Evaluation and Outcome of Patients of Stemi
with Acute Total Occlution of Coronary Artery
in The Setting of Primary PCI, Pharmaco Invasive
PCI and Delayed PCI
Kaushik Paul, Sudeb Mukherjee*, Saumyajit Ghosh and SC Mandal
Department of Cardiology, ICVS, IPGME&R, India
Submission: September 18, 2018; Published: December 12, 2018
*Corresponding author: Sudeb Mukherjee, Department of Cardiology, ICVS, IPGME&R, 4/28 A, Jadavgarh, Dr. BC Roy Road, Kolkata-700078, West
How to cite this article: Kaushik P, Sudeb M, Saumyajit G, SC Mandal. Evaluation and Outcome of Patients of Stemi with Acute Total Occlution of Coronary Artery
in The Setting of Primary PCI, Pharmaco Invasive PCI and Delayed PCI. J Cardiol & Cardiovasc Ther. 2018; 12(5): 555846. DOI: 10.19080/JOCCT.2018.12.555846
Introduction: Better medical facilities have come up and coronary interventions and cardiac surgeries are being performed in nearly all
major Indian cities. Still a vast number of patients are not able to get the benefit of primary Percutaneous Coronary Intervention (PCI). Most of
them can be managed with pharmacoinvasive or delayed PCI, both of which can be beneficial in the long term from prognostic point of view.
Objectives: The present study was therefore carried out to evaluate and compare patients of STEMI with acute total occlusion of coronary
artery in the setting of Primary PCI, PharmacoInvase PCI and Delayed PCI in terms of Left Ventricular Ejection Fraction (LVEF) and mortality at
before discharge at 1 month and 6 months.
Methods: A total of 33,30and 31in the three different categories of PCI patients were studied in detail and analysed accordingly.
Results:Majority of patients have almost same epedemilogical background. In most of the patients (71.4%) Ejection Fraction was between
35-53%. Regarding Ejection fraction fraction improvement Primary PCI showed significant improvement in when preintervention Ejection
fraction was compared with Post intervention Ejection Function just before discharge, at 1 month and 6 months. In Pharmacoinvasive PCI
group there was no significant improvement when preintervention Ejection fraction was compared with Post intervention Ejection Function just
before discharge but showed significant improvement at 1 month and 6 months. In Delayed PCI group there was no significant improvement
when preintervention Ejection fraction was compared with Post intervention Ejection Function just before discharge but showed significant
improvement at 1 month and 6 months. Regarding mortality Primary PCI had more no. of mortality compared with the other two groups.
At the most severe end of the spectrum of acute coronary
syndromes is ST-Segment Elevation Myocardial Infarction
(STEMI), which usually occurs when a fibrin-rich thrombus
completely occludes an epicardial coronary artery. The
diagnosis of STEMI is based on clinical characteristics and
persistent ST-segment elevation as demonstrated by 12-lead
electrocardiography. Patients with STEMI should undergo rapid
assessment for reperfusion therapy, and a reperfusion strategy
should be implemented promptly after the patient’s contact with
the health care system. Two methods are currently available for
establishing timely coronary reperfusion: primary percutaneous
coronary intervention and fibrinolytic therapy . Percutaneous
coronary intervention is the preferred method but is not always
available. ST-segment elevation myocardial infarction (STEMI)
is characterized by total occlusion of the infarct-related artery
in contrast to Unstable Angina or Non-ST elevate d Myocardial
Infarction (UA/NSTEMI) . Evidence from several randomized
clinical trials during the past two decades has established the
importance of the open artery theory, which states that prompt
and complete restoration of flow in the occluded artery decreases
infarct size, preserves Left Ventricular (LV) function, and improves
survival rates. The role of Percutaneous Coronary Interventions
(PCIs) in the early hours of an STEMI can be divided into primary
PCI, Pharmacoinvasive PCI, and Delayed PCI .
