Abstract
Background
The small diameter of radial arteries remains a major limitation of the transradial
approach for percutaneous coronary intervention (PCI). Sheathless guiding catheters
(GCs) might offer an advantage over standard GCs.
Methods
Between 2011 and 2013, we randomized 233 transradial PCIs performed in men with ostial
or bifurcation lesions and in all women between standard GC (Medtronic Launcher; Minneapolis,
MN) and the SheathLess Eaucath GC (Asahi Intecc, Aichi, Japan).
Results
Successful PCI using the transradial approach was not different between the groups
(P = 0.74), however the rate of successful transradial PCI with the designated GC (ie,
without crossover to the opposing GC) was superior in the SheathLess group compared
with the standard GC group (96.5% vs 89.9%; P = 0.047). Safety end point (ie, absence of PCI complication, radial artery occlusion,
perforation, pseudoaneurysm, and Early Discharge after Transradial Stenting of Coronary Arteries [EASY] hematoma grade ≥ 2) did not differ between the groups (60.5% in both
groups). Mean PCI duration (45.1 minutes vs 45.9 minutes), fluoroscopy (20.1 minutes
and 19.9 minutes), and cannulation times (3.6 minutes vs 3.7 minutes), contrast media
volume (196 mL vs 187 mL) and conversion to transfemoral approach (1.8% vs 0.8%) were
not different between the groups. Patients' subjective assessment revealed less arm
pain during navigation of the SheathLess GC (1.9 ± 1.9 vs 4.8 ± 3.6; P < 0.001). Operators graded arm crossability as easier with the SheathLess GC (8.7
± 1.5 vs 5.1 ± 3.5; P < 0.001).
Conclusions
In selected coronary lesions requiring large-bore catheters in men and in all lesions
in women, the SheathLess GC was superior to the standard GC for successful transradial
PCI with the designated GC. The SheathLess GC was also associated with easier arm
navigation and less patient discomfort.
Résumé
Contexte
Le faible diamètre des artères radiales demeure l’une des principales limites pour
ce qui est de l’intervention coronarienne percutanée (ICP) par voie radiale, mais
l’arrivée de nouveaux cathéters-guide sans gaine pourrait améliorer la situation.
Méthodes
Nous avons examiné, de manière aléatoire, 233 ICP par voie radiale effectuées entre
2011 et 2013 pour traiter des des lésions ostiales ou de bifurcation chez des hommes
et à tout type de lésions chez des femmes. Les deux dispositifs comparés dans le cadre
de cette étude étaient le cathéter-guide standard de Medtronic Launcher et le cathéter-guide
sans gaine SheathLess Eaucath GC, fabriqué par Asahi Intecc.
Résultats
Le taux de succès global de l’ICP par voie radiale a été le même pour les deux groupes
(p = 0,74), mais le taux de succès de l’ICP pour un dispositif donné (sans chevauchement
des données) a été supérieur pour le cathéter-guide sans gaine par rapport au cathéter-guide
standard (96,5 vs 89,9 %; p = 0,047). Le paramètre d’évaluation de l’innocuité (absence de complication liée
à l’ICP, d’occlusion de l’artère radiale, de perforation, de pseudoanévrisme, ainsi
que d’hématome ≥ 2 selon l’échelle d’évaluation EASY [Early Discharge after Transradial Stenting of Coronary Arteries]) ne différait pas entre les deux types de dispositifs (60,5 % dans les deux groupes).
Il n’y avait pas non plus de différence entre les deux dispositifs quant à la durée
moyenne de l’ICP (45,1 vs 45,9 minutes), la durée de la fluoroscopie (20,1 vs 19,9 minutes), la durée de la canulation (3,6 vs 3,7 minutes), le volume de produit de contraste requis (196 vs 187 ml) et la nécessité de passer à une intervention par voie fémorale (1,8 vs 0,8 %). Selon l’évaluation subjective des patients, le cathéter-guide sans gaine
aurait causé moins de douleur au bras en cours d’intervention (1,9 ± 1,9 vs 4,8 ± 3,6; p < 0,001). Les opérateurs ont pour leur part indiqué avoir eu plus de facilité à remonter
l’artère du bras avec le cathéter-guide sans gaine (8,7 ± 1,5 vs 5,1 ± 3,5; p < 0,001).
