The document summarizes the NAUSICA trial which compared outcomes of percutaneous coronary interventions (PCI) using 4 French versus 6 French guide catheters. The trial found that 4 French PCI resulted in significantly lower access site complications and hemostasis times compared to 6 French PCI, with comparable procedural success. 4 French PCI also showed a numerically lower risk of radial artery occlusion. The 4 French coronary accessor was also found to be useful for the mother-child guiding catheter technique, providing backup support comparable to larger catheters.

1. NAUSICA Trial
(Novel Angioplasty USIng
Coronary Accessor)
Shigeru Saito, MD, FACC, FSCAI, FJCC
On behalf of NAUSICA Trial Investigators

2. The Distribution of Radial Artery
Diameter
Saito S, Ikei H, Hosokawa G, Tanaka S. Influence of the ratio between radial artery
inner diameter and sheath outer diameter on radial artery flow after transradial
coronary intervention. Catheter Cardiovasc Interv 1999; 46: 173-8.
Cummulative Frequency of Radial Artery Inner Diameter
%Cummulative Frequency
100
80
Female
60
40
20
Male
6Fr
7Fr
8Fr
0
1.2 1.4 1.6 1.8 2.0 2.2 2.4 2.6 2.8 3.0 3.2 3.4 3.6 3.8 4.0 4.2 4.4
Radial Artery Diameter (mm)

3. Radial Artery Diameter, Sheath Diameter
and Radial Artery Occlusion
Saito S, Ikei H, Hosokawa G, Tanaka S. Influence of the ratio between radial
artery inner diameter and sheath outer diameter on radial artery flow after
transradial coronary intervention. Catheter Cardiovasc Interv 1999; 46: 173-8.
Sensitivity (-)
Specificity (-)
Sensitivity AND Specificity
1.0
0.8
0.6
4.0% vs 13.0% (p=0.011)
0.4
0.2
Cut-off line (p=0.0113)
0.0
0.7
0.8
0.9
1.0
1.1
1.2
1.3
1.4
The Ratio of RA Inner Diameter VS Sheath Outer Diameter
1.5

4. Radial Artery Occlusion (RAO)
We found that;
Even by using a 6-Fr introducer, radial
artery occlusion might occur in around 10%
patients after TRI.

5. NPO TRI
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How to overcome the limitation due
to the small artery size
 By downsizing the guidewires:
 Introduction of 0.010-inch guidewire
system
 By downsizing the guiding catheters
 Introduction of 4-Fr coronary accessor
 By downsizing the “virtual” or
“sheathless” guiding catheters
 By downsizing the actual outer diameter
of introduces (Glider Sheath)

6. NPO TRI
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4 French Coronary Accessor
Takeshita S, Shiono T, Takagi A, Ito T, Saito S. Percutaneous coronary
intervention using a novel 4-French coronary accessor. Catheter Cardiovasc
Interv. 2008; 72: 222-7.
Inner diameter
Outer diameter
Total length
０.０５０”（１．２７ｍｍ）
４Ｆｒ
（１．４３ｍｍ）
１０５ ｃｍ
 Can we use it for complex
lesions?

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A Case of CTO in RCA

8. NPO TRI
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A Case of CTO in RCA

9. NPO TRI
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A Case of CTO in RCA

10. NPO TRI
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A Case of CTO in RCA

11. NPO TRI
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Then, Question is:
Can we really achieve
comparable results using 4-Fr
coronary accessor similar to
6-Fr guiding catheters?

12. NPO TRI
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NAUSICA Trial
 Novel Angioplasty USIng Coronary
Accessor (NAUSICA) Trial
 Randomization between 4 and 6 French
TRI groups (>160 Cases in Total)
 Primary Endpoint: Preservation of
Radial Pulse Next Day after TRI
 International Web-base Randomization

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Case Randomization through Web
Page

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BACKGROUND
 The 4-Fr guiding catheter (KIWAMI,
Heartrail II, TERUMO) comes with the outer
diameter of 1.43 mm, allowing the catheter
be inserted into a 4-Fr introducer sheath
 The small profile of the catheter
(approximately 67% of the 6-Fr catheter in
diameter) may have a favorable impact on
vascular access complications.

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OBJECTIVE
 The major hypothesis of this trial
was that the use of a 4-Fr catheter
would decrease radial artery
occlusion, as compared with a 6-Fr
catheter.

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Study Design
 A prospective, open-label,
multicenter, randomized trial
involving patients with coronary
artery diseases undergoing TRI
(ClinicalTrials.gov identifier,
NCT00815997)
 Conducted at 19 institutions in Asia

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Inclusion Criteria
 Every patient undergoing stent
implantation via the transradial
route with age over 18 yrs
 Sufficiently pulsating radial artery
and presence of an ulnar pulse with a
sufficient palmar arch, as evidenced
by the absence of digital ischemia
according to the Allen’s test

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Exclusion Criteria
 Lesions associated with large side
branches requiring wire protection or
kissing balloon technique; and
planned use of a cutting balloon,
rotational atherectomy, directional
coronary atherectomy, and
intravascular ultrasound, which were
not compatible with 4-Fr

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Randomization
 Eligible patients were randomly
assigned in a 1:1 ratio to undergo
either 4-Fr or 6-Fr TRI.
 Randomization was performed with the
use of a computer-based random
generator system.

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End Points
 Primary end point:
 radial artery occlusion at the next day of TRI,
defined as the absence of a radial pulse
confirmed by a negative reversed Allen’s test
 Secondary end points:
 procedural success
 MACE
 access-site complications
 procedural time
 contrast dye usage

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End Points
 Access-site complications were defined
as bleeding, pseudoaneurysm, and
arteriovenous fistula, and occlusion of
the radial artery, and considered as
major if associated with a vascular
repair, or a blood transfusion.