Primary PCI can be defined as coronary angioplasty/stenting
without prior administration of fibrinolytic agents or GPIIb/
IIIa antagonists. A pharmaco-invasive strategy can be defined as
pharmacological reperfusion (using fibrinolytic agents) with an
‘invasive back-up’, which means that patients are transported to
a PCI hospital for either immediate rescue PCI in case of failed
fibrinolysis or nonurgent coronary angiography to determine the
need for additional treatment of the culprit lesion (PCI or bypass surgery). This strategy has been shown to be superior to a very
conservative approach of in-hospital fibrinolysis with transfer to
a PCI centre only in case of failed thrombolysis. Delayed PCI of
the infarct artery is performed in patients treated with an initial
noninvasive strategy (i.e., with fibrinolysis or without reperfusion
therapy) who become unstable because of the development
of cardiogenic shock, acute severe heart failure, or unstable
post infarction angina, provided that invasive management is
not considered futile or inappropriate . Delayed PCI also
encompasses interventions performed for fibrinolytic failure 
or infarct artery re-occlusion, as part of an invasive strategy for
patients after successful fibrinolysis, and for patients who did not
receive reperfusion therapy but who did demonstrate significant
residual ischemia during hospitalization. Primary PCI of the infarct
artery is preferred to fibrinolytic therapy when time-to-treatment
delays are short and the patient presents to a high-volume, wellequipped
center with experienced interventional cardiologists
and skilled support staff. Compared with fibrinolytic therapy,
primary PCI produces higher rates of infarct artery patency, TIMI
3 flow, and access site bleeding and lower rates of recurrent
ischemia, reinfarction, emergency repeat revascularization
procedures, intracranial hemorrhage (ICH), and death .
Primary PCI within the recommended guidelines time window
cannot be offered to all patients, not even with a well-functioning
network of ambulances and hospitals. For some of these patients,
especially those presenting very early without an increased risk
of bleeding, immediate lytic therapy (in the ambulance or the
emergency department of the community hospital) is still the
best treatment, provided they can be transferred to a PCI hospital
for rescue PCI, or for angiography, in order to decide on final
treatment of the culprit lesion (PCI, bypass surgery or in some
cases no mechanical treatment). Ideally, these patients should be
transported to the PCI hospital immediately after starting lytic
therapy. On arrival at the PCI hospital, a new ECG should be taken,
and the decision made to perform angiography either immediately
or within 24 hrs. Even in patients who has Cardiogenic shock or
acute severe HF that develops after initial presentation.
Keeping all the above-mentioned guidelines in mind our
objective is to evaluate and find out the outcome in all these various
group of patients who are undergoing different types of procedure
which are best in their time frame at initial presentation, after one
month and after 6 months of follow up.
Study setting: The study was conducted at the Department of
Cardiology, IPGME&R, S.S.K.M. Hospital, Kolkata.
Study period: Study was conducted from November 2016 to
Study design: Hospital based Prospective type of study
(observational cohort study).
Study population: The study included a consecutive series of
33 patients with acute STEMI who presented within the first 24 h
after symptom onset who were treated with Primary PCI between
November 2015 and October 2016, 30 patients who were treated
with Pharmacoinvasive PCI and 31 patients who were treated
with Delayed PCI.
Inclusion Criteria: 1) Clinical symptoms of MI. 2) Either ≥1
mm ST Elevetion in 2 contiguous leads with acute total occlusion
The clinical characteristics, electrocardiographic parameters,
angiographic and procedural was collected using a pre-designed,
pre-tested and semi structured schedule by the investigator
himself. Informed consent was taken from all the patients.
Echocardiography was done before, and at the time of
discharge, 30 days after and at 6months. Primary objective is
to evaluate the Left Ventricular function at onset, at the time of
discharge after PCI, 1 month after PCI and 6 months after PCI and
mortality was observed Post PCI, 1 month and 6 months after
The primary end point of the study was comparison of Ejection
Fraction in the 3 groups and occurrence of death from any cause.
The follow-up information was collected by a phone call/outpatient
visit till 6 months. Patients who had cardiac complaints
underwent complete clinical, ECG, and laboratory evaluation.
