2. • Nearly 3 million STEMI are estimated to occur in India per
year.
• As per WHO DATA rising prevalence and rapid
‘epidemiological transition’.
• projected that between 1990 and 2020, there will be 117%
and 105% rise in mortality from CAD in men and women
respectively in India.
World Health Organization. World Health Statistics Annual. Geneva, Switzerland:
World Health Organization; 1998.
3. EPIDEMIOLOGY OF ACS &
STEMI IN INDIA
■ STEMI is the predominant form of ACS in India.
■ commoner in Indians as compared to the west.
■ The incidence of STEMI appears to be increasing in India.
■ The case fatality rate & 30-day mortality of STEMI are higher as
compared to the west.
■ STEMI occurs at an average of 10 years earlier in Indians as compared to
Western counterparts.
(53y vs 63 y)
■ Patients are younger at presentation (mean age 57.5 years)
■ 25% AMI<40y
■ Incidence of CAD in young Indians: 12-16%. Higher than any other ethnic
group.(2-5% western world)
■ Guha et al, CSI: Position Statement for management of STEMI in India, Indian Heart Journal, 2017;69:S63-S97 Mansoor & Kaul, Prehospital Thrombolysis,
Indian Heart Journal, Sept-Oct 2009, pg 433
Dalal et al, Role of Thrombolysis in reperfusion therapy for management of AMI: Indian Scenario, Indian Heart Journal 65 (2013): 567
5. ACUTE CORONARYSYNDROMESIN
INDIA
1. Medical attention is received late (e.g.median 6 hr after onset of symptoms, 31%
>12h CREATE registry).
2. Majority of patients receive thrombolysis
3. Median door-to needle time (DTN) is 50 min.
4. Standard of care medications are received less often.
5. Most patients reach hospital by private/ public transport.
Guha et al, CSI: Position Statement for management of STEMI in India, Indian Heart
Journal, 2017;69:S63-S97 Mansoor & Kaul, Prehospital Thrombolysis, Indian Heart
Journal, Sept-Oct 2009, pg 433
Dalal et al, Role of Thrombolysis in reperfusion therapy for management of AMI:
Indian Scenario, Indian Heart Journal 65 (2013): 567
The INTERHEART-South Asia study identified eight coronary risk factors–
abnormal lipids, smoking, hypertension, diabetes, abdominal obesity,
psychosocial factors, low fruit and vegetable consumption, and lack of
physical activity and they accounted for 89% of the cases of all acute MI in
Indians.
Further scrutiny of the INTER-HEART study revealed that Indians who
developed STEMI had lower LDL cholesterol levels than others in the
study. They also had lower HDL cholesterol. ApoB/ApoA1 showed the
strongest association with the risk of acute MI in Indians. This shows that
Indians deserve a separate consensus in the management of ACS as there
are many unknown factors at play.
6. THE INDIAN SCENARIO &THE
CAD EPIDEMIC
■ A vast majority of population lives in villages and smaller towns.
■ Only basic primary healthcare is available there.
■ Besides, there are many big and small townships, located in the
hilly areas, on the sea sides, deltas or in deserts.
■ Infrastructures especially transport systems and hospitals with
modern facilities are far from optimal in these remote townships.
7. ■ Lower socioeconomic groups are substantially affected
(75%).
■ Age adjusted DALY lost /1000 due to CAD in India: 3
times higher than developed countries.
■ Most patients pay directly for their own treatment.
■ STEMI imposes a large financial burden on families:
■ Out-of-pocket expenditure up to 9 times their total
household expenditures.
THE SOCIO-ECONOMIC
PROBLEM
Guha et al, CSI: Position Statement for management of STEMI in India, Indian Heart Journal, 2017;69:S63-S97
Mansoor & Kaul, Prehospital Thrombolysis, Indian Heart Journal, Sept-Oct 2009, pg 433
Dalal et al, Role of Thrombolysis in reperfusion therapy for management of AMI: Indian Scenario, Indian Heart Journal 65
(2013): 567
8. Developed
countries
CREATE
REGISTRY
KERALA
REGISTRY
HP ACS
REGISTRY
Number of pts enrolled 20,468 25,000 5180
% of STEMI 40% 60%
(12,405)
40% 45.5%
Median time for arrival to
hospital after symptom
onset
140 -170
min
300 min >6HOURS 780MINS
For intiation of fibrinolysis 32-40 min 50 min
Using ambulance 5% 15.4%(108
AMBULANCE)
Fibrinolytic therapy 59% 41% 35.6%
Primary PCI 9% 0.6%
9.
