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MINISTRY OF EDUCATION AND TRAINING
MINISTRY OF NATIONAL DEFENCE
CLINICAL RESEARCH INSTITUTE OF MEDICINE AND PHARMACY SCIENCE 108

--------------------------------------------------------

LÊ CAO PHƯƠNG DUY

THE RESULTS OF PRIMARY PERCUTANEOUS
CORONARY INTERVENTION ASSOCIATION
WITH THROMBUS ASPIRATION ON
PATIENTS WITH ACUTE ST-ELEVATION
MYOCARDIAL INFARCTION

Major: Cardiovascular Internal Medicine
ID: 62720141

SUMMARY OF THE DISSERTATION OF DOCTOR OF
PHILOSOPHY IN MEDICINE

Hà Nội - 2019



The research is completed at:
CLINICAL RESEARCH INSTITUTE OF MEDICINE AND
PHARMACY SCIENCE 108

Science advisors:
1. Prof. PhD. Nguyễn Quang Tuấn
2. Assoc Prof. PhD. Phạm Thái Giang

Reviewers:
1.
2.
3.

This thesis will be defended at the meeting of the Dissertation Review
Committee at: Clinical Research Institute of Medicine and Pharmacy
science 108.
At

The thesis can be accessed at:
1. National Library of Vietnam
2. Library of Clinical Medicine Research Institute 108


LIST OF RESEARCH WORKS RELATED TO THE THESIS
1. Lê Cao Phương Duy, Phạm Thái Giang (2018), "The early effect
of thrombus aspiration during primary percutaneous coronary
intervention on patients with acute ST-elevation myocardial
infarction", Journal of Clinical Medicine and Pharmacy 108, (13),
p. 57-65.
2. Lê Cao Phương Duy, Phạm Thái Giang (2018), "Results of
primary percutaneous coronary intervention on patients with
acute ST-elevation myocardial infarction at Nguyen Tri Phuong
Hospital", Journal of Clinical Medicine and Pharmacy 108, (13),
p. 183-188.


1
INTRODUCTION
Coronary heart disease is the most common cause of morbidity
and mortality alongside with heavy burden on treatment cost in
developed countries, and is growing rapidly in developing countries.
Acute myocardial infarction is the necrosis on an area of the
cardiac muscle, result of myocardial ischemia, which is a very common
clinical emergency. Several clinical trials have demonstrated that urgent
recovery of the flow of narrowed or blocked coronary arteries is a major
determinant for short-term as well as long-term survival. Many studies
have shown the efficacy and benefits of early percutaneous coronary
intervention (PCI) as well as the subsequent combination of fibrinolytic
agents (FA) and PCI in patients with acute ST-elevation myocardial
infarction based on some criteria such as overall mortality, secondary
MI and stroke.
However, in primary percutaneous coronary intervention (PPCI),
microvascular embolism due to atherosclerotic fragments from culprit
lesion on distal blood vessels occurs in most patients. Blockage of these
blood vessels causes blockage in the microcirculation and can lead to
suboptimal reperfusion in different areas of the heart muscle.
Thrombosis in the coronary artery is an important step to re-circulate
clogged coronary arteries, improve microcirculation and myocardial
perfusion. Some studies have shown that TA prior to stent insertion in
PCI in patients with acute ST-elevation myocardial infarction can
improve several events such as all-cause mortality, cardiovascular
death, non-fatal MI at one year, and two years; improve myocardial
perfusion and mortality during the procedure; improve microvascular
perfusion, improve left ventricular remodeling and reduce infarct size at
90 days and 6 months. However, data on the role of cardiomyopathy in
PCI is currently not consistent on patients with acute ST-elevation
myocardial infarction.
In Vietnam, there are not many studies on this issue. To contribute


2
in improving the quality of diagnosis and treatment of cardiovascular
disease in general and MI patients in specific, we conducted the study:
“The results of primary percutaneous coronary intervention
association with thrombus aspiration on patients with acute STelevation myocardial infarction” with 2 objectives:
1. Examine clinical and laboratory characteristics, coronary artery
injury, coronary artery intervention in patients with acute ST-elevation
myocardial infarction who receive PPCI association with TA.
2. Assess the results, safety and the relationship between clinical,
laboratory characteristics and major cardiovascular events within 12
months in patients with acute ST-elevation myocardial infarction who
receive PPCI association with TA.
New contributions of the thesis:


Clinical, laboratory, coronary injury and intervention
characteristics in patients with acute ST-elevation myocardial
infarction who receive PPCI association with TA.



