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

Hara, H.; Serruys, P. W.; O'Leary, N.; Gao, C.; Murray, A.; Breslin, E.; Garg, S.; Bureau, C.; Reiber, J. H.; Barbato, E.; Aminian, A.; Janssens, L.; Rosseel, L.; Benit, E.; Campo, G.; Guiducci, V.; Casella, G.; Santarelli, A.; Franze, A.; Diaz, V. A. J.; Iniguez, A.; Brugaletta, S.; Sabate, M.; Amat-Santos, I. J.; Amoroso, G.; Wykrzykowska, J.; von Birgelen, C.; Somi, S.; Liu, T.; Hofma, S. H.; Curzen, N.; Trillo, R.; Ocaranza, R.; Mathur, A.; Smits, P. C.; Escaned, J.; Baumbach, A.; Wijns, W.; Sharif, F.; Onuma, Y.

doi:10.1016/j.ahj.2021.12.018

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 Unique Identifier: NCT04923191 Classifications: Interventional Cardiology

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 / Hara, H.; Serruys, P. W.; O'Leary, N.; Gao, C.; Murray, A.; Breslin, E.; Garg, S.; Bureau, C.; Reiber, J. H.; Barbato, E.; Aminian, A.; Janssens, L.; Rosseel, L.; Benit, E.; Campo, G.; Guiducci, V.; Casella, G.; Santarelli, A.; Franze, A.; Diaz, V. A. J.; Iniguez, A.; Brugaletta, S.; Sabate, M.; Amat-Santos, I. J.; Amoroso, G.; Wykrzykowska, J.; von Birgelen, C.; Somi, S.; Liu, T.; Hofma, S. H.; Curzen, N.; Trillo, R.; Ocaranza, R.; Mathur, A.; Smits, P. C.; Escaned, J.; Baumbach, A.; Wijns, W.; Sharif, F.; Onuma, Y.. - In: AMERICAN HEART JOURNAL. - ISSN 0002-8703. - 246:(2022), pp. 32-43. [10.1016/j.ahj.2021.12.018]