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*

Objective:To evaluate the long-term outcomes and predictors of coronary atherosclerotic lesions deemed functionally non-ischemic (quantitative flow ratio(QFR)>0.80) and deferred from intervention.Methods:This study is a post-hoc analysis of the FAVOR Ⅲ China trial, which enrolled 3 825 patients with stable or unstable angina pectoris or with myocardial infarction occurring at least 72 hours prior to screening, between December 5, 2018 and January 9, 2020 from 26 research centers in China. Coronary vessels with QFR>0.80 and without interventional treatment were analyzed in this study. The primary endpoint was 3-year target vessel revascularization. Vessels with revascularization (revascularized group) during follow-up were matched 1∶1 using propensity score matching to comparable vessels without revascularization (non-revascularized group). Multivariate Cox regression analysis was used to identify the risk factors for target vessel revascularization (TVR).Results:A total of 6 212 functionally negative vessels with deferred intervention were included in the final analysis, among which 153 vessels (2.5%) underwent TVR during a 3-year follow-up. Prior to propensity score matching, 6 059 vessels comprised the non-revascularized group. At the vessel level, compared to the non-revascularized group, the revascularized group exhibited a significantly higher proportion of males (79.1% (121/153) vs. 70.2% (4 253/6 059), P=0.018), higher body mass index ((25.6±4.0) kg/m2 vs. (24.3±5.2) kg/m2, P=0.003), and a higher prevalence of hypertension (73.9% (113/153) vs. 65.1% (3 944/6 059), P=0.025). And 152 pairs of vessels were successfully matched. Multivariate Cox regression analysis identified in-stent restenosis lesions ( HR=2.59, 95% CI 1.28-5.23, P=0.008) as an independent risk factor for target vessel revascularization. Conclusions:Coronary lesions classified as functionally non-ischemic at baseline are not entirely stable and may progress to lesions that requiring revascularization over time. In-stent restenosis emerges as a critical independent predictor of revascularization.

Objective:To evaluate the long-term outcomes and predictors of coronary atherosclerotic lesions deemed functionally non-ischemic (quantitative flow ratio(QFR)>0.80) and deferred from intervention.Methods:This study is a post-hoc analysis of the FAVOR Ⅲ China trial, which enrolled 3 825 patients with stable or unstable angina pectoris or with myocardial infarction occurring at least 72 hours prior to screening, between December 5, 2018 and January 9, 2020 from 26 research centers in China. Coronary vessels with QFR>0.80 and without interventional treatment were analyzed in this study. The primary endpoint was 3-year target vessel revascularization. Vessels with revascularization (revascularized group) during follow-up were matched 1∶1 using propensity score matching to comparable vessels without revascularization (non-revascularized group). Multivariate Cox regression analysis was used to identify the risk factors for target vessel revascularization (TVR).Results:A total of 6 212 functionally negative vessels with deferred intervention were included in the final analysis, among which 153 vessels (2.5%) underwent TVR during a 3-year follow-up. Prior to propensity score matching, 6 059 vessels comprised the non-revascularized group. At the vessel level, compared to the non-revascularized group, the revascularized group exhibited a significantly higher proportion of males (79.1% (121/153) vs. 70.2% (4 253/6 059), P=0.018), higher body mass index ((25.6±4.0) kg/m2 vs. (24.3±5.2) kg/m2, P=0.003), and a higher prevalence of hypertension (73.9% (113/153) vs. 65.1% (3 944/6 059), P=0.025). And 152 pairs of vessels were successfully matched. Multivariate Cox regression analysis identified in-stent restenosis lesions ( HR=2.59, 95% CI 1.28-5.23, P=0.008) as an independent risk factor for target vessel revascularization. Conclusions:Coronary lesions classified as functionally non-ischemic at baseline are not entirely stable and may progress to lesions that requiring revascularization over time. In-stent restenosis emerges as a critical independent predictor of revascularization.

