TIPS versus drug therapy in preventing variceal rebleeding in advanced cirrhosis: a randomized controlled trial.
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).
Escorsell
Angels
A
Hepatic Hemodynamic Laboratory, Liver Unit, Hospital Clínic, IDIBAPS, Barcelona, Spain.
Bañares
Rafael
R
García-Pagán
Juan Carlos
JC
Gilabert
Rosa
R
Moitinho
Eduardo
E
Piqueras
Belén
B
Bru
Concepció
C
Echenagusia
Antonio
A
Granados
Alicia
A
Bosch
Jaume
J
D000319:Adrenergic beta-Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D017048:Health Care Costs; D006470:Hemorrhage / Q000209:etiology* / Q000517:prevention & control*; D006501:Hepatic Encephalopathy / Q000209:etiology; D006801:Humans; D007548:Isosorbide Dinitrate / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*; D008099:Liver / Q000503:physiopathology; D008103:Liver Cirrhosis / Q000150:complications* / Q000401:mortality / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D019168:Portasystemic Shunt, Transjugular Intrahepatic / Q000009:adverse effects; D011433:Propranolol / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D019233:Retreatment; D055502:Secondary Prevention; D014648:Varicose Veins / Q000150:complications* / Q000209:etiology*
D000319:Adrenergic beta-Antagonists; D011433:Propranolol; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate