The PIONEER-IV Study is Comparing Clinical Outcomes Between Angiography-derived Physiology Guidance to Usual Care in an All-comers PCI Population With Unrestrictive Use of the HT Supreme Sirolimus-eluting Stent
Study Details
Study Description
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 (QFR) 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Angiography-derived Physiology Guidance (Quantitative Flow Ratio, QFR)
|
Other: Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care
percutaneous coronary intervention
|
| Other: Local routine diagnostic procedure (LRDP) and usual care
|
Other: Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care
percutaneous coronary intervention
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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)
- Stent Thrombosis [Procedure, 12, 24 and 36 months]
Definite, Probable, Definite or Probable
- 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
Eligibility Criteria
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:
-
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);
-
Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors;
-
Planned major elective surgery requiring discontinuation of (dual)anti platelet therapy (DAPT) within 12 months of procedure;
-
Concurrent medical condition with a life expectancy of less than 3 years;
-
Currently participating in another trial and not yet at its primary endpoint;
-
Active pathological bleeding;
-
History of intracranial haemorrhage.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ASZ Aalst | Aalst | Belgium | ||
| 2 | OLVZ Aalst | Aalst | Belgium | ||
| 3 | Imeldaziekenhuis | Bonheiden | Belgium | ||
| 4 | Jessa Hospital Hasselt | Hasselt | Belgium | ||
| 5 | University Hospital Galway | Galway | Ireland | ||
| 6 | OLVG Amsterdam | Amsterdam | Netherlands | ||
| 7 | Medisch Spectrum Twente, Thoraxcentrum, Endchede | Endchede | Netherlands | ||
| 8 | UMC Groningen | Groningen | Netherlands | ||
| 9 | Medisch Centrum Leeuwarden | Leeuwarden | Netherlands | ||
| 10 | Maasstad Hospital | Rotterdam | Netherlands | ||
| 11 | Lucas Augusti Hospital | Lugo | Spain | ||
| 12 | Hospital Clínico San Carlos | Madrid | Spain | ||
| 13 | Hospital Álvaro Cunqueiro Vigo. | Vigo | Spain | ||
| 14 | Barts Health NHS Trust, London | London | United Kingdom |
Sponsors and Collaborators
- National University of Ireland, Galway, Ireland
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NUIG-2021-001