Randomized Comparison of Terumo® Coated Slender™ versus Terumo® Noncoated Traditional Sheath during Radial Angiography or Percutaneous Coronary Intervention.
Aged
Catheterization, Peripheral
/ adverse effects
Coronary Angiography
/ adverse effects
Denmark
Equipment Design
Female
Humans
Male
Middle Aged
Outcome Assessment, Health Care
Pain Measurement
Pain, Procedural
/ diagnosis
Percutaneous Coronary Intervention
/ adverse effects
Radial Artery
/ physiopathology
Vascular Patency
Journal
Journal of interventional cardiology
ISSN: 1540-8183
Titre abrégé: J Interv Cardiol
Pays: United States
ID NLM: 8907826
Informations de publication
Date de publication:
2019
2019
Historique:
received:
26
11
2018
accepted:
13
02
2019
entrez:
28
11
2019
pubmed:
28
11
2019
medline:
29
2
2020
Statut:
epublish
Résumé
The transradial approach is generally associated with few complications. However, periprocedural pain is still a common issue, potentially related to sheath insertion and/or arterial spasm, and may result in conversion to femoral access. Radial artery occlusion (RAO) following the procedure is also a potential risk. We evaluate whether the design of the sheath has any impact on these variables. A total of 1,000 patients scheduled for radial CAG or PCI were randomized (1:1) to the use of a Slender or a Standard sheath during the procedure. Randomization was stratified according to chosen sheath size (5, 6, 7 French) and gender. A radial band was used to obtain hemostasis after the procedure, employing a rapid deflation technique. A reverse Barbeau test was performed to evaluate radial artery patency after removal of the radial band, and level of pain was assessed using a numeric rating scale (NRS). Use of the Slender sheath was associated with less pain during sheath insertion (median NRS 1 versus 2, p=0.02), whereas no difference was observed in pain during the procedure, radial procedural success rates, use of analgesics and sedatives during the procedure, and radial artery patency following the procedure. Rate of RAO was 1.5% with no difference between groups. The use of the hydrophilic coated Slender sheath during radial CAG or PCI was associated with less pain during sheath insertion, whereas no difference in other endpoints was observed. A rapid deflation technique was associated with RAO of only 1.5%.
Sections du résumé
BACKGROUND
BACKGROUND
The transradial approach is generally associated with few complications. However, periprocedural pain is still a common issue, potentially related to sheath insertion and/or arterial spasm, and may result in conversion to femoral access. Radial artery occlusion (RAO) following the procedure is also a potential risk. We evaluate whether the design of the sheath has any impact on these variables.
METHODS
METHODS
A total of 1,000 patients scheduled for radial CAG or PCI were randomized (1:1) to the use of a Slender or a Standard sheath during the procedure. Randomization was stratified according to chosen sheath size (5, 6, 7 French) and gender. A radial band was used to obtain hemostasis after the procedure, employing a rapid deflation technique. A reverse Barbeau test was performed to evaluate radial artery patency after removal of the radial band, and level of pain was assessed using a numeric rating scale (NRS).
RESULTS
RESULTS
Use of the Slender sheath was associated with less pain during sheath insertion (median NRS 1 versus 2, p=0.02), whereas no difference was observed in pain during the procedure, radial procedural success rates, use of analgesics and sedatives during the procedure, and radial artery patency following the procedure. Rate of RAO was 1.5% with no difference between groups.
CONCLUSION
CONCLUSIONS
The use of the hydrophilic coated Slender sheath during radial CAG or PCI was associated with less pain during sheath insertion, whereas no difference in other endpoints was observed. A rapid deflation technique was associated with RAO of only 1.5%.
Identifiants
pubmed: 31772545
doi: 10.1155/2019/7348167
pmc: PMC6739780
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
7348167Informations de copyright
Copyright © 2019 Birthe Sindberg et al.
Déclaration de conflit d'intérêts
Christian Juhl Terkelsen has received an unrestricted research grant from Terumo to conduct the study.
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