TRAC ORS TransRadial Angioplasty and Coated TerumO Radifocus Sheaths

1
TRAC ORSTransRadial Angioplasty and Coated
TerumO Radifocus Sheaths

• A randomized study on traction forces required to
  retrieve coated and uncoated sheaths from the
  radial artery
• Ferdinand Kiemeneij, MD, PhD and Douglas Fraser,
  MD
• Amsterdam Department of Interventional Cardiology
  
• Onze Lieve Vrouwe Gasthuis
• The Netherlands

2
TRAC ORSTransRadial Angioplasty and Coated
TerumO Radifocus Sheaths

• Backgrounds (2)
• Change in sheath surface properties might lead
  to less friction during sheath withdrawal,
  increasing safety and comfort of the procedure
• Terumo has developed a coating to decrease
  friction between the sheath and the vessel wall
• This randomized study analyzes forces required to
  retrieve the coated and uncoated sheath versions
  from the radial artery
• Objective measurement of force is obtained with
  an Automated Pullback Device (APD)

3
TRAC ORSTransRadial Angioplasty and Coated
TerumO Radifocus Sheaths

• Methods Protocol
• Consecutive pts (n100) treated via TRA (2
  operators)
• Double blind randomization after successful
  radial artery puncture and cocktail
• (5 mg Verapamil and 200 mcr nitroglycerin)
• Adequate skin incision
• Wet sheath surface
• Sheath insertion 6F / 25 cm (C/C-)
• Procedure
• Automated pullback by APD

4
TRAC ORSTransRadial Angioplasty and Coated
TerumO Radifocus Sheaths

• Methods Endpoints
• Primary endpoints
• Maximal pullback force
• Mean pullback force
• Secondary endpoints
• Minimal pullback force
• Pain score
• Complications

5
TRAC ORSTransRadial Angioplasty and Coated
TerumO Radifocus Sheaths

• Methods Statistics
• t test for means and SD
• Chi square for nominal values
• Interim analysis after 60 patients
• Stop study at significant difference in primary
  endpoints between both groups

6
TRAC ORSTransRadial Angioplasty and Coated
TerumO Radifocus Sheaths

• Results
• Between November 20 and December 17, 2001 90
  patients included

7
TRAC ORSTransRadial Angioplasty and Coated
TerumO Radifocus Sheaths

• Results
• Between November 20 and December 17, 2001 90
  patients included

8
TRAC ORSTransRadial Angioplasty and Coated
TerumO Radifocus Sheaths

• Results
• Between November 20 and December 17, 2001 90
  patients included

9
TRAC ORSTransRadial Angioplasty and Coated
TerumO Radifocus Sheaths

• Results
• Between November 20 and December 17, 2001 90
  patients included

10
TRAC ORSTransRadial Angioplasty and Coated
TerumO Radifocus Sheaths

• Results
• Between November 20 and December 17, 2001 90
  patients included

11
TRAC ORSTransRadial Angioplasty and Coated
TerumO Radifocus Sheaths

• Conclusions
• The coated Terumo Radifocus sheath requires less
  force to become retrieved from the radial artery
  compared to the uncoated version
• Use of a coated sheath is associated with less
  discomfort for the patient
• No adverse events associated with this coating
  have been recorded