PPCI association with TA in patients with acute ST-elevation
myocardial infarction showed effectiveness on myocardial
reperfusion criteria but has not shown short-term effectiveness
(within 12 months) based on major cardiovascular events.



It is not recommended to systematically TA during PPCI, the
intervention should based on specific clinical situation.

Dissertation layout:
The thesis consists of 132 pages. Introduction (2 pages),
Conclusions (2 pages), Recommendations (1 page). The thesis has 4
chapters including: Chapter 1: Literature review of 37 pages; Chapter 2:
Materials and Methods of 24 pages; Chapter 3: Results of 29 pages;
Chapter 4: Discussion of 37 pages. The thesis consists of 50 tables, 5
charts, 10 pictures, and 120 references (Vietnamese: 13; English: 107).


3
Chapter 1
LITERATURE REVIEW
1.1. Outline of acute coronary syndrome (ACS) and acute STelevation myocardial infarction (STEMI)
ACS is a term refer to symptoms associated with acute ischemic
heart disease, often due to a sudden reduction in coronary artery blood
flow (coronary artery).
STEMI is a clinical syndrome defined by specific symptoms of
ischemia accompanied by changes of ST elevation could be observed on
electrocardiogram and a significant increase of several biomarkers due
to myocardial necrosis afterward. Diagnosis of ST elevation in the
absence of left ventricular hypertrophy and associated left bundle
branch block were agreed by the ESC, ACCF, AHA and World Heart
Federation, and were considered as global consensus in diagnosis of
acute MI. ST elevation can be summarized as follows:
 ST elevation: ST elevation ≥ 2 mm in men or 1.5 mm in women
on V2 V3 leads and/or ≥ 1 mm in other chest leads and limb leads.
 New occurrence of left bundle branch block or considered as
new is equal to ST elevation.
 ST depression of ≥ 2 mm in V1-V4: posterior myocardial
infarction.
 ST depression in multiple leads alongside with ST elevation in
aVR: occlusion of the left coronary artery or the proximal ventricular
branch.
 ST elevation in V3R - V5R: Right ventricular infarction.
1.2. Treatment of STEMI
1.2.1. Internal medical treatment
Medicine have been proven effective in many studies including:
heparin, dual antiplatelet therapy, statins, beta blockers, angiotensinconverting enzyme inhibitors or receptor inhibitors.


4
1.2.2. Reperfusion strategies
* Fibrinolytic agents (FA): is prescribed when the time from the
first medical exposure to possible coronary intervention is more than
120 minutes. FA should be used as soon as possible with the golden
time of less than 12 hours.
* Primary percutaneous coronary intervention (PPCI): PPCI is
preferred over FA when the delay in treatment is short, large hospital,
adequate equipment, a team of experienced doctors and staffs. The
indication of PPCI is based on the guideline from ACCF / AHA 2013:
including all patients diagnosed with STEMI within 12 hours of onset
of chest pain, or after 12 hours if there are still symptoms of myocardial
ischemia (much elevated chest pain and / or ST elevation on diabetes),
or clinical cardiogenic shock.
* Coronary artery bypass grafting (CABG): CABG used to be
one of the main treatments of coronary artery disease. Today, this
technique is gradually replaced by FA and PCI treatment. Emergency
CABG in STEMI is indicated in the following cases:
- Mechanical complications (perforation of ventricular septal wall,
muscle breakage ...).
- Coronary anatomy is not suitable for PPCI
1.2.3. Thrombus aspiration (TA) technique in PPCI on STEMI
patients
 Theoretical basis of TA in PPCI
PPCI has been shown to be highly effective in the treatment of
STEMI. However, the problem is that normal PCI with balloons and
stents can lead to rupture of a blood clot or atheroma, forming
debris, drifting to distal coronary vessels, causing distal embolism
and reduces myocardial perfusion of these parts. Distal embolization
in coronary artery contributes significantly to vascular dysfunction
and the phenomenon of "no-reflow" flow. Therefore, in addition to
pharmacological treatment and direct stent placement, some TA
devices have been developed to reduce thrombotic burden, reduce
distal thromboembolism, improve myocardial perfusion, and have


