1.A novel biodegradable polymer-coated sirolimus-eluting stent: 1-year results of the HELIOS registry.
Bo ZHENG ; Yi LIU ; Ruining ZHANG ; Wangwei YANG ; Fangju SU ; Rutao WANG ; Dapeng CHEN ; Guidong SHEN ; Yumin QIU ; Lianmin WANG ; Chang CHEN ; Zhongwei WU ; Fei LI ; Jiayi LI ; Chengxiang LI ; Chao GAO ; Ling TAO
Chinese Medical Journal 2023;136(15):1848-1854
BACKGROUND:
The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer. The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world setting.
METHODS:
The HELIOS registry is a prospective, multicenter, cohort study conducted at 38 centers across China between November 2018 and December 2019. A total of 3060 consecutive patients were enrolled after application of minimal inclusion and exclusion criteria. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, non-fatal target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 1-year follow-up. Kaplan-Meier methods were used to estimate the cumulative incidence of clinical events and construct survival curves.
RESULTS:
A total of 2998 (98.0%) patients completed the 1-year follow-up. The 1-year incidence of TLF was 3.10% (94/2998, 95% closed interval: 2.54-3.78%). The rates of cardiac death, non-fatal target vessel MI and clinically indicated TLR were 2.33% (70/2998), 0.20% (6/2998), and 0.70% (21/2998), respectively. The rate of stent thrombosis was 0.33% (10/2998). Age ≥60 years, diabetes mellitus, family history of coronary artery disease, acute myocardial infarction at admission, and device success were independent predictors of TLF at 1 year.
CONCLUSION:
The 1-year incidence rates of TLF and stent thrombosis were 3.10% and 0.33%, respectively, in patients treated with HELIOS stents. Our results provide clinical evidence for interventional cardiologists and policymakers to evaluate HELIOS stent.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT03916432.
Humans
;
Middle Aged
;
Sirolimus/therapeutic use*
;
Drug-Eluting Stents/adverse effects*
;
Prospective Studies
;
Cohort Studies
;
Treatment Outcome
;
Risk Factors
;
Time Factors
;
Percutaneous Coronary Intervention/adverse effects*
;
Cardiovascular Agents/therapeutic use*
;
Coronary Artery Disease/therapy*
;
Myocardial Infarction/etiology*
;
Thrombosis/complications*
;
Polymers
;
Registries
2.Effectiveness and safety of Shexiang Baoxin Pill (MUSKARDIA) in patients with stable coronary artery disease and concomitant diabetes mellitus: a subgroup analysis of a randomized clinical trial.
Jingmin ZHOU ; Haiming SHI ; Fusui JI ; Yang WU ; Yulan ZHAO ; Jun QIAN ; Junbo GE
Chinese Medical Journal 2023;136(1):82-87
BACKGROUND:
Preliminary studies have indicated that Shexiang Baoxin Pill (MUSKARDIA) has a coronary artery dilation effect and increases the coronary blood flow, relieving the symptoms of angina. This study aimed to evaluate the benefit of MUSKARDIA on patients with stable coronary artery disease (CAD) and diabetes mellitus (DM).
METHODS:
This was a subgroup analysis of a multicenter, randomized, placebo-controlled phase IV trial. CAD patients with a medical history of DM or baseline fasting blood glucose (FBG) ≥7.0 mmol/L were grouped according to the treatment (standard therapy plus MUSKARDIA or placebo). The primary outcome was major adverse cardiovascular events (MACEs), which was the composite outcome of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. The secondary outcome was the composite outcome of all-cause death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina or heart failure, and coronary angioplasty.
