Korean Circ J.  2025 Jan;55(1):34-46. 10.4070/kcj.2024.0156.

Cost-effectiveness of Fractional Flow Reserve Versus Intravascular Ultrasound to Guide Percutaneous Coronary Intervention: Results From the FLAVOUR Study

Affiliations
  • 1Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
  • 2Department of Public Health Sciences, Graduate School of Public Health, Seoul National University, Seoul, Korea
  • 3Department of Cardiology, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China
  • 4Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Seoul, Korea
  • 5Department of Cardiology, Keimyung University Dongsan Medical Center, Daegu, Korea
  • 6Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea
  • 7Department of Internal Medicine, Kangwon National University Hospital, Chuncheon, Korea
  • 8Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Seoul, Korea
  • 9Department of Cardiology, Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine, Hangzhou, China
  • 10Department of Cardiology, Hangzhou Normal University Affiliated Hospital, Hangzhou, China
  • 11Department of Cardiology, The 1st Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
  • 12Department of Cardiology, The 2nd Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
  • 13Department of Cardiology, Zhejiang Hospital, Hangzhou, China
  • 14Department of Cardiology, The Third Clinical Institute Affiliated to Wenzhou Medical University, Wenzhou, China
  • 15Department of Cardiology, Ningbo First Hospital, Ningbo, China
  • 16Department of Cardiology, The Affiliated Hospital of Medical School of Ningbo University, Ningbo, China
  • 17Department of Internal Medicine, Wonju Severance Christian Hospital, Wonju, Korea
  • 18Department of Cardiology, Yeungnam University Medical Center, Daegu, Korea
  • 19Department of Internal Medicine, Uijeongbu Eulji Medical Center, Uijeongbu, Korea
  • 20Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea
  • 21Division of Cardiology, Ajou University Hospital, Suwon, Korea

Abstract

Background and Objectives
The Fractional Flow Reserve and Intravascular UltrasoundGuided Intervention Strategy for Clinical Outcomes in Patients with Intermediate Stenosis (FLAVOUR) trial demonstrated non-inferiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared with intravascular ultrasound (IVUS)-guided PCI. We sought to investigate the cost-effectiveness of FFR-guided PCI compared to IVUS-guided PCI in Korea.
Methods
A 2-part cost-effectiveness model, composed of a short-term decision tree model and a long-term Markov model, was developed for patients who underwent PCI to treat intermediate stenosis (40% to 70% stenosis by visual estimation on coronary angiography). The lifetime healthcare costs and quality-adjusted life-years (QALYs) were estimated from the healthcare system perspective. Transition probabilities were mainly referred from the FLAVOUR trial, and healthcare costs were mainly obtained through analysis of Korean National Health Insurance claims data. Health utilities were mainly obtained from the Seattle Angina Questionnaire responses of FLAVOUR trial participants mapped to EQ-5D.
Results
From the Korean healthcare system perspective, the base-case analysis showed that FFR-guided PCI was 2,451 U.S. dollar lower in lifetime healthcare costs and 0.178 higher in QALYs compared to IVUS-guided PCI. FFR-guided PCI remained more likely to be cost-effective over a wide range of willingness-to-pay thresholds in the probabilistic sensitivity analysis.
Conclusions
Based on the results from the FLAVOUR trial, FFR-guided PCI is projected to decrease lifetime healthcare costs and increase QALYs compared with IVUS-guided PCI in intermediate coronary lesion, and it is a dominant strategy in Korea.

Keyword

Coronary artery disease; Percutaneous coronary intervention; Cost; Quality-adjusted life year

Figure

  • Figure 1 Model structure. A 2-part cost-effectiveness model, composed of a short-term decision tree (A) and a long-term Markov model (B), is shown. In the decision tree, a decision was made on FFR or IVUS, and PCI was decided based on the results of the chosen test. Thereafter, non-fatal MI, revascularization, cardiac death, and non-cardiac death could occur within one year. Patients who survived in the one-year decision tree entered into the Markov model, and the entering health state was determined according to the events that occurred in the decision tree. Yearly, patients were at risk of non-fatal MI, revascularization, cardiac death, and non-cardiac death. Non-cardiac death can occur at every state but not shown.DES = drug-eluting stent; FFR = fractional flow reserve; IVUS = intravascular ultrasound; MI = myocardial infarction; MLA = minimal lumen area; PCI = percutaneous coronary intervention.