5
the potential to improve clinical outcomes.
 Assign TA in the PPCI
In current clinical practice, TA is indicated after assessing
coronary artery flow and thrombotic morphology. After passing the
guidewire through the lesion, the surgeon will take a coronarography
before deciding whether or not to have a TA. If the coronary arterial
flow has TIMI of 0 or 1, the surgeon will perform TA with a catheter. If
the coronary arterial flow has TIMI of 2 or 3, the surgeon will conduct
TA when the thrombotic state is G4 grade.
 Evaluate the TA results
TA is rated as successful when:
 The thrombus pumped into the filter could be seen.
 The flow after suction improves TIMI degrees, allowing a clear
determination of atherosclerotic lesions and distal segments of coronary
arteries.
1.3. Current research related to the thesis topic
Many studies assessing the effectiveness of TA during PPCI have
been published in peer reviewed journals, but the results were not
consistent. Three large and scientifically valuable studies on this issue
are: TAPAS (Tone Svilaas et al.), TASTE (Frobert O et al.) and
TOTAL (Jolly SS et al.). The TAPAS study showed that TA improved
myocardial perfusion, improved ST segment recovery and improved
major cardiovascular events at 30 days. However, TASTE and TOTAL
studies have shown the opposite results. The TASTE study consisted of
7244 patients showed mortality and other clinical outcomes such as
stent thrombosis, and myocardial infarction did not differ between the
two groups. The TOTAL study also showed similar results, with no
difference in cardiovascular death, myocardial infarction, cardiogenic
shock or IV NYHA heart failure between the two study groups.


6
Chapter 2
METHODS AND MATERIALS
2.1. RESEARCH SAMPLE
2.1.1. Inclusion criteria
- STEMI patients with indications of TA during PPCI who visit
and treated at Nguyen Tri Phuong Hospital during the study period from
June 2014 to June 2016.
- Patients agree to participate in the study
2.1.2. Exclusion criteria
- Contraindications for use of antiplatelet agents such as aspirine,
clopidogrel...
- Patient who had already taken fibrinolytic drugs.
- New stroke, or gastrointestinal hemorrhage within 3 months.
- Severe renal failure, severe liver failure...
- Severe comorbidities such as: late stage cancer, diabetic coma...
2.1.3. Sample size and research groups: all patients were divided into
two groups:
- Group 1: including all STEMI patients who have successfully
received TA during PPCI.
- Group 2: including all STEMI patients who received TA but did
not succeed during PPCI.
2.1.4. Study site
Department of Interventional Cardiology at Nguyen Tri Phuong
Hospital, Ho Chi Minh City.
2.2. RESEARCH METHODS
2.2.1. Research design: clinical trial, longitudinal.
2.2.2. Research facilities and equipment
- Philip CV20 for digital circuit imaging
- Intervention device: intervention catheter, conductor, balloon,
stent. We used the Export TA catheter, size 6F from Medtronic.


7
- Other equipment: echocardiography, temporary pacemaker,
electric shock device to switch the rhythm, breathing machine ... for
emergency aids.
2.2.3. Steps to conduct research
2.2.3.1. Before implementing PCI
Doctors directly ask for history, medical history and clinical
examination of patients when hospitalized. We recorded the following
clinical features: age, sex, body mass index (BMI), time of admission,
history of cardiovascular disease, cardiovascular risk factors,
accompanying diseases, symptoms of angina, heart rate and blood
pressure at admission, assessment of heart failure level in acute MI
according to Killip classification.
Patients were recorded basic laboratory tests such as cardiac
enzymes (CK-MB, troponin I), blood tests, blood sugar, electrolytes in
the blood, blood lipid complexes, urea , blood creatinine,
electrocardiogram, cardiac Doppler ultrasound. Troponin I is performed
by luminescent immunization on Architect i2000 systems (Abbott) with
the 99th percentile for the upper threshold in men of 0.034 ng/ml and in
women of 0.017 ng/ml.
Clinical and laboratory characteristics are documented through a
standard research record for all patients.
2.2.3.2. PPCI procedure
- Anesthesia method: local anesthesia with Lidocaine 2%.
- Access path: right radial artery or right femoral artery.
- Treatment drugs before performing the procedure:
Anticoagulant: use one of the following two types:
Low molecular weight heparin: intravenous enoxaparin 0.5 mg/kg
before intervention. Then maintain 1 mg/kg subcutaneously every 12
hours.
Unfractionated heparin: 70 - 100 units/kg intravenous dose before
coronary intervention, then repeat 1000 - 1500 units (or 1/4 first dose)
intravenously after each hour if the intervention lasts more than 1 hour.
Dual antiplatelet therapy:


