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Objective: To estimate the prevalence, awareness, treatment and control rate of hypertension among young and middle-aged population in China. Methods: The analysis was based on the results of 2012-2015 China Hypertension Survey, which was a cross-sectional stratified multistage random sampling survey. A total of 229 593 subjects were included in the final analysis. The data including sex, age, living in urban and rural areas, prevalence of hypertension, history of stroke, family history of coronary heart disease and drinking, physical examination, heart rate were collected. Hypertension was defined as mean systolic blood pressure (SBP) ≥140 mmHg (1 mmHg=0.133 kPa), and (or) diastolic blood pressure (DBP) ≥90 mmHg, and (or) self-report a history of hypertension, and (or) use of antihypertensive medicine within 2 weeks before survey. Prehypertension was defined as SBP between 120-139 mmHg, and (or) DBP between 80-89 mmHg. Control of hypertension was considered for hypertensive individuals with SBP<140 mmHg and DBP<90 mmHg. The prevalence of prehypertension, hypertension, awareness, treatment, control rate were calculated, and the control rate among those with antihypertensive medication was also calculated. Results: The prevalence of prehypertension and hypertension was 43.8% (95%CI: 42.3%-45.4%), and 22.1% (95%CI: 20.8%-23.3%), respectively. The prevalence of prehypertension and hypertension was significantly higher among male than female across different age groups. The awareness, treatment, control rate of hypertension and control rate among treated hypertensive participants were 43.8%, 33.2%, 16.7%, and 40.2%, respectively. The prevalence was higher, and the control rate was lower among individuals with higher heart rate. Conclusion: The prevalence of prehypertension and hypertension among young and middle-aged population is high, the awareness, treatment and control rate need to be further improved in this population. The prevention and treatment of hypertension should be strengthened in the future to improve the control rate of hypertension in China.
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Middle Aged , Male , Female , Humans , Antihypertensive Agents/therapeutic use , Prehypertension/epidemiology , Prevalence , Cross-Sectional Studies , Hypertension/drug therapy , Blood Pressure , China/epidemiologyABSTRACT
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.
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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.
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Objective@#Patients with acute coronary syndrome due to multivessel disease (MVD) were at the highest risk of adverse cardiovascular events. Neutrophil to lymphocyte ratio (NLR) was proposed as a marker of cardiovascular risk. Present study evaluated the independent predictive value of NLR for acute myocardial infarction (AMI) patients with MVD.@*Methods@#AMI patients with MVD (n=1 433) underwent percutaneous coronary intervention (PCI) between January 2013 and December 2013 were followed up for 2 years. Patients were divided into 2 sub-groups based on an optimal cut off value of NLR to predict 2-year all-cause mortality. The primary endpoint was all-cause death. The secondary endpoint was long-term major adverse cardiovascular and cerebrovascular events (MACCE).@*Results@#By receiver operating characteristics curve analysis, the optimal cut-off value of admission NLR to predict 2-year all-cause mortality was 3.39 (area under the curve 0.765, sensitivity 71%, specificity 73%). The high NLR group(n=396) had higher prevalence of prior myocardial infarction, prior PCI and intra-aortic balloon pump use (IABP)(P<0.01). Compared to the low NLR group (n=1 037), patients in the high NLR group were older, had higher level of neutrophil count and high-sensitivity C-reactive protein (hs-CRP) (P<0.001), but lower level of lymphocyte count, estimated glomerular filtration rate (eGFR) and ejection fraction (P<0.001). During the follow-up period, rate of long-term all-cause death was significantly higher in the high NLR group than in the low NLR group (5.1% (20/396) vs. 0.8% (8/1 037), P<0.001). Cardiac death (4.0% (16/396) vs. 0.7% (7/1 037), P<0.001) and MACCE (21.7% (86/396) vs. 12.6% (131/1 037), P<0.001) were also significantly higher in the high NLR group than in the low NLR group. Multivariate Cox analysis showed that NLR ≥ 3.39 was determined as an independent predictor of 2-year all-cause mortality (HR=3.23, 95%CI 1.38-7.54, P=0.007) and MACCE (HR=1.58, 95%CI 1.19-2.10, P=0.002) in this patient cohort after adjusting for other risk factors. Correlation analysis showed that the NLR was positively correlated with hs-CRP levels (r=0.241, P<0.001).@*Conclusion@#Our study demonstrates that admission NLR ≥ 3.39 is an independent predictor of long term all cause death and MACCE in AMI patients with MVD post PCI.
