Comparing angiography-derived guidance to usual care in patients with coronary artery disease

Non-inferiority of Angiography-derived Physiology Guidance Versus Usual Care in an All-comers PCI Population Treated With Unrestricted Use of the Healing-Targeted Supreme (HT Supreme) Drug-eluting Stent and P2Y12 Inhibitor Monotherapy After 1-month of Dual-antiplatelet Therapy

This study is testing if using special imaging guidance during heart procedures helps people with coronary artery disease do better than just following standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2540 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National University of Ireland, Galway, Ireland (Academic / other)
• Locations: 19 sites (Aalst and 18 other locations)
• Trial ID: NCT04923191 on ClinicalTrials.gov

What this trial studies

PIONEER-IV is a prospective, single-blind, randomized study that evaluates clinical outcomes in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). Participants will be assigned to either receive angiography-derived physiology guidance or standard care during their treatment. The study aims to include approximately 2540 patients, all of whom will initially receive dual antiplatelet therapy followed by a year of P2Y12 inhibitor monotherapy. The goal is to assess the effectiveness of the different guidance methods in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include patients with chronic stable angina, acute coronary syndromes, or silent ischemia who have significant coronary artery stenoses.

Not a fit: Patients who are pregnant or nursing, or those with contraindications to the study interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved clinical outcomes for patients undergoing PCI by optimizing treatment strategies.

How similar studies have performed: Other studies have shown promise in using angiography-derived guidance for PCI, suggesting that this approach may be beneficial.

Eligibility criteria

Inclusion Criteria:

* Patient has chronic stable angina, acute coronary syndromes or silent ischemia;
* Presence of one or more coronary artery stenoses of ≥50% (by visual assessment) in a native coronary artery (with or without prior stent/other device treatment) or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation;
* The vessel should have a reference vessel diameter of at least 2.25 mm by visual assessment (no limitation on the number of treated lesions, vessels, or lesion length);
* Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee and is willing to comply with all protocol-required (follow-up) evaluations.

Exclusion Criteria:

1. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice);
2. Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors;
3. Planned major elective surgery requiring discontinuation of (dual)anti platelet therapy (DAPT) within 12 months of procedure;
4. Concurrent medical condition with a life expectancy of less than 3 years;
5. Currently participating in another trial and not yet at its primary endpoint;
6. Active pathological bleeding;
7. History of intracranial haemorrhage.

Where this trial is running

Aalst and 18 other locations

• ASZ Aalst — Aalst, Belgium (Recruiting)
• OLVZ Aalst — Aalst, Belgium (Recruiting)
• Imelda Ziekenhuis — Bonheiden, Belgium (Recruiting)
• CHU Charleroi — Charleroi, Belgium (Recruiting)
• Jessa Hospital Hasselt — Hasselt, Belgium (Recruiting)
• University Hospital Galway — Galway, Ireland (Recruiting)
• OLVG Amsterdam — Amsterdam, Netherlands (Recruiting)
• Medisch Spectrum Twente, Thoraxcentrum, Endchede — Enschede, Netherlands (Recruiting)
• UMC Groningen — Groningen, Netherlands (Recruiting)
• Medisch Centrum Leeuwarden — Leeuwarden, Netherlands (Recruiting)
• Maasstad Ziekenhuis — Rotterdam, Netherlands (Recruiting)
• Den Haag Ziekenhuis — The Hague, Netherlands (Recruiting)
• Hospital Clínico de Barcelona — Barcelona, Spain (Recruiting)
• Lucas Augusti Hospital — Lugo, Spain (Recruiting)
• Hospital Clínico Universitario of Valladolid — Valladolid, Spain (Recruiting)
• Hospital Álvaro Cunqueiro Vigo — Vigo, Spain (Recruiting)
• Barts Health NHS Trust, London — London, United Kingdom (Recruiting)
• Freeman Hospital — Newcastle, United Kingdom (Recruiting)
• University Hospitals Southampton — Southampton, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Patrick W Serruys, MD

Conditions Coronary Artery Disease; coronary artery disease; ischemia; quantitative flow ratio; P2Y12 monotherapy; drug-eluting stent; physiology guidance; angio-FFR