The BEAUTIFUL trial was initiated in December 2004, under the guidance of an independent Executive Committee with the first patient being enrolled in early 2005. 10917 CAD patients with LVD, were recruited in 781 centres in 33 countries across 4 continents. The mean heart rate in these patients was 71 bpm and half of the patients had a heart rate more than 70 bpm. The results of the BEAUTIFUL study have shown that these patients with heart rate > 70 bpm are more likely to die or suffer from another cardiovascular event. The increase in risk is 34% for cardiovascular death, 46% for myocardial infarction, 56% for heart failure and 38% for coronary revascularisation.
In the overall study population treatment with ivabradine did not result in a significant reduction of the primary composite end point (Cardiovascular death, admission to hospital for acute MI and admission to hospital for heart failure). However in patients with baseline heart rate more than 70 bpm, ivabradine significantly reduced the risk of hospitalisation for fatal and non-fatal myocardial infarction by 36% (p=0.001) and the risk of coronary revascularisation by 30% (p=0.016).
What is important to note is that most of these patients were already receiving the guidelines-recommended cardiovascular therapy: antiplatelet agents (94%), angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (91%),