FFR Versus IVUS with Angiography-Derived FFR for Clinical Outcomes in Patients with Coronary Artery Disease
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT06218485
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
To compare the clinical outcomes of fractional flow reserve (FFR)-guided strategy versus intravascular ultrasound (IVUS)-guided stent implantation after angiography-derived FFR-based decision-making.
- Detailed Description
1. Hypothesis: The IVUS-guided stent implantation after angiography-derived FFR-based decision-making will show superiority in terms of a lower rate of patients-oriented composite outcomes (POCO) at 24 months after randomization compared with the FFR-guided PCI strategy in patients with coronary stenosis.
2. Research materials and indication for revascularization:
2.1 Experimental group: PCI will be performed if angiography-derived FFR ≤0.80 and will be deferred if angiography-derived FFR \>0.80; If PCI is performed, PCI optimization using IVUS will be performed following the recommended criteria: ① Plaque burden at stent edge ≤55%; ② Minimal stent area ≥ 5.5 mm2, or minimal stent area ≥ distal reference lumen area.
2.2 Control group: PCI will be performed if FFR ≤0.80 and will be deferred if FFR \>0.80; If PCI is performed, PCI optimization using FFR will be performed following the recommended criteria: ① Post-PCI FFR ≥ 0.88, or ② Post-PCI ΔFFR (\[FFR at stent distal edge\] - \[FFR at stent proximal edge\]) \< 0.05.
3. Sample size: In the post-hoc analysis of the FLAVOUR I study applying QFR analysis, the 2-year POCO rate was 13.0% in the PCI group with FFR ≤0.80 and undergoing FFR-based PCI optimization and 7.1% in the PCI group with QFR ≤0.80 and undergoing IVUS-based PCI optimization. Meanwhile, the 2-year POCO rate was 5.8% and 6.5% in the deferral of PCI group with FFR \>0.80 and QFR \>0.80, respectively. Assuming a PCI rate of 70% in patients with coronary artery lesions with 50-90% stenosis that is the inclusion criteria for the current study, and considering event rates from historical studies evaluating FFR- and QFR-guided PCI strategies, the cumulative incidence rate of POCO at 24 months was estimated to be 13.0% in the control group (FFR group) and 9.0% in the experimental group (QFR-IVUS group).
* Primary endpoint: POCO, defined as a composite of death from any cause, MI, or any revascularization at 24 months after randomization.
* Design: superiority
* Sampling ratio: experimental group : control group = 1:1
* Type I error (α): One-sided 2.5%
* Accrual time: 24 months
* Total time: 4 years (accrual 24 months + follow-up 24 months)
* Assumption: POCO 13.0% vs. 9.0% in control or experimental group, respectively
* Statistical power (1- β): 90%
* Primary statistical method: Kaplan-Meier survival analysis with log-rank test
* Estimated attrition rate: total 10%
* Stratification in randomization: Presence of diabetes mellitus
Based on the above assumption, we would need total 1,942 patients (971 patients in each group) with consideration of an attrition rate.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1942
- Subject must be ≥ 19 years.
- Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI with a drug-eluting stent (DES) and he/she or his/her legally authorized representative provides written informed consent.
- Subjects suspected with ischemic heart disease.
- Subjects with coronary artery diameter stenosis 50-90% by angiography-based visual estimation eligible for stent implantation.
- Target vessel size ≥ 2.5mm in visual estimation.
- Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor
- Active pathologic bleeding.
- Gastrointestinal or genitourinary major bleeding within the prior 3 months.
- History of bleeding diathesis, known coagulopathy.
- Non-cardiac co-morbid conditions with life expectancy < 2 years.
- Target lesion located in coronary arterial bypass graft.
- Left main coronary artery stenosis ≥ 50%.
- Chronic total occlusion in the study target vessel.
- Culprit lesion of ST-elevation myocardial infarction (STEMI).
- Not eligible for angiography-derived FFR (ostial RCA ≥ 50% stenosis, severe tortuosity, severe overlap, poor image quality).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Patient-oriented composite outcome 24 months Patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI), or any revascularization at 24 months after randomization.
- Secondary Outcome Measures
Name Time Method All-cause and cardiac death 24 and 60 months All-cause and cardiac death.
Any nonfatal myocardial infarction with peri-procedural myocardial infarction 24 and 60 months Any nonfatal myocardial infarction with peri-procedural myocardial infarction.
Any target vessel/lesion revascularization 24 and 60 months Any target vessel/lesion revascularization.
Any non-target vessel/lesion revascularization 24 and 60 months Any non-target vessel/lesion revascularization.
Target vessel failure 24 and 60 months Target vessel failure, defined as a composite of cardiac death, target-vessel MI, or target vessel revascularization.
Cost-effectiveness analysis 24 and 60 months Incremental cost effectiveness ratio (ICER).
Any nonfatal myocardial infarction without peri-procedural myocardial infarction 24 and 60 months Any nonfatal myocardial infarction without peri-procedural myocardial infarction.
Stent thrombosis (definite/probable/possible) 24 and 60 months Stent thrombosis at 24 and 60 months after randomization.
Any revascularization (ischemia-driven or all) 24 and 60 months Any revascularization (ischemia-driven or all).
Stroke (ischemic and hemorrhagic) 24 and 60 months Stroke at 24 and 60 months after randomization.
Patient-oriented composite outcome at 60 months 60 months Patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI), or any revascularization.
Individual component of Patient-oriented composite outcome 24 and 60 months Individual component of Patient-oriented composite outcome (death, myocardial infarction, revascularization).
Trial Locations
- Locations (25)
Peking University Third Hospital
🇨🇳Beijing, China
Second Affiliated Hospital of Shantou University Medical College
🇨🇳Guangdong, China
The Affiliated Hospital of Hangzhou Normal University
🇨🇳Hangzhou, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Changxing People's Hospital
🇨🇳Huzhou, China
The Affiliated Hospital of Shandong University of TCM
🇨🇳Jinan, China
The Fourth People's Hospital of Jinan
🇨🇳Jinan, China
Jinhua Central Hospital
🇨🇳Jinhua, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
Scroll for more (15 remaining)Peking University Third Hospital🇨🇳Beijing, ChinaLijun Guo, MD, PhDContactguo_li_jun@sohu.com