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Mædica - a Journal of Clinical Medicine
MAEDICA – a Journal of Clinical Medicine
2013; 8(2): 103-107
O RIGINAL
PAPERS
Early Clinical Outcomes of Primary
Percutaneous Coronary
Intervention in Bharatpur, Nepal
Laxman DUBEYa; Rabindra BHATTACHARYAa; Sogunuu GURUPRASADa;
Gangapatnam SUBRAMANYAMa
a
College of Medical Sciences and Teaching Hospital,
Department of Cardiology, Chitwan, Nepal
ABSTRACT
Background: Primary percutaneous coronary intervention represents one of the cornerstone management modalities for patients with acute ST-elevation myocardial infarction and has undergone tremendous growth over the past two decades. This study was aimed to determine the early clinical outcomes of
primary percutaneous coronary interventions in a tertiary-level teaching hospital without onsite cardiac
surgery backup.
Methods: This was a prospective descriptive study which included all consecutive patients who were
admitted for primary percutaneous coronary interventions between March 2011 and January 2013 at
the College of Medical Sciences and Teaching Hospital, Bharatpur, Nepal. Total 68 patients underwent
primary percutaneous coronary interventions as a mode of revascularization. The primary end point
of the study was to identify in-hospital as well as 30-day clinical outcomes of primary percutaneous
coronary interventions.
Results: The mean age was 56.31 ± 11.47 years, with age range of 32 years to 91 years. Of the 68
primary percutaneous coronary interventions performed, 15 (22.05%) were carried out in women and
10 (14.70%) in patients over 75 years of age. Primary percutaneous coronary intervention for anterior
wall myocardial infarction was more common than for non-anterior wall myocardial infarction (55.88%
vs. 44.12%). Proximal artery stenting was performed in 38.50% and the non proximal artery stenting
in 61.50%. The outcomes were mortality (5.88%), cardiogenic shock (5.88%), contrast-induced nephropathy requiring dialysis (2.94%), arrhythmias requiring treatment (4.41%), early stent thrombosis
(2.94%) and minor complications (14.70%).
Conclusion: Primary percutaneous coronary intervention improves the early clinical outcomes in
patient with acute ST-elevation myocardial infarction. Despite having no onsite cardiac surgery backup,
primary percutaneous coronary intervention was feasible with acceptable complications in a tertiarycare teaching hospital.
Keywords: Primary percutaneous coronary intervention; acute ST-elevation
myocardial infarction; clinical outcomes; teaching hospital
Address for correspondence:
Laxman Dubey, College of Medical Sciences and Teaching Hospital, Department of Cardiology, Bharatpur-10, Chitwan, Nepal.
E-mail: [email protected]
Article received on the 9th of April 2013. Article accepted on the 10th of May 2013.
Maedica
A Journal of Clinical Medicine, Volume 8 No.2 2013
103
OUTCOMES OF PRIMARY PERCUTANEOUS CORONARY INTERVENTION
INTRODUCTION
T
he cornerstone of treatment of STsegment elevation myocardial infarction (STEMI) patients is the rapid and
effective restoration of blood flow.
Primary percutaneous coronary intervention (PPCI) in patients with acute STEMI
has now become an established and preferable
method of revascularization. With the combination of catheter technique, experienced operators and the development of new devices
and medications, the procedural outcomes of
PPCI have improved, and as compared to the
fibrinolytic therapy, PPCI has been shown to be
the superior strategy resulting in a markedly
lower occurrence of short-term major adverse
cardiac events (1,2).
Our center is a tertiary-level hospital without cardiac surgery backup which has provided
interventional cardiology services since 2011.
There are only a few hospitals in Nepal which
provide PCI service, and there is limited data
on the outcomes of PPCI in our cohort of patients. Moreover, a limited number of studies
have reported favorable outcomes for PPCI in
hospitals without onsite cardiac surgery (3,4).
The objective of the present study was to evaluate the in-hospital as well as 30-day clinical
outcomes in a cohort of unselected consecutive patients treated with PPCI since over last 2
years. 