RESULTS:
MACEs occurred in 2.6% (9/340) and 4.8% (18/376) of patients in the MUSKARDIA and placebo groups, respectively ( P = 0.192). Secondary composite outcome was significantly less frequent with MUSKARDIA than with placebo (15.3% [52/340] vs . 22.6% [85/376], P = 0.017). Risk of MACEs (hazard ratio [HR] = 0.69, 95% confidence interval [CI]: 0.31-1.57) was comparable between two groups. In patients with uncontrolled DM (≥4 measurements of FBG ≥7 mmol/L in five times of follow-up), the risk of secondary outcome was significantly lower with MUSKARDIA (5/83, 6.0%) than with placebo (15/91, 16.5%) (HR = 0.35, 95%CI: 0.13-0.95).
CONCLUSION:
As an add-on to standard therapy, MUSKARDIA shows a trend of reduced MACEs in patients with stable CAD and DM. Furthermore, MUSKARDIA may reduce the frequency of all-cause death, hospitalization, and coronary angioplasty in this population, especially in those with uncontrolled DM.
TRIAL REGISTRATION
ChiCTR.org.cn, ChiCTR-TRC-12003513.
Humans
;
Coronary Artery Disease/complications*
;
Diabetes Mellitus, Type 2/drug therapy*
;
Myocardial Infarction/complications*
;
Stroke/epidemiology*
3.Current use of oral anticoagulation therapy and influencing factors among coronary artery disease patients with nonvalvular atrial fibrillation in China.
Yan QIAO ; Yue WANG ; Song Nan LI ; Chen Xi JIANG ; Cai Hua SANG ; Ri Bo TANG ; De Yong LONG ; Jia Hui WU ; Liu HE ; Xin DU ; Jian Zeng DONG ; Chang Sheng MA
Chinese Journal of Cardiology 2023;51(5):504-512
Objective: To investigate current use of oral anticoagulant (OAC) therapy and influencing factors among coronary artery disease (CAD) patients with nonvalvular atrial fibrillation (NVAF) in China. Methods: Results of this study derived from "China Atrial Fibrillation Registry Study", the study prospectively enrolled atrial fibrillation (AF) patients from 31 hospitals, and patients with valvular AF or treated with catheter ablation were excluded. Baseline data such as age, sex and type of atrial fibrillation were collected, and drug history, history of concomitant diseases, laboratory results and echocardiography results were recorded. CHA2DS2-VASc score and HAS-BLED score were calculated. The patients were followed up at the 3rd and 6th months after enrollment and every 6 months thereafter. Patients were divided according to whether they had coronary artery disease and whether they took OAC. Results: 11 067 NVAF patients fulfilling guideline criteria for OAC treatment were included in this study, including 1 837 patients with CAD. 95.4% of NVAF patients with CAD had CHA2DS2-VASc score≥2, and 59.7% of patients had HAS-BLED≥3, which was significantly higher than NVAF patients without CAD (P<0.001). Only 34.6% of NVAF patients with CAD were treated with OAC at enrollment. The proportion of HAS-BLED≥3 in the OAC group was significantly lower than in the no-OAC group (36.7% vs. 71.8%, P<0.001). After adjustment with multivariable logistic regression analysis, thromboembolism(OR=2.48,95%CI 1.50-4.10,P<0.001), left atrial diameter≥40 mm(OR=1.89,95%CI 1.23-2.91,P=0.004), stain use (OR=1.83,95%CI 1.01-3.03, P=0.020) and β blocker use (OR=1.74,95%CI 1.13-2.68,P=0.012)were influence factors of OAC treatment. However, the influence factors of no-OAC use were female(OR=0.54,95%CI 0.34-0.86,P=0.001), HAS-BLED≥3 (OR=0.33,95%CI 0.19-0.57,P<0.001), and antiplatelet drug(OR=0.04,95%CI 0.03-0.07,P<0.001). Conclusion: The rate of OAC treatment in NVAF patients with CAD is still low and needs to be further improved. The training and assessment of medical personnel should be strengthened to improve the utilization rate of OAC in these patients.
