In order to bring you the best possible user experience, this site uses Javascript. If you are seeing this message, it is likely that the Javascript option in your browser is disabled. For optimal viewing of this site, please ensure that Javascript is enabled for your browser.
Did you know that your browser is out of date? To get the best experience using our website we recommend that you upgrade to a newer version. Learn more.

We use cookies to optimise the design of this website and make continuous improvement. By continuing your visit, you consent to the use of cookies. Learn more

The BEAUTIFUL study: efficacy of ivabradine in reduction of cardiovascular events among patients with stable coronary artery disease and left ventricular dysfunction.

Hot Line I

The landmark BEAUTIFUL study shows that pure heart rate reduction with ivabradine reduces coronary events by 22% in patients with coronary artery disease and  associated left ventricular systolic dysfunction with heart rate ≥ 70 bpm.

Presenter report:

Fox, Kim (United Kingdom)

Heart rate is increasingly being considered as a modifiable cardiovascular risk factor. However, no prospective study has documented a threshold of heart rate beyond which the risk is increased or to quantify the preventive benefits of heart rate reduction per se. The BEAUTIFUL trial was designed to evaluate if pure heart rate reduction with the If current inhibitor ivabradine improves cardiovascular outcomes in coronary patients with left ventricular (LV) systolic dysfunction.

This randomised, double-blind, placebo-controlled, parallel-group trial recruited 10,917 CAD patients with LV ejection fraction <40%. Patients received ivabradine 5 mg, with the intention of uptitrating to 7.5 mg twice daily (n=5479) or placebo (n=5438) on top of recommended guidelines medication. Most patients were receiving beta-blockade (87%).

Although the primary composite endpoint (cardiovascular death, hospitalisation for acute myocardial infarction, or hospitalisation for new onset or worsening heart failure) was not reached, the BEAUTIFUL trial is already rich in learning:

- It has shown for the first time in a prospective manner that coronary patients with a baseline heart rate ≥70 bpm despite receiving optimal preventive therapy have a significantly higher risk of cardiovascular mortality (34%, p=0.0041), hospitalisation for heart failure (53%, p<0.0001), hospitalisation for actue myocardial infarction (46%, p=0.0066) and coronary revascularisation (38%, p=0.037).

- Ivabradine was beneficial in these patients with heart rate  ≥70 bpm on CAD-related endpoints: hospitalisation for fatal and non-fatal myocardial infarction (36%, p=0.001) and coronary revascularisation (30%, p=0.016).

The BEAUTIFUL trial therefore highlights the importance of routinely measuring heart rate in coronary patients and to consider treating it when the heart rate is above 70 bpm.

Discussant report

Smith, Sidney (United States of America)


Patients receiving ivabradine therapy, the majority of which were on optimal medical therapy, had no benefit on the primary composite end-point of cardiovascular death, hospitalization for acute myocardial infarction, or hospitalization for new onset or worsening heart failure.

This lack of benefit on the primary composite endpoint was true for the entire group of patients with heart rate >60 bpm and also for the prespecified subgroup with heart rate >70bpm. Among patients in the prespecified subgroup with heart rate >70 there was no difference in secondary endpoints of 1) mortality (all cause death, CV death, CAD and HF death), and 2) heart failure endpoints (hospitalization for HF, CV death or hospitalization for HF). However, there was reduction in coronary endpoints (hospitalization for MI, hospitalization for MI or unstable angina and coronary revascularization).

The observation of benefit from ivabradine therapy on coronary endpoints in the prespecified subgroup with HR> 70 bpm does not lead to definite conclusions about efficacy but is hypothesis-generating.

Further studies are indicated to determine the potential benefit and possible mechanisms by which patients with CAD and resting HR > 70 bpm might have improved outcomes if treated by ivabradine therapy in addition to standard guidelines-recommended treatments.

View the Official Press Release - BEAUTIFUL Results - Hotline 1




Hot Line Update I

Notes to editor

This congress report accompanies a presentation given at the ESC Congress 2008. Written by the author himself/herself, this report does not necessarily reflect the opinion of the European Society of Cardiology.

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.