PERSPECTIVE: Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention
Study Details
Study Description
Brief Summary
Fractional flow reserve (FFR) is a physiologic index for the determination of ischemia-causing coronary stenosis as well as drug eluting stent (DES) optimization, even multiple anatomic imaging parameters have been widely used in clinical practice for the assessment of optimal stent procedure. Prognostic value of post-stent FFR (FFRpost) have been rarely evaluated in patient treated with 2nd generation DES. This multicentre, prospective registry was aimed to evaluate the influence of physiologic parameters on the clinical outcome after 2nd generation DES implantation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Patients who diagnosed obstructive coronary artery disease and treated by DES with FFR examination would be enrolled, consecutively. FFR measurement 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. Informed consent should be obtained and protocol should be approved by each collaborator's institutional review board (IRB). 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. Patient will be followed-up at each collaborator's hospital at least 2 year after index procedure. Any adverse event will be reported and addressed immediately by appropriate medical treatment to protect patient.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| FFRpost High FFRpost group and low FFRpost group were defined according to the optimal cut-off value for predicting clinical outcome. |
Outcome Measures
Primary Outcome Measures
- Target-vessel failure [2 years after index procedure]
During two-year follow-up period, target-vessel failure (composite of cardiac death, target-vessel related myocardial infarction, and clinically-driven target vessel revascularization) will be evaluated. Target vessel will be defined as the treated vessel with DES which assessed by post-stent FFR. All clinical outcome will be reported according to the location of target vessel (LAD vs. non-LAD).
Secondary Outcome Measures
- clinical, angiographic and physiologic predictors for target-vessel failure [2 years after index procedure]
Clinical, angiographic and physiologic predictors for target-vessel failure by univariate and multivariate analysis will be performed.
Other Outcome Measures
- Intravascular ultrasound (IVUS) derived predictors for post-stent FFR and target vessel failure [2 years after index procedure]
In patient who performed IVUS examination, IVUS derived parameters will be evaluated for the prediction of post-stent FFR and target-vessel failure
Eligibility Criteria
Criteria
Inclusion Criteria:
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any patient meets eligible criteria who underwent PCI with DES followed by FFR measurement at the index procedure
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patient who provide informed consent
Exclusion Criteria:
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culprit vessel of acute coronary syndrome
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failed achieving TIMI 3 flow at the end of PCI
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left ventricular ejection fraction <30%
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graft vessel
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collateral feeder
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in-stent stenosis
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primary myocardial or valvular heart disease
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in patient whose life expectancy less than 2 years
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visible thrombus of target vessel segment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inje University Ilsan Paik Hospital | Goyang | Gyeonggi | Korea, Republic of | 411-706 |
| 2 | Keimyung University Dongsan Medical Center | Daegu | Korea, Republic of | ||
| 3 | Seoul National University Hospital | Seoul | Korea, Republic of | ||
| 4 | Ulsan University Hospital | Ulsan | Korea, Republic of |
Sponsors and Collaborators
- Inje University
- Seoul National University Hospital
- Keimyung University Dongsan Medical Center
- Ulsan University Hospital
- Busan Veterans General Hospital
- Samsung Medical Center
- Sejong General Hospital
- Tokyo Medical University
- Gifu Heart Center
- Japanese Red Cross Kyoto Daini Hospital
Investigators
- Principal Investigator: Joon Hyung Doh, MD, PhD, Inje Univesity Ilsan Paik Hospital
- Study Director: Bon-Kwon Koo, Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Nam CW, Hur SH, Cho YK, Park HS, Yoon HJ, Kim H, Chung IS, Kim YN, Kim KB, Doh JH, Koo BK, Tahk SJ, Fearon WF. Relation of fractional flow reserve after drug-eluting stent implantation to one-year outcomes. Am J Cardiol. 2011 Jun 15;107(12):1763-7. doi: 10.1016/j.amjcard.2011.02.329. Epub 2011 Apr 8.
- Pijls NH, Klauss V, Siebert U, Powers E, Takazawa K, Fearon WF, Escaned J, Tsurumi Y, Akasaka T, Samady H, De Bruyne B; Fractional Flow Reserve (FFR) Post-Stent Registry Investigators. Coronary pressure measurement after stenting predicts adverse events at follow-up: a multicenter registry. Circulation. 2002 Jun 25;105(25):2950-4.
- Samady H, McDaniel M, Veledar E, De Bruyne B, Pijls NH, Fearon WF, Vaccarino V. Baseline fractional flow reserve and stent diameter predict optimal post-stent fractional flow reserve and major adverse cardiac events after bare-metal stent deployment. JACC Cardiovasc Interv. 2009 Apr;2(4):357-63. doi: 10.1016/j.jcin.2009.01.008.
- Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrøm T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
- IB-2-1306-020