Medicine

OBSERVATIONAL STUDY

Manual Thrombus Aspiration and the Improved Survival of

Patients With Unstable Angina Pectoris Treated With
Percutaneous Coronary Intervention (30 Months Follow-Up)
Bekir S. Yildiz, MD, Murat Bilgin, MD, Mustafa Zungur, MD, Yusuf I. Alihanoglu, MD,
Ismail D. Kilic, MD, Ipek Buber, MD, Ahmet Ergin, Havane A. Kaftan, and Harun Evrengul

Abstract: The clinical effect of intracoronary thrombus aspiration Abbreviations: ACS = acute coronary syndrome, CABG =
during percutaneous coronary intervention in patients with unstable coronary artery bypass grafting, CAD = coronary artery disease,
angina pectoris is unknown. In this study, we aimed to assess how CHF = congestive heart failure, CK-MB mass = creatinine kinase
thrombus aspiration during percutaneous coronary intervention affects MB mass, CPM = cardiac pacemaker, CRT-D/P = cardiac
in-hospital and 30-month mortality and complications in patients with resynchronization therapy and defibrillator/pacemaker, Cx =
unstable angina pectoris. circumflex, DES = drug-eluting stent, GRACE = Global Registry
We undertook an observational cohort study of 645 consecutive of Acute Coronary Events, HF = heart failure, ICD = implantable
unstable angina pectoris patients who had performed percutaneous cardioverter defibrillator, LAD = left anterior descending, LMCA =
coronary intervention from February 2011 to March 2013. Before left main coronary artery, LV volume = left venticular volume,
intervention, 159 patients who had culprit lesion with thrombus were LVEF = left ventricular ejection fraction, MBG = myocardial blush
randomly assigned to group 1 (thrombus aspiration group) and group 2 grade, NSTEMI = non-ST-segment elevation myocardial infarction,
(stand-alone percutaneous coronary intervention group). All patients PCI = percutaneous coronary intervention, QCA = quantitative
were followed-up 30 months until August 2015. coronary angiography, RCA = right coronary artery, REMEDIA =
Thrombus aspiration was performed in 64 patients (46%) whose randomized evaluation of the effect of mechanical reduction of
cardiac markers (ie, creatinine kinase [CK-MB] mass and troponin T) distal embolization by thrombus-aspiration in primary and rescue
were significantly lower after percutaneous coronary intervention than angioplasty, STEMI = ST-segment elevation myocardial infarction,
in those of group 2 (CK-MB mass: 3.80  1.11 vs 4.23  0.89, TA = thrombus aspiration, TAPAS = Thrombus Aspiration During
P ¼ 0.012; troponin T: 0.012  0.014 vs 0.018  0.008, P ¼ 0.002). Percutaneous Coronary Intervention in Acute Myocardial
Left ventricular ejection fraction at 6, 12, and 24 months postinterven- Infarction Study, TASTE = Thrombus Aspiration in ST-Elevation
tion was significantly higher in the group 1. During a mean follow- Myocardial Infarction in Scandinavia, TFC = TIMI frame count,
up period of 28.87  6.28 months, mortality rates were 6.3% in the TIMI = thrombolysis in terms of myocardial infarction, UAP =
group 1 versus 12.9% in the group 2. Thrombus aspiration was also unstable angina pectoris.
associated with significantly less long-term mortality in unstable
angina pectoris patients (adjusted HR: 4.61, 95% CI: 1.16–18.21,
P ¼ 0.029). INTRODUCTION
Thrombus aspiration in the context of unstable angina pectoris is
associated with a limited elevation in cardiac enzymes during inter- U nstable angina pectoris (UAP) is the subset of acute
coronary syndromes (ACS) caused by the erosion or
rupture of atherosclerotic plaque and thrombosis.1,2 The preva-
vention that minimises microembolization and significantly improves
both of epicardial flow and myocardial perfusion, as shown by lence of coronary thrombus has been estimated at 10% to 80%
angiographic TIMI flow grade and frame count. Thrombus aspiration in patients with UAP.3 Primary therapy is often urgently needed
during percutaneous coronary intervention in unstable angina pectoris and/or involves elective percutaneous coronary intervention
patients has better survival over a 30-month follow-up period. (PCI).2 During PCI, the percutaneous dilatation of coronary
stenosis inevitably causes plaque disruption, which may in turn
(Medicine 95(8):e2919) cause the distal embolization of plaque debris or thrombus
material. Myocardial tissue reperfusion often reduces due to
distal vascular debris embolization that prompts the plugging
Editor: Hsueh Wang. of the microvasculature, microvascular dysfunction, and
Received: January 12, 2016; revised: January 22, 2016; accepted: February
2, 2016. myocardial necrosis.4
From the Pamukkale University Medical Faculty, Department of Cardiol- Recent studies using thrombectomy or a distal protection
ogy (BSY, YIA, IDK, IB, HAK, HE), Denizli; Dıskapı Training and apparatus in primary PCI for ST segment elevation myocardial
Research Hospital, Department of Cardiology (MB), Ankara; Sifa infarction (STEMI) have demonstrated that using such appa-
University Medical Faculty, Department of Cardiology (MZ), Izmir; and
Pamukkale University Medical Faculty, Department of Public Health (AE), ratuses can significantly reduce the incidence of distal embo-
Denizli, Turkey. lization and improve both myocardial perfusion and clinical
Correspondence: Bekir S. Yildiz, Pamukkale University Medical Faculty, outcomes.5– 9 Favorable outcomes have also been reported in
Department of Cardiology, Denizli, Turkey patients with non-STEMI (NSTEMI) if angiography suggested
(e-mail: bserhatyildiz@yahoo.com).
The authors have no funding and conflicts of interest to disclose. the presence of thrombus formation.10 That study’s analysis
Copyright # 2016 Wolters Kluwer Health, Inc. All rights reserved. included PCI patients with UAP, in each of whom the appli-
This is an open access article distributed under the Creative Commons cation of manual aspiration catheter for thrombus aspiration
Attribution License 4.0, which permits unrestricted use, distribution, and (TA) during PCI was insufficient.11 Currently, no published
reproduction in any medium, provided the original work is properly cited.
ISSN: 0025-7974 data comparing TA in patients with UAP are available. The
DOI: 10.1097/MD.0000000000002919 primary aim of this observational study was to assess how TA

