Efficacy of PTFE-covered stent grafts versus bare stent grafts TIPS for portal hypertension: a meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

FU Yan ¹ , ZHANG Chao ² , DU Enfu ³ ,  LI Heng ¹

1. Department of General Surgical, Taihe Hospital, Hubei University of Medicine, Shiyan, 442000, P.R.China;
2. Center for Evidence-based Medicine and Clinical Research, Taihe Hospital, Hubei University of Medicine, Shiyan, 442000, P.R.China;
3. Medical Image Center, Taihe Hospital, Hubei University of Medicine, Shiyan, 442000, P.R.China;

Corresponding author：

LI Heng, Email: taiheliheng@163.com

Keywords：

Portal hypertension; Transjugular intrahepatic portosystemic shunt; Shunt dysfunction; Hepatic encephalopathy; Meta-analysis; Systematic review; Randomized controlled trial; Cohort study

DOI：

10.7507/1672-2531.201703142

Video：

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Objectives To systematically review the efficacy of polytetrafluoroethylene (PTFE) covered stent grafts vs. bare stent grafts in transjugular intrahepatic portosystemic shunt (TIPS) for portal hypertension. Methods PubMed, EMbase, The Cochrane Library, and ClinicalTrial.gov were searched online to collect randomized controlled trials (RCTs) and cohort studies of PTFE-covered stent grafts vs. bare stent grafts for portal hypertension from inception to Jan 11^th, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed by RevMan 5.3 software. Results A total of 4 RCTs and 11 cohort studies involving 2 422 patients (1 070 PTFE-covered stent grafts patients and 1 352 bare stent grafts patients) were included. The results of meta-analysis showed that compared with the bare stent grafts group, the PTFE-covered stent grafts group had higher patency rate of intrahepatic shunt (HR=0.38, 95%CI 0.31 to 0.47, P<0.000 01) and survival rate (HR=0.59, 95%CI 0.44 to 0.79,P=0.000 5), lower postoperative complications rate (including gastrointestinal bleeding and refractory ascites) (HR=0.44, 95%CI 0.33 to 0.58, P<0.000 01) and encephalopathy rate (HR=0.76, 95%CI 0.57 to 0.99,P=0.05). Conclusions Current evidence shows that compared with the bare stent grafts, the PTFE-covered stent grafts could effectively improve patency rate of intrahepatic shunt and survival rate with less postoperative complications rate and encephalopathy rate. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.

Citation： FU Yan, ZHANG Chao, DU Enfu, LI Heng. Efficacy of PTFE-covered stent grafts versus bare stent grafts TIPS for portal hypertension: a meta-analysis. Chinese Journal of Evidence-Based Medicine, 2018, 18(1): 35-42. doi: 10.7507/1672-2531.201703142 Copy

