Phác đồ 1 giờ chẩn đoán và loại trừ nhồi máu cơ tim cấp với Troponin T siêu nhạy - Trần Văn Huy

ive; 
ED: Emergency department; NPV: Negative predictive value; PPV: Positive predictive 
value 
Phác đồ 0-1h cTnT chẩn đoán & loại trừ NMCTC 
 A pilot study with 436 patients presenting at the ED <12 h from chest pain onset1 
 Algorithm based on cTnT-hs baseline value and absolute change within the first hour (∆1 h)1 
The APACE study: a 1-hour cTnT-hs algorithm 
Advantageous Predictors of Acute Coronary Syndrome Evaluation 
The APACE study: Algorithm and results 
1. Reichlin et al (2012). Arch Intern Med 172:1211-1218. 
0 h ≥52 ng/L or 
∆1 h ≥5 ng/L 
Rule-in 
Others 
Observational zone 
0 h <12 ng/L and 
∆1 h <3 ng/L 
Rule-out 
60% of patients 
(n = 259) 
Sensitivity: 100% 
NPV: 100% 
cTnT-hs values in patients presenting 
to the ED with chest pain 
Proposed algorithm 
Results 
 0 h: Presentation to the ED; ∆1 h: Absolute change of cTnT-hs within the first 
hour; AMI: Acute myocardial infarction; cTnT-hs: Cardiac Troponin T high-sensitive; 
ED: Emergency department; NPV: Negative predictive value; PPV: Positive predictive 
value 
• Definitive rule-in or rule-out of a total of 77 % of patients within 1 hour1 
• Very high NPV for a safe rule-out of 60 % patients in 1 hour1 
17% of patients 
(n = 76) 
Specificity: 97% 
PPV: 84% 
23% of patients 
(n = 101) 
Prevalence of AMI: 8% 
Low mortality in patients ruled-out for AMI 
Survival at 30 days (A) and 24 months (B) according to cTnT-hs algorithm category 
Rule-out 
(n=491) 
Observational 
zone (n=212) 
Rule-in 
(n=169) 
100 
98 
96 
94 
92 
90 
0 10 20 30 
Time (days) 
Su
rvi
val
 (%
) 
p<0.001 
A 
99.8% 
98.6% 
95.3% 
100 
95 
90 
85 
80 
0 6 12 24 
Time (months) 
Su
rvi
val
 (%
) 
18 
p<0.001 
B 
98.1% 
89.1% 
85.4% 
APACE 2012 results* 
Reichlin T. et al., Arch Int Med 2012; 
172(16):1211-8 
Multicenter evaluation of a 1h-algorithm in the diagnosis of myocardial infarction 
using high-sensitivity cardiac Troponin T 
Christian Mueller, Evangelos Giannitsis, Michael Christ, Jorge Ordóñez-Llanos, Christopher R. deFilippi, James K. McCord, Richard Body, 
Mauro Panteghini, Tomas Jernberg, Mario Plebani, Franck Verschuren, John K. French, Robert H. Christenson, Silvia Weiser, Garnet 
Bendig, Peter Dilba, Bertil Lindahl, 
for the TRAPID-AMI Investigators 
High sensitivity cardiac Troponin T assay for RAPID rule-out of Acute Myocardial Infarction 
Sponsored by 
Slide presented by Prof. Mueller at the ESC 2014.  
Results 
95% CI 98.2-99.7% 95% CI 70.4-83.0% 
cTnT-hs values in1282 patients with chest pain <6h from 3 
continents and 9 countries 
Slide presented by Prof. Mueller at the ESC 2014.  
Results 
0.1% 
Slide presented by Prof. Mueller at the ESC 2014.  
The “APACE revalidation” study 2015: Safe and effective AMI rule-in and rule-
out in 1 hour. Reichlin T. et al., CMAJ. 2015, April 
Aim 
To prospectively validate the cTnT-hs 1-h algorithm in the same APACE study (2006-2009), but 
recruiting new patients (2009-2013) 
Study population 
1714 patients with chest pain with onset/peak within 12 h of ED presentation from APACE 6 centres in 
3 countries (CH, Italy, Spain) 
Final study population: 1320 patients with presentation and 1-hour cTnT-hs values 
Reichlin T. et al., CMAJ. 2015, 
April, 187 (8) 
The “APACE revalidation” study (2015) 
 Results 
Performance of the high-sensitivity cardiac troponin T (cTnT) 1-hour algorithm for rapid diagnosis of acute myocardial 
infarction (MI). 
