-Gastroentérologie, CHU Cavale Blanche, Brest, France; ⁸Service d'Hépato-Gastroentérologie, Groupe Hospitalier du Havre, Le Havre, France; ⁹Service des Maladies du Foie, CHU de Rennes, France; ¹⁰Centre d'Endoscopie Digestive, DMU SAPERE, Sorbonne Université, Hôpital Saint-Antoine AP-HP, Paris, France; ¹¹Service d'Hépato-Gastroentérologie, CHU de Nîmes, Université de Montpellier-Nîmes, Nîmes, France; ¹²Service d'Hépato-Gastroentérologie et Maladies de la Nutrition, CH de Perpignan, Perpignan, France; ¹³Service d'Hépato-Gastroentérologie, Hôpital Trousseau - CHU de Tours, Tours, France; ¹⁴Service d'Hépato-Gastroentérologie, CHR de Metz-Thionville Hôpital Mercy, Metz, France; ¹⁵Service des Maladies de l'Appareil digestif et de la Nutrition, CH de Valenciennes, Valenciennes, France; ¹⁶Service d'Hépato-Gastroentérologie, CHI Lucie et Raymond Aubrac, Villeneuve-Saint-Georges, France; ¹⁷Service de Gastro-Entérologie, Clinique Pasteur, Toulouse, France; ¹⁸Université de Rennes, INSERM Institut Numecan, Rennes, France; ¹⁹Service de Gastroentérologie et Nutrition, Endoscopie Digestive, CHU Jean Minjoz, Besançon, France

## Abbreviations

AE, adverse event; APA, antiplatelet agent; BT, balloon tamponade; ES, esophageal stent; EV, esophageal varices; GI, gastrointestinal; HR, hazard ratio; ICD, International Classification of Diseases; ICU, intensive care unit; IPTW, inverse probability of treatment weighting; MAP, mean arterial pressure; MASLD, metabolic dysfunction-associated steatotic liver disease; MELD, model for end-stage liver disease; OE, outcome event; OR, odds ratio; PH, portal hypertension; PS, propensity score; pTIPS, pre-emptive transjugular intrahepatic portosystemic shunt; RBC, red blood cell; rTIPS, rescue transjugular intrahepatic portosystemic shunt; SMD, standardized mean difference; stlPTW3, stabilized and truncated IPTW; TIPS, transjugular intrahepatic portosystemic shunt.

## Financial support

No funding was received for this study.

## Conflicts of interest

The authors have no conflicts of interest to report.

Please refer to the accompanying ICMJE disclosure forms for further details.

## Authors' contributions

Study conceptualization: DW, J-PC, SK, J-PA, MC-D, MG, MR. Methodology and questionnaire: DW, J-PC, MC, MR. Investigation and data collection: MC, CB, AR, GB, IO-H, NR, CL, CR, MC-D, LC, A-JR, LE, GC, FW, AG, EB-J, J-PA. Data curation and statistical analysis: VDM, DW. Drafting of manuscript: VDM, DW. Review and editing: DW, MC, CB, J-PC, AR, GB, IO-H, NR, CL, CR, MC-D, LC, A-JR, LE, GC, FW, AG, MG, EB-J, SK, J-PA, MR, and VDM. All authors approved the final version of the manuscript. Guarantor of manuscript: DW.

## Data availability

Data collected for the study, including individual participant data, will be made available under transfer agreement from the corresponding author upon reasonable request. A signed data access agreement is required. The data provided will de-identify the participant data. There are restrictions on how the data can be used or how long the data will be available.

## Acknowledgements

We thank Fiona Ecarnot for her editorial assistance. This study was presented at the French Liver Congress (AFEF) in October 2023 and at the AASLD annual meeting in November 2023.

## Supplementary data

Supplementary data to this article can be found online at https://doi.org/10.1016/j.jhepr.2025.101581.

## References

[1] Gralnek IM, Garcia-Pagan JC, Gea VH. Challenges in the management of esophagogastric varices and variceal hemorrhage in cirrhosis - a narrative review. Am J Med 2024;137:210-217.

