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Effects of nicorandil on myocardial infarct size in patients with ST-segment elevation myocardial infarction undergoing Primary percutaneous coronary intervention:study design and protocol for the randomized controlled trial

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Journal of Geriatric Cardiology 2020年第8期17卷 519-524页

作者： Xiao-Si JIANG Li-Chao TIAN Zi-Chao JIANG Yu-Ting ZOU Ping LI Xin-Chun YANG Xi SU Jin-Wen TIAN Bei SHI Zong-Zhuang LI Yong-Jun LI Ren-Qiang YANG Geng QIAN Yun-Dai CHEN Department of Cardiology the First Medical Center of Chinese PLA General HospitalBeijingChina The School of Medicine Nankai UniversityTianjinChina Department of Cardiology the First People's Hospital of YunlinGuangxiChina Department of Cardiology Beijing Chaoyang HospitalCapital Medical UniversityBeijingChina Department of Cardiology Wuhan Asia Heart HospitalWuhanChina Department of Cardiology Hainan Hospital of PLA General HospitalHainanChina Department of Cardiology Affiliated Hospital of Zunyi Medical CollegeGuizhouChina Department of Cardiology Guizhou Provincial People's HospitalGuizhouChina Department of Cardiology the Second Hospital of Hebei Medical UniversityHebeiChina Department of Cardiology the Second Affiliated Hospital of Nanchang UniversityJiangxiChina

Previous studies have shown that nicorandil has a protective effect on cardiomyocytes.However,there is no study to investigate whether perioperative intravenous nicorandil can further reduce the myocardial infarct size in patients with ST-segment elevation myocardial infarction(STEMI)compared to the current standard of percutaneous coronary intervention(PCI)regimen.The CHANGE(China-Administration of Nicorandil Group)study is a multicenter,prospective,randomized,double-blind and parallel-controlled clinical study of STEMI patients undergoing primary PCI in China,aiming to evaluate the efficacy and safety of intravenous nicorandil in ameliorating the myocardial infarct size in STEMI patients undergoing primary PCI and provide evidence-based support for myocardial protection strategies of STEMI patients.

关键词： Cardiovascular disease Myocardial infarct size Nicorandil Primary percutaneous coronary intervention ST-segment elevation myocardial infarction

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Off-hours admission does not impact outcomes in patients undergoing Primary percutaneous coronary intervention and with a first medical contact-to-device time within 90 min

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Chinese Medical Journal 2021年第15期134卷 1795-1802页

作者： Wen-Jian Ma Si-De Gao Si-Zhuang Huang Xu-Ze Lin Yue-Jin Yang Meng-Yue Yu Department of Cardiology Fuwai HospitalNational Center for Cardiovascular DiseasesChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100037China

Background:It remains unclear whether the outcomes of ST-elevation myocardial infarction(STEMI)patients treated with Primary percutaneous coronary intervention(PPCI)during off-hours are as favorable as those treated during on-hours,especially those with a first medical contact-to-device(FMC-to-device)time within 90 min.We aimed to determine whether off-hours admission impacted late outcomes in patients undergoing PPCI and with an FMC-to-device timeintervention of Beijing by the 4tHeart and Brain Green Channel”app.Results:Overall,the median age of the patients was 58.8 years and 19.9%(133/670)were female.Of these,296(44.2%)patients underwent PPCI during on-hours and 374(55.8%)patients underwent PPCI during off-hours.Compared with the on-hours group,the off-hours group had a longer FMC-to-device time and fewer patients with FMC-to-device time0.05).According to the Cox regression analyses,off-hours admission was not a predictor of 2-year MACEs(P=0.788).Similarly,the Kaplan-Meier curves showed that the risks of a MACE,all-cause death,reinfarction,and target vessel revascularization were not significantly different between the two groups(P>0.05).Conclusions:This real-world,multicenter retrospective study demonstrated that for STEMI patients who underwent PPCI within 90 min,off-hours admission was safe,with no difference in the risk of 2-year M

关键词： First medical contact-to-device time ST-segment elevation myocardial infarction Primary percutaneous coronary intervention Major adverse cardiovascular events Off-hours

