APPENDIX
Online Table 1. Baseline Characteristics of Entire PCI Population. Note: there were no
statistically significant differences between groups for these measures (data not shown).
Characteristics
Pre-treatment
No pre-treatment
(N=1389)
(N=1372)
Age yrs, mean (SD)
63·7 (11.3)
63·6 (11.0)
Female sex n, (%)
324 (23·3)
338 (24·6)
Weight kg, mean (SD)
82·2 (14.9)
82·2 (14.9)
BMI ≥ 30 n, (%)*
409 (29·5)
405 (29·6)
Diabetes mellitus
283 (20·4)
277 (20·2)
Hypercholesterolemia
635 (45·7)
629 (45·9)
Hypertension
876 (63·1)
836 (60·3)
Current smoker†
523 (37·7)
483 (35·2)
Eastern Europe/Israel
589 (42·4)
577 (42·1)
Western Europe/Canada
800 (57·6)
795 (57·9)
No ischemic changes
586 (42·5)
592 (43·5)
Ischemic changes (ST depression, transient ST
elevation, T wave inversion)
792 (57·5)
768 (56·5)
<140
1043 (76·6)
1055 (78·8)
≥140
318 (23·4)
284 (21·2)
1341 (96·5)
1323 (96·4)
48 (3·5)
49 (3·6)
37 (2·7)
33 (2·4)
30-≤60 ml/min
190 (13·8)
185 (13·6)
>60 ml/min
1149 (83·5)
1139 (83·9)
Previous MI
199 (14·3)
203 (14·8)
Previous PCI
224 (16·1)
244 (17·8)
78 (5·6)
72 (5·3)
Cardiovascular risk factors n, (%)
Region of enrolment n, (%)
ECG Baseline n, (%)
‡
GRACE score n, (%)§
Killip class n, (%)
Class 1
Class 2-4
Creatinine clearance n, (%)‖
≤30 ml/min
Cardiovascular disease history n, (%)
Previous CABG
1
Access n, (%)
Femoral
777 (56·0)
788 (57·5)
Brachial or radial
610 (44·0)
583 (42·5)
298 (40·9)
282 (38·5)
<6 french
133 (9·8)
138 (10·2)
6 french
1150 (84·4)
1139 (84·4)
>6 french
79 (5·8)
73 (5·4)
Symptom onset to 1st LD hrs, median (Q1, Q3)
14· (8.1, 24.3)
14·7 (8.4, 24.1)
Time from 1st LD to start of coronary
angiogram/PCI hrs, median (Q1, Q3)
4·4 (2.9, 14.7)
4·1 (2.9, 13.4)
276 (20·3)
300 (22·2)
0·42 (0.25, 0.66)
0·40 (0.25, 0.62)
Average vessel diameter mm, mean (SD)¶
2·99 (0.53)
3·01 (0.53)
Multivessel PCI (≥2 major vessels) n,(%)
409 (37·1)
415 (38·4)
18 (1·3)
30 (2·2)
Left anterior descending
553 (39·8)
558 (40·7)
Left circumflex
512 (36·9)
491 (35·8)
Right coronary artery
444 (32·0)
463 (33·8)
Native Artery
1324 (95·3)
1313 (95·7)
Arterial grafts n, (Yes, %)
1 (0·1)
7 (0·5)
Saphenous grafts n, (Yes, %)
37 (2·7)
33 (2·4)
BMS only
499 (36·6)
465 (34·4)
DES only
757 (55·6)
752 (55·7)
41 (3·0)
54 (4·0)
1·35 (0.71)
1·35 (0.70)
≤20 mm
778 (59·3)
767 (59·7)
≥21-≤30 mm
360 (27·5)
346 (26·9)
≥31-≤40 mm
131 (10·0)
122 (9·5)
42 (3·2)
49 (3·8)
1384 (99·3)
1365 (99·2)
Use of closure device for femoral access n, (%)
Sheath size n, (%)¶
Timing hrs, median (Q1, Q4)
Thrombus on angiography during PCI, n, (%)¶
Duration of PCI procedure hrs, median (Q1, Q3) ¶
Vessel treated n, (%)
Left main
Stents n, (%)¶
Both BMS and DES