8
Aspirin: first dose 162 - 325 mg before the intervention (4 tablets
81 mg orally or chewed), maintaining a dose of 75 - 162 mg/day (1
tablet of 81 mg/day). Combined with:
Clopidogrel: the first dose of 8 tablets of 75 mg (600 mg) for all
patients with coronary intervention is first, maintaining 75 mg/day, or
Ticargrelor: the first dose of 2 tablets of 90 mg (180 mg) taken
before the intervention, then maintained 180 mg daily (2 tablets of 90
mg), divided into 2 doses.
Statin: 60 - 80 mg atorvastatin or 30 - 40 mg oral rosuvastatin just
before the intervention, then maintain atorvastatin 20 - 40 mg/day or
rosuvastatin 10-20 mg/day. Long-term treatment goals are LDL <70
mg/dL.
Other drugs: Nitroglycerin, beta blockers, angiotensin inhibitors
or receptor inhibitors... Specifies on case-by-case situation.
Steps to perform the procedure
- Selective coronary angiography procedure: assessing culprit and
non-culprit artery damage including:


Significant number of narrowed coronary arteries (narrow
≥ 70% of vascular diameter)



The narrowing of coronary arteries and lesions include:
calcification level, zigzag level, thrombotic morphology,
and length of injury.



Evaluate collateral circulation and muscle bridge if
available.



Determine the culprit coronary lesions based on changes
in electrocardiography and coronary angiography.



Evaluate flow in the coronary according to TIMI scale.



Evaluate TMP scale cardiac perfusion levels (TIMI
myocardial perfusion grading).

- Coronary artery intervention procedure:
After assessing and determining coronary artery lesions, we
proceeded to pass the intervention wire (guidewire) through the


9
coronary artery lesions. We capture coronary coronary arteries in two
orthogonal postures to re-evaluate lesions, TIMI thrombosis, TIMI flow
levels and myocardial perfusion levels according to TMP. If the patient
has indicated of TA, we will conduct TA with a catheter before the
standard coronary intervention includes: ballooning and/or stenting. If
the patient has no indication of TA, we would conduct standard
coronary intervention and finish the procedure.
- TA technique:
If the patient was indicated TA, surgeon will take TA catheter
along the wire to approach the blood clot in the heart. When the distal
end of the catheter passes through the narrow position or obstruction,
use a syringe attached to the catheter, creating negative pressure to suck
the blood clot into the syringe. The catheter can then be moved
repeatedly and gently through the suction position or until the suction
pressure is no longer felt, the catheter will be pulled out. While pulling
out the TA catheter out, the catheter tip was always attached to the
starting hole of the coronary artery and always kept the TA syringe at
negative pressure to avoid dropping the thrombus into the circulatory
system. Finally, inject blood in TA syringes into the filter, coronary
angioplasty to evaluate the effectiveness of the TA. The facilitator can
perform TA multiple times if necessary. After 3 times of TA, if there is
no improvement in thrombosis and TIMI flow classification on
coronary angiography, the TA procedure would be stopped. The patient
will then be ballooned and put a stent if the injury is appropriate.
2.2.3.3. Monitor patients after PPCI
 ECG and cardiac enzymes are performed at the following times:
immediately after the intervention, after 6 hours, after 24 hours,
and before discharge. ECG is done in bed with 12 standard
leads. In case of suspicion of posterior myocardial infarction or
right ventricular myocardial infarction, additional leads V3R,
V4R, V5R, V7, V8, V9 will be measured.
 All patients were given biochemical and hematological testing
within 24 hours after the intervention. Depending on the clinical
result of each patient, some other specific tests may be
performed if necessary, such as blood electrolytes, arterial
blood gas, blood lactate, ...


10
 Doppler echocardiography is performed within 24 hours after
admission.
 Early evaluation after PCI based on:


Hemodynamic condition.



The level of heart failure according to Killip.



The relief of chest pain.



Flow level according to TIMI.



The level of myocardial perfusion according to TMP.



Recovery of ST elevation.



Major cardiovascular events include: all-cause mortality, reinfarction, thrombosis in the stent, and brain stroke.

 Medical treatment at discharge
All patients after coronary intervention were re-examined at
Nguyen Tri Phuong Hospital's Interventional Cardiology once a month.
Indications for post-PCI treatment were as follows:
Aspirin: all patients after coronary artery intervention continue to
take aspirin 81 mg daily, indefinitely unless contraindicated.
Clopidogrel: if a patient has a stent that is not covered, indicated
for at least 6 months and optimal for 1 year, except for patients at high
risk of bleeding. If stent-coated interventions were performed, indicated
for at least 1 year with a dose of 75 mg/day.
Beta blockers: if there are no contraindications. Appropriate dose
adjustment: starting with low doses and increase the dose slowly,
especially in patients with heart failure.
ACE inhibitors: indicated for patients with heart failure, left
ventricular dysfunction (EF < 40%), hypertension or diabetes.
Angiotensin receptor inhibitors: indicated when the patient is not
tolerated with angiotensin-converting enzyme inhibitors.
Aldosteron resistance: indicated for patients with heart failure but
without kidney failure.


