Photoluminescent Transparent Wood with Excellent UV-Shielding Function.

At present, light transmission, energy saving, environmental protection, and UV-shielding materials are very important for optimizing indoor living environment. Here, a fluorescent transparent wood (FTW) with UV-shielding function was prepared by encapsulating a carbon quantum dot and epoxy resin into a delignification wood template. FTW exhibits excellent optical transmittance (about 91%), water absorption stability (weight gain rate less than 9%), longitudinal tensile strength (139 MPa), and UV-shielding properties. Due to the photoluminescence characteristics of the carbon quantum dot and the natural cellulose skeleton of wood, FTW can show uniform luminescence under ultraviolet lamps. At the same time, it has remarkable UV-shielding performance. This kind of photoluminescent transparent wood with a UV-shielding function also has the potential to be applied to fields such as electromagnetic shielding and harmful gas detection.

Study on Transparent Basswood Dyed with Reactive Dyes and Its Properties.

In this work, sodium chlorite method was used to remove lignin in basswood and then the wood was dyed with reactive red X-3B dye. Finally, ultraviolet curing resins with a refractive index similar to cellulose were vacuum-impregnated into the wood to obtain red transparent wood (RTW). Nowadays, transparent wood can be given color by various means and has a wide range of application prospects in the field of transparent wood decoration, but the color embodiment is relatively single. The aim was to develop a low-priced, easy-to-use process for the preparation of colored transparent wood with a sound color system. Transparent wood with colors will have more decorative and commercial value. The chemical composition, microscopic morphology, mechanical properties, and optical properties of dyed transparent wood were examined and analyzed. The results of the chemical composition analysis showed that after delignified treatment, the wood lost a large amount of lignin. After the dyeing treatment, the content of cellulose, hemicellulose, and lignin was slightly lost, and reactive dye groups appeared in the wood. Infrared spectra of transparent samples showed that the resin was successfully impregnated into the wood. The microscopic morphology analysis results showed that a small amount of dye molecules aggregated on the cell walls after dyeing treatment, and the resin was impregnated into the porous cellulose skeleton of the wood, filling the wood pores. The analysis of mechanical properties showed that the maximum tensile strength of dyed transparent wood reached 122.31 MPa, which was a higher resistance to tensile force compared to raw wood (with a maximum tensile strength of 97.56 MPa); the elongation at break reached 6.26%, which had better toughness compared to log (4.04%). Optical performance analysis showed that the transmittance of dyed transparent wood reached 81%, and dyeing did not change the transmittance of transparent wood. In addition, after undergoing yellowing resistance experiments, the color difference change of dyed transparent wood was much smaller than that of transparent wood.

Willingness to vaccinate against herpes zoster in Chinese urban population: a mixed-methods study.

OBJECTIVE: Although the herpes zoster vaccine has been available in mainland China since June 2020, residents' knowledge of herpes zoster and the herpes zoster vaccine is poor, and vaccination rates are low, especially among the elderly, who are at high risk for herpes zoster. This study assessed willingness to be vaccinated against herpes zoster and factors associated with vaccination among urban residents in China. METHODS: A mixed-methods study was conducted in community health centres from August 2022 to September 2022. We used convenience sampling to select 2864 residents from 9 Chinese cities for the quantitative study and 67 adults for the qualitative study. A structured questionnaire was used for the quantitative study, and data were collected through face-to-face interviews. Multinomial logistic regression was used to analyse factors associated with willingness to vaccinate. Qualitative data were analysed using thematic analysis of barriers to herpes zoster vaccination. RESULTS: A total of 2864 eligible respondents were included in the study. Of these, 42.67% intended to receive the herpes zoster vaccine, 21.44% refused and 35.89% were hesitant. The results of the quantitative and qualitative analyses showed that the factors associated with respondents' willingness to be vaccinated against herpes zoster included: personal characteristics such as gender, age and income; knowledge and attitudes about herpes zoster and the vaccine; vaccine characteristics such as efficacy, safety and price; and other factors such as pain tolerance and accessibility to vaccination. CONCLUSION: The low willingness to vaccinate, especially among the elderly, is mainly related to their poor knowledge and negative attitude towards the infection and vaccination. Therefore, health education about herpes zoster, immunisation promotion, and improvement of accessibility and affordability would be valuable in China.

