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 analyze the impact of target lesion calcification evaluated by coronary angiography on immediate procedure success rate and long-term clinical outcome in patients underwent percutaneous coronary intervention(PCI). Methods:Consecutive patients received angiographic calcification evaluation and underwent PCI in Fuwai Hospital,Chinese Academy of Medical Sciences from January 2017 to December 2018 were prospectively enrolled in this study.Patients are divided into 4 groups,including non-calcification group(n=14 387),mild calcification group(n=8 231),moderate calcification group(n=3 208)and severe calcification group(n=886).The primary endpoint was immediate post-PCI procedure success rate,which was defined as residual stenosis<50%without major operational complications(including coronary artery perforation,coronary artery dissection,intraoperative stent thrombosis)and failure to cross the lesion.The long-term clinical endpoint was the 3-year major adverse cardiovascular events(MACE),which included composite endpoint events such as all cause death,myocardial infarction(MI),and revascularization. Results:The severe calcification group had a lower success rate of interventional therapy(80.59%vs.94.23%vs.94.29%vs.91.49%),a higher incidence of residual stenosis≥50%(17.72%vs.5.03%vs.4.84%vs.7.29%),a higher incidence of coronary artery dissection(1.81%vs.0.66%vs.0.78%vs.1.25%),and a higher incidence of coronary artery perforation(2.14%vs.0.51%vs.0.38%vs.0.69%),and a higher incidence of failure to cross the lesion(0.23%vs.0.12%vs.0.04%vs.0.16%)compared to the non-calcification group,mild calcification group,and moderate calcification group(all P<0.05).Multivariate Cox regression analysis showed that patients with severe calcification had a higher risk of MACE(12.98%vs.9.35%,HR=1.21,95%CI:1.00-1.47,P=0.046),all-cause mortality(4.29%vs.1.80%,HR=1.55,95%CI:1.10-2.18,P=0.013),and MI(2.14%vs.0.97%,HR=1.97,95%CI:1.21-3.20,P=0.006)compared to patients without calcification. Conclusions:Patients with angiographic-detected severe calcification after PCI treatment face higher risk of PCI procedure failure,MACE,all-cause death,and MI compared to patients without,with mild,and moderate calcification.

BACKGROUND AND OBJECTIVES: Over the past decades, transradial approach for percutaneous coronary intervention (PCI) has been increasingly adopted in clinical practice. Women represent a large population who will possibly benefit from PCI, but they are often under-represented in clinical studies. Therefore, the role of TRI in women remains to be further defined. This study sought to compare safety and efficacy for transradial intervention (TRI) and transfemoral intervention (TFI) in women undergoing PCI in China. METHODS: The study population consisted of 5,067 women undergoing PCI at Fuwai Hospital, Beijing, China between 2006 and 2011 (TRI: n=4,105, TFI: n=962). Incidence rates of clinical outcomes during hospitalization and at 1-year follow-up were compared between TRI and TFI. In order to minimize potential biases, a 1:1 propensity score matching (PSM) was performed. A total of 899 pairs were matched. RESULTS: Baseline and procedural characteristics were well-balanced between TRI and TFI groups after controlling for confounders using PSM. TRI was associated with reduced major post-PCI bleeding (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.54–0.76; p < 0.001) and access site complications (OR, 0.67; 95% CI, 0.61–0.74; p < 0.001) after PSM. There was no statistical differences in the incidence rates of major adverse cardiac events (a composite of cardiac death, myocardial infarction, and target vessel revascularization) both during hospitalization and at 1-year follow-up (p > 0.05). CONCLUSIONS: In this propensity score-based analysis of TRI versus TFI in Chinese women, TRI showed advantages of safety and feasibility over TFI. A wider adoption of TRI in women has the potential to improve outcomes in treatment of coronary artery diseases.
Asian Continental Ancestry Group ; Beijing ; Bias (Epidemiology) ; China ; Coronary Artery Disease ; Death ; Female ; Femoral Artery ; Follow-Up Studies ; Hemorrhage ; Hospitalization ; Humans ; Incidence ; Myocardial Infarction ; Percutaneous Coronary Intervention ; Propensity Score ; Radial Artery

BACKGROUND AND OBJECTIVES: Over the past decades, transradial approach for percutaneous coronary intervention (PCI) has been increasingly adopted in clinical practice. Women represent a large population who will possibly benefit from PCI, but they are often under-represented in clinical studies. Therefore, the role of TRI in women remains to be further defined. This study sought to compare safety and efficacy for transradial intervention (TRI) and transfemoral intervention (TFI) in women undergoing PCI in China. METHODS: The study population consisted of 5,067 women undergoing PCI at Fuwai Hospital, Beijing, China between 2006 and 2011 (TRI: n=4,105, TFI: n=962). Incidence rates of clinical outcomes during hospitalization and at 1-year follow-up were compared between TRI and TFI. In order to minimize potential biases, a 1:1 propensity score matching (PSM) was performed. A total of 899 pairs were matched. RESULTS: Baseline and procedural characteristics were well-balanced between TRI and TFI groups after controlling for confounders using PSM. TRI was associated with reduced major post-PCI bleeding (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.54–0.76; p < 0.001) and access site complications (OR, 0.67; 95% CI, 0.61–0.74; p < 0.001) after PSM. There was no statistical differences in the incidence rates of major adverse cardiac events (a composite of cardiac death, myocardial infarction, and target vessel revascularization) both during hospitalization and at 1-year follow-up (p > 0.05). CONCLUSIONS In this propensity score-based analysis of TRI versus TFI in Chinese women, TRI showed advantages of safety and feasibility over TFI. A wider adoption of TRI in women has the potential to improve outcomes in treatment of coronary artery diseases.

Objective: To assess the risk factors for peri-procedural myocardial infarction (PMI) occurrence in patients after percutaneous coronary intervention (PCI) based on the new standard of US Society for cardiovascular angiography and interventions (SCAI). Methods: According to SCAI standard, a total of 3371 relevant patients with 3516 elective PCI in our hospital were enrolled. The baseline clinical features, coronary angiography (CAG) findings and PCI procedural elements were retrospectively studied, the independent risk factors for PMI occurrence were identified by multivariate Logistic regression analysis. Results: There was 108/3516 (3.1%) PMI occurred in all patients. Multivariate Logistic regression analysis presented that age (OR=1.037, 95% CI 1.016-1.058), treating multi-vessel lesions (OR=1.697, 95% CI 1.095-2.629), treating at least 1 bifurcation lesion (OR=1.869, 95% CI: 1.213-2.878) and the total length of lesion (OR=1.016, 95%CI 1.009-1.024) were the independent risk factors for PMI occurrence. Conclusions: Age, treating multi-vessel lesions, at least one bifurcation lesion and the total length of lesion were the independent risk factors for PMI occurrence in patients after elective PCI.

BACKGROUNDDespite its severity, coronary artery ectasia (CAE) is still poorly understood. High-sensitivity C-reactive protein (hs-CRP) has been recognized as a prognostic factor in some cardiovascular diseases but not assessed in CAE. The aim of this observational study was to investigate the prognostic value of hs-CRP in CAE.

METHODSOur analysis evaluated the effect of the baseline hs-CRP on cardiovascular events (CVs) (cardiac death and nonfetal myocardial infarction) in consecutively enrolled stable CAE patients. We used the Cox proportional hazards regression models to examine the association between baseline hs-CRP level and follow-up CVs in CAE. The net reclassification improvement and integrated discrimination improvement (IDI) of hs-CRP were also assessed.

RESULTSWe obtained the follow-up results of 540 patients over a median follow-up period of 36 (37.41 ± 15.88) months. The multivariable Cox analysis showed that the hs-CRP was a significant predictor of adverse outcomes in CAE (hazard ratio [HR]: 2.99, 95% confidence interval [CI]: 1.31-6.81, P = 0.0091). In Kaplan-Meier analysis, the group with hs-CRP >3 mg/L had a lower cumulative 66-month event-free survival rate (log-rank test for trend, P = 0.0235) and a higher risk of CVs (HR = 2.66, 95% CI: 1.22-5.77, P = 0.0140) than the group with hs-CRP ≤3 mg/L. Hs-CRP added predictive information beyond that given by the baseline model comprising the classical risk factors (P value for IDI = 0.0330).

CONCLUSIONSA higher level of hs-CRP was independently associated with cardiac death and nonfatal myocardial infarction in CAE patients. The hs-CRP level may therefore provide prognostic information for the risk stratification of CAE patients.

Aged ; C-Reactive Protein ; metabolism ; Coronary Artery Disease ; metabolism ; pathology ; Female ; Humans ; Male ; Middle Aged ; Prognosis ; Proportional Hazards Models

Objective:To investigate the impact of bifurcation angle (BA) on side branch occlusion (SBO) during percutaneous coronary intervention (PCI) in relevant patients.
Methods: A total of 1171 consecutive patients with 1200 bifurcation lesions who received one stent technique were studied. Based on the median BA of 52°, the patients were divided into 2 groups:Low angle group, n=587 patients with 600 bifurcation lesions and High angle group, n=584 patients with 600 bifurcation lesions. SBO was deifned by either side branch blood lfow disappeared or TIMI grade decreased after PCI. The occurrence rate of SBO was investigated and the impact of BA on SBO during PCI was evaluated by multivariate Logistic regression analysis.
Results:SBO occurred in 88/1200 (7.33%) bifurcation lesions. The occurrence rate of SBO in High angle group was igher than Low angle group (10.5%vs 4.2%, P<0.001). Multivariable Logistic regression analysis showed that high angle was the independent predictor of SBO occurrence (OR=1.026, 95%CI 1.014-1.037, P<0.01).
Conclusion:High BA was an independent predictor of SBO after the main vessel stent implantation, which should not be ignored in clinical practice.

Objective: To explore the correlation between antithrombotic strategy and its prognostic value in coronary artery disease (CAD) patients combining with atrial ifbrillation (AF) after percutaneous coronary intervention (PCI).
Methods: A total of 570 CAD patients with AF received PCI in our hospital from 2012-01 to 2013-12 were retrospectively analyzed by CHADS2 and HAS-BLED Score system. According to CHADS2 < 2 and CHADS2 ≥ 2 or with/without warfarin medication, the patients were divided into 2 groups:①CHADS2 < 2 (Low risk of stroke) group,n=339 including 309 patients without warfarin and 30 with warfarin medication;②CHADS2 ≥ 2 (High risk of stroke) group,n=231 including 200 patients without warfarin and 31 with warfarin medication. All patients were followed-up for 15 months to compare the different anti-platelet/ anti-coagulation strategies for the occurrence rate of MACCE, ischemic and bleeding events.
Results: Compared with Low risk of stroke group, the patients in High risk of stroke group had the worse prognosis and higher rate of MACCE occurrence,P<0.001, HR=2.677, 95% CI (1.535-4.635), more ischemic events,P=0.013, HR=2.080, 95% CI (1.167-3.709). Multi-factor Cox surving analysis indicated that compared with low risk patients without warfarin medication, the high risk patients without warfarin had the higher rate of MACCE occurrence,P=0.001, HR=2.985, 95% CI (1.532-5.816), more ischemic events,P=0.026, HR=2.068, 95% CI (1.090-3.925). Whereas, the occurrence rates of MACCE and ischemic events in high risk, low risk patients with warfarin and low risk patients without warfarin were similar, all P>0.05. The major bleeding events in patients with warfarin were a little higher than those without warfarin,P>0.05. The minor bleeding events were increased in both Low risk stroke group asP<0.001, OR=4.458, 95% CI (1.934-10.277) and High risk stroke group asP=0.002, OR=4.155, 95% CI (1.717-10.055).
Conclusion: Warfarin medication may obviously decrease the occurrence rates of MACCE and ischemic events in high risk of stroke patients, while in low risk patients, warfarin could not further decrease the occurrence of MACCE and ischemic events. Warfarin could increase the risk for minor bleeding in both low risk and high risk of stroke in CAD patients combining with AF after PCI.