Medicine  Volume 95, Number 8, February 2016 www.md-journal.com | 1

Yildiz et al Medicine  Volume 95, Number 8, February 2016

during PCI effects in-hospital and 30-month mortality in UAP without ST elevation or increase in cardiac troponin T greater
patients. Its secondary aim was to assess this effect in relation to than 0.01 ng/ml and creatinine kinase-MB (CK-MB) mass
regional and global contractile left ventricular (LV) function, as greater than 5 ng/ml (ie, local laboratory threshold of myo-
well as examine how TA impacts on post-PCI thrombolysis in cardial infarction). Inclusion criteria for UAP patients were
terms of myocardial infarction (TIMI) flow, TIMI frame count thrombus burden vessel diameter greater than 2.5 mm, and
(TFC), and myocardial blush grade (MBG). technical viability for angioplasty independent of both initial
TIMI flow and angiographic evidence of intraluminal thrombus
in the culprit artery. Thrombus was defined as the presence of a
MATERIALS AND METHODS roundish filling defect of the lumen during dye injection (in
multiple projections either) with or without the persistence of
Study Design and Population luminal contrast following injection. Patients who had been
The present research entailed a multicenter, retrospective, taking anticoagulants and presented with cardiogenic shock
observational, cohort study involving the blind evaluation of and/or thrombus formation as a complication of a PCI (eg,
end points confirmed by the local ethics committee and in vessel closure after stenting) were excluded from the sample.
accordance with the Declaration of Helsinki. We retrospectively Other exclusion criteria were the known existence of a disease
studied 159 patients selected among 645 UAP patients con- resulting in a life expectancy less than 6 months, and the lost of
secutively referred to the catheterization laboratory of our patient during follow-up. Patients with echocardiographic ima-
institutions for coronary angiography and angioplasty. The ge of a poor quality were not accepted for the study. No other
analysis comprised PCI patients with UAP in each of whom clinical exclusion criteria were adopted. The echocardiographic
the export aspiration catheter was applied for TA during PCI at acoustic window was assessed in the emergency department or
Pamukkale University and Sifa University between February catheter laboratory by a staff cardiologist before the procedures.
15, 2011 and March 1, 2013. All patients were followed-up 30 After enrollment and before PCI, 159 patients who had culprit
months until August 1, 2015 except death. lesion with thrombus were randomly assigned to group 1 (TA
UAP was defined as the occurrence of typical chest pain at group) and group 2 (stand-alone PCI group) according to a
rest with or without electrocardiographic signs of ischemia yet computer-generated random series of numbers (Figure 1).

FIGURE 1. Flow diagram of the study profile.

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Medicine  Volume 95, Number 8, February 2016 Manual Thrombus Aspiration in Patients With Unstable Angina Pectoris

