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*

Objectives:The aim of this study was to investigate the value of assessing Selvester QRS score in evaluating myocardial fibrosis in hypertrophic cardiomyopathy(HCM)patients.Methods:A total of consecutive 149 patients with HCM,who were admitted in Fuwai Hospital from October 2008 to September 2013,were enrolled in this study.Qualitative and quantitative analyses of myocardial fibrosis were conducted based on late gadolinium enhancement(LGE)derived from enhanced cardiac magnetic resonance imaging(CMR).According to the qualitative analysis of myocardial fibrosis by CMR-LGE,the patients were divided into the LGE-negative group(n=46)and the LGE-positive group(n=103).Standard 12-lead electrocardiogram examination was performed and the Selvester QRS score was calculated.Multivariate binary Logistic regression analysis was used to analyze the predictive factors of positive LGE,and the correlation analysis between the Selvester QRS score and the LGE score was also performed.Results:Compared with the LGE-negative group,the proportion of patients with a family history of HCM(12.8%vs.28.2%),the proportion of patients with a positive Selvester QRS score(65.2%vs.83.5%)and the Selvester QRS score([1.65±1.81]points vs.[5.71±3.80]points)were higher,the maximum thickness of the left ventricular wall([20.5±3.2]mm vs.[24.5±5.0]mm)and the percentage of left ventricular myocardial scar area([5.0±5.5]%vs.[17.1±11.4]%)were larger in the LGE-positive group(all P<0.05).Multivariate binary logistic regression analysis showed that the Selvester QRS score(OR=1.429,95%CI:1.128-1.802,P=0.003)and the maximum left ventricular wall thickness(OR=1.257,95%CI:1.029-1.537,P=0.025)were independent predictors of positive LGE.Pearson correlation analysis showed that in all HCM patients,the Selvester QRS score was positively correlated with the LGE score(r=0.682,P<0.001),and the percentage of left ventricular myocardial scar area was positively correlated with the percentage of enhanced area to the total mass of left ventricular myocardium(LGE%)(r=0.682,P<0.001);In the LGE positive group,the Selvester QRS score was positively correlated with the LGE score(r=0.569,P<0.001).Receiver operating characteristic(ROC)curve analysis showed that the optimal cut-off values of Selvester QRS score and maximum left ventricular wall thickness for predicting positive LGE were≥3.5 points and≥21 mm,respectively.Conclusions:In HCM patients,the Selvester QRS score is significantly associated with myocardial fibrosis,and the total score≥3.5 serves as a good predictive cutoffvalue for identifying the presence of LGE.

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:Investigate the impact of calcification on the long-term outcomes of patients with coronary chronic total occlusion (CTO) after percutaneous coronary intervention (PCI).Methods:A retrospective cohort study was conducted. Patients who underwent PCI and had at least one CTO lesion at Fuwai Hospital between January 2010 and December 2013 were consecutively enrolled. Calcification was evaluated by coronary angiography, and patients were divided into two groups: moderate/severe calcification group and non/mild calcification group. Clinical follow-up was completed up to 5 years. Incidence of PCI-related complications and immediate procedural outcomes were compared between two groups, and the primary endpoint was the target lesion failure (TLF) at 5 years after PCI. Clinical follow-up endpoint events were analyzed using Kaplan-Meier survival analysis with log-rank test, and Cox multivariate regression model was used to evaluate the relationship between calcification and TLF.Results:The study included 2 659 CTO patients with an age of (57.2±10.5) years, of whom 442 (16.6%) were female, and among whom 13.5% (360/2 659) had moderate/severe calcification. Compared with the non/mild calcification group, the moderate/severe calcification group had a higher incidence of PCI-related complications (43.2% (156/361) vs. 32.5% (772/2 374), P<0.001) and procedural failure (34.3% (124/361) vs. 24.3% (577/2 374), P<0.001). Additionally, the moderate/severe calcification group showed a higher risk of the primary endpoint event (TLF) during the 5-year follow-up (19.8% vs. 15.3%, log-rank P=0.028). Higher incidence of cardiac death was observed in moderate/severe calcification group (5.7% vs. 2.7%, log-rank P=0.003). Cox multivariate regression analysis revealed that moderate/severe calcified plaques remained an independent risk factor for 5-year TLF after CTO-PCI ( HR=1.34, 95% CI: 1.01-1.79, P=0.043). Conclusion:Compared with CTO patients with non/mild calcification, those with moderate/severe calcification have higher procedural failure and complication rates, as well as poorer long-term prognosis, mainly due to an increase in cardiac death.

