Download This Paper
Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed. For more information on this collaboration, see the comments published in The Lancet about the trial period, and our decision to make this a permanent offering, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com.
Cost-Effectiveness of Angiographic Quantitative Flow Ratio-Guided Coronary Intervention: A Multicentre, Randomised, Sham-Controlled Trial
32 Pages Posted: 10 Oct 2023
More...Abstract
Background: The FAVOR III China trial demonstrated that percutaneous coronary intervention (PCI) lesion selection using quantitative flow ratio (QFR) measurement, a novel angiography-based approach to estimate fractional flow reserve, improved two-year clinical outcomes compared with standard angiography guidance. In this study, we sought to investigate the cost-effectiveness of QFR-guided PCI from the current perspective of the Chinese healthcare system.
Methods: This study is a pre-specified analysis of the FAVOR III China trial, a multicentre, blinded, randomised, sham-controlled trial done among Chinese adults with coronary artery disease planned for PCI, who had at least one lesion with a diameter stenosis of 50–90% with a reference vessel of at least 2·5 mm diameter. Patients were randomly assigned (1:1) to either a QFR-guided strategy (PCI performed only if QFR ≤0·80) or an angiography-guided strategy (PCI based on standard visual angiographic assessment). Over the two-year follow-up period, we collected data on clinical outcomes, quality-adjusted life-years (QALY), estimated costs during index procedure hospitalisation (based on reformed healthcare purchase system), costs for outpatient cardiovascular medication use and rehospitalisation due to major adverse cardiac and cerebrovascular events (MACCE). For the primary analysis, the incremental cost-effectiveness ratio (ICER) was expressed as cost per MACCE avoided. An ICER of ¥10000/MACCE event avoided was regarded as to be economically attractive in China. The trial was registered at ClinicalTrials.gov, NCT03656848.
Findings: Between Dec 25, 2018, and Jan 19, 2020, we screened 5881 potential participants and randomised 3825 patients from 26 centres in China in the intention-to-treat population (1913 QFR-guided and 1912 angiography-guided). At two years, MACCE was reduced in the QFR-guided group as compared with angiography-guided group (10·8% vs. 14·7%, p<0·0001). Total two-year costs were similar between the two groups (¥50803±21121 vs. ¥50685±23495, p=0·87). The ICER for the QFR-guided strategy was ¥3055 per MACCE avoided, and the probability that QFR would be economically attractive was 64% at a willingness to pay threshold of ¥10000/MACCE avoided. Sensitivity analysis demonstrated that QFR-guided PCI would become cost saving at a QFR cost <¥3682 (current cost ¥3800). Cost-utility analysis demonstrated an ICER of ¥56163 per QALY gained, with a 53% probability that it would be cost-effective at a willingness to pay threshold of ¥85000 per QALY gained.
Interpretation: In patients undergoing PCI, a QFR-guided strategy appears economically attractive as compared with angiographic guidance from the perspective of the Chinese healthcare system.
Trial Registration: The trial was registered at ClinicalTrials.gov, NCT03656848.
Funding: BX is supported by the Beijing Municipal Science and Technology Commission (Grant No. Z191100006619107) and the National Clinical Research Centre for Cardiovascular Diseases, Fuwai Hospital (Grant No. NCRC2020001); LS is supported by Chinese Academy of Medical Sciences (Grant No. 2022-I2M-C&T-A-009).
Declaration of Interest: Shengxian Tu is the co-founder of Pulse Medical, reports grants and consultancy from Pulse Medical. Javier Escaned reports consulting or speaker fees from Abbott, Philips, and Boston Scientific. William F Fearon reports grants from Abbott Vascular, Boston Scientific, and Medtronic; consulting fees from CathWorks and Siemens; and minor stock options from HeartFlow. David J Cohen reports insititutional research grants from Philips, Cathworks, Abbott, and Boston Scientific, and consulting income from Abbott, Medtronic, and Boston Scientific. In the past three years, Harlan Krumholz received expenses and/or personal fees from UnitedHealth, Element Science, Eyedentifeye, and F-Prime; he is a co-founder of Refactor Health and HugoHealth, and is associated with contracts, through Yale New Haven Hospital, from the Centers for Medicare & Medicaid Services and through Yale University from the Food and Drug Administration, Johnson & Johnson, Google, and Pfizer. All other authors declare no competing interests.
Ethical Approval: The trial was conducted among 26 centres with local ethics committee approval. Written informed consent was obtained from all patients.
Keywords: quantitative flow ratio, percutaneous coronary intervention, major adverse cardiac and cerebrovascular events, incremental cost-effectiveness ratio, quality-adjusted life-years
Suggested Citation: Suggested Citation