11
 Evaluate short-term effectiveness (within 12 months):
Follow up clinically by direct examination. The variables collected
included: chronic heart failure based on NYHA classification.
Evaluation of major cardiovascular complications including: all-cause
mortality, stent thrombosis, myocardial infarction, and brain stroke at
30 days and 12 months for both study groups.
The collected data is included in the patient's medical record.
2.2.4. Standards used in research
- Classification of acute heart failure according to Killip.
- The door-to-balloon time beginning from the moment a patient
was hospitalized until the first balloon was performed.
- TIMI blood clotting standard.
- Method of assessing flow in coronary arteries according to TIMI
scale.
- Assess the level of myocardial perfusion according to TMP.
- TIMI frame count: The number of TIMI calculated by the
number of frames on the vein taken from the moment contrast materials
entered the coronary artery until it reached the distant end of the
coronary artery.
- Technically successful coronary intervention standards: defined
as non-existent stenosis above 20% and normal intravascular artery
flow back to normal (TIMI = 3) and no distal filling thrombosis.
- Clinically successful coronary intervention criteria: Surgical
success, improvement in clinical cardiovascular symptoms and no
cardiovascular events including myocardial infarction, stroke, cardiac
shock and all causes mortality
- Criteria for evaluating the recovery of ST elevation:
 The ST segment returns to normal: the ST segment deflects to ≥
70% compared to before.
 The ST segment partially improves: the ST segment recovers of
30-70% compared to before.
 ST segment does not change: ST differs by <30% compared to
before.


12
- Optimal re-reperfusion standard after intervention: reperfusion is
optimal when there is normal ST return after intervention and TMP = 3.
- Thrombosis in stents is defined according to ARC (Academic
Research Consortium) standard.
2.3. DATA ANALYSIS
- Data were processed following standard statistical method in
medical research using R 3.4.0.


13
Chapter 3
RESULTS
3.1. Clinical, laboratory characteristics, coronary artery lesions,
and coronary artery intervention procedures of STEMI patients
who received TA during PPCI
3.1.1. Clinical characteristics of patients at admission
Table 3.1. Clinical characteristics of patients at admission
Total (n=92)

Characteristics
Gender: Male
Female
Age
BMI, kg/m2
Hour of MI [median]
Chest pain
Killip III-IV classification
Heart rate ≥ 100 bpm
Heart rate < 60 bpm
SBP ≥ 140 mmHg
SBP < 90 mmHg

n (%)
67 (72,8)
25 (27,2)
60,5 ± 14,3
23,1 ± 3,5
3 (2 - 6)
90 (97,8)
12 (13,0)
12 (13,0)
21 (22,8)
30 (32,6)
10 (10,9)

Successful
TA (n=68)
n (%)
49 (72,1)
19 (27,9)
57,6 ± 13,9
23,2 ± 3,4
3 (2 – 5,3)
68 (100)
8 (11,8)
8 (11,8)
15 (22,1)
26 (38,2)
9 (13,2)

Unsuccessful
TA (n=24)
n (%)
18 (75,0)
6 (25,0)
69,0 ± 12,2
23,0 ± 3,9
4 (2,8 – 7,5)
22 (91,7)
4 (16,7)
4 (16,7)
6 (25,0)
4 (16,7)
1 (4,2)

p
0,781
0,001
0,768
0,129w
0,066F
0,504F
0,504F
0,768
0,053
0,445F

Table 3.2. History of cardiovascular disease of patients at admission
Characteristi
cs
Angina
MI
Stroke
PTCA
CABG

Total
(n=92)
n (%)
6 (6,5)
5 (5,4)
5 (5,4)
4 (4,3)
2 (2,2)

Successful
TA (n=68)
n (%)
3 (4,4)
3 (4,4)
5 (7,4)
2 (2,9)
2 (2,9)

Unsuccessful TA
(n=24)
n (%)
3 (12,5)
2 (8,3)
0 (0,0)
2 (8,3)
0 (0,0)

p
0,180F
0,603F
0,321F
0,278F

Table 3.3. Risk factors of coronary disease in patients
Characteristics
Smoking
Hypertension
Diabetes
Dyslipidemia

Total
(n=92)
n (%)
42 (45,7)
46 (50,0)
16 (17,4)
42 (47,2)

Successful
TA (n=68)
n (%)
33 (48,5)
36 (52,9)
12 (17,6)
29 (43,3)

