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.
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.
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;
Parallel
Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care
Other interventionpercutaneous coronary intervention
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.
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
Device-oriented composite endpoint (DoCE)
DoCE is a composite endpoint of: * Cardiovascular Death * Target-vessel related MI * Clinically and physiologically-oriented Target lesion revascularization
Myocardial Infarction (MI)
Peri-procedure Myocardial Infarction according to 4th universal definition
Device Success Rate
according to the statement from European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology (ESC)
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