10. 1)Time is myocardium 2)Infarct size is outcome
Relationship Between Duration of Symptoms of MI Before Reperfusion
Therapy, Mortality Reduction, and Extent of Myocardial Salvage
Modified by collaterals,ischemic preconditioning,myocardial oxygen uptake, duration of sustained ischemia
Gersh, B. J. et al. JAMA 2005;293:979-986.
11. ▪ Time is essence ……
1
1
▪ Choice is reperfusion ......
12. REPERFUSION IS THE KEY TO SAVE
MYOCARDIUM AND LIFE….
Aim is to open the blocked I.R.A.
and Re -establish the coronary blood flow
- Rapid
- Early
- Complete
- Sustained 1
2
13. Every 30-minute delay from
onset of symptoms to
reperfusion. 1 year mortality
is increased by 8%
REDUCTION IN LONG T ERM M ORTALITY
1
3
De Luca et al, Circulation 2004
Every Minute of Delay Counts!!!!!!!
15. 7 7
2
14
5
3
1
8
0
5
10
15
Death Re MI Total Stroke Total
Percentage
fibrinolysis prim PCI
Primary PCI versus fibrinolysis for MI
Meta analysis of 23 trials
Keeley EC. Lancet 2003;361:13-20
P<0.0001
16. Lytic Vs. PCI in Acute M I Patient
s
Fibrinolysis Primary Angioplasty
0%
50%
100%
>95% TIMI 3
0.1% Stroke
5% availability
2% Reocclusion
100%
50%
0%
60% TIMI 3
<50% Treated
5% Reocclusion
1% Stroke
25% Late
occlusion
Availability
1
6
17. How can we improve STEMI care in
INDIA?
• Adherence to guideline-based therapies has been
associated with improved in-hospital, 30 day and 1 year
clinical outcomes in ACS.
• The CRUSADE investigators demonstrated a 2.2% absolute
difference in hospital mortality between the highest and
lowest quartiles of adherence to ACS guidelines.
• Health care system level programmes for the evaluation
and management of STEMI are lacking overall in India,
possibly because there are currently no India-specific
STEMI clinical practice guidelines.
18. The aims of triage protocols
• The aims should be to develop a smooth
continuum of care including
– (a) Early recognition of symptoms of STEMI
– (b) Activation of efficient emergency medical
services (EMS)
– (c) Pre- hospital management
– (d) Pre-determined hospital destination protocols
and
– (e) Timely establishment of reperfusion.
19. Diagnosis of STEMI and early risk
stratification—challenges in India
• Acute chest pain is the most common presenting
symptom of acute myocardial ischemia.
• ACS encompasses all acute chest pain syndromes
resulting from myocardial ischemia.
• Only 20–30% of patients presenting with acute
chest pain are ultimately confirmed to have ACS
upon detailed evaluation
Lee TH, Goldman L. Evaluation of the patients with acute chest pain. N Eng J Med. 2000;342:1187–1195.
Pope JH, Aufderheide TP, Ruthazer R, et al. Missed diagnosis of acute cardiac ischemia in the emergency department. N Eng J
Med. 2000;3
20. • Prospective registries from the Western population
show that up to 30% STEMI patients may present
with atypical symptoms.
Brieger D, Eagle KA, Goodman SG, et al. Acute coronary syndromes without chest pain, an
underdiagnosed and undertreated high-risk group: insights from the Global Registry of
Acute Coronary Events. Chest. 2004;126:461–469.
• However, series of STEMI from India report that
more than 90% of patients (91–99%) present with
classical chest pain, and commonly associated with
sweating (70– 80%). Thus, atypical presentations
seem to be uncommon among Indians.
Seetharama N, Mahalingappa R, Ranjith Kumar GK, Veerappa V, Aravindh CL. Clinical profile of acute
myocardial infarction patients: a study in tertiary care centre. Int J Res Med Sci. 2015;3:412–419.
Shah V, Jain U. Clinical profile of acute myocardial infarction in young adults. Int J Med Sci Public
Health. 2016;5:1709–1713.
21. • For the diagnosis of acute myocardial infarction, the presence of
any two of the following three features is essential: characteristic
chest pain, ECG changes and elevated cardiac enzymes.
• patient’s interpretation of symptoms, availability of ECG and its
interpretation, and widespread non-availability of Troponin testing
are among the major recognized challenges in the diagnosis of
STEMI in India.