Unsuccessful TA
(n=24)
n (%)
9 (37,5)
10 (41,7)
4 (16,7)
13 (59,1)

p
0,351
0,342
1F
0,198


14
Table 3.4. Electrocardiographic characteristics of patients at admission
Characteristics

Total
(n=92)
n (%)
15 (16,5)

Atrioventricular
block
New infarction area
Posterior wall
3 (3,3)
Lower wall
41 (44,6)
Anterior wall
48 (52,2)
Right ventricular
0
ST ↑ (mm)
3,2 ± 1,3

Successful
TA (n=68)
n (%)
11 (16,4)

Unsuccessful TA
(n=24)
n (%)
4 (16,7)

2 (2,9)
28 (41,2)
38 (55,9)
0
3,3 ± 1,3

1 (4,2)
13 (54,2)
10 (41,7)
0
2,7 ± 1,0

p
1F
0,402F
0,271
0,231
-0,044

Comment: In general, clinical and electrocardiographic
characteristics are relatively similar between the two study groups.
Table 3.5. Characteristics of the damaged coronary arteries
Characteristics

Total (n=92)
n (%)

Coronary arterial
system
Balanced
75 (81,5)
Right
12 (13,0)
dorminant
5 (5,5)
Left dorminant
Culprit artery
Left main
0
LAD
45 (48,9)
LCX
6 (6,5)
RCA
41 (44,6)
Number of damaged branches ≥ 70%
1 branch
54 (58,7)
2 branches
28 (30,4)
3 branches
10 (10,9)

Successful
TA (n=68)
n (%)

Unsuccessful
TA (n=24)
n (%)

55 (80,9)
8 (11,8)
5 (7,4)

20 (83,3)
4 (16,7)
0 (0,0)

0,458F

0
36 (52,9)
5 (7,4)
27 (39,7)

0
9 (37,5)
1 (4,2)
14 (58,3)

-0,193
1F
0,114

43 (63,2)
20 (29,4)
5 (7,4)

11 (45,8)
8 (33,3)
5 (20,8)

0,137
0,720
0,120F

p

Table 3.6. TIMI, TMP index before intervention
Characteristics
TIMI
TMP

0–1
2–3
0–1
2–3

Total
(n=92)
n (%)
60 (65,2)
32 (34,8)
83 (90,2)
9 (9,8)

Successful TA
(n=68)
n (%)
45 (66,2)
23 (33,8)
61 (89,7)
7 (10,3)

Unsuccessful TA
(n=24)
n (%)
15 (62,5)
9 (37,5)
22 (91,7)
2 (8,3)

p
0,745
1F


15
Table 3.7. Timing of coronary intervention and door-to-balloon time
Characteristics

Total (n=92)

Successful Unsuccessful
TA (n=68) TA (n=24)

p

PCI before 12 hours

82 (89,1)

64 (94,1)

18 (75)

0,018

Door-to-balloon time < 90 mins

45 (49,5)

35 (52,2)

10 (41,7)

0,374

Time to PCI (hour) *

5,0

5,0

6,5

0,216

Door-to-balloon time (mins)*

90

85

95

0,088

Table 3.8. Characteristics of thrombosis form and location
Total
(n=92)

Successful TA
(n=68)

Unsuccessful
TA (n=24)

n (%)

n (%)

n (%)

1 (1,1)
1 (1,1)
6 (6,5)
10 (10,9)
74 (80,4)

0 (0,0)
0 (0,0)
5 (7,4)
8 (11,8)
55 (80,9)

1 (4,2)
1 (4,2)
1 (4,2)
2 (8,3)
19 (79,2)

Posterior ventricular artery
Proximal part
Central part

20 (43,5)
26 (56,5)

17 (45,9)
20 (54,1)

3 (33,3)
6 (66,7)

0,710F

Circumflex artery
Proximal part
Distal part

3 (50,0)
3 (50,0)

2 (40,0)
3 (60,0)

1 (100,0)
0 (0,0)

1F

Right coronary artery
Proximal part
Middle part
Distal part

14 (35,0)
20 (50,0)
6 (15,0)

9 (34,6)
12 (46,2)
5 (19,2)

5 (35,7)
8 (57,1)
1 (7,1)

Number of suction
1 time
2 times
3 times

15 (16,5)
58 (63,7)
18 (19,8)

11 (16,2)
46 (67,6)
11 (16,2)

4 (17,4)
12 (52,2)
7 (30,4)

Characteristics
G1
G2
G3
G4
G5

p

0,238F

0,609F

0,305F


16
Table 3.9. TA results
Frequency
(n=92)

Percentage
%

Successful TA

68

73,9

Unsuccessful TA

24

26,1

Fail of suction

13

14,1

Catheter cannot pass

10

10,9

Successful suction but the flow remain
unchanged

1

1,1

0

0,0

Characteristics

Reason of unsuccessful TA

Post-suction complications

Figure 3.1. Factors related to successful TA
Comment: Only age of over 60 and the time of coronary
intervention after 12 hours were related to the success of TA.