1.	Boyer TD, Haskal ZJ. The role of transjugular intrahepatic portosystemic shunt (TIPS) in the management of portal hypertension: update 2009. Hepatology, 2010, 51(1): 306.
2.	Charon JP, Alaeddin FH, Pimpalwar SA, et al. Results of a retrospective multicenter trial of the viatorr expanded polytetrafluoroethylene-covered stent-graft for transjugular intrahepatic portosystemic shunt creation. J Vasc Interv Radiol, 2004, 15(11): 1219-1230.
3.	Rossle M, Siegerstetter V, Euringer W, et al. The use of a polytetrafluoroethylene-covered stent graft for transjugular intrahepatic portosystemic shunt (TIPS): Long-term follow-up of 100 patients. Acta Radiol, 2006, 47(7): 660-666.
4.	Vignali C, Bargellini I, Grosso M, et al. TIPS with expanded polytetrafluoroethylene-covered stent: results of an Italian multicenter study. AJR Am J Roentgenol, 2005, 185(2): 472-480.
5.	Clark TW. Management of shunt dysfunction in the era of TIPS endografts. Tech Vasc Interv Radiol, 2008, 11(4): 212-216.
6.	Casado M, Bosch J, Garcia-Pagan JC, et al. Clinical events after transjugular intrahepatic portosystemic shunt: correlation with hemodynamic findings. Gastroenterology, 1998, 114(6): 1296-1303.
7.	Tripathi D, Ferguson J, Barkell H, et al. Improved clinical outcome with transjugular intrahepatic portosystemic stent-shunt utilizing polytetrafluoroethylene-covered stents. Eur J Gastroenterol Hepatol, 2006, 18(3): 225-232.
8.	Cura M, Cura A, Suri R, et al. Causes of TIPS dysfunction. AJR Am J Roentgenol, 2008, 191(6): 1751-1757.
9.	Rossi P, Salvatori FM, Fanelli F, et al. Polytetrafluoroethylene-covered nitinol stent-graft for transjugular intrahepatic portosystemic shunt creation: 3-year experience. Radiology, 2004, 231(3): 820-830.
10.	邓小军, 张宏文, 孙鑫国, 等. 覆膜支架联合长裸支架在 TIPS 治疗中的应用. 世界华人消化杂志, 2016, 24(22): 3428-3432.
11.	Fagiuoli S, Bruno R, Debernardi VW, et al. Consensus conference on TIPS management: Techniques, indications, contraindications. Dig Liver Dis, 2017, 49(2): 121-137.
12.	Riggio O, Ridola L, Angeloni S, et al. Clinical efficacy of transjugular intrahepatic portosystemic shunt created with covered stents with different diameters: results of a randomized controlled trial. J Hepatol, 2010, 53(2): 267-272.
13.	Yang Z, Han G, Wu Q, et al. Patency and clinical outcomes of transjugular intrahepatic portosystemic shunt with polytetrafluoroethylene-covered stents versus bare stents: a meta-analysis. J Gastroenterol Hepatol, 2010, 25(11): 1718-1725.
14.	Higgins J, Green SE. Cochrane handbook for systematic reviews of interventions version 5.1.0. The Cochrane Collaboration (Eds): Naunyn-Schmiedebergs Archiv für experimentelle Pathologie und Pharmakologie, 2011, 2011(14): S38.
15.	Stang A. Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses. Euro J Epidemiol, 2010, 25(9): 603-605.
16.	Wells GA, Shea BJ, O'Connell D, et al. The Newcastle–Ottawa scale (NOS) for assessing the quality of non-randomized studies in meta-analysis. Applied Engineering in Agriculture, 2000, 18(6): 727-734.
17.	Higgins JT, Green S. Cochrane handbook for systematic reviews of interventions, version 5.1.0. Wiley-Blackwell, 2011.
18.	Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ, 2009, 339(4): b2700.
19.	Tierney JF, Stewart LA, Ghersi D, et al. Practical methods for incorporating summary time-to-event data into meta-analysis. Trials, 2007, 8(1): 16.
20.	Guyot P, Ades AE, Ouwens MJ, et al. Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves. Bmc Medical Research Methodology, 2012, 12(1): 9.
21.	Williamson PR, Smith CT, Hutton JL, et al. Aggregate data meta-analysis with time-to-event outcomes. Statistics in Medicine, 2002, 21(22): 3337.
22.	周支瑞, 张天嵩, 李博, 等. 生存曲线中Meta分析适宜数据的提取与转换. 中国循证心血管医学杂志, 2014, 6(3): 243-247.
23.	Angeloni S, Merli M, Salvatori FM, et al. Polytetrafluoroethylene-covered stent grafts for TIPS procedure: 1-year patency and clinical results. Am J Gastroenterol, 2004, 99(2): 280-285.
24.	Angermayr B, Cejna M, Koenig F, et al. Survival in patients undergoing transjugular intrahepatic portosystemic shunt: ePTFE-covered stentgrafts versus bare stents. Hepatology, 2003, 38(4): 1043-1050.
25.	Barrio J, Ripoll C, Banares R, et al. Comparison of transjugular intrahepatic portosystemic shunt dysfunction in PTFE-covered stent-grafts versus bare stents. Eur J Radiol, 2005, 55(1): 120-124.
26.	Bureau C, Pagan JC, Layrargues GP, et al. Patency of stents covered with polytetrafluoroethylene in patients treated by transjugular intrahepatic portosystemic shunts: long-term results of a randomized multicentre study. Liver Int, 2007, 27(6): 742-747.
