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Online Appendix for the following JACC article
TITLE: Radial Versus Femoral Randomized Investigation in ST Elevation Acute Coronary
Syndrome: The RIFLE-STEACS
AUTHORS: Enrico Romagnoli, MD, PHD, Giuseppe Biondi-Zoccai, MD, Alessandro Sciahbasi,
MD, Luigi Politi, MD, Stefano Rigattieri, MD, Gianluca Pendenza, MD, Francesco Summaria, MD,
Roberto Patrizi, MD, Ambra Borghi, MD, Cristian Di Russo, MD, Claudio Moretti, MD,
Pierfrancesco Agostoni, MD, PHD, Paolo Loschiavo, MD, Ernesto Lioy, MD, Imad Sheiban, MD,
Giuseppe Sangiorgi, MD
Appendix 1. Causes of cardiac death
Patient
Randomization group
Cause of cardiac death
C.B.
M.C.
P.G.
V.C.
R.D.
E.G.
C.G.
C.L.
D.B.M.
L.M.
L.F.
B.F.
G.O.
S.L.
S.G.
B.V.
R.N.
F.I.
L.M.
A.A.
M.A.
F.C.
B.R.
G.A.
L.B.O.
M.A.
C.E.
D.G.
D.B.E.
P.A.
Femoral
Radial
Radial
Radial
Femoral
Femoral
Radial
Radial
Femoral
Femoral
Femoral
Femoral
Radial
Radial
Femoral
Radial
Radial
Femoral
Radial
Femoral
Radial
Femoral
Radial
Femoral
Femoral
Femoral
Radial
Femoral
Femoral
Femoral
acute pump failure (secondary to severe MI)
acute pump failure
cardiogenic shock
acute pump failure
cardiogenic shock
cardiogenic shock
cardiogenic shock
acute pump failure
acute pump failure
acute pump failure
cardiogenic shock
cardiac rupture (free ventricular wall)
cardiogenic shock
acute pump failure (secondary to severe MI)
acute pump failure
cardiogenic shock
acute pump failure
acute pump failure
acute pump failure (secondary to severe MI)
acute pump failure
cardiogenic shock
acute pump failure
acute pump failure
acute pump failure
cardiac rupture (free ventricular wall)
acute pump failure
acute pump failure
cardiogenic shock
cardiogenic shock
acute pump failure
1
Time to cardiac death (days)
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
2
2
2
M.P.
Femoral
cardiogenic shock
D.M.N.
Femoral
acute pump failure
M.A.
Femoral
cardiogenic shock
F.S.
Femoral
acute pump failure
C.A.M.
Radial
cardiac rupture (free ventricular wall)
M.P.
Femoral
acute pump failure (secondary to severe MI)
F.A.
Femoral
acute pump failure
F.S.
Femoral
acute pump failure
L.A.
Radial
pump failure
D.M.V.
Radial
pump failure
B.T.
Femoral
cardiac rupture (free ventricular wall)
P.R.
Femoral
pump failure
M.F.
Radial
sudden death (arrhythmic)
M.A.
Femoral
pump failure (secondary to severe MI)
P.F.
Femoral
pump failure
R.G.
Femoral
heart failure
C.P.
Radial
pump failure
M.E.
Femoral
pump failure
N.C.
Femoral
heart failure
M.F.
Femoral
acute pump failure
A.G.
Femoral
pump failure
R.A.M.
Radial
sudden death (arrhythmic)
T.N.
Femoral
cardiac tamponade (Dressler Syndrome)
D.V.R.
Radial
sudden death (possible stent thrombosis)
P.R.
Femoral
heart failure
M.G.
Femoral
heart failure
G.M.L.
Femoral
heart failure
C.A.M.
Femoral
heart failure
P.L.M
Femoral
sudden death (arrhythmic)
V.L.
Radial
heart failure
C.V.
Radial
cardiac rupture (VSD requiring surgical repair)
C.M.
Femoral
sudden death (arrhythmic)
D.L.S.R. Femoral
heart failure
C.M.
Femoral
sudden death (arrhythmic)
F.E.
Radial
heart failure
F.E.
Femoral
sudden death (possible stent thrombosis)
V.L.
Radial
heart failure
G.P.
Radial
sudden death (arrhythmic)
S.G.
Radial
heart failure
D.F.A.
Femoral
heart failure
D.L.B.
Femoral
heart failure
S.C.
Femoral
heart failure
MI = Mitral insufficiency; VSD = Ventricular Septal Defect
2
2
2
2
2
2
2
2
2
3
4
4
4
4
5
5
6
6
6
7
7
7
7
7
9
9
10
12
13
13
15
16
17
17
17
19
21
21
22
22
23
26
28
Appendix 2. Thirty-day clinical outcomes according to per protocol analysis.
Per protocol analysis
Overall
(1001)
Femoral
(534)
Radial
(467)
p
30-day outcome (hierarchical)
NACE
173 (17.3)
117 (21.9)
56 (12.0)
<0.001
MACCE (%)
93 (9.3)
63 (11.8)
30 (6.4)
0.004
Cardiac death (%)
72 (7.2)
52 (9.7)
20 (4.3)
<0.001
7 (0.7)
4 (0.7)
3 (0.6)
1.000
Myocardial infarction (%)
13 (1.3)
6 (1.1)
7 (1.5)
0.781
Target lesion revascularization (%)
15 (1.5)
8 (1.5)
7 (1.5)
1.000
Stent thrombosis (%)
15 (1.5)
8 (1.5)
7 (1.5)
1.000
Definite
12 (1.2)
6 (1.1)
6 (1.3)
1.000
Probable
1 (0.1)
1 (0.2)
0 (0.0)
0.946
Possible
2 (0.2)
1 (0.2)
1 (0.2)
0.539
100 (10.0)
69 (12.9)
31 (6.6)
<0.001
Access site-related
47 (4.7)
38 (7.1)
9 (1.9)
<0.001
Non-access site-related
53 (5.3)
31 (5.8)
22 (4.7)
0.481
21 (2.1%)
18 (3.4)
3 (0.6)
<0.001
Surgical repair required (%)
3 (0.3%)
3 (0.6%)
0 (0.0%)
0.297
Cerebral bleeding (%)
1 (0.1%)
0 (0.0%)
1 (0.2%)
0.946
Intracranial or retroperitoneal bleeding (%)
2 (0.2%)
1 (0.2%)
1 (0.2%)
0.539
79 (7.9%)
55 (10.3%)
24 (5.1%)
<0.001
Intrapericardial with cardiac tamponade (%)
5 (0.5%)
5 (0.9%)
0 (00)
0.100
Fatal bleeding(%)
6 (0.3%)
5 (0.9%)
1 (0.2%)
0.286
6 (5-8)
6 (5-8)
5 (4-7)
0.001
Intensive coronary unit
3 (2-4)
4 (3-5)
3 (2-4)
<0.001
Cardiology ward
3 (1-4)
3 (1-4)
2 (1-4)
0.199
Stroke (%)
Bleeding (%)
Blood transfusion required (%)
Drop in haemoglobin level ≥3 g/dl(%)
Hospital stay (days)*
Total hospital stay
NACE = Net Adverse Clinical Event (MACCE + bleeding); MACCE = hierarchical Major Adverse Cardiac Event
(cardiac death, non fatal myocardial infarction, target lesion revascularization, stroke);
* Expressed as median and quartile.
3