Comparison of a new slender 6 french sheath with a standard 5 french sheath for transradial coronary angiography and intervention: a randomized multicenter trial the RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT) Trial
Eurointervention : Journal of Europcr in Collaboration With the Working Group on Interventional Cardiology of the European Society of Cardiology. 2017;13((5):):e549-e556
AIMS: The 6 French(Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) is a recently developed thin-walled radial sheath with an outer diameter (OD) that is smaller than the OD of standard 6Fr sheaths. The effect of this introducer sheath on radial artery occlusion (RAO) is unknown. METHODS AND RESULTS We conducted a randomized, multicenter, non-inferiority trial comparing the GSS6Fr against the standard 5Fr Glidesheath (GS5Fr, Terumo, Japan) in patients undergoing TR coronary angiography and/or intervention. Patients in each group were subsequently randomized to undergo patent hemostasis or the institutional hemostasis protocol. The primary endpoint was the occurrence of RAO at discharge. A total of 1926 patients were randomized in 12 centers. 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 randomized to patent hemostasis had similar rate of RAO compared with institutional hemostasis (2.61% vs 2.61%, P=1). There was no difference with regard to all secondary end-points, including vascular access-site complication, local bleeding and spasm. CONCLUSIONS In this large multicenter randomized trial, the GSS6Fr was associated with a low event rate for the primary end-point (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 hemostasis, the use of patent hemostasis was not associated with a reduced rate of RAO.