Procedure treated vessel or one of its side branches or the migration of a

In all patients catheterization was performed following the filling defect. No reflow was defined as TIMI flow grade 0 to 1 not
femoral approach by experienced cardiologists. To begin, a due to occlusive thrombus formation, dissection, or coronary
steerable guide wire was passed through the target lesion; direct artery spasm. Baseline, postaspiration, and final post-PCI angio-
stenting was left to the operator’s discretion and usually per- graphic coronary flows were also assessed by means of the
formed according to patent vessel with no or mild calcification. corrected TFC at 12.5 frames/s.13 Baseline and final post-PCI
In patients in the group 2, this step was followed by balloon MBGs were determined.14 Clinical status in terms of stroke,
dilation to assure antegrade flow where as in those in the group reinfarction, bleeding, pacemaker implantation, rehospitalization
1, the step was followed by advancing the 6F export aspiration for heart failure (HF), target vessel revascularization, and death
catheter (Medtronic, Minneapolis, MN), a 6F-compatible TA was determined from hospital records as well as by face to face
catheter with an aspiration lumen of 0.041 in. and cross profile interviews at 1, 6, 12, 24, and 30 months after the procedure.
of 0.068 in., which was handled over a guide wire of 0.014 in. in LV ejection fraction (LVEF) and LV volumes were
a monorail fashion. Suction was performed manually with measured with the modified Simpson rule algorithm by echo-
lockable 20-ml syringes. After crossing the lesion with a guide cardiography.15 The mean value of 3 measurements of the
wire, the export aspiration catheter was advanced into the target technically best cardiac cycles was taken from each examin-
segment during continuous aspiration. The number of passages ation. LVEF and LV volume changes at 6, 12, and 24 months
necessary to achieve an optimal result was left to the judgment were compared within 24 h of admission. Intraobserver and
of the operator, but at least 2  20 ml was aspirated in multiple interobserver variability values in the evaluation of end-dias-
passages. Additional balloon angioplasty was performed when tolic and -systolic volumes were <5%, which suggests the good
necessary for stent delivery. After restoring the antegrade flow, reproducibility of the measurements.16
in patients deemed suitable intracoronary nitrates were given to
achieve maximal epicardial vasodilation, largely to determine Hospital Complications and Study End Points
the length, and size of the stent and facilitate stent placement.5 In-hospital complications such as recurrent MI, stent throm-
After placement, PCI postprocedural peak creatinine kinase MB bosis, atrial fibrillation, ventricular fibrillation, major bleeding
mass (CK-MB) mass and troponin T level were measured. (hemoglobin drop of 3–5 g% or need for blood transfusion, a drop
Measurement of CK-MB mass and troponin T were also in hemoglobin 5 g%, cardiac tamponade, need for surgical
repeated in 6, 24, and 48 h after PCI. Totally cardiac enzymes treatment or hemodynamic instability, and intracranial or intra-
were measured 4 times after PCI. ocular bleeding), stroke, and acute renal failure were noted, in
addition to 30-month mortality, complications, and major adverse
Medication cardiovascular events over a 30-month follow-up in patients
Pharmacological treatment before and after PCI was per- undergoing PCI. The 30-month follow-up was 95% complete.
formed according to European Society of Cardiology guideline.12 The primary end point was all-cause mortality at 30-month
follow-up. We here report the following prespecified secondary
Angiographic and Echocardiographic Analysis end points: stroke, rehospitalization for MI and congestive heart
failure (CHF), cardiac pacemaker (CPM), implantable cardio-
Coronary angiograms were performed digitally (INNOVA
verter defibrillator (ICD) or cardiac resynchronization therapy
2100, GE Healthcare, Waukesha, WI). Calibration of the quan-
and defibrillator/pacemaker (CRT-D/P) implantation, stent
titative coronary angiography (QCA) system was carried out by
thrombosis, and target-lesion revascularization. The incidence
method in which the coronary catheter employed for angio-
of bleeding complications was assessed both during PCI and at
graphy and was used as the calibration object by automated
30 months following PCI.
edge detection technique resulting in corresponding calibration
factors (mm/pixel). The coronary artery contour was detected
by operator independent edge detection algorithms. The dimen- Statistical Analysis
sion of the coronary artery was then measured as a function of For quantitative variables, M and SD were calculated.
catheter diameter; the absolute diameter in mm was calculated Discrete variables are here presented as the number of events
by the computerized software analysis. At least 2 orthogonal and their percentages. Comparisons were made with Chi-square
projections of the coronary segment scheduled for coronary or Fisher exact tests for discrete variables and by unpaired t
intervention were filmed before and after the intervention. All tests, Wilcoxon sign-rank tests, or 1-way analyses of variance
angiograms were evaluated and reviewed offline by 2 experi- (ANOVA) for continuous variables. Repeated measured
enced, interventional cardiologists blind both the results and ANOVA was used for repeatedly measured variables. Survival
success of the technique, as stated in the procedural report, for curves were estimated using the Kaplan–Meier estimator and
the presence of intraluminal filling defects and TIMI flow grade compared using log-rank tests while correlates of 30-month
before PCI, after TA, and at the end of the procedure. The survival were determined using a multivariate backward step-
feasibility, success rate, and occurrence of potential compli- wise Cox analysis. Cumulative hazard functions were computed
cations (eg, coronary dissection and perforation) due to TA were to assess proportionality, and differences were considered sig-
reported. The applicability of the aspiration procedure was nificant at P < 0.05. Statistical analyses were performed by
defined as the ability to advance the aspiration catheter into using the Statistical Package for the Social Sciences for Win-
the target lesion without predilatation, while the accomplish- dows version 17 (SPSS, Chicago, IL).
ment of TA was defined as the visually determined reduction of
intraluminal filling defects in the angiogram and/or the presence RESULTS
of visible thrombus in the aspirate. Improvement in coronary
flow due to TA was defined as the improvement in TIMI flow Patient and Procedural Data
grade by at least one grade. Distal embolization during PCI was A total of 139 UAP patients (mean age 65.02 
defined as the presence of a new distal occlusion of either the 13.00 years, 69.1% male) were studied, 64 of whom 46%

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Yildiz et al Medicine  Volume 95, Number 8, February 2016

