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Long-term Outcomes with Carvedilol versus Propranolol in Patients with Index Variceal Bleed: 6-year Follow-up Study
Sanchit Sharma1, Samagra Agarwal1, Deepak Gunjan1
1Department of Gastroenterology and Human Nutrition Unit, All India Institute of Medical Sciences, New Delhi, 110029, India.
Insights
Carvedilol and propranolol show similar long-term outcomes for preventing rebleeding in patients with acute variceal bleed. However, carvedilol was associated with a lower incidence of ascites development.
Area of Science:
- Hepatology
- Gastroenterology
- Clinical Pharmacology
Background:
- Acute variceal bleed (AVB) is a serious complication of decompensated cirrhosis.
- Secondary prophylaxis is crucial to prevent rebleeding and improve survival.
- Limited comparative data exists for carvedilol versus propranolol in AVB secondary prophylaxis.
Purpose of the Study:
- To compare long-term clinical and safety outcomes of carvedilol and propranolol for secondary prophylaxis after AVB.
- To assess the impact on hepatic venous pressure gradient (HVPG) reduction.
- To evaluate rates of rebleeding, survival, and decompensation events.
Main Methods:
- Post-hoc analysis of an open-label randomized controlled trial.
- Comparison of carvedilol (n=25) and propranolol (n=23) in patients following AVB.
- Long-term follow-up (6 years) assessing rebleed, survival, decompensation, and safety outcomes using competing risks and Kaplan-Meier analyses.
Main Results:
- Carvedilol showed a significantly higher HVPG response rate (72% vs. 47.8%, p=0.047).
- Comparable rates of rebleeding (1-year: 16.0% vs. 8.9%; 3-year: 24.0% vs. 36.7%) and survival were observed.
- New/worsening ascites was less frequent with carvedilol (40% vs. 69.5%, p=0.04); other decompensations and adverse events were similar.
Conclusions:
- Carvedilol offers comparable long-term clinical, survival, and safety outcomes to propranolol after AVB.
- Carvedilol demonstrates a superior HVPG response.
- A notable exception is the reduced incidence of ascites in patients treated with carvedilol.
Aims And Background:
There is limited information on comparison of clinical outcomes with carvedilol for secondary prophylaxis following acute variceal bleed (AVB) when compared with propranolol. We report long-term clinical and safety outcomes of a randomised controlled trial comparing carvedilol with propranolol with respect to reduction in hepatic venous pressure gradient (HVPG) in patients after AVB.
Methods:
We conducted a post-hoc analysis of patients recruited in an open-label randomized controlled trial comparing carvedilol and propranolol following AVB, and estimated long-term rates of rebleed, survival, additional decompensation events and safety outcomes. Rebleed and other decompensations were compared using competing risks analysis, taking death as competing event, and survival was compared using Kaplan-Meier analysis.
Results:
Forty-eight patients (25 taking carvedilol; 23 propranolol) were followed up for 6 years from randomization. More number of patients on carvedilol had HVPG response when compared with those taking propranolol (72%- carvedilol versus 47.8% propranolol, p = 0.047). Comparable 1-year and 3-year rates of rebleed (16.0% and 24.0% for carvedilol versus 8.9% and 36.7% for propranolol; p = 0.457) and survival (94.7% and 89.0% for carvedilol versus 100.0% and 79.8% for propranolol; p = 0.76) were obtained. New/worsening ascites was more common in those receiving propranolol (69.5% vs 40%; p = 0.04). Other clinical decompensations and complications of liver disease occurred at comparable rates between two groups. Drug-related adverse-events were similar in both groups.
Conclusion:
Despite higher degree of HVPG response, long-term clinical, survival and safety outcomes in carvedilol are similar to those of propranolol in patients with decompensated cirrhosis after index variceal bleed with the exception of ascites that developed less frequently in patients with carvedilol.
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