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Long-term Outcomes of Primary percutaneous coronary intervention with Second-generation Drug-eluting Stents in ST-elevation Myocardial Infarction Patients Caused by Very Late Stent Thrombosis

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Chinese Medical Journal 2017年第8期130卷 929-935页

作者： Chen He Yuan-Liang Ma Chuang-Shi Wang Lin Jiang Jia-Hui Zhang Yi Yao Xiao-FangTang Bo Xu Run-Lin Gao Jin-Qing Yuan State Key Laboratory of Cardiovascular Disease National Center for Cardiovascular Diseases Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing 100037 China

Background： The ST-segment elevation myocardial inthrction （STEMI） patients due to stent thrombosis （ST） remain a therapeutic challenge for a clinician. Till date, very few researches have been conducted regarding the safety and effectiveness of Primary percutaneous coronary intervention （PCI） with second-generation drug-eluting stents （DES） for STEMI caused by very late ST （VLST）. This retrospective study evaluated the safety, efficacy, and outcomes of primary PCI with second-generation DES for STEM1 due to VLST compared with primary PCI for STEM1 due to de novo lesion. Methods： Between January 2007 and December 2013, STEMI patients with primary PCI in Fuwai Hospital had only second-generation DES implanted for de novo lesion （558 patients） and VLST （50 patients） were included in this retrospective study. The primary end points included cardiac death and reinfarction. The secondary end points included cardiac death, reinfarction, and target lesion revascularization. Continuous variables were expressed as mean （standard deviation） or median （interquartile range） and compared by Student＇s t-test or Mann-Whitney U-test as appropriate. Categorical variables were expressed as counts and percentages, and comparison of these variables was performed with Chi-square or Fisher＇s exact test. A two-tailed value of P 〈 0.05 was considered statistically significant for all comparisons. Statistical analyses were performed by SAS software （version 9.4, SAS Institute Inc., Cary, USA） for Windows. Results： In-hospital primary end point and the secondary end point were no significant differences between two groups （P = 1.000 and P = 1.000, respectively）. No significant differences between two groups were observed according to the long-term primary end point and the secondary end point. Kaplan-Meier survival curves showed no significant difference between the two groups in the primary end point and the secondary end point at 2 years （P- 0.340 and P = 0,243, respectively）. According to Cox analysis, female, intra-aortic balloon pump

关键词： Primary percutaneous coronary intervention Second-generation Drug-eluting Stents ST-elevation Myocardial Infarction Stent Thrombosis

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Randomized comparison of intracoronary tirofiban versus urokinase as an adjunct to Primary percutaneous coronary intervention in patients with acute ST-elevation myocardial infarction： results of the ICTUS-AMI trial

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Chinese Medical Journal 2013年第16期126卷 3079-3086页

作者： ZHU Tian-qi ZHANG Qi DING Feng-hua QIU Jian-ping JIN Hui-geng JIANG Li LU Lin ZHANG Rui-yan HU Jian YANG Zhen-kun SHEN Ying SHEN Wei-feng Department of Cardiology Rui Jin Hospital Shanghai Jiao Tong University School of Medicine Shanghai 200025 China Department of Cardiology Gong Li Hospital Pudong New DistrictShanghai 200135 China Department of Cardiology Putuo District Central Hospital Shanghai200062 China Department of Cardiology Changning District Central HospitalShanghai 200336 China

