2013 Consensus Statement for Early Reperfusion and Pharmaco-Invasive approach

in patients presenting with Chest pain Diagnosed as STEMI (ST Elevation

Myocardial Infarction) in an Indian Setting

Developed in collaboration with STEMI India

JJ Dalal,T Alexander,V.Dayasagar et al.

ORIGINAL ARTICLE

JAPI.Vol 62.June 2014.

Introduction

• Coronary Artery Disease (CAD) is currently the most common,non

communicable disease in India.

• >65 million people to be affected by 2015.

• One of the gravest complications of CAD is STEMI.

• Reperfusion is a time dependent, key strategy in acute STEMI care.

• Though there are extensive clear guidelines in STEMI

management,a gap between guidelines and implementation in

clinical setting still exists.

• In India, the prevalence of STEMI is rising exponentially leading

to CV morbidity and mortality. Despite advancement in

reperfusion therapy(pharmacological and interventional),the

overall utilization, system of care and timely reperfusion remains

suboptimal.

Challenges for STEMI system of care in India• Primary PCI is available to <10% STEMI patients in India.

• 1.Lack of awareness• 2.Lack of transfer facilities.

Unavailability of hospital with PCI facility.• 3.Casualty/ED –to cath lab

Finance problem

Obtaining consent

Cath lab occupied

Unavailability of cardiologist round the clock.

• Patient awareness and education for early symptom

identification.

• Education required for General Practitioners /Physicians to

implement early time dependent STEMI management.

• PCI is the GOLD standard, yet remains unaccessible to majority

of patients.

<90min

Plight of Reperfusion:What happens in real world ?

• Most complete data about contemporary trends in STEMI

patients in India comes from CREATE Registry, Kerala ACS

Registry.

• CREATE registry, large of its kind on ACS patients from 89

large hospital centers from 10 regions and 50 cities across

India.

• Kerala Registry 25,748 consecutive ACS patients from 2007

-2009 in 125 hospitals in Kerala.

What is the purpose of this consensus?

• Alarming treatment delays exist in patients presenting with chest

pain observed in real world and published evidences.

• Time to diagnose STEMI and initiation of reperfusion therapy at

various first medical contacts (FMC) in India is variable.

• Evidence based explicit recommendations for practicing

clinicians about time dependent early treatment.

• Concept of Pharmaco Invasive(PI) approach contextualized to

the situation in the India.

Process

• Expert steering committee• 150 experts from 16 states in India.• Consensus statement

CREATE Registry

CREATE Developed countries

Number of pts enrolled 20,468

% of STEMI 60% (12,405) 40%

Median time for arrival to hospital after symptom onset

300 min 140 -170 min

For intiation of fibrinolysis 50 min 32-40 min

Using ambulance 5%

Fibrinolytic therapy 59%

Primary PCI 9%

Kerala Registry

• STEMI was the most common ACS admission.

• Highest in hospital mortality rates and non fatal events.

• Less likely to have any formal education.

• Present more than 6 hrs after symptom onset.

• 90% received antiplatelets therapy,

• Thrombolytics were used in 41% of STEMI pts.

• Inappropriate thrombolysis was relatively high.

What is Pharmaco –Invasive approach

• It means FIRST administering EARLY fibrinolysis and then

SYSTEMATICALLY performing an angiography (and then PCI

if needed) WITHIN 3-24 hrs AFTER the START of fibrinolytic

therapy,REGARDLESS of whether fibrinolysis RESULTS in

SUCCESSFUL REPERFUSION or not.

• In the event of fibrinolytic failure, a Rescue PCI should be

immediately performed where one need not wait for the initial 3

hour window.

Why it has to be stressed much regarding this approach ?

• Time is Myocardium.

• For each 30 min delay in treatment in STEMI patient,1 yr mortality

increases by 7.5%.

• Mortality benefit with primary PCI is lost if PCI related delay

exceeded 60 min. Nallamothu et al ,Am J Cardiol,2004;94:772-774

• Practically, early fibrinolytic therapy can compensate for PCI

related delay.