Average number of stents per patient, mean (SD)
¶
Maximum (total) stent length n, (%)¥
≥41 mm
Concomitant medications through 7days n, (%)
Aspirin
2
Antithrombin Use**
UFH
684 (73·1)
679 (73·5)
LMWH
221 (23·6)
219 (23·7)
Bivalirudin
8 (0·9)
8 (0·9)
Fondaparinux
23(2·5)
18 (2·0)
Multiple antithrombin usage n, (%)
390 (28·1)
370 (27·0)
GPIIb/IIIa inhibitor usage n, (%)***
208 (14·9)
220 (16·0)
Beta blockers n, (%)
1211 (86·9)
1189 (86·4)
Statins n, (%)
1282 (92·0)
1277 (92·8)
ARBs n, (%)
182 (13·1)
172 (12·5)
ACE inhibitors n , (%)
1013 (72·7)
1029 (74·8)
Calcium channel blockers n, (%)
403 (29·0)
353 (25·7)
34 (2·5)
30 (2·2)
On a MD of clopidogrel at randomization n, (%)****
*N=1386 for pre-treatment and N=1369 for no pre treatment.
†N=1386 for pre-treatment and N=1371 for no pre-treatment.
‡N=1378 for pre-treatment and N=1360 for no pre-treatment.
§N=1339 for pre-treatment and N=1361 for no pre-treatment.
‖N=1376 for pre-treatment and N=1357 for no pre-treatment.
¶N=1362 for pre-treatment and N=1350 for no pre-treatment.
¥N=1311 for pre-treatment and N=1284 for no pre-treatment.
**Monotherapy is reported; N=936 for pre-treatment and N=924 for no pre-treatment
***N=1394 for pre-treatment and N=1376 for no pre-treatment.
****A 75 mg MD of clopidogrel was allowed per protocol.
There were no statistical differences between groups.
Abbreviations: ACE inhibitors=angiotensin-converting enzyme inhibitor; ARBs=angiotensin receptor
blockers; BMI=body mass index; BMS=bare metal stent; CABG=coronary artery bypass graft; DES=drugeluting stent; GRACE score=Global Registry of Acute Coronary Events score; LD=loading dose;
MD=maintenance dose; LMWH=low molecular weight heparin; MI=myocardial infarction; N=number of
patients; PCI=percutaneous coronary intervention; UFH=unfractionated heparin.
3
Online Table 2. GPIIb/IIIa Bailout Through Seven Days
Reasons, n (%)
Pre-treatment
(N=72)
No pre-treatment
(N=76)
Pre-PCI TIMI flow grade 0-1
31 (43·1)
30 (39·5)
During and post PCI
41 (56·9)
46 (60·5)
3 (7·3)
1 (2·2)
0 (0)
1 (2·2)
4 (9·8)
9 (19·6)
12 (29·3)
9 (19·6)
Dissection with decreased flow
4 (9·8)
4 (8·7)
Distal embolisation
5 (12·2)
3 (6·5)
0 (0)
1 (2·2)
Hemodynamic instability
1 (2·4)
0 (0)
Non-satisfactory revascularization
5 (12·2)
12 (26·1)
Side-branch closure
3 (7·3)
1 (2·2)
0 (0)
4 (8·7)
4 (9·8)
1 (2·2)
Primary reasons for bailout during
and post PCI
Abrupt closure
Biological instability
Clinical instability
Development of visible thrombus
ECG instability
Stent thrombosis
Unknown
Abbreviations: PCI=percutaneous coronary intervention
4
Online Table 3. Baseline Characteristics in Patients with Thrombus Versus No Thrombus
Characteristic
Thrombus seen on
