Safety and efficacy of the second generation biodegradable polymer Cobalt-Chromium sirolimus-eluting stent (EXCEL 2) stent in diabetic patients:A Subgroup analysis of the CREDIT Ⅱ and CREDIT Ⅲ trials / 中国介入心脏病学杂志

Objective To invesgate the safety and efficacy of the second generation biodegradable polymer Cobalt-Chromium sirolimus-eluting stent (EXCEL2) stent in diabetic patients by a subgroup analysis of of the CREDITⅡand CREDIT Ⅲ trials. Methods All patients who were implanted with the EXCEL2 stent were enrolled in the CREDITⅡand CREDIT Ⅲ trials. The primary endpoint was target lesion failure at 24-month, defi ned as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization(TLR). The secondary endpoint was endpoints including all-cause death, all myocardial infarction (MI) or any revascularization.Results A total of 828 patients were included from the patients who were implanted with the EXCEL2 stent in the CREDIT II and CREDIT Ⅲ trials. 24-month follow-up rate was 99.5%. There was no significant difference in the primary endpoint (P>0.05) and event rates of the secondary endpoints(P>0.05) between the diabetic and non-diabetic group, which included all-cause death[diabetics (2.5%)vs.non-diabetics(1.4%),P>0.05],myocardial infarction(MI)(7.5% vs.5.0%,P>0.05),all from of revascularization(5.0% vs.3.9%,P>0.05),and stent thrombosis(0.6% vs.0.4%,P>0.05).Conclusions EXCEL 2 stent met the objective performance goal on effcacy and safety, which can reduce make stent restenosis, target vessel revascularization ,with 160 diabetic cases among them, and stent thrombosis in diabetic patients.

Effect of Au NanoStars/collagen matrix material on oxidative stress damage in ventricular myocytes of newborn rats / 军事医学

Objective To verify antioxidation of Au NanoStars/collagen ( AuNSs/Col ) for ventricular myocytes of newborn rats(NRVMs) by in vitro studies.Methods (1)Different concentrations of AuNSs/Col composite materials were created.The optimum concentration of the material was selected by Live /dead staining and Cell Counting Kit-8 (CCK-8) and Col was used for subsequent experiments .( 2 ) NRVMs were randomly divided into Col group , AuNSs/Col group, H2O2-induced Col group, and H2O2-induced AuNSs/Col group.After 6 h treatment, apoptotic cell morphology and early cell apoptosis rate were observed with Annexin Ⅴ-FITC/propidium iodide ( PI)/4′,6-diamidino-2-phenylindole ( DAPI) and the expressions of apoptosis related proteins-B-cell lymphoma-2 ( Bcl-2 ) and Bcl-2 associated x protein ( Bax ) were detected by Western blotting .Results ( 1 ) Both Live/dead and CCK-8 experiments indicated that the AuNSs/Col composite material with 0.1 mg/ml was nontoxicity to NRVMs and could further promote their proliferation .(2) Compared with the uninduced group , the early apoptosis rate of the Col group and the AuNSs /Col group after H2O2 induction was significantly increased , while the Bcl-2/Bax ratio was decreased , indicating that the oxidative stress damage model was established.After H2O2 induction, compared with the Col group , the early apoptosis rate of the AuNSs/Col group was decreased , but the Bcl-2/Bax ratio was increased .Conclusion AuNSs/Col composite material has protective effect on the oxidative damage of cardiomyocytes cultured in vitro.

