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Background and aim <p>Cirrhotic patients receiving trans-jugular intrahepatic portosystemic shunt (TIPS) for preventing re-bleeding may benefit from a shunt diameter of ≤ 8&#xa0;mm. This study aimed to emulate a target trial comparing decompensation-free survival in patients receiving coaxial stent versus fully- or under-dilated 8&#xa0;mm TIPS for preventing variceal re-bleeding.</p> Approach <p>Participants were recruited from a single-center, prospective, non-randomized cohort after excluding patients impossible to be assigned to the coaxial stent group. The coaxial stent consisted of a pre-implanted 5-/6&#xa0;mm balloon-expandable stent with an internal 8&#xa0;mm Viatorr stent. Causal inference framework was designed based on a directed acyclic graph, incorporating inverse probability weighting (IPW), doubly robust estimation by augmented IPW, mediation analysis, and <i>E</i> value analysis.</p> Results <p>200 patients entered into target trial emulation, with 47 (23.5%), 101 (50.5%), and 52 (26.0%) in coaxial stent, under-dilated, and fully dilated groups. Coaxial stent feasibility was demonstrated by portacaval pressure gradient adjustability (33 pairs before/after dilation: 22.8 ± 3.0 to 17.9 ± 3.1&#xa0;mmHg, <i>p</i> &lt; 0.001) and stability (76 pairs without intervention: 17.7 ± 4.2 to 18.5 ± 4.5&#xa0;mmHg, <i>p</i> = 0.035, <i>r</i> = 0.712, ICC = 0.710). Crude (IPW-weighted) 1-year decompensation-free survival incidences were 57.7% (52.6%), 60.1% (60.0%), and 76.6% (78.9%) for fully dilated, under-dilated, and coaxial stent groups, with doubly robust analysis revealing improved prognosis in coaxial stent versus fully dilated (HR 0.54 [0.25–0.93], <i>p</i> = 0.026, <i>E</i> value = 3.108, direct effect 66.3%) and under-dilated (HR 0.63 [0.34–1.05], <i>p</i> = 0.070, <i>E</i> value = 2.553, direct effect 60.7%) groups. Coaxial stent group demonstrated significantly reduced hepatic encephalopathy risk compared with other groups (<i>p</i> = 0.045/0.026), while other outcomes were comparable.</p> Conclusions <p>The coaxial stent TIPS strategy could effectively achieve controlled expansion of 5–8&#xa0;mm and may improve overall prognosis in cirrhotic patients with previous variceal bleeding.</p>

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Coaxial stent TIPS with 5 to 8 mm controlled expansion improving overall prognosis in cirrhotic patients: a prospective cohort study with target trial emulation

  • 期刊论文

  • 发表日期：

    2026年2月12日

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  • Li Ma,
  • Jingqin Ma,
  • Jiaze Yu,
  • Yaozu Liu,
  • Yongjie Zhou,
  • Minjie Yang,
  • Zhiping Yan,
  • Jianjun Luo,
  • Wen Zhang

摘要

Background and aim

Cirrhotic patients receiving trans-jugular intrahepatic portosystemic shunt (TIPS) for preventing re-bleeding may benefit from a shunt diameter of ≤ 8 mm. This study aimed to emulate a target trial comparing decompensation-free survival in patients receiving coaxial stent versus fully- or under-dilated 8 mm TIPS for preventing variceal re-bleeding.

Approach

Participants were recruited from a single-center, prospective, non-randomized cohort after excluding patients impossible to be assigned to the coaxial stent group. The coaxial stent consisted of a pre-implanted 5-/6 mm balloon-expandable stent with an internal 8 mm Viatorr stent. Causal inference framework was designed based on a directed acyclic graph, incorporating inverse probability weighting (IPW), doubly robust estimation by augmented IPW, mediation analysis, and E value analysis.

Results

200 patients entered into target trial emulation, with 47 (23.5%), 101 (50.5%), and 52 (26.0%) in coaxial stent, under-dilated, and fully dilated groups. Coaxial stent feasibility was demonstrated by portacaval pressure gradient adjustability (33 pairs before/after dilation: 22.8 ± 3.0 to 17.9 ± 3.1 mmHg, p < 0.001) and stability (76 pairs without intervention: 17.7 ± 4.2 to 18.5 ± 4.5 mmHg, p = 0.035, r = 0.712, ICC = 0.710). Crude (IPW-weighted) 1-year decompensation-free survival incidences were 57.7% (52.6%), 60.1% (60.0%), and 76.6% (78.9%) for fully dilated, under-dilated, and coaxial stent groups, with doubly robust analysis revealing improved prognosis in coaxial stent versus fully dilated (HR 0.54 [0.25–0.93], p = 0.026, E value = 3.108, direct effect 66.3%) and under-dilated (HR 0.63 [0.34–1.05], p = 0.070, E value = 2.553, direct effect 60.7%) groups. Coaxial stent group demonstrated significantly reduced hepatic encephalopathy risk compared with other groups (p = 0.045/0.026), while other outcomes were comparable.

Conclusions

The coaxial stent TIPS strategy could effectively achieve controlled expansion of 5–8 mm and may improve overall prognosis in cirrhotic patients with previous variceal bleeding.