• The diagnosis and early risk stratification is usually done at the
point of first medical contact (FMC).
• In the Western world, the FMC is usually the emergency medical
services
• However, general practitioners and often non-physicians are the
FMC in India, especially in rural and semi-urban areas, which poses
unique challenges in the diagnosis of STEMI in India.
Chopra HK. Challenges of STEMI care in India & the real world. Indian Heart J. 2015;67:15–17.
22. PRE-HOSPITAL ECG
• Staffs in the ambulance need to
have medical training and be
able to perform 12 lead ECG at
the time of FMC and transmit it
to pre-determined medical care
facilities.
• Prior transmission of ECG while
the patient is en-route to the
designated receiving hospital
• the use of mobile technology for
quick transmission of information
(Use of android/iOS application
like WhatsApp for ECG
interpretation by expert).
23. ADMINISTRATION OF DRUGS
• ASPIRIN: Patients with ongoing symptoms suggestive of
STEMI should be encouraged to take aspirin (165–325mg, self-
administered or by EMS personnel and community health
workers).
• NITROGLYCERIN: It is recommended that patients who have
been prescribed nitroglycerin previously, should take one
nitroglycerin dose in case of any suggestive episode of chest
discomfort. The patient or their family members are advised
to seek emergency medical help if the chest discomfort does
not improve or worsens even after taking 1 sublingual
nitroglycerin dose.
• PRE-HOSPITAL THROMBOLYSIS:
24. CAPTIM trial: Pre-hospital thrombolysis within 2 hours
is superior to Primary PCI
Similar mortality for primary percutaneous coronary intervention and a policy of
pre-hospital lysis followed by transfer to an interventional center. In addition, for
patients treated within 2 h of symptom onset, 5-year mortality was lower with pre-
hospital lysis.
European Heart Journal (2009) 30, 1598–1606 38
25. STREAM TRIAL
Methods End points and results Conclusions
1892 patients with STEMI
within 3 hours unable to
undergo primary PCI within
1 hour – primary PCI versus
fibrinolytic therapy with
bolus tenecteplase and
transport to PCI capable
hospital
Primary endpoint –
composite of death, shock,
CHF or reinfarction upto
30 days.
Occurred in 12.4% in
fibrinolysis group vs.
14.3% in PPCI group
(p=0.21)
Prehospital fibrinolysis with
timely coronary
angiography resulted in
effective reperfusion in
patients with early STEMI
who could not undergo
primary PCI within 1 hour
after the first medical
contact
26. Preferred fibrinolytic agents
■ Bolus dose medicines (tencteplase/ reteplase) preferred over
infusions & complex calculations (STK/ alteplase).
■ Easier to administer
■ Less chances of medication error
■ Less hypotension/ allergic reaction than STK.
■ Effective
■ Preferred in UK, NZ
■ Recommended by Indian authors:
– Mansoor & Kaul [Pre-hospitalThrombolysis, Indian heart Journal, Sept-Oct, 2009],
– Chopra H.K. [Challenges in STEMI care in India & The Real World, Indian Heart Journal, 2015;67:15-
16],
– Dalal et al [Role of Thrombolysis in reperfusion therapy for management of AMI: Indian Scenario,
Indian Heart Journal 65 (2013): 567]
■ Costly [INR 30,000 -40,000]
27. OCEANIAN GUIDELINES
■ In Australia, the National Heart Foundation has stated that if
patients cannot reach a hospital for thrombolytic therapy within 90
min of calling the emergency service, out-of- hospital thrombolysis
should be considered. [AUSTRALIA] (1)
■ Pre-hospital fibrinolysis is thus the only way that rural patients can
be efficiently managed with modern reperfusion therapy. [NEW
ZEALAND] (2)
(1) National Heart Foundation of Australia and Cardiac Society of Australia and New
Zealand. Guidelines for the management of acute coronary syndromes 2006.
Medical Journal of Australia 2006;184(8): 1-12.
(2) Guidelines for pre-hospital administration of fibrinolytic therapy by New Zealand
general practitioners 2004
28. 2 experiences with PHT
1. Ranchord AM et al, Paramedic administered PHT is safe and reduces time to treatment,
New Zealand Medical Journal, 2009 Sept 11;122(1302):47-53
2. Khan AA et al, Pre-hospital thrombolysis in ST-segment elevation MI: a regional
Australian experience, Medical Journal of Australia, 2016; 205(3):121-125.