Gender difference on five-year outcomes of EXCEL biodegradable polymer-coated sirolimus-eluting stents implantation: results from the CREATE study / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The gender difference on long-term outcome in unselected patients after percutaneous coronary intervention (PCI) has not yet been fully investigated. This study aimed to evaluate the gender difference on five-year outcomes following EXCEL biodegradable polymer-coated sirolimus-eluting stenting in patients with coronary disease.</p><p><b>METHODS</b>A total of 2077 "all comers", consisting of 1528 (73.6%) men and 549 (26.4%) women, who were exclusively treated with EXCEL coronary stents were enrolled in the prospective CREATE study at 59 centers from four countries. After propensity score matching, the baseline characteristics of the two groups were well matched. Recommended antiplatelet regimen was clopidogrel and aspirin for six months followed by chronic aspirin therapy. The primary outcome that was the rate of major adverse cardiac events (MACE), defined as a composite of cardiac mortality, non-fatal myocardial infarction (MI) and target lesion revascularization (TLR), and stent thrombosis (ST) at five years were compared between the two gender groups.</p><p><b>RESULTS</b>In the two groups, women had higher proportions of clinical risk factors, such as being elderly, diabetes mellitus, hypertension and hyperlipidemia, compared to men. Besides, the mean target vessel number per patient was higher and the mean reference vessel diameter smaller for women. Men had higher risks of cardiac death (3.7% vs. 1.6%, P = 0.021) and MACE (8.4% vs. 4.7%, P = 0.004) at five years compared with women. However, the cumulative hazards of non-fatal MI and TLR were similar between men and women. The incidence of Academic Research Consortium (ARC) definite or probable stent thrombosis was similar between the two groups (1.3% vs. 1.0%, P = 0.639). Prolonged clopidogrel therapy (>6 months) did not reduce the cumulative hazards of ST from six months to five years in both men (χ(2) = 0.098, log rank P = 0.754) and women (χ(2) = 2.043, log rank P = 0.153) patients.</p><p><b>CONCLUSIONS</b>Women had a lower MACE and cardiac death rate than men after biodegradable polymer-coated sirolimus-eluting stenting in long term follow-up. Effects of prolonged dual antiplatelet therapy (DAPT) in preventing stent thrombosis was similar with six-month DAPT after EXCEL stent implantation in both men and women groups.</p>

Interleukin-8 monoclonal antibody attenuates smooth muscle cell proliferation and balloon inflation-induced abdominal aorta stenosis in rabbits / 中华心血管病杂志

<p><b>OBJECTIVE</b>To observe the effects of interleukin-8 monoclonal antibody on smooth muscle cell proliferation and balloon inflation-induced abdominal aorta stenosis in rabbits.</p><p><b>METHODS</b>Thirty-six New Zealand white rabbits were randomly assigned to balloon inflation group (group A, n = 12), interleukin-8 monoclonal antibody pre-treated rabbits (2 mg/kg for 3 days before balloon inflation, group B, n = 12) and sham-operated control group (group C, n = 12). Peripheral blood was collected before experiment and at 4 h, 1, 3, 7, 14, and 28 days post balloon inflation or sham operation and the levels of IL-8 were measured by enzyme linked immunosorbent assay (ELISA). The ratio of positive and negative masculine cells in the high power microscopic field was determined in proliferating cell nuclear antigen (PCNA) stained slide. Histopathologic examination was performed in abdominal aorta and luminal area, intima and tunica media area were measured.</p><p><b>RESULTS</b>Plasma interleukin-8 began to rise at 4 h and peaked at 1 day and remained increased up to 28 days after balloon inflation in rabbits of group A, plasma interleukin-8 level in group A was significantly higher than in group B and C at 4 h and thereafter post operation. The ratio of positive and negative masculine cells was significantly increased in group A compared to group C and was significantly lower in group B than in group A. Abdominal aorta stenosis, luminal area, intima and tunica media area were significantly reduced in group B than in group A. Correlation analysis indicated that there were positive relations between plasma IL-8 level and intima thickness, area of intima and tunica media, respectively (r = 0.894, 0.783, 0.801, 0.912, all P < 0.01).</p><p><b>CONCLUSIONS</b>Plasma IL-8 level is increased in this abdominal aorta stenosis model and is positively correlated to the severity of abdominal aorta stenosis. IL-8 monoclonal antibody could significantly reduce abdominal aorta stenosis in this abdominal aorta stenosis model.</p>