  • Figure 2 Selected results of one-way sensitivity analysis. A tornado diagram for FFR- vs. IVUS-guided PCI is presented to visualize the one-way sensitivity analysis. The top 10 variables with considerable INMB variation are shown. The vertical line represents the base-case INMB. The x-axis represented the ranges of INMB when the parameter values were varied over plausible ranges. A value of INMB greater than 0 indicates that IVUS-guided PCI is more cost-effective than FFR-guided PCI under the WTP threshold. Blue color indicates when each parameter has values lower than the base-case value within the range, and orange color indicates when each parameter has higher values.EV = expected value; FFR = fractional flow reserve; INMB = incremental net monetary benefit; IVUS = intravascular ultrasound; MLA = minimal lumen area; PCI = percutaneous coronary intervention; USD = U.S. dollar; WTP = willingness-to-pay.

  • Figure 3 Cost-effectiveness acceptability curves. The results of the probabilistic sensitivity analysis are shown. The curves show the probabilities that each strategy is cost-effective at varying cost-effectiveness threshold ratios. Even as the willingness-to-pay threshold increased, the higher probability that FFR-guided percutaneous coronary intervention would be cost-effective was maintained.FFR = fractional flow reserve; IVUS = intravascular ultrasound; QALY = quality-adjusted life-year; USD = U.S. dollar.


Cited by  1 articles

Cost-Effectiveness Matters! FFR Versus IVUS-Guided PCI in Modern Clinical Practice: Insights From the FLAVOUR Trial
Sun Oh Kim, Jong-Il Park, Ung Kim
Korean Circ J. 2024;55(1):47-49.    doi: 10.4070/kcj.2024.0327.