27.	Tripathi D, Macnicholas R, Kothari C, et al. Good clinical outcomes following transjugular intrahepatic portosystemic stent-shunts in Budd-Chiari syndrome. Aliment Pharmacol Ther, 2014, 39(8): 864-872.
28.	Maleux G, Perez-Gutierrez NA, Evrard S, et al. Covered stents are better than uncovered stents for transjugular intrahepatic portosystemic shunts in cirrhotic patients with refractory ascites: a retrospective cohort study. Acta Gastroenterol Belg, 2010, 73(3): 336-341.
29.	Hernandez-Guerra M, Turnes J, Rubinstein P, et al. PTFE-covered stents improve TIPS patency in Budd-Chiari syndrome. Hepatology, 2004, 40(5): 1197-1202.
30.	Tan HK, James PD, Sniderman KW, et al. Long-term clinical outcome of patients with cirrhosis and refractory ascites treated with transjugular intrahepatic portosystemic shunt insertion. J Gastroenterol Hepatol, 2015, 30(2): 389-395.
31.	Lauermann J, Potthoff A, Mc CM, et al. Erratum to: comparison of technical and clinical outcome of transjugular portosystemic shunt placement between a bare metal stent and a PTFE-stentgraft device. Cardiovasc Intervent Radiol, 2016, 39(4): 547-556.
32.	Perarnau JM, Le Gouge A, Nicolas C, et al. Covered vs. uncovered stents for transjugular intrahepatic portosystemic shunt: a randomized controlled trial. J Hepatol, 2014, 60(5): 962-968.
33.	Wang L, Xiao Z, Yue Z, et al. Efficacy of covered and bare stent in TIPS for cirrhotic portal hypertension: A single-center randomized trial. Scientific Reports, 2016, 6: 21011.
34.	Huang Q, Wu X, Fan X, et al. Comparison study of doppler ultrasound surveillance of expanded polytetrafluoroethylene-covered stent versus bare stent in transjugular intrahepatic portosystemic shunt. J Clin Ultrasound, 2010, 38(7): 353-360.
35.	Gaba RC, Omene BO, Podczerwinski ES, et al. TIPS for treatment of variceal hemorrhage: clinical outcomes in 128 patients at a single institution over a 12-year period. J Vasc Interv Radiol, 2012, 23(2): 227-235.
36.	Clark W, Golkar F, Luberice K, et al. Uncovering the truth about covered stents: is there a difference between covered versus uncovered stents with transjugular intrahepatic portosystemic shunts? Am J Surg, 2011, 202(5): 561-564.
37.	蔡炜, 诸葛宇征, 张建武, 等. 不同支架经颈静脉肝内门体静脉分流术治疗肝硬化食管胃静脉曲张出血的安全性和疗效研究. 中华肝脏病杂志, 2015, 23(4): 258-264.
38.	Papatheodoridis GV, Goulis J, Leandro G, et al. Transjugular intrahepatic portosystemic shunt compared with endoscopic treatment for prevention of variceal rebleeding: A meta-analysis. Hepatology, 1999, 30(3): 612-622.
39.	Nishimine K, Saxon RR, Kichikawa K, et al. Improved transjugular intrahepatic portosystemic shunt patency with PTFE-covered stent-grafts: experimental results in swine. Radiology, 1995, 196(2): 341-347.
40.	Haskal ZJ, Davis A, McAllister A, et al. PTFE-encapsulated endovascular stent-graft for transjugular intrahepatic portosystemic shunts: experimental evaluation. Radiology, 1997, 205(3): 682-688.
41.	Petersen B, Uchida BT, Timmermans H, et al. Intravascular US-guided direct intrahepatic portacaval shunt with a PTFE-covered stent-graft: feasibility study in swine and initial clinical results. J Vasc Interv Radiol, 2001, 12(4): 475-486.
42.	Hausegger KA, Portugaller H, Macri NP, et al. Covered stents in transjugular portosystemic shunt: healing response to non-porous ePTFE covered stent grafts with and without intraluminal irradiation. Eur Radiol, 2003, 13(7): 1549-1558.
43.	Hausegger KA, Karnel F, Georgieva B, et al. Transjugular intrahepatic portosystemic shunt creation with the Viatorr expanded polytetrafluoroethylene-covered stent-graft. J Vasc Interv Radiol, 2004, 15(3): 239-248.
44.	Maleux G, Nevens F, Wilmer A, et al. Early and long-term clinical and radiological follow-up results of expanded-polytetrafluoroethylene-covered stent-grafts for transjugular intrahepatic portosystemic shunt procedures. Eur Radiol, 2004, 14(10): 1842-1850.
45.	de Franchis R. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol, 2015, 63(3): 743-752.
46.	Tripathi D, Stanley AJ, Hayes PC, et al. U.K. guidelines on the management of variceal haemorrhage in cirrhotic patients. Gut, 2015, 64(11): 1680-1704.
47.	Qi X, Guo X, Fan D. A trend toward the improvement of survival after TIPS by the use of covered stents: a meta-analysis of two randomized controlled trials. Cardiovasc Intervent Radiol, 2015, 38(5): 1363-1364.