New Zealand (Kapiti Coast) Australia (Hunter new
England Local Health District)
Period of
study
PHT: 2003-07; IHT: 1999- 2003 Aug. 2008 – Aug. 2013
Number of
pts.
PHT 50 PHT 150, PPCI 334
Time
benefit
44m vs 133m 35m vs 130m
Mortality In-hospital mortality 8% vs 6% [p
value 1.0]
12 month all cause mortality
6.7% vs 7.2%
Other
benefits
Heart failure reduced: 10% vs 26% [p
value 0.04]
Risks 1 minor bleed, no stroke, major bleed,
death
Major bleed 1.3%
29. PRE REQUISITIES FOR
PREHOSPITAL THROMBOLYSIS
a. Well equipped cardiac ambulances.
b. Ability to perform 12 lead ECG in ambulances.
c. Trained medics and paramedics to interpret ECGs.
d. ECG transmission facility to a specialized center.
e. Capability to treat cardiac and cerebrovascular emergencies in
ambulances.
f. Availability of bolus dose – thrombolytic agents.
g. Facility to provide awareness and education programme directed at the
general
population on disease manifestation and strategies to reduce ambulance
service time.
Sathe S & Sathe A, Pre hospital thrombolysis,
33. ECHOCARDIOGRAPHY
• clarifying the diagnosis in patients presenting with non-
diagnostic ECG changes.
• RWMA appear early after coronary artery occlusion.
• RWMA in presence of LBBB.
• mechanical complications of MI and must be performed when
a murmur is identified, or for unexplained hemodynamic
collapse and acute heart failure.
• alternative diagnoses like pulmonary embolism, pericardial
disease
the need for an echocardiogram should not delay the transfer for
angiography in high risk patients.
34. Physical examination
• A quick medical examination is recommended to risk
stratify STEMI patients,
• recognize complications, identify co-morbidities, and
to rule out alternative diagnosis.
• Left ventricular S4 is a common accompaniment.
• Hypotension, basal crepitations and LV S3 indicate poor
prognosis.
• A new systolic murmur usually indicates either mitral
regurgitation or ventricular septal rupture.
• Patients with suspected aortic dissection may have
inequality in pulses.
35. Early risk stratification
The risk factors for early death
following a STEMI
• advanced age, diabetes
mellitus, smoking status,
prior infarction, and prior
use of aspirin.
• On presentation, the
presence of hypotension,
tachycardia, cardiac arrest,
heart failure, and
mechanical complications of
MI augur a poor prognosis.
• One simple classification, Killip
classification which takes into
account signs of HF and
cardiogenic shock must be
documented at presentation in all
patients with STEMI.
• As risk assessment is a
continuous process, they must be
reassessed throughout hospital
stay till discharge.
• TIMI risk score takes into account
the major prognostic factors in
STEMI and is a validated score
The number of risk factors
disproportionately increases the
adverse outcome.
• GRACE score is a multifactor risk
assessment model which is useful
in predicting in-hospital, 30day
and 6-month outcome across ACS
including STEMI
• ECG evidence of anterior
location of infarct, RBBB,
complete heart block in
anterior wall MI, and
significant arrhythmias also
indicate poor early outcomes
in STEMI.
• Biomarker elevation, impaired
renal function and
echocardiographic LV
dysfunction are important
investigations pointing to a
poor outcome.
36.
37. “TIME IS MUSCLE”
■ Timely delivery of reperfusion therapy (whether pharmacological or
mechanical) in patients with STEMI is more important than the choice
of therapy
■ Entire emphasis should be to deliver reperfusion therapy to a patient of
STEMI as rapidly as possible.
The concept of
“first medical contact to device/balloon time”
replaces
the “door to needle” or “door to balloon” time.
38. Timely establishment of reperfusion
CLASS 1 RECOMMENDATIONS
Should be administered to all
eligible patients with STEMI with
symptoms onset within the prior
12 hours(Class 1; LOE: A)
In the absence of
contraindications, fibrinolysis
therapy should be administered to
patients with STEMI at non–PCI-
capable hospitals when the
anticipated FMC-to-device time at
a PCI capable hospital exceeds 120
minutes becaus of unavoidable
delays (LOE: B)
When fibrinolytic therapy is
indicated or chosen athe primary
reperfusion strategy, it should be
administered within 30 minutes
of hospital arrival (LOE: B)
In the absence of contraindications,
fibrinolytic therapy should be given
to patients with STEMI and onset of
ischemic symptoms with the
previous 12 hours when it is
anticipated that primary PCI can be
performed within 120 minutes of
FMC (LOE: A)
39. Selection of reperfusion strategy in
STEMI
• The prompt restoration of antegrade flow is the core aim of therapy
for STEMI.