Reference

1. Writing Committee Members. Lawton JS, Tamis-Holland JE, et al. 2021 ACC/AHA/SCAI guideline for coronary artery revascularization: executive summary: a report of the American College of Cardiology/American Heart Association joint committee on clinical practice guidelines. J Am Coll Cardiol. 2022; 79:197–215. PMID: 34895951.
2. Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J. 2019; 40:87–165. PMID: 30165437.
3. Mintz GS, Guagliumi G. Intravascular imaging in coronary artery disease. Lancet. 2017; 390:793–809. PMID: 28831995.
Article
4. Hong SJ, Kim BK, Shin DH, et al. Effect of intravascular ultrasound-guided vs angiography-guided everolimus-eluting stent implantation: the IVUS-XPL randomized clinical trial. JAMA. 2015; 314:2155–2163. PMID: 26556051.
Article
5. Zhang J, Gao X, Kan J, et al. Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial. J Am Coll Cardiol. 2018; 72:3126–3137. PMID: 30261237.
Article
6. van Nunen LX, Zimmermann FM, Tonino PA, et al. Fractional flow reserve versus angiography for guidance of PCI in patients with multivessel coronary artery disease (FAME): 5-year follow-up of a randomised controlled trial. Lancet. 2015; 386:1853–1860. PMID: 26333474.
Article
7. Xaplanteris P, Fournier S, Pijls NH, et al. Five-year outcomes with PCI guided by fractional flow reserve. N Engl J Med. 2018; 379:250–259. PMID: 29785878.
Article
8. Zimmermann FM, Ferrara A, Johnson NP, et al. Deferral vs. performance of percutaneous coronary intervention of functionally non-significant coronary stenosis: 15-year follow-up of the DEFER trial. Eur Heart J. 2015; 36:3182–3188. PMID: 26400825.
Article
9. Koo BK, Hu X, Kang J, et al. Fractional flow reserve or intravascular ultrasonography to guide PCI. N Engl J Med. 2022; 387:779–789. PMID: 36053504.
Article
10. Kang J, Koo BK, Hu X, et al. Comparison of Fractional FLow Reserve And Intravascular ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with InteRmediate Stenosis (FLAVOUR): rationale and design of a randomized clinical trial. Am Heart J. 2018; 199:7–12. PMID: 29754669.
Article
11. Health Insurance Review & Assessment Service (KR). Guidelines for Economic Evaluation of Pharmaceuticals in Korea. Wonju, Korea: Health Insurance Review & Assessment Service;2021.
12. Hwang D, Kang J, Yang HM, et al. Better prognosis after complete revascularization using contemporary coronary stents in patients with chronic kidney disease. Circ Cardiovasc Interv. 2019; 12:e007907. PMID: 31345065.
Article
13. Kang J, Park KW, Lee HS, et al. Relative impact of clinical risk versus procedural risk on clinical outcomes after percutaneous coronary intervention. Circ Cardiovasc Interv. 2021; 14:e009642. PMID: 33541106.
Article
14. Statistics Korea. Life tables (2020). Updated 2021. Accessed July 20, 2022. https://kosis.kr .
15. Health Insurance Review & Assessment Service (KR). Korean medical service fee (effective December 1, 2021). Updated 2021. Accessed October 18, 2022. https://www.hira.or.kr .
16. Health Insurance Review & Assessment Service (KR). Statistics on medical procedures (tests/surgeries, etc.). Updated 2022. Accessed October 18, 2022. https://opendata.hira.or.kr .
17. Health Insurance Review & Assessment Service (KR). Medical device price list (as of December 1, 2021). Updated 2021. Accessed October 18, 2022. https://www.hira.or.kr .
18. Health Insurance Review & Assessment Service (KR). The weighted price of drug by component in the 2021. Updated 2022. Accessed July 20, 2022. https://www.hira.or.kr .
19. Health Insurance Review & Assessment Service (KR). Pharmaceutical benefit list (2021.12.1.). Updated 2021. Accessed July 20, 2022. https://www.hira.or.kr .
20. Health Insurance Review & Assessment Service (KR). Information on uncovered medical expenses. Accessed April 20, 2022. https://www.hira.or.kr .
21. Lee OH, Hyun DS, Park GH, Kim MJ, Lee YJ, Kim JH. Health Insurance Patient Medical Expenditure Survey in 2020. Wonju, Korea: National Health Insurance Service;2021.
22. Health Insurance Review & Assessment Service (KR). Currently applied drug price file (2021.12.1.). Updated 2021. Accessed July 20, 2022. http://www.hira.or.kr .
23. Kim MJ, Jeon DS, Gwon HC, et al. Health-related quality-of-life after percutaneous coronary intervention in patients with UA/NSTEMI and STEMI: the Korean multicenter registry. J Korean Med Sci. 2013; 28:848–854. PMID: 23772148.
Article
24. Lee HJ, Kim YJ, Ahn JH, et al. The Clinical Usefulness and Cost-effectiveness of CT Coronary Angiography for the Diagnosis of Ischemic Heart Disease in Patients with Chest Pain. Seoul, Korea: National Evidence-based Healthcare Collaborating Agency;2011.
25. Kazi DS, Garber AM, Shah RU, et al. Cost-effectiveness of genotype-guided and dual antiplatelet therapies in acute coronary syndrome. Ann Intern Med. 2014; 160:221–232. PMID: 24727840.
Article
26. Kim HS, Kim Y, Kwon H. Health-related quality of life and readmission of patients with cardiovascular disease in South Korea. Perspect Public Health. 2021; 141:28–36. PMID: 31847706.
Article
27. Park M, Min JH, Ko SH, Lee SW, Ko HY, Shin YI. Recovery and associated factors of cognitive function in patients with hemorrhagic stroke. J Rehabil Res. 2017; 21:247–259.
Article
28. Goldsmith KA, Dyer MT, Buxton MJ, Sharples LD. Mapping of the EQ-5D index from clinical outcome measures and demographic variables in patients with coronary heart disease. Health Qual Life Outcomes. 2010; 8:54. PMID: 20525323.
Article
29. Dakin H, Abel L, Burns R, Yang Y. Review and critical appraisal of studies mapping from quality of life or clinical measures to EQ-5D: an online database and application of the MAPS statement. Health Qual Life Outcomes. 2018; 16:31. PMID: 29433510.
Article
30. Dakin A, Abel L, Burns R, Koleva-Kolarova R, Yang Y. HERC database of mapping studies, version 8.0. Updated 2020. Accessed February, 2022. http://www.herc.ox.ac.uk/downloads/herc-database-of-mapping-studies .
31. Ahn JH, Kim YH, Shin SJ, Park JY. Asian Collaboration on Cost-effectiveness in Health Care Decision Making. Seoul, Korea: National Evidence-based Healthcare Collaborating Agency;2012.
32. Fearon WF, Bornschein B, Tonino PA, et al. Economic evaluation of fractional flow reserve-guided percutaneous coronary intervention in patients with multivessel disease. Circulation. 2010; 122:2545–2550. PMID: 21126973.
Article
33. Mueller C, Hodgson JM, Schindler C, Perruchoud AP, Roskamm H, Buettner HJ. Cost-effectiveness of intracoronary ultrasound for percutaneous coronary interventions. Am J Cardiol. 2003; 91:143–147. PMID: 12521624.
Article
34. Sharp ASP, Kinnaird T, Curzen N, et al. Cost-effectiveness of intravascular ultrasound-guided percutaneous intervention in patients with acute coronary syndromes: a UK perspective. Eur Heart J Qual Care Clin Outcomes. 2023; qcad073.
Article
Full Text Links
  • KCJ
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2025 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr