(Novel Angioplasty USIng
Shigeru Saito, MD, FACC, FSCAI, FJCC
On behalf of NAUSICA Trial Investigators
The Distribution of Radial Artery
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
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)
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 AND Specificity
4.0% vs 13.0% (p=0.011)
Cut-off line (p=0.0113)
The Ratio of RA Inner Diameter VS Sheath Outer Diameter
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.
How to overcome the limitation due
to the small artery size
By downsizing the guidewires:
Introduction of 0.010-inch guidewire
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)
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.
Can we use it for complex
A Case of CTO in RCA
A Case of CTO in RCA
A Case of CTO in RCA
A Case of CTO in RCA
Then, Question is:
Can we really achieve
comparable results using 4-Fr
coronary accessor similar to
6-Fr guiding catheters?
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
Case Randomization through Web
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.
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
A prospective, open-label,
multicenter, randomized trial
involving patients with coronary
artery diseases undergoing TRI
Conducted at 19 institutions in Asia
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
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
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
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:
contrast dye usage
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.
Sample Size Calculation
We supposed the incidence of Radial Artery Occlusion
after TRI to be 6% and 1% after using 6- and 4-Fr
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.
Previous bypass surgery
Lesion AHA/ACC type
Guiding catheter crossover
4-Fr: poor support of the guiding catheter
6-Fr: radial spasm (n=1)
4-Fr: puncture failure of the bil. radial
6-Fr: radial spasm (n=1) and engage failure
radial artery occlusion (n=3)
hematoma extending over the whole
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
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
Another application of 4-Fr
Use of coronary accessor in
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.
Mother and Child Guiding Catheters
5 Fr catheter
6 Fr catheter
In-Vitro Measurement of Backup
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.
Guiding Catheter Sysem
6-Fr Guiding Catheter
4-Fr Child Guiding Catheter
Tip of the 4-Fr
Tip of the 6-Fr
Comparison of Backup Force
*p<0.05 vs. 4-in-6 (0 mm)
**p<0.05 vs. 5-in-6 (0 mm)
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.