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Sample Size Calculation
 We supposed the incidence of Radial Artery Occlusion
after TRI to be 6% and 1% after using 6- and 4-Fr
introducers respectively.
 The sample size of this study was calculated based on
Dunnett-Gent equation for non-inferiority test using
the parameters of 5% of Delta and 90% of power.
 Seventy-one cases are necessary in each group to show
the statistically significant non-inferiority for 4Fr group compared to 6-Fr TRI.
 By adding the cases for dropping out, we assumed 80
cases in each group were necessary for the trial.

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Patient Characteristics
Variables
4-Fr (n=80)
6-Fr (n=80)
p value
67.7±10.7
67.9±11.2
NS
Male gender
63 (79%)
64 (80%)
NS
Diabetes
20 (25%)
28 (35%)
NS
Hypertension
44 (55%)
50 (63%)
NS
Dyslipidemia
40 (50%)
44 (55%)
NS
Smoker
21 (26%)
25 (31%)
NS
Cerebrovascular disease
5 (6%)
7 (9%)
NS
Previous bypass surgery
5 (6%)
5 (6%)
NS
29 (36%)
34 (43%)
NS
A
38 (48%)
35 (44%)
NS
B1
23 (29%)
22 (28%)
NS
B2
13 (16%)
14 (18%)
NS
C
6 (8%)
9 (11%)
NS
Age (yrs)
Multivessel disease
Lesion AHA/ACC type

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Procedural Characteristics
Variables
4-Fr (n=80)
6-Fr (n=80)
p value
Guiding catheter cross-over
3 (4%)
1 (1%)
NS
Access-site crossover
1 (1%)
2 (3%)
NS
79 (99%)
80 (100%)
NS
Procedure time (min)
36.6±21.4
36.7±22.2
NS
Fluoroscopy time (min)
12.8±9.0
11.9±11.2
NS
Contrast dye volume (mL)
87.1±44.7
101.3±67.9
NS
236.7±105.3
319.5±237.7
p=0.007
Access-site complication
0 (0%)
4 (5%)
P=0.04
Radial artery occlusion
0 (0%)
3 (4%)
p=0.08
Procedural success
Hemostasis time (min)

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Crossover
 Guiding catheter crossover
 4-Fr: poor support of the guiding catheter
(n=3)
 6-Fr: radial spasm (n=1)
 Access-site crossover
 4-Fr: puncture failure of the bil. radial
arteries (n=1)
 6-Fr: radial spasm (n=1) and engage failure
(n=1)

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Access-site complications
 4-Fr
none
 6-Fr
radial artery occlusion (n=3)
hematoma extending over the whole
forearm (n=1)

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When compared with 6Fr,
4Fr TRI demonstrated:
 Significantly lower incidence of access-site
complications (0% vs. 5%).
 Numerically lower (but statistically
nonsignificant) incidence of radial artery
occlusion (0% vs. 4%).
 Significantly shorter hemostasis time (3.9
hrs vs. 5.3 hrs)
 Comparable procedural and fluoroscopy time,
with comparable procedural success

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Conclusion
 The current study demonstrated that 4-Fr TRI
could provide procedural success comparable
to 6-Fr TRI, with reduced hemostasis time and
access-site related complications.
 Furthermore, 4-Fr TRI may have a potential to
reduce radial artery occlusions.
 These findings provide the basis for the
concept that 4-Fr PCI may serve as a
minimally invasive approach to treat coronary

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Another application of 4-Fr
Coronary Accessor

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Use of coronary accessor in
Mother-and-Childe technique!
Takahashi S, Saito S, et al. New method to increase a backup support
of a 6 French guiding coronary catheter. Catheter Cardiovasc Interv.
2004 ; 63: 452-6.
Takeshita S, Takagi A, Saito S. Backup support of the mother-child
technique: technical considerations for the size of the mother guiding
catheter. Catheter Cardiovasc Interv. 2012 ; 80: 292-7.
Takeshita S, Shishido K, Sugitatsu K, Okamura N, Mizuno S, Yaginuma K,
Suenaga H, Tanaka Y, Matsumi J, Takahashi S, Saito S. In vitro and
human studies of a 4F double-coaxial technique ("mother-child"
configuration) to facilitate stent implantation in resistant coronary
vessels. Circ Cardiovasc Interv. 2011 ; 4: 155-61.

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Mother and Child Guiding Catheters
5 Fr catheter
6 Fr catheter
Protruded 5F
catheter

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In-Vitro Measurement of Backup
Force
Takahashi S, Saito S, et al. New method to increase a backup support of a 6 French guiding coronary
catheter. Catheter Cardiovasc Interv. 2004 ; 63: 452-6.
160
P<0.0001
140
P<0.0001
P<0.001
120
100
80
P<0.01
60
8Fr alone
7Fr alone
5-in-6 (15mm)
5-in-6 (10mm)
5-in-6 (5mm)
5-in-6 (0mm)
6Fr alone
40
Guiding Catheter Sysem

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4-in-6 System
6-Fr Guiding Catheter
Hemostatic Valve
4-Fr Child Guiding Catheter
Tip of the 4-Fr
Tip of the 6-Fr

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Comparison of Backup Force
400
(gf)
*p<0.05 vs. 4-in-6 (0 mm)
**
**p<0.05 vs. 5-in-6 (0 mm)
300
**
*
200
100
0
*
**
8-Fr
7-Fr
6-Fr

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Summary
 This 4-French Coronary Accessor can
bring the comparable results in the
selected PCI cases with 6-French
guiding catheters with lower RAO and
less contrast dye.
 This 4-French Coronary Accessor is
also useful in Mother-and-Child
guiding catheter technique.