1 / 8

Purpose

BEAUT I f UL : morBidity -mortality EvAlUaTion of the I f inhibitor ivabradine in patients with coronary disease and left ventricULar dysfunction. Purpose

glynis
Download Presentation

Purpose

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. BEAUTIfUL: morBidity-mortality EvAlUaTion of the If inhibitor ivabradine in patients with coronary disease and left ventricULar dysfunction Purpose To assess whether adding ivabradine to standard treatment in order to lower heart rate can reduce cardiovascular dearth and morbidity in patients with coronary artery disease (CAD) and left-ventricular (LV) systolic dysfunction. Fox et al. Lancet 2008;372:807–816.

  2. BEAUTIfUL:TRIAL DESIGN Design Randomized, double-blind, placebo-controlled, parallel-group, multicenter, multinational trial. Patients 12,473 patients who were aged ≥55 years old and who had CAD, LV ejection fraction of <40%, and end-diastolic short-axis internal dimension of >56 mm. Patients from 781 centers in 33 countries were assessed, and 10,917 were randomized. Exclusion criteria included myocardial infarction or coronary revascularization in the previous 6 months, or stroke or cerebral transient ischemic attack in the previous 3 months. Follow-up and primary endpoint Patients underwent follow-up visits at 2 weeks, and 1, 3 and 6 months, and every 6 months thereafter for a median of 19 months. The primary endpoint was a composite of cardiovascular death, acute myocardial infarction admission, and new-onset or worsening heart failure admission. Fox et al. Lancet 2008;372:807–816.

  3. BEAUTIfUL:TRIAL DESIGN Treatment Run-in was a period of 14 days without study treatment. Patients were then randomized to receive ivabradine 5 mg twice daily or matching placebo.After 2 weeks, patients with a resting heart rate of ≥60 bpm received an increased dose of 7.5 mg twice daily. Patients with a resting heart rate of <50 bpm or with signs or symptoms of bradycardia received a reduced dose of 5 mg twice daily if they had been receiving 7.5 mg twice daily, or were discontinued if they had been receiving 5 mg twice daily.Appropriate conventional cardiovascular medical treatment continued throughout study. Beta-blockers were taken by 87% of patients from both treatment groups. Fox et al. Lancet 2008;372:807–816.

  4. BEAUTIfUL: Baseline Characteristics Ivabradine Placebo All patients (n=8576) (n=8502) (n=8502) Mean age (years) 65.3 65.0 65.2 Male (%) 83 83 83 History of hypertension (%) 71 71 71 History of diabetes (years) 37 37 37 Previous myocardial infarction (%) 88 88 89 Heart rate (bpm) 71.6 71.5 71.6 128.0 128.1 127.9 Systolic blood pressure (mm Hg) 77.4 77.4 77.5 Diastolic blood pressure (mm Hg) 32.4 32.4 32.3 LV ejection fraction (%) Fox et al. Lancet 2008;372:807–816.

  5. BEAUTIfUL: RESULTS At 12 months, ivabradine lowered resting heart rates versus placebo over baseline (average reduction, 6.0 bpm), including in patients with baseline heart rate of ≥70 bpm (average reduction, 7.9 bpm). Primary endpoint There was no significant difference between the ivabradine and placebo groups in the occurrence of the primary endpoint (15.4% vs. 15.3%, respectively; hazard ratio [HR], 1.00; p=0.94). Other results There was no significant difference in the number of patients who experienced serious adverse events between ivabradine and placebo patients (22.5% vs. 22.8%, respectively; p=0.70). In patients with a baseline heart rate of ≥70 bpm, ivabradine had no impact on the primary composite outcome (HR, 0.91; p=0.17), cardiovascular death, or admission for new-onset or worsening heart failure. However, in comparison with placebo, ivabradine significantly reduced fatal and non-fatal myocardial infarction admissions (HR, 0.64; p=0.001) and coronary revascularization rates (HR, 0.70; p=0.016). Fox et al. Lancet 2008;372:807–816.

  6. 35 30 Proportionwithcompositeprimaryendpoint(%) 25 20 p=0.94 15 10 Placebo Ivabradine 5 0 0 1.5 2.0 0.5 1.0 Years BEAUTIfULRESULTSKaplan-Meier time-to-event plot for composite primary endpoint Fox et al. Lancet 2008;372:807–816.

  7. 10 Proportionadmitted tohospital withmyocardialinfarction(%) p=0.001 5 Placebo 0 0 0.5 1.0 1.5 2.0 Years BEAUTIfUL:Kaplan-Meier time-to-event plot for admission to hospital for acute myocardial infarction in patients with baseline heart rate of ≥70 bpm Ivabradine Fox et al. Lancet 2008;372:807–816.

  8. BEAUTIfUL: SUMMARY In patients with coronary artery disease and left-ventricular systolic dysfunction: • Ivabradine reduced heart rates by a placebo-corrected 6 bpm at 12 months • In subgroup analysis, ivabradine did not affect the primary composite endpoint of cardiovascular death, admission to hospital for acute myocardial infarction, or admission to hospital for new-onset or worsening heart failure • Consequently, ivabradine can be given safely, even in conjunction with beta-blockers • Ivabradine, combined with beta blockade, is safe and improves coronary artery disease outcomes in those with a baseline heart rate of ≥70 bpm Fox et al. Lancet 2008;372:807–816.

More Related