Objectives:The study assessed the relationship between atherogenic index of plasma(AIP)and the rapid progression of coronary non-target lesions.Methods:A total of 1 247 patients with coronary artery disease who underwent two coronary angiography examinations at Fuwai Hospital,Chinese Academy of Medical Sciences between January 2010 and September 2014 were enrolled in this retrospective study.The AIP is defined as the base 10 logarithm of the ratio of the concentrations of triglyceride to high-density lipoprotein cholesterol.Patients were divided into the high AIP group(n=623)and the low AIP group(n=624)based on the median value of AIP.Lesion rapid progression is defined as an increase of more than 10%in the lumen stenosis of the lesion with a stenosis rate of more than 50%,or an increase of more than 30%in the lumen stenosis rate of the lesion with a stenosis rate of less than 50%,or a progression to total occlusion within 2 years.Results:Median AIP was 0.39(0.23-0.56)in this patient cohort.Rapid progression of non-target lesions occurred in 65(5.21%),including 42(6.74%)in the high AIP group.The Kaplan-Meier curve showed that the cumulative incidence of rapid progression of non-target lesions was higher in the high AIP group than in the low AIP group(HR=1.751,95%CI:1.053-2.912,log-rank P=0.028).In univariate cox analysis,the AIP and high AIP correlated with rapid progression of non-target lesions.After multivariate adjustment,AIP was an independent risk factor for rapid progression of non-target lesions(adjusted HR=2.731,95%CI:1.090-6.844,P=0.032).Conclusions:AIP is an independent risk factor for rapid progression of non-target lesions.AIP should be considered as a biomarker for estimating the risk of cardiovascular disease,along with other traditional risk factors.

Objectives:To explore the relationship between plasma big endothelin-1(Big ET-1)level and left ventricular(LV)remodeling assessed by cardiac magnetic resonance(CMR)in patients with hypertrophic obstructive cardiomyopathy(HOCM).Methods:A total of 180 consecutive HOCM patients were enrolled from November 2013 to July 2015 in Fuwai Hospital,Chinese Academy of Medical Sciences.The baseline characteristics of the patients were collected and the plasma Big ET-1 levels were measured.According to LV remodeling index(LVRI),the patients were divided into severe remodeling group(LVRI>1.3 g/ml,n=119)and mild remodeling group(LVRI≤1.3 g/ml,n=61).The Pearson correlation analysis and multivariate logistic regression analysis were conducted to assess the correlations between plasma Big ET-1 level and indicators of LV remodeling.Results:Compared to the mild remodeling group,the plasma Big ET-1 level([0.84±0.30]pmol/L vs.[0.41±0.19]pmol/L),LVRI([1.7±0.3]g/ml vs.[1.1±0.1]g/ml),the extent of late gadolinium enhancement(LGE)([16.8±8.9]g vs.[7.0±6.6]g)were significantly higher in the severe remodeling group(all P<0.001).Pearson correlation analysis revealed that in patients with HOCM,plasma Big ET-1 level were positively correlated with left atrial anteroposterior diameter,interventricular septal thickness(IVS),LV mass(LVM),LVRI,LGE and LV outflow tract(LVOT)gradient and negatively correlated with LV ejection fraction(all P<0.05).Multivariate logistic regression analysis showed that LVM(OR=1.037,95% CI:1.019-1.056,P<0.001)and plasm Big ET-1 level(OR=11.461,95% CI:2.264-58.014,P=0.003)were the independent determinants for severe LV remodeling in HOCM patients.Conclusions:Among patients with HOCM,the plasma Big ET-1 level are markedly higher in those with severe LV remodeling and are positively associated with left atrial anteroposterior diameter,IVS,LVRI,LVM,LVOT gradient and LGE.Elevated Big ET-1 level and LVM are independent determinants of severe LV remodeling in HOCM patients.