Information on deaths was obtained from hospital records, death
certificates or phone contact with relatives of the patient or the
patient’s referring physician.
All categorical variables are depicted using relative frequency
distributions. Continuous data are presented as the mean ± SD, the
median (with 25th-75th percentiles) or counts and proportions
(percentages) as appropriate. The normality of data distribution
was analyzed using a Kolmogorov-Smirnov test. Normally
distributed, continuous variables are expressed as means (±SD),
while other continuous data are expressed as median with Inter
Quartile Range (IQR). Categorical variables were compared
using the chi-square statistics or Fisher’s exact test for, while the
1-way ANOVA or Kruskal-Wallis test was used for continuous and
ordinal variables, as appropriate. The following variables were
included in the model: age, gender, Killip class (III–IV vs I–II),
preprocedural TIMI flow (3 vs 0, 1, or 2), postprocedural TIMI flow,
anterior location, total ischemic time, and diabetes. β coefficient
was calculated to explain the variation in dependent variable by
independent variables. Independent predictors of mortality were
analyzed using multivariate logistic regression analysis. Odds
ratio was calculated to the following variables were included in
the model: age, gender, Killip class, postprocedural TIMI flow, and risk factors. Event rates were determined and displayed with
Kaplan–Meier methodology and compared with the log-rank test.
Statistical analyses were performed using Statistical Package for
Social Sciences, version 20.0and Stata/SE, version 9.2Texas). p
Values <0.05 were considered statistically significant.
total of 36 STEMI patients underwent primary PCI at our
institution between 2016- 2017. We excluded 2 patients who
underwent primary PCI involving left main coronary artery or
a bypass graft and 1 patient because of missing ECG recordings.
Total 33 patients were included of which 3 patients died after
procedure before discharge and ejection fraction could not be
compared post procedure before discharge, at 1 month and 6
months post discharge. In the pharmacoinvasive group 30 patients
were eligible for the study and recruited. In the delayed PCI group
also 31 patients were eligible for the study and recruited.
A total of 33 patients were studied in primary PCI group.
The minimum and maximum value for age was 45 and 69
years. The mean age is 59.21 with standard deviation of 5.8. In
Pharmacoinvasive group minimum value for age was 42 and
maximum was 71. The mean age was 56.43 with a standard
deviation of 7.22. In delayed PCI group minimum age was 48 and
maximum was 68 years, the mean age was 59.03 with a standard
deviation of 6.24. The difference of mean between the three group
was not statistically significant with a p value of 0.74.
87.9% of the patient in primary PCI group was male and 12.15
were female. In the pharmacoinvasive and delayed group male and
female percentage were 80%:20% and 83.9%16.1% respectively.
Symptomatically almost all presented with severe chest pain.
Almost all the patients had some past history: majority had
Smoking followed by hypertension, Diabetes Mellitus. 1/7th
(15.2%) of patients had positive family H/O cardiovascular disease.
Of the all study subjects, 50-80% had anterior wall MI if all
the three groups are considered. Distribution of subjects according
to CAG findings (%) has been shown in Table 1.
When comparing LVIDD in between the different groups
shows the following results. In the PPCI group (n= 33) the mean
was 48.63 mm (SD-2.70, SE-0.47); pharmacoinvasive group
(n=30) the mean was 47.06 mm (SD-6.23. SE-1.13) and in the
Delayed PCI (31) group mean was 50.87(SD-5.71, SE-1.02).
When comparing LVIDS in between the different groups the
results were with mean value of 37.24mm (SD-3.25, AE-0,56),
34.33 mm (SD-5.81, SE 1.06) and 38.67mm (SD-4.96, SE-0.89) in
the PPCI, pharmacoinvasive and Delayed respectively.
When comparing the Ejection Fraction between different
groups before intervention, revealed mean value of 41.78%
(SD-5.81, SE-1.01) in the PPCI group. For pharmocoinvasive and
delayed group it was 48.43% (SD-5.44, SE-1.01), and 46.93% (SD-
6.21, SE- 1.11) respectively.
