Background—In patients with chronic heart failure (CHF)， a β-blocker is generally added to a regimen containing an angiotensin-converting-enzyme (ACE) inhibitor. It is unknown whether β-blockade as initial therapy may be as useful.

Methods and Results—We randomized 1010 patients with mild to moderate CHF and left ventricular ejection fraction ≤35%， who were not receiving ACE inhibitor， β-blocker， or angiotensin receptor blocker therapy， to open-label monotherapy with either bisoprolol (target dose 10 mg QD; n＝505) or enalapril (target dose 10 mg BID; n＝505) for 6 months， followed by their combination for 6 to 24 months. The 2 strategies were blindly compared with regard to the combined primary end point of all-cause mortality or hospitalization and with regard to each of these end point components individually. Bisoprolol-first treatment was noninferior to enalapril-first treatment if the upper limit of the 95% confidence interval (CI) for the absolute between-group difference was < 5%， corresponding to a hazard ratio (HR) of 1.17. In the intention-to-treat sample， the primary end point occurred in 178 patients allocated to bisoprolol-first treatment versus 186 allocated to enalapril-first treatment (absolute difference －1.6%， 95% CI －7.6 to 4.4%， HR 0.94; 95% CI 0.77 to 1.16). In the per-protocol sample， 163 patients allocated to bisoprolol-first treatment had a primary end point， versus 165 allocated to enalapril-first treatment (absolute difference －0.7%， 95% CI －6.6 to 5.1%， HR 0.97; 95% CI 0.78 to 1.21). With bisoprolol-first treatment， 65 patients died， versus 73 with enalapril-first treatment (HR 0.88; 95% CI 0.63 to 1.22)， and 151 versus 157 patients were hospitalized (HR 0.95; 95% CI 0.76 to 1.19).

Conclusion—Although noninferiority of bisoprolol-first versus enalapril-first treatment was not proven in the per-protocol analysis， our results indicate that it may be as safe and efficacious to initiate treatment for CHF with bisoprolol as with enalapril.

相关幻灯：CIBIS III

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