International Post-PCI FFR Extended Registry

NCT05672862 | Completed DMC

• 1 other identifier: H-2108-211-1251
• Study Type: observational
• Target: 2,128
• Locations: 1 country
• Sites: 1

Brief Summary

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 remains high, and about 10% of patients experienced further cardiovascular events after PCI. Several factors are associated with these poor outcomes. Well-known patient-related risk factors are diabetes mellitus, chronic kidney disease, left ventricular dysfunction, previous MI, and presentation with acute coronary syndrome. Procedure-related factors, such as stent under expansion, malposition, 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, optimal cut-off values of post-PCI FFR ranged widely, from 0.86 to 0.96, and some studies reported the limited prognostic value of post-PCI FFR. This might result from differences in study populations, the definition of outcomes, type of stent used, and distribution of included vessels among previous studies. Previously, the investigators incorporated previous data into the International Post-PCI FFR registry and demonstrated the prognostic value of post-PCI FFR using the machine learning technique. However, the results were based on the two years follow-up of patients after PCI, and the prognostic value of post-PCI FFR in long-term outcomes is still uncertain. Therefore, the investigators planned to extend the International Post-PCI FFR registry to define the long-term prognostic implication of post-PCI FFR.

Conditions

Coronary Disease

Keywords

fractional flow reserve; percutaneous coronary intervention; drug-eluting stent; coronary atherosclerosis

Outcome Measures

Primary Outcomes (1)

• The cumulative incidence (percent) of target vessel failure

  Target vessel failure is a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization. The cumulative incidence will be calculated as Kaplan-Mier estimates at 5 years.

  5 years

Secondary Outcomes (3)

• The cumulative incidence (percent) of cardiac death or myocardial infarction

  5 years

• The cumulative incidence (percent) of target vessel myocardial infarction

  5 years

• The cumulative incidence (percent) of target vessel revascularization

  5 years

Other Outcomes (1)

• Cut-off value of post-PCI FFR

  5 years

Study Arms (1)

Post PCI state

The study population of this study underwent percutaneous coronary intervention(PCI) with drug-eluting stent (DES) and measured fractional flow reserve after PCI.

Device: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention DEVICE

PCI was performed using drug-eluting stents

Post PCI state

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were diagnosed as obstructive coronary artery disease and treated by DES and measured post PCI FFR after PCI.

You may qualify if:

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

You may not qualify if:

• Post-PCI TIMI (The Thrombolysis In Myocardial Infarction) flow of \< 3
• Depressed left ventricular systolic function (ejection fraction \< 30%)
• Culprit lesion for the acute coronary syndrome
• Graft vessel
• Collateral feeder
• In-stent stenosis
• Primary myocardial or valvular heart disease
• Patients with life expectancy \< 2 years.

Sponsors & Collaborators

• Bon-Kwon Koo: lead
• Inje University Ilsan Paik Hospital, Goyang, South Korea: collaborator
• Nanjing First Hospital, Nanjing Medical University, Nanjing, China: collaborator
• Tsuchiura Kyodo General Hospital: collaborator
• Gifu Heart Center, Gifu, Japan: collaborator
• Keimyung University Dongsan Medical Center, Daegu, South Korea: collaborator
• Ulsan University Hospital, Ulsan, South Korea: collaborator
• Samsung Medical Center: collaborator
• Kyoto Second Red Cross Hospital, Kyoto, Japan: collaborator
• Sejong General Hospital: collaborator

Study Sites (1)

Bon-Kwon Koo

Seoul, South Korea

Location

Related Publications (10)

• Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni 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. No abstract available.

  PMID: 30165437 BACKGROUND

• Fearon WF, Nishi T, De Bruyne B, Boothroyd DB, Barbato E, Tonino P, Juni 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.

  PMID: 29097450 BACKGROUND

• Montalescot G, Brieger D, Dalby AJ, Park SJ, Mehran R. Duration of Dual Antiplatelet Therapy After Coronary Stenting: A Review of the Evidence. J Am Coll Cardiol. 2015 Aug 18;66(7):832-847. doi: 10.1016/j.jacc.2015.05.053.

  PMID: 26271067 BACKGROUND

• 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. 2019 Aug 29;15(5):457-464. doi: 10.4244/EIJ-D-18-00913.

  PMID: 30561367 BACKGROUND

• 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.

  PMID: 28456699 BACKGROUND

• 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.

  PMID: 27979031 BACKGROUND

• 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.

  PMID: 30732469 BACKGROUND

• Piroth Z, Toth GG, Tonino PAL, Barbato E, Aghlmandi S, Curzen N, Rioufol G, Pijls NHJ, Fearon WF, Juni P, De Bruyne B. Prognostic Value of Fractional Flow Reserve Measured Immediately After Drug-Eluting Stent Implantation. Circ Cardiovasc Interv. 2017 Aug;10(8):e005233. doi: 10.1161/CIRCINTERVENTIONS.116.005233.

  PMID: 28790165 BACKGROUND

• Hwang D, Lee JM, Yang S, Chang M, Zhang J, Choi KH, Kim CH, Nam CW, Shin ES, Kwak JJ, Doh JH, Hoshino M, Hamaya R, Kanaji Y, Murai T, Zhang JJ, Ye F, Li X, Ge Z, Chen SL, Kakuta T, Koo BK. Role of Post-Stent Physiological Assessment in a Risk Prediction Model After Coronary Stent Implantation. JACC Cardiovasc Interv. 2020 Jul 27;13(14):1639-1650. doi: 10.1016/j.jcin.2020.04.041.

  PMID: 32703590 BACKGROUND

• Hwang D, Chung J, Yang S, Shin ES, Nam CW, Lee HJ, Matsuo H, Lee JM, Shiraishi J, Matsuo A, Doh JH, Chen SL, Kakuta T, Koo BK. Long-Term and Temporal Relationships Between Post-Stent Fractional Flow Reserve and Clinical Outcomes. JACC Cardiovasc Interv. 2025 Dec 8;18(23):2863-2874. doi: 10.1016/j.jcin.2025.09.034.

  PMID: 41371783 DERIVED

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Bon-Kwon Koo, MD

  Seoul National University Hospital, Seoul, South Korea

  STUDY CHAIR

• Joon-Hyung Doh, MD

  Inje University Ilsan Paik Hospital, Goyang, South Korea

  PRINCIPAL INVESTIGATOR

• Shao-Liang Chen, MD

  Nanjing First Hospital, Nanjing Medical University, Nanjing, China

  PRINCIPAL INVESTIGATOR

• Tsunekazu Kakuta, MD

  Tsuchiura Kyodo General Hospital

  PRINCIPAL INVESTIGATOR

• Hitoshi Matsuo, MD

  Gifu Heart Center, Gifu, Japan

  PRINCIPAL INVESTIGATOR

• Chang-Wook Nam, MD

  Keimyung University Dongsan Medical Center, Daegu, South Korea

  PRINCIPAL INVESTIGATOR

• Eun-Seok Shin, MD

  Ulsan University Hospital, Ulsan, South Korea

  PRINCIPAL INVESTIGATOR

• Joo Myung Lee, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Akiko Matsuo, MD

  Kyoto Second Red Cross Hospital, Kyoto, Japan

  PRINCIPAL INVESTIGATOR

• Hyun-Jong Lee, MD

  Sejong General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: January 5, 2023
• Study Start: September 6, 2021
• Primary Completion: May 30, 2022
• Study Completion: December 31, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

KR (1)