underwent thrombectomy. TA was attempted before PCI in acute renal failure were not significantly different between
UAP patients (aged 64.28  12.7 years) who had angiography- the 2 groups (Table 4).
detected of thrombus formation. Four hundred eighty-six Death, stroke, bleeding complications, recurrent MI, stent
patients were excluded from analysis (Figure 1). There were thrombosis, occurrence of AF, occurrence of VT/VF, new renal
no statistically significant between-group differences in age, dialysis, new CABG, rehospitalization for HF, CPM implan-
sex, duration of chest pain, risk factors (ie, body mass index, tation, ICD or CRT-D/P implantation were assessed within 30
diabetes mellitus, hypertension, hyperlipidemia, smoking, renal months following PCI. Death was significantly lower in the
insufficiency, family history and history of coronary artery group 1 (unadjusted OR: 0.29, 95% CI: 0.09–0.93, P ¼ 0.030).
disease [CAD], coronary artery bypass grafting [CABG], In a multiple logistic regression model adjusted for age, sex,
cerebrovascular accident, CHF, and peripheral artery disease), systolic blood pressure, glomerular filtration rate, multivessel
ECG parameters (ie, heart rate and rhythm at admission), blood CAD, GRACE score at admission, initial TIMI flow, LVEF at 6
parameters, drugs or medication taken before admission, LVEF months, or concomitant use of GP IIb–IIIa inhibitors, TA was
within 24 h, Global Registry of Acute Coronary Events associated with a significant reduction in 30-month mortality
(GRACE) score, and Killip classification at admission. Baseline (adjusted OR: 7.36, 95% CI: 1.20–45.10, P ¼ 0.031). Stroke,
demographics and clinical characteristics are shown in Table 1. recurrent MI, occurrence of AF, occurrence of VT/VF, ICD
The culprit coronary artery was the right coronary artery implantation, rehospitalization for HF, new CABG were also
(RCA) in 34.4% of the group 1 and in 22.7% of the group 2, the significantly lower in the group 1 than in the group 2 (Table 5).
left anterior descending artery (LAD) in 48.4% and 56% of the 2 During a mean follow-up period of 28.87  6.28 months
groups, the left circumflex artery (Cx) in 15.6% and 18.7%, and (30.18  4.16 months in the group 1 vs 27.76 þ 7.49 months in
the left main coronary artery (LMCA) in 1.6% and 2.7% the group 2), 18 patients (12.9%) died. Of these, 4 patients were
(P < 0.486). Three and more vessel disease was present in from the group 1 (6.3%) and 14 from the group 2 (18.7%)
17.2% of patients in the group 1 versus 28% of patients in (unadjusted HR: 3.24, 95% CI: 1.06–9.58, P ¼ 0.038). Using
the group 2. Stent implantation was performed in 92.2% of Cox multivariate analysis, TA was associated with significantly
patients in the group 1 and in 98.7% in the group 2. The use of a less long-term mortality even after the same variables were
drug-eluting stent (DES) was similar in both groups corrected in all UAP patients (adjusted HR: 4.61, 95% CI:
(P ¼ 0.268). Direct stenting was performed in 46 patients 1.16–18.21, P ¼ 0.029). The Kaplan–Meier cumulative survive
(34%). Cardiac markers (ie, CK-MB mass and troponin T) curve appears in Figure 3.
were significantly lower after PCI in the group 1 than the group
2 (CK-MB mass: 3.80  1.11 vs 4.23  0.89, P ¼ 0.012; tropo-
nin T: 0.012  0.014 vs 0.018  0.008, P ¼ 0.002). There were DISCUSSION
no statistically significant between-group differences in occlu- In this trial, the process of manual TA during PCI in
sion pre-PCI, balloon angioplasty, balloon length and diameter, patients with UAP and thrombus-containing lesions was found
balloon inflation time, indeflator pressure, stent diameter and to be associated with better long-term survival and lower rates
length, stent balloon inflation time, indeflator pressure for stent of stroke, recurrent MI, arrhythmias (AF, VT/VF), rehospita-
balloon, stent postdilatation, or procedure complication (eg, lization for CHF, and new CABG and ICD implantation within
coronary dissection, coronary perforation, hematoma, and arter- 30 months than in patients treated with PCI only. To the best of
iovenous fistula). Duration of hospitalization was statistically our knowledge, this study is the first of PCI-treated UAP
briefer in the group 1 than in the group 2 (4.25  4.02 day vs patients to have demonstrated an association between TA
6.49  5.83 day, P ¼ 0.011). The use of anticoagulants and and reduced mortality.
antiaggregants was generally similar between both groups, as Previous studies assessing the use of TA in STEMI patients
was treatment by statins, b-blockers, ACEi, or ARB during the and its outcomes have demonstrated different results.5,8,17–20
first 24 h. TA was associated with an increased rate of TIMI- The Thrombus Aspiration during Percutaneous Coronary Inter-
flow 3 (37.5% in group 1 and 34.7% in the group 2 preprocedure vention in Acute Myocardial Infarction Study (TAPAS) is the
vs 93.8% and 78.7%, respectively, at the end of procedure). The only randomized trial to have demonstrated a significant
number of patients with postoperative TIMI grade 3 blood flow beneficial effect on mortality: an approximately 50% reduction
was significantly higher in the group 1 (P ¼ 0.036). The number in 1-year mortality.8 Conversely, the Thrombus Aspiration in
of patients with a no-reflow rate was lower in the group 1 than in ST-Elevation Myocardial Infarction in Scandinavia (TASTE)
the group 2, though not significantly (P ¼ 0.687) while the study showed that routine thrombectomy use did not reduce 30-
incidence of MBG 3 was 90.6% and 70.3%, respectively day mortality.21 Similar conflicting results were demonstrated
(P ¼ 0.031). TFCs were significantly decreased in infarct in NSTEMI patients. Vlaar et al10 found that manual TA was
related arteries in both groups after PCI. The decrease in TFCs associated with a significant reduction of TIMI thrombus score
was far greater in the group 1 than in the group 2 and statistically and an increased rate of TIMI flow grade 3 in NSTEMI patients.
significant (Table 2). Furthermore, a significant decrease in Thiele et al22 showed that TA in conjunction with PCI in
TFCs also emerged following aspiration in all coronary arteries NSTEMI with a thrombus-containing lesion did not precipitate
in group 1 (TFC-LAD preaspiration: 25.93  4.46 vs postas- any reduction in microvascular obstruction. Hermens et al11
piration: 17.25  2.17, P ¼ 0.001; TFC-CX preaspiration: published their initial experiences with manual TA in 14
20.07  2.46 vs postaspiration: 14.35  2.06, P ¼ 0.001; TFC- patients with stable or UAP and recommended that myocardial
RCA preaspiration: 18.20  5.33 vs postaspiration: 14.65  perfusion might benefit from TA in patients with stable or
2.59, P ¼ 0.001) (Table 3). unstable angina. Based on these data, current American and
At 6, 12, and 24 months post-PCI, the mean LVEF was European guidelines suggest performing manual TA in only
significantly higher in the group 1 versus the group 2 (Figure 2). STEMI patients with a class IIa level of evidence B recom-
In-hospital mortality, stroke, stent thrombosis, major mendation.23,24
bleeding, recurrent MI, onset of atrial fibrillation (AF) or In this study, manual TA was associated with a significant
ventricular tachycardia/ventricular fibrillation (VT/VF), and reduction of TFC and an increase in the rate of TIMI flow 3 and

