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Prognostic Implications of Physiologic Investigation After Revascularization With Stent

Prognostic Implications of Physiologic Investigation After Revascularization With Stent

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04684043
Acronym
POST-PCI FLOW
Enrollment
5100
Registered
2020-12-24
Start date
2020-05-16
Completion date
2021-02-28
Last updated
2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease

Keywords

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

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'.

Interventions

DEVICEPercutaneous coronary intervention

PCI was performed using drug-eluting stents

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 100 Years

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Target vessel failure2 yearsA composite of cardiac death, target vessel myocardial infarction and target vessel revascularization

Secondary

MeasureTime frameDescription
Cardiac death or myocardial infarction2 yearsa composite of cardiac death and target vessel myocardial infarction
Target vessel myocardial infarction2 years
Target vessel revascularization2 years

Other

MeasureTime frameDescription
Cut-off value of post-PCI FFR2 yearsDefine the best cut-off value for predicting the future adverse events

Countries

South Korea

Contacts

Primary ContactBon-Kwon Koo, MD, PhD
bkkoo@snu.ac.kr82-2-2072-2062
Backup ContactDoyeon Hwang, MD
cardiol.intv@gmail.com82-10-7446-2779

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026