When comparing the Ejection Fraction in Primary PCI in
different time frame the following values were obtained (Table 2).
Comparison between PreIntervention EF and Post intervention
EF before discharge in Primary PCI group revealed improvement
from mean of 42.60% to 46.76% with statistical significant p
value of 0.0025. at 1 month mean EF was 52.13 (p value 0.0001)
and at after 6 months EF was 54.80 with p value 0.0001 compared
to pre-interventional value. However, Comparison between Post
intervention EF after 1 month of discharge and Post intervention
EF after 6 months of discharge did not reveal statistical significant
When Ejection Fraction was compared in Pharmacoinvasive
Group in different time period the following results were obtained
(Table 3). Comparison between PreIntervention EF and Post
intervention EF before discharge revealed improvement in EF
from 48.36% to 51.06% with p value of 0.06. At 1 month the LVEF
was 52.86% (p value of 0.0047) and at 6 months 54.23% with p value of 0.0007. Comparison between Post intervention EF before
discharge and Post intervention EF after1 month of discharge
did not reveal significant value (p=0.2540) and at 6 months
When comparing the Ejection fraction in Delayed PCI (Table
4) LVEF improvement was not statistically significant between
PreIntervention EF and Post intervention EF before discharge.
(46.93% to 49.35% with p value of 0.1177). However, at 1 month
and 6 months the improvement was significant with p value of
0.0011 and at 6 months p=0.0001 respectively.
Comparison between Post intervention EF before discharge
and Post intervention EF after 1 month of discharge did not reveal
any significant improvement (p=0.062). Comparison between
Post intervention EF before discharge and Post intervention EF
after 6 month of discharge revealed improvement with significant
p value of 0.0013.
Kaplan–Meier survival curves was drawn for Ejection
Fraction. Quantitative variables were transformed into categorical
variables, as appropriate.
Kaplan-Meier Survival Probability analysis was made to
estimate time-to-Death and compare survival experiences of
different groups. The lengths of the horizontal lines along the
X-axis of serial times represent the survival duration for that
interval. The interval is terminated by the occurrence of Death.
The cumulative probability of surviving a given time is seen on
the Y-axis. The vertical distances between horizontals illustrate
the change in cumulative probability as the curve advances.
The survival curves were compared statistically by testing
the null hypothesis i.e. there is no difference regarding survival
among groups. This null hypothesis was statistically tested by
another test known as log-rank test and Cox proportion hazard
test In log-rank test we calculated the expected number of death
in each. The test calculates the chi-square (X2) for each event time
for each group and sums the results. The summed results for each
group are added to derive the ultimate chi-square to compare the
full curves of each group Comparison of survival curves by log
rank test found that though Death occurred in Primary PCI group,
difference was not statistically significant for Ejection Fraction
In our study we found that majority (97%,96.7%,80.6%)
had Smoking followed by hypertension (60.6%,26%,41.9%),
Diabetes Mellitus (21.2%,6.7%,6.5%) in each group of PPCI,
Pharmacoinvasive and Delayed PCI respectively. In Indian
subcontinent percentage of smokers are quite high and this
has been reflected in our data. 1/5th (17.9%) of patients had
positive family H/O cardiovascular disease. This high prevalence
of hypertension, Diabetes positive in the study group are in
accordance with the risk factors of AMI. The prevalence of diabetes
has increased in last two decades and India has earned the dubious
distinction of becoming the world’s capital of coronary heart
disease and diabetes. There was statistical significant difference
between mean systolic BP when Primary and Pharmacoinvasive
group, Pharmacoinvasive and Delayed PCI group were compared
but not between Primary and Delayed group. Mean BMI came out
to be 25, 24.5, 25.77 respectively. For many Asian populations,
additional trigger points of BMI for public health action were
identified, and in this study, more than half (55.4%) of the patients
falls in the category of increased risk of co-morbid conditions.