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Medicine  Volume 95, Number 8, February 2016 Manual Thrombus Aspiration in Patients With Unstable Angina Pectoris

TABLE 1. Baseline Characteristics of Study Population

Thrombus Aspiration Stand-Alone PCI

(n) Mean  SD (%) (n) Mean  SD (%) P

Age (y) 64.28  12.70 65.65  13.30 0.537
Duration of chest pain (h) 6.85  3.62 7.07  4.32 0.755
Sex 0.941
Female 20 31.3 23 30.7
Male 44 68.8 52 69.3
Risk factors
BMI (kg/m2) 26.00  2.30 26.08  2.51 0.846
DM 24 37.5 25 33.3 0.608
HT 39 60.9 40 53.3 0.367
HLP 13 20.3 19 25.3 0.483
Smoking 19 29.7 25 33.3 0.645
Family history 10 15.6 11 14.7 0.875
History
Previous CAD 12 18.8 17 22.7 0.571
Previous PAD 5 7.8 6 8.0 0.967
Previous CABG 7 10.9 8 10.7 0.959
Previous CVA 3 4.7 5 6.7 0.726
Previous CHF 5 7.8 4 5.3 0.732
Chronic renal failure 9 14.1 15 20.0 0.356
Clinical
SBP (mm Hg) 143.73  11.83 142.45  16.49 0.605
DBP (mm Hg) 85.39  14.06 83.98  17.53 0.608
ECG
HR beats/min 78.14  19.24 75.61  16.54 0.406
Rhythm at admission 0.754
SR 57 89.1 68 90.7
AF 7 10.9 7 9.3
RBBB 7 10.7 6 8.0 0.553
LBBB 12 18.8 11 14.7 0.518
AV block 11 17.2 20 26.7 0.181
Bloods
Hg (g/dl) 13.01  2.37 13.34  1.78 0.354
Plt (k/ml) 232.10  41.52 220.44  51.50 0.148
WBC (k/ml) 7.74  1.55 7.50  1.30 0.328
Urea (mg/dl) 37.09  14.26 42.32  22.25 0.108
Creatinine (mg/dl) 1.01  0.27 1.01  0.29 0.978
GFR (ccs/min) 83.71  33.54 76.25  31.75 0.181
Hs-CRP (mg/L) 2.79  1.20 2.59  0.93 0.272
Uric acid (mg/dl) 7.03  2.18 7.21  1.86 0.615
Glucose (mg/dl) 132.35  36.98 134.40  69.32 0.833
CK-MB mass (ng/ml)y 2.39  0.97 2.26  1.06 0.456
Troponin T (ng/ml)z 0.0034  0.0038 0.0034  0.0040 0.910
LDL cholesterol (mg/dl) 112.34  31.99 109.02  28.07 0.516
HDL cholesterol (mg/dl) 42.62  9.43 40.68  11.28 0.277
Triglyceride (mg/dl) 208.14  86.71 197.28  109.62 0.523
Total cholesterol (mg/dl) 192.70  26.44 195.90  32.64 0.531
Drugs before admission
Aspirin 22 34.4 34 45.3 0.189
Clopidogrel 13 20.3 14 18.7 0.807
ACEi or ARB 34 53.1 42 56.0 0.734
b-blocker 36 56.3 36 48.0 0.332
Statin 17 26.6 26 34.7 0.303
LVEF%
Within 24 h 47.26  9.87 46.21  9.94 0.534
GRACE score (death) 93.62  24.79 100.40  18.33 0.067
GRACE score (death þ MI) 114.40  28.69 122.86  22.74 0.055
Admission Killip class 1.34  0.47 1.32  .52 0.782
ACEi ¼ angiotensin converting enzyme inhibitor, AF ¼ atrial fibrillation, ARB ¼ angiotensin receptor blocker, AV block ¼ atrioventricular block,
BMI ¼ body mass index, CABG ¼ coronary artery bypass grafting, CAD ¼ coronary artery disease, CHF ¼ congestive heart failure, CK-MB
mass ¼ creatinine kinase MB mass, CVA ¼ cerebrovascular accident, DBP ¼ diastolic blood pressure, DM ¼ diabetes mellitus, GFR ¼ glomerular
glomerular filtration rate, HDL ¼ high density lipoprotein, Hg ¼ hemoglobin, HLP ¼ hyperlipidemia, HR ¼ heart rate, HT ¼ hypertension,
LBBB ¼ left bundle branch block, LDL ¼ low density lipoprotein, LVEF ¼ left ventricular ejection fraction, NSTEMI ¼ non-ST-segment elevation
myocardial infarction, PAD ¼ peripheral artery disease, PCI ¼ percutaneous coronary intervention, Plt ¼ platelet, RBBB ¼ right bundle branch block,
SBP ¼ systolic blood pressure, SD ¼ standard deviation, SR ¼ sinus rhythm, STEMI ¼ ST-segment elevation myocardial infarction, UAP ¼ unstable
angina pectoris, VT ¼ ventricular tachycardia, WBC ¼ white blood cell.

Fischer exact test was used.
y
CK-MB mass normal range: 0–5 ng/ml.
z
Troponin T normal range: 0–0.014 ng/ml.

