Coronary Artery Disease
Conditions
Keywords
coronary artery disease, ischemia, quantitative flow ratio (QFR), P2Y12 monotherapy, drug-eluting stent, physiology guidance, angio-FFR, Coronary Angiography-derived FFR (caFFR)
Brief summary
PIONEER-IV is a prospective, single-blind (patient), randomized, 1:1, controlled, multi-center study comparing clinical outcomes between angiography-derived physiology guidance to LRDP and usual care in an all-comers patient population (including patients with high bleeding risk, HBR) undergoing PCI with unrestrictive use of the HT Supreme sirolimus-eluting stent. Patients will be randomized to either angio-based physiology guidance angio-FFR (Quantitative Flow Ratio and coronary angiography-derived FFR, caFFR) or local routine diagnostic procedure (LRDP) and usual care. Patients will be treated with 1-year P2Y12 inhibitor monotherapy after 1-month of dual-antiplatelet therapy in approximately 2540 (2\*1270) patients. All patients (both cohorts) must receive dual anti-platelet therapy, being aspirin (ASA) and ticagrelor for 1 month, followed by 11 months of ticagrelor only (i.e. monotherapy). At 1 year, ticagrelor monotherapy is replaced by aspirin monotherapy or left to the discretion of the operator.
Interventions
OTHERAngiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care
percutaneous coronary intervention
Sponsors
National University of Ireland, Galway, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-oriented Composite Endpoint (PoCE) | 12 months | PoCE is a composite clinical endpoint of: * all-cause death; * any stroke, Modified Rankin scale, (MRS ≥1); * any myocardial infarction; * any clinically and physiologically driven revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device-oriented composite endpoint (DoCE) | 12, 24 and 36 months | DoCE is a composite endpoint of: * Cardiovascular Death * Target-vessel related MI * Clinically and physiologically-oriented Target lesion revascularization |
| Myocardial Infarction (MI) | 48 hours post-procedure | Peri-procedure Myocardial Infarction according to 4th universal definition |
| Device Success Rate | index procedure | according to the statement from European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology (ESC) |
| Vessel-oriented composite endpoints (VoCE) | 12, 24 and 36 months | VoCE is a composite clinical endpoint of: * Vessel-related cardiovascular Death * Target-vessel related MI * Clinically and physiologically-oriented Target vessel revascularization |
| Target Vessel Failure (TVF) | 12, 24 and 36 months | TVF is a composite of: * Cardiovascular Death * Target-vessel related MI * Clinically and physiologically-oriented Target vessel revascularization |
| Bleeding | 12, 24 and 36 months follow-up | Bleeding according to Bleeding Academic Research Consortium (BARC) (BARC 2, 3 and 5) classification |
| Stent Thrombosis | Procedure, 12, 24 and 36 months | Definite, Probable, Definite or Probable |
Countries
Belgium, Ireland, Netherlands, Spain, United Kingdom
Contacts
Primary ContactPatrick W Serruys, MD
Backup ContactYoshinobu Onuma, MD
Outcome results
None listed