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经桡动脉与经股动脉途径行冠状动脉介入手术时术者辐射暴露的随机比较:经桡动脉入路减少不良出血事件及血管造影X线辐射剂量系统实施研究(RAD-MATRIX)的原理与设计

Randomized comparison of operator radiation exposure comparing transradial and transfemoral approach for percutaneous coronary procedures: rationale and design of the minimizing adverse haemorrhagic events by TRansradial access site and systemic implementation of angioX - RAdiation Dose study (RAD-MATRIX).

作者信息

Sciahbasi Alessandro, Calabrò Paolo, Sarandrea Alessandro, Rigattieri Stefano, Tomassini Francesco, Sardella Gennaro, Zavalloni Dennis, Cortese Bernardo, Limbruno Ugo, Tebaldi Matteo, Gagnor Andrea, Rubartelli Paolo, Zingarelli Antonio, Valgimigli Marco

机构信息

Interventional Cardiology, Sandro Pertini Hospital - ASL RMB, Rome.

Division of Cardiology - Department of Cardio-Thoracic Sciences - Second University of Naples.

出版信息

Cardiovasc Revasc Med. 2014 Jun;15(4):209-13. doi: 10.1016/j.carrev.2014.03.010. Epub 2014 Mar 26.

DOI:10.1016/j.carrev.2014.03.010
PMID:24746599
Abstract

BACKGROUND

Radiation absorbed by interventional cardiologists is a frequently under-evaluated important issue. Aim is to compare radiation dose absorbed by interventional cardiologists during percutaneous coronary procedures for acute coronary syndromes comparing transradial and transfemoral access.

METHODS

The randomized multicentre MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) trial has been designed to compare the clinical outcome of patients with acute coronary syndromes treated invasively according to the access site (transfemoral vs. transradial) and to the anticoagulant therapy (bivalirudin vs. heparin). Selected experienced interventional cardiologists involved in this study have been equipped with dedicated thermoluminescent dosimeters to evaluate the radiation dose absorbed during transfemoral or right transradial or left transradial access. For each access we evaluate the radiation dose absorbed at wrist, at thorax and at eye level. Consequently the operator is equipped with three sets (transfemoral, right transradial or left transradial access) of three different dosimeters (wrist, thorax and eye dosimeter). Primary end-point of the study is the procedural radiation dose absorbed by operators at thorax. An important secondary end-point is the procedural radiation dose absorbed by operators comparing the right or left radial approach. Patient randomization is performed according to the MATRIX protocol for the femoral or radial approach. A further randomization for the radial approach is performed to compare right and left transradial access.

CONCLUSIONS

The RAD-MATRIX study will probably consent to clarify the radiation issue for interventional cardiologist comparing transradial and transfemoral access in the setting of acute coronary syndromes.

摘要

背景

介入心脏病专家所吸收的辐射是一个经常未得到充分评估的重要问题。目的是比较介入心脏病专家在急性冠状动脉综合征经皮冠状动脉介入手术期间,经桡动脉和经股动脉途径所吸收的辐射剂量。

方法

随机多中心MATRIX(通过桡动脉入路和血管造影X系统实施减少不良出血事件)试验旨在比较根据入路部位(经股动脉与经桡动脉)和抗凝治疗(比伐卢定与肝素)进行侵入性治疗的急性冠状动脉综合征患者的临床结局。参与本研究的选定经验丰富的介入心脏病专家配备了专用热释光剂量计,以评估经股动脉、右桡动脉或左桡动脉入路期间所吸收的辐射剂量。对于每种入路,我们评估在手腕、胸部和眼部水平所吸收的辐射剂量。因此,操作人员配备了三组(经股动脉、右桡动脉或左桡动脉入路)三种不同的剂量计(手腕、胸部和眼部剂量计)。该研究的主要终点是操作人员在胸部所吸收的手术辐射剂量。一个重要的次要终点是比较右桡动脉或左桡动脉入路时操作人员所吸收的手术辐射剂量。患者根据MATRIX方案进行股动脉或桡动脉入路的随机分组。对桡动脉入路进行进一步随机分组,以比较右桡动脉和左桡动脉入路。

结论

RAD-MATRIX研究可能有助于在急性冠状动脉综合征背景下比较经桡动脉和经股动脉入路时,阐明介入心脏病专家的辐射问题。

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