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 2540 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.

Angiography-derived physiology guidance versus usual care in an All-comers PCI population treated with the Healing-Targeted Supreme stent and Ticagrelor monotherapy: PIONEER IV trial design

Campo, Gianluca;Casella, Gianni;
2022

Abstract

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 2540 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.
Hara, Hironori; Serruys, Patrick W; O'Leary, Neil; Gao, Chao; Murray, Alicia; Breslin, Elaine; Garg, Scot; Bureau, Christophe; Reiber, Johan Hc; Barbato, Emanuele; Aminian, Abdel; Janssens, Luc; Rosseel, Liesbeth; Benit, Edouard; Campo, Gianluca; Guiducci, Vincenzo; Casella, Gianni; Santarelli, Andrea; Franzè, Alfonso; Diaz, Victor Alfonso Jimenez; Iñiguez, Andres; Brugaletta, Salvatore; Sabate, Manel; Amat-Santos, Ignacio J; Amoroso, Giovanni; Wykrzykowska, Joanna; von Birgelen, Clemens; Somi, Samer; Liu, Tommy; Hofma, Sjoerd H; Curzen, Nick; Trillo, Ramiro; Ocaranza, Raymundo; Mathur, Anthony; Smits, Pieter C; Escaned, Javier; Baumbach, Andreas; Wijns, William; Sharif, Faisal
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11392/2472362
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