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S ystolic H eart failure treatment with the I f inhibitor ivabradine T rial. Influence of background treatment with mineralocorticoid receptor antagonists on ivabradine's effects in patients with chronic heart failure.
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Systolic Heart failure treatment withthe Ifinhibitor ivabradine Trial Influence of background treatment with mineralocorticoid receptor antagonists on ivabradine's effects in patients with chronic heart failure KomajdaM, Böhm M, Borer J et al. EurJ Heart Fail. 2013;15(1):79-84 www.shift-study.com
Objective To explore whether ivabradine is beneficial in patients with systolic HF, in sinus rhythm, with resting HR ≥70 bpm, and whose guideline-recommended background therapy includes mineralocorticoid receptor antagonist KomajdaM, Böhm M, Borer J, et al. EurJ Heart Fail. 2013;15(1):79-84 www.shift-study.com
Statistical method • Effect of ivabradine was assessed • separately in patients with and without MRA at baseline • using a time-to-first-event survival analysis (a Cox’s proportional hazards model including treatment effect and adjusted for prognostic factors at baseline such as BB intake, HR, NYHA class, LVEF, ischaemic cause of HF, age, SBP, EGFR) • p value for interaction between treatment and presence or not of MRA was provided by adding this interaction to the Cox model KomajdaM, Böhm M, Borer J, et al. EurJ Heart Fail. 2013;15(1):79-84 www.shift-study.com
Baseline characteristics KomajdaM, Böhm M, Borer J, et al. EurJ Heart Fail. 2013;15(1):79-84 www.shift-study.com
Baseline background treatment KomajdaM, Böhm M, Borer J, et al. EurJ Heart Fail. 2013;15(1):79-84 www.shift-study.com
Effect of ivabradine on heart rate KomajdaM, Böhm M, Borer J, et al. EurJ Heart Fail. 2013;15(1):79-84 www.shift-study.com
Effect of ivabradine on major outcomes ratio* Ivabradine Placebo Hazard pinteraction Primaryendpoint • With MRA, n=3922 28% 33% 0.82 0.916 • Without MRA,n=2583 19% 23% 0.81 Cardiovasculardeath • With MRA, n=3922 16% 18% 0.88 0.279 • Without MRA,n=2583 11% 11% 1.02 Hospitalization for HF • WithMRA, n=3922 19% 23% 0.77 0.304 • WithoutMRA,n=2583 11% 17% 0.67 Deathfromany cause • WithMRA, n=3922 17% 19% 0.88 0.366 • WithoutMRA,n=2583 13% 13% 0.99 Deathfromheartfailure • WithMRA, n=3922 4% 6% 0.73 0.723 • WithoutMRA,n=2583 3% 3% 0.80 1.4 0.8 0.4 0.6 1.0 1.2 1.6 * adjusted for prognostic factors at baseline Favors placebo Favors ivabradine KomajdaM, Böhm M, Borer J, et al. EurJ Heart Fail. 2013;15(1):79-84 www.shift-study.com
Safety * Differences is significant KomajdaM, Böhm M, Borer J, et al. EurJ Heart Fail. 2013;15(1):79-84 www.shift-study.com
Conclusion • Ivabradine improves outcomes in the SHIFT population receiving or not aldosterone antagonists and the magnitude of the improvement is similar in the two groups • The addition of ivabradine should be considered in patients with heart failure with reduced LVEF, sinus rhythm and heart rate of 70 bpm or higher, whatever their background neurohormonal treatment KomajdaM, Böhm M, Borer J, et al. EurJ Heart Fail. 2013;15(1):79-84 www.shift-study.com