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[Clinical trial of the month. The CIBIS-II study]
1Service de Cardiologie, Université de Liège.
Insights
Bisoprolol significantly reduced all-cause mortality in patients with severe heart failure. This large trial demonstrated a clear survival benefit for bisoprolol in heart failure management.
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacology
Background:
- Heart failure affects millions globally, necessitating effective treatments.
- Beta-blockers are a cornerstone of heart failure therapy.
- Optimizing beta-blocker use in severe heart failure requires robust evidence.
Purpose of the Study:
- To evaluate the efficacy of bisoprolol in reducing mortality in patients with severe heart failure.
- To assess the impact of bisoprolol on all-cause mortality and sudden death.
- To determine if treatment effects vary by heart failure severity or etiology.
Main Methods:
- A multicenter, double-blind, randomized, placebo-controlled trial (CIBIS-II).
- Enrolled 2,647 patients with Class III-IV heart failure and ejection fraction ≤35%.
- Patients received standard therapy plus either placebo or bisoprolol (titrated up to 10 mg/day).
Main Results:
- All-cause mortality was significantly lower in the bisoprolol group (11.8%) compared to placebo (17.3%; p < 0.0001).
- The study was stopped early due to a significant mortality benefit observed in the bisoprolol arm.
- Fewer sudden deaths occurred in patients treated with bisoprolol.
Conclusions:
- Bisoprolol provides a significant mortality benefit in patients with severe heart failure.
- The benefits of bisoprolol are consistent across different severities and causes of heart failure.
- Bisoprolol is a valuable therapeutic option for managing advanced heart failure.
Abstract:
CIBIS-II was a multicentre bouble-blind randomized placebo-controlled trial which enrolled 2,647 class III-IV heart failure patients, with a left ventricular ejection fraction < or = 35%, receiving standard therapy with a diuretic and ACEI and randomly assigned to placebo (n = 1,320) or to bisoprolol (n = 1,327) 1.25 mg/day, progressively increased to a maximum of 10 mg/day. Mean follow-up was 1.3 years. The study was stopped early because the 2nd interim analysis showed a significant mortality benefit in the treated group. All cause mortality was significantly lower in the bisoprolol group (156 [11.8%] vs 228 [17.3%]; p < 0.0001). Sudden deaths were fewer among patients on bisoprolol and treatment effects were independent on severity and aetiology of heart failure.