• Proportional mortality reduction was significantly higher in patients

treated within 2 hrs with fibrinolytics..

Circulation 2004;109:1223-1225

Indications

• It is appropriate for patients with STEMI who are eligible for

treatment with fibrinolytics drugs and in whom

Transfer time ≥30 min, or

DTB(door to balloon) time≥90 min,

[FMC to balloon time > 120 min].

• PCI related delay : (door to balloon) – (door to needle) > 60

minutes.

Shortening the time to reperfusion of the Infarct related artery.

Optimal reperfusion strategy for patients with STEMI.

TRIAL EVIDENCE

• CARESS- in- AMI trial .• STREAM trial• STEPP AMI

What do they conclude • …..> 80% IRA patency is assosciated with early fibrinolysis

even when the total ischemic time is about 4 hrs.• Significant portion of patients did not require stenting.• Lower thrombus burden.• No increase in bleeding risk.

Early Reperfusion and Pharmaco Invasive approach

1.FMC at the level of General practitioner or consulting physician in private clinic/OPD.

All patients of chest pain/suspected of AMI on clinical diagnosis should

receive prophylactic dose of 350 mg soluble/chewable aspirin

immediately (not enteric coated).

ECG for diagnosis.

Clopidogrel (300mg <75 yrs, 75 mg if >75 yrs) and atorvastatin (40-80

mg) after confirmation by ECG.

Transfer immediately by ambulance to nearest PCI capable

hospital/hospitals where fibrinolysis is possible.

• Avoid referring patients to diagnostic centers as they take 3-4 hrs of precious time for ECG reporting that may add to delay in timely interventions.

• Condition of the patient to be explained to attendants and gain their confidence for preparedness for PCI

2.First/Second Medical contact at the level of emergency

physician at non PCI capable hopsital/nursing home capable of

fibrinolysis.

• Transfer to PPCI capable center only if transfer time < 30 min.

• Call the PPCI capable hospital and send the case.

• If occupied –thrombolyse and then transfer.

• If > 30 min - thrombolyse immediately.

3.Medical contact at the level of PPCI capable hospitals

• Patient counselling

• ED- cath lab transfer

• Patient relative unwilling for quick decision.

• Cath lab occupied.

• DTB <90 min – PPCI

• DTB > 90min - fibrinolysis

Choice of agents

• Tenecteplase 0.53 mg/kg single blous iv over 5 seconds

(LOE 1 A)• Reteplase 10 MU bolus – 30 mins +10 MU bolus

(LOE grade 1B)• Alteplase 15 mg IV bolus,0.75 mg/kg over 30 min ,0.5 mg/kg

over 60 min (LOE grade 1C)• Streptokinase 1.5 MU over 30 -60 min (LOE grade 2B)

• For streptokinase –perform PCI in the later half of 3-24 hrs.• Radial approach is the preferred route.

Choice of fibrinolyticsFIRST GENERATION SECOND THIRD IN PIPELINE

Streptokinase Alteplase Increased fibrin specificity

Lanoteplase

antigenic accelerated dose Resistance to plasminogen activators

Alfimeprase

IV infusion IV infusion Reteplase 60%

less fibrin specific 54% Tenecteplase

TIMI grade 3flow more specific

32% single bolus

wt based regimen

TIMI 3 flow - 63%

PCI

FMC to PCI capable hospital

Primary PCI

<90 min

Facilitated PCI(use of half dose of fibrinolytics

)

obsolete

Deferred PCI

Stenting later

Pharmaco Invasive approach >90 min

PCI 3-24 hrs after

fibrinolysis

PCI 14-24 hrs after

STK

Delayed PCI

12-72 hrs

after STEMI

FMC to Non PCI hosptial

Transport <120 min (including

90 min)

Primary

PCI

> 120 min

PI approach

PCI

Failed thrombolysis

Rescue PCI

THANK YOU