• Delay in reperfusion is associated with higher mortality and
morbidity rates.
• Despite recent advances in pharmacological and interventional
reperfusion strategies, timely reperfusion still remains suboptimal
in patients with STEMI.
• Initial timely thrombolysis followed by early PCI to improve the
patency rates, labeled as PI strategy, is an attractive option of
reperfusion in STEMI and may bridge the gaps in systems of care.
• The contemporary studies from India report that only half the
hospitalized patients of STEMI undergo some form of reperfusion
42. Reperfusion utilisation in various
Indian STEMI/ACS registeries
STUDY Total no. Proportion
of STEMI (%)
AMONG ACS
THROMBOLYSIS
%
STK(%) TNK(%) PCI(%)
CREATE 20937 60.6 58.5 96.3 3.7 8
Kerala ACS 25748 37.0 41.4 84.8 15.2 12
HP ACS 5180 45.5 35.6 - - 0.9
44. • Re-occlusion of the IRA following successful reperfusion is
another important limitation of the thrombolytics and is due
to the plasminemia induced by the thrombolytics which in
turn activates thrombin formation.
• GUSTO trials of STK, alteplase and reteplase reported re-
occlusion rates of 4.3% during hospitalization at a median
time of 3.8 days.76
• Benefit of thrombolysis in STEMI is not yet established in
patients over 85 years of age.77
• Failed thrombolysis can be diagnosed by persisting or
worsening chest pain or less than 50% resolution of ST-
segment elevation after 90 min of thrombolysis in the lead
showing maximum ST-segment elevation at presentation.
• Rescue PCI is advocated for such patients and patients should
be transferred to a PCI-capable centre immediately.
45.
46. Strategies for improving pharmacological
reperfusion
Improved
antiplatelet co-
therapy
i.v. glycoprotein
IIb/IIIa inhibitors
Clopidogrel
Improved
antithrombotic
co-therapy
Direct thrombin
inhibitors
(hirudin,
bivalirudin) Low
mol.
weight heparins
(enoxaparin)
Improved
fibrinolytic
Agents
convenience
(tenecteplase,
retepla)
Risk of major bleeds
(tenecteplase)
47. ASPIRIN
• Irreversibly inhibits cyclooxygenase-1 and 2 enzymes
decreased formation of prostaglandin and thromboxane A2
inhibit platelet aggregation
ACC/AHA Recommendations
PPCI
162-325 mg loading dose (IB) followed by ASA 81 mg daily (indefinitely) (IA)
Fibrinolysis
162-325 mg loading dose (IA) followed by ASA 81 mg daily (indefinitely) (IA)
O’Gara PT et al. Circulation;
48. THIENOPYRIDINES
• Prevents P2Y12 component of ADP receptors on the
platelet surface blocking activation of GPIIb/IIIa
receptor complex, thereby reduce platelet aggregation
O’Gara PT et al. Circulation;
ACC/AHA Recommendations
Fibrinolytics:
1. Clopidogrel:
a. Age ≤ 75 years: 300 mg loading dose (IA) followed by 75 mg daily for at
least 14 days (IA) to 1 year in
absence of bleeding (IC)
b. Age >75 year: 75 mg once (IA) then daily for at least 14 days (IA)
up to 1 year (IC) in absence of bleeding
50. Enoxaparin improves infarct-related artery patency at 90
minutes
100
80
60
40
20
0
Enoxaparin
Unfractionated heparin
TIMI flow at 90 minutes
52.9
47.6
27.2
27.5
%
of
patients
TIMI 2
TIMI 3
Therefore, such a regimen was evaluated in ASSENT-3, the first large-scale trial to compare the two
antithrombotics in combination with fibrinolysis.
The ASSENT-3 Investigators. Efficacy and safety of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: the ASSENT-3
randomised trial in acute myocardial infarction. Lancet 2001; 358: 605–13.
Ross et al, Circulation 2001
Enoxaparin improves infarct-
related artery patency at 90
minutes
In the HART II study, 90
minutes after starting
therapy, patency rates (TIMI
flow grade 2/3) were 80.1%
and 75.1% in the enoxaparin
and UFH
groups, respectively.
Overall, enoxaparin
appeared to be at least as
effective as UFH as an
adjunct to
thrombolysis, with a trend
toward higher recanalization
rates and less reocclusion at
5 to 7 days.