Effect of M-type reactive dyes on dyeing properties of twisted bamboo fiber bundles.

The dyeing properties of twisted bamboo fiber bundles were studied by using the combination of three primary colors in M-type reactive dyes. The study found that the three dyes of red, yellow and blue have good color rendering in the actual dyeing process, and because the molecular structures of the three are similar, the chemical reactions during the fixation are the same, so the final dyeing rate results are similar, which were 29-32%. Compared with the undyed twisted bamboo fiber bundle, the mechanical properties of the three-color twisted bamboo fiber bundle also changed significantly, and the tensile strength increased by 13.79% on average. The changes of elastic modulus and elongation at break showed that the three-color twisted bamboo fiber bundle had excellent flexibility. In addition, there are significant color differences between the samples of each color. When the color indexes of DB are used as the benchmark, the ΔE* of other dyed samples varies from 40 to 80, and the color of each sample is relatively uniform, without an obvious color flower phenomenon. This indicates that twisted bamboo fiber bundles with richer colors can be prepared by different combinations of three primary dyes, which can improve the ornamental value of bamboo fiber bundles after processing into large blocks and their application potential in home textiles, interior decoration and other fields.

Expression and clinical significance of Capase3 and C-IAP1/2 in ectopic endometrium of patients with endometriosis.

To analyze the expression of capase3 and C-IAP1/2 in endometriosis and their relationship with clinical practice. Ectopic and eutopic endometrial tissues were collected from women with endometriosis, and the control tissues were obtained from regular patients without endometriosis. The expression level of capase3 and C-IAP1/2 was detected by immunohistochemistry; in addition, the relationship between C-IAP1/2 expression and the clinical stage of endometriosis was analyzed. The expression of Caspase-3 in ectopic and eutopic endometrium was significantly lower than that in the control group (P < 0.005). The expression of C-IAP1/2 in ectopic and situ endometrium was significantly higher than in the control group (P < 0.005). The expression of C-IAP1/2 in stage III-IV was higher than in stage I-II endometriosis. The positive expression of c-IAP1 protein in ectopic endometrial tissue was negatively correlated with the positive expression of Caspase-3 protein in ectopic endometrial tissue (P<0.001). The low expression of Caspase-3 and the high expression of C-IAP1/2 in the ectopic endometrium and eutopic endometrial tissues compared with the controls. The results indicated that the apoptotic ability of eutopic and ectopic endometrium is weakened, which is involved in the pathogenesis of endometriosis. It is expected to be a target for the diagnosis and therapy of this disease. At the same time, the expression level of C-IAP1/2 is related to the stage of endometriosis, which can guide clinical treatment.

Machine learning prediction of motor function in chronic stroke patients: a systematic review and meta-analysis.

Background: Recent studies have reported that machine learning (ML), with a relatively strong capacity for processing non-linear data and adaptive ability, could improve the accuracy and efficiency of prediction. The article summarizes the published studies on ML models that predict motor function 3-6 months post-stroke. Methods: A systematic literature search was conducted in PubMed, Embase, Cochorane and Web of Science as of April 3, 2023 for studies on ML prediction of motor function in stroke patients. The quality of the literature was assessed using the Prediction model Risk Of Bias Assessment Tool (PROBAST). A random-effects model was preferred for meta-analysis using R4.2.0 because of the different variables and parameters. Results: A total of 44 studies were included in this meta-analysis, involving 72,368 patients and 136 models. Models were categorized into subgroups according to the predicted outcome Modified Rankin Scale cut-off value and whether they were constructed based on radiomics. C-statistics, sensitivity, and specificity were calculated. The random-effects model showed that the C-statistics of all models were 0.81 (95% CI: 0.79; 0.83) in the training set and 0.82 (95% CI: 0.80; 0.85) in the validation set. According to different Modified Rankin Scale cut-off values, C-statistics of ML models predicting Modified Rankin Scale>2(used most widely) in stroke patients were 0.81 (95% CI: 0.78; 0.84) in the training set, and 0.84 (95% CI: 0.81; 0.87) in the validation set. C-statistics of radiomics-based ML models in the training set and validation set were 0.81 (95% CI: 0.78; 0.84) and 0.87 (95% CI: 0.83; 0.90), respectively. Conclusion: ML can be used as an assessment tool for predicting the motor function in patients with 3-6 months of post-stroke. Additionally, the study found that ML models with radiomics as a predictive variable were also demonstrated to have good predictive capabilities. This systematic review provides valuable guidance for the future optimization of ML prediction systems that predict poor motor outcomes in stroke patients. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022335260, identifier: CRD42022335260.

