Radial versus femoral approach comparison in percutaneous coronary intervention with intra-aortic balloon pump support

1. RADIAL VERSUS FEMORAL
APPROACH COMPARISON IN
PERCUTANEOUS CORONARY
INTERVENTION WITH INTRA-AORTIC
BALLOON PUMP SUPPORT
Enrico Romagnoli, MD, PhD
Policlinico Casilino, Rome Italy
2nd Advanced
International Masterclass
AIM-RADIAL 2013

2. I, Enrico Romagnoli DO NOT have any real
or apparent conflict of interest in the
context of the subject of this presentation.

3. Radial Pump up – rationale
§ The
role of intra-aortic balloon pump (IABP)
during percutaneous coronary intervention (PCI)
in high-risk acute patients remains debated
( device-related complications?, complex
patient management?)
§ Transradial approach seems to improve outcome
by means of an evident peri-procedural bleeding
prevention, especially in the context of acute
coronary syndromes…
but is it always true?

4. Radial Pump up – objectives
To evaluate if the selection of transradial approach still
represents an advantage in terms of bleeding reduction
and clinical outcome also in patients needing intraaortic balloon pump (IABP) support:
§ Primary end-point
30-day procedural success (NACE)*
§ Secondary end-points
access-related bleeding rate
hospital stay length
*NACE = composite of post-procedural bleeding, cardiac death, myocardial infarction, target lesion
revascularization and stroke)

5. Radial Pump up – methods
§ Multicenter investigator-initiated registry
§ We retrospectively analysed 321 consecutive patients
receiving IABP support during PCI in four
independent high-volume centres.
§ Patients were further divided in two groups:
§ 209 patients receiving double femoral (FF) access;
§ 112 patients receiving both radial and femoral (RF) approaches.

6. Radial Pump up – population
Demographic characteristics
Double Femoral
(n=209)
Radial + femoral
(n=112)
p value
70 (61-80)
69 (57-77)
0.104
Female gender (%)
29.2
23.2
0.251
Body mass index
26 (24-29)
26 (24-28)
0.257
CKD (GRF <60 ml/min/1.732) (%)
49.3
42.9
0.250
Peripheral arterial disease (%)
31.1
31.3
0.978
Diabetes (%)
28.2
31.3
0.571
30 (25-40)
30 (25-42)
0.587
Prior MI (%)
21.5
24.1
0.598
Prior stroke (%)
6.7
3.6
0.246
Prior revascularization (%)
24.4
26.8
0.639
Age (years)
LVEF (%)

7. Radial Pump up – population
Clinical characteristics
Double Femoral
(n=209)
Radial + femoral
(n=112)
p value
STEMI
79.0%
70.5%
0.101
NSTEMI
12.9%
17.9%
0.233
Unstable angina
1.4%
4.5%
0.115
Stable angina
3.8%
7.1%
0.193
Acute heart failure
2.9%
0.0%
0.095
Diagnosis (%)
Killip class (%)
0.210
I
6.7%
3.6%
0.246
II
11.0%
17.0%
0.131
III
10.5%
16.1%
0.152
IV
71.8%
63.4%
0.122

8. Radial Pump up – population
Clinical characteristics
Double Femoral
(n=209)
Radial + femoral
(n=112)
Severity of CAD
p value
0.517
Not significant (%)
3.3%
0.0%
0.101
Single vessel disease (%)
22.0%
25.9%
0.433
Double vessel disease (%)
32.1%
26.8%
0.327
Triple vessel disease (%)
42.6%
47.3%
0.415
88 (70-95)
90 (80-100)
0.006
Inotropic support (%)
67.9
58.0
0.077
Mechanical ventilation (%)
36.8
26.8
0.068
EuroSCORE additive
11 (9-14)
11 (8-13)
0.132
EuroSCORE logistic
27 (12-48)
24 (12-41)
0.190
SAP at admission (mmHg)

9. Radial Pump up – population
Procedural characteristics
Double Femoral
(n=209)
Radial + femoral
(n=112)
p value
≤ 6 French
76.1%
98.2%
<0.001
≥ 7 French
23.9%
1.8%
<0.001
(Failed) thrombolysis
1.9%
4.5%
0.187
Heparin dose (U/Kg)
83 (68-100)
88 (70-100)
0.420
GP IIb/IIIa inhibitors
48.3%
39.3%
0.121
Thrombectomy device use
34.9%
44.6%
0.089
Bail-out IABP
27.8%
31.3%
0.368
Angiographic failure
17.2%
13.4%
0.372
Arterial sheath size
(TIMI flow <3 and/or residual stenosis ≥30%)

10. Radial Pump up – results
30-day NACE
Double +femoral arm
p = 0.001
p = 0.001
p = 0.027
57.4%
36.6%
33.5%
Radial + femoral arm
38.3%
25.9%
16.1%
Bleedings
NACE
MACCE
• Bleeding = type 2, type 3 nd type 5 from BARC classification
• Major Adverse Cardiac and Cerebrovascular event (MACCE) = composite of
cardiac death, myocardial infarction, target vessel revascularization, stroke
• Net Adverse Clinical Event (NACE) = MACCE + bleeding

11. Radial Pump up – results
30-day NACE
Double +femoral arm
p = 0.001
p = 0.001
p = 0.027
57.4%
36.6%
33.5%
Radial + femoral arm
38.3%
25.9%
16.1%
Bleedings
NACE
MACCE
• Bleeding = type 2, type 3 nd type 5 from BARC classification
• Major Adverse Cardiac and Cerebrovascular event (MACCE) = composite of
cardiac death, myocardial infarction, target vessel revascularization, stroke
• Net Adverse Clinical Event (NACE) = MACCE + bleeding

12. Radial Pump up – results
30-day bleedings* (BARC)
Double +femoral arm
Radial + femoral arm
p = 0.001
p = 0.002
p = 0.204
33.5%
16.1%
18.7%
14.8%
6.3%
Bleedings*
Access site related
9.8%
Non access site related
• including Type 2, Type 3 and Type 5 from BARC classification.