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Yildiz et al Medicine  Volume 95, Number 8, February 2016

TABLE 2. Procedural Characteristics, Angiographic, and Echocardiographic Results of Study Population

Thrombus Aspiration Stand-Alone PCI

(n) Mean  SD (%) (n) Mean  SD (%) P

Culprit coronary vessel 0.486

LMCA 1 1.6 2 2.7
CX 10 15.6 14 18.7
LAD 31 48.4 42 56
RCA 22 34.4 17 22.7
CAD extension 0.036
1 vessel 37 57.8 27 36.0
2 vessels 16 25.0 27 36.0
3 and more vessels 11 17.2 21 28.0
Balloon angioplasty 51 79.7 53 70.7 0.222

Stent implanted 61 95.3 74 98.7 0.334
Stent type 0.684
BMS 22 34.4 30 40.0
DES 39 60.9 43 57.3
Direct stenting 19 29.7 27 36.0 0.476
Occlusion pre-PCI (%) 92.17  4.46 90.71  6.32 0.212
Balloon diameter (mm) 1.81  1.13 1.67  1.26 0.500
Balloon length (mm) 13.72  8.19 12.52  9.91 0.444
Balloon inflation time (s) 27.58  18.12 27.60  22.27 0.995
Indeflator pressure (atm) 10.34  5.62 9.45  7.08 0.419
Stent diameter (mm) 2.80  0.82 2.84  0.61 0.773
Stent length (mm) 20.89  8.58 21.69  10.89 0.634
Stent balloon inflation time (s) 20.47  9.98 19.07  7.38 0.344
Indeflator pressure for stent balloon (atm) 14.70  3.80 14.64  3.03 0.920
Stent postdilatation 7 10.9 7 9.3 0.754

No-reflow 2 3.1 4 5.3 0.687
Procedure complication 10 15.6 10 13.3 0.701
Procedure complication type 0.572
Coronary dissection 4 40.0 2 20.0
Coronary perforation 0 0 1 10.0
Hematoma 5 50.0 5 50.0
Arteriovenous fistula 1 10.0 2 20.0
Post-PCI CK-MB mass (ng/ml) 3.80  1.11 4.23  0.89 0.012
Post-PCI troponin T (ng/ml) 0.012  0.014 0.018  0.008 0.002
Hospitalization time (d) 4.25  4.02 6.49  5.83 0.011
Drugs
Glycerol trinitrate (before/during angiography) 16 25.0 23 30.7 0.459
Glycoprotein IIb–IIIa inhibitors 12 18.8 8 10.7 0.176
(before/during angiography)
Ca-channel blocker (before/during angiography) 8 12.5 8 10.7 0.736
Aspirin in first 24 h 62 96.9 73 97.3 0.872
Clopidogrel first 49 76.6 55 73.3 0.662
Prasugrel first 5 7.8 6 8.0 0.967
LMWH (before/during angiography) 49 76.6 47 62.7 0.077
UFH (before/during angiography) 31 48.4 46 61.3 0.127
Statin in first 24 h 39 60.9 52 69.3 0.299
ACEi or ARB in first 24 h 30 46.9 33 44.0 0.734
b blockers in first 24 h 29 45.3 37 49.3 0.636
TIMI flow before PCI 0.718
1 9 14.1 8 10.7
2 31 48.4 41 54.7
3 24 37.5 26 34.7
TIMI flow after PCI 0.036
1 1 1.6 2 2.7
2 3 4.7 14 18.7
3 60 93.8 59 78.7
Myocardial blush grade pre-PCI 0.553

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Medicine  Volume 95, Number 8, February 2016 Manual Thrombus Aspiration in Patients With Unstable Angina Pectoris

TABLE 2. (Continued)
Thrombus Aspiration Stand-Alone PCI

(n) Mean  SD (%) (n) Mean  SD (%) P

1 10 15.6 8 10.7
2 34 53.1 46 61.3
3 20 31.3 21 28
Myocardial blush grade post-PCI 0.031
1 1 1.6 2 2.7
2 5 7.8 18 24.0
3 58 90.6 55 73.3
TIMI frame count
LAD
Pre-PCI 31 25.93  4.46 42 24.01  2.76 0.050
Post-PCI 31 15.43  3.07 42 18.18  1.39 0.001
Cx
Pre-PCI 10 21.00  3.65 14 20.07  2.46 0.438
Post-PCI 10 13.78  2.69 14 16.78  2.11 0.003
RCA
Pre-PCI 22 18.20  5.33 17 18.62  3.30 0.779
Post-PCI 22 14.13  2.48 17 16.12  3.00 0.027
EF%
After 6 months post-PCI 63 53.12  8.57 73 49.54  10.12 0.029
After 12 months post-PCI 63 52.38  10.62 70 48.18  12.19 0.037
After 24 months post-PCI 62 52.54  11.39 61 48.03  11.86 0.033

ACEi ¼ angiotensin converting enzyme inhibitor, ARB ¼ angiotensin receptor blocker, BMS ¼ bare metal stent, CAD ¼ coronary artery disease,
Cx ¼ circumflex, CK-MB mass ¼ creatinine kinase MB mass, DES ¼ drug eluting stent, LAD ¼ left anterior ascending, LMCA ¼ left main coronary
artery, LMWH ¼ low molecular weight heparin, NSTEMI ¼ non-ST-segment elevation myocardial infarction, PCI ¼ percutaneous coronary
intervention, RCA ¼ right coronary artery, SD ¼ standard deviation, STEMI ¼ ST-segment elevation myocardial infarction, TIMI ¼ thrombolysis
in myocardial infarction, UAP ¼ unstable angina pectoris, UFH ¼ unfractionated heparin.
Bold value signifies statistically significant.

Fischer exact test was used.

