Coronary Artery Disease
Conditions
Keywords
Angiography-derived fractional flow reserve, Intravascular ultrasound, Percutaneous coronary intervention, Fractional flow reserve
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 \[3mm2 \< MLA ≤ 4mm2 and plaque burden \> 70%\].
Interventions
PROCEDUREAngiography-derived FFR
The percutaneous coronary intervention using drug-eluting stent will be indicated according to following criteria in the Angiography-derived FFR-guided strategy arm \*Criteria for revascularization: Angiography-derived FFR ≤ 0.80
PROCEDUREIVUS
The percutaneous coronary intervention 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 3\< MLA ≤ 4mm2 & Plaque burden \> 70%
Sponsors
Seoul National University Hospital
Affiliated Hangzhou First People's Hospital
Wuhan University
Peking University Third Hospital
The Affiliated Hospital of Hangzhou Normal University
RenJi Hospital
Second Hospital of Shanxi Medical University
First Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital of Wenzhou Medical University
Changxing People's Hospital
The Affiliated Hospital of Medical College, Ningbo University
Jinhua Central Hospital
Shandong University of Traditional Chinese Medicine
Dongyang People's Hospital
The First Affiliated Hospital of Nanchang University
Jining First People's Hospital
Second Affiliated Hospital of Shantou University Medical College
Ulsan University Hospital
Huizhou Municipal Central Hospital
Zhejiang Greentown Cardiovascular Hospital
The Fourth People's Hospital of Jinan
First Affiliated Hospital of Kunming Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 \[RCA\])
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Any target vessel/lesion revascularization | 12, 24 and 60 months | Any target vessel/lesion revascularization |
| Any non-target vessel/lesion revascularization | 12, 24 and 60 months | Any non-target vessel/lesion revascularization |
| Any revascularization (ischemia-driven or all) | 12, 24 and 60 months | Any revascularization (ischemia-driven or all) |
| 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) |
| Any nonfatal MI with peri-procedural MI | 12, 24 and 60 months | Any nonfatal MI with peri-procedural MI |
| 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 |
| 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 |
| Cost-effectiveness analysis | 12, 24 and 60 months | Cost-effectiveness analysis |
Countries
China, South Korea
Outcome results
None listed