Fructose-6-phosphate-2-kinase/fructose-2,6-bisphosphatase regulates energy metabolism and synthesis of storage products in developing rice endosperm.

Starch accounts for about 80-85 % of the dry weight of grains and determines yield by impact on grain weight. And, the content and composition of starch also determine appearance, eating, cooking and nutritional quality of rice. By coordinating crucial reactions of the primary carbohydrate metabolism in all eukaryotes, fructose-2,6-bisphosphate (Fru-2,6-P2) is a traffic signal in metabolism. However, the metabolic regulation of starch in plant sink tissues by Fru-2,6-P2 remains unclear. Here we isolated rice mutant floury endosperm23 (flo23) which has opaque endosperm and anomalous compound starch grains (SGs). flo23 mutant grains had reduced contents of starch, lipids and proteins. Map-based cloning and genetic complementation experiments showed that FLO23 encodes a cytoplasmic Fructose-6-phosphate-2-kinase/Fructose-2,6-bisphosphatase (F2KP). Mutation of OsF2KP2 decreased Fru-2,6-P2 content in endosperm cells, leading to drastically reduced phosphoenolpyruvate (PEP) and pyruvate contents and disordered glycolysis and energy metabolism. The results imply that OsF2KP2 participates in the glycolytic pathway by providing precursors and energy for synthesis of grain storage compounds.

Evaluation of laboratory predictors for intravenous immunoglobulin resistance and coronary artery aneurysm in Kawasaki Disease before and after therapy.

OBJECTIVES: We aimed to evaluate the clinical and laboratory characteristics of patients with Kawasaki disease (KD) before and after therapy. METHODS: Patients with KD were divided into different groups according to their responsiveness to initial intravenous immunoglobulin (IVIG) treatment and coronary status. The clinical and laboratory parameters before and after therapy were compared. Multivariate analysis was performed to identify the independent risk factors, and the receiver operating characteristic (ROC) curve was applied to assess and compare the prediction ability of risk factors and their fluctuations. RESULTS: Of the 153 patients included in the study, 41 (26.8%) had IVIG resistance and 37 (24.2%) had developed CAA. After stratifying by therapy response, the two groups differed in the levels of total bilirubin (TSB), albumin, and sodium, neutrophil-to-lymphocyte count ratio (NLR), platelet-to-lymphocyte count ratio (PLR), TSB-to-albumin (B/A) ratio, and prognostic nutritional index (PNI) before IVIG, and in the white blood cell count (WBC), neutrophil count, levels of hemoglobin, C-reactive protein (CRP), alanine aminotransferase (ALT), and albumin, NLR, PNI, capillary leakage index (CLI), and systemic immune-inflammation index (SII) after IVIG. Multivariate analysis revealed that the B/A ratio before IVIG and CLI and SII after IVIG were significantly and positively associated with IVIG resistance and that there was a larger decline in the B/A ratio and smaller decline in CLI and SII pre- and post-treatment in the IVIG-resistant group than in the IVIG-responsive group. However, no statistical differences in the fluctuations of the B/A ratio, CLI, and SII as well as all parameters before and after therapy were observed in patients with and without CAA. ROC curve analyses found a greater AUC value of post-treatment parameters (0.751 and 0.706 for CLI and SII, respectively) compared with pre-treatment parameters (0.654 for B/A ratio) in predicting IVIG resistance; however, the predictive ability of the fluctuations in risk factors before and after therapy was not superior to that of baseline values. CONCLUSIONS: The B/A ratio before IVIG and CLI and SII after IVIG were risk factors for IVIG resistance in patients with KD, independent of CAA development. Key Points • A high total bilirubin-to-albumin ratio before IVIG and high capillary leakage and systemic immune-inflammation indices after IVIG may indicate an increased risk of intravenous immunoglobulin resistance in patients with Kawasaki disease. • Post-treatment parameters were superior to pre-treatment parameters in terms of prediction; therefore, rapid and repeated assessment of risk factors before and after treatment must be considered in children in whom the vital signs and symptoms do not improve after treatment.