Objectives:To explore the predictive value of residual Murray's law-based quantitative flow ratio(μQFR)on long-term vessel-oriented composite endpoints(VoCE).Methods:This retrospective study included 3 510 patients from the FAVOR Ⅲ China trial.Offline residual μQFR analysis was performed on all vessels(diameter≥2.5 mm)with 50%-90%stenotic lesions.Patients were stratified into high-,intermediate-,and low-risk groups based on residual μQFR tertiles.The primary endpoint was 3-year VoCE,defined as a composite of cardiac death related to the target vessel,target vessel-related spontaneous myocardial infarction,and ischemia-driven target vessel revascularization.Results:Offline analysis was performed on 5 256 vessels from 3 510 patients.The mean residual μQFR was 0.92±0.75.The high-risk group(residual μQFR≤0.91)with 1 554 patients(1 958 vessels);the intermediate-risk group(residual μQFR 0.92-0.96)with 1 211 patients(1 906 vessels);and the low-risk group(residual μQFR>0.96)with 745 patients(1 392 vessels).Over 3-year follow-up,VoCE occurred in 227 vessels(4.3%).The 3-year VoCE incidence was significantly higher in the high-risk group compared to the intermediate-and low-risk groups(6.2%vs.4.1%vs.2.5%,log-rank P<0.001),primarily driven by ischemia-driven target vessel revascularization(5.0%vs.3.0%vs.1.6%,log-rank P<0.001).Hypertension(OR=0.83,95%CI:0.72-0.96),hypercholesterolemia(OR=0.84,95%CI:0.73-0.97),bifurcation lesions(OR=0.72,95%CI:0.63-0.83),moderate/severe calcification(OR=0.70,95%CI:0.57-0.84),and tandem lesions(OR=0.59,95%CI:0.47-0.75)were independent predictors of lower residual μQFR values.Conclusions:Lower residual μQFR is significantly associated with increased VoCE risk during the 3-year follow up period.

Objectives:The aim of this study was to investigate the value of assessing Selvester QRS score in evaluating myocardial fibrosis in hypertrophic cardiomyopathy(HCM)patients.Methods:A total of consecutive 149 patients with HCM,who were admitted in Fuwai Hospital from October 2008 to September 2013,were enrolled in this study.Qualitative and quantitative analyses of myocardial fibrosis were conducted based on late gadolinium enhancement(LGE)derived from enhanced cardiac magnetic resonance imaging(CMR).According to the qualitative analysis of myocardial fibrosis by CMR-LGE,the patients were divided into the LGE-negative group(n=46)and the LGE-positive group(n=103).Standard 12-lead electrocardiogram examination was performed and the Selvester QRS score was calculated.Multivariate binary Logistic regression analysis was used to analyze the predictive factors of positive LGE,and the correlation analysis between the Selvester QRS score and the LGE score was also performed.Results:Compared with the LGE-negative group,the proportion of patients with a family history of HCM(12.8%vs.28.2%),the proportion of patients with a positive Selvester QRS score(65.2%vs.83.5%)and the Selvester QRS score([1.65±1.81]points vs.[5.71±3.80]points)were higher,the maximum thickness of the left ventricular wall([20.5±3.2]mm vs.[24.5±5.0]mm)and the percentage of left ventricular myocardial scar area([5.0±5.5]%vs.[17.1±11.4]%)were larger in the LGE-positive group(all P<0.05).Multivariate binary logistic regression analysis showed that the Selvester QRS score(OR=1.429,95%CI:1.128-1.802,P=0.003)and the maximum left ventricular wall thickness(OR=1.257,95%CI:1.029-1.537,P=0.025)were independent predictors of positive LGE.Pearson correlation analysis showed that in all HCM patients,the Selvester QRS score was positively correlated with the LGE score(r=0.682,P<0.001),and the percentage of left ventricular myocardial scar area was positively correlated with the percentage of enhanced area to the total mass of left ventricular myocardium(LGE%)(r=0.682,P<0.001);In the LGE positive group,the Selvester QRS score was positively correlated with the LGE score(r=0.569,P<0.001).Receiver operating characteristic(ROC)curve analysis showed that the optimal cut-off values of Selvester QRS score and maximum left ventricular wall thickness for predicting positive LGE were≥3.5 points and≥21 mm,respectively.Conclusions:In HCM patients,the Selvester QRS score is significantly associated with myocardial fibrosis,and the total score≥3.5 serves as a good predictive cutoffvalue for identifying the presence of LGE.

