Clinical trial NCT04265443: Prognostic Perspective of Invasive Hyperemic and Non-Hyperemic Physiologic Indices Measured After Percutaneous Coronary Intervention
Official title: Prognostic Perspective of Invasive Hyperemic and Non-Hyperemic Physiologic Indices Measured After Percutaneous Coronary Intervention (PERSPECTIVE-PCI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Keywords: fractional flow reserve
non-hyperemic pressure ratio
percutaneous coronary intervention
prognosis
myocardial ischemia
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Inje University Ilsan Paik Hospital
name: Ulsan University Hospital
name: Sejong General Hospital
name: Chosun University Hospital
First posted: 2020-02-11
Enrollment: 588
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Target Vessel Failure
timeFrame: 2 years after index procedure
Secondary outcomes:
measure: independent predictors for target-vessel failure
timeFrame: 2 years after index procedure
measure: delta FFR per unit time
timeFrame: At the time of index procedure
measure: Relative percent increase of physiologic indices
timeFrame: At the time of index procedure
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Sejong General Hospital
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Joo Myung Lee, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.