51. ROUTINE MEDICAL THERAPIES
O’Gara PT et
al. Circulation; 2013; 127 DiPiro J. Acute Coronary Syndrome. In:
Therapy Indications Contraindications (CI) ACC/AHA
Recommendation
s
B-blockers Initiated in the
first 24 hours in
all patient s
without CI
CHF
, shock, reactive airway
disease, PR interval >0.24
secs, 2nd or 3rd degree AV
block, HR <60 bpm, SBP
<90 mmHg
IB
ACEI Initiated in the
first 24 hours for
patients with
anterior infarction,
LV dysfunction (EF
≤
0.40) or HF
SBP <100 mmHg,
intolerant to ACEI,
bilateral renal stenosis,
serum potassium >5.5
mmol/L, ARF
, Pregnancy
IA
ARB For patient
intolerant to ACE
Same as ACEI IB
52. ROUTINE MEDICAL THERAPIES
O’Gara PT et
al. Circulation; 2013; 127 DiPiro J. Acute Coronary Syndrome. In:
Therapy Indications Contraindications
(CI)
ACC/AHA
Recommendations
Aldostero
ne
Antagonis
ts
LVEF ≤ 0.40 and
either DM or HF
who are already on
ACEI and b- blockers
Hypotension,
hyperkalemia (serum
potassium >5.0
mmol/L), SCr >2.5
mmol/L or CrCl
<30 mL/min
IB
Statin High intensity statin
to all patients
without CI
Serum transaminase
3X ULN, Pregnancy,
active liver disease
IB
Nitroglycerin Patient with
ongoing ischemic
discomfort,
hypertension and
HF
Hypotension , use
of
sildenafil/vardenafi
l within 24 h or
tadalafil within 48
h
̶
53. 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.
55. CONCENSUS DOCUMENT: STEMI
INDIA/CSI RECOMMENDATION
Patients in rural areas, with
long transportation times to
PCI capable hospitals, will
utilise the Pharmaco-
invasive strategy-of
thrombolysis followed by
catheterization and PCI if
indicated, within 3–24 h of
thrombolysis.
■Goal: FMC to drug ≤ 30 min.
PROPOSED SPOKE &
HUB MODEL
Alexander et al, CSI Forum: Consensus Statement Framework
for a National STEMI Program: Consensus document
developed by STEMI INDIA, Cardiological Society of India and
Association Physicians of India, Indian Heart Journal, 67 (2015)
497–502
Guha et al, CSI:Position Statement for management ofSTEMI
in India, Indian HeartJournal, 2017;69:S63-S97
57. Pharmacoinvasive Therapy
5
7
Why unified approach ?
•
Logistic & economic difficulties of PPCI
Benefits of prehospital thrombolysis.
Overreaching importance of time to
•
•
reperfusion regardless of strategy.
Thrombolysis alone has serious limitations.
•
58.
59. STEPP AMI
Methods End points and results Conclusions
200 consecutive patients
with STEMI
Pharmacoinvasive therapy
in group A (n=45 )
Primary PCI in group B
(n=155)
Primary endpoint –
composite of death ,
cardiogenic shock,
reinfarction, repeat
revascularisation of culprit
artery and CHF at 30 days
11.1% in group A vs. 3.9% in
group B (p=0.07)
Infarct related artery patency
ant angiogram- 82.2% in
group A and 22.2% in group B
(p<0.001)
At the end of 2-year follow-
up, the initial benefit from
primary PCI seems to be
narrowed as more events
have occurred in the primary
PCI group (A-17.8% vs. B-
13.6%, p = 0.47).
Pharmacoinvasive strategy
can be implemented in
patients not selected for
primary PCI in India
60. • STREAM trial is one of the pivotal trials, which compared the
pharmacoinvasive strategy with primary PCI in STEMI patients. The
combined primary endpoint of death, shock, congestive heart
failure, or re-infarction was similar between the groups at 30 days
and at 1 year as in this study.
• The FAST-MI Registry evaluated the ‘‘real world’’ management of
1492 patients with STEMI in France, who sought medical treatment
within 12 h of symptom onset.
o 96% of the patients treated with fibrinolysis underwent coronary
angiography within 3–24h and 84% underwent subsequent PCI.
o Survival at 5 years was 88% in the fibrinolysis group and 84% for
those in PPCI group. (HR = 0.73; CI: 0.50–1.06; p = 0.1).
o However, pre-hospital fibrinolysis resulted in lower 5-year mortality
(HR = 0.57; CI: 0.36– 0.88), whereas in-hospital fibrinolysis was
associated with a tendency toward increased 5-year mortality (HR =
1.19; CI: 0.72–1.96) when compared to primary PCI.
