Comparative study between nadolol and 5-isosorbide mononitrate vs. endoscopic band ligation plus sclerotherapy in the prevention of variceal rebleeding in cirrhotic patients: a randomized controlled trial.
BACKGROUND
After variceal bleeding, cirrhotic patients should receive secondary prophylaxis.


OBJECTIVE
To compare nadolol plus 5-isosorbide mononitrate (5-ISMN) with endoscopic band ligation. The end points were rebleeding, treatment failure and death.


METHODS
One hundred and nine cirrhotic patients with a recent variceal bleeding were randomized: nadolol plus 5-ISMN in 57 patients and endoscopic band ligation in 52 patients.


RESULTS
The mean follow-up was 17 and 19 months in nadolol plus 5-ISMN and endoscopic band ligation groups, respectively. No differences were observed between groups in upper rebleeding (47% vs. 46%), variceal rebleeding (40% vs. 36%), failure (32% vs. 22%), major complications (7% vs. 13.5%) and death (19% vs. 20%), respectively. The actuarial probability of remaining free of rebleeding, failure and deaths were similar in both groups. Time to rebleeding shows that endoscopic band ligation patients had an early rebleed, with a median of 0.5 month (95% CI: 0.0-4.2) compared with patients from nadolol plus 5-ISMN, 7.6 months (95% CI: 2.9-12.3, P < 0.013). Multivariate analysis indicated that outcome-specific predictive factor(s) for rebleeding was Child A vs. B + C (P < 0.01); for failure was Child A vs. B + C (P < 0.02); and for death ascites (P < 0.01) and rebleeding (P < 0.02).


CONCLUSIONS
This trial suggests no superiority of endoscopic band ligation over nadolol plus 5-ISMN mononitrate for the prevention of rebleeding in cirrhotic patients.
Romero
G
G
Liver Unit, Hospital de Gastroenterologia Prof. Bonorino Udaondo, Buenos Aires, Argentina.
Kravetz
D
D
Argonz
J
J
Vulcano
C
C
Suarez
A
A
Fassio
E
E
Dominguez
N
N
Bosco
A
A
Muñoz
A
A
Salgado
P
P
Terg
R
R
D016099:Endoscopy, Gastrointestinal; D004932:Esophageal and Gastric Varices / Q000188:drug therapy*; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000517:prevention & control*; D006801:Humans; D007548:Isosorbide Dinitrate / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008026:Ligation / Q000379:methods; D008103:Liver Cirrhosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009248:Nadolol / Q000627:therapeutic use*; D015911:Sclerotherapy / Q000379:methods; D055502:Secondary Prevention
D009248:Nadolol; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate