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:To evaluate the coronary microcirculatory function in patients with hypertrophic cardiomyopathy(HCM). Methods:Patients who diagnosed with HCM and underwent the measurement of index of microcirculatory resistance(IMR)using pressure-sensing guide wire from November 2021 to April 2023 were prospectively included.Coronary microcirculatory dysfunction(CMD)was defined as IMR≥25 U and patients were grouped accordingly to compare the clinical characteristics. Results:A total of 25 HCM patients were included.Mean age was(58.4±13.3)years,18 were men and mean body mass index was(26.7±3.6)kg/m2.Coronary microcirculatory function was successfully evaluated in all patients and the mean value of IMR was(30.5±15.3)U.There were 15 patients with CMD.Baseline clinical characteristics,laboratory examinations and medications were simialr between patients with and without CMD.The maximal left ventricular wall was significant thicker in patients with CMD compared with that in patients without CMD([20.2±2.8]mm vs.[16.9±2.3]mm,P=0.005).There was no significant difference in other echocardiographic parameters between two groups(all P>0.05).In the range of IMR value less than 50 U(n=22),there was a significant linear positive correlation between maximal left ventricular wall thickness and IMR(r=0.423,P=0.049).There was no significant difference in coronary flow reserve and fractional flow reserve between two groups. Conclusions:The severity of CMD is positively correlated with left ventricular wall thickness in HCM patients.

Background::A phase II trial on recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has previously shown its preliminary efficacy in ST elevation myocardial infarction (STEMI) patients. This study was designed as a pivotal postmarketing trial to compare its efficacy and safety with rrecombinant human tissue-type plasminogen activator alteplase (rt-PA) in Chinese patients with STEMI.Methods::In this multicenter, randomized, open-label, non-inferiority trial, patients with acute STEMI were randomly assigned (1:1) to receive an intravenous bolus of 16 mg rhTNK-tPA or an intravenous bolus of 8 mg rt-PA followed by an infusion of 42 mg in 90 min. The primary endpoint was recanalization defined by thrombolysis in myocardial infarction (TIMI) flow grade 2 or 3. The secondary endpoint was clinically justified recanalization. Other endpoints included 30-day major adverse cardiovascular and cerebrovascular events (MACCEs) and safety endpoints.Results::From July 2016 to September 2019, 767 eligible patients were randomly assigned to receive rhTNK-tPA ( n = 384) or rt-PA ( n = 383). Among them, 369 patients had coronary angiography data on TIMI flow, and 711 patients had data on clinically justified recanalization. Both used a –15% difference as the non-inferiority efficacy margin. In comparison to rt-PA, both the proportion of patients with TIMI grade 2 or 3 flow (78.3% [148/189] vs. 81.7% [147/180]; differences: –3.4%; 95% confidence interval [CI]: –11.5%, 4.8%) and clinically justified recanalization (85.4% [305/357] vs. 85.9% [304/354]; difference: –0.5%; 95% CI: –5.6%, 4.7%) in the rhTNK-tPA group were non-inferior. The occurrence of 30-day MACCEs (10.2% [39/384] vs. 11.0% [42/383]; hazard ratio: 0.96; 95% CI: 0.61, 1.50) did not differ significantly between groups. No safety outcomes significantly differed between groups. Conclusion::rhTNK-tPA was non-inferior to rt-PA in the effect of improving recanalization of the infarct-related artery, a validated surrogate of clinical outcomes, among Chinese patients with acute STEMI.Trial registration::www.ClinicalTrials.gov (No. NCT02835534).

Objectives:To evaluate the efficacy and safety of drug-coated balloon in the treatment of de novo coronary chronic occlusive lesions. Methods:Consecutive patients with de novo coronary chronic occlusive lesions treated with drug-coated balloons only were included in this study.The general information,medical history,and surgical information of the patients were recorded,and major adverse cardiovascular events(MACE,including cardiac death,myocardial infarction,and target vessel revascularization)were recorded by telephone or outpatient follow-up. Results:A total of 160 patients were included.There were 26 ostial lesions(16.3%),42 bifurcated lesions(26.3%),117 diffuse lesions(73.1%),and 87 calcified lesions(54.4%).The reference vessel diameter was(2.3±0.4)mm.During hospitalization,there were no acute myocardial infarction,cardiac death,target lesion revascularization,or acute coronary thrombosis.Cardiac death occurred in 1 case and target vessel revascularization occurred in 6 cases during follow-up.The MACE rate is 4.4%. Conclusions:Drug balloon therapy for de novo coronary chronic occlusive lesions is safe and effective,and the prognosis is satisfactory.

Humans ; Cohort Studies ; Body Mass Index ; Percutaneous Coronary Intervention ; Coronary Artery Disease ; Inflammation ; Treatment Outcome ; Risk Factors

Objectives:To analyze the efficacy and safety of drug coated balloon for coronary de novo lesions in real world. Methods:We enrolled consecutive patients with coronary de novo lesions treated with drug coated balloons from January 2020 to June 2021 in Fuwai Hospital.The baseline data,procedure data and in-hospital cardiac events were collected through case query.All patients were followed up by clinical visit or telephone call.Major adverse cardiac events(MACE)were defined as the composite of the cardiac death,acute myocardial infarction,target lesion revascularization.According to the diameter of the blood vessels,the patients are divided into the large vessel lesion group(vessel diameter≥2.75 mm,n=337),and the small vessel lesion group(vessel diameter<2.75 mm,n=575). Results:There were 940 coronary de novo lesions in 912 patients.A total of 974 drug balloons were used,average diameter was(2.6±0.8)mm,average length was(21.0±6.0)mm,average pressure was(10.0±3.8)atm.Among the 940 primary coronary artery lesions,343 lesions had a diameter≥2.75 mm,and 597 lesions had a diameter<2.75 mm.During hospitalization,two patients with acute ST-segment elevation myocardial infarction died of cardiac rupture after emergency coronary interventional treatment,acute vessel closure because of coronary hematoma occurred in 1 patient and bailout drug-eluting stent was used in this patient,five patients received salvage stent treatment due to type C dissection immediately after drug coated balloon treatment.During follow-up,Target lesion revascularization(TLR)occurred in 15(1.6%)patients(including coronary artery bypass grafting in 1 patient).Nonfatal acute myocardial infarction occurred in 1 patient,cardiac death occurred in 1 patient,2 patients died of cerebral hemorrhage,1 patient died of cerebral infarction,MACE rate was 1.9%(17/912).MACE rate during follow-up was similar between large vessels group and small vessels group(1.8%vs.1.9%,P>0.05). Conclusions:Our study indicates that drug coated balloon for coronary de novo lesion is safe and effective.There is no difference of MACE rate between large vessel group and small vessel group.

Objectives:To investigate the clinical impacts of chronic total occlusion (CTO) in acute non-ST segment elevation myocardial infarction (NSTEMI) patients underwent primary percutaneous coronary intervention (PCI).Methods:A total of 2 271 acute NSTEMI patients underwent primary PCI from China Acute Myocardial Infarction Registry were enrolled in this study and divided into the CTO group and the non-CTO group according to the angiography. The primary endpoint was in-hospital mortality and mortality during a 2-year follow-up. The secondary endpoint was major adverse cardiovascular events (MACE) including revascularization, death, re-myocardial infarction, heart failure readmission, stroke and major bleeding.Results:Thirteen-point four percent of the total acute NSTEMI patients had concurrent CTO. In-hospital mortality (3.6% vs. 1.4%, P<0.01) and 2-year mortality (9.0% vs. 5.1%, P<0.01) were significantly higher in the CTO group than those in the non-CTO group, respectively. Multiple regression analyses showed that chronic obstructive pulmonary disease ( HR 7.28, 95% CI 1.50-35.35, P=0.01) was an independent risk factor of in-hospital mortality, and advanced age ( HR 1.04, 95% CI 1.01-1.07, P<0.01), and low levels of ejection fraction ( HR 0.95, 95% CI 0.93-0.98, P<0.01) were independent risk factors of 2-year mortality. CTO ( HR1.67, 95% CI 1.10-2.54, P=0.02) was an independent risk factor of revascularization, but not a risk factor of mortality. Conclusions:Although acute NSTEMI patients concurrent with CTO had higher mortality, CTO was only an independent risk factor of revascularization, but not of mortality. Advanced age and low levels of ejection fraction were independent risk factors of long-term death among acute NSTEMI patients.

