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经经验丰富的术者在日常实践中经桡动脉和股动脉入路进行的冠状动脉造影术放射暴露随机非劣效性试验:EXPERT 试验。

Randomized Noninferiority Trial of Radiation Exposure During Coronary Angiography: the Transradial and Transfemoral Approach by EXPERienced Operators in Daily rouTine (EXPERT) Trial.

机构信息

Cardiology Institute, Rio Grande do Sul/University Foundation of Cardiology (IC-FUC), Department of Invasive Cardiology and Hemodynamics, Porto Alegre, Rio Grande do Sul, Brazil.

Graduate Program in Health Sciences (Cardiology - PPG), University Foundation of Cardiology, Porto Alegre, Rio Grande do Sul, Brazil.

出版信息

Tex Heart Inst J. 2023 Mar 1;50(2). doi: 10.14503/THIJ-22-7930.

Abstract

BACKGROUND

The transradial approach (TRA) to coronary angiography reduces vascular complications but is associated with greater radiation exposure than the transfemoral approach (TFA). It is unknown whether exposure remains higher when TRA is performed by experienced operators.

METHODS

Patients were randomly, prospectively assigned to TRA or TFA. The primary end point was patient radiation dose; secondary end points were the physician radiation dose and 30-day major adverse cardiac event rate. Coronary angiography was performed by experienced operators using a standardized protocol.

RESULTS

Clinical and procedural characteristics were similar between the TRA (n = 150) and TFA (n = 149) groups, and they had comparable mean (SD) radiation doses for patients (616.51 [252] vs 585.57 [225] mGy; P = .13) and physicians (0.49 [0.3] vs 0.46 [0.29] mSv; P = .32). The mean (SD) fluoroscopy time (3.52 [2.02] vs 3.13 [2.46] min; P = .14) and the mean (SD) dose area product (35,496.5 [15,670] vs 38,313.4 [17,764.9] mGy·cm2; P = .2) did not differ. None of the following factors predicted higher radiation doses: female sex (hazard ratio [HR], 0.69 [95% CI, 0.38-1.3]; P = .34), body mass index >25 (HR, 0.84 [95% CI, 0.43-1.6]; P = .76), age >65 years (HR, 1.67 [95% CI, 0.89-3.1]; P = .11), severe valve disease (HR, 1.37 [95% CI, 0.52-3.5]; P = .68), or previous coronary artery bypass graft (HR, 0.6; 95% CI, 0.2-1.8; P = .38).

CONCLUSION

TRA for elective coronary angiography is noninferior to TFA when performed by experienced operators.

摘要

背景

经桡动脉入路(TRA)行冠状动脉造影术可减少血管并发症,但与经股动脉入路(TFA)相比,其放射暴露量更大。尚不清楚当由经验丰富的术者施行 TRA 时,放射暴露量是否仍较高。

方法

患者被随机、前瞻性地分配至 TRA 组或 TFA 组。主要终点是患者的放射剂量;次要终点是医师的放射剂量和 30 天主要不良心脏事件发生率。采用标准化方案由经验丰富的术者施行冠状动脉造影术。

结果

TRA 组(n=150)和 TFA 组(n=149)的临床和手术特征相似,且患者(616.51[252]比 585.57[225]mGy;P=0.13)和医师(0.49[0.3]比 0.46[0.29]mSv;P=0.32)的平均(SD)放射剂量相当。平均(SD)透视时间(3.52[2.02]比 3.13[2.46]min;P=0.14)和平均(SD)剂量面积乘积(35496.5[15670]比 38313.4[17764.9]mGy·cm2;P=0.2)无差异。以下因素均未预测更高的放射剂量:女性(风险比[HR],0.69[95%CI,0.38-1.3];P=0.34)、体质指数(BMI)>25(HR,0.84[95%CI,0.43-1.6];P=0.76)、年龄>65 岁(HR,1.67[95%CI,0.89-3.1];P=0.11)、严重瓣膜疾病(HR,1.37[95%CI,0.52-3.5];P=0.68)或既往冠状动脉旁路移植术(HR,0.6;95%CI,0.2-1.8;P=0.38)。

结论

当由经验丰富的术者施行时,TRA 用于择期冠状动脉造影术不劣于 TFA。

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