Coronary angiography-guided percutaneous coronary intervention (PCI) remains the standard treatment strategy for patients with coronary artery disease; however, suboptimal post-PCI physiological outcomes remain common and are associated with adverse cardiovascular prognosis. Quantitative Flow Ratio (QFR)-based virtual stenting technology enables simulation of post-intervention coronary physiology before PCI and may facilitate individualized optimization of stent implantation strategies.
This multicenter, prospective, randomized controlled trial aims to evaluate whether preprocedural physiological optimization of PCI using coronary imaging-physiology fusion-based virtual stenting technology improves clinical outcomes compared with conventional angiography-guided PCI. Eligible patients undergoing PCI for coronary artery disease will be randomized in a 1:1 ratio to either virtual stenting-guided PCI optimization or standard angiography-guided PCI.
The primary endpoint is major adverse cardiovascular events (MACE), defined as a composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization within 1 year after PCI. Secondary endpoints include post-PCI physiological optimization, cardiovascular death or nonfatal myocardial infarction, repeat revascularization, quality of life, procedural safety, and health economic outcomes.
Age ≥18 years.
Diagnosis of coronary artery disease requiring percutaneous coronary intervention (PCI) according to current clinical practice.
Presence of at least one target coronary lesion considered suitable for PCI and evaluable by angiography-derived Quantitative Flow Ratio (QFR).
Ability to undergo coronary angiography and PCI. Provision of written informed consent before study participation.
Contraindications to PCI or inability to undergo coronary intervention. Severe renal dysfunction or other conditions making angiographic procedures unsuitable.
High bleeding risk judged by investigators.
Inability to complete follow-up or comply with study procedures.
Life expectancy less than 1 year due to non-cardiovascular comorbidities.
Parallel
Virtual Stenting-Guided PCI Optimization
Procedure/SurgeryPreprocedural physiological optimization of PCI using coronary imaging-physiology fusion-based virtual stenting technology based on angiography-derived Quantitative Flow Ratio (QFR) assessment to guide stent implantation strategy.
Standard Angiography-Guided PCI
Procedure/SurgeryConventional percutaneous coronary intervention performed according to angiographic findings and routine clinical practice without use of virtual stenting-guided physiological optimization.
Major Adverse Cardiovascular Events (MACE)
Composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization after index PCI.
Post-PCI Physiological Optimization
Successful physiological optimization defined as postprocedural TIMI grade 3 flow and post-PCI Quantitative Flow Ratio (QFR) ≥0.90 in the target vessel immediately after PCI.
Cardiovascular Death or Nonfatal Myocardial Infarction
Composite of cardiovascular death and nonfatal myocardial infarction after index PCI.
Myocardial Infarction
This includes perioperative myocardial infarction and non-fatal myocardial infarction (including target vessel and non-target vessel related myocardial infarction) (30 days, 6 months, and 1 year postoperatively).
All-Cause Mortality
Death from any cause, including cardiovascular death, non-cardiovascular death, or death of undetermined cause.
Ischemia-Driven Repeat Revascularization
Repeat coronary revascularization (PCI or CABG) associated with ischemic symptoms, positive functional testing, angiographic stenosis ≥50% with ischemic evidence, or stenosis ≥70% regardless of symptoms.
All revascularization
Including target-vessel and non-target vessel, ischemia-driven and non-ischemia driven
Definite or Probable Stent Thrombosis
Definite or probable stent thrombosis according to ARC-2 definitions, including acute, subacute, late, and very late stent thrombosis.
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