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  • Title: Expanded polytetrafluoroethylene (ePTFE)-covered stents versus bare stents for transjugular intrahepatic portosystemic shunt in people with liver cirrhosis.
    Author: Zhu P, Dong S, Sun P, Belgaumkar AP, Sun Y, Cheng X, Zheng Q, Li T.
    Journal: Cochrane Database Syst Rev; 2023 Aug 02; 8(8):CD012358. PubMed ID: 37531575.
    Abstract:
    BACKGROUND: Transjugular intrahepatic portosystemic shunt (TIPS) is a widely used procedure for management of uncontrolled upper gastrointestinal bleeding and refractory ascites in people with liver cirrhosis. However, nearly half of the people experience shunt dysfunction and recurrent symptoms within one year of the procedure. Expanded polytetrafluoroethylene (ePTFE)-covered stents are assumed to decrease shunt dysfunction by approximately 20% to 30%. OBJECTIVES: To evaluate the benefits and harms associated with the use of expanded polytetrafluoroethylene (ePTFE)-covered stents versus bare stents in transjugular intrahepatic portosystemic shunts (TIPSs) for managing people with liver cirrhosis. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 28 February 2023. SELECTION CRITERIA: Randomised clinical trials comparing ePTFE-covered stents versus bare stents in TIPS for treatment of people with liver cirrhosis. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. all-cause mortality, 2. procedure-related complications, and 3. health-related quality of life. Our secondary outcomes were 4. upper gastrointestinal bleeding, 5. recurrence of ascites, 6. hepatic encephalopathy, 7. kidney failure, 8. early thrombosis, 9. non-serious adverse events, and 10. shunt dysfunction. We used GRADE to assess certainty of evidence. We analysed outcome data at the maximum follow-up, except for the 'early thrombosis' outcome for which it was within 12 weeks after the TIPS procedure. MAIN RESULTS: We included four trials with 565 randomised participants (age range: 18 to 75 years; male range: 63.6% to 75.0%). A total of 527 participants provided data for analyses because of losses to follow-up. Two trials were conducted in China; one in France; and one in France, Spain, and Canada. Participants were classified with cirrhosis Child-Pugh class A, B, or C, and for some, the class was not reported. We used intention-to-treat principle (four trials) and per-protocol analysis (one trial) to meta-analyse the data. One trial compared ePTFE-covered stents versus bare stents of the same diameter and three trials compared ePTFE-covered stents versus stents of different diameters. ePTFE-covered stents versus bare stents of the same diameter One trial with 258 participants compared 8 mm covered stent versus 8 mm bare stent. Mortality in the covered stent group is possibly lower than in the bare stent group (risk ratio (RR) 0.63, 95% confidence interval (CI) 0.43 to 0.92; low-certainty evidence). Upper gastrointestinal bleeding (RR 0.54, 95% CI 0.35 to 0.84), recurrence of ascites (RR 0.42, 95% CI 0.20 to 0.87), and shunt dysfunction (RR 0.42, 95% CI 0.28 to 0.61) occurred more often in the bare stent group than in the covered stent group (all low-certainty evidence). There was no difference in hepatic encephalopathy between groups (RR 1.10, 95% CI 0.76 to 1.61; very low-certainty evidence). The trial did not report data on procedure-related complications, health-related quality of life, early thrombosis, and segmental liver ischaemia (a non-serious adverse event). ePTFE-covered stents versus bare stents of different stent diameters Three trials compared ePTFE-covered stents versus bare stents of different diameters (10.5 (standard deviation (SD) 0.9) mm versus 11.7 (SD 0.8) mm; 8 mm versus 10 mm; and one trial used 10-mm stents that could be dilated from 8 mm to 10 mm). There was no evidence of a difference between the ePTFE-covered stents versus bare stents groups in mortality (RR 0.75, 95% CI 0.48 to 1.16; 3 trials, 269 participants), procedure-related complications (RR 0.53, 95% CI 0.05 to 5.57; 1 trial, 80 participants), upper gastrointestinal bleeding (RR 0.46, 95% CI 0.15 to 1.38; 3 trials, 269 participants), hepatic encephalopathy (RR 0.93, 95% CI 0.66 to 1.30; 3 trials, 269 participants), and kidney failure (RR 7.59, 95% CI 0.40 to 143.92; 1 trial, 121 participants) (all very low-certainty evidence). Recurrence of ascites (RR 0.30, 95% CI 0.11 to 0.85; 3 trials, 269 participants; low-certainty evidence), shunt dysfunction (RR 0.50, 95% CI 0.28 to 0.92; 3 trials, 269 participants; low-certainty evidence), and early thrombosis (RR 0.28, 95% CI 0.09 to 0.82; I2 = 0%; 3 trials, 261 participants; very low-certainty evidence) occurred more often in the bare stents group. There was no evidence of a difference in segmental liver ischaemia (RR 5.25, 95% CI 0.26 to 106.01; 1 trial, 80 participants; very low-certainty evidence). No trial presented data on health-related quality of life. Funding One trial did not clearly report funding sources. The remaining three trials declared that they had no funding with vested interests. AUTHORS' CONCLUSIONS: Based on the small number of trials with insufficient sample size and events, and study limitations, we assessed the overall certainty of evidence in the predefined outcomes as low or very low. Therefore, we are uncertain which of the two interventions (ePTFE-covered stents or bare stents of the same diameter and ePTFE-covered stents versus bare stents of different stent diameters) is effective for the evaluated outcomes. None of the four trials reported data on health-related quality of life, and data on complications were either missing or rarely reported. We lack high-quality trials to evaluate the role of ePTFE-covered stents for TIPS for managing people with liver cirrhosis.
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