[2] Kaplan DE, Ripoll C, Thiele M, et al. AASLD Practice Guidance on risk stratification and management of portal hypertension and varices in cirrhosis. Hepatology 2024;79:1180-1211.

[3] Sengstaken RW, Blakemore AH. Balloon tamponade for the control of hemorrhage from esophageal varices. Ann Surg 1950;131:781-789.

[4] Hunt PS, Korman MG, Hansky J, et al. An 8-year prospective experience with balloon tamponade in emergency control of bleeding esophageal varices. Dig Dis Sci 1982;27:413-416.

[5] Keung CY, Morgan A, Le ST, et al. Survival outcomes and predictors of mortality, re-bleeding and complications for acute severe variceal bleeding requiring balloon tamponade. World J Hepatol 2022;14:1584-1597.

[6] Zehetner J, Shamiyeh A, Wayand W, et al. Results of a new method to stop acute bleeding from esophageal varices: implantation of a self-expanding stent. Surg Endosc 2008;22:2149-2152.

[7] Pfisterer N, Riedl F, Pachofszky T, et al. Outcomes after placement of a SX-ELLA oesophageal stent for refractory variceal bleeding-a national multicentre study. Liver Int 2019;39:290-298.

[8] Lo GH. The use of esophageal stent in controlling acute refractory variceal bleeding. Hepatology 2017;65:385-386.

[9] Songtanin B, Kahathuduwa C, Nugent K. Esophageal stent in acute refractory variceal bleeding: a systematic review and a meta-analysis. J Clin Med 2024;13:357.

[10] de Franchis R, Bosch J, Garcia-Tsao G, et al. Baveno VII - renewing consensus in portal hypertension. J Hepatol 2022;76:959-974.
[11] Escorsell A, Pavel O, Cardenas A, et al. Esophageal balloon tamponade vs. esophageal stent in controlling acute refractory variceal bleeding: a multi-center randomized, controlled trial. Hepatology 2016;63:1957-1967.

[12] Rudler M. Management of refractory variceal bleeding. Cham: Springer International Publishing; 2022. p. 477-483.

[13] Garcia-Pagan JC, Caca K, Bureau C, et al. Early use of TIPS in patients with cirrhosis and variceal bleeding. N Engl J Med 2010;362:2370-2379.

[14] Rodrigues SG, Cardenas A, Escorsell A, et al. Balloon tamponade and esophageal stenting for esophageal variceal bleeding in cirrhosis: a systematic review and meta-analysis. Semin Liver Dis 2019;39:178-194.

[15] Kumar R, Kerbert AJC, Sheikh MF, et al. Determinants of mortality in patients with cirrhosis and uncontrolled variceal bleeding. J Hepatol 2021;74:66-79.

[16] de Franchis R, Baveno VIF. Expanding consensus in portal hypertension: report of the Baveno VI Consensus Workshop: stratifying risk and individualizing care for portal hypertension. J Hepatol 2015;63:743-752.

[17] Thabut D, Pauwels A, Carbonell N, et al. Cirrhotic patients with portal hypertension-related bleeding and an indication for early-TIPS: a large multicenter audit with real-life results. J Hepatol 2017;68:73-81.

[18] Haute Autorité de Santé. Removable covered self-expanding esophageal stent (SX-ELLA Stent Danis) and its extraction system (ELLA Extractor). www.has-sante.fr/jcms/p_3211567/fr/danis-stent. [Accessed 4 September 2025].

[19] Weil D, Thabut D, Hernandez-Gea V, et al. Rescue TIPS (rTIPS) must be considered as soon as a tamponade is used: results from two international multicenter cohorts of 3019 patients with portal hypertension (PHT)-related bleeding. Hepatology 2022;76:S151-S154.

Keywords: Portal hypertension; Esophageal varices; Tamponade devices; Rescue transjugular intrahepatic portosystemic shunt (rTIPS); Mortality.

Received 17 January 2025; received in revised form 13 August 2025; accepted 25 August 2025; Available online 30 August 2025