MBG 3 in the manual TA group. Vlaar et al10 found an increase that TA reduces thrombus burden and prevents distal emboliza-
in TIMI 3 flow after TA in NSTEMI patients while Burzotta tion in causing microvascular injury. Thereby, increased micro-
et al17 found significant improvement of MBG in patients with vascular flow improves myocardial reperfusion and clinical
successful TA in STEMI patients. In our study, postprocedural outcomes.25,26
levels of CK-MB mass and troponin T were higher in the stand- In the present study, we also evaluated LV functions of
alone PCI group than in the TA group. These results show UAP patients, and baseline LVEFs were similar between the 2

TABLE 3. Comparison of TIMI Frame Counts of All Patients

TIMI Frame Count

Thrombus P, Pre-Asp– P, Pre-Asp– P, Post-Asp–

Aspiration (þ) Pre-Asp Post-Asp Post-PCI Post-Asp Post-PCI Post-PCI

LAD (n ¼ 31) 25.93  4.46 17.25  2.17 15.43  3.07 0.001 0.001 0.028
CX (n ¼ 10) 20.07  2.46 14.35  2.06 13.78  2.69 0.001 0.001 0.120
RCA (n ¼ 22) 18.20  5.33 14.65  2.59 14.13  2.48 0.001 0.001 0.037
TIMI Frame Count

Thrombus Aspiration () Pre-PCI Post-PCI P, Pre-PCI–Post-PCI

LAD (n ¼ 42) 24.01  2.74 18.18  1.39 0.001

CX (n ¼ 14) 21.00  3.65 16.78  2.11 0.001
RCA (n ¼ 17) 18.62  3.30 16.12  3.00 0.001
Cx ¼ circumflex, LAD ¼ left anterior descending, PCI ¼ percutaneous coronary intervention, Post-asp ¼ postthrombus aspiration, Pre-asp ¼
prethrombus aspiration, RCA ¼ right coronary artery, TIMI ¼ thrombolysis in terms of myocardial infarction.
Bold value signifies P < 0.05.

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Yildiz et al Medicine  Volume 95, Number 8, February 2016

groups. By the time that LVEFs were changed in 6, 12, and 24

months after PCI in both groups. LVEF was significantly higher
in the TA group than in the stand-alone group during 24 months.
The LVEF increases in both groups at the 1st echo during
follow-up, then goes down and plateaus in the thrombectomy
group while declining further in the nonthrobectomy group. We
may accept that LVEF is acutely depressed or biomarker release
(hibernation) and that it improves after revascularization.
Decrease in LVEF in the stand-alone PCI group after 6 months
may be explained by higher incidence of complications like
recurrent MI in this group. Similarly, Liistro et al27 showed that
manual TA in the context of primary PCI improves myocardial
tissue-level perfusion as well as LV functional recovery and
remodeling at 6 months. Conversely, in the myocardial contrast
echocardiographical substudy of the REMEDIA trial.28 TA was
associated with no significant reduction in LV remodeling at 6
months. Despite conflicting results, our findings suggest that
TA may help to reduce the infarct size and preserve the
myocardial function by protecting microvascular obstruction.
According to our study, TA appears to be a valuable
approach to improving outcomes in UAP patients with visible
thrombus. In this study, improved procedural outcomes with
manual TA were observed, though these improvements were
not associated with better hospital mortality or in-hospital
FIGURE 2. Two-year LVEF according to the use of thrombus
aspiration in UAP patients. P values come from repeated measured complication rates. Although there was no significant difference
analysis of variance. in relationship to hospital complications, duration of hospital-
ization was significantly briefer in the TA group. Lower long-
term complication rates may be attributed to the use of TA
during PCI, since TA may help to reduce infarct size, prevent
cardiac remodeling, and/or preserve myocardial function by

TABLE 4. In-Hospital Complications

Thrombus Aspiration Group Stand-Alone PCI Group P, Odds Ratio (95% CI)

Death 1.000
(n) 1 2 0.579
(%) 1.6 2.7 (0.051–6.542)

Stroke 0.624
(n) 1 3 0.381
(%) 1.6 4 (0.039–3.755)

Stent thrombosis 0.452
(n) 2 5 0.452
(%) 3.1 6.7 (0.085–2.411)
Major bleeding 0.993
(n) 6 7 1.005
(%) 9.4 9.3 (0.320–3.159)

Recurrent MI 0.624
(n) 1 3 0.381
(%) 1.6 4 (0.039–3.755)
Onset AF 0.343
(n) 6 11 0.602
(%) 9.4 14.7 (0.209–1.731)
Onset VT/VF 0.086
(n) 2 8 0.270
(%) 3.1 10.7 (0.055–1.322)
Acute renal failure 0.291
(n) 3 7 0.478
(%) 4.7 9.3 (0.118–1.930)

AF ¼ atrial fibrillation, CI ¼ confidence interval, NSTEMI ¼ non-ST-segment elevation myocardial infarction, PCI ¼ percutaneous coronary
intervention, STEMI ¼ ST-segment elevation myocardial infarction, UAP ¼ unstable angina pectoris, VT/VF ¼ ventricular tachcardia, ventricular
fibrillation.

Fischer exact test was used.

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Medicine  Volume 95, Number 8, February 2016 Manual Thrombus Aspiration in Patients With Unstable Angina Pectoris

TABLE 5. Comparison of Complications Over 30 Months Following in Patients Undergoing Percutaneous Coronary Intervention
(PCI)

Thrombectomy Group Stand-Alone PCI Group P, Odds Ratio (95% CI)

Death 0.030
(n) 4 14 0.290
(%) 6.3 18.7 (0.090–0.933)
Stroke 0.033
(n) 2 10 0.210
(%) 3.1 13.3 (0.044–0.995)
Stent thrombosis 0.246
(n) 4 9 0.489
(%) 6.3 12 (0.143–1.670)
Major bleeding 0.901
(n) 9 10 1.064
(%) 14.1 13.3 (0.403–2.804)
Recurrent MI 0.030
(n) 4 14 0.290
(%) 6.3 18.7 (0.090–0.933)
AF 0.032
(n) 3 12 0.258
(%) 4.7 16 (0.069–0.960)
VT/VF 0.019
(n) 4 15 0.267
(%) 6.3 20 (0.084–0.850)
ICD implantation 0.027
(n) 5 16 0.313
(%) 7.8 21.3 (0.108–0.908)