Objectives:The study assessed the relationship between atherogenic index of plasma(AIP)and the rapid progression of coronary non-target lesions.Methods:A total of 1 247 patients with coronary artery disease who underwent two coronary angiography examinations at Fuwai Hospital,Chinese Academy of Medical Sciences between January 2010 and September 2014 were enrolled in this retrospective study.The AIP is defined as the base 10 logarithm of the ratio of the concentrations of triglyceride to high-density lipoprotein cholesterol.Patients were divided into the high AIP group(n=623)and the low AIP group(n=624)based on the median value of AIP.Lesion rapid progression is defined as an increase of more than 10%in the lumen stenosis of the lesion with a stenosis rate of more than 50%,or an increase of more than 30%in the lumen stenosis rate of the lesion with a stenosis rate of less than 50%,or a progression to total occlusion within 2 years.Results:Median AIP was 0.39(0.23-0.56)in this patient cohort.Rapid progression of non-target lesions occurred in 65(5.21%),including 42(6.74%)in the high AIP group.The Kaplan-Meier curve showed that the cumulative incidence of rapid progression of non-target lesions was higher in the high AIP group than in the low AIP group(HR=1.751,95%CI:1.053-2.912,log-rank P=0.028).In univariate cox analysis,the AIP and high AIP correlated with rapid progression of non-target lesions.After multivariate adjustment,AIP was an independent risk factor for rapid progression of non-target lesions(adjusted HR=2.731,95%CI:1.090-6.844,P=0.032).Conclusions:AIP is an independent risk factor for rapid progression of non-target lesions.AIP should be considered as a biomarker for estimating the risk of cardiovascular disease,along with other traditional risk factors.

Objectives:To explore the predictive value of residual Murray's law-based quantitative flow ratio(μQFR)on long-term vessel-oriented composite endpoints(VoCE).Methods:This retrospective study included 3 510 patients from the FAVOR Ⅲ China trial.Offline residual μQFR analysis was performed on all vessels(diameter≥2.5 mm)with 50%-90%stenotic lesions.Patients were stratified into high-,intermediate-,and low-risk groups based on residual μQFR tertiles.The primary endpoint was 3-year VoCE,defined as a composite of cardiac death related to the target vessel,target vessel-related spontaneous myocardial infarction,and ischemia-driven target vessel revascularization.Results:Offline analysis was performed on 5 256 vessels from 3 510 patients.The mean residual μQFR was 0.92±0.75.The high-risk group(residual μQFR≤0.91)with 1 554 patients(1 958 vessels);the intermediate-risk group(residual μQFR 0.92-0.96)with 1 211 patients(1 906 vessels);and the low-risk group(residual μQFR>0.96)with 745 patients(1 392 vessels).Over 3-year follow-up,VoCE occurred in 227 vessels(4.3%).The 3-year VoCE incidence was significantly higher in the high-risk group compared to the intermediate-and low-risk groups(6.2%vs.4.1%vs.2.5%,log-rank P<0.001),primarily driven by ischemia-driven target vessel revascularization(5.0%vs.3.0%vs.1.6%,log-rank P<0.001).Hypertension(OR=0.83,95%CI:0.72-0.96),hypercholesterolemia(OR=0.84,95%CI:0.73-0.97),bifurcation lesions(OR=0.72,95%CI:0.63-0.83),moderate/severe calcification(OR=0.70,95%CI:0.57-0.84),and tandem lesions(OR=0.59,95%CI:0.47-0.75)were independent predictors of lower residual μQFR values.Conclusions:Lower residual μQFR is significantly associated with increased VoCE risk during the 3-year follow up period.