Green, Sustainable Architectural Bamboo with High Light Transmission and Excellent Electromagnetic Shielding as a Candidate for Energy-Saving Buildings.

Currently, light-transmitting, energy-saving, and electromagnetic shielding materials are essential for reducing indoor energy consumption and improving the electromagnetic environment. Here, we developed a cellulose composite with excellent optical transmittance that retained the natural shape and fiber structure of bamboo. The modified whole bamboo possessed an impressive optical transmittance of approximately 60% at 6.23 mm, illuminance of 1000 luminance (lux), water absorption stability (mass change rate less than 4%), longitudinal tensile strength (46.40 MPa), and surface properties (80.2 HD). These were attributed to not only the retention of the natural circular hollow structure of the bamboo rod on the macro, but also the complete bamboo fiber skeleton template impregnated with UV resin on the micro. Moreover, a multilayered device consisting of translucent whole bamboo, transparent bamboo sheets, and electromagnetic shielding film exhibited remarkable heat insulation and heat preservation performance as well as an electromagnetic shielding performance of 46.3 dB. The impressive optical transmittance, mechanical properties, thermal performance, and electromagnetic shielding abilities combined with the renewable and sustainable nature, as well as the fast and efficient manufacturing process, make this bamboo composite material suitable for effective application in transparent, energy-saving, and electromagnetic shielding buildings.

Primary and Acquired Resistance against Immune Check Inhibitors in Non-Small Cell Lung Cancer.

Immune checkpoint inhibitors have emerged as the treatment landscape of advanced non-small cell lung cancer (NSCLC) in recent years. However, approximately 80% of NSCLC patients do not benefit from ICIs due to primary resistance (no initial response) or acquired resistance (tumor relapse after an initial response). In this review, we highlight the mechanisms of primary and secondary resistance. Furthermore, we provide a future direction of the potential predictive biomarkers and the tumor microenvironmental landscape and suggest treatment strategies to overcome these mechanisms.

Hypertension in adolescents: The role of obesity and family history.

We evaluated the combined effect of obesity and family history (FH) on the risk of hypertension in adolescents. We studied 1288 school-aged adolescents aged 16.0 ± 0.5 years (49.0% males) attending the medical examination for enrollment in the city of Nanning, China. Their blood pressure, weight, and height were measured. A questionnaire was administered to both adolescents and their parents to obtain information on the participants' medical history. Multiple logistic regression analysis, according to bodyweight categories and adjusted for age, gender, and body mass index (BMI), was done to determine the association of FH with hypertension. Hypertension was found in 14.1% of adolescents. The prevalence of hypertension was significantly higher in adolescents with obesity and positive FH than their normal weight and negative FH counterparts. For adolescents with normal weight and waist circumstance (WC), those with a positive FH in parents compared to those without had an significantly increased risk for hypertension (odds ratio [OR], 2.15; 95% confidence interval [CI] 1.28-3.61, and 1.96; 95% CI 1.16-3.32, respectively). These findings were adjusted for age, gender, and BMI. Our study showed that routine screening for pediatric hypertension should be performed in adolescents who are overweight and obese. Furthermore, parental FH of hypertension played an important role in predicting the hypertension phenotype among adolescents with normal weight.

Lifestyle Clusters and Cardiometabolic Risks in Adolescents: A Chinese School-Based Study Using a Latent Class Analysis Approach.

