International Post-PCI FFR Extended Registry

Sponsor

Bon-Kwon Koo (Other)

Overall Status

Completed

CT.gov ID

NCT05672862

Collaborator

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

2,128

Enrollment

Location

15.8

Actual Duration (Months)

134.7

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease	Device: Percutaneous coronary intervention

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 measured 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. As the current study will evaluate clinical outcomes at 5 years, 2,128 patients who underwent PCI and measured post-PCI FFR between June 2011 and Nov 2016 will be included and studied. 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 Design

Study Type:

Observational

Actual Enrollment :

2128 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 6, 2021

Actual Primary Completion Date :

May 30, 2022

Actual Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

The cumulative incidence (percent) of target vessel failure [5 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 5 years.

Secondary Outcome Measures

The cumulative incidence (percent) of cardiac death or myocardial infarction [5 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 5 years.
The cumulative incidence (percent) of target vessel myocardial infarction [5 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 5 years.
The cumulative incidence (percent) of target vessel revascularization [5 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 5 years.

Other Outcome Measures

Cut-off value of post-PCI FFR [5 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bon-Kwon Koo	Seoul		Korea, Republic of

Sponsors and Collaborators

Bon-Kwon Koo
Inje University Ilsan Paik Hospital, Goyang, South Korea
Nanjing First Hospital, Nanjing Medical University, Nanjing, China
Tsuchiura Kyodo General Hospital
Gifu Heart Center, Gifu, Japan
Keimyung University Dongsan Medical Center, Daegu, South Korea
Ulsan University Hospital, Ulsan, South Korea
Samsung Medical Center
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: Shao-Liang Chen, MD, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
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: Akiko Matsuo, MD, Kyoto Second Red Cross Hospital, Kyoto, Japan
Principal Investigator: Hyun-Jong Lee, MD, Sejong General Hospital, Bucheon, South Korea