BACKGROUND & AIMS:Variceal bleeding increases morbidity and mortality among patients with noncirrhotic portal hypertension (NCPH). Blockers of β-adrenergic receptor signaling and endoscopic variceal ligation (EVL) have been used to prevent recurrence of bleeding, based on data from cirrhotic patients. We compared the efficacy and safety of the β-blocker propranolol with that of EVL in preventing the recurrence of variceal bleeding in patients with NCPH. METHODS:Consecutive patients with NCPH with a history of variceal bleeding in the past 6 weeks were assigned randomly to groups treated every 3 weeks with EVL (n = 51) or propranolol (until they had a resting heart rate of 55 beats per minute or to a maximum of 320 mg/day; n = 50). Primary end points were recurrence of variceal bleeding or death. Secondary end points were complications of EVL in patients given EVL, variceal eradication after EVL, variceal recurrence after EVL, or a decrease in variceal grade in patients given propranolol. RESULTS: After a median follow-up period of 23 months, rates of recurrence of bleeding were similar between the groups (EVL, 23.5%; propranolol, 18%; P = .625). The actuarial probability of remaining free of bleeding recurrence was similar between the groups. No deaths occurred in either group. Of the patients given propranolol, 47% had a decrease in the grade of varices and none experienced bleeding. Adverse events were minor and comparable between groups (EVL, 12%; propranolol, 18%; P = .635). CONCLUSIONS:EVL was not more effective than the β-blocker propranolol for the secondary prophylaxis of variceal bleeding in patients with NCPH.
RCT Entities:
BACKGROUND & AIMS: Variceal bleeding increases morbidity and mortality among patients with noncirrhotic portal hypertension (NCPH). Blockers of β-adrenergic receptor signaling and endoscopic variceal ligation (EVL) have been used to prevent recurrence of bleeding, based on data from cirrhotic patients. We compared the efficacy and safety of the β-blocker propranolol with that of EVL in preventing the recurrence of variceal bleeding in patients with NCPH. METHODS: Consecutive patients with NCPH with a history of variceal bleeding in the past 6 weeks were assigned randomly to groups treated every 3 weeks with EVL (n = 51) or propranolol (until they had a resting heart rate of 55 beats per minute or to a maximum of 320 mg/day; n = 50). Primary end points were recurrence of variceal bleeding or death. Secondary end points were complications of EVL in patients given EVL, variceal eradication after EVL, variceal recurrence after EVL, or a decrease in variceal grade in patients given propranolol. RESULTS: After a median follow-up period of 23 months, rates of recurrence of bleeding were similar between the groups (EVL, 23.5%; propranolol, 18%; P = .625). The actuarial probability of remaining free of bleeding recurrence was similar between the groups. No deaths occurred in either group. Of the patients given propranolol, 47% had a decrease in the grade of varices and none experienced bleeding. Adverse events were minor and comparable between groups (EVL, 12%; propranolol, 18%; P = .635). CONCLUSIONS:EVL was not more effective than the β-blocker propranolol for the secondary prophylaxis of variceal bleeding in patients with NCPH.
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