Coronary Artery Disease
Conditions
Brief summary
To investigate the feasibility of physiological map generated from angiography-derived fractional flow reserve (FFR) (angio-FFR) pullback and its value in predicting physiological and clinical outcomes after stenting.
Detailed description
Physiological coronary lesion evaluation such as fractional flow reserve (FFR) is now recommended by guidelines to guide percutaneous coronary intervention (PCI). However, it was not widely used in subsequent years for a variety of reasons, including the additional time needed to measure pressure wire-derived FFR, technical challenges and the small risk associated with maneuvering a pressure wire down a coronary artery, the added time to assess multiple vessels, issues with drift in the pressure wire reading, and the time, expense, and associated side effects with some hyperemic agents necessary to measure FFR. In recent years, advancements in technology made it possible to calculate FFR from conventional coronary angiography without the need of a pressure wire or hyperemic agent. The FAVOR III (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous InterVention in Patients With cORonary Artery Disease) China has demonstrated that angiography-derived FFR (angio-FFR) improved outcomes for PCI compared with a standard angiography-guided strategy. Like FFR, angio-FFR is also performed in a binary manner to determine whether a vessel requires intervention and does not automatically indicate the haemodynamic improvement that would be expected post stenting. However, one advantage of angio-FFR is that virtual pullback could be generated during its calculation. Most importantly, though hyperemic blood flow was applied in angio-FFR calculation, it was predicted from resting flow with mathematical algorithm. As resting flow is more constant, consistent, and predictable across different stenoses, then resting pressure changes measured along the length of a vessel will be more predictable. Using this property, a physiological vessel map could be produced with angio-FFR by co-registration the pullback onto coronary angiogram, which not only highlight functional significant lesions and lesion locations, but also offer the possibility of prospective simple computerized virtual PCI to assess the potential hemodynamic impact before actual stent implantation. In this regard, the investigators aim to calculate angio-FFR and to develop an angio-FFR pullback. And the investigators hypothesize that angio-FFR-derived pullback would be possible to produce a physiological map showing lesion severity and location, in addition, it could be used to perform virtual PCI and predict the physiological impact of stenting; the physiological map could be used to measure physiological lesion length and intensity.
Interventions
DEVICEPercutaneous coronary intervention
1. Pre-PCI angio-FFR was calculated and virtual pullback was generated 2. Automated algorithm to calculate delta angio-FFR per unit length and co-registered onto coronary angiogram was developed 3. PCI was performed using 2nd generation DES
Sponsors
Shanghai Zhongshan Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* any patient meets eligible criteria who underwent PCI with DES followed by invasive physiologic assessment at the index procedure * any patient who underwent PCI for lesions with pre-PCI FFR\<=0.80 * available of both pre- and post-PCI FFR measurement * available of both pre- and post-PCI angio-FFR calculation * available of pre-PCI co-registration of angio-FFR with coronary angiogram
Exclusion criteria
* unavailable pre-PCI angio-FFR calculation and co-registration with coronary angiogram * unavailable post-PCI angio-FFR calculation * culprit vessel of acute coronary syndrome * failed achieving TIMI 3 flow at the end of PCI * left ventricular ejection fraction \<30% * graft vessel * collateral feeder * in-stent restenosis * primary myocardial or valvular heart disease * in patient whose life expectancy less than 2 years * visible thrombus of target vessel segment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Propotion of angio-FFR based physiological map successfully created | Immediate after angiography | Propotion of successful angio-FFR based physiological map created by overlaying the angio-FFR based pullback onto coronary angiogram will be calculated |
| Correlation of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI | Immediate post-PCI | Pearson Correlation analysis will be performed to assess the correlation of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI |
| Agreement of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI | Immediate post-PCI | Bland-altman analysis will be performed to assess the agreement of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement of post-PCI angio-FFR with post-PCI FFR | Immediate post-PCI FFR measurement | Bland-altman analysis will be performed to assess the agreement of post-PCI angio-FFR with post-PCI FFR |
| Correlation of pre-PCI angio-FFR derived pullback pressure gradient (PPG) with post-PCI angio-FFR | Immediate post-PCI | Pearson Correlation analysis will be performed to assess the correlation of pre-PCI angio-FFR derived pullback pressure gradient with post-PCI angio-FFR |
| Correlation of pre-PCI angio-FFR with pre-PCI FFR | Immediate after pre-PCI FFR measurement | Pearson Correlation analysis will be performed to assess the correlation of pre-PCI angio-FFR with pre-PCI FFR |
| Target Vessel Failure | 2 years after index procedure | a composite of cardiac death, clinical-driven target vessel-related myocardial infarction, and clinical-driven target vessel revascularization. The target vessel will be defined as the treated vessel with 2nd generation DES which was assessed by post-stenting fractional flow reserve. |
| Correlation of pre-PCI angio-FFR derived pullback pressure gradient with post-PCI FFR | Immediate post-PCI | Pearson Correlation analysis will be performed to assess the correlation of pre-PCI angio-FFR derived pullback pressure gradient with post-PCI FFR |
| Agreement of pre-PCI angio-FFR with pre-PCI FFR | Immediate after pre-PCI FFR measurement | Bland-altman analysis will be performed to assess the agreement of pre-PCI angio-FFR with pre-PCI FFR |
| Correlation of post-PCI angio-FFR with post-PCI FFR | Immediate post-PCI FFR measurement | Pearson Correlation analysis will be performed to assess the correlation of post-PCI angio-FFR with post-PCI FFR |
Countries
China
Contacts
Primary ContactNeng Dai, MD
Outcome results
None listed