Prevention of variceal rebleeding is mandatory in cirrhotic patients. We compared the efficacy, safety, and cost of transjugular intrahepatic
portosystemic shunt (
TIPS) versus pharmacologic
therapy in preventing variceal rebleeding in patients with advanced
cirrhosis. A total of 91 Child-Pugh class B/C cirrhotic patients surviving their first episode of variceal
bleeding were randomized to receive
TIPS (n = 47) or
drug therapy (
propranolol +
isosorbide-5-mononitrate) (n = 44) to prevent variceal rebleeding. Mean follow-up was 15 months. Rebleeding occurred in 6 (13%)
TIPS-treated patients versus 17 (39%)
drug-treated patients (P =.007). The 2-year rebleeding probability was 13% versus 49% (P =.01). A similar number of reinterventions were required in the 2 groups; these were mainly angioplasty +/- restenting in the
TIPS group (90 of 98) and endoscopic
therapy for rebleeding in the medical group (45 of 62) (not significant).
Encephalopathy was more frequent in
TIPS than in
drug-treated patients (38% vs. 14%, P =.007). Child-Pugh class improved more frequently in
drug-treated than in
TIPS-treated patients (72% vs. 45%; P =.04). The 2-year survival probability was identical (72%). The identified cost of
therapy was double for
TIPS-treated patients. In summary, medical
therapy was less effective than
TIPS in preventing rebleeding. However, it caused less
encephalopathy, identical survival, and more frequent improvement in Child-Pugh class with lower costs than
TIPS in high-risk cirrhotic patients. This suggests that
TIPS should not be used as a first-line treatment, but as a rescue for failures of medical/endoscopic treatments (first-option
therapies).