International Post PCI FFR Registry

Coronary Disease Clinical Trial

Official title:

International Post PCI FFR Registry for Prognostic Factors After Coronary Stenting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012281
• Other study ID #: 1906-152-1044
• Status: Completed
• Start date: August 17, 2010
• Est. completion date: March 28, 2019

Study information

• Verified date: July 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The prognostic factors after a percutaneous coronary intervention (PCI) have not been comprehensively investigated. The investigators sought to develop a risk model to predict future clinical events after PCI using contemporary coronary stents.

Description:

Percutaneous coronary intervention (PCI) is a standard treatment strategy for coronary artery disease (CAD). With the presence of myocardial ischemia, PCI reduces the risks of death, myocardial infarction (MI) and revascularization compared to medical therapy. However, the risk of future clinical events still remain high and about 10% of patients experienced further cardiovascular events after PCI. There are several factors that are associated with these poor outcomes. Known patient-related risk factors are diabetes mellitus, chronic kidney disease, left ventricular dysfunction, previous MI and presentation with the acute coronary syndrome. Procedure-related factors, such as stent underexpension, malapposition, edge dissection, the number of the used stent and total stent length, are also related to poor prognosis after PCI. Recent studies reported that fractional flow reserve (FFR) after coronary stenting, or post PCI FFR, was associated with future clinical outcomes after PCI and low post PCI FFR value was associated with procedural factors. However, all of these risk factors were identified in individual studies there have been no studies that comprehensively evaluated these risk factors. Therefore, the investigators sought to investigate the risk predictors of future clinical events in patients after PCI and develop a risk model, incorporating clinical, angiographic, and physiologic factors, to predict the clinical events after PCI using contemporary coronary stents.

The study population of this study is from the International Post PCI FFR Registry, which included 4 different registries from Korea, China, and Japan. All patients in this registry are available with clinical, angiographic and physiologic data and used 2nd generation drug-eluting stent (DES) for PCI. The COE-PERSPECTIVE registry (NCT01873560) was designed to evaluate the clinical relevance of post PCI FFR from 9 hospitals in Korea and Japan and enrolled a total of 835 patients available post PCI FFR value after angiographically successful PCI between May 2013 and December 2016. The 3V-FFR-FRIENDS registry (NCT01621438) enrolled a total of 1,136 patients (3,298 vessels) who underwent 3-vessel FFR measurements from 12 centers in Korea, Japan, and China between November 2011 and March 2014. Among them, 266 patients with 337 vessels who measure post PCI FFR values were included in this international registry. The DKCRUSH VII registry (ChiCTR-PRCH-12001976) enrolled a total of 1,476 patients from 9 hospitals (5 hospitals in China, 2 hospitals in the United States, 1 hospital in Asia and 1 hospital in European country) between May 2012 and September 2013 to evaluate the prognostic value of post PCI FFR on patients' future outcome. For this international registry, 780 patients with 794 vessels from Nanjing First Hospital in China, who were available with whole clinical, angiographic and physiologic data, were included in this registry. Last, the Institutional registry of Tsuchiura Kyodo General Hospital, Ibaraki, Japan included 347 patients (357 vessels) who underwent PCI and final post-PCI FFR measurement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2228
• Est. completion date: March 28, 2019
• Est. primary completion date: February 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients who underwent PCI and post-PCI FFR measurements after angiographically successful stent implantation (residual stenosis < 20% by visual estimation)

• Patients who provided informed consent

Exclusion Criteria:

• Post-PCI TIMI flow of < 3

• Depressed left ventricular systolic function (ejection fraction < 30%)

• Culprit lesion for acute coronary syndrome

• Graft vessel

• Collateral feeder

• In-stent stenosis

• Primary myocardial or valvular heart disease

• Patients with life expectancy < 2 years.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• Percutaneous coronary intervention
PCI was performed using 2nd generation DES

Locations

Country	Name	City	State
n/a

Sponsors (12)

Lead Sponsor	Collaborator
Seoul National University Hospital	Busan Veterans General Hospital, Gifu Heart Center, Inje University, Japanese Red Cross Kyoto Daini Hospital, Keimyung University Dongsan Medical Center, Samsung Medical Center, Sejong General Hospital, The First Affiliated Hospital with Nanjing Medical University, Tokyo Medical University, Tsuchiura Kyodo General Hospital, Ulsan University Hospital

References & Publications (6)

Fearon WF, Nishi T, De Bruyne B, Boothroyd DB, Barbato E, Tonino P, Jüni P, Pijls NHJ, Hlatky MA; FAME 2 Trial Investigators. Clinical Outcomes and Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease: Three-Year Follow-Up of the FAME 2 Trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation). Circulation. 2018 Jan 30;137(5):480-487. doi: 10.1161/CIRCULATIONAHA.117.031907. Epub 2017 Nov 2. — View Citation

Hwang D, Lee JM, Lee HJ, Kim SH, Nam CW, Hahn JY, Shin ES, Matsuo A, Tanaka N, Matsuo H, Lee SY, Doh JH, Koo BK. Influence of Target Vessel on Prognostic Relevance of Fractional Flow Reserve After Coronary Stenting. EuroIntervention. 2018 Dec 18. pii: EIJ-D-18-00913. doi: 10.4244/EIJ-D-18-00913. [Epub ahead of print] — View Citation

Li SJ, Ge Z, Kan J, Zhang JJ, Ye F, Kwan TW, Santoso T, Yang S, Sheiban I, Qian XS, Tian NL, Rab TS, Tao L, Chen SL. Cutoff Value and Long-Term Prediction of Clinical Events by FFR Measured Immediately After Implantation of a Drug-Eluting Stent in Patients With Coronary Artery Disease: 1- to 3-Year Results From the DKCRUSH VII Registry Study. JACC Cardiovasc Interv. 2017 May 22;10(10):986-995. doi: 10.1016/j.jcin.2017.02.012. Epub 2017 Apr 26. — View Citation

Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Jüni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group . 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. — View Citation

Rimac G, Fearon WF, De Bruyne B, Ikeno F, Matsuo H, Piroth Z, Costerousse O, Bertrand OF. Clinical value of post-percutaneous coronary intervention fractional flow reserve value: A systematic review and meta-analysis. Am Heart J. 2017 Jan;183:1-9. doi: 10.1016/j.ahj.2016.10.005. Epub 2016 Oct 11. Review. — View Citation

van Zandvoort LJC, Masdjedi K, Witberg K, Ligthart J, Tovar Forero MN, Diletti R, Lemmert ME, Wilschut J, de Jaegere PPT, Boersma E, Zijlstra F, Van Mieghem NM, Daemen J. Explanation of Postprocedural Fractional Flow Reserve Below 0.85. Circ Cardiovasc Interv. 2019 Feb;12(2):e007030. doi: 10.1161/CIRCINTERVENTIONS.118.007030. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discrimination index of prediction model for target-vessel failure	A risk model for target-vessel failure, incorporating clinical, angiographic, and additional physiologic predictors, will be developed using this cohort.; Target vessel failure is a composite of cardiac death, clinically-driven target vessel-related myocardial infarction, and clinically-driven target vessel revascularization. The target vessel will be defined as the treated vessel with 2nd generation DES which was assessed by post stent fractional flow reserve.	2 years after index procedure
Secondary	Independent predictors for target vessel failure	Clinical, angiographic and physiologic covariables will be evaluated using machine learning for identifying the independent predictors (ex. random survival forest model).	2 years after index procedure