Background No randomized trial has been performed to compare the efficacy of an intracoronary bolus of tirofiban versus urokinase during Primary percutaneous coronary intervention （PCI）.We investigated whether the effects of adjunctive therapy with an intracoronary bolus of urokinase was noninferior to the effects of an intracoronary bolus of tirofiban in patients with ST-elevation myocardial infarction （STEMI） undergoing PCI.Methods A total of 490 patients with acute STEMI undergoing primary PCI were randomized to an intracoronary bolus of tirofiban （10 μg/kg; n=247） or urokinase （250 kU/20 ml; n=243）.Serum levels of P-selectin,von Willebrand factor （vWF）,CD40 ligand （CD40L）,and serum amyloid A （SAA） in the coronary sinus were measured before and after intracoronary drug administration.The primary endpoint was the rate of complete （＞70％） ST-segment resolution （STR） at 90 minutes after intervention,and the noninferiority margin was set to 15％.Results In the intention-to-treat analysis,complete STR was achieved in 54.4％ of patients treated with an intracoronary bolus of urokinase and in 60.6％ of those treated with an intracoronary bolus of tirofiban （adjusted difference：-7.0％;95％ confidence interval：-15.7％ to 1.8％）.The corrected TIMI frame count of the infarct-related artery was lower,left ventricular ejection fraction was higher,and the 6-month major adverse cardiac event-free survival tended to be better in the intracoronary tirofiban group.An intracoronary bolus of tirofiban resulted in lower levels of P-selectin,vWF,CD40L,and SAA in the coronary sinus compared with an intracoronary bolus of urokinase after primary PCI （P＜0.05）.Conclusions An intracoronary bolus of urokinase as an adjunct to primary PCI for acute STEMI is not equally effective to an intracoronary bolus of tirofiban with respect to improvement in myocardial reperfusion assessed by STR.This may be caused by less reduction in coronary circulatory platelet activation and inflammation.

关键词： acute myocardial infarction electrocardiography Primary percutaneous coronary intervention tirofiban urokinase

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Rationale and Design of a Randomized Controlled Trial of Bivalirudin with a Prolonged High-Dose Infusion Versus Heparin Monotherapy During Primary percutaneous coronary intervention in Patients with Acute ST-Segment Elevation Myocardial Infarction:The BRIGHT-4 Trial

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Cardiology Discovery 2022年第4期2卷 226-230页

作者： Zhenyang Liang Yi Li Gregg W.Stone Yaling Han Cardiovascular Research Institute and Department of Cardiology General Hospital of Northern Theater CommandShenyang 110016China Zena and Michael A.Wiener Cardiovascular Institute Icahn School of Medicine at Mount SinaiNew YorkNew York 10029-5674USA

Intravenous anticoagulant therapy is critical to prevent ischemic events without increasing the risk of bleeding in patients with ST-segment elevation myocardial infarction(STEMI)undergoing Primary percutaneous coronary intervention(PPCI).Heparin and bivalirudin are the most commonly used adjunctive anticoagulant agents during PPCI.However,the superiority of the 2 most optimal regimens with these agents in patients undergoing PPCI remains controversial.The BivaliRudin with prolonged high-dose Infusion durinG PPCI versus Heparin Trial 4(BRIGHT-4)is a large-scale,prospective,multicenter,active-control,parallel-group,open-label,randomized trial designed to test whether bivalirudin with a post-PCI high-dose infusion is superior to heparin monotherapy in STEMI patients undergoing PPCI.A total of 6000 patients will be enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio.Patients allocated to the bivalirudin group will be treated with a high-dose bivalirudin infusion(1.75 mg/(kg·h))after PCI for 2 to 4 hours.In the heparin group,the use of glycoprotein IIb/IIIa inhibitors will be reserved for the development of procedural thrombotic complications.The efficacy and safety of bivalirudin will be evaluated at 30 days,6 months,and 12 months after the randomization.The primary endpoint is a composite of all-cause death or Bleeding Academic Research Consortium(BARC)types 3 to 5 bleeding at 30 days after randomization.The BRIGHT-4 study protocol has received approval from the ethics committee of General Hospital of Northern Theater Command(Shenyang,China).The procedures set out in this protocol are in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines.The results will be published following the Consolidated Standards of Reporting Trials statement in a peer-reviewed scientific journal(Trial registration number:NCT03822975).