METHODS
A
ll patients who underwent PPCI for the
STEMI from March 2011 to January 2013
in our center were included in this study. Total
68 patients had undergone PPCI with stent deployment, where PCI was performed as a mode
of reperfusion, through femoral as well as radial
route. Both written and informed consent were
obtained. Patients who had prior PCI at other
hospitals and all lesions treated with plain old
balloon angioplasty were excluded.
All patients received loading dose of aspirin,
clopidogrel and atorvastatin in the emergency
room. After coronary angiography, if the anatomy was eligible for PCI, additional heparin
(100 units/kg) was administered intravenously
and PCI was done according to the standard
guidelines. However, strategic planning of the
procedure and device selection was dependent on the operator’s discretion. After the
PCI, patients received 150-300 mg of aspirin
104
Maedica
A Journal of Clinical Medicine, Volume 8 No.2 2013
daily, clopidogrel 75 mg twice daily for the first
month thereafter once daily, and atorvastatin
20-80 mg daily with other standard medications. After discharge from the hospital, patients were asked to come for follow-up at 30
day and also they were followed by a phone
survey for 30 days.
STEMI was diagnosed on ECG changes with
ST segment elevation or new onset left bundle
branch block. PPCI was defined as the coronary intervention procedure for the treatment
of acute STEMI performed in an emergency
setting. The data collected included age, gender, past medical history of hypertension (systolic blood pressure ≥140 mm Hg, and/or diastolic pressure ≥90 mmHg, and/or on medication),
dyslipidemia (fasting cholesterol ≥200 mg/dl
and/or low density lipoprotein ≥130 mg/dl or
on treatment), diabetes (defined as a fasting
glucose >126 mg/dl and/or on treatment) and
smoking; and the in-hospital as well as 30 day
clinical outcomes were recorded. The clinical
outcomes included were mortality, arrhythmia
requiring treatment, cardiogenic shock, stroke,
contrast induced nephropathy (CIN) requiring
dialysis, and minor complications. CIN was defined as the impairment of renal function with
either a 25% increase in serum creatinine from
baseline or 0.5 mg/dL increase in absolute value, within 48 hours of PCI. 
STATISTICAL ANALYSIS
D
escriptive statistics of different variables of
the sample population were computed.
Means and standard deviations were calculated for quantitative variables like age and hospital stay. Categorical variables reported in percentages for the gender, history of dyslipidemia,
diabetes, hypertension and smoking, and clinical outcomes were considered. Frequency of
complications was noted as the primary outcome of the study. The statistical package for
social sciences version 13.0 (SPSS Inc., Chicago, IL, USA) was used for data analysis. P values
<0.05 were considered to be statistically significant. 
RESULTS
S
ixty eight consecutive patients who underwent PPCI were included in the study. The
mean age was 56.31±11.47 years, with age
range of 32 years to 91 years. Baseline clinical
characteristics of the patients are shown in Ta-
OUTCOMES OF PRIMARY PERCUTANEOUS CORONARY INTERVENTION
ble 1. Of the 68 PPCIs performed, 22.05%
were carried out in women and 14.70% in patients over 75 years of age. Past medical history
showed diabetes mellitus in 20 (29.41%), systemic hypertension in 41 (60.29%), dyslipidemia in 7 (10.29%) and current or former
smoking in 52 (76.47%) patients. Because
more than one stent was required in some patients, total stents used were 76 and in all patients cobalt-chromium bare metal stents were
deployed. Mean hospital stay duration was
5±2 days. Characteristics of culprit lesion
stenting are shown in Table 2.
Among the clinical outcomes of PPCI, cardiogenic shock in 4 (5.88%), CIN requiring dialysis in 2 (2.94%), arrhythmias requiring treatment in 3 (4.41%), minor complications which
were managed conservatively in 10 (14.70%),
early stent thrombosis in 2 (2.94%), and death
in 4 (5.88%) patients was witnessed. There
were no occurrences of stroke or transient ischemic attack. Clinical outcomes of the patients
are shown in Table 3. PPCI for anterior wall
myocardial infarction was more common than
for non-anterior wall myocardial infarction
(55.88% vs 44.12%). Direct stenting was performed in 28 (41.18%) patients.
