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).

Background::Risk assessment and treatment stratification for three-vessel coronary disease (TVD) remain challenging. This study aimed to investigate the prognostic value of left atrial volume index (LAVI) with the Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score II, and its association with the long-term prognosis after three strategies (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG], and medical therapy [MT]) in patients with TVD.Methods::This study was a post hoc analysis of a large, prospective cohort of patients with TVD in China, that aimed to determine the long-term outcomes after PCI, CABG, or optimal MT alone. A total of 8943 patients with TVD were consecutively enrolled between 2004 and 2011 at Fuwai Hospital. A total of 7818 patients with available baseline LAVI data were included in the study. Baseline, procedural, and follow-up data were collected. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), which was a composite of all-cause death, myocardial infarction (MI), and stroke. Secondary endpoints included all-cause death, cardiac death, MI, revascularization, and stroke. Long-term outcomes were evaluated among LAVI quartile groups. Results::During a median follow-up of 6.6 years, a higher LAVI was strongly associated with increased risk of MACCE (Q3: hazard ratio [HR] 1.20, 95% confidence interval [CI] 1.06-1.37, P = 0.005; Q4: HR 1.85, 95%CI 1.64-2.09, P <0.001), all-cause death (Q3: HR 1.41, 95% CI 1.17-1.69, P <0.001; Q4: HR 2.54, 95%CI 2.16-3.00, P <0.001), and cardiac death (Q3: HR 1.81, 95% CI 1.39-2.37, P <0.001; Q4: HR 3.47, 95%CI 2.71-4.43, P <0.001). Moreover, LAVI significantly improved discrimination and reclassification of the SYNTAX score II. Notably, there was a significant interaction between LAVI quartiles and treatment strategies for MACCE. CABG was associated with lower risk of MACCE than MT alone, regardless of LAVI quartiles. Among patients in the fourth quartile, PCI was associated with significantly increased risk of cardiac death compared with CABG (HR: 5.25, 95% CI: 1.97-14.03, P = 0.001). Conclusions::LAVI is a potential index for risk stratification and therapeutic decision-making in patients with three-vessel coronary disease. CABG is associated with improved long-term outcomes compared with MT alone, regardless of LAVI quartiles. When LAVI is severely elevated, PCI is associated with higher risk of cardiac death than CABG.

Hypertension is the most common chronic non-communicable disease and the primary risk factor for cardiovascular events.The traditional management methods for hypertension are often purely internal medicine and basically unrelated to percutaneous interventional techniques.In recent decades,with the development of imaging technology and interventional devices,the application of transcatheter interventional techniques in hypertension has become widespread.This article reviews the current status and prospect of transcatheter interventional techniques in the clinical diagnosis and treatment of hypertension.

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

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 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.
Middle Aged ; Male ; Female ; Humans ; Antihypertensive Agents/therapeutic use* ; Prehypertension/epidemiology* ; Prevalence ; Cross-Sectional Studies ; Hypertension/drug therapy* ; Blood Pressure ; China/epidemiology*

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: 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.

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.

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.