TY - JOUR
T1 - Angiography-derived physiology guidance vs usual care in an All-comers PCI population treated with the healing-targeted supreme stent and Ticagrelor monotherapy
T2 - PIONEER IV trial design
AU - Hara, Hironori
AU - Serruys, Patrick W.
AU - O'Leary, Neil
AU - Gao, Chao
AU - Murray, Alicia
AU - Breslin, Elaine
AU - Garg, Scot
AU - Bureau, Christophe
AU - Reiber, Johan H. C.
AU - Barbato, Emanuele
AU - Aminian, Adel
AU - Janssens, Luc
AU - Rosseel, Liesbeth
AU - Benit, Edouard
AU - Campo, Gianluca
AU - Guiducci, Vincenzo
AU - Casella, Gianni
AU - Santarelli, Andrea
AU - Franzè, Alfonso
AU - Diaz, Victor Alfonso Jimenez
AU - Iñiguez, Andrés
AU - Brugaletta, Salvatore
AU - Sabate, Manel
AU - Amat-Santos, Ignacio J.
AU - Amoroso, Giovanni
AU - Wykrzykowska, Joanna
AU - von Birgelen, Clemens
AU - Somi, Samer
AU - Liu, Tommy
AU - Hofma, Sjoerd H.
AU - Curzen, Nick
AU - Trillo, Ramiro
AU - Ocaranza, Raymundo
AU - Mathur, Anthony
AU - Smits, Pieter C.
AU - Escaned, Javier
AU - Baumbach, Andreas
AU - Wijns, William
AU - PIONEER IV trial investigator
AU - Sharif, Faisal
AU - Onuma, Yoshinobu
N1 - Funding Information: Dr Hara reports a grant for studying overseas from Japanese Circulation Society, a grant-in-Aid for JSPS Fellows, a grant-in-aid from Japan Foundation for Applied Enzymology, and a grant from Fukuda Foundation for Medical Technology. Dr Serruys reports personal fees from, Philips/Volcano, Xeltis, Novartis, Meril Life, and SMT outside the submitted work. AlchiMedics SAS received payments from Sinomed in previous work linked to the development of the BuMA, BuMA Supreme and HT Supreme DES. The eG technology and the coating of the HT Supreme DES are protected by patents owned by AlchiMedics SAS. AlchiMedics SAS is a fully owned subsidiary of Sinomed, sponsor of the Pioneer IV study and manufacturer of the HT Supreme DES. Dr Bureau is an employee of Sinomed, sponsor of the Pioneer IV study and manufacturer of the HT Supreme DES. Dr Reiber is CSO at Medis Medical Imaging Systems bv, and has equity. Dr Campo reports grants from SMT, grants from SIEMENS, grants from MEDIS, grants from BOSTON SCIENTIFIC, outside the submitted work. Dr Sabaté reports consultant fees from Abbott Vascular and Ivascular outside the submitted work. Dr von Birgelen reported institutional research grants to the research department of Thoraxcentrum Twente from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic, outside the submitted work. Dr van Geuns reports grants and personal fees from Abbott, grants from Amgen, personal fees from Sanofi, grants from InfraRedx, outside the submitted work. Dr Hofma reports institutional research grants to the department of Cardiology by Abbott Vascular, outside the submitted work. Dr Curzen reports unrestricted grants from Boston Scientific, HeartFlow and Beckmann Coulter, speaker fees/consultancy from Boston Scientific, HeartFLow, Edwards and Abbott, outside the submitted work. Dr Baumbach reports personal fees from Microport, personal fees from Sinomed, grants and personal fees from Abbot Vascular, personal fees from KSH, personal fees from Medtronic, outside the submitted work. Dr Wijns has received institutional research grants and honoraria from MicroPort, outside this study; medical advisor of Rede Optimus Research and co-founder of Argonauts, an innovation facilitator. All other authors have no conflict of interest to declare. Funding Information: The PIONEER IV trial is an investigator-initiated trial sponsored by The National University of Ireland Galway, which received funding from SINOMED (Tianjin, China). Publisher Copyright: © 2022
PY - 2022/4/1
Y1 - 2022/4/1
N2 - Background: Current ESC guidelines recommend the use of intra-coronary pressure guidewires for functional assessment of intermediate-grade coronary stenoses. Angiography-derived quantitative flow ratio (QFR) is a novel method of assessing these stenoses, and guiding percutaneous coronary intervention (PCI). Methods/Design: The PIONEER IV trial is a prospective, all-comers, multi-center trial, which will randomize 2,540 patients in a 1:1 ratio to PCI guided by angiography-derived physiology or usual care, with unrestricted use in both arms of the Healing-Targeted Supreme sirolimus-eluting stent (HT Supreme). The stent's fast, biologically healthy, and robust endothelial coverage allows for short dual-antiplatelet therapy (DAPT); hence the antiplatelet regimen of choice is 1-month DAPT, followed by ticagrelor monotherapy. In the angiography-derived physiology guided arm, lesions will be functionally assessed using on-line QFR, with stenting indicated in lesions with a QFR ≤0.80. Post-stenting, QFR will be repeated in the stented vessel(s), with post-dilatation or additional stenting recommended if the QFR<0.91 distal to the stent, or if the delta QFR (across the stent) is >0.05. Usual care PCI is performed according to standard clinical practice. The primary endpoint is a non–inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization with a non–inferiority risk-difference margin of 3.2%, at 1-year post-procedure. Clinical follow-up will be up to 3 years. The PIONEER IV trial aims to demonstrate non–inferiority of QFR-guided PCI to usual care PCI with respect to POCE at 1-year in patients treated with HT Supreme stents and ticagrelor monotherapy. Clinical Trial Registration: ClinicalTrials.gov
AB - Background: Current ESC guidelines recommend the use of intra-coronary pressure guidewires for functional assessment of intermediate-grade coronary stenoses. Angiography-derived quantitative flow ratio (QFR) is a novel method of assessing these stenoses, and guiding percutaneous coronary intervention (PCI). Methods/Design: The PIONEER IV trial is a prospective, all-comers, multi-center trial, which will randomize 2,540 patients in a 1:1 ratio to PCI guided by angiography-derived physiology or usual care, with unrestricted use in both arms of the Healing-Targeted Supreme sirolimus-eluting stent (HT Supreme). The stent's fast, biologically healthy, and robust endothelial coverage allows for short dual-antiplatelet therapy (DAPT); hence the antiplatelet regimen of choice is 1-month DAPT, followed by ticagrelor monotherapy. In the angiography-derived physiology guided arm, lesions will be functionally assessed using on-line QFR, with stenting indicated in lesions with a QFR ≤0.80. Post-stenting, QFR will be repeated in the stented vessel(s), with post-dilatation or additional stenting recommended if the QFR<0.91 distal to the stent, or if the delta QFR (across the stent) is >0.05. Usual care PCI is performed according to standard clinical practice. The primary endpoint is a non–inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization with a non–inferiority risk-difference margin of 3.2%, at 1-year post-procedure. Clinical follow-up will be up to 3 years. The PIONEER IV trial aims to demonstrate non–inferiority of QFR-guided PCI to usual care PCI with respect to POCE at 1-year in patients treated with HT Supreme stents and ticagrelor monotherapy. Clinical Trial Registration: ClinicalTrials.gov
UR - http://www.scopus.com/inward/record.url?scp=85123382782&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.ahj.2021.12.018
DO - https://doi.org/10.1016/j.ahj.2021.12.018
M3 - Article
C2 - 34990582
SN - 0002-8703
VL - 246
SP - 32
EP - 43
JO - American Heart Journal
JF - American Heart Journal
ER -