关键词： Heparin Bivalirudin ST-segment elevation myocardial infarction Primary percutaneous coronary intervention

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Impact of Primary percutaneous coronary intervention on blood perfusion in nonculprit artery in patients with anterior ST elevation myocardial infarction

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Chinese Medical Journal 2013年第1期126卷 22-26页

作者： WANG Jian LIU Jing-hua ZHENG Bin ZHANG Ming WANG Shao-ping ZHENG Ze Department of Cardiology Beijing Anzhen Hospital CapitalMedical University Beijing Institute of Heart Lung and VesselDiseases Beijing 100029 China

Background Recent studies have demonstrated that epicardial flow in nonculprit arteries, which has been assumed to be normal, was slowed in the setting of ST-elevation myocardial infarction （STEMI）. However, the impact of Primary percutaneous coronary intervention （PCI） on blood perfusion in nonculprit arteries in patients with STEMI has not been clarified. The purpose of this study was to investigate the impact of primary PCI on blood perfusion in nonculprit arteries in patients with STEMI and correlated clinical factors. Methods A total of 117 patients with anterior wall STEMI, the culprit artery being the left anterior descending artery （LAD）, undergoing primary PCI （the study group） and 100 patients with normal coronary angiography （the control group） were enrolled. To observe the differences of corrected TIMI frame count （cTFC） and myocardial blush grade （MBG） before and after primary PCI in both culprit and nonculprit arteries, the left circumflex coronary artery （LCX）, cTFC and MBG in the LAD and LCX were measured in the study group and control group. The study group was divided into three groups; refiow in the culprit artery group （the R group）, no reflow in culprit artery group （the NR group）, and no reflow in both the culprit artery and nonculprit artery group （the NRB group） according to MBG grade. The level of serum C-reactive protein （CRP）, catecholamine, and fibroblast growth factor-21 （FGF21）were assayed. The clinical and angiographic characteristics were also analyzed. Results cTFC （28.1±24.3 vs. 20.3±19.3, P 〈0.05） and MBG in the LCX were different in the study group compared to the control group before primary PCI. cTFC （25.2±22.3 vs. 28.1±24.3, P 〈0.05） and the MBG level in the LCX were improved after successful primary PCI, but were not recovered to the normal level. Patients with no reflow in the culprit artery had a higher incidence of no-reflow in the nonculprit artery （78% vs. 19%, P 〈0.0001）, and the levels of CRP （（3.29±1.31） mg/dl vs. （2.51±1.14） mg/dl vs. （2.93±1.07） mg/dl, P 〈0.05, re

关键词： ST elevation myocardial infarction nonculprit artery blood flow perfusion Primary percutaneous coronary intervention

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Thorombolytic therapy with rescue percutaneous coronary intervention versus Primary percutaneous coronary intervention in patients with acute myocardial infarction： a multicenter randomized clinical trial

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Chinese Medical Journal 2010年第11期123卷 1365-1372页

作者： GAO Run-lin HAN Ya-ling YANG Xin-chun MAO Jie-ming FANG Wei-yi WANG Lei SHEN Wei-feng LI Zhan-quan JIA Guo-liang LU Shu-zheng WEI Meng ZENG Ding-yin CHEN Ji-lin QIN Xue-wen XU Bo DU Chang-hui Department of Cardiology Cardiovascular Institute & Fu WaiHospital Chinese Academy of Medical Sciences Beijing 100037China Department of Cardiology Shenyang Northern HospitalShenyang Liaoning 110840 China Depal-tment of Cardiology Beijing Chaoyang Hospital Beijing100020 China Department of Cardiology Peking University Third HospitalBeijing 100083 China Department of Cardiology First Affiliated Hospital of DalianMedical University Dalian Liaoning 116011 China Department of Cardiology Beijing Friendship Hospital Beijing100050 China Department of Cardiology Ruijin Hospital Shanghai Jiao TongUniversity School of Medicine Shanghai 200025 China Department of Cardiology Liaoning Provincial People's HospitalShenyang Liaoning 110016 China Department of Cardiology Xijing Hospital Forth Military MedicalUniversity Xi'an Shaanxi 710032 China Department of Cardiology Beijing Anzhen Hospital CapitalMedical University Beijing 100029.C.hina Department of Cardiology Shanghai sixth People's HospitalShanghai 200233 China Western China Public Health Institute Sichuan UniversityChengdu Sichuan 610041 China