Background: Unhealthy dietary and lifestyle behaviors are associated with a higher prevalence of non-communicable chronic diseases and higher mortality in adults. However, there remains some uncertainty about the magnitude of the associations between lifestyle behaviors and cardiovascular factors in adolescents. Methods: We conducted a school-based cross-sectional study of 895 Chinese adolescents aged 15-19 years. They participated in a questionnaire survey, physical examination, and blood sample collection. Latent class analysis (LCA) was used to identify heterogeneous subgroups of lifestyle behaviors. A set of 12 latent class indicators, which reflected lifestyle behaviors including dietary habits, physical activity, sleep duration, screen time, and pressure perception, were included in the analysis. Logistic regression analysis was performed to determine whether the derived classes were related to a cardiometabolic risk. Results: In total, 13.7 and 5.6% of the participants were overweight and obese, respectively, and 8.4 and 14.1% reported having pre-hypertension and hypertension, respectively. A two-class model provided the best fit with a healthy lifestyle pattern (65.8%) and a sub-healthy lifestyle pattern (34.2%). There were more female participants with a healthy lifestyle (56.2 vs. 43.8%), whereas there were more males with a sub-healthy lifestyle (45.4 vs. 54.6%), (all P = 0.002). Increased risk of cardiometabolic abnormality (BMI categories, blood pressure and lipids) was not significant across lifestyle patterns, except for waist circumference (70.5 vs 69.1 cm, P = 0.044). There was no significant difference in physical activity and intake of fruit and vegetable between the two patterns. Conclusion: Primary prevention based on lifestyle modification should target patterns of behaviors at high risk in adolescents. Due to the complex effect of lifestyle clusters on cardiometabolic risks, well-designed and prospective studies in adolescents are needed in the future.

Four-Year Outcomes of Multivessel Percutaneous Coronary Intervention With Xience V Everolimus-Eluting Stents.

OBJECTIVES: We evaluated the long-term outcomes of multivessel compared with single-vessel percutaneous coronary intervention (PCI) with Xience V everolimus-eluting stents in real-world patients. BACKGROUND: Treatment options for multivessel disease include PCI, coronary artery bypass grafting, and medical therapy. Patients with multivessel disease are at a higher risk for ischemic complications than those with single-vessel disease. METHODS: The XIENCE V USA study was a condition-of-approval, single-arm, prospective study in unselected real-world patients. Patients who underwent multivessel PCI (n = 655) were compared with those who underwent single-vessel PCI (n = 4079). Major clinical outcomes, including mortality, stent thrombosis, and target-lesion failure (TLF), were evaluated at 4 years. RESULTS: At 4 years, mortality was similar in both groups (11.1% in multivessel patients vs 9.8% in single-vessel patients; P=.31). The multivessel PCI group had higher rates of Academic Research Consortium (ARC)-defined TLF (24.3% vs 16.4% in single-vessel patients; P<.001) and ARC-defined definite and probable stent thrombosis (2.43% vs 1.11% in single-vessel patients; P=.02). The independent predictors of ARC-defined TLF at 4 years on multivariable analysis were prior myocardial infarction, number of treated vessels, total stent length, and sex. CONCLUSION: Despite significant differences in baseline characteristics, long-term mortality rates were similar in both groups. Although ischemic complications were higher in the multivessel PCI group, the overall rates were acceptable, demonstrating the safety and efficacy of Xience V everolimus-eluting stents for the treatment of multivessel disease in a real-world population.

Late-term safety and effectiveness of everolimus-eluting stents in chronic total coronary occlusion revascularization: Final 4-year results from the evaluation of the XIENCE coronary stent, Performance, and Technique in Chronic Total Occlusions (EXPERT CTO) multicenter trial.

