Hemostasis pad combined with compression device after transradial coronary procedures: A randomized controlled trial

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, 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

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT02954029.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1. CONSORT flow chart of the…
Fig 1. CONSORT flow chart of the study.
Fig 2. Study devices.
Fig 2. Study devices.
(A) Both rotatory compression device and hemostasis pad were used for the patients in the study group. (B) After placing the hemostasis pad over the puncture site, the rotatory compression device was applied.
Fig 3. The primary endpoint, time to…
Fig 3. The primary endpoint, time to hemostasis of the study and control groups.
Fig 4. Subjective discomfort assessed by visual…
Fig 4. Subjective discomfort assessed by visual analogue scale.

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Source: PubMed

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