title: Comparison of a new slender 6 Fr sheath with a standard 5 Fr sheath for transradial coronary angiography and intervention: RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT), a randomised multicentre trial.
abstract: OBJECTIVE
  The 6 Fr Glidesheath Slender (GSS6Fr) is a recently developed thin-walled radial sheath with an outer diameter (OD) that is smaller than the OD of standard 6 Fr sheaths. The purpose of this trial was to clarify whether the use of this new slender sheath would result in similar rates of RAO to a standard 5 Fr sheath in unselected patients undergoing transradial (TR) coronary angiography and/or intervention, and to assess the relative importance of sheath size and haemostasis protocol on the rate of RAO.
  
  
  RESULTS
  We conducted a randomised, multicentre, non-inferiority trial comparing the GSS6Fr against the standard GS5Fr in patients undergoing TR coronary angiography and/or intervention. Patients in each group were subsequently randomised to undergo patent haemostasis or the institutional haemostasis protocol. The primary endpoint was the occurrence of RAO at discharge. A total of 1,926 patients were randomised in 12 centres. The incidence of RAO was 3.47% with GSS6Fr compared with 1.74% with GS5Fr (risk difference 1.73%, 95% CI: 0.51-2.95%; pnon-inferiority=0.150). Patients randomised to patent haemostasis had a similar rate of RAO compared with institutional haemostasis (2.61% vs. 2.61%, p=1). There was no difference with regard to all secondary endpoints, including vascular access-site complications, local bleeding and spasm.
  
  
  CONCLUSIONS
  In this large multicentre randomised trial, the GSS6Fr was associated with a low event rate for the primary endpoint (RAO), although non-inferiority to the GS5Fr was not met, due to a lower than expected rate of RAO in the GS5Fr group. As compared to institutional haemostasis, the use of patent haemostasis was not associated with a reduced rate of RAO.
authors.affiliation: Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.
authors.forename: Adel
authors.initials: A
authors.lastname: Aminian
authors.forename: Shigeru
authors.initials: S
authors.lastname: Saito
authors.forename: Akihiko
authors.initials: A
authors.lastname: Takahashi
authors.forename: Ivo
authors.initials: I
authors.lastname: Bernat
authors.forename: Robert Lee
authors.initials: RL
authors.lastname: Jobe
authors.forename: Takashi
authors.initials: T
authors.lastname: Kajiya
authors.forename: Ian C
authors.initials: IC
authors.lastname: Gilchrist
authors.forename: Yves
authors.initials: Y
authors.lastname: Louvard
authors.forename: Ferdinand
authors.initials: F
authors.lastname: Kiemeneij
authors.forename: Niels
authors.initials: N
authors.lastname: Van Royen
authors.forename: Seiji
authors.initials: S
authors.lastname: Yamazaki
authors.forename: Takashi
authors.initials: T
authors.lastname: Matsukage
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
mesh_terms: D000368:Aged; D001157:Arterial Occlusive Diseases / Q000601:surgery*; D006328:Cardiac Catheterization / Q000379:methods; D017023:Coronary Angiography / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D005260:Female; D006470:Hemorrhage / Q000209:etiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods; D011446:Prospective Studies; D017534:Radial Artery / Q000601:surgery*; D014654:Vascular Patency / Q000502:physiology*