BACKGROUND: The FAVOR (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease) III China trial demonstrated that percutaneous coronary intervention (PCI) lesion selection using quantitative flow ratio (QFR) measurement, a novel angiography-based approach for estimating fractional flow reserve, improved two-year clinical outcomes compared with standard angiography guidance. This study aimed to assess the cost-effectiveness of QFR-guided PCI from the perspective of the current Chinese healthcare system. METHODS: This study is a pre-specified analysis of the FAVOR III China trial, which included 3825 patients randomized between December 25, 2018, and January 19, 2020, from 26 centers in China. Patients with stable or unstable angina pectoris or those ≥72 hours post-myocardial infarction who had at least one lesion with a diameter stenosis between 50% and 90% in a coronary artery with a ≥2.5 mm reference vessel diameter by visual assessment were randomized to a QFR-guided strategy or an angiography-guided strategy with 1:1 ratio. During the two-year follow-up, data were collected on clinical outcomes, quality-adjusted life-years (QALYs), estimated costs of index procedure hospitalization, outpatient cardiovascular medication use, and rehospitalization due to major adverse cardiac and cerebrovascular events (MACCE). The primary analysis calculated the incremental cost-effectiveness ratio (ICER) as the cost per MACCE avoided. An ICER of ¥10,000/MACCE event avoided was considered economically attractive in China. RESULTS: At two years, the QFR-guided group demonstrated a reduced rate of MACCE compared to the angiography-guided group (10.8% vs . 14.7%, P <0.01). Total two-year costs were similar between the groups (¥50,803 ± 21,121 vs . ¥50,685 ± 23,495, P = 0.87). The ICER for the QFR-guided strategy was ¥3055 per MACCE avoided, and the probability of QFR being economically attractive was 64% at a willingness-to-pay threshold of ¥10,000/MACCE avoided. Sensitivity analysis showed that QFR-guided PCI would become cost-saving if the cost of QFR were below ¥3682 (current cost: ¥3800). Cost-utility analysis yielded an ICER of ¥56,163 per QALY gained, with a 53% probability of being cost-effective at a willingness-to-pay threshold of ¥85,000 per QALY gained. CONCLUSION: In patients undergoing PCI, a QFR-guided strategy appears economically attractive compared to angiographic guidance from the perspective of the Chinese healthcare system. TRIAL REGISTRATION ClinicalTrials.gov , NCT03656848.
Humans ; Cost-Benefit Analysis ; Percutaneous Coronary Intervention/methods* ; Male ; Female ; Coronary Angiography/methods* ; Middle Aged ; Aged ; Coronary Artery Disease/surgery* ; Quality-Adjusted Life Years ; Fractional Flow Reserve, Myocardial/physiology*

PURPOSE: Antibody mediated rejection (AMR), although less common than acute cellular rejection (ACR), may be recalcitrant to conventional rescue therapy. AMR is caused by de novo B-cell mediated production of immunoglobulin G antibody (IgG) targeted against specific allograft antigen in a presensitized recipient. Rituximab is a chimeric murine- human anti-CD20 monoclonal antibody which targets CD-20 positive B-cells for elimination. Rituximab has been described to improve allograft salvage for refractory AMR. METHODS: From January 2002 to May 2004, 11 patients were diagnosed with AMR. The first 5 patients (non-rituximab group: NRG) were treated with high dose steroids, plasmapheresis followed by IVIG (500 mg/kg/dose) in addition to OKT3 and/or rabbit antithymocyte globulin. The latter 6 patients (rituximab group: RG) were given Rituximab (375 mg/m2) with IVIG following plasmapheresis. All patients had biopsy proven AMR. RESULTS: Four patients received allografts from living donors and one patient from cadaveric donor in NRG. Each three patients received allografts from living or cadaveric donors in RG. One patient of RG had a positive anti-HLA B-cell crossmatch by CDC (complement dependent cytotoxicity). The anti-donor antibody was reduced to zero with negative CDC and flowcytometry through a desensitization protocol prior to transplantation. The time to diagnosis of AMR in both groups were 17.8+/-18.17 days (NRG); 11+/-2.5 days (RG). ACR was identified in conjunction with AMR in 2 (40%: NRG), 4 patients (66.7%: RG), respectively. All patients had biopsies with classic features of AMR on light microscopy, including C4d staining. Three (50%) patients of RG had positive post-transplantation CDC and donor-specific antibody (DSA) identified. Mean serum creatinine (SCr) upon diagnosis of AMR were 4.3+/-1.71 mg/dL (NRG); 5.77+/-2.65 mg/dL (RG). The rescue rate of RG was superior than NRG (83% vs. 40%, P>0.05). The time to rescue from AMR in both groups were 40.5 +/-28.99 days (NRG); 48+/-54.67 days (RG). Mean SCr of the rescued patients were 1.65+/-0.07 mg/dL (NRG); 2.2+/-1.4 (RG) with median follow up of 120 days (range 33~319 days). Allograft nephrectomies were performed in 3 patients of NRG. CONCLUSION: Rescue therapy with Rituximab improves allograft salvage after AMR and should be considered early in the treatment of biopsy proven AMR.
Allografts ; Antilymphocyte Serum ; B-Lymphocytes ; Biopsy ; Cadaver ; Centers for Disease Control and Prevention (U.S.) ; Creatinine ; Diagnosis ; Follow-Up Studies ; Humans ; Immunoglobulin G ; Immunoglobulins, Intravenous ; Kidney Transplantation* ; Kidney* ; Living Donors ; Microscopy ; Muromonab-CD3 ; Nephrectomy ; Plasmapheresis ; Rituximab ; Steroids ; Tissue Donors