Clinical trial NCT04684043: Prognostic Implications of Physiologic Investigation After Revascularization With Stent
Official title: Prognostic Implications of Physiologic Investigation After Revascularization With Stent
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Disease
Keywords: fractional flow reserve
percutaneous coronary intervention
drug-eluting stent
coronary atherosclerosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Inje University Ilsan Paik Hospital, Goyang, South Korea
name: Nanjing First Hospital, Nanjing Medical University, Nanjing, China
name: Tsuchiura Kyodo General Hospital
name: McGovern Medical School at UTHealth and Memorial Hermann Hospital, TX, USA
name: Nagoya City University Graduate School of Medical Science, Nagoya, Japan
name: Rutgers Robert Wood Johnson Medical School
name: Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
name: San Raffaele Scientific Institute, Milan, Italy
name: Ajou University Hospital, Suwon, South Korea
name: University of Cincinnati
name: Kyoto Second Red Cross Hospital, Kyoto, Japan
name: Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
name: Tokyo Medical University Hachioji Medical Center, Tokyo, Japan
First posted: 2020-12-24
Enrollment: 5100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed description: This study population was incorporated from studies which were already published. Investigators will incorporate all known registries to the POST-PCI FLOW registry by requesting data from principal investigator of each registry.

Investigators will perform systemic review of the previous published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies. The electronic search strategy was complemented by manual examination of references cited by included articles, recent reviews, editorials, and meta-analyses. No restrictions were imposed on language, study period, or sample size. Searching key words included 'post', 'after', 'PCI', 'Percutaneous coronary intervention', 'coronary stenting', 'stenting', 'stent', 'stent implantation', 'FFR', and 'fractional flow reserve'.

Eligibility criteria: 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.

Primary outcomes:
measure: Target vessel failure
timeFrame: 2 years
Secondary outcomes:
measure: Cardiac death or myocardial infarction
timeFrame: 2 years
measure: Target vessel myocardial infarction
timeFrame: 2 years
measure: Target vessel revascularization
timeFrame: 2 years
Other outcomes:
measure: Cut-off value of post-PCI FFR
timeFrame: 2 years
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Select
Study officials:
affiliation: Seoul National University Hospital, Seoul, South Korea
name: Bon-Kwon Koo, MD, PhD
role: STUDY_CHAIR
affiliation: Inje University Ilsan Paik Hospital, Goyang, South Korea
name: Joon Hyung MD, PhD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanjing First Hospital, Nanjing Medical University, Nanjing, China
name: Shao-Liang Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tsuchiura Kyodo General Hospital
name: Tsunekazu Kakuta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGovern Medical School at UTHealth and Memorial Hermann Hospital, TX, USA
name: Nils P. Johnson, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Nagoya City University Graduate School of Medical Science, Nagoya, Japan
name: Tsuyoshi Ito, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers Robert Wood Johnson Medical School
name: Abdul Hakeem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
name: Bernard De Bruyne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Raffaele Scientific Institute, Milan, Italy
name: Lorenzo Azzalini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University Hospital, Suwon, South Korea
name: Hong-Seok Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Massoud A. Leesar, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyoto Second Red Cross Hospital, Kyoto, Japan
name: Akiko Matsuo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tokyo Medical University Hachioji Medical Center, Tokyo, Japan
name: Nobuhiro Tanaka, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
name: Joo Myung Lee, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. 2019 Aug 29;15(5):457-464. doi: 10.4244/EIJ-D-18-00913.
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.
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.
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.