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.
Am Heart J
; 246: 32-43, 2022 04.
Article
in En
| MEDLINE
| ID: mdl-34990582
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 2,540 patients in a 11 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.
Full text:
1
Database:
MEDLINE
Main subject:
Coronary Artery Disease
/
Drug-Eluting Stents
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Percutaneous Coronary Intervention
Type of study:
Clinical_trials
/
Guideline
/
Observational_studies
/
Risk_factors_studies
Limits:
Humans
Language:
En
Journal:
Am Heart J
Year:
2022
Type:
Article
Affiliation country:
Ireland