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Objective@#To investigate the impact of coronary lesion calcification on the long-term outcome of patients with coronary heart disease after percutaneous coronary intervention.@*Methods@#In this prospective observational study, a total of 10 119 consecutive patients with coronary heart disease undergoing percutaneous coronary intervention from January 1 to December 31, 2 103 in our hospital were enrolled. The patients were divided into non/mild calcification group (8 268 cases) and moderate/severe calcification group (1 851 cases) according to the angiographic results. The primary endpoint was one-year major adverse cardiovascular events (MACE), including all-cause death, myocardial infarction, and target vessel revascularization.@*Results@#The patients were (58.3±10.3) years old, and there were 2 355 females (23.3%). Compared with non/mild calcification group, patients in the moderate/severe calcification group were older ((60.0±10.6) years vs. (57.9±10.2) years, P<0.01), and had higher proportion of female (25.4% (470/1 851) vs. 22.8% (1 885/8 268), P=0.02), debates (33.9% (628/1 851) vs. 29.0% (2 399/8 268), P<0.01), hypertension (68.0% (1 259/1 851) vs. 63.7% (5 264/8 268), P<0.01), coronary artery bypass grafting (4.6% (85/1 851) vs. 3.2% (268/8 268), P<0.01), stroke (12.6% (233/1 851) vs. 10.4% (861/8 268), P=0.01), and renal dysfunction (6.2% (115/1 851) vs. 3.7% (303/8 268), P<0.01). Compared with non/mild calcification group, patients in themoderate/severe calcification group experienced longer procedure time (37 (24, 61) min vs. 27 (17,40) min, P<0.01) and stent length was longer (32 (23,48) mm vs. 27 (18,38) mm, P<0.01), and percent of rotational atherectomy was higher (2.56%(57/2 229) vs. 0.03% (3/11 930), P<0.01). One-year follow-up results showed that MACE (7.5% (139/1 846) vs. 4.9% (402/8 243), P<0.01), all-cause death (1.0% (19/1 846) vs. 0.6% (49/8 243), P=0.04), myocardial infarction (2.2% (41/1 846) vs. 1.4% (114/8 243), P=0.01), and target vessel revascularization (5.0% (92/1 846) vs. 3.2% (266/8 243), P<0.01) were all significantly higher in moderate/severe calcification group than in non/mild group. Multivariate Cox regression analysis showed that moderate/severe calcification was an independent predictor of MACE at one-year after the procedure (HR=1.41, 95%CI 1.16-1.72, P<0.01).@*Conclusion@#Moderate/severe calcification in coronary lesion is an independent predictor of long-term poor prognosis in coronary heart disease patients undergoing percutaneous coronary intervention.
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Objective@#To observe the use of clopidogrel and related factors for patients with acute coronary syndrome (ACS) in terms of early use, loading dose, dual antiplatelet therapy (DAPT) and maintenance dose hospitalized in non-PCI country hospitals in China.@*Methods@#Patients hospitalized for ACS from 101 non-PCI country hospitals across China were recruited prospectively from October 2011 to November 2014. In-hospital clopidogrel use rate, the proportions of early use (within 24 hours), loading dose use (≥300 mg), DAPT (early use combined with aspirin) and maintenance dose use (following dose≥75 mg/d) were analyzed. Generalized estimated equation (GEE) model was used to explore factors associated to in-hospital clopidogrel use and loading dose use in both univariate and multivariate analyses, adjusting for cluster effect.@*Results@#A total of 14 809 ACS patients were included, with an average age of (64.1±11.6) years and 60% (8 888/14 809) were male. The in-hospital clopidogrel use rate was 66.4% (9 828/14 809), which varied across different regions, years and sub-types of ACS (all P<0.05). Among users, the proportions of patients with early use, DAPT and maintenance dose use were 91.3% (8 734/9 562), 89.2% (8 526/9 562) and 95.1% (9 094/9 562), respectively, but the proportion of patients received loading dose was only 41.8% (3 995/9 562). Multivariate analyses showed that patients who admitted to hospital in earlier years and with non-ST elevation ACS, ≥75 years old, female, non-smoking, illiterate, heart rate≥100 beats per minute, atrial fibrillation, not on ECG monitoring, and not using other anti-ACS drugs were less likely to receive clopidogrel (all P<0.05). And those clopidogrel users who with non-ST elevation ACS, ≥75 years old, non-smoking, illiterate, not using other anti-ACS drugs were less likely to receive loading dose (all P<0.05).@*Conclusion@#The use rate of clopidogrel and the loading dose among in-hospital ACS patients are both low and remain to be improved in non-PCI county hospitals in China. Special attention should be paid on non-ST elevation ACS, ≥75 years old, female, and illiterate patients to increase the rational use of clopidogrel and the loading dose.
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Objective@#To compare the clinical characteristics and long-term prognosis between male and female patients with premature coronary artery disease (PCAD) post coronary intervention, and analyse the risk factors of major adverse cardio-cerebrovascular events (MACCE) and bleeding events.@*Methods@#This was a prospective single-center observational study. From January 2013 to December 2013, 4 744 patients diagnosed as PCAD and treated with percutaneous coronary intervention (PCI) in Fuwai Hospital were enrolled. The general clinical data, laboratory results and interventional treatment data of all patients were collected, and patients were followed up for 2 years after PCI and the incidence of events including MACCE and bleeding was analyzed. The baseline data and clinical events of PCAD patients of different genders were compared. Survival curves were estimated by Kaplan-Meier method. Univariate and multivariate Cox regression were used to analyze whether gender was an influencing factor of different clinical events of PCAD patients within 2 years after PCI, and other relevant influencing factors of MACCE and bleeding events.@*Results@#Among the 4 744 PCAD patients included, there were 3 390 (71.5%) male aged (47.0±5.4) years old and 1 354 (28.5%) female aged (57.0±5.8) years old. Compared with female patients, male patients had higher body mass index, higher proportion of hyperlipidemia, smoking, myocardial infarction, previous PCI, preoperative estimated glomerular filtration rate, ST-segment elevation myocardial infarction, radial artery approach, intravenous ultrasound use and chronic occlusive lesions (all P<0.05). Age, left ventricular ejection fraction, prevalence of hypertension, diabetes mellitus, past stroke history, non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and the use of calcium channel blockers were lower in male patients than in female patients (all P<0.05). The 2-year follow-up results showed that the incidence of BARC type 1 hemorrhage was significantly higher in female patients than in male patients (6.9%(92/1 343) vs. 3.7%(126/3 378), P<0.001); however, the incidence of MACCE, all-cause death, cardiac death, recurrent myocardial infarction, revascularization (target vessel revascularization and target lesion revascularization), stent thrombosis, stroke and BARC type 2-5 hemorrhage were similar between the two groups (all P>0.05). Multivariate Cox regression analysis showed that gender was an independent risk factor for BARC type 1 bleeding in PCAD patients (HR=2.180, 95%CI 1.392-3.416, P<0.001), but it was not an independent risk factor for MACCE and BARC type 2-5 bleeding(all P>0.05). Hyperlipidemia, preoperative SYNTAX score, multivessel lesions and NSTE-ACS were the independent risk factors for MACCE in PCAD patients with PCI (the HRs(95%CI) were 1.289(1.052-1.580), 1.030(1.019-1.042), 1.758(1.365-2.264), 1.264(1.040-1.537), respectively); gender (HR=1.579, 95%CI 1.085-2.297, P=0.017), hyperlipidemia (HR=1.305, 95%CI 1.005-1.695, P=0.046), anticoagulant drugs including low molecular weight heparin (HR=1.321, 95%CI 1.002-1.741, P=0.048) or sulfonate(HR=1.659, 95%CI 1.198-2.298, P=0.002) were the independent risk factors for bleeding events.@*Conclusions@#There are differences in clinical and coronary artery lesion characteristics between different genders in patients with PCAD. The incidence of minor bleeding is significantly higher in female PCAD patients than in male PCAD patients. Hyperlipidemia, preoperative SYNTAX score, multivessel lesions and NSTE-ACS are the independent risk factors for MACCE, and gender, hyperlipidemia, anticoagulant drugs including low molecular weight heparin or sulfonate are the independent risk factors for bleeding events in patients with PCAD.
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Objective@#To observe the safety and impact of short-term anticoagulant therapy on prognosis after selective percutaneous coronary intervention (PCI) in patients with coronary artery disease.@*Methods@#From January 2013 to December 2013, 9 769 consecutive patients underwent selective PCI in Fuwai Hospital were retrospectively included in this study. Patients were divided into two groups, including non-post-PCI anticoagulant therapy group and low-dose and short-time post-PCI anticoagulant therapy group (enoxaparin 0.4 ml/12 h or fondaparinux 2.5 mg/day by subcutaneous injection for 2-3 days after PCI). All patients were evaluated at 30 days, 180 days and 12 months for major adverse coronary and cerebral events (MACCE) including all-cause death, myocardial infarction, revascularization and stroke as well as in-stent thrombosis and bleeding events. Data from 1 755 pairs of patients were analysis after propensity score matching. The clinical outcomes were compared between groups by using Kaplan-Meier survival analysis before and after propensity score matching. Multivariable Cox analysis was used to define the impact and determinants of post-PCI anticoagulation on clinical outcomes.@*Results@#one thousand seven hundred and fifty-five (18.0%) patients didn′t receive post-PCI anticoagulation and 8 014 (82.0%) patients received post-PCI anticoagulation, 5 666 (58.0%) patients received enoxaparin and 2 348 (24.0%) patients received fondaparinux. Patients were younger and incidence of female patients was less, incidence of renal dysfunction and acute coronary syndrome were higher in low-dose and short-time post-PCI anticoagulant therapy group than in non-post-PCI anticoagulation group (all P<0.05). Similarly, patients with post-PCI anticoagulation were associated with more left main coronary artery lesion and branch lesion (P<0.05). Post-PCI anticoagulation patients were associated with less trans-femoral process, more drug-eluting stents implantation and less simple balloon dilatation (all P<0.05). Nine thousand seven hundred and seventeen (99.5%) patients completed 2 years follow up. Post-PCI anticoagulation patients had significantly lower 30-day all-cause death (0.05% (4 cases) vs. 0.46% (8 cases), P<0.001) and stroke (0 vs. 0.11% (2 cases), P=0.003), lower 180-day all-cause death (0.17% (14 cases) vs. 0.57% (10 cases), P=0.002), revascularization (2.07% (166 cases) vs. 3.71% (65 cases), P<0.001) and MACCE (3.49% (280 cases) vs. 5.47% (96 cases), P<0.001), lower 2-year revascularization (7.61% (610 cases) vs. 12.84% (225 cases), P<0.001) and MACCE (10.92 (875 cases) vs. 16.01% (281 cases), P<0.001). Multivariable Cox regression analysis showed that post-PCI anticoagulant therapy was an independent protective factor of 30-day (HR=0.17, 95%CI 0.05-0.62, P=0.007), 180-day all-cause death (HR=0.37, 95%CI 0.16-0.87, P=0.023) and MACCE (HR=0.74, 95%CI 0.58-0.94, P=0.013), 2-year MACCE (HR=0.71, 95%CI 0.62-0.81, P<0.001). After propensity score matching, post-PCI anticoagulation therapy remained as an independent protective factor of 30-day all-cause death (HR=0.11, 95%CI 0.01-0.92, P=0.042) and 2-year MACCE (HR=0.81, 95%CI 0.68-0.96, P=0.015).@*Conclusions@#Low-dose and short-time post-PCI anticoagulant therapy may decrease 30-day all-cause death, 180-day all-cause death and MACCE and 2-year MACCE, and meanwhile this option does not increase bleeding risk in patients underwent selective PCI.
