作者
Hironori Hara,Patrick W. Serruys,Neil O’Leary,Chao Gao,Alicia Murray,Elaine Breslin,Scot Garg,Christophe Bureau,Johan H. C. Reiber,Emanuele Barbato,Abdel Aminian,Luc Janssens,Liesbeth Rosseel,Edouard Benit,Gianluca Campo,Vincenzo Guiducci,Gianni Casella,Andrea Santarelli,Alfonso Franzè,Víctor Alfonso Jiménez Díaz,Andrés Íñiguez,Salvatore Brugaletta,Manel Sabaté,Ignacio J. Amat‐Santos,Giovanni Amoroso,Joanna J. Wykrzykowska,Clemens von Birgelen,Samer Somi,Tommy Liu,Sjoerd H. Hofma,Nick Curzen,Ramiro Trillo,Raymundo Ocaranza,Anthony Mathur,Pieter C. Smits,Javier Escaned,Andreas Baumbach,William Wijns,Faisal Sharif,NULL AUTHOR_ID
摘要
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).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.ClinicalTrials.gov UNIQUE IDENTIFIER: NCT04923191 CLASSIFICATIONS: Interventional Cardiology.