Objective: To establish a risk prediction model and scoring system in patients with side branch (SB) occlusion during coronary bifurcation intervention. Methods: A total of 7007 consecutive patients who received percutanenous coronary intervention (PCI) in our hospital from 2012-02 to 2012-07 were recruited and 1545 patients (with 1601 bifurcation lesions) treated by single stent technique or main vessel stenting ifrst strategy were selected for our study. According to weather SB occlusion occurred during operation, the lesions were divided into 2 groups: Non-SB occlusion group,n=1431 and SB occlusion group,n=114. The data set of the ifrst 1200/1601 lesions by time sequence, was used for establishing the risk model and scoring system, the data set of rest 401 lesions was used for model validation. Results: The modeling data set presented that the relationship between pre-operative main vessel plaque and the position of branch vessel, the main blood vessel pre-stenting TIMI grade, the stenosis degree of pre-operative bifurcation nucleus, the angle of pre-operative bifurcation and the ratio of pre-senting stenosis degree of branch diameter and pre-operative main vessel to branch vessel diameter were the independent risk factors for branch occlusion. The risk model ROC=0.80, 95% CI 0.75-0.85, Hosmer-Lemeshow HLP=1.00; the scoring system ROC=0.76, 95% CI 0.71-0.82, HLP=0.12. The validation data set ROC=0.81, 95% CI 0.73-0.89, HLP=0.77; the scoring system ROC=0.77, 95% CI 0.69-0.86, HLP=0.58. The quartile integration of both data sets indicated that the patients with the integration score ≥ 10 had the higher risk for SB occlusion than those with integration score < 10 during the operation,P<0.001. Conclusion: Our research developed a simple and user-friendly system, it may distinguish the patients with high risk of SB occlusion during bifurcation intervention by quantitative stratiifcation of coronary angiographic imaging.

Objective: To investigate the prognostic factor for small side branch (SB) occlusion during coronary bifurcation intervention with the incidence rate of peri-procedural myocardial injury (PMI) in relevant patients.
Methods: A total of 925 consecutive patients who received coronary bifurcation intervention were enrolled and there were 949 SB lesions ≤ 2.0 mm conifrmed by quantitative coronary angiography (QCA). The patients were divided into 2 groups: SB occlusion group,n=85, including 86 bifurcation lesions and Non-SB occlusion group,n=840, including 863 bifurcation lesions. The clinical characteristics, QCA findings and PCI procedural conditions were studied by Multivariate logistic regression analyses to explore the independent predictors of SB occlusion and to compare the incidence rate of PMI.
Results: The total SB occlusion rate was 9.1% (86/949). SB occlusion group had the higher incidence rate of PMI (26/83, 31.3%) vs (77/821, 9.4%) and peri-operative MI mortality(6/83, 7.2%) vs (11/821, 1.3%) than Non-SB occlusion group, both P<0.001. In SB occlusion group, the diameter ratio of main vessel (MV)/SB was obviously higher than Non-SB occlusion group,P<0.001. The independent predictors of SB occlusion included in true bifurcation lesion, irregular plaque, pre-dilation of SB, TIMI lfow grade of pre-procedural SB, stenosis degrees of distal MV and bifurcation core, bifurcation angle, diameter ratio of MV/SB and the stenosis degree of SB before MV stenting.
Conclusion: Coronary bifurcation lesion patients with SB occlusion had the higher risk of PMI during the interventional procedure.