Angiography-derived physiology guidance vs usual care in an All-comers PCI population treated with the healing-targeted supreme stent and Ticagrelor monotherapy: PIONEER IV trial design - 07/03/22
, Neil O'Leary, PhD d, Chao Gao, MD b, e, f, Alicia Murray, PhD d, Elaine Breslin, PhD d, Scot Garg, MD, PhD g, Christophe Bureau, PhD h, Johan HC Reiber, PhD i, Emanuele Barbato, MD, PhD j, Adel Aminian, MD k, Luc Janssens, MD l, Liesbeth Rosseel, MD m, Edouard Benit, MD n, Gianluca Campo, MD o, Vincenzo Guiducci, MD p, Gianni Casella, MD q, Andrea Santarelli, MD r, Alfonso Franzè, MD s, Victor Alfonso Jimenez Diaz, MD t, Andrés Iñiguez, MD, PhD t, u, Salvatore Brugaletta, MD, PhD v, Manel Sabate, MD, PhD v, Ignacio J. Amat-Santos, MD, PhD w, Giovanni Amoroso, MD x, Joanna Wykrzykowska, MD, PhD y, Clemens von Birgelen, MD, PhD z, aa, Samer Somi, MD, PhD ab, Tommy Liu, MD ab, Sjoerd H. Hofma, MD, PhD ac, Nick Curzen, BM(hons), PhD ad, Ramiro Trillo, MD ae, Raymundo Ocaranza, MD af, Anthony Mathur, MD, PhD ag, ah, Pieter C. Smits, MD, PhD ai, Javier Escaned, MD, PhD aj, Andreas Baumbach, MD, PhD ah, ak, al, William Wijns, MD, PhD am, Faisal Sharif, MD, PhD b, an, Yoshinobu Onuma, MD, PhD bOn behalf of the
PIONEER IV trial investigator
Résumé |
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.
Summary |
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
Unique Identifier |
NCT04923191
Classifications |
Interventional Cardiology
Le texte complet de cet article est disponible en PDF.Abbreviations : CAD, CEC, DAPT, DSMB, DOCE, FFR, HR, iFR, IVUS, MI, NOAC, OCT, PCI, POCE, QCA, QFR, SES, STEMI, TVF, VOCE
Plan
Vol 246
P. 32-43 - avril 2022 Retour au numéro
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