Journal of vascular and interventional radiology : JVIR · 2025
Early Endovascular Intervention in Combination with Medical Therapy versus Medical Therapy Alone in the Initial Management of Patients with Primary Budd-Chiari Syndrome: A Randomized Controlled Trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Biswas Sagnik, Swaroop Shekhar, Mehta Shubham, Aggarwal Arnav, Saxena Sarthak, Agarwal Samagra, Gunjan Deepak, Gamanagatti Shivanand, Shalimar
Аннотация
PURPOSE: To compare the clinical outcomes between standard medical therapy (SMT) and early endovascular intervention as the first step of management in primary Budd-Chiari syndrome (BCS).
MATERIALS AND METHODS: Symptomatic patients with primary BCS having either hepatic vein (HV) obstruction (Type II) or combined obstruction of HV and inferior vena cava (Type III) were enrolled. Twenty-three patients were randomized to receive SMT for 12 weeks, whereas 21 received early endovascular intervention with SMT. Primary outcome was complete response (CR) at 12 weeks: resolution of ascites, normalization of serum bilirubin, prevention of first episode of variceal bleeding or its recurrence, and absence of spontaneous bacterial peritonitis. Adverse events (AEs) were reported as per the Society of Interventional Radiology (SIR) guidelines.
RESULTS: Baseline characteristics were comparable. A significantly higher proportion of patients undergoing endovascular intervention (19/21, 90.5%) achieved CR at 12 weeks, compared with those who received SMT (4/23, 17.4%; P < .01). Endovascular interventions led to greater hepatic decongestion (mean reduction in liver stiffness measurement, -16.9 kPa [95% CI, -24.9 to -8.8]) than SMT (-2.0 [95% CI, -11.8 to 7.8]; P = .02) over 12 weeks. Three patients had Grade ≥3 AE after interventions (encephalopathy [2] and transjugular intrahepatic portosystemic shunt block [1]); however, the differences in AE between the 2 groups were not statistically significant. Three deaths occurred in the SMT group within 12 weeks compared with none in the intervention group (P = .234).
CONCLUSIONS: Early endovascular interventions result in higher rates of clinical response and hepatic decongestion than SMT alone in primary BCS.
MATERIALS AND METHODS: Symptomatic patients with primary BCS having either hepatic vein (HV) obstruction (Type II) or combined obstruction of HV and inferior vena cava (Type III) were enrolled. Twenty-three patients were randomized to receive SMT for 12 weeks, whereas 21 received early endovascular intervention with SMT. Primary outcome was complete response (CR) at 12 weeks: resolution of ascites, normalization of serum bilirubin, prevention of first episode of variceal bleeding or its recurrence, and absence of spontaneous bacterial peritonitis. Adverse events (AEs) were reported as per the Society of Interventional Radiology (SIR) guidelines.
RESULTS: Baseline characteristics were comparable. A significantly higher proportion of patients undergoing endovascular intervention (19/21, 90.5%) achieved CR at 12 weeks, compared with those who received SMT (4/23, 17.4%; P < .01). Endovascular interventions led to greater hepatic decongestion (mean reduction in liver stiffness measurement, -16.9 kPa [95% CI, -24.9 to -8.8]) than SMT (-2.0 [95% CI, -11.8 to 7.8]; P = .02) over 12 weeks. Three patients had Grade ≥3 AE after interventions (encephalopathy [2] and transjugular intrahepatic portosystemic shunt block [1]); however, the differences in AE between the 2 groups were not statistically significant. Three deaths occurred in the SMT group within 12 weeks compared with none in the intervention group (P = .234).
CONCLUSIONS: Early endovascular interventions result in higher rates of clinical response and hepatic decongestion than SMT alone in primary BCS.