NAUSICA Trial
(Novel Angioplasty USIng
Coronary Accessor)
Shigeru Saito, MD, FACC, FSCAI, FJCC
On behalf of NAUSICA Trial ...
The Distribution of Radial Artery
Diameter
Saito S, Ikei H, Hosokawa G, Tanaka S. Influence of the ratio between radial ar...
Radial Artery Diameter, Sheath Diameter
and Radial Artery Occlusion
Saito S, Ikei H, Hosokawa G, Tanaka S. Influence of th...
Radial Artery Occlusion (RAO)
We found that;
Even by using a 6-Fr introducer, radial
artery occlusion might occur in aroun...
NPO TRI
Internationa
l Network

How to overcome the limitation due
to the small artery size

 By downsizing the guidewire...
NPO TRI
Internationa
l Network

4 French Coronary Accessor

Takeshita S, Shiono T, Takagi A, Ito T, Saito S. Percutaneous ...
NPO TRI
Internationa
l Network

A Case of CTO in RCA
NPO TRI
Internationa
l Network

A Case of CTO in RCA
NPO TRI
Internationa
l Network

A Case of CTO in RCA
NPO TRI
Internationa
l Network

A Case of CTO in RCA
NPO TRI
Internationa
l Network

Then, Question is:
Can we really achieve
comparable results using 4-Fr
coronary accessor s...
NPO TRI
Internationa
l Network

NAUSICA Trial

 Novel Angioplasty USIng Coronary
Accessor (NAUSICA) Trial
 Randomization...
NPO TRI
Internationa
l Network

Case Randomization through Web
Page
NPO TRI
Internationa
l Network

BACKGROUND

 The 4-Fr guiding catheter (KIWAMI,

Heartrail II, TERUMO) comes with the out...
NPO TRI
Internationa
l Network

OBJECTIVE

 The major hypothesis of this trial
was that the use of a 4-Fr catheter
would ...
NPO TRI
Internationa
l Network

Study Design

 A prospective, open-label,
multicenter, randomized trial
involving patient...
NPO TRI
Internationa
l Network

Inclusion Criteria

 Every patient undergoing stent
implantation via the transradial
rout...
NPO TRI
Internationa
l Network

Exclusion Criteria

 Lesions associated with large side
branches requiring wire protectio...
NPO TRI
Internationa
l Network

Randomization

 Eligible patients were randomly
assigned in a 1:1 ratio to undergo
either...
NPO TRI
Internationa
l Network

End Points

 Primary end point:
 radial artery occlusion at the next day of TRI,
defined...
NPO TRI
Internationa
l Network

End Points

 Access-site complications were defined
as bleeding, pseudoaneurysm, and
arte...
NPO TRI
Internationa
l Network

Sample Size Calculation

 We supposed the incidence of Radial Artery Occlusion
after TRI ...
NPO TRI
Internationa
l Network

Patient Characteristics
Variables

4-Fr (n=80)

6-Fr (n=80)

p value

67.7±10.7

67.9±11.2...
NPO TRI
Internationa
l Network

Procedural Characteristics
Variables

4-Fr (n=80)

6-Fr (n=80)

p value

Guiding catheter ...
NPO TRI
Internationa
l Network

Crossover

 Guiding catheter crossover
 4-Fr: poor support of the guiding catheter
(n=3)...
NPO TRI
Internationa
l Network

Access-site complications

 4-Fr
none

 6-Fr
radial artery occlusion (n=3)
hematoma e...
NPO TRI
Internationa
l Network

When compared with 6Fr,
4Fr TRI demonstrated:

 Significantly lower incidence of access-s...
NPO TRI
Internationa
l Network

Conclusion

 The current study demonstrated that 4-Fr TRI
could provide procedural succes...
NPO TRI
Internationa
l Network

Another application of 4-Fr
Coronary Accessor
NPO TRI
Internationa
l Network

Use of coronary accessor in
Mother-and-Childe technique!

Takahashi S, Saito S, et al. New...
NPO TRI
Internationa
l Network

Mother and Child Guiding Catheters

5 Fr catheter

6 Fr catheter

Protruded 5F
catheter
NPO TRI
Internationa
l Network

In-Vitro Measurement of Backup
Force

Takahashi S, Saito S, et al. New method to increase ...
NPO TRI
Internationa
l Network

4-in-6 System
6-Fr Guiding Catheter

Hemostatic Valve

4-Fr Child Guiding Catheter
Tip of ...
NPO TRI
Internationa
l Network

Comparison of Backup Force
400

(gf)

*p<0.05 vs. 4-in-6 (0 mm)

**

**p<0.05 vs. 5-in-6 (...
NPO TRI
Internationa
l Network

Summary

 This 4-French Coronary Accessor can
bring the comparable results in the
selecte...
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Saito S - AIMRADIAL 2013 - NAUSICA trial

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NAUSICA Trial (Novel Angioplasty USIng Coronary Accessor)

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Saito S - AIMRADIAL 2013 - NAUSICA trial

  1. 1. NAUSICA Trial (Novel Angioplasty USIng Coronary Accessor) Shigeru Saito, MD, FACC, FSCAI, FJCC On behalf of NAUSICA Trial Investigators
  2. 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. 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. 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. 5. NPO TRI Internationa l Network 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. 6. NPO TRI Internationa l Network 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?
  7. 7. NPO TRI Internationa l Network A Case of CTO in RCA
  8. 8. NPO TRI Internationa l Network A Case of CTO in RCA
  9. 9. NPO TRI Internationa l Network A Case of CTO in RCA
  10. 10. NPO TRI Internationa l Network A Case of CTO in RCA
  11. 11. NPO TRI Internationa l Network Then, Question is: Can we really achieve comparable results using 4-Fr coronary accessor similar to 6-Fr guiding catheters?
  12. 12. NPO TRI Internationa l Network 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
  13. 13. NPO TRI Internationa l Network Case Randomization through Web Page
  14. 14. NPO TRI Internationa l Network 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.
  15. 15. NPO TRI Internationa l Network 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.
  16. 16. NPO TRI Internationa l Network 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
  17. 17. NPO TRI Internationa l Network 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
  18. 18. NPO TRI Internationa l Network 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
  19. 19. NPO TRI Internationa l Network 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.
  20. 20. NPO TRI Internationa l Network 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
  21. 21. NPO TRI Internationa l Network 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.
  22. 22. NPO TRI Internationa l Network 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.
  23. 23. NPO TRI Internationa l Network 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
  24. 24. NPO TRI Internationa l Network 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)
  25. 25. NPO TRI Internationa l Network 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)
  26. 26. NPO TRI Internationa l Network Access-site complications  4-Fr none  6-Fr radial artery occlusion (n=3) hematoma extending over the whole forearm (n=1)
  27. 27. NPO TRI Internationa l Network 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
  28. 28. NPO TRI Internationa l Network 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
  29. 29. NPO TRI Internationa l Network Another application of 4-Fr Coronary Accessor
  30. 30. NPO TRI Internationa l Network 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.
  31. 31. NPO TRI Internationa l Network Mother and Child Guiding Catheters 5 Fr catheter 6 Fr catheter Protruded 5F catheter
  32. 32. NPO TRI Internationa l Network 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
  33. 33. NPO TRI Internationa l Network 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
  34. 34. NPO TRI Internationa l Network 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
  35. 35. NPO TRI Internationa l Network 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.

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