JHOSPITALIST network GUIDE-IT trial; The Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure multicentre randomised clinical trial 20171010 1
70 (EF 30%), (PCI), (HbA1c 7) 2, β, ACE,,,, DPP4 110,. egfr 68ml/min/1.7m^2. 2
3,,.,,., 1-2, X, BNP? 3
. (Stage C/D), (I), (I) (IIb) NYHA II-IV(Stage C/D) (I) (Stage A/B), (IIa) 4 2017 ACC/AHA/HFSA Heart Failure Focused Update pg.19 2010pg. 9
BNP, NT-proBNP NT-proBNPNYHA,,. () 2013., BNPNTproBNP. () Am Heart J 2002; 144: 834-839. Arch Intern Med. 2006;166(3):315-320. Circulation. 2003;107(9):1278-1283. NYHA NT-proBNP pg/ml median BNP (pg/ml) I 83.1 (49.4-137) II 235 (137-391) III 459 (200-871) IV 1119 (728-1300) no CHF 9.29 BNP pg/ml 8000 1000 4000 600 900 200 400 100 125 40 55 20 18.4 n=472 2010, 2011 ESC Guidelines for the diagnosis and treatment of acute and 5 chronic heart failure 2012. Eur Heart J 2012; 33: 1787-1847.
EBM 5 steps Step1: (PICO) Step2: Step3: Step4: Step5: Step1-4 6
EBM 5 steps Step1: (PICO) Step2: Step3: Step4: Step5: Step1-4 7
Step1: P I BNPNT-pro-BNP CX O Clinical question 8
EBM 5 steps Step1: (PICO) Step2: Step3: Step4: Step5: Step1-4 9
Step2: Pubmed[BNP,chronic heart failure, clinic]. 2017randomised controlled clinical trial. 10 JAMA. 2017;318(8):713-720.
Step1: PICO PEF40%, 12, 30NT-proBNP 2000pg/ml or BNP 400pg/ml I NT-proBNP-guided strategy ; NT-proBNP 1000pg/ml CNT-proBNP O12 11
, 201311620169203 45 12
Patient: Inclusion criteria 1. 18 2. 12(*) 3. 12EF40%() 4. 30BNP > 400 pg/ml NT-proBNP > 2000 pg/ml * (a) (b) (c) 13
Patient: Exclusion criteria 1. 30 2. 3CRT(*)CRT 3. 4. 12 5. 6. 7. 8. 12 9. 10. 11. 14 (*)CRT :
Intervention/Comparison EF 40%, 12, 30NT-proBNP>2000 pg/mlbnp>400pg/ml Biomarker-guided therapy NT-proBNP<1000 pg/ml Guideline-directed management and therapy ACCF/AHA 2 6 3 6 9 12,2,6,312,1. 15 18 21, Cre, BUN,, NT-proBNP, QOL, 6 24 15
2013ACCF/AHA HFrEFHFpEF, HFrEF, EFHFpEF. Stage Stage A-D. NYHA 2.. HFrEF 3;,, CRT.. patient patient 1. ACCF/AHAHFrEFHFpEF EF HErEF 40% HFpEF 50% 41-49% >40% 2. stagenyha ACCF/AHA stage NYHA A B I C IIV D IV 16
2013 ACCF/AHA HFrEF, Stage C, NYHA I-IV HFrEF, Stage C, NYHA I-IV() ACEi/ARB+BB (Class IA) volume overloadnyha II-IV (Class IC) NYHA II-IVeGFR>30K<5 (CRT) EF35%, DCM 40NYHA II-III (Class IA) EF35%,, LBBB, QRS 0.15msecNYHA II-IV (Class IB) (Class IA) NYHA III-IV NYHA IEF 30%, 40 (Class IB) (Class IA) 17 Yancy et al. JACC. 2013; 62:1495-1539.
ACEi. ARB β NT-proBNP>5000 pg/ml ACEiARB ( CRTCCRT CRT ACCF/AHA 18
Outcomes Primary outcome12 Secondary outcomes,,, primary outcome, QOL, resource utilisation,, 19 p.714,715
Statistical analysis 90%, 5% () 40% 1220% 1100. 894, primary outcome(2 primary outcome 37%),. 200 20 p.715
Informed consent Informed Consent. institutional review board). An independent DSMB. 21 p.714
EBM 5 steps Step1: (PICO) Step2: Step3: Step4: Step5: Step1-4 22
Step3: -1. -2. -3. -1. -1. -2. -3. 23
-1. -2. 1:1. 1:1.. 24 p.714
-3.,,,,, EF(%), NYHA, (,,, ),,, NT-proBNP,, (β, ACE/ARB,,, CCRT). 25 BMI,.
-1. 1:1.,,. -1. -2. -3. 89.0%, 90.2% ITT.. 894 152. 26
Step3: RRR, ARR, NNT 95%CI 27
. 28
Primary outcome 12 37%(164/446) 37%(164/448) (ARR=0, RRR=0). 29
Secondary outcomes,,,,. 12NT-proBNP ΔNT-proBNP NT-proBNP<1000pg/ml 2568 1209pg/ml 46% (p = 0.21) 2678 1397pg/ml 40% 30
NT-proBNP1000 pg/ml, ACCF/AHA,. 31
Limitations. 2,..,. 32
EBM 5 steps Step1: (PICO) Step2: Step3: Step4: Step5: Step1-4 33
Step4: 34
70EF30%,, Inclusion criteria,. Exclusion criteria. 35
NT-proBNP30-40, BNP40-50. BNP,. BNP/NT-proBNP140. 1. 1. 12 BNP 36 11 25 60 130 140 880
EBM 5 steps Step1: (PICO) Step2: Step3: Step4: Step5: Step1-4 37
Step5: Step1-4 Step 1PICO. Step 2PubmedRCT. 38
Step 3 (81%). 12, NT-proBNP(2, ). Step 4. 39
,, 12. 40
BNP EF<45%, BNP,.. 41