1. Boyer TD, Haskal ZJ. The role of transjugular intrahepatic portosystemic shunt (TIPS) in the management of portal hypertension: update 2009. Hepatology, 2010, 51(1): 306.
2. Charon JP, Alaeddin FH, Pimpalwar SA, et al. Results of a retrospective multicenter trial of the viatorr expanded polytetrafluoroethylene-covered stent-graft for transjugular intrahepatic portosystemic shunt creation. J Vasc Interv Radiol, 2004, 15(11): 1219-1230.
3. Rossle M, Siegerstetter V, Euringer W, et al. The use of a polytetrafluoroethylene-covered stent graft for transjugular intrahepatic portosystemic shunt (TIPS): Long-term follow-up of 100 patients. Acta Radiol, 2006, 47(7): 660-666.
4. Vignali C, Bargellini I, Grosso M, et al. TIPS with expanded polytetrafluoroethylene-covered stent: results of an Italian multicenter study. AJR Am J Roentgenol, 2005, 185(2): 472-480.
5. Clark TW. Management of shunt dysfunction in the era of TIPS endografts. Tech Vasc Interv Radiol, 2008, 11(4): 212-216.
6. Casado M, Bosch J, Garcia-Pagan JC, et al. Clinical events after transjugular intrahepatic portosystemic shunt: correlation with hemodynamic findings. Gastroenterology, 1998, 114(6): 1296-1303.
7. Tripathi D, Ferguson J, Barkell H, et al. Improved clinical outcome with transjugular intrahepatic portosystemic stent-shunt utilizing polytetrafluoroethylene-covered stents. Eur J Gastroenterol Hepatol, 2006, 18(3): 225-232.
8. Cura M, Cura A, Suri R, et al. Causes of TIPS dysfunction. AJR Am J Roentgenol, 2008, 191(6): 1751-1757.
9. Rossi P, Salvatori FM, Fanelli F, et al. Polytetrafluoroethylene-covered nitinol stent-graft for transjugular intrahepatic portosystemic shunt creation: 3-year experience. Radiology, 2004, 231(3): 820-830.
10. 邓小军, 张宏文, 孙鑫国, 等. 覆膜支架联合长裸支架在 TIPS 治疗中的应用. 世界华人消化杂志, 2016, 24(22): 3428-3432.
11. Fagiuoli S, Bruno R, Debernardi VW, et al. Consensus conference on TIPS management: Techniques, indications, contraindications. Dig Liver Dis, 2017, 49(2): 121-137.
12. Riggio O, Ridola L, Angeloni S, et al. Clinical efficacy of transjugular intrahepatic portosystemic shunt created with covered stents with different diameters: results of a randomized controlled trial. J Hepatol, 2010, 53(2): 267-272.
13. Yang Z, Han G, Wu Q, et al. Patency and clinical outcomes of transjugular intrahepatic portosystemic shunt with polytetrafluoroethylene-covered stents versus bare stents: a meta-analysis. J Gastroenterol Hepatol, 2010, 25(11): 1718-1725.
14. Higgins J, Green SE. Cochrane handbook for systematic reviews of interventions version 5.1.0. The Cochrane Collaboration (Eds): Naunyn-Schmiedebergs Archiv für experimentelle Pathologie und Pharmakologie, 2011, 2011(14): S38.
15. Stang A. Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses. Euro J Epidemiol, 2010, 25(9): 603-605.
16. Wells GA, Shea BJ, O'Connell D, et al. The Newcastle–Ottawa scale (NOS) for assessing the quality of non-randomized studies in meta-analysis. Applied Engineering in Agriculture, 2000, 18(6): 727-734.
