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)

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

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.

Trial registration: ClinicalTrials.gov NCT01433627.

Keywords: Dosimetry; Percutaneous coronary intervention; Radiation; Transradial.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Absorption, Radiation
  • Acute Coronary Syndrome / diagnostic imaging*
  • Acute Coronary Syndrome / therapy*
  • Anticoagulants / adverse effects
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / methods*
  • Catheterization, Peripheral / adverse effects
  • Catheterization, Peripheral / methods*
  • Clinical Protocols
  • Coronary Angiography* / adverse effects
  • Europe
  • Femoral Artery / diagnostic imaging*
  • Hemorrhage / etiology
  • Hemorrhage / prevention & control*
  • Heparin / adverse effects
  • Hirudins / adverse effects
  • Humans
  • Occupational Exposure* / adverse effects
  • Occupational Health
  • Peptide Fragments / adverse effects
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / methods*
  • Prospective Studies
  • Radial Artery / diagnostic imaging*
  • Radiation Dosage*
  • Radiography, Interventional* / adverse effects
  • Recombinant Proteins / adverse effects
  • Research Design*
  • Risk Factors
  • Thermoluminescent Dosimetry
  • Time Factors
  • Treatment Outcome

Substances

  • Anticoagulants
  • Hirudins
  • Peptide Fragments
  • Recombinant Proteins
  • Heparin
  • bivalirudin

Associated data

  • ClinicalTrials.gov/NCT01433627