Table 1.
Characteristics of RCTs comparing BMSs to ePTFE-SGs.
| Study | Design | Groups/Pts | Stents/Nominal Diameter (mm) | Indication/n | Etiology of Cirrhosis/n | Follow-Up (Days) | Study End-Points | Results |
|---|---|---|---|---|---|---|---|---|
| Bureau et al., 2007 [32] | Multicente, unblinded |
BMS 41 | Memotherm Flexx® (BARD), Wallstent® (Boston), Luminex® (BARD), Sinus Stent® (MEDCARE)/NA # |
RA, 12; AVB, 14; Prevention of rebleeding, 15. |
Alcohol, 22. | 430 ± 322 | 1st—shunt dysfunction rate. 2nd—relapse of ascites (need for LVP) or gastrointestinal bleeding; number of revisions for shunt patency; rates of complication, HE and survival. |
ePTFE-SG improved primary patency, reduced clinical relapses and post-TIPS HE rate. No significant difference in survival rate. |
| ePTFE-SG 39 | Viatorr® (GORE)/NA # | RA, 20; AVB, 9; Prevention of rebleeding, 10. | Alcohol, 22. | 585 ± 438 | ||||
| Huang et al., 2010 [48] | Single-center, unblinded |
BMS 30 | Wallstents® (Boston)/10 | PH-related bleeding, 26; RA or hydrothorax, 4. | Viral, 29; Alcohol, 1. |
249 ± 132 | The role of Doppler US in quantitative assessment of shunt function and the usefulness of routine US follow-up of ePTFE-SGs. |
Routine US surveillance may not be necessary for ePTFE-SG. ePTFE-SG improved primary patency rate. |
| ePTFE-SG 30 | Fluency® (BARD)/8 | PH-related bleeding, 25; RA or hydrothorax, 5. | Viral, 28; Alcohol, 2. |
186 ± 117 | ||||
| Perarnau et al., 2014 [31] | Multicenter, single-blind |
BMS 66 | Luminexx® (BARD), Palmaz Genesis® (Cordis), Smart® (Cordis), Wallstent® (Boston), Zilver® (Cook)/NA # |
Prevention of rebleeding, 22; RA, 46; Hydrothorax, 6 †. | Alcohol, 61; Viral, 8; NASH, 1; Others, 2. |
654 § (IQR 171–723) | 1st—shunt dysfunction rate. 2nd—early complications (≤1 month); symptoms recurrence; rate of HE/ disabling chronic; quality of life; early (≤1 month) and late mortality. |
ePTFE-SG improved primary patency and reduced clinical relapses rate. No significant difference in post-TIPS HE and survival rate. |
| ePTFE-SG 71 | Fluency® (BARD), Fluency® + BMs, Viatorr® (GORE)/10 |
Prevention of rebleeding, 20; RA, 54; Hydrothorax, 3 †. | Alcohol, 52; Viral, 10; NASH, 6; Others, 1. |
708 § (IQR 420–723) | ||||
| Wang et al., 2016 [49] | Single-center, double-blind |
BMS 131 | Smart® (Cordis)/8 | PH-related bleeding, 122; RA, 22 †. | Viral, 102; Others, 25. |
NA (5 year) |
Restenosis/occlusion rate; recurrence of gastrointestinal bleeding, ascites/ hydrothorax; rate of secondary interventional therapy, HE and survival. | ePTFE-SGs improved both primary and secondary patency rate, and reduced clinical relapses rate.ePTFE-SG significantly improved long-term survival. No significant difference in post-TIPS HE rate. |
| ePTFE-SG 127 | Fluency® (BARD)/8 | PH-related bleeding, 123; RA, 20. | Viral, 104; Alcohol, 27. |
AVB, acute variceal bleeding; BMSs, bare metal stents; ePTFE-SGs, expanded polytetrafluoroethylene-stent grafts; HE, hepatic encephalopathy; LVP, large volume paracentesis; NASH, non-alcoholic steatohepatitis; PH, portal hypertension; RA, refractory ascites; TIPS, transjugular intrahepatic portosystemic shunt; US, ultrasound. # The nominal diameter of stents is not specified, and shunt diameter is only expressed as mean ± SD for each group. † TIPS indications may be more than one. § Median follow-up.