61. CLINICAL TRIALS :PHARMACOINVASIVE
THERAPY
Methods End points and results Conclusions
212 STEMI patients.
Early routine fibrinolysis
(tenecteplase) (n=104)
versus
Primary angioplasty
with abciximab (n=108)
Epicardial and
myocardial reperfusion
(21 vs. 6%, p=0.003)
Extent of left
ventricular myocardial
damage (no difference)
6 mth cumulative
incidence of endpoint
(10 vs. 12%, p=0.57)
Early routine post
fibrinolysis angioplasty
safely results in better
myocardial perfusion
than primary
angioplasty. It is
equivalent to primary
PCI in limiting infarct size
and preserving left
ventricular function
62. Methods End points and results Conclusions
1059 high risk patients with
STEMI.
Fibrinolytic therapy in
centers with no facility of
PCI subjected to standard
treatment ( ± rescue PCI or
delayed angiography)
versus immediate transfer
and PCI within 6 hours
after fibrinolysis.
All received
aspirin,tenecteplase and
heparin or enoxaparin.
Clopidogrel recommended
Primary endpoint :
Composite of death,
reinfarction, recurrent
ischemia, new or
worsening CHF or
cardiogenic shock within
30 days.
PCI in 88.7% patients with
standard treatment after
median 32.5 hrs and
98.5% patients with early
PCI after median of 2.8
hrs.
30 day mortality in 11%
patients with routine PCI
and 17.2% patients with
standard treatment
(p=0.004)
In high risk patients with
STEMI and treated with
fibrinolysis , transfer for
PCI within 6 hours after
fibrinolysis associated
with significantly fewer
ischemic complications
63. Methods End points and results Conclusions
Nationwide registry in
France (223 centers)
1714 patients over 1 month
60% reperfusion therapy
33% PPCI and 29% with
intravenous thrombolysis
(18% pre-hospital)
Time to reperfusion
significantly less in
thrombolysis group than
PPCI (median 130 minutes
vs. 300 minutes)
In hospital mortality –
4.3% for thrombolysis and
5% for PPCI
Patients with thrombolysis
– 30 day mortality 9.2%
when PCI not used vs.
3.9% when PCI performed.
1 yr survival – 94% for
thrombolysis and 92% for
PPCI
When used early ,
pharmacoinvasive
therapy ( thrombolysis
with PCI) yields early and
1 yr. survival rates
comparable to PPCI
64. Methods End points and results Conclusions
266 patients with acute
STEMI living in rural areas
& more than 90-min
transfer delays to PCI.
Treated with tenecteplase,
aspirin, enoxaparin, and
clopidogrel.
Randomized to immediate
transfer for PCI or to
standard management in
the local hospitals with
early transfer, only if
indicated for rescue or
clinical deterioration
Primary outcome -
composite of death,
reinfarction, stroke, or
new ischemia at 12
months.
Primary end point reached
in 21% in early invasive vs.
27% in conservative group
(p=0.19)
Significantly reduced at 12
months in early invasive
vs. conservative group (6%
vs. 16%, p=0.01)
No difference in bleeding
or infarct size
Immediate transfer for PCI
reduced the rate of death,
reinfarction, or stroke at 12
months in patients with
STEMI treated with
thrombolysis and
clopidogrel in areas with
long transfer distances
65. Methods End points and results Conclusions
600 high risk patients < 75
years treated in hospitals with
half dose reteplase and
abciximab.
Immediate transfer for PCI vs.
management in local hospital
and transfer only if indicated
(extensive ST-segment
elevation, new-onset left
bundle branch block, previous
myocardial infarction, Killip
class >2, or left ventricular
ejection fraction < or =35%)
Primary outcome was a
composite of death,
reinfarction, or refractory
ischemia at 30 days.
Occurred in 4.4% in
immediate PCI group vs.
