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BEAUTIFUL
Morbidity-mortality Evaluation of the If inhibitor ivabradine in patients with coronary disease and left ventricular dysfunction
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Author(s) |
(a) Fox K, Ferrari R, Tendera M, Steg PG, Ford I
(b) BEAUTIFUL Study Group
(c) Fox K, Ford I, Steg PG, Tendera M, Ferrari R |
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Title(s) |
(a) Rationale and design of a randomized, double-blind, placebo-controlled trial of ivabradine in patients with stable coronary artery disease and left ventricular systolic dysfunction: the morBidity-mortality EvAlUaTion of the If inhibitor ivabradine in patients with coronary disease and left ventricULar dysfunction (BEAUTIFUL) Study
(b) The BEAUTIFUL study: randomized trial of ivabradine in patients with stable coronary artery disease and left ventricular systolic dysfunction – baseline characteristics of the study population
(c) Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial |
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Reference(s) |
(a) Am Heart J 2006;152:860–6
(b) Cardiology 2008;110:271–82
(c) Lancet 2008;372:807–16
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Disease |
Coronary artery disease, left ventricular dysfunction |
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Purpose |
To compare the effect of ivabradine vs placebo on cardiovascular events in patients with stable coronary artery disease and left ventricular dysfunction |
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Study design |
Randomised, double-blind, placebo-controlled, parallel-group
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Follow-up |
Median 19 months
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Patients |
10,917 patients (5479 ivabradine, 5438 placebo), mean age 65 years, with documented coronary artery disease, resting heart rate ≥ 60 beats/min, left ventricular ejection fraction < 40% and left ventricular dilatation > 56 mm |
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Treatment regimen |
Ivabradine, 5 mg bid for 2 weeks, then 7.5 mg bid if heart rate still ≥ 60 beats/min, or placebo |
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Concomitant therapy |
Optimal cardiovascular treatment including beta-blockers, statins, ACE inhibitors/angiotensin-receptor blockers and antiplatelets |
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Results |
The primary composite endpoint of cardiovascular death, admission to hospital for MI or admission to hospital for new onset or worsening heart failure occurred in 844 patients in the ivabradine group and 832 patients in the placebo group (15.4% vs 15.3%, hazard ratio 1.0, 95% CI 0.91–1.10; p = 0.94) |
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Comments |
Data from a subgroup analysis assessing heart rate as a prognostic risk factor in patients from the BEAUTIFUL trial have been published in Lancet 2008;372:817–21. Data from a subgroup analysis of patients whose limiting symptom at baseline was angina pectoris have been published in Eur Heart J 2009;30:2337–45 |
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