17
3.2. Assessing the effect, safety and the relationship between
clinical, liboratory characteristics and major cardiovascular events
within 12 months of TA during PPCI on STEMI patients
Table 3.10. Mean index of TIMI, TMP and level of ST elevation
before and after intervention
Characteristics
Mean TIMI

Successful TA (n=68)

Unsuccessful TA (n=24)

Before

After

Trước

0,9 ± 1,3

3,0 ± 0,2

1,1 ± 1,4

p < 0,001
Mean TMP

0,3 ± 0,7

Sau
2,6 ± 0,9

p < 0,001

2,9 ± 0,3

0,2 ± 0,6

2,0 ± 0,8

p < 0,001

p < 0,001

59 (86,8)

6 (26,1)

ST back to normal

p < 0,001

Table 3.11. TIMI = 3, TMP = 3 after intervention in two groups
Total
(n=92)
n (%)

Successful TA
(n=68)
n (%)

Unsuccessful TA
(n=24)
n (%)

p

TIMI after intervention
=3

83 (91,2)

65 (95,6)

18 (78,3)

0,023F

TMP after intervention
=3

65 (71,4)

61 (89,7)

4 (17,4)

<0,001

Characteristics

Table 3.12. Time of hospitalization and complications during
treatment process at the hospital
Total
(n=92)
n (%)

Successful TA
(n=68)
n (%)

Unsuccessful TA
(n=24)
n (%)

p

Arrhythmia

5 (5,4)

2 (2,9)

3 (12,5)

0,109F

Pneumonia
Kidney failure
Time of hospitalization

8 (8,7)
4 (4,3)
5,0

5 (7,4)
1 (1,5)
5,0

3 (12,5)
3 (12,5)
5,0 (3,8 – 9,3)

0,399F
0,048F
0,699w

Characteristics
Complications


18
Table 3.13. Major cardiovascular events during hospitalization
Total (n=92)

Successful TA
(n=68)

Unsuccessful
TA (n=24)

n (%)

n (%)

n (%)

Death

4 (4,3%)

3 (4,4%)

1 (4,2%)

> 0,05

Stroke

4 (4,3%)

2 (2,9%)

2 (8,3%)

> 0,05

Recurrent acute
myocardial
infarction

0

0

0

Thrombosis in stent

0

0

0

Events

p

Comment: There was no difference in major cardiovascular events
between the two study groups during the time of hospitalization.
Table 3.14. The effect of successful TA on the disappearance of chest
pain after PCI
No chest pain
Characteristics
Yes (n %)

No (n %)

Successful TA

59 (86,8)

9 (13,2)

Unsuccessful TA

10 (43,5)

13 (56,5)

OR (95% CI)

p

8,52 (2,96 – 26,24)

<0,001

Table 3.15. The effectiveness of successful TA on ST segment
back to normal after PCI
ST segment back to normal
Characteristics
Yes (n %)

No (n %)

Successful TA

59 (86,8)

9 (13,2)

Unsuccessful TA

6 (26,1)

17 (73,9)

OR (95%
CI)

p

18,57
<0,001
(6,12–64,40)


19

Table 3.16. The effect of TA on TMP = 3 after PCI
TMP = 3
Characteristics

OR (95% CI)
Yes (n %)

No (n %)

Successful TA

61 (89,7)

7 (10,3)

Unsuccessful TA

4 (17,4)

19 (82,6)

41,39
(12,0 - 179,09)

p

<0,001

Table 3.17. Effect of TA on optimal reperfusion criterion
Optimal reperfusion
Characteristics

Successful TA
Unsuccessful TA

OR (95% CI)
Yes (n %)

No (n %)

53 (77,9)

15 (22,1)

1 (4,3)

22 (95,7)

77,73
(14,51 - 1449,77)

p

<0,001

Table 3.18. The effectiveness of successful TA on major
cardiovascular events at 30 days after intervention
MACE 30 days
Characteristics

No (n %)

Yes (n
%)

Successful TA

65 (95,6)

3(4,4)

Unsuccessful TA

21 (87,5)

3 (12,5)

OR
(95% CI)

p

0,32
(0,06 – 1,86)

0,186


20
Table 3.19. The effect of successful TA on major cardiovascular
events monitoring for 12 months
Characteristics

MACE after 12 months
No (n %)