10.7% in standard treatment
group (p=0.004)
Bleeding (3.4% vs. 2.7%,
p=0.47)
Stroke (0.7% vs. 1.3%,
p=0.50)
Immediate transfer for PC
improves outcome in high
patients with STEMI treat
a non interventional cent
with half dose abciximab
reteplase
66. Observational study comparing Pharmaco-invasive strategy
with primary PCI in patients presenting with ST elevation MI
to a tertiary care centre in India
65
Alex et al (CMC, Vellore) Journal of PG Med 2018; 64:2; 80-85
Results
At 1 month follow up, incidence rate for primary endpoints was 5 events per
43 patients (11.6%) in pharmaco-invasive arm & 18 events per 95 patients
(18.9%) in primary PCI arm, a difference of
– 7.3% (95% confidence interval: 18.5, 7.1).
Pharmaco-invasive strategy as compared with primary PCI in the management
of STEMI was equivalent in terms of composite primary outcome.
There was no significant difference between the secondary
outcomes between the two groups.
Use of thrombus aspiration device and in turn the thrombus
burden was significantly lower in the pharmaco-invasive arm.
67. Observational study comparing Pharmaco-invasive strategy
with primary PCI in patients presenting with ST elevation MI
to a tertiary care centre in India
Alex et al (CMC, Vellore) Journal of PG Med 2018; 64:2; 80-85
Conclusion
Pharmaco-invasive strategy was as good as
primary PCI in STEMI, in the setting, where
primary PCI may be delayed or not possible at all
due to financial and logistic constraints.
6
7
68. SUMMARY OF MANAGEMENT OF
STEMI IN PCI NON CAPABLE CENTRE
PCI non capable centres in India are an important component in delivery of efective
STEMI care
They help in early diagnosis ,triaging ,initiating immediate pharmacotherpy and giving
supportive treatment ,thrombolyisng (if so deemed )and transferring patients
Thrombolyis can be intiated by a qualified medical person at a centre where facility of
ECG ,defibrillator and ressuscitation measure are available
Occasionally they may be the sole centre offering thrombolysis and/or medical
management
They need to act in tandem with other components of STEMI care for effective patient
care
They can be a wide spectrum in terms of their nature ranging from small clinics with
physicians to larger hospitals. On basis of management strategy they are broadly of
two types PCI non capable centres that do an ECG and transfer and PCI non capable
centres which do an ECG thrombolyse the patients and consider transfering them to a
PCI capable centre when feasible
69. Management of STEMI: late presenters
(more than 24 h)
• Any patient presenting 24h after onset of chest pain due to STEMI
represents a failure of the prevailing STEMI care-system. The “total
ischaemic time” (symptom onset to initiation of reperfusion therapy)
has two components:
• (a) Patient delay and
• (b) System delay (including FMC to diagnosis and diagnosis to
initiation of reperfusion therapy).
• Proportion of late comers (>12 h) is significant even in data from the
west: 11% in GRACE study and as high as 40% in the TETAMI
study.62
• In an Indian study162 done from Uttar Pradesh, 32.3% patients with
STEMI had presented after 24 h
70.
71. Major components of time delay between onset of infarction
and restoration of flow in the infarct-related artery.
72. TAKE HOME MESSAGE
Chopra H.K., Challenges in STEMI care in India &The RealWorld, Indian
Heart Journal, 2015;67:15-16
■ In India, <10% of STEMI patients receive PCI, primary PCI
cannot and will not be the answer for every patient of STEMI.
■ Rely on thrombolysis, especially bolus agents like Tenecteplase
(TNK),and promptly shifting the patients to a PCI capable centre.
■ Considering the efficacy, a strategy of prehospital
thrombolysis should be ideally suited for Indian conditions.
■ Considering the diverse Indian conditions, a combination of
strategies could be more appropriate.
73. TAKE HOME MESSAGE
Chopra H.K., Challenges in STEMI care in India &The RealWorld, Indian
Heart Journal, 2015;67:15-16
■ Primary PCI: preferred strategy in hospitals, offering
24x7 emergency PCI services and the patient can reach the
available STEMI Care PPCI capable centres <90min
■ Delay in access to PPCI capable centre thrombolysis
with TNK± management of complications organized
way of early transfer for early angiogram and PCI.
■ For rest of rural India, prehospital thrombolysis with TNK
could be the ideal strategy.
■ Needed: “Integrated STEMI Care Systems”.
■ Need of the Hour: Emergency (108) ambulances, equipped
with a facility to do an ECG and transmit to a central
station, wherein a cardiologist can ascertain STEMI.
74. CONCLUSION
7
4
Time is Essence
- Time is “Muscle”
- Valid with both PCI & Thrombolysis.
Choice is Reperfusion
- Timely Reperfusion is more important than
the choice of Reperfusion.