Randomized study on the safety and efficacy of dual-axis rotational versus standard coronary angiography in / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Dual-axis rotational coronary angiography (DARCA) was developed as an innovative adaptation of rotational angiography (RA), but it requires a longer coronary injection compared to standard coronary angiography (SA). As the body of the average Chinese patient is smaller than that of most western patients, with the same contrast injection time, the risk of complications from the contrast agent is increased in this population. The purpose of this study was to assess the clinical safety and efficacy of DARCA in the diagnosis of coronary artery disease (CAD) in the Chinese population by directly comparing it to SA.</p><p><b>METHODS</b>Two hundred Chinese patients were randomized to either the SA group (n = 100) or DARCA group (n = 100). Contrast utilization, radiation exposure and procedure time were recorded for each modalities. Blood pressure (BP), heart rate (HR) pre and post injection symptoms and any arrhythmias were recorded.</p><p><b>RESULTS</b>Compared to the SA group, there was a 42% reduction in contrast utilization, 55% reduction in radiation exposure and a 31% shorter procedure time in the DARCA group. In both groups, there were slight declines in the systolic BP values in the left coronary artery (LCA) post injection (P < 0.01). Moreover, post injection HRs for the LCA were also reduced in the DARCA group (P < 0.01). But all of these changes were small, transient and without clinical importance. Only one patient (1%) in the DARCA group had an attack of ventricular tachycardia immediately post injection and it resolved by itself during LCA angiography. No arrhythmias occurred in the SA group.</p><p><b>CONCLUSION</b>DARCA is a safe, efficient, and clinically comparable alternative to SA in the diagnosis of coronary artery disease in the Chinese population with less contrast utilized, which is less radiation exposure and a shorter procedure time than SA.</p>

Long-term effects of biodegradable versus durable polymer-coated sirolimus-eluting stents on coronary arterial wall morphology assessed by virtual histology intravascular ultrasound / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The durable presence of polymer coating on drug-eluting stent (DES) surface may be one of the principal reasons for stent thrombosis. The long-term coronary arterial response to biodegradable polymer-coated sirolimus-eluting stent (BSES) in vivo remained unclear.</p><p><b>METHODS</b>Forty-one patients were enrolled in this study and virtual histology intravascular ultrasound (VH-IVUS) was performed to assess the native artery vascular responses to BSES compared with durable polymer-coated SES (DSES) during long-term follow-up (median: 8 months). The incidence of necrotic core abutting to the lumen was evaluated at follow-up.</p><p><b>RESULTS</b>With similar in-stent late luminal loss (0.15 mm (0.06-0.30 mm) vs. 0.19 mm (0.03-0.30 mm), P = 0.772), the overall incidence of necrotic core abutting to the lumen was significantly less in BSES group than in DSES group (44% vs. 63%, P < 0.05) (proximal 18%, stented site 14% and distal 12% in BSES group, proximal 19%, stented site 28% and distal 16% in DSES group). The DSES-treated segments had a significant higher incidence of necrotic core abutting to the lumen through the stent struts (73% vs. 36%, P < 0.01). In addition, more multiple necrotic core abutting to the lumen was observed in DSES group (overall: 63% vs. 36%, P < 0.05). Furthermore, when the stented segments with necrotic core abutting to the lumen had been taken into account only, DSES-treated lesions tended to contain more multiple necrotic core abutting to the lumen through the stent struts than BSES-treated lesions (74% vs. 33%), although there was no statistically significant difference between them (P = 0.06).</p><p><b>CONCLUSIONS</b>By VH-IVUS analysis at follow-up, a greater frequency of stable lesion morphometry was shown in lesions treated with BSESs compared with lesions treated with DSESs. The major reason was BSES produced less toxicity to the arterial wall and facilitated neointimal healing as a result of polymer coating on DES surface biodegraded as time went by.</p>

