To compare the safety and efficacy of FFR (fractional flow reserve)-guided percutaneous coronary intervention (PCI) strategy with IVUS (intravascular ultrasound \[IVUS\])-guided PCI in patients with intermediate coronary stenosis.
1. Study overview This study is a prospective, open-label, randomized, multicenter trial to test the safety and efficacy of physiology- or imaging-guided PCI in patients with intermediate coronary stenosis. The primary hypothesis is that FFR-guided strategy will show non-inferior rate of patients-oriented composite outcomes (POCO) at 24 months after randomization, compared with IVUS-guided strategy in patients with intermediate coronary stenosis. 2. Study population and sample size calculation Sample Size Calculation Based on the event rates of previous trials, investigators predicted the rates of POCO at 24 months after PCI will be 10% in the FFR-guided arm, and 12% in the IVUS-guided arm. * Primary endpoint: patient-oriented composite outcome (a composite of all-cause death, MI, any repeat revascularization) at 24 months after PCI * Design: non-inferiority , delta = 2.5% * Sampling ratio: FFR-guided strategy : IVUS-guided strategy = 1:1 * Type I error (α): One-sided 5% * Accrual time : 2 years * Total time : 4 years (accrual 2 year + follow-up 2 years) * Assumption: POCO 10.0% vs. 12.0% in FFR or IVUS-guided strategy, respectively * Statistical power (1- β): 90% * Primary statistical method : Kaplan-Meier survival analysis with log-rank test * Potential withdrawal rates : total 2% * Stratification in Randomization: Presence of Diabetes Mellitus (600 patients (35%) will be Diabetic patients, with 300 patients in each group) Based on the above assumption, 1,700 patients (850 patients in each group) will be enrolled in this study with consideration of withdrawal rates. 3. Research Materials and Indication for Revascularization For the FFR-guided strategy arm, a pressure-sensor wire system will be used and the criterion for revascularization is FFR ≤ 0.80. Hyperemia will be induced by intravenous infusion of adenosine (140ug/kg/min). For the IVUS-guided strategy arm, the criterion for revascularization is MLA ≤ 3mm2 or \[3mm2 \< MLA ≤ 4mm2 and plaque burden \> 70%\]. 4. Funding This is an investigator-initiated study with grant support from Boston Scientific. Other than financial sponsorship, the company has no role in protocol development or the implementation, management, data collection, and analysis of this study. 5. Extended Outcome Follow-Up Following the 2-year follow-up period, clinical outcomes will also be collected until September 30, 2024, to assess the long-term outcomes of each treatment group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,700
The percutaneous coronaryintervention using drug-eluting stent will be indicated according to following criteria in the FFR-guided strategy arm \* Criteria for revascularization: The FFR ≤ 0.80 will be targeted for PCI
The percutaneous coronaryintervention using drug-eluting stent will be indicated according to following criteria in the IVUS-guided strategy arm \* Criteria for revascularization: Minimum lumen area (MLA) ≤ 3mm2 or (MLA ≤ 4mm2 AND Plaque burden \>70%)
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Zhejiang, China
Keimyung University Dongsan Medical Center
Daegu, South Korea
Inje University Ilsan Paik Hospital
Goyang, South Korea
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea
Patient-oriented composite outcome
a composite of all death, myocardial infarction (MI) or any revascularization
Time frame: 24 months
Long-term patient-oriented composite outcome
A composite of all death, myocardial infarction \[MI, including peri-procedural MI\] or any revascularization during the extended follow-up period after randomization according to the ARC consensus.
Time frame: Up to 7 years
Patient-oriented composite outcome
a composite of all death, myocardial infarction (MI) or any
Time frame: 12 months
Stent-oriented composite endpoint
a composite of cardiac death, target-vessel MI, or target lesion revascularization
Time frame: 12 months
Stent-oriented composite endpoint
a composite of cardiac death, target-vessel MI, or target lesion revascularization
Time frame: 24 months
Cost-effectiveness analysis
medical expenses of treatment and follow-up. Cost estimates utilize micro-costing, the total cost by identifying the utilization of medical resources used, and macro-costing, medical expenses resulting from clinical events from health insurance data.
Time frame: 24 months
All-cause death
death from any cause
Time frame: 24 months
Cardiac death
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Seoul National University Hospital, Seoul, Korea
Seoul, South Korea
death from cardiaccause
Time frame: 24 months
Target-vessel and all-cause nonfatal myocardial infarction without per-procedural myocardial infarction
Myocardial infarction during 24 months follow-up without periprocedural myocardial infarction
Time frame: 24 months
Target-vessel and all-cause nonfatal myocardial infarction with per-procedural myocardial infarction
Myocardial infarction during 24 months follow-up with periprocedural myocardial infarction
Time frame: 24 months
Peri-procedural MI using referred definitions
Number of participants with peri-procedural myocardial infarction after PCI
Time frame: At discharge (1 week after index procedure)
Target vessel/lesion revascularization
Number of participants and vessels/lesions with ischemia-driven or any reavascularizations at target vessel/lesion
Time frame: 24 months
Non-target vessel/lesion revascularization
Number of participants and vessels/lesions with ischemia-driven or any reavascularizations at non-target vessel/lesion.
