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COMPARISION OF 1 DAY VERSUS 5 DAYS OF OCTREOTIDE INFUSION ALONG WITH ENDOSCOPIC THERAPY IN PREVENTING EARLY REBLEEDING AND MORTALITY FROM ESOPHAGEAL VARICES: A NATIONWIDE, MULTICENTER, NON-INFERIORITY, RANDOMIZED CONTROL TRIAL - PRELIMINARY RESULT
Date
May 19, 2024
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Introduction
Variceal bleeding represents a critical complication with high mortality. Baveno VII recommends vasoactive agents to achieve hemostasis and prevent rebleeding. However, an optimal shorter time frame limit for vasoactive drug therapy remains unclear, and no specific duration is mentioned. The aim of this study is to compare the efficacy of 1 day versus 5 days of octreotide infusion along with endoscopic therapy in preventing early rebleeding at 5 days, rebleeding at 6 weeks, and all-cause mortality at 6 weeks.
Method
This was a nationwide, multicenter, non-inferiority, randomized control trial including 151 patients with acute variceal bleeding who underwent endoscopic therapy; they were assigned randomly to 1 day (n=76) and 5 days (n=75) of continuous octreotide infusion (50 μg/hr). Early rebleeding (5-day treatment failure of index bleed according to Baveno VII consensus guideline), transfusion requirement, and mortality were assessed.
Results
The study had predominantly male patients, with an average age of 55 years. The 5-day rebleeding (1.3% vs 1.3%, p = 0.99), 6-week rebleeding (9.2% vs 9.3%, p = 0.97), and 6-week all-cause mortality (7.8% vs 5.3%, p = 0.74) were similar in both groups. Patients in the 1-day group demonstrated fewer transfusion requirements, a significantly shorter time to initiate a solid diet, and a significantly reduced length of stay. Carvedilol was associated with higher all-cause mortality compared to propranolol (12.1% vs 1.9%, p = 0.031). The effect of proton pump inhibitor use after endoscopy was not associated with a decreased risk of variceal bleeding or adverse events in such patients. Hepatic encephalopathy grade 3/4 and no beta-blocker therapy at discharge were associated with increased 6-week all-cause mortality.
Conclusions
The 1-day regimen of octreotide infusion, following successful endoscopic therapy for variceal bleeding, demonstrates no inferiority compared to the standard 5-day regimen in preventing early rebleeding, 6-week rebleeding, and 6-week all-cause mortality.
Variceal bleeding represents a critical complication with high mortality. Baveno VII recommends vasoactive agents to achieve hemostasis and prevent rebleeding. However, an optimal shorter time frame limit for vasoactive drug therapy remains unclear, and no specific duration is mentioned. The aim of this study is to compare the efficacy of 1 day versus 5 days of octreotide infusion along with endoscopic therapy in preventing early rebleeding at 5 days, rebleeding at 6 weeks, and all-cause mortality at 6 weeks.
Method
This was a nationwide, multicenter, non-inferiority, randomized control trial including 151 patients with acute variceal bleeding who underwent endoscopic therapy; they were assigned randomly to 1 day (n=76) and 5 days (n=75) of continuous octreotide infusion (50 μg/hr). Early rebleeding (5-day treatment failure of index bleed according to Baveno VII consensus guideline), transfusion requirement, and mortality were assessed.
Results
The study had predominantly male patients, with an average age of 55 years. The 5-day rebleeding (1.3% vs 1.3%, p = 0.99), 6-week rebleeding (9.2% vs 9.3%, p = 0.97), and 6-week all-cause mortality (7.8% vs 5.3%, p = 0.74) were similar in both groups. Patients in the 1-day group demonstrated fewer transfusion requirements, a significantly shorter time to initiate a solid diet, and a significantly reduced length of stay. Carvedilol was associated with higher all-cause mortality compared to propranolol (12.1% vs 1.9%, p = 0.031). The effect of proton pump inhibitor use after endoscopy was not associated with a decreased risk of variceal bleeding or adverse events in such patients. Hepatic encephalopathy grade 3/4 and no beta-blocker therapy at discharge were associated with increased 6-week all-cause mortality.
Conclusions
The 1-day regimen of octreotide infusion, following successful endoscopic therapy for variceal bleeding, demonstrates no inferiority compared to the standard 5-day regimen in preventing early rebleeding, 6-week rebleeding, and 6-week all-cause mortality.
Table 1 Baseline Characteristics and Clinical Outcomes
Table 2 Multivariable Analysis for Predictors of 6-week rebleed and 6-week all-cause mortality
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