Department of Cardiology, First Hospital of Shanxi Medical University, No. 85, JieFang South Road, Yingze District, Taiyuan, Shanxi 030001, China.
First Clinical Medical College, Shanxi Medical University, No. 85, JieFang South Road, Yingze District, Taiyuan, Shanxi 030001, China.
J Interv Cardiol. 2022 Apr 5;2022:2345584. doi: 10.1155/2022/2345584. eCollection 2022.
At present, the use of particular radial hemostatic devices after coronary angiography (CAG) or percutaneous coronary intervention (PCI) has become the primary method of hemostasis. Most control studies are based on the products already on the market, while only a few studies are on the new hemostatic devices. The aim of this study is to compare a new radial artery hemostasis device which is transformed based on the invention patent (Application number: CN201510275446) with TR Band (Terumo Medical) to evaluate its clinical effects.
In a prospective randomized clinical trial, 60 patients after CAG or PCI were randomly divided into two groups, patients in the trial group (CD group) using a new radial artery hemostasis device to stop bleeding and the control group (TR group) using the TR Band. The method is to collect relevant data of the two groups and compare the differences in hemostasis, local complications, and patient discomfort between the two groups.
The hemostatic devices in both groups achieved adequate hemostasis, and there was no failure to stop bleeding. The new radial artery hemostasis device was better than the TR band in pain and swelling ( < 0.05). There were no significant differences in bleeding, hematoma, ecchymosis, skin damage, and local infection between the two groups ( > 0.05).
The sample of the new radial artery hemostasis device can stop bleeding effectively at the puncture site after CAG or PCI and is not inferior to the TR Band balloon hemostatic device in safety and is better in comfort.
目前，经冠状动脉造影（CAG）或经皮冠状动脉介入治疗（PCI）后使用特定的桡动脉止血装置已成为主要的止血方法。大多数对照研究都是基于已上市的产品，而只有少数研究是关于新的止血装置。本研究旨在比较一种新的桡动脉止血装置，该装置是基于发明专利（申请号：CN201510275446）转化而来，与 TR Band（泰尔茂）进行比较，以评估其临床效果。
前瞻性随机临床试验中，将 60 例 CAG 或 PCI 后患者随机分为两组，试验组（CD 组）使用新型桡动脉止血装置止血，对照组（TR 组）使用 TR Band。收集两组相关数据，比较两组止血、局部并发症及患者舒适度的差异。
两组止血装置均达到充分止血，无止血失败。新型桡动脉止血装置在疼痛和肿胀方面优于 TR 带（<0.05）。两组在出血、血肿、瘀斑、皮肤损伤和局部感染方面无显著差异（>0.05）。
新型桡动脉止血装置的样本可有效止血在 CAG 或 PCI 后的穿刺部位，在安全性方面与 TR Band 球囊止血装置相当，在舒适度方面更好。
