Dr. Sydney Smith
Mr Kim Fox,
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 reportSmith, 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
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.
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