Routine Addition of Stent Placement in Angioplasty for Budd-Chiari Syndrome Improves Recanalization Patency and Reduces Symptom Recurrence with Adequate Safety: A Randomized Controlled Trial

Background: Angioplasty recanalization is recommended as the first-line interventional treatment for Budd-Chiari syndrome (BCS). Despite its long-term patency is particularly significant for being indicative of disease resolution and correlating to ensuing treatment and patient outcome, restenosis of angioplasty is rather frequent. We therefore designed the current randomized controlled trial to test whether routine stenting in angioplasty for BCS can improve patency and treatment efficacy with adequate safety. Methods: Consecutive BCS patients amenable to recanalization were randomly assigned to angioplasty alone (AP) or with routine stent placement (AP+SP). Primary endpoint was restenosis. Secondary endpoints included symptom recurrence, procedure-related complications, hepatocellular carcinoma (HCC), liver function, and survival. Findings: From July 2014 to September 2017, 88 were enrolled and assigned to AP group (n=45) and AP+SP group (n=43). During a median follow-up of 27 months, AP+SP group has significantly lower restenosis incidence than AP group (4% vs. 40% at 3 years, log-rank p