Supplement: Exclusion criteria, Informed consent, Post procedural assessment,
description of the Eliminate catheter, results of per-treatment analysis and
additional figures
Exclusion criteria
Clinical exclusion criteria were the following: pregnancy; known intolerance to
aspirin, clopidogrel, heparin, stainless steel, limus drugs, contrast material; diameter
stenosis <30% in the target lesion; multi-vessel coronary artery disease (DS>50%);
unprotected left main coronary artery stenosis >30% by visual assessment; distal
vessel occlusion; severe tortuous, calcified or angulated coronary anatomy of the
study vessel that in the opinion of the investigator would result in sub-optimal
imaging or excessive risk of complication from insertion of an OFDI catheter;
fibrinolysis prior to PCI; platelet count less than 100 000 cells/μl; active bleeding or
coagulopathy or patients with chronic anticoagulation therapy; cardiogenic shock;
significant comorbidities precluding clinical follow-up as judged by investigators;
major planned surgery that requires discontinuation of dual antiplatelet therapy;
proximal RCA stenosis (>30%) if the infarct-related artery is mid or distal-RCA.
Informed consent
Before enrolment, informed consent was obtained for all subjects, either written or
orally given with written conformation by the impartial witness, according to the
procedures defined by the local ethics committees. In the latter case, the patient had to
give his/ her signature whenever he or she became capable of signing consent.
Post procedural assessments
The following laboratory assessments were to be obtained at 6-12 and 18-24
hours after the PPCI and at any time of suspected re-infarction: Creatine kinase (CK),
Creatine kinase myocardial-band isoenzyme (CK-MB) and Troponin.
Electrocardiogram was obtained 1hour post procedure and in case of recurrent chest
pain lasting more than 20 min.
All patients enrolled in the study were maintained on the same thienopyridine
class of ADP receptor inhibitors (Clopidogrel /Prasugrel/ Ticlopidine) during the
entire duration of the study and if not, the rational for change had to be documented.
Unless contraindicated, peri-procedural IIb/IIIa inhibitor was given according to the
ESC guidelines. 1 All patients received  75 mg of aspirin daily and indefinitely.
Patients were followed after hospital discharge up to 1 year after the index procedure.
This includes clinic visits regarding cardiovascular drug use, hospitalizations,
invasive or non-invasive diagnostic tests. Clinic visit was planned at 30 days, 6
months and 1 year. Up to 40 patients in each arm (thrombectomy vs. nonthrombectomy) are planned to undergo a repeat OFDI imaging of the infarct culprit
coronary artery at 6 months in selected centres.
Description of the Eliminate® catheter
The Eliminate® is a manual aspiration device for thrombus removal from the
vasculature. The Eliminate® is used as an adjunctive device to improve clinical
outcome by aspirating and extracting emboli or thrombi from the target lesion during
balloon dilatation or stenting against the narrowed or occluded coronary or peripheral
arteries with thrombosis. The Eliminate® has been in regular use in Japan for several
years and has also received regulatory approval in Europe (CE Mark).
The Eliminate device has the following features:








The Eliminate® catheter is a dual lumen rapid exchange catheter.
The Guidewire lumen is used facilitate passage of a guide wire which must not
exceed 0.014” (0.36 mm) in diameter.
The larger extraction lumen allows the removal of thrombus (thrombi) by use
of the included aspiration syringe through the extension line.
The catheter shaft is braided with Stainless Steel construction (SUS 304)
which covers the entire length of the catheter shaft all the way to the distal
part.
The catheter has a proximal stiff region and a distal flexible region that is
coated with hydrophilic polymer which generates lubricity when wet.
The catheter is designed with 10 cm-length depth maker located at 90 cm from
the distal tip.
Short and thin 1 mm distal radiopaque maker located at 4 mm from the tip and
1 mm from inner lumen provides excellent fluoroscopy visualization and
increase distal flexibility.
The proximal end of the catheter is equipped with a standard luer adapter to
facilitate the attachment of the included extension line and syringe.
Specifications of Eliminates®
Code
EG1602
Guiding
Catheter
Compatibility
O.D.
(Distal/Proximal)
I.D.
(Distal/Proximal)
6 Fr.
5.3/4.2 Fr.
1.00/1.05 mm
(I.D.≥0.70
inch)
EG1652
7 Fr.
(I.D.≥0.80
inch)
5.9/4.8 Fr.
1.25/1.30 mm
Gide Wire
Compatibility
GW port
Length
0.014 inch
230 mm
Usable
Catheter
Length
1400
mm
Supplement
Table. OFDI results in per-treatment analysis
68 patients
68 lesions
21.84±9.76
8.97±2.32
Nonthrombectomy
59 patients
59 lesions
21.23±7.77
8.29±2.12
0.37±0.22
0.34±0.21
0.03
0.44
0.14±0.26
0.14±0.26
0.00
1.00
8.69±2.26
7.08±2.11
7.62±2.23
8.04±2.16
6.50±2.02
7.05±2.12
0.65
0.57
0.57
0.10
0.12
0.14
Thrombectomy
Stent length, mm
Mean stent area, mm2
Mean intra-stent structure area
(protrusion + isolated
intraluminal mass), mm2
Incomplete strut apposition
area, mm2
Mean flow area, mm2
Minimum flow area, mm2
Minimum stent area, mm2
Values are expressed as mean ± Standard deviation.
Difference
p-value
0.61
0.68
0.70
0.09
Supplementary Fig 1
Venn diagrams of the randomized arms showing absence, presence and/ or coexistence of tissue prolapse/attached intraluminal mass (P), intraluminal defect
free from vessel wall (ILD) and incomplete stent apposition (ISA) in analyzed instent cross sections. Statistically there are no differences between two groups,
regarding each category of Venn diagrams.
Suppl.
Fig 1 Non-thrombectomy group
Total frame = 1350
Thrombectomy group
Total frame = 1533
None of these
N=286
(21.2%)
P+ILD
N=93
(6.9%)
Isolated
intraluminal
Defect (ILD)
only
N=0
(0%)
None of these
N=303
(19.8%)
Protrusion
(P) only
Protrusion
(P) only
N=731
(54.2%)
N=848
(55.3%)
P+ISA
+ILD
N=16
(1.2%)
ILD+ISA
N=2
(0.2%)
P+ISA
N=175
(13.0%)
Incomplete
scaffold
apposition
only
N=47
(3.5%)
P+ILD
N=112
(7.3%)
Isolated
intraluminal
Defect (ILD)
only
N=0
(0%)
P+ISA
+ILD
N=28
(1.8%)
ILD+ISA
N=3
(0.2%)
P+ISA
N=198
(12.9%)
Incomplete
scaffold
apposition
only
N=41
(2.7%)
Supplementary Fig 2
This figure shows 2D (A-C, A’-C’) and 3D-OFDI images (D, D’) of the same patient
post procedure and at follow-up. Immediately after procedure, there were tissue
prolapse observed in the stented segment (upper panel, yellow arrows), which
disappeared at 6 months (lower panel, yellow arrow). Late acquired
malapposition was observed at 6 months (lower panel, light blue arrows).
Suppl.
Fig 2
Post Procedure
sb
*
A
B
C
D
6M follow-up
A’
sb
B’
C’
D’
Supplementary file - Video
This video shows a fly-through view of 3-dimensional OFDI reconstruction in the
same coronary artery at baseline (left) and at 6 months (right). At baselines,
some stent struts (colored as white) were covered by protrusion and therefore
were not visible, while at 6 months these struts became visible due to resolution
of these materials.
Reference
1.
Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber
K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF,
Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW,
Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization.
European heart journal 2010;31(20):2501-55.