Objective To evaluate the health-related quality of life (HRQoL) in children with β-thalasse-mia major and their parents,and to analyze its affecting factors.Methods PedsQLTM 4.0 generic core scale and a demographic questionnaire were used to assess HRQoL in 45 children with β-thalassemia major and their parents,which were between 5 and 12 years old,had received blood transfusion in Chengdu Women and Children's Central Hospital during 2016.Results The total summary score of patients' HRQoL was (74.58 ± 7.29) score,in which,the social functioning subscale score was the highest,and school functioning subscale score was the lowest.The total summary score of parents' HRQoL was (64.43 ± 11.54) score,and the difference was statistically significant (P ＜ 0.05).Parents' s core of the psychosocial health [(69.03 ± 12.24) score],the emotional functioning [(67.78 ± 12.67)score]and the School functioning [(57.92 ± 11.61) score]were significantly lower than those of children[(78.19 ±13.42) score,(83.75 ±9.05) score,(69.58 ± 10.30) score],and the differences were statistically significant(all P ＜0.05).The HRQoL of children was positively correlated with onset age of anemia and hemoglobin (Hb) level before transfusion (r =0.771,0.824,all P ＜ 0.01),but which was negatively correlated with iron chelation therapy (r =-0.573,P ＜ 0.01).In contrast,gender,frequency of blood transfusions during the previous 3 months,the type of blood transfusion and iron chelation treatment were not significantly related to HRQoL among these patients.All of these factors were not related to the HRQoL of their parents(P ＞ 0.05).A multiple regression analysis revealed that the HRQoL of children with β-thalassemia major was significantly correlated with onset age of anemia(P =0.005),Hb level before transfusion (P =0.026) and iron chelation therapy (P =0.000).Conclusions The HRQoL of children with β-thalassemia major and their parents were remarkably low.Comprehensive programs including social support,medical service and psychological care should be provided for these children and their parents.

Objective To investigate the relationship between serum uric acid level and body fat depots as well as the possible influencing factors of the relationship in type 2 diabetic patients.Methods Five hundred and thirty two patients hospitalized for type 2 diabetes were recruited in this study.According to serum uric acid,the subjects were classified into normal uric acid group (group NUA,n =426) and high uric acid group ( group HUA,n =106 ).Anthropometry ( BMI,waist circumference,hip circumference and WHR),serum uric acid level,blood glucose,renal function and lipid levels were compared between the two groups.Results Serum uric acid level was closely related to body fat distribution:(1) in group HUA,WHR,BMI,BUN,SCr and TG were significantly higher than that of group NUA ( [ 0.94 ± 0.07 ] vs.[ 0.91 ± 0.07 ],[ 26.91 ± 3.90 ]kg/m2 vs.[23.84 ±3.80] kg/m2,[8.66 ±5.94] mmol/L vs.[6.29 ±3.64] mmol/L,[93.9 ± 67.6 ] μmol/Lvs.[63.9 ± 20.6 ] μmol/L,[ 2.65 ± 1.92 ] mmol/L vs.[ 1.86 ± 1.46 ] mmol/L,respectively; all P ＜ 0.05 ] ;while HDL-C was lower in Group HUA than in group NUA ( [ 1.09 ± 0.32 ] mmol/L vs.[ 1.24 ± 0.45 ] mmol/L,P ＜0.05).(2) Multiple regression analysis revealed that the serum uric acid levels were positively correlated with BMI,SCr,and TG ( b =0.201,0.500,0.153,respectively,P ＜ 0.05 ),but negatively correlated with HbA(1)c and HDL-C ( b =- 0.168 and - 0.121,P ＜ 0.05 ).Conclusion In patients with type 2 diabetes,serum uric acid levels are closely related with the BMI and Glucose/lipid metabolism,which suggests that body weight control is as important as the uric acid lowering treatment in patients with type 2 diabetes to cut the risks of cardiac and vascular diseases.

Objective To evaluate the sensitivity and specificity of BP180NC16a-ELISA in the diagnosis of bullous pemphigoid (BP). Methods A multi-center, randomized, double-blind, parallel-controlled study was conducted. Sera were collected from 106 patients with clinically confirmed active BP and 106 control subjects including patients with non-BP bullous diseases, scleroderma, psoriasis or systemic lupus erythematosus,late pregnant women and healthy blood donors. BP180NC16a-ELISA was performed on these sera. The IgG antibody levels measured by ELISA kit were compared with those measured by indirect immunofluorescence (IIF) test. Results Of the 106 BP sera, 81 were positive for BP180NC16a-ELISA with a sensitivity of 76.4%,83 for ⅡF test with a sensitivity of 78.3%. Among the 106 control serum samples, 95 were negative for BP180NC16A-ELISA with a specificity of 89.6%, and 102 for ⅡF test with a specificity of 96.2%. There was no significant difference between the two tests in dignostic sensitivity and specificity for BP (both P ＞ 0.05).Conclusion BP180NC16A-ELISA may serve as an adjuvant tool for the diagnosis of BP.