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

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.

Impact of sheath size and hemostasis time on radial artery patency after transradial coronary angiography and intervention in Japanese and non‐Japanese patients: A substudy from RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT) randomized multicenter trial

“…The 6 French (Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) is the first commercially available thin‐walled radial sheath with an outer diameter (OD) smaller than the OD of current standard 6 Fr sheaths . The Radial Artery Patency and Bleeding, Efficacy, Adverse evenT (RAP and BEAT) trial was a large randomized, multicenter trial, assessing non‐inferiority of the GSS6Fr against the standard 5 Fr Glidesheath (GS5Fr, Terumo, Japan), and superiority of a patent hemostasis protocol against the institutional hemostasis protocol, in 1,836 patients undergoing TR coronary angiography and/or intervention . The RAP and BEAT trial showed that use of the GSS6Fr was associated with a low event rate for the primary outcome (RAO) although non‐inferiority against the GS5Fr was not met, due to a lower than expected rate of RAO in the GS5Fr group.…”

Sheath size, radial occlusion, and ethnicity: Real or confounded?

“…The Radial Artery Patency and Bleeding, Efficacy, Adverse evenT (RAP and BEAT) trial randomized 1,836 patients undergoing transradial coronary catheterization to receive the 6Fr Glidesheath Slender or the 5Fr sheath. 1 This study failed to show noninferiority of the slender sheath in terms of RAO when compared to the 5Fr sheath.…”

“…The use of smaller profile sheaths (like Glidesheath Slender series, Terumo, Japan) is intended to reduce the incidence of RAO as having a smaller profile than regular 6Fr sheaths. The Radial Artery Patency and Bleeding, Efficacy, Adverse evenT (RAP and BEAT) trial randomized 1,836 patients undergoing transradial coronary catheterization to receive the 6Fr Glidesheath Slender or the 5Fr sheath . This study failed to show noninferiority of the slender sheath in terms of RAO when compared to the 5Fr sheath.…”

Antiplatelet agents in uncertain clinical scenarios—a bleeding nightmare

“…Historically, vascular access site has been a major driver of bleeding in many studies, although this influence has decreased for several reasons. Measures such as reduction in the sheath size, use of slender technologies, greater attention to the femoral puncture (68)(69)(70) and, ultimately, the switch by many operators to the transradial approach, has significantly reduced the rate of bleeding (66). The transradial approach has arguably been the greatest driver in the crusade to reduce bleeding rates, and subsequently mortality (62)(63)(64)(65)(66)(67).…”

“…Assessment of the patient's ischemic and bleeding risks is recommended along with early discontinuation of Aspirin once the INR is therapeutic (i.e., 2-3 for NVAF) to avoid any prolonged duration TT. Achieving a therapeutic INR should be done using a slow induction protocol to avoid high INRs (70). Recommendations to tightly control the INR between 2.0-2.5 are notoriously difficult to achieve in the real-world setting most likely requiring more frequent monitoring.…”