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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,540
percutaneous coronary intervention
ASZ Aalst
Aalst, Belgium
RECRUITINGOLVZ Aalst
Aalst, Belgium
RECRUITINGImelda Ziekenhuis
Bonheiden, Belgium
RECRUITINGCHU Charleroi
Charleroi, Belgium
RECRUITINGJessa Hospital Hasselt
Hasselt, Belgium
RECRUITINGUniversity Hospital Galway
Galway, Ireland
RECRUITINGOLVG Amsterdam
Amsterdam, Netherlands
RECRUITINGMedisch Spectrum Twente, Thoraxcentrum, Endchede
Enschede, Netherlands
RECRUITINGUMC Groningen
Groningen, Netherlands
RECRUITINGMedisch Centrum Leeuwarden
Leeuwarden, Netherlands
RECRUITING...and 9 more locations
Patient-oriented Composite Endpoint (PoCE)
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.
Time frame: 12 months
Vessel-oriented composite endpoints (VoCE)
VoCE is a composite clinical endpoint of: * Vessel-related cardiovascular Death * Target-vessel related MI * Clinically and physiologically-oriented Target vessel revascularization
Time frame: 12, 24 and 36 months
Device-oriented composite endpoint (DoCE)
DoCE is a composite endpoint of: * Cardiovascular Death * Target-vessel related MI * Clinically and physiologically-oriented Target lesion revascularization
Time frame: 12, 24 and 36 months
Myocardial Infarction (MI)
Peri-procedure Myocardial Infarction according to 4th universal definition
Time frame: 48 hours post-procedure
Device Success Rate
according to the statement from European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology (ESC)
Time frame: index procedure
Stent Thrombosis
Definite, Probable, Definite or Probable
Time frame: Procedure, 12, 24 and 36 months
Target Vessel Failure (TVF)
TVF is a composite of: * Cardiovascular Death * Target-vessel related MI * Clinically and physiologically-oriented Target vessel revascularization
Time frame: 12, 24 and 36 months
Bleeding
Bleeding according to Bleeding Academic Research Consortium (BARC) (BARC 2, 3 and 5) classification
Time frame: 12, 24 and 36 months follow-up
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