Humans
;
Female
;
Male
;
Atrial Fibrillation/drug therapy*
;
Coronary Artery Disease/complications*
;
Anticoagulants/therapeutic use*
;
Platelet Aggregation Inhibitors/therapeutic use*
;
Risk Factors
;
China
;
Administration, Oral
;
Stroke
5.2014 Korean Guidelines for Appropriate Utilization of Cardiovascular Magnetic Resonance Imaging: A Joint Report of the Korean Society of Cardiology and the Korean Society of Radiology.
Yeonyee E YOON ; Yoo Jin HONG ; Hyung Kwan KIM ; Jeong A KIM ; Jin Oh NA ; Dong Hyun YANG ; Young Jin KIM ; Eui Young CHOI
Korean Journal of Radiology 2014;15(6):659-688
Cardiac magnetic resonance (CMR) imaging is now widely used in several fields of cardiovascular disease assessment due to recent technical developments. CMR can give physicians information that cannot be found with other imaging modalities. However, there is no guideline which is suitable for Korean people for the use of CMR. Therefore, we have prepared a Korean guideline for the appropriate utilization of CMR to guide Korean physicians, imaging specialists, medical associates and patients to improve the overall medical system performances. By addressing CMR usage and creating these guidelines we hope to contribute towards the promotion of public health. This guideline is a joint report of the Korean Society of Cardiology and the Korean Society of Radiology.
Cardiomyopathies/diagnosis/radiography
;
Cardiotonic Agents/therapeutic use
;
Chest Pain/complications/diagnosis/radiography
;
Coronary Artery Bypass
;
Coronary Artery Disease/*diagnosis/drug therapy/radiography
;
Dobutamine/therapeutic use
;
Echocardiography
;
Heart Defects, Congenital/diagnosis/radiography
;
Heart Failure/diagnosis/ultrasonography
;
Humans
;
*Magnetic Resonance Imaging
;
Mucocutaneous Lymph Node Syndrome/complications/diagnosis
;
Percutaneous Coronary Intervention
;
Prognosis
;
Risk Assessment
;
Ventricular Function, Left/physiology
6.Effect of formula of removing both phlegm and blood stasis on inflammatory reaction in Chinese mini-swine with coronary atherosclerosis.
Jian-Xun REN ; Lei LI ; Cheng-Ren LIN ; Jian-Hua FU ; Yue-Ying MA ; Jun-Mei LI ; Hong-Hai LI ; Min WANG ; Jian-Xun LIU
China Journal of Chinese Materia Medica 2014;39(2):285-290
OBJECTIVETo observe the effect of formula of removing both phlegm and blood stasis (TYTZ) in inhibiting the inflammatory reaction in Chinese mini-swine with coronary atherosclerosis.
METHODTotally 36 Chinese mini-swine were randomly divided to six groups: the normal control group, the model group, the Shujiangzhi group and TYTZ groups with does of 2.0, 1.0 and 0.5 g x kg(-1), and six each in every group. Except for the normal control group, all of other groups were fed with high-fat diet for 2 weeks. Interventional balloons are adopted to injure their left anterior descending artery endothelium. After the operation, they were fed with high-fat diet for 8 weeks to prepare the coronary atherosclerosis model. In the 8th week after the operation and administration, the intravascular ultrasound was adopted to observe the coronary artery plaque burden of each group and the pathological morphology of coronary artery. Such inflammatory factors as high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor (TNF)-alpha and interleukin (IL)-6 were detected by ELISA. The expression of NF-kappaB p65 nuclear translocation was observed by the immunohistochemical method.
RESULTCompared with the normal control group, the model group showed significant increase in the coronary artery plaque burden at the end of the experiment (P < 0.01), notably abnormal structural changes in atherosclerotic vascular tissues, luminal stenosis, a large number of foam cells and inflammatory cell infiltration, remarkable growth of hs-CRP, TNF-alpha and IL-6 levels (P < 0.01). The immunohistochemical staining also showed the significant increase in the NF-kappaB p65 nuclear translocation of coronary artery of Chinese mini-swine in the model group. Compared with the model group, TYTZ could significantly attenuate atherosclerotic plaque burden (P < 0.01), inhibit the coronary luminal stenosis, reduce inflammatory cell infiltration, decrease such inflammatory cell factors as hs-CRP, TNF-alpha and IL-6 in serum, and inhibit the NF-kappaB p65 nuclear translocation of coronary artery (P < 0.05 or P < 0.01).