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Objective To evaluate the effect of comprehensive intervention program on hypertension control in workplaces in China.Methods The study design was a non-randomized controlled trial.First,20 sub-centers were selected across China,then hypertension patients in 2-4 workplaces were selected as the intervention group,and hypertension patients in 1 comparable workplace selected,as the control group in each sub-center.The comprehensive intervention strategy which integrating workplace primary prevention of cardiovascular diseases and standardized management of hypertension was adopted in the intervention group for at least 2 years.Patients in the control group continued their usual health care,and only baseline data and 2-year data was collected.Analyses were conducted for hypertension patients in 30 stated-owned enterprises (SOEs),including 20 for the intervention group and 10 for the control group.The primary outcome was the control rate ofhypertension while the intervention effect (IE) was estimated by using the formula:differential value of intervention group [rate (mean)] — differential value of control group [rate (mean)].Results Overall,2 622 patients completed the 2-year follow-up,of which 2 055 were in the intervention group and 567 in the control group,respectively.After 2 years of intervention,the IE on the level of SBP and DBP for intervention group and control group were-7.5 and-3.9 mmHg,respectively (P＜0.05).BMI decreased by 0.4 kg/m2,with the regular exercise rate as 36.4％ and alcohol consumption rate decreased by 14.0％,respectively (P＜0.05).The smoking rate decreased by 6.1％ (P＞0.05).The overall hypertension control rate was 25.0％,and further subgroup analysis showed that our intervention program was particularly effective for those with high education level (27.6％),white-collar employees (41.9％),and those from SOEs whose affiliated hospital had been separated away (41.9％).Conclusion The comprehensive intervention program could greatly improve the hypertension control in the workplaces in China.
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Objective To evaluate the effect of comprehensive intervention program on hypertension control in workplaces in China.Methods The study design was a non-randomized controlled trial.First,20 sub-centers were selected across China,then hypertension patients in 2-4 workplaces were selected as the intervention group,and hypertension patients in 1 comparable workplace selected,as the control group in each sub-center.The comprehensive intervention strategy which integrating workplace primary prevention of cardiovascular diseases and standardized management of hypertension was adopted in the intervention group for at least 2 years.Patients in the control group continued their usual health care,and only baseline data and 2-year data was collected.Analyses were conducted for hypertension patients in 30 stated-owned enterprises (SOEs),including 20 for the intervention group and 10 for the control group.The primary outcome was the control rate ofhypertension while the intervention effect (IE) was estimated by using the formula:differential value of intervention group [rate (mean)] — differential value of control group [rate (mean)].Results Overall,2 622 patients completed the 2-year follow-up,of which 2 055 were in the intervention group and 567 in the control group,respectively.After 2 years of intervention,the IE on the level of SBP and DBP for intervention group and control group were-7.5 and-3.9 mmHg,respectively (P＜0.05).BMI decreased by 0.4 kg/m2,with the regular exercise rate as 36.4％ and alcohol consumption rate decreased by 14.0％,respectively (P＜0.05).The smoking rate decreased by 6.1％ (P＞0.05).The overall hypertension control rate was 25.0％,and further subgroup analysis showed that our intervention program was particularly effective for those with high education level (27.6％),white-collar employees (41.9％),and those from SOEs whose affiliated hospital had been separated away (41.9％).Conclusion The comprehensive intervention program could greatly improve the hypertension control in the workplaces in China.
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Objective@#This study sought to evaluate the safety and efficacy of FIREHAWK, a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) in patients with moderate-complex coronary lesions (including patients with small vessel disease, long lesion and multi vessel disease), and to validate the ability of the SYNTAX score (SS) to predict clinical outcomes in patients treated with FIREHAWK stent. @*Methods@#TARGETⅡ was a prospective, multicenter, single-arm clinical trial, a total of 730 patients who underwent percutaneous coronary intervention (PCI) of de novo lesions in native coronary arteries in 24 medical centers in China from August 2011 to February 2012 were enrolled in this study. All patients were exclusively treated with the FIREHAWK stent. Clinical data including patients with diabetes, small vessel disease, long lesion and multi vessel disease were analyzed. The primary composite endpoint was the target lesion failure (TLF) of cardiac death, target vessel-related myocardial infarction (TV-MI), or target lesion revascularization (TLR). The secondary composite endpoint was patient-oriented endpoint (PoCE), a composite of all death, all myocardial in farction (MI), or any repeat revascularization; definite/probable stent thrombosis (ST) (including acute, late, and very late thrombosis) . SS was calculated in lesions with stenosis more than 50% with coronary artery diameter greater than 1.5 mm. Patients were grouped by tertiles of SS (≤7, >7 to ≤12, >12). Follow-up was performed up to 5 years. @*Results@#A total of 730 patients were enrolled in the TARGET Ⅱ trial. The average SS was 10.9±6.9. 683 (93.6%) patients completed 5-year clinical follow-up. The 5-year incidence of TLF was 8.5%(58/683). The incidence of TLF components was as follows: cardiac death 2.0%(14/683), TV-MI 4.4%(30/683), TLR 3.4%(23/683). The incidence of PoCE was 16.4%(112/683). The incidence of definite/probable stent thrombosis was 0.7%(5/683).Multivariable Cox regression analysis showed that the diabetes subgroup (HR=1.123, 95%CI 0.623-2.026, P=0.699), the small vessel disease subgroup (HR=0.909, 95%CI 0.526-1.570, P=0.732), the long lesion subgroup (HR=1.561, 95%CI 0.922-2.640, P=0.097), and the multi vessel disease subgroup (HR=1.062, 95%CI 0.611-1.846, P=0.830) did not increase the HR of TLF compared with the counterpart subgroups. Multivariable Cox regression analysis showed that the hazard of TLF was not increased in the middle and high SS groups as compared with the low SS group (HR=1.203,95%CI 0.607-2.385,P=0.597;HR=1.548,95%CI 0.829-2.892,P=0.171). @*Conclusions@#The 5 years follow-up results of TARGET Ⅱ trial shows that the biodegradable polymer of FIREHAWK stents have long-lasting safety and efficacy for patients with moderate-complex coronary lesions. SS is not the predicting factor for the occurrence of TLF in FIREHAWK treated patients with moderate-complex coronary lesions. Trial Registration Clinical Trials.gov, NCT0141264.
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Objective@#To evaluate the predictive value of GRACE discharge score on the long-term out-of-hospital coronary thrombotic events (CTE) after percutaneous coronary intervention (PCI) with drug-eluting stents.@*Methods@#Present study was a prospective, observational, single center study. 10 724 consecutive patients underwent PCI in Fuwai Hospital between January and December 2013 were included, stents were implanted with conventional method. After PCI, patients were prescribed aspirin 100 mg once daily indefinitely, and either clopidogrel 75 mg once daily or ticagrelor 90 mg twice daily for at least 1 year. A total of 9 782 patients were included in the final analysis after excluding patients who did not undergo successful stent implantation, who were not discharged on dual anti-platelet therapy (DAPT), who only underwent bare-metal stents, who experienced in-hospital major bleeding, stent thrombosis, myocardial infarction (MI) or death,and who lost follow up. Clinical data were collected from all patients. 9 543 patients with complete baseline data were further analyzed for risk stratification and predictive value of GRACE discharge score. CTE was defined as stent thrombosis or spontaneous myocardial infarction. All patients were followed through Fuwai Hospital Follow-up Center, and evaluated either by phone, letter, or clinic visits or at 1, 6, 12 and 24 months after PCI. Risk stratification was performed according to the GRACE discharge score, and the predictive value of the GRACE discharge score was assessed using the receiver operating characteristic (ROC) curve.@*Results@#After 2 years follow-up, there were 95 CTE among the 9 782 patients. The patients were divided into 2 groups according to the presence or absence of CTE: CTE group (95 cases) and no CTE group (9 687 cases). GRACE discharge score was significantly higher in CTE group than no CTE group (82.98±27.58 vs. 75.51±22.46, t=-2.57, P=0.012). According to risk stratification of GRACE discharge score, the patients were divided into low-risk (≤88) group (n=6 902), moderate-risk (89-118) (n=2 988) and high-risk (>118) (n=343) groups. As compared to the low-risk group, CTE risk in moderate- and high-risk groups was 1.59 times (HR 1.59, 95%CI 1.01-2.52, P=0.046) and 3.89 times higher (HR 3.89, 95%CI 1.98-7.65, P<0.001), respectively. Further analysis showed that the GRACE score had predictive value in the total cohort for CTE (area under the receiver operating characteristic (AUROC) 0.576, 95%CI 0.512-0.640, P=0.012) and in the acute coronary syndromes(ACS) subgroup for CTE: (AUROC 0.594, 95%CI 0.509-0.680, P=0.019), but not in the non-ACS subgroup: (AUROC 0.561, 95%CI 0.466-0.657, P=0.187).@*Conclusion@#GRACE discharge score can predict the long-term out-of-hospital CTE in patients undergoing PCI with drug-eluting stents and treated with DAPT, and patients can be stratified into the low-, moderate- and high-risk groups of CTE by the GRACE discharge score.
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Objective@#To investigate the relationship between thrombolysis in myocardial infarction risk index(TRI) and the severity of coronary artery lesions and long-term outcome in acute myocardial infarction(AMI) patients undergoing percutaneous coronary intervention(PCI).@*Methods@#A total of 1 663 consecutive AMI patients undergoing PCI between January and December 2013 in Fuwai hospital were prospectively included in this study. The severity of coronary artery lesions was evaluated using the SYNTAX score. Receiver operating characteristic(ROC) curve was used to analyze the optimal cut-off value of TRI on predicting all-cause mortality at 2 years after PCI.The patients were divided into 2 groups based on the optimal cut-off value of TRI:high TRI group (TRI ≥ 23.05, 465 cases) and low TRI group(TRI<23.05, 1 198 cases). Multivariate logistic regression analyses were used for determining the relationship between TRI and SYNTAX scores≥33. A multivariate Cox regression analyses was used to identify the influence factors of long-term outcome after PCI.@*Results@#SYNTAX score was higher in high TRI group than in low TRI group (13.00(7.00, 20.50) vs.10.25(7.00, 17.00), P<0.001). TRI was independently associated with SYNTAX score ≥ 33 (OR=1.09,95% CI 1.03-1.16, P=0.004). After the 2 years follow-up, rates of all-cause death (4.1% (19/465) vs. 0.3% (4/1 198) , P<0.001), cardiac death (2.6% (12/465) vs. 0.2% (2/1 198) , P< 0.001) and stent thrombosis (1.7% (8/465) vs. 0.5% (6/1 198) , P=0.015) were all significantly higher in high TRI group than in low TRI group. Multivariate Cox regression analyses showed that TRI≥ 23.05 was an independent risk factor of all-cause death (HR=5.22, 95%CI 1.63-16.72, P=0.005), cardiac death (HR=8.48, 95%CI 1.75-41.07, P=0.008) and stent thrombosis(HR=3.87, 95%CI 1.32-11.41, P=0.014) at 2 years after PCI in AMI patients, but which was not the independent risk factor of major adverse cardiovascular and cerebrovascular events (HR=0.96, 95%CI 0.69-1.36, P=0.834) .The area under ROC curve of TRI ≥ 23.05 on predicting 2 years all-cause mortality in AMI patients undergoing PCI was 0.803(95%CI 0.711-0.894, P<0.001).@*Conclusions@#TRI is independently associated with SYNTAX score ≥ 33. TRI is also an independent risk factor of 2 years all-cause death, cardiac death and stent thrombosis in AMI patients undergoing PCI.
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Objective@#To investigate the impact of direct bilirubin on long-term prognosis of acute coronary syndrome (ACS) patients post percutaneous coronary intervention(PCI).@*Methods@#As a prospective and observational cohort study, a total of 6 431 consecutive ACS patients underwent PCI from January to December 2013 in Fuwai hospital were included. Patients were divided into 3 groups according to tertiles values of direct bilirubin as follows: low direct bilirubin group(<2.2 μmol/L, n=2 219), moderate direct bilirubin group(2.2-3.0 μmol/L, n=2 016), and high direct bilirubin group(>3 μmol/L, n=2 196). The clinical characteristics were compared among the 3 groups, and the impact of direct bilirubin on clinical adverse events (main adverse cardiovascular and cerebrovascular events included cardiogenic death, myocardial infarction, revascularization, stroke, and stent thrombosis) were analyzed at 2 years after PCI.@*Results@#(1) Percent of male patients was 66.5%(1 475/2 219), 78.0%(1 572/2 016), and 86.2%(1 892/2 196), body mass index was(25.7±3.1), (26.0±3.3),and (26.0±3.2) kg/m2, the ratio of the history of old myocardial infarction was 11.9%(264/2 219), 13.0%(263/2 016),and 14.9%(328/2 196), the ratio of the current smoker was 56.3%(1 249/2 219), 59.1%(1 192/2 016),and 60.0%(1 317/2 196) in low, moderate and high direct bilirubin groups respectively, and the differences were statistically significant (P<0.01 or 0.05). (2) Two years after PCI, the all-cause mortality was 0.8%(17/2 219), 1.8%(36/2 016), and 1.5%(33/2 196) (P=0.011),the cardiogenic mortality was 0.5%(12/2 219), 1.3%(26/2 016), and 0.6%(13/2 196) (P=0.010),the ratio of myocardial infarction was 2.2%(49/2 219), 2.4%(49/2 016), and 1.4%(31/2 196)(P=0.044),the ratio of revascularization was 8.8%(195/2 219), 8.3%(168/2 016),and 8.9%(196/2 196)(P=0.783),the ratio of stroke was 1.4%(30/2 219),1.1%(22/2 016), and 1.9%(42/2 196)(P=0.076),the ratio of stent thrombosis was 0.9%(19/2 219), 1.2%(24/2 016),and 0.7%(15/2 196)(P=0.210) in low, moderate and high direct bilirubin groups, respectively. (3) Multivariable Cox regression analysis showed that, patients in moderate direct bilirubin group faced increased the risk of all-cause mortality compared with patients in the low direct bilirubin group (HR=2.23, 95%CI 1.23-4.05, P= 0.009), and the risk of all-cause mortality was similar between high direct bilirubin group and low direct bilirubin group (HR=1.84, 95%CI 0.99-3.38, P= 0.051). There were no statistically significant difference in the risks of main adverse cardiovascular and cerebrovascular events,cardiogenic death, myocardial infarction, revascularization, stroke, and stent thrombosis in moderate and high direct bilirubin groups compared with low direct bilirubin group (all P>0.05).@*Conclusion@#Moderate direct bilirubin level is associated with increased risk of all-cause death at 2 years after PCI compared with low level of direct bilirubin group.
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Objective@#To investigate the efficacy of bare metal stent for treating focal coronary artery aneurysm complicating with severe stenosisin single coronary artery.@*Methods@#This retrospective analysis was performed in 7 patients who were diagnosed as local coronary artery aneurysm complicating with severe stenosis(≥70%) in single coronary artery and treated with bare metal stent during the period from December 2012 to June 2015 in Fuwai Hospital. All 7 patients were male with age of (62±11) years old. During the interventional operation, the narrow parts were pre-expanded,and all patients received bare metal stents implantation to cover aneurysms.The clinical and imaging data of patients immediately post procedure and at postoperative follow-up were collected to evaluate the clinical efficacy.@*Results@#There were 5 cases of left anterior descending aneurysms and 2 cases of right coronary artery aneurysms. The diameter of aneurysm was (5.21±1.28)mm, and the length was (13.71±3.88)mm. There was intracranial vortex in coronary arteriography immediately after intervention.Proximalstenosis of coronary artery aneurysm was disappeared,and the distal blood flow was TIMI class 3.There were no signs of aortic dissection and thrombus formation.During 6(6 16) months follow-up, the aneurysms were disappeared,and there were no major adverse cardiovascular events which including myocardial ischemia, acute myocardial infarction, revascularization,bleeding,and death for all patients.@*Conclusion@#Initial experience shows that double-layer bare metal stents implantation for patients with localized coronary artery aneurysm complicating with severe stenosis in single vessel is safe and effective.
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Objective@#To investigate the prognostic value of SYNTAX score on 1 year outcome in coronary heart disease patients underwent percutaneous coronary intervention(PCI).@*Methods@#The present study (PANDA Ⅲ trial) was a perspective, multi-center, randomized controlled trial. Between December 2013 and August 2014, 2 348 patients who underwent PCI from 46 centers were enrolled. SYNTAX score was calculated from all patients. Patients were divided into 3 groups based on SYNTAX score: lower risk group (SYNTAX score≤22, 1 777 patients), intermediate risk group (SYNTAX score 23-32, 412 patients), and higher risk group (SYNTAX score≥33, 159 patients). The patients were followed up after the procedure for one year.Primary endpoint was target lesion failure (TLF), including cardiac death, target vessel myocardial infarction,and ischemia driven target lesion revascularization. Secondary endpoints included stent thrombosis and major adverse cardiac events were defined as a composite of all-cause death, myocardial infarction and any revascularization.@*Results@#(1) A total of 1 766 (99.2%), 411 (99.8%),and 159 (100%) patients in the lower risk group, intermediate risk and higher risk group completed the 1 year follow up. (2) Incidence of TLF were 5.6%(99/1 763) in lower risk group, 8.8%(36/411) in intermediate risk group,and 8.8%(14/159) in higher risk group(P=0.03). The incidence of target vessel myocardial infarction in lower risk group was 3.9%(68/1 763), 6.6%(27/411) in intermediate risk group,and 7.5% (12/159) in higher risk group(P=0.01).Prevalence of cardiac death and ischemia driven target lesion revascularization was similar among the 3 groups(P>0.05).(3) The probable stent thrombosis events rate was 0.1% (1/1 763), 0.7% (3/411), and 0.6% (1/159) in the lower, intermediate,and higher risk groups respectively (P=0.02). The incidence of major adverse cardiac events was 8.1% (142/1 763) in lower-risk group, 11.7% (48/411) in intermediate risk group, and 14.5% (23/159) in higher risk group (P<0.01). The incidence of all-cause death was 1.7%(30/1 763) in lower-risk group, 1.7%(7/411) in intermediate risk group, and 6.3%(10/159)in higher risk group (P<0.01). The incidence of myocardial infarction was 4.2% (74/1 763) in lower-risk group, 6.6% (27/411) in intermediate risk group, and 8.2% (13/159) in higher risk group(P=0.02).Incidence of any revascularization was similar among groups(P=0.59). (4) The multivariable Cox analysis showed that age (HR=1.04, 95%CI 1.02-1.06, P<0.01), total implanted stent length (HR=1.01, 95%CI 1.00-1.02, P=0.03), and baseline SYNTAX score (HR=1.02, 95%CI 1.02-1.04, P=0.02) were independent risk factors of TLF after PCI in this patient cohort.@*Conclusion@#The SYNTAX score is a valuable tool for predicting prognosis on 1 year in coronary heart disease patients underwent PCI. Trial Registration www.clinicaltrials.gov, NCT02017275.
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To explore the relationship between blood level of big endothelin and contrast-induced acute kidney injury (CI-AKI) in patients with emergent percutaneous coronary intervention (PCI). Methods: A total of 1061 consecutive patients received emergent PCI in our hospital from 2013-01 to 2015-06 were enrolled. According to blood levels of big endothelin, the patients were divided into 2 groups: Normal big endothelin group, n=236 and Elevated big endothelin group, n=825. The baseline condition, procedural features, occurrence rate of CI-AKI and composite endpoint events at 6 and 12 months post-operation were studied which including nonfatal myocardial infarction, revascularization, stroke and all-cause death. The risk factors for CI-AKI occurrence were identified by Logistic analysis. Results: The overall occurrence rate of CI-AKI was 22.7% (241/1061). Compared with Normal big endothelin group, Elevated big endothelin group had the higher incidence of CI-AKI, increased composite endpoint events at 6 and 12 months post-operation with P=0.041, P=0.040 and P=0.021, respectively. With adjusted covariates, elevated blood level of big endothelin, no matter as a continuous variable or categorical variable had the enhanced risk of CI-AKI incidence in patients after emergent PCI. Conclusion: Elevated blood level of big endothelin may significantly increase the risk of CI-AKI in patients with emergent PCI.
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Objective: To explore the prevalence and risk factors of mitral regurgitation (MR) in the population ≥35 years in China in order to provide prevention reference for high risk crowd. Methods: The residents ≥35 years were taken by a stratified multistage sampling method. General information of crowd was collected by predesigned questionnaire and physical examination including life style, disease history, body weight and height. Echocardiography was conducted, fasting blood glucose and blood lipid levels were measured. Results: A total of 28814 subjects were enrolled. The overall MR detection rate was 18.4%, the detection rate in male and female were both 18.4%. The detection rates of moderate and severe MR were 0.3% in the paticipants at (35-50) years, 0.9% at (51-64) years and 2.2% at ≥65 years. MR prevalence showed an increasing trend with aging. Multivariate Logistic regression analysis indicated that age, systolic blood pressure, urban and rural, district, left atrial front and back diameter, left ventricular end diastolic front and back diameter, left ventricular ejection fraction, stroke, atrial fibrillation and heart failure were the risk factors for MR occurrence. Conclusion: MR detection rate was rather high in China. Specific prevention action should be taken for those with theabove risk factors.
