Eur HeartJ 2015; 36: 657

TRACTAMENT FARMACOLÒGIC

•304 ambulatory symptomatic•left ventricular ejection fraction ≤45% •elevated natriuretic peptides,•iron deficiency (ferritin <100 ng/mL or 100–300 ng/mL iftransferrin saturation <20%).

Eur HeartJ 2015; 36: 657

Hospitalització per IC

TRACTAMENT FARMACOLÒGIC

TRACTAMENT FARMACOLÒGIC

Eur Heart J 2014; 35:1559-67

TRACTAMENT FARMACOLÒGIC

Eur Heart J 2014; 35:1559-67

TOTAL COHORT

< 75 YEARS

≥ 75 YEARS

All cause death

HF hospitalization

Eur Heart J 2014; 35:1559-67

TRACTAMENT FARMACOLÒGIC

Lancet 2014; 384: 2235-43

TRACTAMENT FARMACOLÒGIC

18.254 pacients10 estudis aleatoritzats

Lancet 2014; 384: 2235-43

TRACTAMENT FARMACOLÒGIC

All-cause death

CV hospital admission

SR AF

TRACTAMENT NO FARMACOLÒGIC

EP 1º: change in left ventricular end systolic diameter(LVESD) from baseline (randomization visit) to 6 months

EP 2º: QoL, NYHA, others

TRACTAMENT NO FARMACOLÒGIC

All-cause death or worsening HF hospitalization

TRACTAMENT NO FARMACOLÒGIC

A preliminary analysis of the data identified a statist ically significant 2.5 percent absolute increased risk of cardiovascular mortality for those patients in the trial who received ASV therapy per yearcompared to those in the control group. In the study, t hecardiovascular mortality rate in the ASV group was 10 percent per year compared to 7.5 percent per year in the control group.

Eur J Heart Fail 2014; 16: 796

TRACTAMENT NO FARMACOLÒGIC

Eur Heart J 2015; 36: 1090-7

Eur Heart J 2015; 36: 1123-35

Eur Heart J 2015; 36: 1078-89

LION-HEARTLevosimendan Intermittent administration in Outpatients:

effects on Natriuretic peptides in advanced chronic HEART failure

Multicentre, randomized, double-blind, parallel group, placebo-controlled trial

to test the efficacy and safety of intravenous administration of intermittent

doses of levosimendan in outpatients with advanced chronic heat failure

J. Comín-Colet (PI), N. Manito, J. Segovia, J. Delgado, L. Almenar. E. de Teresa,

M.G. Crespo-Leiro, A. Sionis, M. Grau and J. Bruguera for the LION-Heart

Investigators

EudraCT Number 2009-014242-28

www.ClinicalTrials.gov identifier NCT 01536132

UN ALTRE CANVI DE PARADIGMA?

Darrera

hora

LION-HEART – Study Protocol

1

Informed Consent

70 patients

Primary End-Point

Changes in NT-proBNP

Comparing AUC of NT-proBNP from

pre and post 24h infusion levels of NT-proBNP)

Screening

1 week

Randomization

69 patients

Outpatient Therapy

3 months

Follow-up

9 months

End of Study

2 3 4 5 6

PRO

Week 13

PRO

Week 25

Levosimendan

0.2µg/Kg/min for 6 hours

every 2 weeks

Levosimendan

0.2µg/Kg/min for 6 hours

every 2 weeksPlacebo

0.2µg/Kg/min for 6 hours every 2

weeks

Placebo

0.2µg/Kg/min for 6 hours every 2

weeks

Arrhythmia Evaluation

(24 h Holter Monitoring)

LION-HEART – Study Results

LION-HEART – Study Results- Clinical Events

Placebo

n=21

Levosimendan

n=48

p-

valueHR (95% CI)*

Heart Failure Hospitalization 14 (67%) 11 (23%) 0.002 0.25 (0.11-0.55)

All-cause Death 7 (33%) 14 (29%) 0.951 0.85 (0.34-2.12)

All-cause Death or Heart Failure

Hospitalization17 (81%) 23 (48%) 0.022 0.39 (0.21-0.74)

*Cox Proportional Hazards Models

(time to first event)

HF HospitalizationHF HospitalizationAll-cause death or HF

Hospitalization

All-cause death or HF

Hospitalization

KM curves

UN ALTRE CANVI DE PARADIGMA?

Ann Intern Med. 2009;150:784-794Mayo Clin Proc 2015; 90: 765

UN ALTRE CANVI DE PARADIGMA?

Mayo Clin Proc 2015; 90: 765

Survival curves according quintiles Risk of death according heart rate and age

Q1< 60x’Q2 60-67x’Q3 68-73x’Q4 74-82x’Q5 ≥83x’

Unitat d’Insuficiència CardíacaHospital Universitari Germans Trias i Pujol

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