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Randomized Controlled Trial
. 2016 Feb 15:6:21011.
doi: 10.1038/srep21011.

Efficacy of covered and bare stent in TIPS for cirrhotic portal hypertension: A single-center randomized trial

Lei Wang  1 , Zhibo Xiao  2 , Zhendong Yue  1 , Hongwei Zhao  1 , Zhenhua Fan  1 , Mengfei Zhao  1 , Fuliang He  1 , Shan Dai  1 , Bin Qiu  1 , Jiannan Yao  3 , Qiushi Lin  4 , Xiaoqun Dong  1   4 , Fuquan Liu  1
Affiliations
Randomized Controlled Trial

Efficacy of covered and bare stent in TIPS for cirrhotic portal hypertension: A single-center randomized trial

Lei Wang et al. Sci Rep. .

Abstract

We conducted a single-center randomized trial to compare the efficacy of 8 mm Fluency covered stent and bare stent in transjugular intrahepatic portosystemic shunt (TIPS) for cirrhotic portal hypertension. From January 2006 to December 2010, the covered (experimental group) or bare stent (control group) was used in 131 and 127 patients, respectively. The recurrence rates of gastrointestinal bleeding (18.3% vs. 33.9%, P = 0.004) and refractory hydrothorax/ascites (6.9% vs. 16.5%, P = 0.019) in the experimental group were significantly lower than those in the control group. The cumulative restenosis rates in 1, 2, 3, 4, and 5-years in the experimental group (6.9%, 11.5%, 19.1%, 26.0%, and 35.9%, respectively) were significantly lower (P < 0.001) than those in the control group (27.6%, 37.0%, 49.6%, 59.8%, 74.8%, respectively). Importantly, the 4 and 5-year survival rates in the experimental group (83.2% and 76.3%, respectively) were significantly higher (P = 0.001 and 0.02) than those in the control group (71.7% and 62.2%, respectively). The rate of secondary interventional therapy in the experimental group was significantly lower than that in the control group (20.6% vs. 49.6%; P < 0.001). Therefore, Fluency covered stent has advantages over the bare stent in terms of reducing the restenosis, recurrence, and secondary interventional therapy, whereas improving the long-term survival for post-TIPS patients.

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Figures

Figure 1
Figure 1. Inclusion and exclusion criteria for patient recruitment in this retrospective study.
Figure 2
Figure 2
(A) A covered stent with the diameter of 8 × 8 mm was used to establish the shunt channel in TIPS. Portography indicated normal blood flow in the shunt channel. (B) Portography at 21 months after the operation identified occlusion of the shunt at the proximal (hepatic vein) end. (C) Another stent was implanted at the occlusion end. Portography demonstrated that the shunt channel was patent again, and the blood flow was normal.
Figure 3
Figure 3
(A) Portography at 9 months after establishing shunt channel with 8 × 8 mm bare stent in TIPS suggested that the whole shunt channel was occluded. (B) Balloon dilation of the occluded shunt channel. (C) Another stent was implanted in the shunt channel. Portography clarified an effective shunting characterized by recovery of blood flows through the shunt channel.
Figure 4
Figure 4. Effects of covered (experimental) vs. bare (control) stent in TIPS on overall survival (5-years follow-up) of patients with cirrhotic portal hypertension.
See this image and copyright information in PMC

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