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Objective@#To investigate the in-hospital and long-term outcomes of patients with left ventricular ejection fraction (LVEF) <50% undergoing percutaneous coronary intervention (PCI) .@*Methods@#From January to December 2013, 10 445 consecutive patients who underwent PCI in Fuwai Hospital and the LVEF value was available were prospectively included. The patients were divided into LVEF≥50% group (9 896 cases) and LVEF<50% group (549 cases) . The in-hospital and 2-year clinical outcomes were compared between the 2 groups. The association between LVEF<50% and clinical outcomes was assessed using multivariable Cox regression analysis.@*Results@#(1) Compared with LVEF ≥50% group, LVEF< 50% group had higher rates of in-hospital all-cause death (1.1% (6/549) vs. 0.2% (17/9 896) , P<0.01) , cardiac death (1.1% (6/549) vs. 0.1% (12/9 896) , P<0.01) , in-stent thrombosis (0.7% (4/549) vs. 0.2% (18/9 896) , P<0.01) , myocardial infarction (2.4% (13/549) vs. 1.2% (121/9 896) , P<0.05) ,and major adverse cardiovascular and cerebrovascular events (MACCE) which including death, myocardial infarction, revascularization, in-stent thrombosis, and stroke (3.6% (20/549) vs. 1.4% (137/9 896) , P<0.01) . (2) A total of 10 388 (99.5%) patients completed 2-year follow-up. Compared with LVEF ≥50% group, LVEF<50% group had higher rates of 2-year all-cause death (4.7% (26/549) vs. 1.0% (101/9 896) , P<0.01) , cardiac death (4.0% (22/549) vs. 0.5% (50/9 896) , P<0.01) , in-stent thrombosis (3.1% (17/549) vs. 0.7% (71/9 896) , P<0.001) , myocardial infarction (4.2% (23/549) vs. 1.9% (186/9 896) , P<0.01) ,and MACCE (17.9% (98/549) vs. 11.8% (1 172/9 896) , P<0.01) . There were no significant differences on the rates of 2-year target-vessel revascularization, bleeding and stroke between the two groups. (3) The multivariable Cox regression analysis demonstrated that LVEF< 50% was the independent risk factor of 2-year all-cause death (HR=2.47, 95%CI 1.49-4.08, P<0.01) , cardiac death (HR=3.25, 95%CI 1.79-5.90, P<0.01) , in-stent thrombosis (HR=4.19, 95%CI 2.39-7.34, P<0.01) , myocardial infarction (HR=2.00, 95%CI 1.26-3.16, P<0.01) , and MACCE (HR=1.40, 95%CI 1.13-1.74, P<0.01) . (4) After propensity score matching, all in-hospital outcomes were similar between the two groups, including all-cause death, cardiac death, in-stent thrombosis, myocardial infarction, revascularization, bleeding, stroke, and MACCE (all P>0.05) . After propensity score matching,the multivariable Cox regression analysis demonstrated that LVEF<50% was still an independent risk factor of 2-year all-cause death (HR=3.08, 95%CI 1.37-6.89, P<0.01) , cardiac death (HR= 4.12, 95%CI 1.53-11.07, P<0.01) ,and in-stent thrombosis (HR=3.82, 95%CI 1.27-11.5, P<0.05) .@*Conclusion@#LVEF< 50% is an independent risk factor of 2-year all-cause death, cardiac death, and in-stent thrombosis in patients undergoing PCI, but it does not increase the risk of target-vessel revascularization, bleeding or stroke.
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Objective@#To compare the long term safety and efficacy of the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent(Firehawk stent) and permanent polymer coating everolimus eluting stent(Xience V stent) for the treatment of coronary de novo lesions.@*Methods@#This prospective, multi-center, non-inferiority, randomized control trial(TARGETⅠ trial) was performed between August 2010 and April 2011, a total of 460 patients with primary, de novo, single vessel and single coronary lesion from 16 medical centers were enrolled. The diameter stenosis of target lesion was ≥70%, and lesion length was≤24 mm. The patients were randomly assigned to treatment with Firehawk stent (Firehawk stent group) or Xience V stent (Xience V stent group) groups by a web-based allocation system and was stratified by center. The late lumen loss after 9 months, target lesion failure (TLF) which was a composite of cardiac death, target vessel myocardial infarction, or ischemia driven target lesion revascularization, patient-oriented composite endpoint (PoCE) which was a composite of all cause death, all cause myocardial infarction, or any revascularization, and stent thrombosis after 5 years were compared between the two groups.@*Results@#(1) There were 2 patients without stent implantation dropped out of this trial. There were 227 patients in Firehawk stent group, and 231 patients in Xience V stent group. The baseline characteristics were similar between the two groups(all P>0.05). (2) The 9 months late lumen loss in Firehawk stent group was non-inferior to that in Xience V stent group ((0.13±0.24)mm vs. (0.13±0.18)mm, P=0.94). (3) A total of 442 (96.5%) patients completed 5 years clinical follow-up. There were no significant differences on 5-year TLF rate (6.0%(13/217) vs. 6.7% (15/225), P=0.77) and PoCE rate (12.0%(26/217) vs. 17.8% (40/225), P=0.09) between the Firehawk stent group and Xience V stent group. (4) Kaplan-Meier analysis showed that TLF rates between 1-5 years were similar in Firehawk stent group and Xience V stent group (5.7% and 6.6% respectively, HR=0.88, 95%CI 0.42-1.84, P=0.72). Land-Mark analysis showed that TLF rates bewteen 1-5 years were similar in Firehawk stent group and Xience V stent group (3.6% and 4.4% respectively, HR=0.83, 95%CI 0.34-2.00, P=0.67). Kaplan-Meier analysis showed that PoCE rates between 1-5 years were also similar in Firehawk stent group and Xience V stent group (11.4% and 17.3% respectively, HR=0.64, 95%CI 0.39-1.04, P=0.07). Land-Mark analysis showed that PoCE rates after 5 years were similar in Firehawk stent group and Xience V stent group (8.4% and 10.0% respectively, HR=0.66, 95%CI 0.40-1.10, P=0.11). (5) No stent thrombosis was documented in Firehawk stent group during the 5 years follow-up period, and there was 1 case of stent thrombosis in Xience V stent group after 3 years of stent implantation.@*Conclusion@#TARGETⅠ trial results of 5 years follow up indicate the novel Firehawk stent have a durable safety and efficacy profile which is comparable to the Xience V stent in treating patients with single de novo coronary lesion. Clinical Trial Registration North American Clinical Trial Registration Center, NCT01196819.