Adel Aminian1, Gregory A Sgueglia2, Marcus Wiemer3, Gabriele Luigi Gasparini4, Joelle Kefer5, Zoltan Ruzsa6, Maarten A H van Leeuwen7, Bert Vandeloo8, Claudiu Ungureanu9, Sasko Kedev10, Juan F Iglesias11, Gregor Leibundgut12, Karim Ratib13, Ivo Bernat14, Irene Barriocanal15, Vladimir Borovicanin15, Shigeru Saito16. 1. Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium. Electronic address: adaminian@hotmail.com. 2. Division of Cardiology, Sant'Eugenio Hospital, Rome, Italy. 3. Department of Cardiology and Intensive Care, Johannes Wesling University Hospital Ruhr University Bochum, Minden, Germany. 4. Humanitas Clinical and Research Center, IRCCS, Rozzano-Milan, Italy. 5. Division of Cardiology, Cliniques Universitaires Saint-Luc, Brussels, Belgium. 6. Department of Internal Medicine, Invasive Cardiology Division, University of Szeged, Medical Faculty, Szeged, Hungary; Cardiology Division, Bács-Kiskun County Hospital, Invasive Cardiology, Kecskemét, Hungary. 7. Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands. 8. Department of Cardiology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel (VUB), Brussels, Belgium. 9. Department of Cardiology, Jolimont Hospital, La Louvière, Belgium. 10. Interventional Cardiology Department, University Clinic of Cardiology, Skopje, Macedonia. 11. Department of Cardiology, Geneva University Hospital, Geneva, Switzerland. 12. Kantonsspital Baselland, Liestal, Switzerland. 13. Centre for Prognosis Research, Keele Cardiovascular Research Group, Institute for Primary Care and Health Sciences, Keele University, United Kingdom. 14. Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Charles University, Pilsen, Czech Republic. 15. European Medical and Clinical Division, Terumo Europe N.V., Leuven, Belgium. 16. Department of Cardiology, Shonan Kamakura General Hospital, Kanagawa, Japan.
Abstract
BACKGROUND: Transradial access (TRA) has become the default access method for coronary diagnostic and interventional procedures. As compared to transfemoral access, TRA has been shown to be safer, cost-effective and more patient-friendly. Radial artery occlusion (RAO) represents the most frequent complication of TRA, and precludes future coronary procedures through the radial artery, the use of the radial artery as a conduit for coronary artery bypass grafting or as arteriovenous fistula for patients on hemodialysis. Recently, distal radial access (DRA) has emerged as a promising alternative to TRA, yielding potential for minimizing the risk of RAO. However, an international multicenter randomized comparison between DRA, and conventional TRA with respect to the rate of RAO is still lacking. TRIAL DESIGN: DISCO RADIAL is a prospective, multicenter, open-label, randomized, controlled, superiority trial. A total of 1300 eligible patients will be randomly allocated to undergo coronary angiography and/or percutaneous coronary intervention (PCI) through DRA or TRA using the 6 Fr Glidesheath Slender sheath introducer. Extended experience with both TRA and DRA is required for operators' eligibility and optimal evidence-based best practice to reduce RAO systematically implemented by protocol. The primary endpoint is the incidence of forearm RAO assessed by vascular ultrasound at discharge. Several important secondary endpoints will also be assessed, including access-site cross-over, hemostasis time, and access-site related complications. SUMMARY: The DISCO RADIAL trial will provide the first large-scale multicenter randomized evidence comparing DRA to TRA in patients scheduled for coronary angiography or PCI with respect to the incidence of RAO at discharge.
BACKGROUND: Transradial access (TRA) has become the default access method for coronary diagnostic and interventional procedures. As compared to transfemoral access, TRA has been shown to be safer, cost-effective and more patient-friendly. Radial artery occlusion (RAO) represents the most frequent complication of TRA, and precludes future coronary procedures through the radial artery, the use of the radial artery as a conduit for coronary artery bypass grafting or as arteriovenous fistula for patients on hemodialysis. Recently, distal radial access (DRA) has emerged as a promising alternative to TRA, yielding potential for minimizing the risk of RAO. However, an international multicenter randomized comparison between DRA, and conventional TRA with respect to the rate of RAO is still lacking. TRIAL DESIGN: DISCO RADIAL is a prospective, multicenter, open-label, randomized, controlled, superiority trial. A total of 1300 eligible patients will be randomly allocated to undergo coronary angiography and/or percutaneous coronary intervention (PCI) through DRA or TRA using the 6 Fr Glidesheath Slender sheath introducer. Extended experience with both TRA and DRA is required for operators' eligibility and optimal evidence-based best practice to reduce RAO systematically implemented by protocol. The primary endpoint is the incidence of forearm RAO assessed by vascular ultrasound at discharge. Several important secondary endpoints will also be assessed, including access-site cross-over, hemostasis time, and access-site related complications. SUMMARY: The DISCO RADIAL trial will provide the first large-scale multicenter randomized evidence comparing DRA to TRA in patients scheduled for coronary angiography or PCI with respect to the incidence of RAO at discharge.
Authors: Alexandru Achim; Kornél Kákonyi; Zoltán Jambrik; Ferenc Nagy; Julia Tóth; Viktor Sasi; Péter Hausinger; Attila Nemes; Albert Varga; Olivier F Bertrand; Zoltán Ruzsa Journal: J Clin Med Date: 2021-12-20 Impact factor: 4.241