Automated Algorithm Detecting Physiologic Major Stenosis and Its Relationship With Post-PCI Clinical Outcomes

NCT04304677 | Completed DMC

• 1 other identifier: Algorithm20200211
• Study Type: observational
• Target: 486
• Locations: 1 country
• Sites: 1

Brief Summary

The presence of myocardial ischemia is the most important prognostic indicator in patients with coronary artery disease. Therefore, the purpose of percutaneous coronary intervention (PCI) is to relieve myocardial ischemia caused by the target stenosis. Fractional flow reserve (FFR) is an invasive physiologic index used to define functionally significant coronary stenosis, and its prognostic implications are supported by numerous studies. Contrary to the clear cutoff value and the benefit of FFR in pre-PCI evaluation, there have been various results regarding optimal cut-off values for post-PCI FFR. Nevertheless, the positive association between post-PCI FFR and the risk of future events has been reproduced by several studies. PCI with stent implantation is basically a local treatment and post-PCI FFR reflects both residual stenosis in the stented segment and remaining disease beyond the stented segment in the target vessel(s). Therefore, post-PCI FFR alone cannot fully discriminate the degree of contribution of each component. The relative increase of FFR with PCI is determined by the interaction of baseline severity of a target lesion, baseline disease burden of a target vessel, adequacy of PCI and residual disease burden in a target vessel. However, the most important problem in stratifying patients with better expected post-PCI physiologic results and following clinical outcome would be that there has been no clear method to identify these patients in pre-PCI phase. In this regard, we hypothesized that the amount of FFR step-up in pre-PCI pullback recording would determine the physiologic nature of target stenosis. For example, stenosis with sufficient step-up of FFR would deserve local treatment with PCI and these lesions would result in higher percent FFR increase, post-PCI FFR, and better clinical outcome than those without sufficient amount of FFR step-up. For this, we sought to develop automated algorithm to define physiologic major stenosis versus minor stenosis using pre-PCI pullback recording.

Conditions

Ischemic Heart Disease

Keywords

fractional flow reserve; delta FFR per unit time; percutaneous coronary intervention; prognosis

Outcome Measures

Primary Outcomes (2)

• Percent FFR increase after PCI

  (\[Post-PCI FFR - Pre-PCI FFR\]/Pre-PCI FFR \* 100)

  Immediate post-PCI

• Post-PCI FFR

  FFR value measured after angiographically successful PCI

  Immediate post-PCI

Secondary Outcomes (1)

• Target Vessel Failure

  2 years after index procedure

Study Arms (1)

Pre PCI state

The current study will analyze the pre-PCI pullback recording and amount of FFR step-up. The association of the amount of FFR step-up with post-PCI percent FFR increase, post-PCI FFR, and clinical outcome at 2 years will be analyzed

Device: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention DEVICE

1. Pre-PCI FFR pullback recording was done with conventional system 2. Automated algorithm to calculate delta FFR per unit time was developed 3. PCI was performed using 2nd generation DES

Also known as: Fractional flow reserve

Pre PCI state

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who diagnosed obstructive coronary artery disease and evaluated by pre-PCI FFR measurement and pullback recording, then treated by DES with invasive physiologic evaluation at the index procedure.

You may qualify if:

• 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 pre-PCI FFR pullback recording
• available both post-PCI FFR measurement

You may not qualify if:

• unavailable pre-PCI FFR pullback recording
• unavailable post-PCI FFR measurement
• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Inje University Ilsan Paik Hospital: collaborator
• Keimyung University Dongsan Medical Center: collaborator
• Ulsan University Hospital: collaborator
• Sejong General Hospital: collaborator
• Seoul National University Hospital: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (2)

• 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.

  PMID: 34412795 DERIVED

• Lee SH, Shin D, Lee JM, Lefieux A, Molony D, Choi KH, Hwang D, Lee HJ, Jang HJ, Kim HK, Ha SJ, Kwak JJ, Park TK, Yang JH, Song YB, Hahn JY, Doh JH, Shin ES, Nam CW, Koo BK, Choi SH, Gwon HC. Automated Algorithm Using Pre-Intervention Fractional Flow Reserve Pullback Curve to Predict Post-Intervention Physiological Results. JACC Cardiovasc Interv. 2020 Nov 23;13(22):2670-2684. doi: 10.1016/j.jcin.2020.06.062. Epub 2020 Oct 14.

  PMID: 33069650 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: March 22, 2016
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

KR (1)