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

Catheter Cardiovasc Interv. 2018 Nov 1;92(5):844-851. doi: 10.1002/ccd.27526. Epub 2018 Feb 16.

Abstract

Background: During transradial (TR) access, it remains unclear whether differences in baseline patients characteristics and hemostasis care impact the rate of radial artery occlusion (RAO). We sought to compare the rate of RAO after TR access with the 6 French(Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) or a standard 5 Fr sheath in Japanese and non-Japanese patients.

Methods and results: The Radial Artery Patency and Bleeding, Efficacy, Adverse evenT (RAP and BEAT) trial randomized 1,836 patients undergoing TR coronary angiography and/or interventions to receive the GSS6Fr or the standard 5 Fr Glidesheath (GS5Fr, Terumo, Japan). Out of this study population, 1,087 were Japanese patients and 751 non-Japanese patients. The overall incidence of RAO was significantly higher in Japanese patients (3.6% vs. 1.2%, P = 0.002). Use of GSS6Fr was associated with higher rates of RAO than GS5Fr in Japanese patients (5% vs. 2.2%, P = 0.02) and with similar RAO rates in non-Japanese patients (1.3 vs. 1.1%, P = 1). The mean hemostasis time was significantly longer in Japanese patients (378 ± 253 vs. 159 ± 136 min, P < 0.001) and more Japanese patients had a hemostasis time of more than 6 hr (16.2% vs. 4.9%, P < 0.0001). Longer hemostasis time was an independent predictor of RAO (OR per additional hour 1.070, 95% CI 1.008-1.136, P = 0.03).

Conclusions: Use of GSS6Fr was associated with a higher rate of RAO than a standard 5 Fr sheath in Japanese patients but not in non-Japanese patients. Whether improvement in post-procedural care and reduced hemostasis time could impact the incidence of RAO in Japanese patients should be further assessed.

Keywords: radial artery occlusion; slender sheath; transradial.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Arterial Occlusive Diseases / diagnostic imaging
  • Arterial Occlusive Diseases / ethnology*
  • Arterial Occlusive Diseases / physiopathology
  • Asian People*
  • Cardiac Catheters*
  • Catheterization, Peripheral / adverse effects
  • Catheterization, Peripheral / instrumentation*
  • Coronary Angiography / adverse effects
  • Coronary Angiography / instrumentation*
  • Coronary Artery Disease / diagnostic imaging*
  • Coronary Artery Disease / ethnology
  • Coronary Artery Disease / physiopathology
  • Coronary Artery Disease / therapy*
  • Equipment Design
  • Female
  • Hemorrhage / ethnology*
  • Hemostasis*
  • Humans
  • Incidence
  • Japan / epidemiology
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Prospective Studies
  • Radial Artery / diagnostic imaging
  • Radial Artery / physiopathology*
  • Risk Factors
  • Single-Blind Method
  • Time Factors
  • Treatment Outcome
  • United States / epidemiology
  • Vascular Patency*