S ystolic H eart failure treatment with the I f inhibitor ivabradine T rial Main results www.shift-study.com Swedberg K, et al. Lancet. 2010;376(9744):875-885.

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Presentation transcript:

S ystolic H eart failure treatment with the I f inhibitor ivabradine T rial Main results Swedberg K, et al. Lancet. 2010;376(9744):

Primary composite endpoint (CV death or hospital admission for worsening HF) 18% Cumulative frequency (%) Placebo Ivabradine HR = 0.82 (0.75–0.90) P < Months Swedberg K, et al. Lancet. 2010;376(9744):

Hospitalization Hospitalization for HF 26% Placebo Ivabradine HR = 0.74 (0.66–0.83) P < Months Cumulative frequency (%) Swedberg K, et al. Lancet. 2010;376(9744):

Death from heart failure 26% HR = 0.74 (0.58–0.94) P = Placebo Ivabradine Months Cumulative frequency (%) Swedberg K, et al. Lancet. 2010;376(9744):

Effect of ivabradine on outcomes Endpoints Hazard ratio 95% CI p value Primary composite endpoint (CV death or hospital admission for worsening HF)0.82[0.75;0.90] p< All-cause mortality0.90[0.80;1.02] p=0.092 Death from heart failure0.74[0.58;0.94] p=0.014 All-cause hospital admission0.89[0.82;0.96] p=0.003 Any CV hospital admission0.85[0.78;0.92] p= CV death/hospital admission for HF or non-fatal MI0.82[0.74;0.89] p< Swedberg K, et al. Lancet. 2010;376(9744):

Age <65 years ≥65 years Sex Male Female Beta-blockers No Yes Aetiology of heart failure Non-ischaemic Ischaemic NYHA class NYHA class II NYHA class III or IV Diabetes No Yes Hypertension No Yes Baseline heart rate <77 bpm ≥77 bpm Test for interaction P = Hazard ratio Favours ivabradineFavours placebo Effect of ivabradine in prespecified subgroups Swedberg K, et al. Lancet. 2010;376(9744):

Mean heart rate reduction 70% of patients on ivabradine 7.5 mg bid 02 weeks Months Heart rate (bpm) Placebo Ivabradine Swedberg K, et al. Lancet. 2010;376(9744):

NYHA class changes ImprovementStabilityWorsening P = Patients (%) Ivabradine Placebo Swedberg K, et al. Lancet. 2010;376(9744):

Incidence of selected adverse events (n = 6492) Patients with an event Ivabradine N=3232, n (%) Placebo N=3260, n (%) p value All serious adverse events 1450 (45%) 1553 (48%) All adverse events 2439 (75%) 2423 (74%) Symptomatic bradycardia 150 (5%) 32 (1%) < Asymptomatic bradycardia 184 (6%) 48 (1%) < Atrial fibrillation 306 (9%) 251 (8%) Phosphenes89 (3%) 17 (1%) < Blurred vision 17 (1%) 7 (<1%) Swedberg K, et al. Lancet. 2010;376(9744):

Patients with an adverse event, leading to withdrawal Ivabradine N=3232, n (%) Placebo N=3260, n (%) p value All adverse events467 (14%) 416 (13%) Symptomatic bradycardia20 (1%) 5 (<1%) Asymptomatic bradycardia28 (1%) 5 (<1%) < Atrial fibrillation135 (4%) 113 (3%) Phosphenes7 (<1%) 3 (<1%) Blurred vision1 (<1%) Treatment discontinuation Swedberg K, et al. Lancet. 2010;376(9744):

Ivabradine significantly reduces major risks associated with heart failure:  18% reduction in CV death or hospital admission for worsening HF  26% reduction in death from heart failure  26% reduction in hospital admission for worsening heart failure Benefits are apparent early, are consistent in predefined subgroups, and have been demonstrated on top of recommended therapy Treatment is well tolerated Conclusion Swedberg K, et al. Lancet. 2010;376(9744):