CONCLUSIONTYTZ can reduce the downstream inflammatory reaction by controlling NF-kappaB p65 nuclear translocation, so as to inhibit the occurrence and development of coronary atherosclerotic plaque in Chinese mini-swine.
Animals ; C-Reactive Protein ; metabolism ; Coronary Artery Disease ; blood ; complications ; drug therapy ; pathology ; Female ; Inflammation ; complications ; Interleukin-6 ; blood ; Male ; Medicine, Chinese Traditional ; methods ; Mucous Membrane ; drug effects ; secretion ; Swine ; Swine, Miniature ; Tumor Necrosis Factor-alpha ; blood
7.Long-Term Outcomes of Complete Versus Incomplete Revascularization for Patients with Multivessel Coronary Artery Disease and Left Ventricular Systolic Dysfunction in Drug-Eluting Stent Era.
Gwan Hyeop SOHN ; Jeong Hoon YANG ; Seung Hyuk CHOI ; Young Bin SONG ; Joo Yong HAHN ; Jin Ho CHOI ; Hyeon Cheol GWON ; Sang Hoon LEE
Journal of Korean Medical Science 2014;29(11):1501-1506
We aimed to investigate that complete revascularization (CR) would be associated with a decreased mortality in patients with multivessel disease (MVD) and reduced left ventricular ejection fraction (LVEF). We enrolled a total of 263 patients with MVD and LVEF <50% who had undergone percutaneous coronary intervention with drug-eluting stent between March 2003 and December 2010. We compared major adverse cardiac and cerebrovascular accident (MACCE) including all-cause death, myocardial infarction, any revascularization, and cerebrovascular accident between CR and incomplete revascularization (IR). CR was achieved in 150 patients. During median follow-up of 40 months, MACCE occurred in 52 (34.7%) patients in the CR group versus 51 (45.1%) patients in the IR group (P=0.06). After a Cox regression model with inverse-probability-of-treatment-weighting using propensity score, the incidence of MACCE of the CR group were lower than those of the IR group (34.7% vs. 45.1%; adjusted hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.44-0.95, P=0.03). The rate of all-cause death was significantly lower in patients with CR than in those with IR (adjusted HR, 0.48; 95% CI, 0.29-0.80, P<0.01). In conclusion, the achievement of CR with drug-eluting stent reduces long-term MACCE in patients with MVD and reduced LVEF.
Age Factors
;
Aged
;
Coronary Artery Disease/*drug therapy/mortality/physiopathology
;
Diabetes Mellitus, Type 2/complications
;
*Drug-Eluting Stents
;
Female
;
Follow-Up Studies
;
Humans
;
Kaplan-Meier Estimate
;
Male
;
Middle Aged
;
Myocardial Infarction/etiology
;
Myocardial Revascularization
;
Percutaneous Coronary Intervention/adverse effects
;
Proportional Hazards Models
;
Renal Insufficiency, Chronic/complications
;
Retrospective Studies
;
Sex Factors
;
Treatment Outcome
;
Ventricular Dysfunction, Left/physiopathology
9.Expression of sICAM-1 in children with intravenous immunoglobulin-resistant Kawasaki disease.
Chinese Journal of Contemporary Pediatrics 2013;15(12):1109-1112
OBJECTIVETo investigate the expression of soluble intercellular adhesion molecule-1 (sICAM-1) and itd significance in children with intravenous immunoglobulin (IVIG)-resistant Kawasaki disease (KD).