BACKGROUND: Limited study has detailed the late-term safety and efficacy of chronic total coronary occlusion (CTO) revascularization among multiple centers applying modern techniques and with newer-generation drug-eluting stents. METHODS: Among 20 centers, 222 patients enrolled in the XIENCE coronary stent, performance, and technique (EXPERT) CTO trial underwent CTO percutaneous coronary intervention (PCI) with everolimus-eluting stents (EES). Through planned 4-year follow-up, the primary composite endpoint of major adverse cardiac events (MACE; death, myocardial infarction [MI] and target lesion revascularization) and rates of individual component endpoints and stent thrombosis were determined. RESULTS: Demographic, lesion, and procedural characteristics included prior bypass surgery, 9.9%; diabetes, 40.1%; lesion length, 36.1 ± 18.5 mm; and stent length, 51.7 ± 27.2 mm. By 4 years, MACE rates were 31.6 and 22.4% by the pre-specified ARC and per-protocol definitions, respectively. Clinically-indicated target lesion revascularization at 4 years was 11.3%. In landmark analyses of events beyond the first year of revascularization, the annualized rates of target vessel-related MI and clinically-indicated target lesion revascularization were 0.53 and 1.3%, respectively. Through 4 years, the cumulative definite/probable stent thrombosis rate was 1.7% with no events occurring beyond the initial year of index revascularization. CONCLUSIONS: In a multicenter registration trial representing contemporary technique and EES, these results demonstrate sustained long-term safety and effectiveness of EES in CTO percutaneous revascularization and can be used to inform shared decision making with patients being considered for CTO PCI relative to late safety and vessel patency.

Sex disparities in acute myocardial infarction care and outcomes.

AIM: We investigated sex-based and regional outcomes after contemporary percutaneous coronary intervention (PCI) with the Xience V stent in patients with acute myocardial infarction (AMI). METHODS AND RESULTS: This patient level pooled analysis includes three multi-center, prospective post-market registries performed in the US, Japan, and China. A total of 1,938 patients treated with Xience V stents in the setting of AMI were enrolled. Compared to men, women had higher major adverse cardiac events (MACE) (14.1% vs. 9.8% P < 0.01, RR 1.4, 95% CI 1.1-1.4) and all-cause mortality (10% vs. 6.2% P < 0.01, RR 1.61, 95% CI 1.14-2.27) at one year, without any significant difference in device specific outcomes of target vessel failure (TVF). US patients compared to the patients from China and Japan had increased MACE (female: 18% vs. 7.1%, P = 0.0012, male: 15.7% vs. 4.1%, P < 0.0001). Multivariable analysis demonstrated that major bleeding was the strongest predictor of MACE (OR 10.51, 95%CI 4.01-27.50, P < 0.0001), MI (OR 4.26, 95%CI 1.37-13.29, P = 0.012), and all-cause death (OR 5.3, 95%CI 2.32-12.13, P < 0.0001). CONCLUSION: Women with AMI who underwent PCI with XIENCE DES have higher all-cause mortality at one year in compared to men. Region based outcomes demonstrated increased MACE among US patients compared to the patients from China and Japan. After adjusting for differences in demographics, major bleeding, rather than female sex, predicted the higher observed all-cause mortality.

Efficacy and Safety of the Absorb Everolimus-Eluting Bioresorbable Scaffold for Treatment of Patients With Diabetes Mellitus: Results of the Absorb Diabetic Substudy.

OBJECTIVES: The study sought to evaluate the efficacy and safety of the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) (Abbott Vascular, Abbott Park, Illinois) in patients with diabetes mellitus. BACKGROUND: Randomized, controlled trials have demonstrated comparable clinical outcomes following percutaneous coronary intervention with either Absorb BVS or metallic Xience everolimus-eluting stent. However, these trials lack power required to provide reliable treatment effect estimates in this high-risk population. METHODS: In a pre-specified, powered analysis, patients with diabetes who received ≥1 Absorb were pooled from the ABSORB II, III, and JAPAN randomized trials and from the single arm ABSORB EXTEND registry. The study composite primary endpoint was target lesion failure (TLF) at 1 year following Absorb BVS compared with a performance goal of 12.7%. RESULTS: Among 754 diabetic patients included in analysis (27.3% insulin treated), the 1-year TLF rate was 8.3% (upper 1-sided 95% confidence limit: 10.1%; p = 0.0001 vs. performance goal). Scaffold thrombosis (definite or probable) was observed in 2.3% of patients. Multivariable regression identified older age, insulin treatment, and smaller pre-procedure reference vessel diameter as significant independent predictors of 1-year TLF. CONCLUSIONS: The Absorb diabetic substudy suggests efficacy and safety of the Absorb BVS for treatment of patients with diabetes mellitus.