Conclusion
Dans le cas de certaines lésions coronaires nécessitant un cathéter de gros calibre
chez l’homme et pour toutes les lésions chez la femme, le cathéter-guide sans gaine
s’est révélé supérieur au cathéter-guide standard en ce qui a trait au succès de l’ICP
par voie radiale avec un dispositif donné. Le cathéter-guide sans gaine a aussi été
jugé plus facile à utiliser dans le bras et a suscité moins d’inconfort chez les patients.
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References
- Percutaneous transradial artery approach for coronary stent implantation.Cathet Cardiovasc Diagn. 1993; 30: 173-178
- Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; systematic overview and meta-analysis of randomized trials.J Am Coll Cardiol. 2004; 44: 349-356
- Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials.Am Heart J. 2009; 157: 132-140
- Association of the arterial access site at angioplasty with transfusion and mortality: the M.O.R.T.A.L study (Mortality benefit Of Reduced Transfusion after percutaneous coronary intervention via the Arm or Leg).Heart. 2008; 94: 1019-1025
- Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial.Lancet. 2015; 385: 2465-2476
- Transradial artery catheterization in the United States.Cardiac Interventions Today. 2014; : 29-34
- Transradial sheathless approach for PCI.Curr Cardiol Rep. 2015; 17: 47
- High-speed rotational atherectomy using the radial artery approach and a sheathless guide: a single-centre comparison with the “conventional” femoral approach.EuroIntervention. 2014; 10: 694-699
- Use of the sheathless guide catheter during routine transradial percutaneous coronary intervention: a feasibility study.Catheter Cardiovasc Interv. 2010; 75: 596-602
- Complex percutaneous coronary interventions by transradial approach using sheathless guiding catheters.Cardiovasc Med. 2012; 15: 218-223
- Complex transradial percutaneous coronary intervention using a sheathless guide catheter.Heart Lung Circ. 2013; 22: 188-192
- Comparison of novel 6.5 Fr sheathless guiding catheters versus 5 Fr guiding catheters for transradial coronary intervention.EuroIntervention. 2011; 7: 930-935
- Atraumatic complex transradial intervention using large bore sheathless guide catheter.Catheter Cardiovasc Interv. 2008; 72: 357-364
- Transradial simultaneous kissing stenting (SKS) with SheathLess access.Catheter Cardiovasc Interv. 2010; 75: 222-224
- Evaluation of the ulnopalmar arterial arches with pulse oximetry and plethysmography: comparison with the Allen's test in 1010 patients.Am Heart J. 2004; 147: 489-493
- One-year clinical outcome after abciximab bolus-only compared with abciximab bolus and 12-hour infusion in the randomized EArly Discharge after Transradial Stenting of CoronarY Arteries (EASY) study.Am Heart J. 2008; 156: 135-140
- Sheathless guide catheter in transradial percutaneous coronary intervention for ST-segment elevation myocardial infarction.Catheter Cardiovasc Interv. 2016; 87: 1111-1117
- ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomized clinical trial: the STEMI-RADIAL trial.J Am Coll Cardiol. 2014; 63: 964-972
- Effects of radial versus femoral artery access in patients with acute coronary syndromes with or without ST-segment elevation.J Am Coll Cardiol. 2012; 60: 2490-2499
- Routine use of the transradial approach in primary percutaneous coronary intervention: procedural aspects and outcomes in 2209 patients treated in a single high-volume centre.Heart. 2011; 97: 1938-1942
- Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study.J Am Coll Cardiol. 2012; 60: 2481-2489
- Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial.Lancet. 2011; 377: 1409-1420
- 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: 173-178
- Safety and feasibility of the new 5 Fr Glidesheath Slender.Cardiovasc Interv Ther. 2016; 31: 38-41
- Initial experience with the Glidesheath Slender for transradial coronary angiography and intervention: a feasibility study with prospective radial ultrasound follow-up.Catheter Cardiovasc Interv. 2014; 84: 436-442
- Sheathless guide catheter coronary intervention via radial artery: single-center experience with 9658 procedures.J Invasive Cardiol. 2015; 27: 237-241
Article info
Publication history
Published online: April 04, 2016
Accepted:
March 27,
2016
Received:
December 26,
2015
Footnotes
See page 1431 for disclosure information.
Identification
Copyright
© 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
