The ACCESS-I study randomized 1000 patients scheduled for radial angiography or angioplasty to either a Terumo® Glidesheath Slender TM (Slender) or a Terumo® standard sheath. The study found that patients who received the slender sheath reported less pain during sheath insertion, with a median VAS score of 1 versus 2 for the standard sheath (p=0.02). However, no differences were found between the sheaths for pain during the procedure, use of sedatives or analgesics, success of the radial procedure, or patency of the radial artery after the procedure.

1. Randomized comparison of coated slender versus un-coated traditional sheath
during radial angiography or angioplasty
Department of Cardiology, Aarhus University Hospital Skejby and Viborg Regional Hospital.
Birthe Sindberg, Marianne Hestbjerg Poulsen, Christel Gry Aagren Nielsen,
Martin Rasmussen; Hanne Maare Søndergaard, Michael Mæng, Christian Juhl Terkelsen
The ACCESS-I study

2. Disclosure
Terumo provided an unrestricted grant for the ACCESS-I study

3. Background
It is unknown whether the combination of smaller external diameter and
hydrophilic coating of radial sheaths has any impact on spasm tendency, pain,
success rate or post procedural radial artery patency

4. Methods and Materials
1000 patients from 2 centers scheduled for radial angiography or angioplasty were
randomized (1:1) to a Terumo® Glidesheath Slender TM (Slender) or a Terumo®
standard sheath.
Inclusion in the Access1 study from the 15th of December 2015 to the 12th of July
2016
Randomization was stratified according to chosen French size (5, 6, 7 Fr.) and
gender.

5. Inclusion and exclusion criteria
Inclusion criteria
• A normal pulse oximetry test, age ≥
18 years, and signed informed
consent.
Exclusion Criteria
• Negative pulse oximetry test
• Planned CAG / PCI procedure with 8F
equipment

6. Patient characteristics
Standard Slender P
Age, mean(SD) years 66.9 (11.0) 65.9 (11.8) 0.27
CAG:PCI 66% vs. 34% 64% vs. 36% 0.65
Diabetes 19.5% 18.4% 0.70
Hypertension 56.9% 60.3% 0.31
Hyperlipedemia 59.5% 54.5% 0.13
Previous MI 21.7% 17.9% 0.16
Previous PCI 25.0% 22.7% 0.42
BMI, mean (SD) 25.1 (20.4) 24.1 (22.5) 0.25
Systolic BP, mmHg 139 (24) 140 (23) 0.55
Diastolic BP, mmHg 77 (13) 78 (13) 0.07

7. Endpoints
• Pain during sheath insertion (VAS-scale),
• Pain during the procedure (VAS-scale)
• Successful radial procedure
• Analgesics and sedatives during the procedure,
• Radial patency evaluated by the
reverse Barbeau test after the procedure

8. Visual analogue scale
No pain Worst possible pain
• were instructed to state the number that best illustrated their
worst episode of pain and discomfort during sheath insertion,
and during the procedure (including sheath removal)
Methods

9. Describtions and results

10. Median 2 versus 1 in VAS, score, P=0.019.
65% versus 72% with VAS<=2

11. Results
• Use of a slender sheath was associated with less pain during sheath
insertion (median VAS-scale 1 versus 2, p=0.02), whereas no difference
was observed in any of the remaining endpoints.
• No difference in pain during the procedure
• No difference in use of sedatives or analgetics during the procedure
• No difference in proportion with successful radial procedure
• No difference in radial artery patency evaluated by the reverse Barbeau
test

12. Conclusion
The use of a slender sheath was associated with less pain during sheath insertion,
whereas no difference was observed in pain during the procedure, use of sedatives
and analgesics, procedural success or patency following the procedure.