Prognostic Implications of Physiologic Investigation After Revascularization With Stent

NCT04684043 | Unknown DMC

• 1 other identifier: H-2009-042-1155
• Study Type: observational
• Target: 5,100
• 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 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, optimal cut-off values of post-PCI FFR ranged widely, from 0.86 to 0.96, and some study 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. To establish the clinical relevance of post-PCI FFR and to evaluate the useful cut-off value of post-PCI FFR in daily practice, investigators planned to incorporate all previous evidence of post-PCI FFR by collaboration with international researchers.

Conditions

Coronary Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Target vessel failure

  A composite of cardiac death, target vessel myocardial infarction and target vessel revascularization

  2 years

Secondary Outcomes (3)

• Cardiac death or myocardial infarction

  2 years

• Target vessel myocardial infarction

  2 years

• Target vessel revascularization

  2 years

Other Outcomes (1)

• Cut-off value of post-PCI FFR

  2 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: 20 Years - 100 Years
• Sex: all
• 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.

Articles were included when they met the following prespecified criteria: (1) included the patients who underwent PCI with drug-eluting stent (DES); (2) post-PCI FFR was measured after DES implantation; (3) pre-PCI FFR measurement was not mandatory for article inclusion; (4) patients were followed up at least 6 months; (5) clinical outcomes, including all-cause death, cardiac death, target vessel myocardial infarction (TVMI) or target vessel revascularization (TVR), were clearly reported; (6) randomized controlled trials or non-randomized prospective or retrospective registries were included. Two independent investigators screened titles and abstracts, identified duplicated studies, performed full-article reviews, and determined the studies' inclusion. The third investigator supervised the searching process and adjudicated all the disagreements. * Patients with life expectancy \< 2 years.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

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
• McGovern Medical School at UTHealth and Memorial Hermann Hospital, TX, USA: collaborator
• Nagoya City University Graduate School of Medical Science, Nagoya, Japan: collaborator
• Rutgers Robert Wood Johnson Medical School: collaborator
• Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium: collaborator
• San Raffaele Scientific Institute, Milan, Italy: collaborator
• Ajou University Hospital, Suwon, South Korea: collaborator
• University of Cincinnati: collaborator
• Kyoto Second Red Cross Hospital, Kyoto, Japan: collaborator
• Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea: collaborator
• Tokyo Medical University Hachioji Medical Center, Tokyo, Japan: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Select, 03080, South Korea

RECRUITING

Related Publications (8)

• 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

• 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

• Choi KH, Kwon W, Shin D, Lee SH, Hwang D, Zhang J, Nam CW, Shin ES, Doh JH, Chen SL, Kakuta T, Toth GG, Piroth Z, Hakeem A, Uretsky BF, Hokama Y, Tanaka N, Lim HS, Ito T, Matsuo A, Azzalini L, Leesar MA, Daemen J, Collison D, Collet C, De Bruyne B, Koo BK, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Differential Impact of Fractional Flow Reserve Measured After Coronary Stent Implantation by Left Ventricular Dysfunction. JACC Asia. 2023 Dec 12;4(3):229-240. doi: 10.1016/j.jacasi.2023.10.009. eCollection 2024 Mar.

  PMID: 38463680 DERIVED

• Yang S, Hwang D, Zhang J, Park J, Yun JP, Lee JM, Nam CW, Shin ES, Doh JH, Chen SL, Kakuta T, Toth GG, Piroth Z, Johnson NP, Hakeem A, Uretsky BF, Hokama Y, Tanaka N, Lim HS, Ito T, Matsuo A, Azzalini L, Leesar MA, Neleman T, van Mieghem NM, Diletti R, Daemen J, Collison D, Collet C, De Bruyne B, Koo BK. Clinical and Vessel Characteristics Associated With Hard Outcomes After PCI and Their Combined Prognostic Implications. J Am Heart Assoc. 2023 Sep 5;12(17):e030572. doi: 10.1161/JAHA.123.030572. Epub 2023 Aug 29.

  PMID: 37642032 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, PhD

  Seoul National University Hospital, Seoul, South Korea

  STUDY CHAIR

• Joon Hyung MD, PhD, MD, PhD

  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, PhD

  Tsuchiura Kyodo General Hospital

  PRINCIPAL INVESTIGATOR

• Nils P. Johnson, MD, MS

  McGovern Medical School at UTHealth and Memorial Hermann Hospital, TX, USA

  PRINCIPAL INVESTIGATOR

• Tsuyoshi Ito, MD

  Nagoya City University Graduate School of Medical Science, Nagoya, Japan

  PRINCIPAL INVESTIGATOR

• Abdul Hakeem, MD

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

• Bernard De Bruyne, MD, PhD

  Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium

  PRINCIPAL INVESTIGATOR

• Lorenzo Azzalini, MD, PhD

  San Raffaele Scientific Institute, Milan, Italy

  PRINCIPAL INVESTIGATOR

• Hong-Seok Lim, MD, PhD

  Ajou University Hospital, Suwon, South Korea

  PRINCIPAL INVESTIGATOR

• Massoud A. Leesar, MD, PhD, MSc

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

• Akiko Matsuo, MD

  Kyoto Second Red Cross Hospital, Kyoto, Japan

  PRINCIPAL INVESTIGATOR

• Nobuhiro Tanaka, MD, PhD, MSc

  Tokyo Medical University Hachioji Medical Center, Tokyo, Japan

  PRINCIPAL INVESTIGATOR

• Joo Myung Lee, MD, PhD, MSc

  Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bon-Kwon Koo, MD, PhD

CONTACT

82-2-2072-2062; bkkoo@snu.ac.kr

Doyeon Hwang, MD

CONTACT

82-10-7446-2779; cardiol.intv@gmail.com

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: December 22, 2020
• First Posted: December 24, 2020
• Study Start: May 16, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

KR (1)