Angiography
(N=576)
Thrombus not seen on
Angiograpy
(N=2136)
P
value
Age (mean, yrs)
62
64
<0·001
Female sex (%)
20
25
0·009
BMI ≥ 30 (%)
26
31
0·086
17·9
20·6
0·148
Diabetes, yes (%)
0·628
GRACE score (%)
<140
79
78
≥140
21
22
15
18
0·124
11
10
0·274
Average duration of procedure hrs,
mean (SD)
0·55 (0.39)
0·48 (0.36)
Average vessel diameter mm, (mean
(SD)
3·06 (0.53)
2·98 (0.53)
0·002
Multivessel PCI (≥2 major vessels; %)
37
38
0·788
DES only usage (%)
49
58
<0·001
Previous PCI (%)
Sheath size (%)
<6 french
<0·001
0·167
Maximum stent length (%)
≤20 mm
56
60
21-30 mm
28
27
31-40 mm
11
9
>41 mm
5
3
5
Antithrombin use at baseline (%)
UFH
60
61
0·766
LMWH
16
15
0·328
Bivalirudin
1·0
0·8
0·568
38
9
GPIIb/IIIa inhibitor use through seven
days (%)
<0·001
Abbreviations: BMI=body mass index; DES=drug eluting stent; GPIIb/IIIa=glycoprotein IIb/IIIa inhibitor;
LMWH=low molecular weight heparin; PCI=percutaneous coronary intervention; UFH=unfractionated
heparin.
6
Online Table 4. Primary and Secondary Efficacy Endpoints Through Seven Days and 30 Days
From First Loading Dose by Thrombus Seen or Not Seen on Angiography
Efficacy Endpoint
Thrombus
seen on
Angiography
Thrombus not seen
on Angiograpy
Hazard Ratio
95% CI
p-value
(N=579)
(N=2148)
150 (25·9)
205 (9·5)
3·01 (2·42,3·71)
<0·001
CVD
2 (0·35)
5 (0·23)
NE
MI
64 (11·1)
155 (7·2)
1·57 (1·17, 2·10)
0·002
Stroke
1 (0·17)
7 (0·33)
Urgent revascularization
17 (2·9)
19 (0·88)
3·36 ( 1·75, 6·47)
<0·001
GPIIb/IIIa bailout
96 (16·6)
48 (2·2)
8·03 (5·68, 11·3)
<0·001
Definite or probable stent
thrombosis
2 (0·35)
2 (0·09)
NE
30 Days
(N=576)
(N=2136)
150 (26·04)
222 (10·39)
2·79 (2·27, 3·43)
<0·001
CVD
4 (0·69)
15 (0·70)
1·06 (0·35, 3·21)
0·924
MI
64 (11·1)
160 (7·49)
1·52 (1·14, 2·03)
0·004
Stroke
2 (0·35)
11 (0·51)
0·67 (0·15, 3·03)
0·602
Urgent revascularization
19 (3·30)
29 (1·36)
2·46 (1·38, 4·39)
0·002
GPIIb/IIIa bailout
95 (16·49)
50 (2·34)
7·63 (5·42, 10·75)
<0·001
2 (0·35)
5 (0·23)
NE
Seven Days
CVD, MI, stroke, UR or
GPIIb/IIIa bailout
CVD, MI, stroke, UR or
GPIIb/IIIa bailout
Definite or probable stent
thrombosis
NE
NE
NE
Abbreviations: CVD=cardiovascular death; GPIIb/IIIa=glycoprotein IIb/IIIa; MI=myocardial infarction;
UR=urgent revascularization
7
Supplemental Statistical Testing
In order to assess the impact of pretreatment on the use of PCI, a chi-squared test was performed.
Selection for PCI was not impacted by pretreament or no-pretreatment (p=0.866). In addition, PCI
did not impact the primary endpoint, as indicated by a lack of interaction between cohort (PCI
only, PCI = CABG, CABG only, or medical management) and treatment group (p>0.50 for both 7
and 30 day outcomes).
8