Coronary plaque characterization of nonculprit or nontarget lesions assessed by analysis of in vivo intracoronary ultrasound radio-frequency data / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Unheralded sudden death and acute myocardial infarction are common manifestations of coronary atherosclerosis. Such events are related to thrombotic occlusion at the site of non-flow limiting atherosclerotic plaques in epicardial coronary arteries. This study aimed to assess plaque characterization of nonculprit lesions in patients with acute coronary syndrome (ACS) compared with those with stable angina pectoris (SAP) determined by analysis of intravascular ultrasound (IVUS) radiofrequency (RF) data.</p><p><b>METHODS</b>In 81 patients, nonculprit vessels with < 50% diameter stenosis and nontarget segment of culprit vessels with < 50% diameter stenosis were studied with IVUS. Tissue maps were reconstructed from RF data using IVUS-Virtual Histology software.</p><p><b>RESULTS</b>Mean lipid core percentage was significantly higher in patients with ACS than in those with SAP ((25.78 +/- 6.30)% vs (9.11 +/- 4.90)%, P < 0.001). In addition, patients with SAP showed more fibrotic vessels ((59.66 +/- 16.87)% vs (49.07 +/- 10.20)%, P < 0.001). There was no significant difference in either mean calcium ((4.37 +/- 2.40)% vs (5.12 +/- 3.00)%, P = 0.225) or fibrolipid ((24.94 +/- 9.40)% vs (25.82 +/- 13.60)%, P = 0.731) percentages in nonculprit vessels, but the mean calcium percentage was significantly higher in nontarget lesions of culprit vessels ((5.51 +/- 3.29)% vs (3.57 +/- 2.10)%, P = 0.003). In addition, there was a positive correlation between lipid core and remodeling index (RI) (r = 0.847, P < 0.001) and a negative correlation between fibrous tissue and RI (r = -0.946, P < 0.001).</p><p><b>CONCLUSIONS</b>In this study, in both nonculprit vessels and nontarget lesion of culprit vessels, plaque characterization of nonculprit lesions determined by spectral analysis of IVUS RF data was significantly different in patients with ACS. The percentage of lipid core was significantly higher in patients with ACS than in those with SAP. Conversely, SAP patients showed more fibrotic content. In vivo plaque composition and morphological changes were related to remodeling of the coronary artery tree.</p>

Mechanisms of improvement of left ventricle remodeling by trans-planting two kinds of autologous bone marrow stem cells in pigs / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The necrosis of a large number of myocardial cells after acute myocardial infarction (AMI) results in a decrease of cardiac function and ventricle remodeling. Stem cell transplantation could improve cardiac function after AMI, but the involving mechanisms have not been completely understood. The present study aimed to investigate the effects of transplantation of autologous bone marrow mononuclear cells (BM-MNC) and mesenchymal stem cells (MSCs) via the coronary artery on the ventricle remodeling after AMI as well as the mechanisms of the effects of transplantation of different stem cells on ventricle remodeling.</p><p><b>METHODS</b>A total of 36 male pigs were enrolled in this study, which were divided into 4 groups: control group, simple infarct model group, BM-MNC transplantation group, and MSCs transplantation group. At 90 minutes when a miniature porcine model with AMI was established, transplantation of autologous BM-MNC ((4.7 +/- 1.7) x 10(7)) and MSCs ((6.2 +/- 1.6) x 10(5)) was performed in the coronary artery via a catheter. Ultrasound, electron microscope, immunohistochemical examination and real time reverse transcriptase-polymerase chain reaction were used respectively to observe cardiac functions, counts of blood vessels of cardiac muscle, cardiac muscle nuclear factor (NF)-kappaB, myocardial cell apoptosis, and the expression of the mRNA of vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in cardiac muscles. Multivariate Logistic regression was used to analyze the correlation factors of left ventricular end-diastolic diameter (EDD).</p><p><b>RESULTS</b>The number of blood vessels in the infarct zone and around its border in the BM-MNC transplantation group was more than those in the infarct model group and MSCs group (P = 0.0001) and there was less myocardial cell apoptosis in the stem cell transplantation group than that in the infarct model group (all P < 0.01). The positive rate of NF-kappaB in the stem cell transplantation group was lower than that in the infarct model group (P = 0.001). The gene expression of VEGF in the infarct border zone of the BM-MNC group was higher than that in the MSCs group (P = 0.0001). The gene expression of bFGF in the infarct border zone in the MSCs transplantation group was higher than that in the infarct model group and the BM-MNC group (P = 0.0001). Left ventricular ejection fraction was inversely proportional to the apoptotic rate of myocardial cells and cardiac muscle NF-kappaB but positively correlated with the number of blood vessels and the expression of VEGF and bFGF in the infarct zone and infarct border zone. The Multivariate Logistic regression analysis on the factors influencing the left ventricular end-diastolic diameter after stem cell transplantation showed that the expression of VEGF mRNA in the cardiac muscles in the infarct zone, the number of apoptotic myocardial cells and the expression of NF-kappaB in the infarct border zone were independent factors for predicting the inhibitory effect on the dilation of left ventricular EDD after stem cell transplantation.</p><p><b>CONCLUSIONS</b>Transplantation of autologous BM-MNC and MSCs in pigs can improve the condition of left ventricular remodeling and recover the cardiac functions after AMI. The improvement of cardiac functions is related to the increase of blood vessels, the increased expression of VEGF and bFGF, the reduction of myocardial cell apoptosis, and the decrease of NF-kappaB level in cardiac muscle tissues after stem cell transplantation.</p>