17. Higgins JT, Green S. Cochrane handbook for systematic reviews of interventions, version 5.1.0. Wiley-Blackwell, 2011.
18. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ, 2009, 339(4): b2700.
19. Tierney JF, Stewart LA, Ghersi D, et al. Practical methods for incorporating summary time-to-event data into meta-analysis. Trials, 2007, 8(1): 16.
20. Guyot P, Ades AE, Ouwens MJ, et al. Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves. Bmc Medical Research Methodology, 2012, 12(1): 9.
21. Williamson PR, Smith CT, Hutton JL, et al. Aggregate data meta-analysis with time-to-event outcomes. Statistics in Medicine, 2002, 21(22): 3337.
22. 周支瑞, 张天嵩, 李博, 等. 生存曲线中Meta分析适宜数据的提取与转换. 中国循证心血管医学杂志, 2014, 6(3): 243-247.
23. Angeloni S, Merli M, Salvatori FM, et al. Polytetrafluoroethylene-covered stent grafts for TIPS procedure: 1-year patency and clinical results. Am J Gastroenterol, 2004, 99(2): 280-285.
24. Angermayr B, Cejna M, Koenig F, et al. Survival in patients undergoing transjugular intrahepatic portosystemic shunt: ePTFE-covered stentgrafts versus bare stents. Hepatology, 2003, 38(4): 1043-1050.
25. Barrio J, Ripoll C, Banares R, et al. Comparison of transjugular intrahepatic portosystemic shunt dysfunction in PTFE-covered stent-grafts versus bare stents. Eur J Radiol, 2005, 55(1): 120-124.
26. Bureau C, Pagan JC, Layrargues GP, et al. Patency of stents covered with polytetrafluoroethylene in patients treated by transjugular intrahepatic portosystemic shunts: long-term results of a randomized multicentre study. Liver Int, 2007, 27(6): 742-747.
27. Tripathi D, Macnicholas R, Kothari C, et al. Good clinical outcomes following transjugular intrahepatic portosystemic stent-shunts in Budd-Chiari syndrome. Aliment Pharmacol Ther, 2014, 39(8): 864-872.
28. Maleux G, Perez-Gutierrez NA, Evrard S, et al. Covered stents are better than uncovered stents for transjugular intrahepatic portosystemic shunts in cirrhotic patients with refractory ascites: a retrospective cohort study. Acta Gastroenterol Belg, 2010, 73(3): 336-341.
29. Hernandez-Guerra M, Turnes J, Rubinstein P, et al. PTFE-covered stents improve TIPS patency in Budd-Chiari syndrome. Hepatology, 2004, 40(5): 1197-1202.
30. Tan HK, James PD, Sniderman KW, et al. Long-term clinical outcome of patients with cirrhosis and refractory ascites treated with transjugular intrahepatic portosystemic shunt insertion. J Gastroenterol Hepatol, 2015, 30(2): 389-395.
31. Lauermann J, Potthoff A, Mc CM, et al. Erratum to: comparison of technical and clinical outcome of transjugular portosystemic shunt placement between a bare metal stent and a PTFE-stentgraft device. Cardiovasc Intervent Radiol, 2016, 39(4): 547-556.
32. Perarnau JM, Le Gouge A, Nicolas C, et al. Covered vs. uncovered stents for transjugular intrahepatic portosystemic shunt: a randomized controlled trial. J Hepatol, 2014, 60(5): 962-968.
33. Wang L, Xiao Z, Yue Z, et al. Efficacy of covered and bare stent in TIPS for cirrhotic portal hypertension: A single-center randomized trial. Scientific Reports, 2016, 6: 21011.