Efficacy and Safety of the Absorb Everolimus-Eluting Bioresorbable Scaffold for Treatment of Patients With Diabetes Mellitus: Results of the Absorb Diabetic Substudy

OBJECTIVES The study sought to evaluate the efficacy and safety of the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) (Abbott Vascular, Abbott Park, Illinois) in patients with diabetes mellitus.BACKGROUND Randomized, controlled trials have demonstrated comparable clinical outcomes following percutaneous coronary intervention with either Absorb BVS or metallic Xience everolimus-eluting stent. However, these trials lack power required to provide reliable treatment effect estimates in this high-risk population.METHODS In a pre-specified, powered analysis, patients with diabetes who received $1 Absorb were pooled from the ABSORB II, III, and JAPAN randomized trials and from the single arm ABSORB EXTEND registry. The study composite primary endpoint was target lesion failure (TLF) at 1 year following Absorb BVS compared with a performance goal of 12.7%.RESULTS Among 754 diabetic patients included in analysis (27.3% insulin treated), the 1-year TLF rate was8.3% (upper 1-sided 95% confidence limit: 10.1%; p » 0.0001 vs. performance goal). Scaffold thrombosis(definite or probable) was observed in 2.3% of patients. Multivariable regression identified older age, insulin treatment, and smaller pre-procedure reference vessel diameter as significant independent predictors of 1-year TLF.CONCLUSIONS The Absorb diabetic substudy suggests efficacy and safety of the Absorb BVS for treatment of patients with diabetes mellitus.

Clinical outcomes in real-world patients with small vessel disease treated with XIENCE V® everolimus-eluting stents: one year results from the XIENCE V® USA condition of approval post-market study.

OBJECTIVES: The purpose of this study was to evaluate the 1-year clinical outcomes of more complex XIENCE V USA real-world patients with small versus nonsmall vessel lesions. BACKGROUND: Patients with small vessel lesions undergoing coronary stent placement are at higher risk of major adverse cardiac events. Improved safety and efficacy of XIENCE V everolimus eluting stents (EES) have been previously demonstrated in selected low-risk small vessel populations in randomized clinical trials. METHODS: The XIENCE V USA study was a condition of approval, single-arm study in unselected real-world patients. Baseline and 1-year clinical outcomes were compared between XIENCE V USA patients who received a single 2.5 mm stent (small vessel group, N = 838) and patients implanted with a single >2.5 mm stent (non-small vessel group, N = 2,015). Mean reference vessel diameter was 2.55 ± 0.36 and 3.25 ± 0.46 mm in the small and non-small vessel groups, respectively (P < 0.001). RESULTS: Small vessel group had more females, presented with a higher rate of diabetes, and had more complex lesion characteristics. The definite or probable ST rates analyzed using Kaplan-Meier method were low and not significantly different between the groups at 0.37 and 0.40% for the small and nonsmall vessel group (P = 0.88), respectively. The composite rate of cardiac death or MI was comparable at 4.5% for the small and 5.1% for the non-small vessel 1 groups (P = 0.57). The 1-year target lesion revascularization rate was also comparable in the small vessel group (3.8% vs. 3.0%, P = 0.35). CONCLUSIONS: Despite gender difference, higher prevalence of diabetes and more complex lesions in the small vessel groups, the 1-year clinical outcomes were similar in both small and nonsmall vessel groups. These results demonstrate the therapeutic benefit of XIENCE V EES in a real-world all inclusive patient population with small vessel disease.

Clinical outcomes in real-world patients with acute myocardial infarction receiving XIENCE V® everolimus-eluting stents: one-year results from the XIENCE V USA study.

