International Post-PCI FFR Extended Registry

January 12, 2023 updated by: Bon-Kwon Koo

International Post-PCI FFR Registry for Extended Follow up Outcomes After Coronary Stenting

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 acute coronary syndrome. Procedure-related factors, such as stent under expansion, malposition, 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 studies 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. Previously, the investigators incorporated previous data into the International Post-PCI FFR registry and demonstrated the prognostic value of post-PCI FFR using the machine learning technique. However, the results were based on the two years follow-up of patients after PCI, and the prognostic value of post-PCI FFR in long-term outcomes is still uncertain. Therefore, the investigators planned to extend the International Post-PCI FFR registry to define the long-term prognostic implication of post-PCI FFR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators planned to extend the International Post-PCI FFR registry (NCT04684043) to explore the long-term prognostic value of post-PCI FFR. The International Post-PCI FFR registry (NCT04684043) already included the 2,200 patients who underwent PCI and measure post-PCI FFR between June 2011 and May 2018. As the clinical, angiographic, and physiologic data are already collected in the International Post PCI FFR registry, the investigators will further collect the most recent clinical outcome data until 2021.5 and incorporate them into the International Post-PCI FFR Extended registry. The investigators will request further clinical outcome data from 10 hospitals that provided the data for the International Post-PCI FFR registry before.

A standardized form of a spreadsheet, including standardized definitions of variables, was used to collect the individual patient data from the principal investigators of each qualified registry. Patient clinical, angiographic, and physiologic data at the time of index PCI were recorded and already collected at Seoul National University Hospital. As clinical outcome data of 2 years of follow-up after index PCI are already collected in the International Post-PCI FFR registry (NCT04684043), clinical outcome data after 2 years of index PCI will be collected by medical records until 2021.5 of each hospital. All submitted data were double-checked by a central monitoring team in Seoul National University Hospital. All patients' identifying numbers are anonymized as "Subject_No" and the investigators will request the patients' clinical outcome data using these anonymized identifying numbers of the patients. Also, the investigators will share collected data with collaborators, using these numbers.

Study Type

Observational

Enrollment (Actual)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

19 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 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)

Exclusion Criteria:

  • Post-PCI TIMI (The Thrombolysis In Myocardial Infarction) flow of < 3
  • Depressed left ventricular systolic function (ejection fraction < 30%)
  • Culprit lesion for the 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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cumulative incidence (percent) of target vessel failure
Time Frame: 6 years

Target vessel failure is a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization.

The cumulative incidence will be calculated as Kaplan-Mier estimates at 6 years.
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cumulative incidence (percent) of cardiac death or myocardial infarction
Time Frame: 6 years

This outcome is a composite of cardiac death and target vessel myocardial infarction.

The cumulative incidence will be calculated as Kaplan-Mier estimates at 6 years.
6 years
The cumulative incidence (percent) of target vessel myocardial infarction
Time Frame: 6 years

Target vessel myocardial infarction is myocardial infarction that occurred in the target vessel in which post-PCI FFR was measured.

The cumulative incidence will be calculated as Kaplan-Mier estimates at 6 years.
6 years
The cumulative incidence (percent) of target vessel revascularization
Time Frame: 6 years

Target vessel revascularization is a revascularization event in the target vessel in which post-PCI FFR was measured.

The cumulative incidence will be calculated as Kaplan-Mier estimates at 6 years.
6 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cut-off value of post-PCI FFR
Time Frame: 6 years

Define the best cut-off value for predicting future adverse events.

The optimal cut-off value of post-PCI FFR for predicting outcomes was calculated based on maximizing the difference of log-rank statistics.
6 years

Collaborators and Investigators

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

Sponsor

Bon-Kwon Koo

Collaborators

Samsung Medical Center
Tsuchiura Kyodo General Hospital
Inje University Ilsan Paik Hospital, Goyang, South Korea
Nanjing First Hospital, Nanjing Medical University, Nanjing, China
Gifu Heart Center, Gifu, Japan
Keimyung University Dongsan Medical Center, Daegu, South Korea
Ulsan University Hospital, Ulsan, South Korea
Kyoto Second Red Cross Hospital, Kyoto, Japan
Sejong General Hospital, Bucheon, South Korea

Investigators

  • Study Chair: Bon-Kwon Koo, MD, Seoul National University Hospital, Seoul, South Korea
  • Principal Investigator: Joon-Hyung Doh, MD, Inje University Ilsan Paik Hospital, Goyang, South Korea
  • Principal Investigator: Tsunekazu Kakuta, MD, Tsuchiura Kyodo General Hospital
  • Principal Investigator: Hitoshi Matsuo, MD, Gifu Heart Center, Gifu, Japan
  • Principal Investigator: Chang-Wook Nam, MD, Keimyung University Dongsan Medical Center, Daegu, South Korea
  • Principal Investigator: Eun-Seok Shin, MD, Ulsan University Hospital, Ulsan, South Korea
  • Principal Investigator: Joo Myung Lee, MD, Samsung Medical Center
  • Principal Investigator: Hyun-Jong Lee, MD, Sejong General Hospital, Bucheon, South Korea

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)

September 6, 2021

Primary Completion (Actual)

May 30, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

November 4, 2021

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2108-211-1251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

This issue has to be discussed with collaborators.

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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