International Post PCI FFR Registry

July 13, 2019 updated by: Bon-Kwon Koo, Seoul National University Hospital

International Post PCI FFR Registry for Prognostic Factors After Coronary Stenting

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2228

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who were diagnosed as obstructive coronary artery disease and treated by 2nd generation DES and measured post PCI FFR after PCI.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post PCI state
The study population of this study underwent percutaneous coronary intervention(PCI) with 2nd generation drug-eluting stent (DES) and measured fractional flow reserve after PCI
Device: Percutaneous coronary intervention
PCI was performed using 2nd generation DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discrimination index of prediction model for target-vessel failure
Time Frame: 2 years after index procedure

A 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.
2 years after index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Independent predictors for target vessel failure
Time Frame: 2 years after index procedure
Clinical, angiographic and physiologic covariables will be evaluated using machine learning for identifying the independent predictors (ex. random survival forest model).
2 years after index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

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

Investigators

  • Study Director: Bon-Kwon Koo, MD, PhD, Seoul National University Hospital
  • Principal Investigator: Joon Hyung Doh, MD, PhD, Inje University
  • Principal Investigator: Joo Myung Lee, MD, PhD, Samsung Medical Center
  • Principal Investigator: Shao-Liang Chen, MD, Nanjing First Hospital, Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2010

Primary Completion (Actual)

February 11, 2019

Study Completion (Actual)

March 28, 2019

Study Registration Dates

First Submitted

July 3, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 13, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1906-152-1044

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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