Yes (n %)

Successful TA

63 (92,6)

5 (7,4)

Unsuccessful TA

19 (79,2)

5 (20,8)

OR
(95% CI)

p

0,30
(0,08 - 1,19)

0,080

Figure 3.2. Factors related to the effectiveness of TA based on
major cardiovascular events within 12 months

Chapter 4
DISCUSSION
4.1. Clinical, laboratory characteristics, coronary artery lesions,
and coronary artery intervention procedures of STEMI patients
who received TA during PPCI
The patients in our study were mainly men (72.8%). The mean age
was 60.5 ± 14.3. Almost all patients had symptoms of chest pain when
hospitalized (97.8%). Most patients had a Killip I or II grade at the time


21
of admission. Cardiovascular risk factors included: hypertension,
dyslipidemia, smoking, diabetes. This result is similar to some other
domestic and foreign studies.
In terms of coronary artery lesions, the anterior ventricular artery
was the most prevalent (48.9%), most patients in our study only
damaged one coronary branch (58, 7%). About 2/3 of patients had TIMI
of 0 or 1 before the intervention (65.2%). Most patients had TMP of 0
or 1 before the intervention (90.2%). This result is similar to a study by
Nguyen Quang Tuan in Bach Mai Hospital and other foreign studies
such as TAPAS and TOTAL studies.
Most patients received intervention before 12 hours (89.1%). The
mean coronary intervention time was 5th hour. The mean time of doorto-balloon was 90 minutes, about half of our patients had a time of
under 90 minutes (49.5%). This rate is higher than Nguyen Quang Tuan
at Bach Mai Hospital and Horie H.'s research. However, the target
participants and main criteria of these studies were different from our
study.
The majority of thrombosis was G4 and G5 (91.3%), the rate of
successful TA was 73.9%. All patients in our study were treated with
manually TA using Export catheter size 6F. The success rate of TA in
our research was similar to some other studies such as: TAPAS
(72.9%), VAMPIRE (75%), TOTAL (82.5%), but our standard for
assessing TA was more rigorous than the mentioned studies.
There was an improvement in arterial myocardial flow and
perfusion of coronary culprit after the TA in successful TA group. In
relation to the success of TA procedure, we found that: age ≥ 60 reduces
the possibility of successful HHs. The timing of coronary intervention
before 12 hours has a higher success rate of TA.
4.2. Assessing the effect, safety and the relationship between
clinical, liboratory characteristics and major cardiovascular events
within 12 months of TA during PPCI on STEMI patients
On clinical aspect, after the intervention, all patients had improved in


22
chest pain symptoms, though the difference in Killip level was not
statistically significant between the two study groups. The procedural
success in our study was 91.2%. This result is similar to some other studies:
Nguyen Quang Tuan (91.6%), Phillip K H (88.1%), Dudek D (87.1%). Our
clinical success was 95.7%. This result is similar to many other studies:
Huynh Trung Cang (91.4%), Nguyen Quang Tuan (91.6%), Truong Quang
Binh (92.6%).
ST returned to normal after intervention was 71.4%. This result is
higher than some other studies: Dudek D (49.4%), REMEDIA (42.4%),
Nguyen Quang Tuan (33.3%). This difference is due to different inclusion
criteria and different levels of ST difference before PCI. There was no
difference in hospital stay and events during hospital stay between the two
study groups.
Regarding the effect on reperfusion, in the successful TA group, the
rate of patients with ST return to normal after intervention was 86.8%, with
TMP = 3 after intervention was 89.7%, re-irrigated optimal blood is 77.9%.
All of them had statistically significant differences compared with
unsuccessful TA group (p <0.001). This result is similar to other studies
such as TOTAL, TAPAS, REMEDIA, DEAR-MI, PIHATE.
In terms of short-term efficacy at 30 days and 12 months, there were
no statistically significant difference between the two study groups.
Specifically, at 30 days, the successful TA group had the major
cardiovascular event rate of 4.4%, while it was 12.5% in the unsuccessful
TA group (p = 0.186). At 12 months, the successful TA group had a rate of
7.4%, the number of unsuccessful TA group was 20.8% (p = 0.080). This
result is similar to most of the research about TA worldwide such as
TASTE, TOTAL, PIHATE, Jones D A et al., Tamhane UU et al., Beran et
al., Jaiswal et al.
In relation to major cardiovascular events within 12 months, we found
that only heart rate at admission of more than 100 bpm and pre-intervention
TMP level of 0 or 1 were related to the effectiveness of TA.
Our study has some limitations: small sample size which is not
representative, short follow-up time, the method to assess cardiac muscle


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