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

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.

Use of concomitant variceal embolization and prophylactic antiplatelet/anticoagulative in transjugular intrahepatic portosystemic shunting

“…A single-center randomized trial further showed that the cumulative stenosis rates with a 8-mm covered Fluency stent were 6.9%, 11.5%, 19.1%, 26.0%, and 35.9% at 1, 2, 3, 4, and 5 years, with significantly higher restenosis rates in patients with bare stents at these time points (27.6%, 37.0%, 49.6%, 59.8%, and 74.8%, respectively). [ 20 ] In contrast, the cumulative stenosis frequency of stent at a variable size was relatively lower in our cohort (6%, 10%, 12%, and 12% at 1, 2, 3, and years, respectively). Moreover, our results showed that pre-existing liver function impairment was not predictive of the long-term shunt stenosis.…”

Where does TIPS fit in the management of patients with cirrhosis?

“…Interestingly, TIPS decreased the probability of in-hospital (absolute risk reduction [ARR]: 20%) and 1-year (ARR: 27%) mortality, while the decrease in bleeding-related mortality did not reach statistical significance despite an ARR of 19%. Although this study provided important evidence supporting the preemptive use of TIPS, its results have to be interpreted/ extrapolated with caution, as both the TIPS technique (uncovered vs. polytetrafluoroethylene [PTFE]-covered stents [36][37][38] ) and conventional therapy (sclerotherapy vs. endoscopic variceal ligation [EVL]) have changed since the conduct of the study. Moreover, the use of HVPG for risk stratification and treatment assignment (i.e., personalised therapy) has important limitations, since its assessment is challenging in the context of AVB (as evidenced by 5 patients not undergoing HVPG), and most importantly, its availability is restricted to large centres.…”

Transjugular Intrahepatic Portosystemic Shunt in Ascites: Updates

“…16 A meta-analysis comparing TIPS creation using bare stents to TIPS creation using covered stents across a variety of indications found that patients who received a covered stent had significantly better overall survival and shunt patency compared with patients who received a bare stent. [17][18][19][20][21] Few studies, however, have focused on the clinical outcomes associated with covered stent use when refractory ascites is the indication for TIPS. We review three such studies below.…”