Date Published: July 24, 2017
Publisher: Public Library of Science
Author(s): Si-Hyuck Kang, Donghoon Han, Sehun Kim, Chang-Hwan Yoon, Jin-Joo Park, Jung-Won Suh, Young-Seok Cho, Tae-Jin Youn, In-Ho Chae, Salvatore De Rosa.
Arterial access and hemostasis are important processes during percutaneous coronary procedures. In this study, we tested if the use of chitosan-based pads on top of compression devices could improve hemostasis efficacy compared with compression devices alone after transradial coronary angiography or interventions.
This study was a single-center open-label randomized controlled trial. Patients who underwent coronary angiography or intervention with the transradial approach were randomly assigned to the study (compression device and a chitosan-based pad) or control (compression devices alone) group in a 2:1 fashion. The primary endpoint was time to hemostasis, categorized into ≤5, 6–10, 11–20, and >20 minutes.
Between April and July 2016, 95 patients were enrolled (59 were assigned to the study arm and 36 to the control arm). Time to hemostasis, the primary endpoint, was significantly lower in the study group than in the control group (p<0.001). Both groups showed low rates of vascular complications. This study suggests that the use of a hemostasis pad in combination with rotatory compression devices is a safe and effective hemostasis strategy after radial artery access. ClinicalTrials.gov NCT02954029
The transradial approach is increasingly used for arterial access during percutaneous cardiovascular procedures. The main advantages of the transradial approach over the transfemoral approach include patient convenience, reduced time to hemostasis, a lower risk of acute kidney injury, and improved outcomes such as a lower risk of bleeding.[1, 2] However, radial access is still associated with significant complications such as access site bleeding and vessel occlusion.
Between April and July 2016, 95 patients were enrolled, and all the study participants received assigned treatment (59 assigned to the study arm, and 36 to the control arm, Fig 1). Patients in the control arm received a CD after removal of the sheath, while CD was applied on top of the hemostasis pad for those in the study arm (Fig 2). There were no significant differences in baseline characteristics between the groups (Table 1). The mean age was 65 years, and 67% of the patients were men. The right radial artery was the main approach route. Five-Fr. sheaths were used in 62.1% of the subjects; 6-Fr. sheaths were used in the remaining subjects.
Arterial access management is a key process during percutaneous cardiovascular procedures. Rotatory CD and the chitosan-based hemostasis pad are both widely used hemostasis strategies in clinical practice after radial artery access. This prospective randomized controlled trial demonstrated that the combination of the two hemostasis strategies was safe and superior to CD alone in reducing the time to hemostasis. In addition, this strategy was not associated with an increased risk of vascular complications.