Rahman Nasir, Artani Azmina, Baloch Farhala, Artani Moiz, Fatima Huma, Salam Abdus, Ahmed Sher
Department of Medicine, Aga Khan University Hospital, Karachi, Pakistan.
Jinnah Medical and Dental College, Karachi, Pakistan.
Asian Cardiovasc Thorac Ann. 2021 Jun 29:2184923211027790. doi: 10.1177/02184923211027790.
Radial artery occlusion is a common complication of coronary angiography via radial artery, attributed to the prolonged use of trans-radial band post procedure. Literature suggests there is no standard protocol for radial band deflation, and it varies across institutions. However, the protocol suggested by Cohen and Alfonso is widely used globally. This study aims to test whether our hospital's radial band deflation protocol is non-inferior to the protocol of Cohen and Alfonso, which affirms lesser complications.
This is an outcome assessor blinded, non-inferiority trial conducted at a tertiary care hospital in Karachi. We enrolled 100 patients who underwent coronary angiography from radial access and gave written informed consent. The intervention group received protocol A, that is in practice at the institution, while the control group received protocol B, developed by Cohen and Alfonso. The primary outcome was occurrence of radial artery occlusion at 24 h. The secondary outcomes included hematoma and bleeding after radial band removal.
The mean age of the participants in the trial was 58.3 ± 11.5 years, while 63% of them were men. Participants in both the groups had similar baseline characteristics. Radial artery occlusion was not significantly different between protocol A and protocol B (10% vs. 14%, = 0.49, respectively). Similarly, hematoma and bleeding after trans-radial band removal showed no statistical difference between the groups.
Trans-radial band deflation practice at our institution was non-inferior to Cohen and Alfonso's protocol in the incidence of radial artery occlusion after coronary angiography.
This trial is registered at clinicaltrials.gov (https://clinicaltrials.gov) with registration number NCT03298126.
桡动脉闭塞是经桡动脉行冠状动脉造影的常见并发症，这归因于术后长时间使用桡动脉压迫带。文献表明，对于桡动脉压迫带放气没有标准方案，各机构的做法也有所不同。然而，科恩和阿方索建议的方案在全球被广泛使用。本研究旨在检验我院的桡动脉压迫带放气方案是否不劣于科恩和阿方索的方案，后者证实并发症较少。
这是一项在卡拉奇一家三级护理医院进行的结果评估者盲法非劣效性试验。我们纳入了100例经桡动脉途径行冠状动脉造影并签署书面知情同意书的患者。干预组接受机构实际使用的方案A，而对照组接受由科恩和阿方索制定的方案B。主要结局是24小时时桡动脉闭塞的发生情况。次要结局包括桡动脉压迫带移除后的血肿和出血情况。
试验参与者的平均年龄为58.3±11.5岁，其中63%为男性。两组参与者的基线特征相似。方案A和方案B之间的桡动脉闭塞情况无显著差异（分别为10%和14%，P = 0.49）。同样，桡动脉压迫带移除后的血肿和出血情况在两组之间也无统计学差异。
在冠状动脉造影后桡动脉闭塞的发生率方面，我院的桡动脉压迫带放气做法不劣于科恩和阿方索的方案。
本试验已在clinicaltrials.gov（https://clinicaltrials.gov）注册，注册号为NCT03298126。
