Prognostic Implications of Physiologic Investigation After Revascularization With Stent

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.

Conditions

• Coronary Disease

Interventions

DEVICE

Percutaneous coronary intervention

PCI was performed using drug-eluting stents

Sponsors & Collaborators

• Inje University Ilsan Paik Hospital, Goyang, South Korea

  collaborator UNKNOWN

• Nanjing First Hospital, Nanjing Medical University, Nanjing, China

  collaborator UNKNOWN

• Tsuchiura Kyodo General Hospital

  collaborator OTHER

• McGovern Medical School at UTHealth and Memorial Hermann Hospital, TX, USA

  collaborator UNKNOWN

• Nagoya City University Graduate School of Medical Science, Nagoya, Japan

  collaborator UNKNOWN

• Rutgers Robert Wood Johnson Medical School

  collaborator OTHER

• Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium

  collaborator UNKNOWN

• San Raffaele Scientific Institute, Milan, Italy

  collaborator UNKNOWN

• Ajou University Hospital, Suwon, South Korea

  collaborator UNKNOWN

• University of Cincinnati

  collaborator OTHER

• Kyoto Second Red Cross Hospital, Kyoto, Japan

  collaborator UNKNOWN

• Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

  collaborator UNKNOWN

• Tokyo Medical University Hachioji Medical Center, Tokyo, Japan

  collaborator UNKNOWN

• Bon-Kwon Koo

  lead OTHER

Principal Investigators

• Bon-Kwon Koo, MD, PhD · Seoul National University Hospital, Seoul, South Korea

• Joon Hyung MD, PhD, MD, PhD · Inje University Ilsan Paik Hospital, Goyang, South Korea

• Shao-Liang Chen, MD · Nanjing First Hospital, Nanjing Medical University, Nanjing, China

• Tsunekazu Kakuta, MD, PhD · Tsuchiura Kyodo General Hospital

• Nils P. Johnson, MD, MS · McGovern Medical School at UTHealth and Memorial Hermann Hospital, TX, USA

• Tsuyoshi Ito, MD · Nagoya City University Graduate School of Medical Science, Nagoya, Japan

• Abdul Hakeem, MD · Rutgers Robert Wood Johnson Medical School

• Bernard De Bruyne, MD, PhD · Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium

• Lorenzo Azzalini, MD, PhD · San Raffaele Scientific Institute, Milan, Italy

• Hong-Seok Lim, MD, PhD · Ajou University Hospital, Suwon, South Korea

• Massoud A. Leesar, MD, PhD, MSc · University of Cincinnati

• Akiko Matsuo, MD · Kyoto Second Red Cross Hospital, Kyoto, Japan

• Nobuhiro Tanaka, MD, PhD, MSc · Tokyo Medical University Hachioji Medical Center, Tokyo, Japan

• Joo Myung Lee, MD, PhD, MSc · Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

Eligibility

Min Age

20 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-16

Primary Completion

2021-02-28

Completion

2021-02-28

Countries

• South Korea

Study Locations