CRT-D/P implantation 0.506
(n) 3 6 0.566
(%) 4.7 8 (0.136–2.359)

CPM implantation 1.000
(n) 2 2 1.177
(%) 3.1 2.7 (0.161–8.605)
Rehospitalization for HF 0.015
(n) 6 19 0.305
(%) 9.4 25.3 (0.113–0.819)
New renal dialysis 0.051
(n) 3 11 0.286
(%) 4.7 14.7 (0.076–1.075)
New CABG 0.030
(n) 4 14 0.290
(%) 6.3 18.7 (0.090–0.933)

AF ¼ atrial fibrillation, CABG ¼ coronary artery bypass grafting, CI ¼ confidence interval, CPM ¼ cardiac pacemaker, CRT-D/P ¼ cardiac
resynchronization therapy and defibrillator/pacemaker, HF ¼ heart failure, ICD ¼ implantable cardioverter defibrillator, NSTEMI ¼ non-ST-segment
elevation myocardial infarction, STEMI ¼ ST-segment elevation myocardial infarction, UAP ¼ unstable angina pectoris, VT/VF ¼ ventricular
tachycardia/ventricular fibrillation.

Fischer exact test was used.

protecting microvascular obstruction. Lower stroke rates up target-vessel tortuosity). In addition, we have not standardized
until the 30-month follow-up in our study can be explained by a our determination of whether the aspiration catheter crossed the
significant reduction in the onset of AF or VT/VF. culprit lesion and lacked information concerning the amount of
thrombus material removed. Also, the study population
remained small.
Study Limitations
In this study, for UAP patients the decision to perform TA CONCLUSIONS
was made after careful consideration by experienced interven- This study demonstrates that manual TA in the context of
tional cardiologists. Nevertheless, absent the use of intravas- UAP is associated with a limited elevation in cardiac enzymes
cular ultrasound or optical coherence tomography, even during PCI that minimizes microembolization with a significant
experienced operators have a limited ability to distinguish improvement both of the coronary artery flow and myocardial
intracoronary thrombus formation from calcified lesions. Our perfusion, as assessed by the use angiographic TIMI flow grade,
data lack information on culprit lesion characteristics (eg, TFC, and MBG. The improvement in tissue perfusion is also

Copyright # 2016 Wolters Kluwer Health, Inc. All rights reserved. www.md-journal.com | 9
Yildiz et al Medicine  Volume 95, Number 8, February 2016

5. Svilaas T, Vlaar PJ, van der Horst IC, et al. Thrombus aspiration
during primary percutaneous coronary intervention. N Engl J Med.
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6. Mizote I, Ueda Y, Ohtani T, et al. Distal protection improved
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7. Ikari Y, Sakurada M, Kozuma K, et al. Upfront thrombus aspiration
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(VAcuuM asPIration thrombus REmoval) trial. JACC Cardiovasc
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8. Vlaar PJ, Svilaas T, van der Horst IC, et al. Cardiac death and
reinfarction after 1 year in the Thrombus Aspiration during
Percutaneous coronary intervention in Acute Myocardial Infarction
Study (TAPAS): a 1-year follow-up study. Lancet. 2008;371:
1915–1920.
9. Noman A, Egred M, Bagnall A, et al. Impact of thrombus aspiration
during primary percutaneous coronary intervention on mortality in
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10. Vlaar PJ, Diercks GF, Svilaas T, et al. The feasibility and safety
of routine thrombus aspiration in patients with non-ST-elevation
FIGURE 3. Kaplan–Meier curves for overall survival up to 30- myocardial infarction. Catheter Cardiovasc Interv. 2008;72:937–942.
month follow-up according to the use of thrombus aspiration in
UAP patients. Log-rank: x2: 4.83, P < 0.028. 11. Hermens JA, van Houwelingen GK, de Man FH, et al. Thrombus
aspiration in a series of patients with stable or unstable angina
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the use of thrombectomy during PCI in UAP patients given its management of acute coronary syndromes in patients presenting
association with better survival over a 30-month follow-up without persistent ST-segment elevation: the Task Force for the
period. Using thrombectomy given the suspicion of thrombus management of acute coronary syndromes (ACS) in patients present-
formation in UAP patients affords better results. Nevertheless, ing without persistent ST-segment elevation of the European Society
further studies with larger sample sizes are needed to evaluate of Cardiology (ESC). Eur Heart J. 2011;32:2999–3054.
the clinical value of and long-term prognosis following 13. Gibson CM, Cannon CP, Daley WL, et al. TIMI frame count: a
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ACKNOWLEDGMENTS 14. van ’t Hof AW, Liem A, Suryapranata H, et al. Angiographic
We are deeply indebted to the devoted personnel of the assessment of myocardial reperfusion in patients treated with
Coronary Angiography Units of Pamukkale University Medical primary angioplasty for acute myocardial infarction: myocardial
blush grade. Zwolle Myocardial Infarction Study Group. Circulation.
Faculty Department of Cardiology and Sifa University Medical
1998;97:2302–2306.
Faculty, Department of Cardiology; to Huseyin Ergun (tech-
nician) and to Ali Curaci (technician) for their careful data 15. Schiller NB, Shah PM, Crawford M, et al. Recommendations for
management and invaluable assistance in designing coronary quantitation of the left ventricle by two-dimensional echocardiogra-
angiography CDs. They gave permission to be named. phy. American Society of Echocardiography Committee on Stan-
dards, Subcommittee on Quantitation of Two-Dimensional
Echocardiograms. J Am Soc Echocardiogr. 1989;2:358–367.
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