Background Although thrombolytic therapy with rescue percutaneous coronary intervention （PCI） is a common treatment strategy for ST-segment elevation acute myocardial infarction （STEMI）, scant data are available on its efficacy relative to primary PCI, and comparison was therefore the aim of this study. Methods This multicenter, open-label, randomized, parallel trial was conducted in 12 hospitals on patients （age 〈70 years） with STEMI who presented within 12 hours of symptom onset （mean interval 〉3 hours）. Patients were randomized to three groups： primary PCI group （n=101）; recombinant staphylokinase （r-Sak） group （n=-104）; and recombinant tissue-type plasminogen activator （rt-PA） group （n=-106）. For all patients allocated to the thrombolytic therapy arm, coronary angiography was performed at 90 minutes after drug therapy to confirm infarct-related artery （IRA） patency; rescue PCI was performed in cases with TIMI flow grade 〈2. Bare-metal stent implantation was planned for all patients. Results After randomization it required an average of 113.4 minutes to start thrombolytic therapy （door-to-needle time）and 141.2 minutes to perform first balloon inflation in the IRA （door to balloon time）. Rates of IRA patency （TIMI flow grade 2 or 3） and TIMI flow grade 3 were significantly lower in the thrombolysis group at 90 minutes after drug therapy than in the primary PCI group at the end of the procedure （70.5% vs. 98.0%, P 〈0.0001, and 53.0% vs. 85.9%, P 〈0.0001, respectively）. Rescue PCI with stenting was performed in 117 patients （55.7%） in the thrombolytic therapy arm. Rates of patency and TIMI flow grade 3 were still significantly lower in the rescue PCI than in the primary PCI group （88.9% vs. 97.9%, P=-0.0222, and 68.4% vs. 85.0%, P=0.0190, respectively）. At 30 days post-therapy, mortality rate was significantly higher in the thrombolysis combined with rescue PCI group than in primary PCI group （7.1% vs. 0, P=0.0034）. Rates of death/MI and bleeding complications were significantly higher in the thrombolysis with re

关键词： acute myocardial infarction thorombolytic therapy rescue percutaneous coronary intervention Primary percutaneous coronary intervention

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Comparison of tirofiban combined with dalteparin or unfractionated heparin in Primary percutaneous coronary intervention of acute ST-segment elevation myocardial infarction patients

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Chinese Medical Journal 2011年第20期124卷 3275-3280页

作者： LI Wei-ming YANG Xin-chun WANG Le-feng GE Yong-gui WANG Hong-shi XU Li NI Zhu-hua ZHANG Da-peng The Heart Center Beijing Chao Yang Hospital Capital MedicalUniversity Beijing 100020 China

Background Primary percutaneous coronary intervention （PCI） is the best treatment of choice for acute ST segment elevation myocardial infarction （STEMI）. This study aimed to determine the clinical outcomes of tirofiban combined with the low molecular weight heparin （LMWH）, dalteparin, in primary PCI patients with acute STEMI. Methods From February 2006 to July 2006, a total of 120 patients with STEMI treated with primary PCI were randomised to 2 groups： unfractionated heparin （UFH） with tirofiban （group I： 60 patients, （61.2±9.5） years）, and dalteparin with tirofiban （group il： 60 patients, （60.5±10.1） years）. Major adverse cardiac events （MACE） during hospitalization and at 4 years after PCI were examined. Bleeding complications during hospitalization were also examined. Results There were no significant differences in sex, mean age, risk factors, past history, inflammatory marker, or echocardiography between the 2 groups. In terms of the target vessel and vascular complexity, there were no significant differences between the 2 groups. During the first 7 days, emergent revascularization occurred only in 1 patient （1.7%） in group I. Acute myocardial infarction （AMI） occurred in 1 （1.7%） patient in group I and in 1 （1.7%） in group II. Three （5.0%） patients in group I and 1 （1.7%） in group II died. Total in-hospital MACE during the first 7 days was 4 （6.7%） in group I and 2 （3.3%） in group Ⅱ. Bleeding complications were observed in 10 patients （16.7%） in group I and in 4 patients （6.7%） in group II, however, the difference was not statistically significant. No significant intracranial bleeding was observed in either group. Four years after PCI, death occurred in 5 （8.3%） patients in group I and in 4 （6.7%） in group Ⅱ. MACE occurred in 12 （20.0%） patients in group I and in 10 （16,7%） patients in group Ⅱ. Conclusions Dalteparin was effective and safe in primary PCI of STEMI patients and combined dalteparin with tirofiban was effective and safe without significant bleeding complications compared with UFH. Although the

