Background—Interventional cardiologists are increasingly exposed to radiation-induced diseases like cataract and the stochastic risk of left-sided brain tumors. The RADPAD is a sterile, disposable, lead-free shield placed on the patient with the aim to minimize operator-received scatter radiation. The objective of the trial was to examine the RADPAD’s efficacy in a real-world situation.

Methods and Results—In the current, double-blind, sham-controlled, all-comer trial, patients undergoing diagnostic catheterization or percutaneous coronary interventions were randomized in a 1:1:1 ratio to a radiation absorbing shield (RADPAD), standard treatment (NOPAD), or a sham shield (SHAMPAD). The sham shield allowed testing for shield-induced radiation behavior. The primary outcome was the difference in relative exposure of the primary operator between the RADPAD and NOPAD arms and was defined as the ratio between operator’s exposure (E in µSv) and patient exposure (dose area product in mGy·cm²), measured per procedure. A total of 766 consecutive coronary procedures were randomized to the use of RADPAD (N=255), NOPAD (N=255), or SHAMPAD (N=256). The use of RADPAD was associated with a 20% reduction in relative operator exposure compared with that of NOPAD (P=0.01) and a 44% relative exposure reduction compared with the use of a SHAMPAD (P<0.001). Use of the SHAMPAD was associated with a 43% higher relative radiation exposure than procedures with NOPAD (P=0.009).

Conclusions—In clinical daily practice, the standard use of the RADPAD radiation shield reduced operator radiation exposure compared with procedures with NOPAD or SHAMPAD. This study supports the routine use of RADPAD in the catheterization laboratory.

Clinical Trial Registration—URL: https://www.clinicaltrials.gov. Unique identifier: NCT03139968.

背景—介入心脏病专家越来越多地暴露于辐射诱发的疾病，例如白内障和左侧脑部肿瘤的随机风险。RADPAD是放置在患者身上的无菌，一次性，无铅屏蔽罩，旨在最大程度地减少操作员接收到的散射辐射。该试验的目的是检验RADPAD在现实情况下的功效。

方法和结果—在当前的一项双盲，假对照，全民试验中，接受诊断性导管插入术或经皮冠状动脉介入治疗的患者以1：1：1的比例随机分配至标准的放射线吸收罩（RADPAD） （NOPAD）或假盾牌（SHAMPAD）。假屏蔽可测试屏蔽引起的辐射行为。主要结局是RADPAD和NOPAD组之间主要操作者相对暴露的差异，定义为操作者暴露（E以µSv为单位）与患者暴露（以mGy·cm ^{2为单位的}剂量面积乘积）之比。），按程序进行测量。总共766次连续的冠状动脉手术被随机分配为使用RADPAD（N = 255），NOPAD（N = 255）或SHAMPAD（N = 256）。与NOPAD相比，使用RADPAD可使操作员相对暴露减少20％（P = 0.01），与SHAMPAD相比，使用RADPAD可使相对暴露减少44％（P <0.001）。与使用NOPAD的程序相比，使用SHAMPAD的相对放射线暴露量高43％（P = 0.009）。

结论—在临床日常实践中，与使用NOPAD或SHAMPAD的程序相比，RADPAD辐射防护罩的标准使用减少了操作员的辐射暴露。这项研究支持在导管实验室常规使用RADPAD。

临床试验注册-URL：https : //www.clinicaltrials.gov。唯一标识符：NCT03139968。