13. Radial Pump up – results
BARC definitions*
321 consecutive patients requiring
peri-procedural IABP support
• TYPE 1: bleeding not actionable and
does not cause unscheduled studies,
treatment or hospitalization
• TYPE 2: any overt, actionable sign
Double Femoral arm
(N=209)
Radial + femoral arm
(N=112)
of hemorrhage that does not fit the
criteria for type 3, 4, or 5
Bleeding
• TYPE 3:
• overt bleeding plus Hb drop >3g/dL
• any transfusion with overt bleeding
• cardiac tamponade
• bleeding requiring surgical
intervention
• bleeding requiring intravenous
vasoactive agents
33.5%
Bleeding
16.1%
Type 0-1
66.5%
Type 0-1
83.9%
Type 2
7.7%
Type 2
6.3%
Type 3
24.4%
Type 3
8.9%
Type 4
0%
Type 4
0%
Type 5
1.4%
Type 5
0.9%
• TYPE 4: CABG-related bleeding
• TYPE 5: fatal bleeding
P = 0.001
*Mehran R. et al, Circulation 2011;123(23):2736-47

14. Radial Pump up – results
30-day NACE
Double +femoral arm
p = 0.001
p = 0.001
p = 0.027
57.4%
36.6%
33.5%
Radial + femoral arm
38.3%
25.9%
16.1%
Bleedings
NACE
MACCE
• Bleeding = type 2, type 3 nd type 5 from BARC classification
• Major Adverse Cardiac and Cerebrovascular event (MACCE) = composite of
cardiac death, myocardial infarction, target vessel revascularization, stroke
• Net Adverse Clinical Event (NACE) = MACCE + bleeding

15. Radial Pump up – results
30-day NACE
Double +femoral arm
p = 0.001
p = 0.001
p = 0.027
57.4%
36.6%
33.5%
Radial + femoral arm
38.3%
25.9%
16.1%
Bleedings
NACE
MACCE
• Bleeding = type 2, type 3 nd type 5 from BARC classification
• Major Adverse Cardiac and Cerebrovascular event (MACCE) = composite of
cardiac death, myocardial infarction, target vessel revascularization, stroke
• Net Adverse Clinical Event (NACE) = MACCE + bleeding

16. Radial Pump up – results
30-day MACCE
Double +femoral arm
Radial + femoral arm
p = 0.004
34.9%
19.6%
p = 0.523
6.7% 7.1%
Cardiac death
p = 0.881
3.8% 5.4%
Myocardial
Infarction
Target Vessel
Revascularization
p = 0.364
1.9% 3.6%
Cerebrovascular
Accident

17. Radial Pump up – results
30-day outcome and hospital stay*
Double +femoral arm
OR
0.57
(CI
95%
0.4-­‐0.9)
p=
0.007†
Radial + femoral arm
Double
Femoral
Radial +
femoral
(n=209)
(n=112)
10 (7-18)
9 (7-14)
0.379
Intensive coronary care unit
6 (3-9)
4 (2-7)
0.078
Cardiology ward
4 (1-6)
4 (1-7)
0.975
Hospital stay
† Propensity adjusted
* Expressed as median and quartiles
p
value

18. Radial Pump up – conclusions
§ Transradial approach use for PCI requiring IABP
support positively impacts peri-procedural
NACEs rate by means of a significant accesssite-related bleeding prevention.
§ Further studies are warranted to assess whether
the routine application of transradial approach
might represent an opportunity to improve
outcome in high-risk patients undergoing PCI.

19. Radial Pump up – NACE & access site
12
(10.7%)
RF
group
Pa4ent
with
only
bleeding
52
(16.2%)
p
=
0.073
40
(19.1%)
FF
group
23
(20.5%)
RF
group
Pa4ent
with
NACE
162
(50.2%)
Pa4ent
with
only
MACCE
73
(22.7%)
p
=
0.582
50
(23.9%)
FF
group
6
(5.4%)
RF
group
Pa4ent
with
MACCE
+
bleeding
36
(11.2%)
p
=
0.024
30
(14.3%)
FF
group

20. Radial Pump up – participating Centres
Ospedale
Morgagni
Pierantoni,
Forlì
(Fabio
Taran4ni)
Policlinico
Casilino
(Ernesto
Lioy)
Azienda
Ospedaliera
Fatebenefratelli
(Bernardo
Cortese)
Università
CaTolica
del
Sacro
Cuore
(Carlo
Trani)

21. RADIAL VERSUS FEMORAL
APPROACH COMPARISON IN
PERCUTANEOUS CORONARY
INTERVENTION WITH INTRA-AORTIC
BALLOON PUMP SUPPORT
Enrico Romagnoli, MD, PhD
Policlinico Casilino, Rome Italy
2nd Advanced
International Masterclass
AIM-RADIAL 2013

22. Radial Pump up – IABP & radial trend
88
72
78%
52
64%
80%
58
51
62%
22%
36%
2008
2009
20%
2007
total
IABP
use
Double
Femoral
32%
38%
68%
2010
2011
Radial
+
Femoral