Pharmacoinvasive approach for STEMI- evidence and trials

1. Pharmaco-Invasive approach in patients of
STEMI (ST Elevation Myocardial Infarction)

21. Primary Endpoint
30-day death, re-MI, HF, severe recurrent ischemia,
cardiogenic shock

27. Study Protocol

28. TIMI Flow rates

29. Single endpoints upto 30 days

30. STROKE RATES

31. In Hospital bleeding complications

34. Indian Scenario

35. • 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.

36. 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.

37. • 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.

38. 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.

39. 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%

41. 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.

42. 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.

43. 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

44. 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.

45. 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.
ORIGINALARTICLE
JAPI.Vol 62.June 2014.

46. 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.

47. • 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

48. 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.

49. 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

50. 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.

51. Choice of fibrinolytics
FIRST 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%

53. PCI
FMC to PCI capable
hospital
Primary
PCI
<90 min
Facilitated
PCI(use of
half dose
of
fibrinolytic
s)
obsolete
Deferred
PCI
Stenting
later
Pharmaco Invasive
approach >90 min
PCI 3-24
hrs after
fibrinolysi
s
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

54. Thank you