关键词： acute myocardial infarction, heparin Primary percutaneous coronary intervention

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Association of neutrophil/lymphocyte ratio with long-term mortality after ST elevation myocardial infarction treated with Primary percutaneous coronary intervention

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Chinese Medical Journal 2010年第23期123卷 3438-3443页

作者： SHEN Xu-hua CHEN Qi SHI yan LI Hong-wei Department of Cardiology Beijing Friendship Hospital Affiliatedto Capital Medical University Beijing 100050 China Department of Computer Capital Medical University Beijing100030 China

Background Primary percutaneous coronary interventions （PCI） have been proposed as a novel superior management strategy in patients with ST elevation myocardial infarction （STEMI）. This study tested the hypothesis that in the acute phase of myocardial infarction with ST-segment elevation, the neutrophil/lymphocyte （N/L） ratio is a predictor of long-term prognosis.Methods We analyzed 551 consecutive STEMI patients treated with primary PCl at a single university center. Patients were stratified according to quartiles of the mean neutrophil/lymphocyte ratio.Results Kaplan-Meier survival analysis showed a cumulative eight-year survival of 94.2% in the first quartile, 92.0% in the second quartile, 91.3% in the third quartile, and 75.4% in the fourth quartile （P ＜0.001 by log rank）. Relative to patients in the other three lower N/L ratio quartiles, patients in the highest quartile were more than four times more likely to die during hospitalization （P ＜0.001） and during long-term follow-up （P ＜0.001）. By multivariate Cox regression analysis including baseline demographic, clinical, and angiographic covariables, the N/L ratio in the highest quartile remained an independent predictor of mortality （hazard ratio 2.38, 95% confidence interval （CI） 1.42 to 3.98; P=0.001）.Conclusion The neutrophil/lymphocyte ratio is a strong independent predictor of long-term mortality after ST elevation myocardial infarction treated with very early revascularization.

关键词： neutrophil/lymphocyte ratio Primary percutaneous coronary intervention ST elevation myocardial infarction inflammation

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Staged Revascularization for Chronic Total Occlusion in the Non-IRA in Patients with ST-segment Elevation Myocardial Infarction Undergoing Primary percutaneous coronary intervention:An Updated Systematic Review and Meta-analysis

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Cardiovascular Innovations and Applications 2022年第2期6卷 209-218页

作者： Yu Geng Yintang Wang Lianfeng Liu Guobin Miao Ou Zhang Yajun Xue Ping Zhang Department of Cardiology Beijing Tsinghua Changgung HospitalSchool of Clinical MedicineTsinghua UniversityBeijingChina

Objectives:Meta-analysis was performed to evaluate the effect of staged revascularization with concomitant chronic total occlusion(CTO)in the non-infarct-associated artery(non-IRA)in patients with ST-segment elevation myocardial infarction(STEMI)treated with Primary percutaneous coronary intervention(p-PCI).Methods:Various electronic databases were searched for studies published from inception to June,2021.The primary endpoint was all-cause death,and the secondary endpoint was a composite of major adverse cardiac events(MACEs).Odds ratios(ORs)were pooled with 95%conﬁdence intervals(CIs)for dichotomous data.Results:Seven studies involving 1540 participants were included in theﬁnal analysis.Pooled analyses revealed that patients with successful staged revascularization for CTO in non-IRA with STEMI treated with p-PCI had overall lower all-cause death compared with the occluded CTO group(OR,0.46;95%CI,0.23–0.95),cardiac death(OR,0.43;95%CI,0.20–0.91),MACEs(OR,0.47;95%CI,0.32–0.69)and heart failure(OR,0.57;95%CI,0.37–0.89)com-pared with the occluded CTO group.No signiﬁcant differences were observed between groups regarding myocardial infarction and repeated revascularization.Conclusions:Successful revascularization of CTO in the non-IRA was associated with better outcomes in patients with STEMI treated with p-PCI.

关键词： ST segment elevation myocardial infarction chronic total occlusion Primary percutaneous coronary intervention

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