POST-PCI FLOW: Prognostic Implications of Physiologic Investigation After Revascularization With Stent

Sponsor

Bon-Kwon Koo (Other)

Overall Status

Recruiting

CT.gov ID

NCT04684043

Collaborator

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

5,100

Enrollment

Location

9.5

Anticipated Duration (Months)

539

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 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.

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

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'.

Study Design

Study Type:

Observational

Anticipated Enrollment :

5100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Prognostic Implications of Physiologic Investigation After Revascularization With Stent

Actual Study Start Date :

May 16, 2020

Anticipated Primary Completion Date :

Feb 28, 2021

Anticipated Study Completion Date :

Feb 28, 2021

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

Target vessel failure [2 years]
A composite of cardiac death, target vessel myocardial infarction and target vessel revascularization

Secondary Outcome Measures

Cardiac death or myocardial infarction [2 years]
a composite of cardiac death and target vessel myocardial infarction
Target vessel myocardial infarction [2 years]
Target vessel revascularization [2 years]

Other Outcome Measures

Cut-off value of post-PCI FFR [2 years]
Define the best cut-off value for predicting the future adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 100 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul	Select	Korea, Republic of	03080

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
McGovern Medical School at UTHealth and Memorial Hermann Hospital, TX, USA
Nagoya City University Graduate School of Medical Science, Nagoya, Japan
Rutgers Robert Wood Johnson Medical School
Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
San Raffaele Scientific Institute, Milan, Italy
Ajou University Hospital, Suwon, South Korea
University of Cincinnati
Kyoto Second Red Cross Hospital, Kyoto, Japan
Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Tokyo Medical University Hachioji Medical Center, Tokyo, Japan

Investigators

Study Chair: Bon-Kwon Koo, MD, PhD, Seoul National University Hospital, Seoul, South Korea
Principal Investigator: Joon Hyung MD, PhD, MD, PhD, 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, PhD, Tsuchiura Kyodo General Hospital
Principal Investigator: Nils P. Johnson, MD, MS, McGovern Medical School at UTHealth and Memorial Hermann Hospital, TX, USA
Principal Investigator: Tsuyoshi Ito, MD, Nagoya City University Graduate School of Medical Science, Nagoya, Japan
Principal Investigator: Abdul Hakeem, MD, Rutgers Robert Wood Johnson Medical School
Principal Investigator: Bernard De Bruyne, MD, PhD, Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
Principal Investigator: Lorenzo Azzalini, MD, PhD, San Raffaele Scientific Institute, Milan, Italy
Principal Investigator: Hong-Seok Lim, MD, PhD, Ajou University Hospital, Suwon, South Korea
Principal Investigator: Massoud A. Leesar, MD, PhD, MSc, University of Cincinnati
Principal Investigator: Akiko Matsuo, MD, Kyoto Second Red Cross Hospital, Kyoto, Japan
Principal Investigator: Nobuhiro Tanaka, MD, PhD, MSc, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan
Principal Investigator: Joo Myung Lee, MD, PhD, MSc, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea