BEAUTIFUL Principal Results
The BEAUTIFUL study demonstrated that Ivabradine (Procoralan*) reduces myocardial infarction (fatal or nonfatal) (Figure 1) and revascularization in coronary patients with elevated heart rate. These results were presented at the ESC Munich and published in The Lancet.
Figure 1. Ivabradine reduces the risk of fatal and nonfatal myocardial infarction in patients with HR≥ 70 bpm.
A total of 10 917 coronary patients with left ventricular dysfunction were recruited in 781 centers in 33 countries, and were followed up for a median duration of 19 months and a maximum duration of 35 months. Although the primary composite end point of the study did not reach statistical significance, the results have provided answers to some very important questions in the management of CAD patients.
The BEAUTIFUL study is the first prospective study to demonstrate that coronary patients with a baseline heart rate ≥70 bpm have a significantly higher risk of cardiovascular events, (Figure 2) independently of other comorbidities or treatments.
Figure 2. Heart rate above 70 bpm is associated with higher risk of myocardial infarction.
BEAUTIFUL has also shown that in these coronary patients with a heart rate more than 70 bpm, ivabradine significantly reduces the risk of
• Coronary events by 22% (P=0.023)
• Fatal and nonfatal myocardial infarction by 36% (P=0.001)
• Coronary revascularization by 30% (P=0.016).
It is important to note that Ivabradine is the first antianginal treatment demonstrated to reduce the risk of myocardial infarction and revascularization in stable coronary patients, even when they were receiving optimal preventive therapy.
These results can have huge clinical implications. Heart rate should now guide optimal preventive therapy in coronary patients. More than half of coronary patients have a HR ≥ 70 bpm, and these patients could benefit from a reduction of coronary events with ivabradine.
References :
1. Fox K, Ford I, Steg PG, Tendera M, Robertson M, Ferrari R; BEAUTIFUL Investigators. Heart rate as a prognostic risk factor in patients with coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a subgroup analysis of a randomised controlled trial. Lancet. 2008;372:817-822.
2. Fox K, Ford I, Steg PG, Tendera M, Ferrari R; BEAUTIFUL Investigators. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372:807-816.