METHODSA total of 271 children with KD who received IVIG treatment (including 252 IVIG-sensitive cases and 19 IVIG-resistant cases) were selected in the study; 78 of the 271 children had coronary artery dilation. Thirty-six age-matched healthy children were selected as the control group. Plasma sICAM-1 levels were measured using enzyme-linked immunosorbent assay. White blood cell count (WBC), neutrophil count, C-relative protein (CRP), aspartate aminotransferase(AST), serum sodium, and serum potassium were measured by laboratory tests.
RESULTSBefore IVIG treatment, the IVIG-sensitive cases and IVIG-resistant cases had significantly higher sICAM-1 levels than the control group (P<0.05), and the IVIG-resistant cases had significantly higher sICAM-1 levels than the IVIG-sensitive cases (P<0.05). After 24-48 hours of IVIG treatment, the IVIG-resistant cases had significantly higher sICAM-1 levels than the IVIG-sensitive cases (P<0.05). Before IVIG treatment, among the IVIG-sensitive cases, the sICAM-1 level was significantly higher in those with coronary artery dilation than in those without coronary artery dilation (P<0.05); among the IVIG-resistant cases, the sICAM-1 level was significantly higher in those with coronary artery dilation than in those without coronary artery dilation (P<0.05). In the IVIG-resistant cases, sICAM-1 level was positively correlated with WBC (before and after treatment) (r=0.7562, P<0.01; r=0.8435, P<0.01) and CRP (after treatment) (r=0.8936, P<0.01).
CONCLUSIONSHigh sICAM-1 level may be used as a risk factor for resistance to IVIG and coronary artery dilation in children with KD.
Child ; Child, Preschool ; Coronary Artery Disease ; blood ; Female ; Humans ; Immunoglobulins, Intravenous ; therapeutic use ; Infant ; Intercellular Adhesion Molecule-1 ; blood ; Male ; Mucocutaneous Lymph Node Syndrome ; blood ; complications ; drug therapy
10.Persistence of Orientia tsutsugamushi in Humans.
Moon Hyun CHUNG ; Jin Soo LEE ; Ji Hyeon BAEK ; Mijeong KIM ; Jae Seung KANG
Journal of Korean Medical Science 2012;27(3):231-235
We investigated the persistence of viable Orientia tsutsugamushi in patients who had recovered from scrub typhus. Blood specimens were available from six patients with scrub typhus who were at 1 to 18 months after the onset of the illness. The EDTA-treated blood specimens were inoculated into ECV304 cells, and cultures were maintained for 7 months. Sequencing of the 56-kDa type-specific antigen gene of O. tsutsugamushi was performed to ascertain the homology of isolates. O. tsutsugamushi was isolated from all six patients, and nucleotide sequences of isolates serially collected from each patient were identical in all five patients in whom nucleotide sequences were compared. One patient relapsed 2 days after completion of antibiotic therapy; two patients complained of weakness for 1 to 2.5 months after the illness; one patient underwent coronary angioplasty 6 months later; and one patient suffered from a transient ischemic attack 8 months later. This finding suggests that O. tsutsugamushi causes chronic latent infection, which may be associated with certain clinical illnesses, preceded by scrub typhus. Antibiotic therapy abates the symptoms of scrub typhus, but does not eradicate O. tsutsugamushi from the human body.
Adult
;
Aged
;
Aged, 80 and over
;
Antigens, Bacterial/genetics
;
Bacterial Proteins/genetics
;
Base Sequence
;
Case-Control Studies
;
Chronic Disease
;
Coronary Artery Disease/etiology
;
DNA, Bacterial/genetics/isolation & purification
;
Female
;
Genes, Bacterial
;
Humans
;
Ischemic Attack, Transient/etiology
;
Male
;
Membrane Proteins/genetics
;
Middle Aged
;
Muscle Weakness/etiology
;
Orientia tsutsugamushi/genetics/immunology/*isolation & purification
;
Recurrence
;
Scrub Typhus/complications/drug therapy/*microbiology
;
Time Factors

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