Phác đồ 1 giờ trong chẩn đoán và điều trị nhồi máu cơ tim cấp

The “APACE revalidation” study.Prospective validation of a 1-hour algorithm to rule-out and rule-in acute myocardial infarction using a high-sensitivity cardiac troponin T assay Reichl

Phác Đồ 1 Giờ Chẩn Đoán Và Loại Trừ Nhồi Máu Cơ

Tim Cấp Với Troponin T Siêu Nhạy

The one-hour algorithm to rule-out and rule-in of Acute Myocardial Infarction with cardiac Troponin T-high sensitive

PGS TS Trần Văn Huy FACC FESC

Phó Chủ Tịch Phân Hội THA VN,

Trưởng Khoa TM BV Tỉnh Khánh Hòa

Giảng Viên Thỉnh Giảng ĐHYD Huế, ĐHTN

Test early

Treat right

Save lives

Có gì mới nổi bật trong khuyến cáo về chẩn đoán NMCT cấp

Initial assessment of patients with suspected acute coronary syndromes

ESC GUIDELINES NSTAMI European Heart Journal Advance Access published August 29, 2015

Khuyến cáo ESC 2015 về chẩn đoán, phân tầng nguy cơ và vai trò troponin ở bệnh nhân nghi ngờ hội chứng mạch vành ST không chênh

Diagnosis and risk stratification

It is recommended to base diagnosis and initial short-term ischaemic

and bleeding risk stratification on a combination of clinical history,

symptoms, vital signs, other physical findings, ECG and laboratory

results

A rapid rule-out and rule-in protocol at 0 h and 1 h is

recommended if a high-sensitivity cardiac troponin test with a

validated 0 h/1 h algorithm is available Additional testing after

3–6 h is indicated if the first two troponin measurements are not

conclusive and the clinical condition is still suggestive of ACS

39, 51–55

It is recommended to use established risk scores for prognosis

estimation

ESC GUIDELINES NSTAMI European Heart Journal Advance Access published August 29, 2015

0 h/3 h rule-out algorithm of non-ST-elevation acute coronary syndromes using high-sensitivity cardiac troponin assays

ESC GUIDELINES NSTAMI European Heart Journal Advance Access published August 29, 2015

Phác đồ rule-in và rule out 0 h/1 h bằng hs-cTn ở bệnh nhân nghi ngờ NMCT không ST chênh lên (NSTEMI)

ESC GUIDELINES NSTAMI European Heart Journal Advance Access published August 29, 2015

Chứng cứ nào cho phác đồ 0-1h hs cTn?

14 nghiên cứu về phác đồ 0-1h, trong đó hs cTnT 10/14

• APACE (Advantageous Predictors of Acute Coronary Syndrome Evaluation ) 2012

• TRAPID-AMI (High sensitivity cardiac Troponin T assay for RAPID rule-out of

Acute Myocardial Infarction) is a Roche-sponsored clinical trial presented at the

meeting ESC 2014

• APACE : 2015 The “APACE revalidation” study.(Prospective validation of a 1-hour algorithm to rule-out and rule-in acute myocardial infarction using a high-sensitivity

cardiac troponin T assay)

Reichlin T et al., CMAJ 2015, April

• 1-h algorithm for hs-cTnI

Rubini Gimenez M et al., Am J Med 2015, Mar 31

Acute myocardial infarction (AMI)

Time is life

Each year over

7 million people have an AMI

worldwide 1

Every 30 minutes of delay between symptoms and treatment increases the relative risk of 1-year mortality by 7.5% in patients with AMI 2

• Serial blood samples at variable time intervals are required for the diagnosis of AMI and to

differentiate acute from chronic cardiac disease1

• 2011 ESC guidelines recommend, in conjunction with full clinical assessment including

12–lead ECG, either a 6-9 hours observation time with conventional cTn tests or 3 hours out protocol using high sensitivity Troponin1

rule-Time is life

Is a safe AMI diagnosis possible in a shorter time?

1 Hamm et al (2011) Eur Heart J 32:2999–3054 cTn: Cardiac troponin; ECG: Electrocardiogram;

ED: Emergency department; ESC: European Society of Cardiology

Time since admission (hours)

Reduce time to diagnosis Faster rule-in Faster appropriate therapy

Faster rule-out Reduced ED crowding

cTnT-hs values in patients presenting

to the ED with chest pain

Proposed algorithm

1 Reichlin et al (2012) Arch Intern Med 172:1211-1218

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

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 onset 1

 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

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

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)

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 http://www.medscape.com/viewarticle/830723

Results

cTnT-hs values in1282 patients with chest pain <6h from 3

continents and 9 countries

Slide presented by Prof Mueller at the ESC 2014 http://www.medscape.com/viewarticle/830723

Results

0.1%

Slide presented by Prof Mueller at the ESC 2014 http://www.medscape.com/viewarticle/830723

The “APACE revalidation” study 2015: Safe and effective AMI in and out in 1 hour Reichlin T et al., CMAJ 2015, April

rule-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”

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

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

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: http://www.medscape.com/viewarticle/830723

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

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

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

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

• 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): R esults

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

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

LAB cTnT-hs 1-h algo:

APACE I 2 , II 3 , TRAPID-AMI 4

Final diagnose Early triage and initial diagnose

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

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

Test early

Treat right Save lives

Thank you