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S ystolic H eart failure treatment with the I f inhibitor ivabradine T rial

S ystolic H eart failure treatment with the I f inhibitor ivabradine T rial. Effects of selective heart rate reduction with ivabradine on left ventricular remodelling and function: results from the SHIFT echocardiography substudy. www.shift-study.com.

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S ystolic H eart failure treatment with the I f inhibitor ivabradine T rial

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  1. Systolic Heart failure treatment withthe Ifinhibitor ivabradine Trial Effects of selective heart rate reduction with ivabradine on left ventricular remodelling and function: results from the SHIFT echocardiography substudy www.shift-study.com Tardif JC, O'Meara E, Komajda M, et al. Eur Heart J. 2011;32(20):2507-15

  2. Background • Cardiac remodeling is central to the pathophysiology of heart failure (HF) and is a prognostic factor in patients with HF • Left ventricular (LV) enlargement and reduced ejection fraction are powerful predictors of outcomes in heart failure • Therapeutic effects of drugs and devices on LV remodeling are associated with their longer-term effects on mortality www.shift-study.com Tardif JC, O'Meara E, Komajda M, et al. Eur Heart J. 2011;32(20):2507-15

  3. Objective of the pre-specified echocardiography substudy • To evaluate the effects of the If inhibitor ivabradine on LV remodeling and function: • Primary endpoint: the change in the LV end-systolic volume index (LVESVI) from baseline to 8 months • Secondary endpoints: changes during the same interval in • LV end-diastolic volume index (LVEDVI) • LV end-systolic, end-diastolic volumes (LVESV, LVEDV) • LV ejection fraction (LVEF) www.shift-study.com Tardif JC, O'Meara E, Komajda M, et al. Eur Heart J. 2011;32(20):2507-15

  4. Sub-study population 611 patients included from 89 centers in 21 countries 307 patients Placebo 304 patients Ivabradine Excluded (N=104) Excluded (N=96) 52: Poor quality of echo recording 19: No baseline and/or 8-month recording 8: Non-matching biplane or 4-chamber views 13: Withdrawn due to death 4: Consent withdrawn 52: Poor quality of echo recording 15: No baseline and/or 8- month recording 1: Non-matching biplane or 4-chamber views 23: Withdrawn due to death 13: Consent withdrawn 208 patients Ivabradine 203 patients Placebo Median follow-up after 8-month echocardiogram: 16.1 months www.shift-study.com Tardif JC, O'Meara E, Komajda M, et al. Eur Heart J. 2011;32(20):2507-15

  5. Baseline characteristics www.shift-study.com Tardif JC, O'Meara E, Komajda M, et al. Eur Heart J. 2011;32(20):2507-15

  6. Baseline background treatment www.shift-study.com Tardif JC, O'Meara E, Komajda M, et al. Eur Heart J. 2011;32(20):2507-15

  7. LV end-systolic volume index and outcome in the placebo group Patients with primary composite endpoint, % HR 1.62, p=0.04 60 LVESVI > 59 mL/m2 40 LVESVI < 59 mL/m2 20 www.shift-study.com Tardif JC, O'Meara E, Komajda M, et al. Eur Heart J. 2011;32(20):2507-15

  8. Primaryendpoint: change in LVESVIfrombaseline to 8 months Left ventricular end-systolic volume index ∆ -5.8,P<0.001 75 70 D- 7.0 ± 16.3 D - 0.9 ± 17.1 65 mL/m2 60 63.6 ±30.1 65.2±29.1 62.8 ±28.7 58.2±28.3 55 50 0 Baseline 8 months Baseline 8 months Ivabradine (n=208) Placebo (n=203) www.shift-study.com Tardif JC, O'Meara E, Komajda M, et al. Eur Heart J. 2011;32(20):2507-15

  9. D-7.9 ± 18.9 D -1.8 ± 19.0 Secondaryendpoint: change in LVEDVI frombaseline to 8 months Left ventricular end-diastolic volume index ∆ -5.5, P=0.002 100 95 90 mL/m2 85 90.8 ±33.1 89.0±31.6 93.9 ±32.8 85.9 ±30.9 80 75 0 Baseline 8 months Baseline 8 months Ivabradine (n=204) Placebo (n=199) www.shift-study.com Tardif JC, O'Meara E, Komajda M, et al. Eur Heart J. 2011;32(20):2507-15

  10. D2.4 ± 7.7 D - 0.1 ± 8.0 M008 M008 Baseline Baseline Secondary endpoint: change in LVEF from baseline to 8 months ∆ + 2.7,P<0.001 Left ventricular ejection fraction 40 35 30 65.2 ± 29.1 25 31.6 ±9.3 31.5±10.0 32.3±9.1 34.7±10.2 % 20 15 10 5 0 Baseline 8 months Baseline 8 months Ivabradine (n=204) Placebo (n=199) www.shift-study.com Tardif JC, O'Meara E, Komajda M, et al. Eur Heart J. 2011;32(20):2507-15

  11. Summary of changes in HR, LV end-systolic/end-diastolic volume indexes www.shift-study.com Tardif JC, O'Meara E, Komajda M, et al. Eur Heart J. 2011;32(20):2507-15

  12. Conclusions • Heart rate reduction with ivabradine reverses left ventricular remodeling in patients with heart failure and LV systolic dysfunction: • Marked reductions of LV volumes • Significant improvement of LV ejection fraction • These results suggest that ivabradine modifies disease progression in patients with HF receiving background therapy www.shift-study.com Tardif JC, O'Meara E, Komajda M, et al. Eur Heart J. 2011;32(20):2507-15

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