Ischemic Heart Disease
Conditions
Keywords
fractional flow reserve, non-hyperemic pressure ratio, percutaneous coronary intervention, prognosis, myocardial ischemia
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.
Interventions
DEVICEPercutaneous coronary intervention
PCI was performed using 2nd generation DES
Sponsors
Inje University Ilsan Paik Hospital
Ulsan University Hospital
Sejong General Hospital
Chosun University Hospital
Samsung Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Failure | 2 years after index procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| independent predictors for target-vessel failure | 2 years after index procedure | independent predictors for target-vessel failure by univariate and multivariate analysis will be performed. |
| delta FFR per unit time | At the time of index procedure | delta FFR per unit time in pre-PCI pullback recording |
| Relative percent increase of physiologic indices | At the time of index procedure | Percent increase of FFR or non-hyperemic pressure ratios |
Countries
South Korea
Outcome results
None listed