Time frame: 24 months
Any revascularization
Number of participants and vessels/lesions with ischemia-driven or any revascularizations at any vessel/lesion
Time frame: 24 months
Academic Research Consortium defined - Stent thrombosis
Number of participants with definite/probable/possible stent thrombosis
Time frame: 24 months
Stroke
Number of participants with ischemic or hemorrhagic stroke
Time frame: 24 months
Acute success of procedure
Device-related, lesion-related and procedure-related success of index procedure (residual diameter stenosis\<50% and thrombolysis in myocardial infarction flow 3)
Time frame: immediately after the intervention
Angina severity measured with Seattle Angina Questionnaires
Seattle Angina Questionnaires (physical limitation and angina frequency were classified as minimal: 75-100, mild: 50-74, moderate: 25-49, severe: 0-24)
Time frame: 12 months
Angina severity measured with Seattle Angina Questionnaires
Seattle Angina Questionnaires (physical limitation and angina frequency were classified as minimal: 75-100, mild: 50-74, moderate: 25-49, severe: 0-24)
Time frame: 24 months
Long-term patient-oriented composite outcome in subgroups by use of anti-platelet agent and lipid-lowering agents
A composite of all death, myocardial infarction \[MI, including peri-procedural MI\] or any revascularization during the extended follow-up period in subgroups stratified by use of anti-platelet agent and lipid-lowering agents
Time frame: Up to 7 years
Long-term patient-oriented composite outcome in subgroups by lipid profiles
Long-term patient-oriented composite outcome in subgroups stratified by changes in LDL-cholesterol, HDL-cholesterol, and triglyceride during the extended follow-up period
Time frame: Up to 7 years
Long-term mortality
All-cause and cardiac death during the extended follow-up period
Time frame: Up to 7 years
Long-term myocardial infarction
Myocardial infarction during the extended follow-up period
Time frame: Up to 7 years
Long-term any revascularization
Any revascularization during the extended follow-up period
Time frame: Up to 7 years
Long-term target vessel failure
Target vessel failure (cardiac death, target vessel MI, target vessel revascularization) during the extended follow-up period
Time frame: Up to 7 years
Long-term target vessel myocardial infarction
Target vessel myocardial infarction during the extended follow-up period
Time frame: Up to 7 years
Long-term target vessel revascularization
Target vessel revascularization during the extended follow-up period
Time frame: Up to 7 years
Long-term target lesion revascularization
Target lesion revascularization during the extended follow-up period
Time frame: Up to 7 years
Long-term non-target lesion revascularization-target vessel revascularization
Non-target lesion revascularization-target vessel revascularization during the extended follow-up period
Time frame: Up to 7 years
Long-term stent thrombosis
Stent thrombosis (definite/probable/possible) during the extended follow-up period
Time frame: Up to 7 years
Long-term stroke
Stroke (ischemic and hemorrhagic) during the extended follow-up period
Time frame: Up to 7 years
Landmark analysis for patient-oriented composite outcome
A 2 year landmark analysis of patient-oriented composite outcome and its individual outcome components
Time frame: Up to 7 years
Long-term patient-oriented composite outcome in the medical treatment group
Patient-oriented composite outcome and individual components of outcomes in the medical treatment group
Time frame: Up to 7 years
Long-term patient-oriented composite outcome in the PCI group
Patient-oriented composite outcome and individual components of outcomes in the PCI group
Time frame: Up to 7 years
Long-term patient-oriented composite outcome according to PCI optimization
Patient-oriented composite outcome and individual outcome components among patients in the PCI group, comparing those who received PCI optimization to those who did not.
Time frame: Up to 7 years
Landmark analysis for target vessel failure
A 2 year landmark analysis of target vessel failure and its individual outcome components
Time frame: Up to 7 years
Long-term target vessel failure in the medical treatment group
Target vessel failure and individual components of outcomes in the medical treatment group
Time frame: Up to 7 years
Long-term target vessel failure in the PCI group
Target vessel failure and individual components of outcomes in the PCI group
Time frame: Up to 7 years
Long-term target vessel failure according to PCI optimization
Target vessel failure and individual outcome components among patients in the PCI group, comparing those who received PCI optimization to those who did not.
Time frame: Up to 7 years
Long-term target vessel failure according to IVUS-derived plaque characteristics
Target vessel failure (cardiac death, target vessel MI, target vessel revascularization) during the extended follow-up period according to IVUS-derived plaque characteristics
Time frame: Up to 7 years
Long-term target vessel failure according to QFR values
Target vessel failure (cardiac death, target vessel MI, target vessel revascularization) during the extended follow-up period according to QFR values
Time frame: Up to 7 years