Effect of hemostatic device on radial artery occlusion: A randomized comparison of compression devices in the radial hemostasis study.

BACKGROUND

Asymptomatic radial artery occlusion (RAO) is a major limitation of transradial catheterization (TRC). Two radial compression hemostatic devices are compared for their respective effects on RAO.

METHODS

In a prospective, randomized, single center, blinded trial, 320 patients were randomly treated with a TR band (Terumo Corporation) or Safeguard Radial (Merit Medical). Institution wide protocols consisting of anticoagulation, patent hemostasis, duration of compression, and use of 6 French slender sheaths (Terumo Corporation) were observed. Patient discomfort related to the device was recorded using the universal pain scale. Radial artery patency was evaluated by reverse Barbeau's test prior to discharge (1-hour post-diagnostic catheterization or 6-24 hour post-intervention) and at 30-days.

RESULTS

Of the 320 patients, 155 were randomized to the TR group (TRG) and 159 to the Safeguard group (SGG). 6 patients were excluded due to the inability to insert 6 Fr slender sheaths or patient withdrawing consent. Demographic and procedural characteristics were similar with the exception of the type of coronary procedure performed. Both bands were equally effective in achieving patent hemostasis. Despite having a higher rate of post-procedure hematoma (1.29% TRG vs. 3.1% SGG, p = 0.04) and acute RAO (3.8% TRG vs. 6.28% SGG, p = 0.05) with the Safeguard band, at 30 days RAO was similar in both groups (1.9% TRG vs. 2.5% SGG; p = 0.21). Patients in the SGG reported significantly less band discomfort and were found to require less air to achieve patent hemostasis.

CONCLUSION

Evidence-based contemporary TRC protocols of using smaller diameter access, anticoagulation, and use of just enough pressure for the shortest duration of time to achieve hemostasis is associated with very low RAO rate at 30 days irrespective of the radial compression device used.