Alessandro Sciahbasi1, Enrico Frigoli2, Alessandro Sarandrea3, Martina Rothenbühler4, Paolo Calabrò5, Alessandro Lupi6, Francesco Tomassini7, Bernardo Cortese8, Stefano Rigattieri1, Enrico Cerrato7, Dennis Zavalloni9, Antonio Zingarelli10, Paolo Calabria11, Paolo Rubartelli12, Gennaro Sardella13, Matteo Tebaldi14, Stephan Windecker15, Peter Jüni4, Dik Heg4, Marco Valgimigli16. 1. Interventional Cardiology, Sandro Pertini Hospital, Rome, Italy. 2. Eustrategy Association, Forlì, Italy. 3. Department of Radiation Protection, HSE Management, Rome, Italy. 4. CTU Bern, and Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland. 5. Department of Cardio-Thoracic Sciences, Second University of Naples, Naples, Italy. 6. Cardiology, ASL VCO, Domodossola, Italy. 7. Department of Cardiology, Infermi Hospital, Rivoli, Italy. 8. Interventional Cardiology, Fatebenefratelli Hospital, Milan, Italy. 9. Humanitas Research Hospital, IRCCS, Rozzano, Italy. 10. Interventional Cardiology Unit, IRCCS AOU San Martino, IST, Genova, Italy. 11. Cardiology Unit, Misericordia Hospital, Grosseto, Italy. 12. Villa Scassi Hospital, Genova, Italy. 13. Department of Cardiovascular Sciences, Policlinico Umberto I, Rome, Italy. 14. Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy. 15. Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland. 16. Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland. Electronic address: marco.valgimigli@insel.ch.
Abstract
BACKGROUND: It remains unclear whether radial access increases the risk of operator or patient radiation exposure compared to transfemoral access when performed by expert operators. OBJECTIVES: This study sought to determine whether radial access increases radiation exposure. METHODS: A total of 8,404 patients, with or without ST-segment elevation acute coronary syndrome, were randomly assigned to radial or femoral access for coronary angiography and percutaneous intervention, and collected fluoroscopy time and dose-area product (DAP). RAD-MATRIX is a radiation sub-study of the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX) trial. We anticipated that 13 or more operators, each wearing a thorax (primary endpoint), wrist, and head (secondary endpoints) lithium fluoride thermoluminescent dosimeter, and randomizing at least 13 patients per access site, were needed to establish noninferiority of radial versus femoral access. RESULTS: Among 18 operators, performing 777 procedures in 767 patients, the noninferiority primary endpoint was not achieved (p value for noninferiority = 0.843). Operator equivalent dose at the thorax (77 μSv) was significantly higher with radial than femoral access (41 μSv; p = 0.02). After normalization of operator radiation dose by fluoroscopy time or DAP, the difference remained significant. Radiation dose at wrist or head did not differ between radial and femoral access. Thorax operator dose did not differ for right radial (84 μSv) compared to left radial access (52 μSv; p = 0.15). In the overall MATRIX population, fluoroscopy time and DAP were higher with radial compared to femoral access: 10 min versus 9 min (p < 0.0001) and 65 Gy·cm2 versus 59 Gy·cm2 (p = 0.0001), respectively. CONCLUSIONS: Compared to femoral access, radial access is associated with greater operator and patient radiation exposure when performed by expert operators in current practice. Radial operators and institutions should be sensitized towards radiation risks and adopt adjunctive radioprotective measures. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX; NCT101433627).
RCT Entities:
BACKGROUND: It remains unclear whether radial access increases the risk of operator or patient radiation exposure compared to transfemoral access when performed by expert operators. OBJECTIVES: This study sought to determine whether radial access increases radiation exposure. METHODS: A total of 8,404 patients, with or without ST-segment elevation acute coronary syndrome, were randomly assigned to radial or femoral access for coronary angiography and percutaneous intervention, and collected fluoroscopy time and dose-area product (DAP). RAD-MATRIX is a radiation sub-study of the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX) trial. We anticipated that 13 or more operators, each wearing a thorax (primary endpoint), wrist, and head (secondary endpoints) lithium fluoride thermoluminescent dosimeter, and randomizing at least 13 patients per access site, were needed to establish noninferiority of radial versus femoral access. RESULTS: Among 18 operators, performing 777 procedures in 767 patients, the noninferiority primary endpoint was not achieved (p value for noninferiority = 0.843). Operator equivalent dose at the thorax (77 μSv) was significantly higher with radial than femoral access (41 μSv; p = 0.02). After normalization of operator radiation dose by fluoroscopy time or DAP, the difference remained significant. Radiation dose at wrist or head did not differ between radial and femoral access. Thorax operator dose did not differ for right radial (84 μSv) compared to left radial access (52 μSv; p = 0.15). In the overall MATRIX population, fluoroscopy time and DAP were higher with radial compared to femoral access: 10 min versus 9 min (p < 0.0001) and 65 Gy·cm2 versus 59 Gy·cm2 (p = 0.0001), respectively. CONCLUSIONS: Compared to femoral access, radial access is associated with greater operator and patient radiation exposure when performed by expert operators in current practice. Radial operators and institutions should be sensitized towards radiation risks and adopt adjunctive radioprotective measures. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX; NCT101433627).
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