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| Name | Class |
|---|---|
| Inje University Ilsan Paik Hospital | OTHER |
| Ulsan University Hospital | OTHER |
| Sejong General Hospital | OTHER |
| Chosun University Hospital |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention | Device | PCI was performed using 2nd generation DES |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| delta FFR per unit time |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who diagnosed obstructive coronary artery disease and treated by DES with invasive physiologic evaluation at the index procedure
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| Name | Affiliation | Role |
|---|---|---|
| Joo Myung Lee, MD, MPH, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sejong General Hospital | Bucheon-si | South Korea | ||||
| Inje University Ilsan Paik Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36747363 | Derived | 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. | |
| 32819481 |
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De-identified patient data will be shared upon reasonable request after discussion in executive committee.
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| OTHER |
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delta FFR per unit time in pre-PCI pullback recording
| At the time of index procedure |
| Relative percent increase of physiologic indices | Percent increase of FFR or non-hyperemic pressure ratios | At the time of index procedure |
| Goyang-si |
| South Korea |
| Chosun University Hospital | Gwangju | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Ulsan Medical Center | Ulsan | South Korea |
| 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. |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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