Comparing the type of vessel treated there
was no significant difference between proximal
LAD artery stenting as compared to proximal
LCX/ RCA stenting (34.15% vs. 42.86%) and
also the non proximal LAD artery stenting as
compared to non proximal LCX/RCA stenting
(65.85 vs. 57.14%). But the number of non
proximal artery stenting was significantly higher
as compared to the proximal artery stenting
(66% vs. 34% and 57% vs. 43% in LAD and
LCX/RCA respectively, P<0.05) Table 4. 
Age
Mean
56.31±11.47
Range
32 to 91 years
MI location
Anterior wall
38 (55.88%)
Inferior wall
24 (35.29%)
Others
6 (8.83%)
Smoker
52 (76.47%)
Type-2 Diabetes
20 (29.41%)
Systemic hypertension
41 (60.29%)
Dyslipidemia
7 (10.29%)
Hospital stay duration (days)
5±2
TABLE 1. Baseline characteristics of the patients treated with
primary PCI.
MI: Myocardial Infarction.
LAD
LCX
(n=41)
(n=9)
Proximal
14
4
Mid
22
0
Distal
5
5
TABLE 2. Characteristics of culprit lesion stenting.
RCA
(n=26)
11
9
6
LAD: Left anterior descending coronary artery; LCX: Left circumflex coronary
artery; RCA: Right coronary artery.
Variables
n=68 (%)
Cardiogenic shock
Arrhythmias requiring treatment
CIN requiring dialysis
Early stent thrombosis
Minor complications
Death
TABLE 3. Clinical outcomes.
4 (5.88 %)
3 (4.41%)
2 (2.94%)
2 (2.94%)
10 (14.70%)
4 (5.88%)
CIN: Contrast induced nephropathy; Minor complications include groin
hematoma, chills and rigor, vasovagal reaction, contrast induced nephropathy
not requiring dialysis.
LCX and
P value
RCA
Proximal (n=41)
14 (34.15%) 15 (42.86%)
NS
Non Proximal (n=35)
22
0
9
P value
<0.05
<0.05
TABLE 4. Proximal and non proximal vessel stenting details.
LAD
LAD: Left anterior descending coronary artery; LCX: Left circumflex coronary
artery; RCA: Right coronary artery.
DISCUSSION
T
hrombolytic therapy and PPCI are used as
reperfusion strategies in acute STEMI. However, several randomized trials and meta-analyses have shown that PPCI is superior to thrombolysis in the treatment of STEMI in terms of
death, reinfarction and stroke (1,5). Therefore,
PPCI is now considered to be a superior strategy in the management of patients with acute
STEMI and has undergone tremendous growth
over the past two decades (1).
There has been a good progress in the field
of interventional cardiology and the number of
PCI procedures has increased considerably in
Nepal in recent years. Till date there are only
two hospitals outside the capital city Kathmandu that are equipped with a cardiac catheterization laboratory facility, and this number is
too small to satisfy the medical needs of patients with CAD. This procedure has been carried in College of Medical Sciences since 2011.
We started doing PCI without cardiac surgery
backup and the first PPCI was done in June,
2011.
Initially, PCI was performed at clinical sites
with surgical backup as complication rates and
need of urgent surgery were high. With the im-
Maedica
A Journal of Clinical Medicine, Volume 8 No.2 2013
105
OUTCOMES OF PRIMARY PERCUTANEOUS CORONARY INTERVENTION
provement in catheter technique, experienced
operators and the development of new devices, overall complication rates of PCI are low
and emergency cardiac surgery rates resulting
from PCI procedure are at 0.2% (6).
Our study revealed that the early clinical
outcomes including death following PPCI in a
newly emerging cardiac catheterization laboratory is considerable low. Our study represents
the analysis of PPCI in a tertiary care hospital
from an underdeveloped world without on-site
cardiac surgery backup, and reflects a more
challenging cohort of patients than those included in randomized controlled trials (7, 8).
