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Addition of Carvedilol to Gastric Variceal Obturation Does Not Decrease Recurrence of Gastric Variceal Bleeding in
Wen-Chi Chen1, I-Fang Hsin2, Ping-Hsien Chen2
1Division of Gastroenterology and Hepatology, Department of Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; School of Medicine, National Yang-Ming University, Taipei, Taiwan.
Insights
Adding carvedilol to gastric variceal obturation (GVO) did not reduce gastric variceal bleeding (GVB) recurrence in cirrhosis patients. However, it decreased overall upper gastrointestinal bleeding (UGIB) but increased adverse events.
Area of Science:
- Hepatology
- Gastroenterology
- Clinical Trials
Background:
- Gastric variceal bleeding (GVB) has a high recurrence rate after initial treatment with gastric variceal obturation (GVO).
- Secondary prophylaxis strategies are crucial for managing GVB recurrence in patients with cirrhosis.
Purpose of the Study:
- To evaluate the efficacy of carvedilol combined with GVO for secondary prevention of GVB.
- To compare recurrent GVB, upper gastrointestinal bleeding (UGIB), adverse events, and survival rates between patients receiving repeated GVO and those receiving repeated GVO plus carvedilol.
Main Methods:
- A multicenter, randomized controlled trial involving 121 patients with cirrhosis and GVB.
- Patients received either repeated GVO or repeated GVO plus carvedilol.
- Outcomes assessed included recurrent GVB, UGIB, adverse events, and survival.
Main Results:
- GVB recurrence rates were 34% with repeated GVO and 23% with GVO plus carvedilol (P = .18).
- Recurrent UGIB occurred in 48% with repeated GVO versus 28% with GVO plus carvedilol (P = .03), with carvedilol associated with reduced UGIB risk.
- Adverse events were significantly higher in the carvedilol group (53%) compared to the GVO-only group (15%) (P < .001).
Conclusions:
- Carvedilol addition to GVO did not significantly decrease GVB recurrence but did reduce UGIB recurrence in patients with cirrhosis.
- The combination therapy led to a significant increase in adverse events.
- No significant difference in mean survival times was observed between the groups.
Background & Aims:
Gastric variceal bleeding (GVB) frequently recurs after hemostasis by gastric variceal obturation (GVO). We performed a multicenter, randomized controlled trial to determine the efficacy of carvedilol plus GVO in secondary prophylaxis of GVB.
Methods:
We performed a prospective study of 121 patients with cirrhosis (ages 20-80 years) with GVB proven by endoscopy within 24 hours of bleeding and stable hemodynamics for at least 3 days after initial GVO. Patients were randomly assigned into a group that underwent repeated GVO (n = 61) or a group received repeated GVO plus carvedilol (n = 60). Recurrent GVB, upper gastrointestinal bleeding (UGIB), adverse events, and survival were compared between the groups.
Results:
GVB recurred in 21 patients (34%) in the group that received repeated GVO and 14 patients (23%) in the group that received repeated GVO plus carvedilol (P = .18). Ascites (relative risk [RR], 2.69; 95% CI, 1.33-5.48; P = .006) and hepatoma (RR, 2.10; 95% CI, 1.03-4.28; P = .04) were associated with recurrent GVB. Twenty-nine patients (48%) in the group that received repeated GVO and 17 patients (28%) in the group that received repeated GVO plus carvedilol had recurrent UGIB (P = .03). Carvedilol (RR, 0.44; 95% CI, 0.24-0.80; P = .007) was associated with reduced risk of UGIB recurrence. Ascites (RR, 3.02; 95% CI, 1.59-5.73; P = .001) and hepatoma (RR, 2.07; 95% CI, 1.10-3.88; P = .02) were associated with recurrent UGIB. A higher proportion of patients in the group that received repeated GVO plus carvedilol (53%) had adverse events than the group that received repeated GVO (15%) (P < .001). Mean survival times were 21 ± 18 months in the group that received repeated GVO vs 25 ± 20 months in the group that received repeated GVO plus carvedilol (P = .30).
Conclusion:
In a randomized controlled trial, we found that addition of carvedilol to GVO did not decrease recurrence of GVB in patients with cirrhosis but was associated with decreased recurrence of UGIB. However, carvedilol plus GVO produced significantly more adverse events. Mean survival times did not differ significantly between groups. ClinicalTrials.gov no: NCT02504723.
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