Prognostic Impact of Lesion-specific Hemodynamic Index in Patients With Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— PRIME-FFR  

Official title:

Prognostic Impact of Lesion-specific Hemodynamic Index and Disease Characteristics in Patients With Coronary Artery Disease Assessed by Fractional Flow Reserve

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05250557
• Other study ID #: H-2107-230-1240
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2022
• Source: Seoul National University Hospital
• Contact: Bon-Kwon Koo, MD, PhD
• Phone: +82-2-2072-2062
• Email: bkkoo[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators aim to investigate the additive prognostic value of lesion-specific hemodynamic index such as ΔFFR, non-hyperemic pressure ratio such as RFR, over % diameter stenosis and FFR according to treatment strategy, and to find the prognostic implications of post-PCI FFR after adjustment of various clinical and disease characteristics, and to construct a comprehensive risk prediction model for post-PCI outcomes.

Description:

Fractional flow reserve (FFR)-based revascularization is the currently best practice recommended by guidelines. In addition to the use of coronary physiological indices as a vessel-specific metric, recent studies suggested the clinical importance of local hemodynamics in prediction of risk for target vessel failure or acute coronary syndrome in patients with coronary artery disease. In patients who receive percutaneous coronary intervention (PCI), the absolute value and pattern of FFR change after stenting are helpful in defining the additional target for PCI and risk stratification after PCI. However, there has been no prospective study that proved the benefit of change in FFR across the lesion (ΔFFR) in daily clinical practice, and FFR usage after stenting is much less than before stenting. Accordingly, we will prove the benefit of ΔFFR in addition to FFR, prognostic implications of combining RFR and FFR, and the comprehensive risk model with post-PCI FFR, clinical and disease characteristics in a prospective study, to maximize the benefit of invasive physiologic assessment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2429
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Age =20 years

2. All comers who underwent successful FFR measurement and pullback tracing

Exclusion Criteria:

1. Chronic renal failure (estimated glomerular filtration rate <30)

2. ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery history

3. Primary myocardial or valvular disease

4. Left ventricular ejection fraction < 30%

5. Hemodynamically unstable clinical conditions

6. Life expectancy < 2 years

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Fractional flow reserve
Physiologic assessment includes ? FFR (lesion-specific) and FFR (vessel-specific) measurement. ? FFR is defined as a pressure step up across the lesion. Coronary angiography and physiologic assessment will be analyzed by an independent core laboratory (Seoul National University Hospital, Clinical Trial Center, Seoul, South Korea).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (11)

Lead Sponsor	Collaborator
Seoul National University Hospital	Dong-A University Hospital, Gyeongsang National University Hospital, Inje University, KangWon National University Hospital, Keimyung University Dongsan Medical Center, Seoul National University Bundang Hospital, Tsuchiura Kyodo General Hospital, Ulsan University Hospital, Wonju Severance Christian Hospital, Yongin Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (14)

Choi G, Lee JM, Kim HJ, Park JB, Sankaran S, Otake H, Doh JH, Nam CW, Shin ES, Taylor CA, Koo BK. Coronary Artery Axial Plaque Stress and its Relationship With Lesion Geometry: Application of Computational Fluid Dynamics to Coronary CT Angiography. JACC Cardiovasc Imaging. 2015 Oct;8(10):1156-1166. doi: 10.1016/j.jcmg.2015.04.024. Epub 2015 Sep 9. — View Citation

Hakeem A, Uretsky BF. Role of Postintervention Fractional Flow Reserve to Improve Procedural and Clinical Outcomes. Circulation. 2019 Jan 29;139(5):694-706. doi: 10.1161/CIRCULATIONAHA.118.035837. Review. — View Citation

Hsieh FY, Lavori PW. Sample-size calculations for the Cox proportional hazards regression model with nonbinary covariates. Control Clin Trials. 2000 Dec;21(6):552-60. — View Citation

Hwang D, Lee JM, Lee HJ, Kim SH, Nam CW, Hahn JY, Shin ES, Matsuo A, Tanaka N, Matsuo H, Lee SY, Doh JH, Koo BK. Influence of target vessel on prognostic relevance of fractional flow reserve after coronary stenting. EuroIntervention. 2019 Aug 29;15(5):457-464. doi: 10.4244/EIJ-D-18-00913. — View Citation

Hwang D, Lee JM, Yang S, Chang M, Zhang J, Choi KH, Kim CH, Nam CW, Shin ES, Kwak JJ, Doh JH, Hoshino M, Hamaya R, Kanaji Y, Murai T, Zhang JJ, Ye F, Li X, Ge Z, Chen SL, Kakuta T, Koo BK. Role of Post-Stent Physiological Assessment in a Risk Prediction Model After Coronary Stent Implantation. JACC Cardiovasc Interv. 2020 Jul 27;13(14):1639-1650. doi: 10.1016/j.jcin.2020.04.041. — View Citation