OBJECTIVES: The objective of this analysis was to evaluate the safety and effectiveness of XIENCE V in acute myocardial infarction (AMI). BACKGROUND: The XIENCE V(®) Everolimus-eluting coronary stent was superior to the TAXUS(®) paclitaxel-eluting stent in angiographic and clinical outcomes in the SPIRIT II, III, and IV randomized controlled trials, but patients with AMI were excluded. METHODS: XIENCE V USA is a large, prospective, multicenter, real-world single-arm postmarket surveillance trial. Consecutive patients undergoing PCI with XIENCE V were enrolled. For this analysis, clinical outcomes in 673 patients presenting with AMI (STEMI, n = 125) were as compared to patients without AMI (n = 3528) at 1 year. RESULTS: At 1 year, ARC-defined stent thrombosis (ST) rates were 1.08% in AMI vs. 0.85% in the non-AMI group (P = 0.4987). The late ST (30 days-1 year) rates were 0.31% vs. 0.47% (AMI vs. non-AMI, P = 0.7551). Rates of target lesion revascularization (TLR) were 4.1% vs. 4.6% (P = 0.6104), and rates of target lesion failure (TLF) were 9.1% vs. 8.5%, (P = 0.5964). With the historical WHO definition of MI, 1 year TLF rates were 7.0% vs. 6.7% (P = 0.8001). Improvements in quality of life, angina frequency, angina stability, and physical limitations occurred at 6 months (each P < 0.0001) and were sustained at 1 year in both groups. There were no significant differences in clinical outcomes between STEMI and non-STEMI patients. CONCLUSIONS: At 1 year, AMI patients treated with XIENCE V had low rates of ST, TLR, and TLF, similar to non-AMI patients. Marked improvements in patients' health status in this subgroup were also demonstrated.

Sustained low clinical event rates in real-world patients receiving everolimus-eluting coronary stent system from a large, prospective, condition of approval study: 2-year clinical outcomes from the XIENCE V USA Study.

OBJECTIVES: This 2-year follow-up of the XIENCE V USA study examines both the long-term safety and effectiveness of the everolimus-eluting coronary stent system (EECSS) in real-world patients. BACKGROUND: The safety and effectiveness of EECSS at 1 year in real-world clinical settings have been demonstrated in XIENCE V USA trial with low rates of target lesion revascularization (TLR), cardiac death, myocardial infarction (MI), and stent thrombosis (ST). Data on whether efficacy is maintained after 1 year and the event rate of very late stent thrombosis (VLST) between 1 and 2 years have not yet been reported. METHODS: XIENCE V USA is a prospective, multicenter, single-arm, FDA required condition of approval study designed to examine the safety and effectiveness of EECSS in an all-inclusive, consecutively enrolled population from real-world clinical settings. Clinical end-point events, including ST, cardiac death, MI, and revascularization were adjudicated by an independent Clinical Events Committee. RESULTS: Four thousand eight hundred and seventy-three (96.4%) out of 5,054 participants (1,875 standard-risk; 3,059 extended-risk) reached 2-year follow-up. The 2-year rate of Academic Research Consortium (ARC)-defined definite and probable ST was 0.96% (95% CI 0.70-1.28) in the overall population and 0.34% (95% CI 0.12-0.74) and 1.33% (95% CI 0.95-1.81) in the standard-risk and extended-risk cohorts, respectively. The rate of VLST was 0.06% in the overall population, 0.0% in the standard-risk, and 0.10% in the extended-risk cohorts. The 2-year composite rate of cardiac death and ARC-defined MI was 8.9% (95% CI 8.08-9.70) in the overall population and 5.6% (95% CI 4.61-6.78) and 10.8% (95% CI 9.71-11.94) in the standard-risk and extended-risk cohorts, respectively. CONCLUSION: Low event rates observed at 1 year were maintained through 2 years. Despite the increased number of patients who discontinued dual antiplatelet therapy by 2 years, the ST rate remained consistently low, and <1% at 2 years due to low VLST occurrence. These results demonstrate continued safety and effectiveness of the XIENCE V everolimus-eluting stent in a highly complex, real-world patient population through 2 years.