Objective:To compare the influence of single and staged percutaneous coronary intervention (PCI) on long-term prognosis in patients with multi-vessel coronary artery disease.Methods:Using prospective research methods, 1 832 patients with multi-vessel coronary artery disease from January to December 2013 in Fuwai Hospital, Chinese Academy of Medical Sciences were selected. According to the time of PCI, the patients were divided into single PCI group (1 218 cases) and staged PCI group (614 cases). The patients were followed up for 2 years, the primary endpoint was major cardiovascular and cerebrovascular event (MACCE), including target vessel-related myocardial infarction (TV-MI), target vessel-related revascularization (TVR), cardiogenic death and stroke, and the secondary endpoint was stent thrombosis. The propensity score matching (PSM) was applied to balance the discrepancies between 2 groups, and the baseline and follow-up data were compared. The Kaplan-Meier survival curves were drawn to evaluate the survival rates events; multifactor Cox proportional risk regression was used to analyze whether staged PCI was an independent risk factor for the endpoint events.Results:The in-hospital stay, duration of procedure and synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) score in single PCI group were significantly lower than those in staged PCI group: (5.54±3.09) d vs. (9.50±4.06) d, (43.12±28.55) min vs. (79.54±44.35) min, (14.04±7.63) scores vs. (18.51±7.79) scores, and there were statistical differences ( P<0.01); there were no statistical difference in complete revascularization rate and SYNTAX score after PCI between 2 groups ( P>0.05). Based on 2-year follow-up, the incidences of TV-MI and stent thrombosis in staged PCI group were significantly higher than those in single PCI group: 2.1% (13/614) vs. 0.5% (6/1 218) and 2.0% (12/614) vs. 0.4% (5/1 218), and there were statistical differences ( P<0.01). Kaplan-Meier survival curves analysis results showed that the event-free survival rates of TV-MI and stent thrombosis in single PCI group were better than those in staged PCI group (99.5% vs. 97.9% and 99.6% vs. 98.0%, P<0.01). Multifactor Cox proportional risk regression analysis results showed that staged PCI was an independent risk factor for stent thrombosis ( HR = 3.91, 95% CI 1.25 to 12.18, P = 0.019). After PSM, the incidences of TV-MI and stent thrombosis in staged PCI group were significantly higher than those in single PCI group: 2.1% (13/614) vs. 0.7% (4/614) and 2.0% (12/614) vs. 0.5% (3/614), and there were statistical differences ( P<0.05); Kaplan-Meier survival curve analysis results showed that the event-free survival rates of TV-MI and stent thrombosis in single PCI group were significantly higher than those in staged PCI group: (99.3% vs. 97.9% and 99.5% vs. 98.0%, P<0.05); multifactor Cox proportional risk regression analysis results showed that staged PCI was not an independent risk factor of stent thrombosis ( HR = 2.29, 95% CI 0.58 to 9.00, P = 0.234). Both before and after PSM, there were no evidences for interaction between the type of angina pectoris and staged PCI ( P>0.05). Conclusions:Although a seemingly increase exists in the incidence of TV-MI and stent thrombosis in the staged PCI group, staged PCI is an independent risk factor neither for MACCE and its components, nor for stent thrombosis. In addition single PCI reduces the in-hospital days and duration of PCI procedure, which may be a relatively reasonable approach to clinical practice.

