Prognostic Perspective of Invasive Hyperemic and Non-Hyperemic Physiologic Indices Measured After Percutaneous Coronary Intervention

NCT04265443 | Completed DMC

• 1 other identifier: POSTPCI_NHPRs20200206
• Study Type: observational
• Target: 588
• Locations: 1 country
• Sites: 5

Brief Summary

Coronary physiologic assessments by the pressure-derived fractional flow reserve (FFR) have become standard methods for identifying hemodynamic deprivation in coronary arterial stenosis for evidence-based percutaneous coronary intervention (PCI). Invasive physiologic indices-guidance enables on-site real time assessment for functional significance of epicardial coronary stenosis and the use of those indices has shown to be effective to guide treatment decision. Several studies further support the role of post-PCI FFR measurement as a functional marker of residual disease after PCI and prognostic indicator of patients. Although optimal cut-off values of post-PCI FFR varied across studies, an inverse relationship between post-PCI FFR and the risk of future clinical events have been reported consistently. Recently, non-hyperemic pressure ratios (NHPRs) have been introduced in clinical practice. Although there are several different NHPRs, previous studies consistently indicated that those NHPRs shares similar diagnostic performance and prognostic implications. Nevertheless, few reports were available for clinical relevance of NHPRs in evaluation of post-PCI status. In this context, we will evaluate the physiologic characteristics and prognostic implication of post-PCI NHPRs and compare with those of post-PCI FFR in patients who underwent angiographically successful PCI with 2nd generation drug-eluting stent implantation (DES).

Conditions

Ischemic Heart Disease

Keywords

fractional flow reserve; non-hyperemic pressure ratio; percutaneous coronary intervention; prognosis; myocardial ischemia

Outcome Measures

Primary Outcomes (1)

• Target Vessel Failure

  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 Outcomes (3)

• independent predictors for target-vessel failure

  2 years after index procedure

• delta FFR per unit time

  At the time of index procedure

• Relative percent increase of physiologic indices

  At the time of index procedure

Study Arms (1)

Post PCI state

The study population of this study underwent percutaneous coronary intervention(PCI) with 2nd generation drug-eluting stent (DES) and measured invasive physiologic indices after PCI

Device: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention DEVICE

PCI was performed using 2nd generation DES

Post PCI state

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who diagnosed obstructive coronary artery disease and treated by DES with invasive physiologic evaluation at the index procedure

You may qualify if:

• any patient meets eligible criteria who underwent PCI with DES followed by invasive physiologic assessment at the index procedure
• available both post-PCI resting pressure tracing and FFR

You may not qualify if:

• culprit vessel of acute coronary syndrome
• failed achieving TIMI 3 flow at the end of PCI
• left ventricular ejection fraction \<30%
• graft vessel
• collateral feeder
• in-stent restenosis
• primary myocardial or valvular heart disease
• in patient whose life expectancy less than 2 years
• visible thrombus of target vessel segment
• unmeasured post-PCI resting pressure tracings

Sponsors & Collaborators

• Samsung Medical Center: lead
• Inje University Ilsan Paik Hospital: collaborator
• Ulsan University Hospital: collaborator
• Sejong General Hospital: collaborator
• Chosun University Hospital: collaborator

Study Sites (5)

Sejong General Hospital

Bucheon-si, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, South Korea

Location

Chosun University Hospital

Gwangju, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Ulsan Medical Center

Ulsan, South Korea

Location

Related Publications (2)

• Lee JM, Joh HS, Choi KH, Hong D, Park TK, Yang JH, Song YB, Choi JH, Choi SH, Jeong JO, Lee JY, Choi YJ, Chae JK, Hur SH, Bae JW, Oh JH, Chun KJ, Kim HJ, Cho BR, Shin D, Lee SH, Hwang D, Lee HJ, Jang HJ, Kim HK, Ha SJ, Shin ES, Doh JH, Hahn JY, Gwon HC; SMART-REWARD Investigators. Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice. J Korean Med Sci. 2023 Feb 6;38(5):e34. doi: 10.3346/jkms.2023.38.e34.

  PMID: 36747363 DERIVED

• Shin D, Lee SH, Lee JM, Choi KH, Hwang D, Lee HJ, Jang HJ, Kim HK, Kwak JJ, Ha SJ, Song YB, Shin ES, Doh JH. Prognostic Implications of Post-Intervention Resting Pd/Pa and Fractional Flow Reserve in Patients With Stent Implantation. JACC Cardiovasc Interv. 2020 Aug 24;13(16):1920-1933. doi: 10.1016/j.jcin.2020.05.042.

  PMID: 32819481 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Joo Myung Lee, MD, MPH, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 11, 2020
• Study Start: May 13, 2013
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

KR (5)