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International Post PCI FFR Registry

International Post PCI FFR Registry for Prognostic Factors After Coronary Stenting

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04012281
Enrollment
2228
Registered
2019-07-09
Start date
2010-08-17
Completion date
2019-03-28
Last updated
2019-07-16

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

Conditions

Coronary Disease

Keywords

drug eluting stent, coronary atherosclerosis

Brief summary

The prognostic factors after a percutaneous coronary intervention (PCI) have not been comprehensively investigated. The investigators sought to develop a risk model to predict future clinical events after PCI using contemporary coronary stents.

Detailed description

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 still remain high and about 10% of patients experienced further cardiovascular events after PCI. There are several factors that are associated with these poor outcomes. 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, all of these risk factors were identified in individual studies there have been no studies that comprehensively evaluated these risk factors. Therefore, the investigators sought to investigate the risk predictors of future clinical events in patients after PCI and develop a risk model, incorporating clinical, angiographic, and physiologic factors, to predict the clinical events after PCI using contemporary coronary stents. The study population of this study is from the International Post PCI FFR Registry, which included 4 different registries from Korea, China, and Japan. All patients in this registry are available with clinical, angiographic and physiologic data and used 2nd generation drug-eluting stent (DES) for PCI. The COE-PERSPECTIVE registry (NCT01873560) was designed to evaluate the clinical relevance of post PCI FFR from 9 hospitals in Korea and Japan and enrolled a total of 835 patients available post PCI FFR value after angiographically successful PCI between May 2013 and December 2016. The 3V-FFR-FRIENDS registry (NCT01621438) enrolled a total of 1,136 patients (3,298 vessels) who underwent 3-vessel FFR measurements from 12 centers in Korea, Japan, and China between November 2011 and March 2014. Among them, 266 patients with 337 vessels who measure post PCI FFR values were included in this international registry. The DKCRUSH VII registry (ChiCTR-PRCH-12001976) enrolled a total of 1,476 patients from 9 hospitals (5 hospitals in China, 2 hospitals in the United States, 1 hospital in Asia and 1 hospital in European country) between May 2012 and September 2013 to evaluate the prognostic value of post PCI FFR on patients' future outcome. For this international registry, 780 patients with 794 vessels from Nanjing First Hospital in China, who were available with whole clinical, angiographic and physiologic data, were included in this registry. Last, the Institutional registry of Tsuchiura Kyodo General Hospital, Ibaraki, Japan included 347 patients (357 vessels) who underwent PCI and final post-PCI FFR measurement.

Interventions

DEVICEPercutaneous coronary intervention

PCI was performed using 2nd generation DES

Sponsors

The First Affiliated Hospital with Nanjing Medical University
CollaboratorOTHER
Tsuchiura Kyodo General Hospital
CollaboratorOTHER
Keimyung University Dongsan Medical Center
CollaboratorOTHER
Ulsan University Hospital
CollaboratorOTHER
Busan Veterans General Hospital
CollaboratorUNKNOWN
Samsung Medical Center
CollaboratorOTHER
Sejong General Hospital
CollaboratorOTHER
Tokyo Medical University
CollaboratorOTHER
Gifu Heart Center
CollaboratorOTHER
Japanese Red Cross Kyoto Daini Hospital
CollaboratorUNKNOWN
Inje University
CollaboratorOTHER
Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Discrimination index of prediction model for target-vessel failure2 years after index procedureA risk model for target-vessel failure, incorporating clinical, angiographic, and additional physiologic predictors, will be developed using this cohort. Target vessel failure is a composite of cardiac death, clinically-driven target vessel-related myocardial infarction, and clinically-driven target vessel revascularization. The target vessel will be defined as the treated vessel with 2nd generation DES which was assessed by post stent fractional flow reserve.

Secondary

MeasureTime frameDescription
Independent predictors for target vessel failure2 years after index procedureClinical, angiographic and physiologic covariables will be evaluated using machine learning for identifying the independent predictors (ex. random survival forest model).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026