Central Blood Pressure and the Extent of Coronary Artery Disease / 中华高血压杂志

50%.The patients were categorized into as:one-,two-, and three-vessels coronary artery disease group.Central aortic SBP and DBP was measured by cathetarization dur- ing angiography of coronary artery and brachial blood pressure was measured using cuff method.Results Periph- eral SBP,PP and ascending aortic SBP,PP,fractional systolic pressure(FSP=SBP/MAP)were increased and as cending aortic fractional diastolic pressure(FDP=DBP/MAP)was reduced when the diseased coronary vessels were increased(P

Apolipoprotein E gene polymorphisms and risk for coronary artery disease in Chinese Xinjiang Uygur and Han population / 中国医学科学杂志(英文版)

<p><b>OBJECTIVE</b>To examine the relationship between apolipoprotein E (Apo E) gene polymorphism and risk of coronary artery disease (CAD), analyzing association of polymorphism with classical risk factors.</p><p><b>METHODS</b>A total of 124 patients (including 84 Han population and 40 Uygur population) with angiographically verified CAD or myocardial infarction were prospectively evaluated. Data referring to hypertension, diabetes, and tobacco consumption were recorded. The levels of total cholesterol (TC), high density lipoprotein (HDL) cholesterol, Apo A1 and B, and triglycerides (TG) were determined. DNA was obtained from 124 patients and 70 controls. In order to determine Apo E genotypes, DNA was PCR amplified and digested with HhaI. The genetic polymorphism of Apo E is due to three common alleles, epsilon (epsilon) 2, epsilon3, epsilon4, at a single autosomal gene locus. These alleles determine the six phenotypes E2/2, E3/3, E4/4, E4/2, E4/3, and E3/2.</p><p><b>RESULTS</b>In Uygur population, the frequency of the epsilon2, epsilon3, and epsilon4 was 0.155, 0.648, and 0.197 respectively. In Han population, the frequency of the epsilon2, epsilon3, and epsilon4 was 0.081, 0.772, and 0.146 respectively. In the patient group, the frequency of the epsilon2, epsilon3, and epsilon4 was 0.060, 0.758, and 0.182 respectively. In the control group, the frequency of the epsilon2, epsilon3, and epsilon4 was 0.193, 0.671, and 0.136 respectively. epsilon2 frequency of Uygur' patients and controls was 0.050 and 0.290 respectively. Serum low density lipoprotein (LDL) cholesterol, TC, and TG values tended to decrease from the Apo E-4 phenotypes to Apo E-2 phenotypes. When deletion polymorphism of epsilon2 was compared with the common risk factors for CAD, its risk ratio (RR) is 4.38.</p><p><b>CONCLUSIONS</b>These studies confirm and find that Apo E phenotype distribution in Uygur population differs significantly from that in Han population in Xinjiang. CAD patients have significantly lower epsilon2 allele and slightly higher epsilon3 or epsilon4 allele frequency than controls, especially in Uygur population. It shows protective effects of epsilon2 on CAD.</p>