Objective: To analyze the association between plasma high-density lipoprotein cholesterol (HDL-C) levels and the severity of coronary artery disease, and to evaluate the impact of HDL-C levels on long-term outcomes in patients underwent percutaneous coronary intervention (PCI). Methods: A total of 10 458 consecutive patients underwent PCI from January 2013 to December 2013 at Fuwai hospital were enrolled in this study. Patients were divided into three groups according to HDL-C tertiles: low HDL-C group (HDL-C≤0.89 mmol/L, n=3 525), median HDL-C group (HDL-C>0.89-1.11 mmol/L, n=3 570) and high HDL-C group (HDL-C>1.11 mmol/L, n=3 363). SYNTAX score was used to evaluate the severity of coronary artery disease, linear regression was used to analyze the relationship of HDL-C and SYNTAX score. Kaplan-Meier survival analysis was used to compare the outcomes among the three groups. Multivariate Cox regression was used to define the potential associations of HDL-C and outcomes. Results: The HDL-C level was (1.03±0.28) mmol/L and the SYNTAX score was 11.7±8.1. Patients were older, proportion of female, stable angina pectoris, successful PCI and left ventricular eject fraction value were higher, while incidence of diabetes mellitus was lower, hyperlipidemia, old myocardial infraction, smoking history and left main and three vessels disease were lower in high HDL-C group (all P<0.05). Patients in high HDL-C group also had the lowest SYNTAX score (12.2±8.4 vs. 11.7±8.1 vs. 11.2±7.8, P<0.001). Both univariate and multivariate linear regression analysis showed that HDL-C was negatively associated with SYNTAX score, e.g. Univariate analysis: β=-0.046, P<0.001; Multivariate analysis: β=-0.058, P=0.001. And 10 400 (99.4%) patients completed 2-year follow up. At 2-year follow-up, there were no difference in all-cause death, cardiac death, myocardial infarction, revascularization, stroke, major adverse cardiovascular and cerebral events (MACCE) and stent thrombosis among three groups (P for trend>0.05), while patient in high HDL-C group experienced the highest BARC type 2 bleeding events (P for trend=0.018). Multivariate Cox regression analysis showed that HDL-C level was not an independent risk factor of 2-year adverse ischemia events (P>0.05) and 2-year bleeding events (P>0.05). Conclusion In patients underwent PCI, plasma HDL-C level is negatively associated with SYNTAX score, but not an independent risk factor of ischemic and bleeding events post PCI.

Objective:This observational study was aimed to analyze the clinical characteristics of infective endocarditis (IE) in patients with hypertrophic cardiomyopathy (HCM).Methods:A total of 668 patients with IE, and 7 427 patients with HCM were treated in Fuwai Hospital from August 2006 to December 2018. Among them, 14 patients were diagnosed with HCM and IE. The clinical characteristics of these patients including clinical manifestations, pathogen distribution, echocardiography features, in-hospital treatment and outcomes were analyzed retrospectively.Results:The proportion of HCM patients with IE was 0.19%,with the estimated incidence of 0.15/1 000 person-years in HCM patients. Of the 14 patients, 11 patients were male. The most common clinical manifestations were fever and heart murmur, and the main complications were heart failure (12/14) and bacterial embolism (8/14). There were 8 cases (8/14) with positive blood culture, and all causative bacteria were gram positive coccus, in which 5/8 were Streptococcus. The median interventricular septum thickness was (21.2±2.7) mm, and left ventricular outflow obstruction was severe based on echocardiography (Echo) examination. The Echo showed that vegetation was found in all 14 patients and most of the vegetation attached at the anterior leaflet of mitral valve (12/14). The proportions of patients with circulatory embolism (8/14) and valve lesions (12/14) were relatively high. Most cases (10/14) were cured, especially those underwent cardiac surgery (8 cases). The rest 4 cases died with 2 in hospital and 2 after auto-discharge. Conclusions:HCM patients complicated with IE are rare. Septic embolization and valve lesions are common in these patients. IE patients with HCM might have a poor prognosis compared to those without HCM and should receive cardiac surgery as early as possible.