Financial
News release
TopLeuven, Belgium – June 15, 2022 – Terumo Europe N.V., a leading medical device company, announces the publication of the DIStal versus COnventional RADIAL access (DISCO RADIAL) clinical trial. DISCO RADIAL is the first large international randomized study designed to compare distal access over conventional radial access with respect to the incidence of radial artery occlusion (RAO) while systematically implementing best practices to reduce RAO.
Transradial access (TRA) is the standard vascular approach for coronary angiography and intervention recommended by both the ESC/EACTS1,2 and ACC/AHA/SCAI Guidelines3. However, real-world incidence of RAO remains high and prevents further percutaneous coronary or non-coronary procedure using radial access. Recently, distal radial access (DRA) from the anatomical snuffbox on the dorsal side of the hand has emerged as an alternative access to conventional TRA to reduce the occurrence of RAO.
Patients from 16 centers across Europe and Japan undergoing a coronary angiography and/or intervention were randomized to TRA (n=657) or DRA (n=650). 6Fr Glidesheath Slender™ was used as the default sheath for both TRA and DRA (>99%). More than 96% of TRA patients received TR Band™ with patent hemostasis implemented according to the PROPHET protocol4, while hemostasis was per hospital practice for DRA patients. Forearm RAO did not differ between groups (0.91% vs 0.31%, p=0.29: TRA and DRA respectively). While showing no difference in the primary endpoint, this exceptionally low incidence of RAO highlights the importance of a rigorous hemostasis protocol and sets a new benchmark for conventional TRA.
Vascular access in the DRA group showed a higher crossover rate (3.5% vs 7.4%, p=0.002) and a higher spasm rate (2.7% vs 5.4%, p=0.015) compared to the TRA group. However, DRA was associated with a shorter hemostasis time than TRA (180 vs 153 min, p<0.001). A similarly low rate of vascular complications and mostly trivial puncture site-related bleedings was reported for both groups.
DISCO RADIAL results bring additional evidence to support conventional TRA as the gold standard for vascular access as well as the relevance of the implementation of best practice recommendations for RAO avoidance. Moreover, it supports DRA as a valid alternative to conventional TRA.
Principal investigator Dr Saito, Interventional Cardiologist from Shonan Kamakura General Hospital, Japan, commented: “The outcomes of the DISCO RADIAL support distal radial approach as a valid alternative to conventional radial access, supporting shorter and simpler hemostasis. This study offers the choice to opt for conventional or distal radial access depending on physician’s preference and experience and opens the door for further research projects to advance radial access and the prevention of radial artery occlusion.”
Principal investigator Dr Aminian, Interventional Cardiologist from Centre Hospitalier Universitaire de Charleroi, Belgium, said: “The results of the DISCO RADIAL study establish compliance to best practice recommendations for RAO avoidance as a mandatory new reference in transradial practice. At the same time, distal radial artery arises as a valid alternative associated with higher crossover rates, but with a simpler and shorter hemostasis process."
Mrs Ghada Farah, Senior Vice President of Terumo Interventional System EMEA commented: “Terumo’s commitment to improve patient outcomes is underscored by our sponsorship of this large-scale international study assessing two radial access methods. Those results, published 30 years after the first radial PCI was performed, reflect Terumo’s contribution to further support the radial-first strategy all around the world.”
For more details, discover the study published in the Journal of the American College of Cardiology, on May 17th, or watch Dr Aminian’s presentation during the “New insights from clinical trials in coronary artery disease” session at EuroPCR 2022.
Transradial access (TRA) is the standard vascular approach for coronary angiography and intervention recommended by both the ESC/EACTS1,2 and ACC/AHA/SCAI Guidelines3. However, real-world incidence of RAO remains high and prevents further percutaneous coronary or non-coronary procedure using radial access. Recently, distal radial access (DRA) from the anatomical snuffbox on the dorsal side of the hand has emerged as an alternative access to conventional TRA to reduce the occurrence of RAO.
Patients from 16 centers across Europe and Japan undergoing a coronary angiography and/or intervention were randomized to TRA (n=657) or DRA (n=650). 6Fr Glidesheath Slender™ was used as the default sheath for both TRA and DRA (>99%). More than 96% of TRA patients received TR Band™ with patent hemostasis implemented according to the PROPHET protocol4, while hemostasis was per hospital practice for DRA patients. Forearm RAO did not differ between groups (0.91% vs 0.31%, p=0.29: TRA and DRA respectively). While showing no difference in the primary endpoint, this exceptionally low incidence of RAO highlights the importance of a rigorous hemostasis protocol and sets a new benchmark for conventional TRA.
Vascular access in the DRA group showed a higher crossover rate (3.5% vs 7.4%, p=0.002) and a higher spasm rate (2.7% vs 5.4%, p=0.015) compared to the TRA group. However, DRA was associated with a shorter hemostasis time than TRA (180 vs 153 min, p<0.001). A similarly low rate of vascular complications and mostly trivial puncture site-related bleedings was reported for both groups.
DISCO RADIAL results bring additional evidence to support conventional TRA as the gold standard for vascular access as well as the relevance of the implementation of best practice recommendations for RAO avoidance. Moreover, it supports DRA as a valid alternative to conventional TRA.
Principal investigator Dr Saito, Interventional Cardiologist from Shonan Kamakura General Hospital, Japan, commented: “The outcomes of the DISCO RADIAL support distal radial approach as a valid alternative to conventional radial access, supporting shorter and simpler hemostasis. This study offers the choice to opt for conventional or distal radial access depending on physician’s preference and experience and opens the door for further research projects to advance radial access and the prevention of radial artery occlusion.”
Principal investigator Dr Aminian, Interventional Cardiologist from Centre Hospitalier Universitaire de Charleroi, Belgium, said: “The results of the DISCO RADIAL study establish compliance to best practice recommendations for RAO avoidance as a mandatory new reference in transradial practice. At the same time, distal radial artery arises as a valid alternative associated with higher crossover rates, but with a simpler and shorter hemostasis process."
Mrs Ghada Farah, Senior Vice President of Terumo Interventional System EMEA commented: “Terumo’s commitment to improve patient outcomes is underscored by our sponsorship of this large-scale international study assessing two radial access methods. Those results, published 30 years after the first radial PCI was performed, reflect Terumo’s contribution to further support the radial-first strategy all around the world.”
For more details, discover the study published in the Journal of the American College of Cardiology, on May 17th, or watch Dr Aminian’s presentation during the “New insights from clinical trials in coronary artery disease” session at EuroPCR 2022.
1 Roffi M et al. Eur Heart J 2016;37:267–315
2 Neumann FJ et al. Eur Heart J 2019;40:87–165;
3 Lawton J.S. et al. Circulation. 2022;145:e18–e114
4 Pancholy S. et al. Catheter Cardiovasc Interv. 2008;72:335–340.
About Terumo Europe
Terumo Europe N.V., founded in 1971, is a core player in the EMEA healthcare market by providing best in class quality medical products and services. We are a strong actor of the Terumo Group by contributing to innovation and sustainable growth. Terumo Europe produces, distributes, markets and sells a vast range of medical devices in four main business units: Hospital and Laboratory Systems, Global Pharmaceutical Solutions, Interventional Systems and Cardiovascular Products. Terumo Europe EMEA headquarters and production facilities are located in Haasrode (Belgium), production facility in Knowsley (UK) and sales units across EMEA.
www.terumo-europe.com
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About Terumo
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.