Our study had in-hospital as well as early 30
day mortality of 5.88%, which is slightly higher
as compared to international data which
showed in-hospital mortality of 3% in ASSENT
4 trial (9) and Kenney and colleagues who reported 30-day mortality of 1.47% in 546 PCI
procedures performed in a low volume center
(10). However, mortality following PPCI in our
study is comparable to another study conducted in the National Heart Center, Nepal which
showed in hospital mortality of 7.5% (11).
Among four deaths, two patients died who
were in cardiogenic shock and one patient
died next day due to retroperitoneal hematoma. One patient died 3 days after discharge at
home who had multivessel disease where the
culprit lesion stenting in LAD was done.
Anterior wall STEMI was more common
than non anterior wall MI (55.88% vs. 44.12%).
There were more stenting in LAD artery (n=41)
as compared to RCA (n=26) and LCX artery
(n=9). Management of proximal CAD is important due to the large areas of myocardium that
lie downstream of the stenosis. The proximal
LAD artery supplies nearly 40-50% of the total
left ventricular myocardium, thus the proximal
LAD stenosis could result in ischemia to a large
area of myocardium (12,13). Alidoosti and colleagues (14) have reported that the outcomes
of PCI in patients with proximal LAD stenosis
were similar to patients with proximal LCX/
RCA and non proximal LAD stenosis. In our
study, there was no difference in number of
stenting to the proximal LAD as compared to
the proximal LCX/RCA, however, there was significantly higher number of stenting in the non
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Maedica
A Journal of Clinical Medicine, Volume 8 No.2 2013
proximal LAD and LCX/RCA as compared to
the proximal parts (61.50% vs 38.50%,
p<0.05). This finding showed that non proximal stenting in our study was higher than the
proximal artery stenting.
In 68 PPCI cases, total 76 stents were deployed. At least 5 to 10% of patients who undergo cardiac catheterization experience a
transient rise in the plasma creatinine concentration of more than 1.0 mg/dL (88 μmol/L) due
to contrast-induced renal dysfunction (15). The
incidence of CIN related to CAG or PCI is about
3.3% to 20% in the general population (16). In
our study, CIN developed in 6 (8.88%) patients
who underwent PPCI. Among those who developed CIN, four patients recovered on conservative management, however, 2 (2.94%)
patients required hemodialysis. Moreover, two
patients had documented early stent thrombosis and were managed with plain old balloon
angioplasty only.
Door to balloon (D2B) time is an important
determinant of quality of care. Guidelines recommended D2B time of less than 90 minutes,
however achieving this time is possible only in
ideal world scenario. In our study, the median
D2B time was 110 minutes and only in 35% of
patients PPCI was performed at or less than 90
minutes. In developing countries like ours, financial constraints, insurance coverage problems, and delay in decision making due to lack
of knowledge are the major obstacles in following D2B time recommendations (17).
There are some limitations of our study. This
study was performed in a single center and the
number of patient included in the study was
less. Moreover, only 30-day clinical outcomes
were analyzed. Bare metal stents were used in
our cases because of the financial constraint of
the patient and lack of national health insurance facility in this underdeveloped country.
In conclusion, PPCI improves the early clinical outcomes in patient with acute STEMI,
moreover, despite having no cardiac surgery
backup, early clinical outcomes including
death following PPCI were acceptable in our
center.
Conflict of interest: none declared.
Financial support: none declared.
OUTCOMES OF PRIMARY PERCUTANEOUS CORONARY INTERVENTION
REFERENCES
1.
2.
3.
4.
5.
6.
7.
