The role of propranolol in addition to endoscopic variceal ligation in the prevention of first variceal bleed has not been evaluated.
Dr Sarin and colleagues from India conducted a prospective randomized controlled trial comparing endoscopic variceal ligation with propranolol and endoscopic variceal ligation alone in the prevention of first variceal bleed among patients with high-risk varices.
The researchers randomly allocated 144 consecutive patients with high-risk varices to 2 groups.
Group 1 received endoscopic variceal ligation plus propranolol (n = 72) and group 2 underwent endoscopic variceal ligation alone (n = 72).
The research team undertook endoscopic variceal ligation at 2 week intervals until the varices were obliterated.
In the first group, the investigators administered incremental dosages of propranolol, sufficient to reduce heart rate to 55 beats/min or a 25% reduction from baseline and continued this after the obliteration of the varices.
The endpoints of the study were bleeding and death.
The researchers reported that the 2 groups of patients had comparable baseline characteristics.
|At follow-up, 4 patients in the combination group and 11 in the single treatment group had recurrence of varices|
|American Journal of Gastroenterology|
The follow-up time for group 1 was a mean of 13 months and 11 months for group 2.
The team noted that the proportion of cirrhotic and noncirrhotic portal hypertension patients in group 1 was 89% and 11%, respectively, and 88% and 13% in group 2.
The frequency of Child's A was 15 in group 1 versus 18 in group 2, Child’s B was 38 versus 35, and Child’s C compared equally with 19 versus 19.
The investigative team observed that the mean daily propranolol dose achieved in groups 1 was 96mg.
In total, the researchers found that 11 patients had bleeds, with 5 in group 1 and 6 in group 2.
The investigators also reported that all patients bled before the obliteration of varices, the actuarial probability of first bleed at 20 months was 7% in group 1 and 11% in group 2.
The team noted that 6 patients died in the combination group and 8 in endoscopic variceal ligation group.
All deaths in group 1 were reported to be nonbleed-related causes, while in group 2 the deaths were bleed related, with an 8% versus 15% probability of death at 20, respectively.
The probability of bleed-related death was comparable between the groups.
The researchers found that at the end of follow-up, 4 patients in group 1 and 11 in group 2 had recurrence of varices.
In addition, the research team noted side effects on propranolol in 22% patients, and in 8% it had to be stopped, but there were no serious complications of endoscopic variceal ligation.
Dr Sarin’s team concluded, “Both endoscopic variceal ligation plus propranolol and endoscopic variceal ligation alone are effective in primary prophylaxis of bleed from high-risk varices.”
“The addition of propranolol does not decrease the probability of first bleed or death in patients on endoscopic variceal ligation.”
“However, the recurrence of varices is lower if propranolol is added to endoscopic variceal ligation.”