Fractional FLow Reserve and IVUS for Clinical OUtcomes in Patients with InteRmediate Stenosis
- Conditions
- Stable Angina
- Interventions
- Procedure: IVUS-guided stentingProcedure: FFR-guided stenting
- Registration Number
- NCT02673424
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1700
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IVUS-guided stenting IVUS-guided stenting Percutaneous coronaryintervention using drug-eluting stent(s) will be performed by IVUS-guided strategy. FFR-guided stenting FFR-guided stenting Percutaneous coronaryintervention using drug-eluting stent(s) will be performed by FFR-guided strategy.
- Primary Outcome Measures
Name Time Method Patient-oriented composite outcome 24 months a composite of all death, myocardial infarction (MI) or any revascularization
Long-term patient-oriented composite outcome Up to 7 years 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.
- Secondary Outcome Measures
Name Time Method All-cause death 24 months death from any cause
Long-term target vessel failure according to PCI optimization Up to 7 years Target vessel failure and individual outcome components among patients in the PCI group, comparing those who received PCI optimization to those who did not.
Any revascularization 24 months Number of participants and vessels/lesions with ischemia-driven or any revascularizations at any vessel/lesion
Angina severity measured with Seattle Angina Questionnaires 24 months Seattle Angina Questionnaires (physical limitation and angina frequency were classified as minimal: 75-100, mild: 50-74, moderate: 25-49, severe: 0-24)
Long-term patient-oriented composite outcome in subgroups by lipid profiles Up to 7 years Long-term patient-oriented composite outcome in subgroups stratified by changes in LDL-cholesterol, HDL-cholesterol, and triglyceride during the extended follow-up period
Long-term target vessel myocardial infarction Up to 7 years Target vessel myocardial infarction during the extended follow-up period
Long-term target vessel revascularization Up to 7 years Target vessel revascularization during the extended follow-up period
Long-term target lesion revascularization Up to 7 years Target lesion revascularization during the extended follow-up period
Long-term non-target lesion revascularization-target vessel revascularization Up to 7 years Non-target lesion revascularization-target vessel revascularization during the extended follow-up period
Long-term patient-oriented composite outcome in the medical treatment group Up to 7 years Patient-oriented composite outcome and individual components of outcomes in the medical treatment group
Long-term patient-oriented composite outcome in the PCI group Up to 7 years Patient-oriented composite outcome and individual components of outcomes in the PCI group
Landmark analysis for target vessel failure Up to 7 years A 2 year landmark analysis of target vessel failure and its individual outcome components
Long-term target vessel failure in the medical treatment group Up to 7 years Target vessel failure and individual components of outcomes in the medical treatment group
Long-term target vessel failure according to IVUS-derived plaque characteristics Up to 7 years Target vessel failure (cardiac death, target vessel MI, target vessel revascularization) during the extended follow-up period according to IVUS-derived plaque characteristics
Long-term target vessel failure according to QFR values Up to 7 years Target vessel failure (cardiac death, target vessel MI, target vessel revascularization) during the extended follow-up period according to QFR values
Patient-oriented composite outcome 12 months a composite of all death, myocardial infarction (MI) or any
Target-vessel and all-cause nonfatal myocardial infarction with per-procedural myocardial infarction 24 months Myocardial infarction during 24 months follow-up with periprocedural myocardial infarction
Cost-effectiveness analysis 24 months 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.
Target-vessel and all-cause nonfatal myocardial infarction without per-procedural myocardial infarction 24 months Myocardial infarction during 24 months follow-up without periprocedural myocardial infarction
Non-target vessel/lesion revascularization 24 months Number of participants and vessels/lesions with ischemia-driven or any reavascularizations at non-target vessel/lesion.
Stent-oriented composite endpoint 24 months a composite of cardiac death, target-vessel MI, or target lesion revascularization
Peri-procedural MI using referred definitions At discharge (1 week after index procedure) Number of participants with peri-procedural myocardial infarction after PCI
Long-term myocardial infarction Up to 7 years Myocardial infarction during the extended follow-up period
Long-term any revascularization Up to 7 years Any revascularization during the extended follow-up period
Long-term stent thrombosis Up to 7 years Stent thrombosis (definite/probable/possible) during the extended follow-up period
Long-term patient-oriented composite outcome according to PCI optimization Up to 7 years 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.
Long-term target vessel failure in the PCI group Up to 7 years Target vessel failure and individual components of outcomes in the PCI group
Cardiac death 24 months death from cardiaccause
Stroke 24 months Number of participants with ischemic or hemorrhagic stroke
Long-term patient-oriented composite outcome in subgroups by use of anti-platelet agent and lipid-lowering agents Up to 7 years 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
Landmark analysis for patient-oriented composite outcome Up to 7 years A 2 year landmark analysis of patient-oriented composite outcome and its individual outcome components
Target vessel/lesion revascularization 24 months Number of participants and vessels/lesions with ischemia-driven or any reavascularizations at target vessel/lesion
Academic Research Consortium defined - Stent thrombosis 24 months Number of participants with definite/probable/possible stent thrombosis
Long-term mortality Up to 7 years All-cause and cardiac death during the extended follow-up period
Long-term stroke Up to 7 years Stroke (ischemic and hemorrhagic) during the extended follow-up period
Acute success of procedure immediately after the intervention Device-related, lesion-related and procedure-related success of index procedure (residual diameter stenosis\<50% and thrombolysis in myocardial infarction flow 3)
Long-term target vessel failure Up to 7 years Target vessel failure (cardiac death, target vessel MI, target vessel revascularization) during the extended follow-up period
Trial Locations
- Locations (5)
Seoul National University Hospital, Seoul, Korea
🇰🇷Seoul, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Goyang, Korea, Republic of
The Second Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Zhejiang, China
Samsung Medical Center, Sungkyunkwan University School of Medicine
🇰🇷Seoul, Korea, Republic of