CMAJ, May 19, 2015, 187(8) 
 Kaplan–Meier curves showing cumulative mortality within 30 days (A) and 2 
years (B) of follow-up according to the classification into “rule-out” (n = 786), 
“observational zone” (n = 318) and “rule-in” (n = 216) as determined by the 
high-sensitivity cardiac troponin T 1-hour algorithm 
CMAJ, May 19, 2015, 187(8) 
Kết Luận Nghiên Cứu “APACE 2015” 
• Chiến lược sử dụng những giá trị nền và những thav đổi tuyệt đối 
của hs cTnT trong vòng 1 giờ để chẩn đoán những bệnh nhân 
nghi ngờ NMCT đã cho thấy an toàn loại trừ cũng như chẩn đoán 
chính xác NMCT cấp 3 trong 4 bệnh nhân. 
• Tỷ lệ tử vong 30 ngày ở bệnh nhân loại trừ là 0% trong phác đồ 
hs cTnT 1 giờ 
, 
Reichlin T. et al., CMAJ. 2015, 
April, 187 (8) 
Tóm lược chứng cứ phác đồ hs cTnT chẩn đoán nhanh NMCT cấp 
Giá trị cTnT-hs 0-1h trong đau ngực cấp tại phòng cấp cứu 
APACE-2012*, 
APACE -2015** 
TRAPI-AMI 
2014*** 
60% -63.4% 
NPV: 99.1-100% 
22.2- 24% 
Tần suất NMCTC 8-22% 
14.4 -17% 
PPV: 77.2 -84% 
0 h <12 ng/L và 
∆1 h <3 ng/L 
Rule out 
Khác 
Vùng quan sát 
0 h ≥52 ng/L hoặc 
∆1 h ≥5 ng/L 
Rule in 
Giá trị phác đồ 1h 
cTnT-hs ở 
 3038 bênh nhân 
76-78% rule in - rule out NMCTC 
* Reichlin et al (2012). Arch Intern Med 172:1211-1218; ** Reichlin T. et al., CMAJ. 2015, April, 187 (8) 
*** Mueller et al:  
NPV: giá trị dự đoán âm., PPV: giá trị dự đoán dương 
Benefit 1: Medical value for patients 
Time is Life 
1. Hamm et al (2011). Eur Heart J 32:2999–3054. 
2. De Luca et al (2004). Circulation 109:1223-1225. cTn: Cardiac troponin; ECG: Electrocardiogram; 
ED: Emergency department; 
ESC: European Society of Cardiology 
 APACE 2012- 2015, TRAPID-AMI cTnT-hs 1 h algorithm is faster than the 3–6 h proposed by 2011 
guidelines1 
 Every 30 minutes of delay between symptoms and treatment increases the relative risk of 1-year mortality 
by 7.5% in patients with AMI2 
 Faster time to diagnosis likely to reduce patient’s anxiety 
Reduce time to diagnosis Faster rule-in Faster appropriate therapy Faster rule-out Reduced ED crowding 
1. 2. 
Conventional troponin test1 
2. 
High sensitivity troponin test1 
2. 
APACE 2012-2015 
0 6 3 1 
Time since admission (hours) 
with 
cTnT-hs 
3 h saving time: 
Estimated reduction in1 year mortality2 ≈ 45% 
Benefit 2: Medical value for physicians 
Time is Myocardium 
1. Hamm et al (2011). Eur Heart J 32:2999–3054. cTn: Cardiac troponin; ECG: Electrocardiogram; 
ED: Emergency department; 
ESC: European Society of Cardiology 
Used in conjunction with ECG & other clinical information 
 APACE 2012-2015, TRAPID-AMI with cTnT-hs will allow: 
 rapid rule-out with safety and peace of mind in decision to discharge patients 
 rapid rule-in for faster initiation of the appropriate therapy 
«The beauty of the 1 hour algorithm is that we can accelerate our diagnostic procedure» 
Reduce time to diagnosis Faster rule-in Faster appropriate therapy Faster rule-out Reduced ED crowding 
1. 2. 