Johnson NP, Tóth GG, Lai D, Zhu H, Açar G, Agostoni P, Appelman Y, Arslan F, Barbato E, Chen SL, Di Serafino L, Domínguez-Franco AJ, Dupouy P, Esen AM, Esen OB, Hamilos M, Iwasaki K, Jensen LO, Jiménez-Navarro MF, Katritsis DG, Kocaman SA, Koo BK, López-Palop R, Lorin JD, Miller LH, Muller O, Nam CW, Oud N, Puymirat E, Rieber J, Rioufol G, Rodés-Cabau J, Sedlis SP, Takeishi Y, Tonino PA, Van Belle E, Verna E, Werner GS, Fearon WF, Pijls NH, De Bruyne B, Gould KL. Prognostic value of fractional flow reserve: linking physiologic severity to clinical outcomes. J Am Coll Cardiol. 2014 Oct 21;64(16):1641-54. doi: 10.1016/j.jacc.2014.07.973. — View Citation

Lee JM, Choi G, Koo BK, Hwang D, Park J, Zhang J, Kim KJ, Tong Y, Kim HJ, Grady L, Doh JH, Nam CW, Shin ES, Cho YS, Choi SY, Chun EJ, Choi JH, Nørgaard BL, Christiansen EH, Niemen K, Otake H, Penicka M, de Bruyne B, Kubo T, Akasaka T, Narula J, Douglas PS, Taylor CA, Kim HS. Identification of High-Risk Plaques Destined to Cause Acute Coronary Syndrome Using Coronary Computed Tomographic Angiography and Computational Fluid Dynamics. JACC Cardiovasc Imaging. 2019 Jun;12(6):1032-1043. doi: 10.1016/j.jcmg.2018.01.023. Epub 2018 Mar 14. Erratum in: JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 1):2288-2289. — View Citation

Lee JM, Hwang D, Choi KH, Rhee TM, Park J, Kim HY, Jung HW, Hwang JW, Lee HJ, Jang HJ, Kim SH, Song YB, Cho YK, Nam CW, Hahn JY, Shin ES, Kawase Y, Matsuo A, Tanaka N, Doh JH, Koo BK, Matsuo H. Prognostic Implications of Relative Increase and Final Fractional Flow Reserve in Patients With Stent Implantation. JACC Cardiovasc Interv. 2018 Oct 22;11(20):2099-2109. doi: 10.1016/j.jcin.2018.07.031. — View Citation

Lee JM, Lee SH, Hwang D, Rhee TM, Choi KH, Kim J, Park J, Kim HY, Jung HW, Cho YK, Yoon HJ, Song YB, Hahn JY, Nam CW, Shin ES, Doh JH, Hur SH, Koo BK. Long-Term Clinical Outcomes of Nonhyperemic Pressure Ratios: Resting Full-Cycle Ratio, Diastolic Pressure Ratio, and Instantaneous Wave-Free Ratio. J Am Heart Assoc. 2020 Sep 15;9(18):e016818. doi: 10.1161/JAHA.120.016818. Epub 2020 Sep 11. — View Citation

Li SJ, Ge Z, Kan J, Zhang JJ, Ye F, Kwan TW, Santoso T, Yang S, Sheiban I, Qian XS, Tian NL, Rab TS, Tao L, Chen SL. Cutoff Value and Long-Term Prediction of Clinical Events by FFR Measured Immediately After Implantation of a Drug-Eluting Stent in Patients With Coronary Artery Disease: 1- to 3-Year Results From the DKCRUSH VII Registry Study. JACC Cardiovasc Interv. 2017 May 22;10(10):986-995. doi: 10.1016/j.jcin.2017.02.012. Epub 2017 Apr 26. — View Citation

Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Jüni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. Erratum in: Eur Heart J. 2019 Oct 1;40(37):3096. — View Citation

Park JB, Choi G, Chun EJ, Kim HJ, Park J, Jung JH, Lee MH, Otake H, Doh JH, Nam CW, Shin ES, De Bruyne B, Taylor CA, Koo BK. Computational fluid dynamic measures of wall shear stress are related to coronary lesion characteristics. Heart. 2016 Oct 15;102(20):1655-61. doi: 10.1136/heartjnl-2016-309299. Epub 2016 Jun 14. — View Citation

Rimac G, Fearon WF, De Bruyne B, Ikeno F, Matsuo H, Piroth Z, Costerousse O, Bertrand OF. Clinical value of post-percutaneous coronary intervention fractional flow reserve value: A systematic review and meta-analysis. Am Heart J. 2017 Jan;183:1-9. doi: 10.1016/j.ahj.2016.10.005. Epub 2016 Oct 11. Review. — View Citation

Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics. 1983 Jun;39(2):499-503. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse cardiovascular event according to ?FFR (Deferral of PCI group)	Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death	Upto 2 years after index procedure
Primary	Adverse cardiovascular event according to post-PCI FFR (PCI group)	Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death	Upto 2 years after index procedure