34. Huang Q, Wu X, Fan X, et al. Comparison study of doppler ultrasound surveillance of expanded polytetrafluoroethylene-covered stent versus bare stent in transjugular intrahepatic portosystemic shunt. J Clin Ultrasound, 2010, 38(7): 353-360.
35. Gaba RC, Omene BO, Podczerwinski ES, et al. TIPS for treatment of variceal hemorrhage: clinical outcomes in 128 patients at a single institution over a 12-year period. J Vasc Interv Radiol, 2012, 23(2): 227-235.
36. Clark W, Golkar F, Luberice K, et al. Uncovering the truth about covered stents: is there a difference between covered versus uncovered stents with transjugular intrahepatic portosystemic shunts? Am J Surg, 2011, 202(5): 561-564.
37. 蔡炜, 诸葛宇征, 张建武, 等. 不同支架经颈静脉肝内门体静脉分流术治疗肝硬化食管胃静脉曲张出血的安全性和疗效研究. 中华肝脏病杂志, 2015, 23(4): 258-264.
38. Papatheodoridis GV, Goulis J, Leandro G, et al. Transjugular intrahepatic portosystemic shunt compared with endoscopic treatment for prevention of variceal rebleeding: A meta-analysis. Hepatology, 1999, 30(3): 612-622.
39. Nishimine K, Saxon RR, Kichikawa K, et al. Improved transjugular intrahepatic portosystemic shunt patency with PTFE-covered stent-grafts: experimental results in swine. Radiology, 1995, 196(2): 341-347.
40. Haskal ZJ, Davis A, McAllister A, et al. PTFE-encapsulated endovascular stent-graft for transjugular intrahepatic portosystemic shunts: experimental evaluation. Radiology, 1997, 205(3): 682-688.
41. Petersen B, Uchida BT, Timmermans H, et al. Intravascular US-guided direct intrahepatic portacaval shunt with a PTFE-covered stent-graft: feasibility study in swine and initial clinical results. J Vasc Interv Radiol, 2001, 12(4): 475-486.
42. Hausegger KA, Portugaller H, Macri NP, et al. Covered stents in transjugular portosystemic shunt: healing response to non-porous ePTFE covered stent grafts with and without intraluminal irradiation. Eur Radiol, 2003, 13(7): 1549-1558.
43. Hausegger KA, Karnel F, Georgieva B, et al. Transjugular intrahepatic portosystemic shunt creation with the Viatorr expanded polytetrafluoroethylene-covered stent-graft. J Vasc Interv Radiol, 2004, 15(3): 239-248.
44. Maleux G, Nevens F, Wilmer A, et al. Early and long-term clinical and radiological follow-up results of expanded-polytetrafluoroethylene-covered stent-grafts for transjugular intrahepatic portosystemic shunt procedures. Eur Radiol, 2004, 14(10): 1842-1850.
45. de Franchis R. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol, 2015, 63(3): 743-752.
46. Tripathi D, Stanley AJ, Hayes PC, et al. U.K. guidelines on the management of variceal haemorrhage in cirrhotic patients. Gut, 2015, 64(11): 1680-1704.
47. Qi X, Guo X, Fan D. A trend toward the improvement of survival after TIPS by the use of covered stents: a meta-analysis of two randomized controlled trials. Cardiovasc Intervent Radiol, 2015, 38(5): 1363-1364.

Chinese Journal of Evidence-Based Medicine

Efficacy of PTFE-covered stent grafts versus bare stent grafts TIPS for portal hypertension: a meta-analysis

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