Clinical trial NCT05496023: Angiography-derived FFR GPS in Predicting Post-PCI Physiological and Clinical Outcomes
Official title: Pre-stenting Angiography-derived Fractional Flow Reserve Pullback Guided PercutaneouS Coronary Intervention Predicts Physiological and Clinical Outcomes in Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who diagnosed obstructive coronary artery disease and evaluated by pre-PCI FFR measurement, then treated by DES with invasive physiologic evaluation at the index procedure.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Propotion of angio-FFR based physiological map successfully created
timeFrame: Immediate after angiography
measure: Correlation of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI
timeFrame: Immediate post-PCI
measure: Agreement of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI
timeFrame: Immediate post-PCI
Secondary outcomes:
measure: Correlation of pre-PCI angio-FFR with pre-PCI FFR
timeFrame: Immediate after pre-PCI FFR measurement
measure: Agreement of pre-PCI angio-FFR with pre-PCI FFR
timeFrame: Immediate after pre-PCI FFR measurement
measure: Correlation of post-PCI angio-FFR with post-PCI FFR
timeFrame: Immediate post-PCI FFR measurement
measure: Agreement of post-PCI angio-FFR with post-PCI FFR
timeFrame: Immediate post-PCI FFR measurement
measure: Correlation of pre-PCI angio-FFR derived pullback pressure gradient (PPG) with post-PCI angio-FFR
timeFrame: Immediate post-PCI
measure: Correlation of pre-PCI angio-FFR derived pullback pressure gradient with post-PCI FFR
timeFrame: Immediate post-PCI
measure: Target Vessel Failure
timeFrame: 2 years after index procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
Study officials:
affiliation: Fudan University
name: Junbo Ge, MD
role: STUDY_CHAIR
References:
citation: Dai N, Che W, Liu L, Zhang W, Yin G, Xu B, Xu Y, Duan S, Yu H, Li C, Yao K, Huang D, Ge J. Diagnostic Value of Angiography-Derived IMR for Coronary Microcirculation and Its Prognostic Implication After PCI. Front Cardiovasc Med. 2021 Oct 15;8:735743. doi: 10.3389/fcvm.2021.735743. eCollection 2021.
citation: Shin D, Dai N, Lee SH, Choi KH, Lefieux A, Molony D, Hwang D, Kim HK, Jeon KH, Lee HJ, Jang HJ, Ha SJ, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Doh JH, Shin ES, Nam CW, Koo BK, Gwon HC, Ge J, Lee JM. Physiological Distribution and Local Severity of Coronary Artery Disease and Outcomes After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2021 Aug 23;14(16):1771-1785. doi: 10.1016/j.jcin.2021.06.013.
citation: Dai N, Hwang D, Lee JM, Zhang J, Jeon KH, Paeng JC, Cheon GJ, Koo BK, Ge J. Feasibility of Quantitative Flow Ratio-Derived Pullback Pressure Gradient Index and Its Impact on Diagnostic Performance. JACC Cardiovasc Interv. 2021 Feb 8;14(3):353-355. doi: 10.1016/j.jcin.2020.10.036. No abstract available.