Prognostic Implications of Physiologic Investigation After Revascularization With Stent

Coronary Disease Clinical Trial

— POST-PCI FLOW  

Official title:

Prognostic Implications of Physiologic Investigation After Revascularization With Stent

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04684043
• Other study ID #: H-2009-042-1155
• Status: Recruiting
• Start date: May 16, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: February 2021
• Source: Seoul National University Hospital
• Contact: Bon-Kwon Koo, MD, PhD
• Phone: 82-2-2072-2062
• Email: bkkoo[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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'.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5100
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Disease

Intervention

Device:
• Percutaneous coronary intervention
PCI was performed using drug-eluting stents

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Select

Sponsors (14)

Lead Sponsor

Collaborator

Bon-Kwon Koo

Ajou University Hospital, Suwon, South Korea, Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium, Inje University Ilsan Paik Hospital, Goyang, South Korea, Kyoto Second Red Cross Hospital, Kyoto, Japan, McGovern Medical School at UTHealth and Memorial Hermann Hospital, TX, USA, Nagoya City University Graduate School of Medical Science, Nagoya, Japan, Nanjing First Hospital, Nanjing Medical University, Nanjing, China, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, San Raffaele Scientific Institute, Milan, Italy, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan, Tsuchiura Kyodo General Hospital, Ibaraki, Japan, University of Cincinnati, Cincinnati, OH, USA

Country where clinical trial is conducted

Korea, Republic of, 

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. 2019 Aug 29;15(5):457-464. doi: 10.4244/EIJ-D-18-00913. — 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. Erratum in: Eur Heart J. 2019 Oct 1;40(37):3096. — 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
Other	Cut-off value of post-PCI FFR	Define the best cut-off value for predicting the future adverse events	2 years
Primary	Target vessel failure	A composite of cardiac death, target vessel myocardial infarction and target vessel revascularization	2 years
Secondary	Cardiac death or myocardial infarction	a composite of cardiac death and target vessel myocardial infarction	2 years
Secondary	Target vessel myocardial infarction		2 years
Secondary	Target vessel revascularization		2 years