Conventional troponin test1 
2. 
High sensitivity troponin test1 
2. 
APACE 2012-15 
0 6 3 1 
Time since admission (hours) 
with 
cTnT-hs 
Benefit 3: Medical value for healthcare system 
Time is Money 
1. Hamm et al (2011). Eur Heart J 32:2999–3054. cTn: Cardiac troponin; ECG: Electrocardiogram; 
ED: Emergency department; 
ESC: European Society of Cardiology 
 Faster diagnosis with the application of APACE, TRAPID-AMI algorithm will: 
 reduce the need for extended observation or repeated testing 
 optimize resources saves cost for hospital stay 
“This is a critical help in the allocation of resources in the ED” 
Reduce time to diagnosis Faster rule-in Faster appropriate therapy Faster rule-out Reduced ED crowding 
1. 2. 
Conventional troponin test1 
2. 
High sensitivity troponin test1 
2. 
0 6 3 1 
Time since admission (hours) 
with 
cTnT-hs 
APACE 2012-15 
 Còn vai trò của hs cTnI như thế nào trong phác đồ 1h ? 
1-h algorithm for hs-cTnI (Abbott) 
 One-hour rule-in and rule-out of acute myocardial infarction using high-sensitivity cardiac troponin I 
Aim: 
• To derive a 1h-algorithm for early rule-out and rule-in of AMI in APACE 
similar to cTnT-hs using hs-cTnI from Abbott. 
Study population 
 Patients with chest pain with onset/peak within 12 h of ED presentation from APACE (9 centres in 3 countries) (Switzerland, 
Spain, Italy) 
 Final study population: 1811 patients with presentation and 1 hour- hs-cTnI-hs values 
Methods 
• Algorithm: Derivation cohort (n= 906), Validation cohort (n= 905) 
Rubini Gimenez M. et al., Am J Med 2015, 
1-h algorithm for hs-cTnI (Abbott): Results 
Rubini Gimenez et al American J Medicine, Vol 128, No 8, August 2015 
Only 1 publication with 
Abbott’s hs–TnI 1-h algorithm 
Results suggest that 
performance of is better for 
Roche’s cTnT-hs 
Algorithm safety confirmed 
by 30d-mortality of the 
patients rule-out (0.1%) and 
high NPV (>99.1-100%) 
cTnT-hs 1-h performs well 
for early AMI rule-out and 
rule-in 
and reduces diagnosis time to 
1h in 76-78% of acute chest 
pain patients 
Three studies use Roche’s 
cTnT-hs 1-hour algorithm 
(n>3’000) and Roche cTnT-hs 
Roche cTnT-hs validates the 
use of hs-cTn with a 
recommended delta change 
0-1h hs TNT : Key messages 
Safe and effective AMI rule-in and rule-out in 1 hour 
cTnT-hs 
APACE 
APACE re-validation 
TRAPID-AMI 
n>3’000 99.1-100%NPV 
30 day mortality 
More patients 
More rule-in/out 
1h 
cTnT-hs cTnT-hs 
diagnosed in 
1 hour 
76-78% 
How to use the PoC cTnT with cTnT-hs in full confidence 
Test all pre-hospital patients with chest pain using Point of Care 
Troponin T 
GP’s office 
Emergency Room with lab test 
turn around time>1 hour 
Use POC Troponin T 
≥50 
<50 
≥50 
<50 
POC cTnT ≥50 ng/L 
PreHAP1 
LAB cTnT-hs 1-h algo: 
APACE I2, II3, TRAPID-AMI4 
Final diagnose Early triage and initial diagnose 
Pre-hospital Hospital 
Coronary Intensive 
Care Unit or Cath Lab 
Slide 27 See slide notes for ref 
Rule out: Other reason for chest pain 
<12 
 and <3 ng/L 
≥52 
Or ≥5 ng/L 
Rule-out/Rule-in 
using cTnT-hs and 1 h 
algorithm 
APACE 
2015 
Phác đồ rule in-rule out 0-1h với hs cTnT (Elecsys) 
NSTAMI theo khuyến cáo ESC 2015 
5 
12 
3 
52 
5 
hs cTnT 
 Re-test hs cTnT: 3h 
76-78% rule in- rule out 
 Test early. 
Treat right. 
Save lives. 
Thank you