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

Ischemic Heart Disease Clinical Trial

— PERSPECTIVEPCI  

Official title:

Prognostic Perspective of Invasive Hyperemic and Non-Hyperemic Physiologic Indices Measured After Percutaneous Coronary Intervention (PERSPECTIVE-PCI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265443
• Other study ID #: POSTPCI_NHPRs20200206
• Status: Completed
• Start date: May 13, 2013
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Patients who diagnosed significant coronary artery disease and treated by 2nd generation DES with post-PCI physiologic evaluation would be enrolled. Invasive physiologic assessment including recording of resting pressure trecing would be required at the baseline and at the end of index PCI procedure. PCI procedure would be performed upon local routine. Any available 2nd generation DES could be used. Web-based electronic-case record form (CRF) system will be used for collecting data. All data will be handled and analyzed by blind fashion at independent core lab. 2-year clinical outcome after index procedure will be analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 588
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Percutaneous coronary intervention
PCI was performed using 2nd generation DES

Locations

Country	Name	City	State
Korea, Republic of	Sejong General Hospital	Bucheon
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang-si
Korea, Republic of	Chosun University Hospital	Gwangju
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Ulsan Medical Center	Ulsan

Sponsors (5)

Lead Sponsor	Collaborator
Samsung Medical Center	Chosun University Hospital, Inje University Ilsan Paik Hospital, Sejong General Hospital, Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	independent predictors for target-vessel failure	independent predictors for target-vessel failure by univariate and multivariate analysis will be performed.	2 years after index procedure
Secondary	delta FFR per unit time	delta FFR per unit time in pre-PCI pullback recording	At the time of index procedure
Secondary	Relative percent increase of physiologic indices	Percent increase of FFR or non-hyperemic pressure ratios	At the time of index procedure