Randomized comparison of sheath size for coronary intervention: time to hemostasis and risk of radial artery occlusion
Abstract
Background
Transradial access is the preferred approach for coronary procedures due to lower complication rates compared to femoral access. However, minimizing equipment for radial access may further reduce bleeding and radial artery occlusion (RAO).
Aims
This study assessed whether the use of 5F sheaths, compared to 6F sheaths, reduces time to hemostasis and the risk of RAO in patients undergoing diagnostic coronary angiography and/or coronary intervention.
Methods
3600 patients were randomized to 5F or 6F sheaths, except when operators preferred 6F sheaths. TR-band deflation and removal times were recorded, and
radial artery patency was assessed at discharge using the reverse Barbeau test, with Types C and D indicating RAO.
Results
942 patients were randomized to 5F and 945 to 6F sheath. In 1713 patients, 6F sheaths were chosen up front by the operator. In intention-to-treat analysis no significant differences were observed between the randomized groups in time to TR-band removal (101 vs. 105 min, p = 0.07), or RAO (1.6 % vs. 2.1 %, p = 0.44). A significant crossover to 6F sheaths occurred in the 5F group. In as-treated analyses, TR-band removal times were shorter with 5F compared to 6F and operator-preferred 6F sheaths (98.5 min, 105 min, 111 min, P < 0.01). No significant differences in RAO risk were observed between groups (1.8 %, 1.9 %, 1.2 %, P = 0.34).