Angiography-Derived FFR And IVUS for Clinical Outcomes in Patients With Coronary Artery Disease
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: Angiography-derived FFRProcedure: IVUS
- Registration Number
- NCT04397211
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
Comparison of Angiography-derived Fractional FLow Reserve And IntraVascular Ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with CoRonary Artery Disease
- Detailed Description
1. The primary hypothesis is that angiography-derived FFR-guided strategy for PCI with a drug-eluting stent (DES) will show non-inferiority in rates of patients-oriented composite outcomes (POCO) at 12 months after randomization, compared with IVUS-guided strategy for PCI with a DES in patients with coronary artery disease.
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 12 months after PCI will be 7% in the Angiography-derived FFR-guided arm, and 8% in the IVUS-guided arm
* Primary endpoint: patient-oriented composite outcome (a composite of all-cause death, MI, any revascularization) at 12 months after PCI
* Design: non-inferiority, delta = 2.5%
* Sampling ratio: angiography-derived FFR-guided strategy: IVUS-guided strategy = 1:1
* Type I error (α): One-sided 2.5%
* Accrual time: 3 years
* Total time: 4 years (accrual 3 years + follow-up 1 years)
* Assumption: POCO 7.0% vs. 8.0% in angiography-derived FFR or IVUS-guided strategy, respectively
* Statistical power (1- β): 80%
* Primary statistical method: Kaplan-Meier survival analysis with log-rank test
* Estimated attrition rate: total 5%
* Stratification in Randomization: Presence of diabetes mellitus (35% of patients in each group) Based on the above assumption, we would need total 1,872 patients (936 patients in each group) with consideration of an attrition rate.
3. Research Materials and Indication for Revascularization： For the angiography-derived FFR-guided strategy arm, criteria for revascularization: angiography-derived FFR ≤ 0.80. For the IVUS-guided strategy arm, the criterion for revascularization is MLA ≤ 3mm2 or \[3mm2 \< MLA ≤ 4mm2 and plaque burden \> 70%\].
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1872
- ① Subject must be ≥ 18 years. ② Subject is able to verbally confirm understandings 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 prior to any study related procedure. ③ Patients suspected with ischemic heart disease. ④ Patients with ≥ 50% stenosis by angiography-based visual estimation eligible for stent implantation. ⑤ Target vessel size ≥ 2.5mm in visual estimation. ⑥ Target vessels are limited to major epicardial coronary arteries (left anterior descending artery[LAD], left circumflex artery [LCX], right coronary artery [RCA])
- ① The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled.) ② Patients with active pathologic bleeding. ③ Gastrointestinal or genitourinary major bleeding within the prior 3 months. ④ History of bleeding. diathesis, known coagulopathy (including heparin-induced thrombocytopenia). ⑤Non-cardiac co-morbid conditions with life expectancy < 1 year. ⑥ Target vessel total occlusion. ⑦ Target lesion located in coronary arterial bypass graft. ⑧ Left main coronary artery stenosis ≥ 50%. ⑨ Not eligible for angiography-derived FFR (ostial RCA ≥ 50% stenosis, myocardial bridging, severe tortuosity, severe overlap, poor image quality)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Angiography-derived FFR-guided PCI group Angiography-derived FFR Percutaneous coronary intervention using drug-eluting stent(s) will be performed by Angiography-derived FFR-guided strategy IVUS-guided PCI group IVUS Percutaneous coronary intervention using drug-eluting stent(s) will be performed by IVUS-guided strategy
- Primary Outcome Measures
Name Time Method Patient-oriented composite outcome 12 months Patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or any revascularization at 12 months after randomization according to the ARC definitions.
- Secondary Outcome Measures
Name Time Method Any non-target vessel/lesion revascularization 12, 24 and 60 months Any non-target vessel/lesion revascularization
Cost-effectiveness analysis 12, 24 and 60 months Cost-effectiveness analysis
Any nonfatal MI with peri-procedural MI 12, 24 and 60 months Any nonfatal MI with peri-procedural MI
Stent thrombosis (definite/probable/possible) 12, 24 and 60 months Stent thrombosis (definite/probable/possible)
Stroke (ischemic and hemorrhagic) 12, 24 and 60 months Stroke (ischemic and hemorrhagic)
Acute success of procedure and rate of PCI optimization At discharge (1 week after index procedure) Acute success of procedure and rate of PCI optimization
Patient-oriented composite outcome (POCO) 24, 60 months POCO at 24 and 60 months after randomization according to the ARC consensus
Target vessel failure 12, 24 and 60 months Target vessel failure (a composite of cardiac death, target-vessel MI, or target vessel revascularization)
All-cause and cardiac death 12, 24 and 60 months All-cause and cardiac death
Any nonfatal MI without peri-procedural MI 12, 24 and 60 months Any nonfatal MI without peri-procedural MI
Any target vessel/lesion revascularization 12, 24 and 60 months Any target vessel/lesion revascularization
Any revascularization (ischemia-driven or all) 12, 24 and 60 months Any revascularization (ischemia-driven or all)
Trial Locations
- Locations (23)
Second Affiliated Hospital, School of Medicine, Zhejiang University, China
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Greentown Cardiovascular Hospital
🇨🇳Hangzhou, China
Changxing People's Hospital
🇨🇳Huzhou, China
Huzhou Central Hospital
🇨🇳Huzhou, China
Second Affiliated Hospital of Shantou University Medical College
🇨🇳Guangdong, China
Affiliated Hangzhou First People's Hospital
🇨🇳Hangzhou, China
Peking University Third Hospital
🇨🇳Beijing, China
The Affiliated Hospital of Hangzhou Normal University
🇨🇳Hangzhou, China
The Fourth People's Hospital of Jinan
🇨🇳Jinan, China
Jinhua Central Hospital
🇨🇳Jinhua, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, China
Dongyang People's Hospital
🇨🇳Jinhua, China
Renji Hospital Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
The first affiliated hospital of Wenzhou Medical University
🇨🇳Wenzhou, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
The Affiliated Hospital of Medical College, Ningbo University
🇨🇳Ningbo, China
Shandong Jining No.1 People's Hospital
🇨🇳Shandong, China
Shandong University of Traditional Chinese Medicine
🇨🇳Shandong, China
Second hospital of Shanxi Medical University
🇨🇳Taiyuan, China
The second affiliated hospital of Wenzhou Medical University
🇨🇳Wenzhou, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, China
Seoul National University Hospital,
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of