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Welcome Ask The Experts March 24-27, 2007 New Orleans, LA

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Welcome Ask The Experts March 24-27, 2007 New Orleans, LA. FUSION II: Follow-Up Serial Infusions of Nesiritide for the Management of Patients With Heart Failure Clyde W. Yancy, MD, FACC, FAHA, FACP Medical Director Baylor Heart & Vascular Institute Dallas, TX.

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Presentation Transcript
slide1
Welcome

Ask The Experts

March 24-27, 2007

New Orleans, LA

slide2
FUSION II: Follow-Up Serial Infusions of Nesiritide for the Management of Patients With Heart FailureClyde W. Yancy, MD, FACC, FAHA, FACPMedical Director Baylor Heart & Vascular InstituteDallas, TX
slide3
Results of the Follow-up Serial Infusions of Nesiritide for the Management of Patients With [Advanced] Heart Failure (FUSION II) TrialAmerican College of Cardiology56th Annual Scientific SessionNew Orleans, LouisianaMarch 25, 2007

Clyde W. Yancy, M.D.

on behalf of the FUSION II Steering Committee

Henry Krum, MD; Barry M. Massie, MD; Marc A Silver, MD; Lynne W. Stevenson, MD

and the FUSION II Investigators

fusion i mortality all cause hospitalization high risk patients acc aha stage d hf or cdhf
FUSION I: Mortality & All-cause Hospitalization (High Risk Patients- ACC/AHA Stage D HF or ‘CDHF’)

P=0.03

P=0.23

fusion ii study design
FUSION II Study Design

Nesiritide* 2x/wk +Intensive Disease Management (n = 300)

Placebo 2x/wk +Intensive Disease Management (n = 150)

n = 900

Nesiritide* 1x/wk +Intensive Disease Management (n = 300)

Phase IIb

Double-blind

Randomized

Multi-center

Placebo 1x/wk +Intensive Disease Management (n = 150)

12 week blinded

follow-up period

12 week treatment period

*Dosing: 2 g/kg bolus, then

0.01 g/kg /min infusion x 4-6 hours

1° and 2° Endpoints

AdditionalEndpoints

Yancy CW et al. Am Heart J 2007; in press. Available online 3/10/2007, DOI: 10.1016/j.ahj.2007.02.004

efficacy endpoints
Efficacy Endpoints
  • Primary
    • Time to all cause death or first CV and/or renal hospitalization through Week 12
  • Secondary*
    • Number of CV and/or renal hospitalizations adjusted for observation period duration
    • Days alive and out of hospital
    • Change in KCCQ summary score
    • Time to CV death

*from day of randomization through week 12, or week 13 for KCCQ

Yancy CW et al. Am Heart J 2007; in press. Available online 3/10/2007, DOI: 10.1016/j.ahj.2007.02.004

baseline therapy fusion i vs fusion ii
530% increase

56% increase

160%

increase

Baseline TherapyFUSION I vs. FUSION II

Percent of patients treated

*Includes both carvedilol and extended release metoprolol in FUSION II and any beta- blocker in FUSION I

inotrope infusions fusion i vs fusion ii
Inotrope InfusionsFUSION I vs FUSION II

FUSION I

FUSION I

Percent of patients treated

FUSION II

FUSION II

Pre-randomization

Inotropes

Outpatient Inotropes

During Study

*Refers to exposure to inotropes within 2 weeks of randomization

fusion ii primary composite endpoint through week 12
FUSION II: Primary Composite Endpoint Through Week 12

*P value: NES vs. placebo stratified by dose group

†Modified ITT: all treated ITT patients

fusion ii secondary endpoints week 12
FUSION II: Secondary Endpoints Week 12

*P value nesiritide vs. placebo stratified by dose group

safety any adverse event
SAFETY Any Adverse Event

AE: Adverse event

SAE: Serious adverse event that results in death, is life-threatening, requires inpatient hospitalization, or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity.

safety protocol specified changes in serum creatinine
SAFETY Protocol Specified Changes in Serum Creatinine*

P=0.046

Percent of patients with SCr increases

P=0.931

P=0.458

*Outpatient Clinic Visit Values Only

fusion ii conclusions
FUSION II – Conclusions
  • In this patient population with advanced HF and serial infusions of nesiritide:
    • No evidence of drug induced renal harm compared to placebo
    • No evidence of increased mortality at pre-specified endpoints
fusion ii conclusions1
FUSION II - Conclusions
  • In the context of optimal adherence to evidence based medical and device therapies and in concert with excellent disease management, serial infusions of nesiritide did not result in a demonstrable clinical benefit over intensive outpatient management of patients with CDHF
  • Adherence to guideline based therapy AND meticulous follow-up should be optimized for patients with CDHF
slide16
Question

&

Answer

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Thank You!

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