In the present study, there were more patients with Anterior
wall MI (78.78%,76.66%,54.83%) as compared to Inferior wall
(21.21%,23.33%,45.16%). Gjin Ndrepepa et al also had Similar
findings in their study (Anterior wall MI- 61.6%). Main culprit vessel
was Left Anterior Descending Artery (44.64%,47.92%,47.5%)
followed by Right Coronary Artery (28.78%,20.88%,22.5%) and Left Circumflex artery (28.57%,31.25%,30% respectively there
was no significant difference in TIMI Score in between the three
groups. Majority of patients were in Killip Class I and II.
Mean LVEF in each individual group before and after
intervention has been depicted in (Table 1-3). Similar findings
were seen in a study conducted by Kaul U et al. , they found
that young Indian patients with MI and obstructive CAD have a
high frequency of coronary risk factors, especially smoking and
severe multiple-vessel disease.
When comparing the ejection fraction in primary PCI group
and all the four point of time was considered then P value was
found to be statistically significant showing that Primary PCI
had significant benefit as per Ejection fraction is considered.
Comparison between Preintervention group and Post Intervention
group before discharge at one month and at 6 month showed
significant benefit with P value of 0.0025, P<0,0001), (P<0,0001).
Comparison between Post Intervention group before discharge
and after 1 month of discharge and at 6 months also found
statistically significant benefit with P value0,0001. But there
was no statically significant benefit with p value of 0.07 when
improvement from 1 month to 6 months is considered.
When comparing the ejection fraction in Pharmacoinvasive
PCI group and all the four point of time was considered then
P value was found to be statistically significant with P value
of 0.063. When Preintervention Group was compared with
PostIntervention after 1 month (P<0,0047) after 6 (P<0,0007).
When comparing the ejection fraction in Delayed PCI group
and all the four point of time was considered then P value was
found to be statistically significant.
When primary PCI is compared with Pharmacoinvasive PCI
statically significance was found in Preintervention(P<0.0001)
group and Post Intervention group(P<0.0004) before discharge
but not between Post Intervention Group at 1 month(P=0.63)
and at 6 month(P=0.74).Our study correlate well with study
performed by TimoBaks, Robert-Janvan Geuns et.al who found a
marked increase in overall mean EF was observed from 48±11%
at baseline to 55±9% at follow-up .
The main endpoint of the current study was the occurrence
of death during a 6 months follow-up after Primary PCI,
Pharmacoinvasive PCI and Delayed PCI. Among Primary PCI
group there was initially 33 patients 3 Patient died Predischarge
although there was no evidence of death after discharge in
Primary PCI group over 6 months follow up. In PharmacoInvasive
PCI there was no death post PCI over 6 months follow up. In
delayed PCI also there was no death Post PCI over a period of 6
month. Cardiac event occurred in males more than females and
who had risk factors like smoking, diabetes or hypertension and
anterior wall MI with low ejection fraction.
In recent years, significant changes have occurred in the
strategy of reperfusion therapy in patients with STEMI that
have included a more liberal use of Primary PCI, the routine use
of stents and glycoprotein IIb/ IIIa inhibitors, the creation of
integrated networks for the treatment of STEMI, and the extension
of revascularization procedures to a broader population who
present with a greater clinical risk profile than previously [9-11].
Several data indicate that the main determinant of the recovery of
LV function  and ultimately of the prognosis  in patients.
However, primary PCI is performed at less than 25% of acute care
hospitals even in the United States [14,15].
Even as CVD rates skyrocket, the availability of better
cardiology facilities and dedicated cardiac centres have come
as a welcome relief and India has seen a big leap in the fields of
interventional cardiology and cardiac surgery in recent times .
Many patients with myocardial infarction with ST-segment
elevation present to hospitals that do not have the capability of
performing PCI and therefore cannot undergo PCI within the
timelines recommended in the guidelines  instead, they
receive fibrinolysis as the initial reperfusion therapy.
A mounting body of evidence suggests that delayed
stent implantation is also helpful to patients as adjunctive
anticoagulation and antiplatelet therapy have allowed thrombus
burden meltdown [17,18].
This study showed the same kind of predilection that
pharmacoinvasive and Delayed PCI approach where applicable
can be of greater help considering the improvement of LV function.