Keeley EC, Boura JA, Grines CL
– Primary Angioplasty versus Intravenous Thrombolytic Therapy for Acute
Myocardial Infarction: A Quantitative
Review of 23 Randomised Trials. Lancet
2003;361:13-20
Zijlstra F, De Boer MJ, Hoorntje JC, et
al. – A Comparison of Immediate
Coronary Angioplasty with Intravenous Streptokinase in Acute Myocardial Infarction. N Engl J Med 1993;
328:680-4
Paraschos A, Callwood D, Woghtman
MB, et al. – Outcomes Following
Elective Percutaneous Coronary
Intervention without Onsite Surgical
Backup in a Community Hospital. Am J
Cardiol 2005; 95:1091-3
Ting HH, Raveendran G, Lennon RJ,
et al. – A Total of 1007 Percutaneous
Coronary Interventions without
Cardiac Surgery: Acute and Long-Term
Outcomes. J Am Coll Cardiol 2006;
47:1713-21
De Luca G, Suryapranata H, Marino P
– Reperfusion Strategies in Acute
St-Elevation Myocardial Infarction: An
Overview of Current Status. Prog
Cardiovasc Dis 2008; 50:352-82
Lemkes JS, Peels JOJ, Huybregts R, et
al. – Emergency Cardiac Surgery after a
Failed Percutaneous Coronary
Intervention in an Interventional Centre
Without On-Site Cardiac Surgery. Neth
Heart J 2007; 15:173-77
Moses JW, Leon MB, Popma JJ, et al.
– SIRIUS Investigators. Sirolimus-Elut-
ing Stents versus Standard Stents in
Patients with Stenosis in a Native
Coronary Artery. N Engl J Med 2003;
349:1315-23
8. Stone GW, Ellis SG, Cox DA, et al.
– TAXUS-IV Investigators. A PolymerBased, Paclitaxel-Eluting Stent in
Patients with Coronary Artery Disease.
N Engl J Med 2004; 350: 221-31
9. Assessment of the Safety and Efficacy
of a New Treatment Strategy with
Percutaneous Coronary Intervention
(ASSENT-4 PCI) investigators – Primary versus Tenecteplase-Facilitated
Percutaneous Coronary Intervention in
Patients with St-Segment Elevation
Acute Myocardial Infarction (Assent-4
Pci): Randomised Trial. Lancet 2006;
367:569-78
10. Kenney KM, Marzo MC, Ondrasik
NR, et al. – Percutaneous Coronary
Intervention Outcomes in a Low
Volume Center: Survival, Stent
Thrombosis, and Repeat Revascularization. Circ Cardiovasc Qual Outcomes
2009; 2:671-677
11. Adhikari CM, Bhatta YD, Malla R, et
al. – Outcomes of Primary Percutaneous Coronary Intervention at Shahid
Gangalal National Heart Centre,
Kathmandu, Nepal. J Adv in Int Med
2013; 02:6-9
12. Mahmarian JJ, Pratt CM, Boyce TM, et
al. – The Variable Extent of Jeopardized
Myocardium in Patients with Single
Vessel Coronary Artery Disease:
Maedica
13.
14.
15.
16.
17.
Quantification by Thallium-201 Single
Photon Emission Computed Tomography. J Am Coll Cardiol 1991; 17:355-62
Klein LW, Weintraub WS, Agarwal JB,
et al. – Prognostic Significance of
Severe Narrowing of the Proximal
Portion of the Left Anterior Descending
Coronary Artery. Am J Cardiol 1986;
58:42-6
Alidoosti M, Salarifar M, Zeinali AM,
et al. – Comparison of Outcomes of
Percutaneous Coronary Intervention on
Proximal Versus Non-Proximal Left
Anterior Descending Coronary Artery,
Proximal Left Circumflex, and Proximal
Right Coronary Artery: A Cross-Sectional Study. BMC Cardiovasc Disord
2007;7:7
Tomasso CL – Contrast Induced
Nephrotoxicity in Patients Undergoing
Cardiac Catheterization. Cath Cardiovasc
Diagn 1994; 31:316-21
Kong DG, Hou YF, Ma LL, et al.
– Comparison of Oral and Intravenous
Hydration Strategies for the Prevention
of Contrast-Induced Nephropathy in
Patients Undergoing Coronary
Angiography or Angioplasty: A
Randomized Clinical Trial. Acta Cardiol
2012; 67:565-9
Khosravi AR, Hoseinabadi M,
Pourmoghadas M, et al. – Primary
Percutaneous Coronary Intervention in
the Isfahan Province, Iran; A Situation
Analysis and Needs Assessment. ARYA
Atheroscler 2013; 9:38-44.
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