Author + information
- Received February 16, 2017
- Revision received March 8, 2017
- Accepted March 10, 2017
- Published online March 18, 2017.
- Alessandro Sciahbasi, MD, PhD1,
- Enrico Frigoli, MD2,
- Alessandro Sarandrea, Eng3,
- Martina Rothenbühler, M. Sc.4,
- Paolo Calabrò, MD, PhD5,
- Alessandro Lupi, MD6,
- Francesco Tomassini, MD7,
- Bernardo Cortese, MD8,
- Stefano Rigattieri, MD, PhD1,
- Enrico Cerrato, MD7,
- Dennis Zavalloni, MD9,
- Antonio Zingarelli, MD10,
- Paolo Calabria, MD11,
- Paolo Rubartelli, MD12,
- Gennaro Sardella, MD13,
- Matteo Tebaldi, MD14,
- Stephan Windecker, MD15,
- Peter Jüni, MD4,
- Dik Heg, PhD4 and
- Marco Valgimigli, MD, PhD15,∗ ()
- 1Interventional Cardiology, Sandro Pertini Hospital, ASL RM2, Rome, Italy
- 2Eustrategy Association, Forlì, Italy
- 3HSE Management, Rome, Italy
- 4CTU Bern, and Institute of Social and Preventive Medicine, University of Bern, Switzerland
- 5Department of Cardio-Thoracic Sciences, Second University of Naples, Italy
- 6Cardiology, ASL VCO, Domodossola, Italy
- 7Department of Cardiology, Infermi Hospital, Rivoli, Italy
- 8Interventional Cardiology, Fatebenefratelli Hospital, Milan, Italy
- 9Humanitas Research Hospital, IRCCS, Rozzano, Italy
- 10Interventional Cardiology Unit, IRCCS AOU San Martino, IST, Genova, Italy
- 11Cardiology Unit, Misericordia Hospital, Grosseto, Italy
- 12Villa Scassi Hospital, Genova, Italy
- 13Departmentof Cardiovascular Sciences, Policlinico Umberto I, Rome, Italy
- 14Cardiology Unit, AziendaOspedalieraUniversitaria di Ferrara, Italy
- 15Swiss Cardiovascular Center, Bern University Hospital, Switzerland
- ↵∗Address for correspondence: Dr. Marco Valgimigli Swiss Cardiovascular Center Bern Bern University Hospital 3010 Bern, Switzerland Telephone: +41 31 632 96 53 Fax: +41 31 632 47 71.
Background It remains unclear whether radial increases the risk of operator or patient radiation exposure when performed by expert operators
Objectives To determine whether radial access increases radiation exposure
Methods We randomly assigned 8404 patients, with or without ST-segment elevation acute coronary syndrome, to radial or femoral access for coronary angiography and percutaneous intervention, and collected fluoroscopy time and dose area product (DAP). In the radiation sub-study (RAD-MATRIX), we anticipated that 13 or more operators, each wearing a thorax (primary endpoint), wrist and head (secondary endpoints) lithium fluoride thermo luminescent dosimeter and randomizing at least 13 patients per access site were needed to establish non-inferiority of radial versus femoral access.
Results Among eighteen operators, performing 777 procedures in 767 patients, the non-inferiority primary endpoint was not achieved (p-value for non-inferiority=0.843). Operator equivalent dose at the thorax was significantly higher with radial than femoral access (77 μSv [IQR:40-112] vs. 41 μSv [IQR:23-59], 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 in the right radial (84 μSv [IQR:47-146]) compared to the left radial access (52 μSv [IQR:33-92]; p=0.15) In the overall MATRIX population, fluoroscopy time (10 min; IQR:6-16 vs. 9 min IQR:5-15; p<0.0001] and DAP—available in 7570 procedures and 6902 patients—(65 Gy*cm2 [IQR:29-120] vs. 59 Gy*cm2 [26-110]; p=0.0001) were higher with radial as compared to femoral access.
Conclusions Radial, as compared with femoral 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 radio-protective measures.
The MATRIX program is conducted with support from The Medicines Company and Terumo.
Conflicts of Interest
Dr. Rigattieri reports personal fees from Astra Zeneca, outside the submitted work; Dr. Cortese reports personal fees from The Medicines Company, during the conduct of the study; personal fees from Astra Zeneca, grants and personal fees from Abbott Vascular, grants, personal fees and non-financial support from AB Medica, grants and non-financial support from Innova HTS, grants and non-financial support from Kardia, grants and non-financial support from Stentys, grants from Hexacath, grants from Amgen, outside the submitted work; Dr. Windecker reports personal fees from ASTRA ZENECA, grants from Biotronik, grants and personal fees from Boston Scientific, personal fees from Daiichi Sankyo, grants from Edwards life sciences, grants from Medtronic, outside the submitted work; Dr.Jüni reports other from Abbott Vascular, other from Biosensors, other from Medtronic, other from Johnson & Johnson, other from Ablynx, other from Amgen, other from AstraZeneca, other from Boehringer-Ingelheim, other from Eisai, other from Eli Lilly, other from Exelixis, other from Geron, other from Gilead Sciences, other from Nestlé, other from Novartis, other from Novo Nordisc, other from Padma, other from Roche, other from Schering-Plough, other from St. Jude Medical, other from Swiss Cardio Technologies, outside the submitted work; and Unpaid steering committee or statistical executive committee member of trials funded by Abbott Vascular, Biosensors, Medtronic and Johnson & Johnson. Dr. Valgimigli reports grants from Terumo, grants from The Medicines Company, during the conduct of the study; grants and personal fees from Astra Zeneca, personal fees from Terumo, personal fees from Bayer, personal fees from Biosensors, outside the submitted work.
The other authors report nothing to disclose.
- Received February 16, 2017.
- Revision received March 8, 2017.
- Accepted March 10, 2017.