MedicalResearch.com Interview with:
Dr. Marco Valgimigli, MD, PhD
Sandro Pertini Hospital, ASL RM2, Rome, Italy
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Every year millions of people with coronary artery disease are treated worldwide with percutaneous coronary intervention (PCI). Radial access as compared to femoral access reduces bleeding and mortality in patients with acute coronary syndrome (ACS) undergoing invasive management. However, prior studies have raised concerns over the increased risk of radiation exposure for both patients and operators with radial instead of femoral access and it remains still unclear whether radial access increases the risk of operator or patient radiation exposure in contemporary practice when performed by expert operators.
The MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) trial is the largest randomized trial comparing radial versus femoral access in ACS patients undergoing invasive management. In this radiation sub-study (RAD-MATRIX), we collected fluoroscopy time and dose area product (DAP) and equipped radial operators consenting to participate with dedicated dosimeters, each wearing a thorax (primary endpoint), wrist and head (secondary endpoints) lithium fluoride thermo luminescent dosimeter, during study conduct to establish non-inferiority of radial versus femoral access.
Among eighteen operators, performing 777 procedures in 767 patients, the non-inferiority primary endpoint was not achieved. Operator equivalent dose at the thorax was significantly higher with radial than femoral access. 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 in the right radial compared to the left radial access. In the overall MATRIX population, fluoroscopy time and DAP were higher with radial as compared to femoral access.
MedicalResearch.com: What should readers take away from your report?
Response: In this clinical trial that included 8404 patients and 18 radial expert operators equipped with dedicated dosimeters, performing 777 procedures and 767 patients, radial, as compared with femoral access is associated with greater operator and patient radiation exposure.
The take-home message of our analysis is that radial operators and institutions should be sensitized towards radiation risks and adopt adjunctive radio-protective measures.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: The inclusion of 18 experienced operators from different centers likely provided a representative sample of current practice with radial access, but cannot be translated to less experienced operators or operators with limited training in the radial access site.
The null finding of right versus left right radial comparison in terms of operator exposure may reflect a power issue and requires further investigation.
However, future research should be mainly focused to effectively reduce the radiation exposure for radial operators.
MedicalResearch.com: Is there anything else you would like to add?
Response: MATRIX trial enrolled 8404 patients from October 11, 2011, to November 7, 2014, at 78 centers in Italy, the Netherlands, Spain, and Sweden, representing thus the contemporary clinical practice in Europe. The trial was designed by the principal investigator (MV), sponsored by the Italian Society of Interventional Cardiology (SICI-Gruppo Italiano Studi Emodinamica, GISE), a non-profit organization, and received grant support from The Medicines Company and TERUMO, however, sponsors and companies had no role in study design, data collection, data monitoring, analysis, interpretation, or writing of the study results
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