Current guidelines recommend dual antiplatelet therapy (DAPT) of aspirin plus a P2Y12 inhibitor for at least 12 months after implantation of drug-eluting stents (DES) in patients with acute coronary ...syndrome. However, available data about the optimal duration of DAPT in patients with acute coronary syndrome undergoing percutaneous coronary intervention are scant. We aimed to investigate whether a 6-month duration of DAPT would be non-inferior to the conventional 12-month or longer duration of DAPT in this population.
We did a randomised, open-label, non-inferiority trial at 31 centres in South Korea. Patients were eligible if they had unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction, and underwent percutaneous coronary intervention. Enrolled patients were randomly assigned, via a web-based system by computer-generated block randomisation, to either the 6-month DAPT group or to the 12-month or longer DAPT group, with stratification by site, clinical presentation, and diabetes. Assessors were masked to treatment allocation. The primary endpoint was a composite of all-cause death, myocardial infarction, or stroke at 18 months after the index procedure in the intention-to-treat population. Secondary endpoints were the individual components of the primary endpoint; definite or probable stent thrombosis as defined by the Academic Research Consortium; and Bleeding Academic Research Consortium (BARC) type 2–5 bleeding at 18 months after the index procedure. The primary endpoint was also analysed per protocol. This trial is registered with ClinicalTrials.gov, number NCT01701453.
Between Sept 5, 2012, and Dec 31, 2015, we randomly assigned 2712 patients; 1357 to the 6-month DAPT group and 1355 to the 12-month or longer DAPT group. Clopidogrel was used as a P2Y12 inhibitor for DAPT in 1082 (79·7%) patients in the 6-month DAPT group and in 1109 (81·8%) patients in the 12-month or longer DAPT group. The primary endpoint occurred in 63 patients in the 6-month DAPT group and in 56 patients in the 12-month or longer DAPT group (cumulative event rate 4·7% vs 4·2%; absolute risk difference 0·5%; upper limit of one-sided 95% CI 1·8%; pnon-inferiority=0·03 with a predefined non-inferiority margin of 2·0%). Although all-cause mortality did not differ significantly between the 6-month DAPT group and the 12-month or longer DAPT group (35 2·6% patients vs 39 2·9%; hazard ratio HR 0·90 95% CI 0·57–1·42; p=0·90) and neither did stroke (11 0·8% patients vs 12 0·9%; 0·92 0·41–2·08; p=0·84), myocardial infarction occurred more frequently in the 6-month DAPT group than in the 12-month or longer DAPT group (24 1·8% patients vs ten 0·8%; 2·41 1·15–5·05; p=0·02). 15 (1·1%) patients had stent thrombosis in the 6-month DAPT group compared with ten (0·7%) in the 12-month or longer DAPT group (HR 1·50 95% CI 0·68–3·35; p=0·32). The rate of BARC type 2–5 bleeding was 2·7% (35 patients) in the 6-month DAPT group and 3·9% (51 patients) in the 12-month or longer DAPT group (HR 0·69 95% CI 0·45–1·05; p=0·09). Results from the per-protocol analysis were similar to those from the intention-to-treat analysis.
The increased risk of myocardial infarction with 6-month DAPT and the wide non-inferiority margin prevent us from concluding that short-term DAPT is safe in patients with acute coronary syndrome undergoing percutaneous coronary intervention with current-generation DES. Prolonged DAPT in patients with acute coronary syndrome without excessive risk of bleeding should remain the standard of care.
Abbott Vascular Korea, Medtronic Vascular Korea, Biosensors Inc, and Dong-A ST.
Use of intravascular ultrasound (IVUS) promotes better clinical outcomes for coronary intervention in complex coronary lesions. However, randomized data demonstrating the clinical usefulness of IVUS ...are limited for lesions treated with drug-eluting stents.
To determine whether the long-term clinical outcomes with IVUS-guided drug-eluting stent implantation are superior to those with angiography-guided implantation in patients with long coronary lesions.
The Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL) randomized, multicenter trial was conducted in 1400 patients with long coronary lesions (implanted stent ≥28 mm in length) between October 2010 and July 2014 at 20 centers in Korea.
Patients were randomly assigned to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation.
Primary outcome measure was the composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 1 year, analyzed by intention-to-treat.
One-year follow-up was complete in 1323 patients (94.5%). Major adverse cardiac events at 1 year occurred in 19 patients (2.9%) undergoing IVUS-guided and in 39 patients (5.8%) undergoing angiography-guided stent implantation (absolute difference, -2.97% 95% CI, -5.14% to -0.79%) (hazard ratio HR, 0.48 95% CI, 0.28 to 0.83, P = .007). The difference was driven by a lower risk of ischemia-driven target lesion revascularization in patients undergoing IVUS-guided (17 2.5%) compared with angiography-guided (33 5.0%) stent implantation (HR, 0.51 95% CI, 0.28 to 0.91, P = .02). Cardiac death and target lesion-related myocardial infarction were not significantly different between the 2 groups. For cardiac death, there were 3 patients (0.4%) in the IVUS-guided group and 5 patients (0.7%) in the angiography-guided group (HR, 0.60 95% CI, 0.14 to 2.52, P = .48). Target lesion-related myocardial infarction occurred in 1 patient (0.1%) in the angiography-guided stent implantation group (P = .32).
Among patients requiring long coronary stent implantation, the use of IVUS-guided everolimus-eluting stent implantation, compared with angiography-guided stent implantation, resulted in a significantly lower rate of the composite of major adverse cardiac events at 1 year. These differences were primarily due to lower risk of target lesion revascularization.
clinicaltrials.gov Identifier: NCT01308281.
Despite their unparalleled theoretical capacity, lithium‐metal anodes suffer from well‐known indiscriminate dendrite growth and parasitic surface reactions. Conductive scaffolds with lithium uptake ...capacity are recently highlighted as promising lithium hosts, and carbon nanotubes (CNTs) are an ideal candidate for this purpose because of their capability of percolating a conductive network. However, CNT networks are prone to rupture easily due to a large tensile stress generated during lithium uptake–release cycles. Herein, CNT networks integrated with a polyrotaxane‐incorporated poly(acrylic acid) (PRPAA) binder via supramolecular interactions are reported, in which the ring‐sliding motion of the polyrotaxanes endows extraordinary stretchability and elasticity to the entire binder network. In comparison to a control sample with inelastic binder (i.e., poly(vinyl alcohol)), the CNT network with PRPAA binder can endure a large stress during repeated lithium uptake–release cycles, thereby enhancing the mechanical integrity of the corresponding electrode over battery cycling. As a result, the PRPAA‐incorporated CNT network exhibits substantially improved cyclability in lithium–copper asymmetric cells and full cells paired with olivine‐LiFePO4, indicating that high elasticity enabled by mechanically interlocked molecules such as polyrotaxanes can be a useful concept in advancing lithium‐metal batteries.
A polyrotaxane‐linked poly(acrylic acid) (PRPAA) binder is incorporated to a carbon nanotube (CNT) network that serves as a lithium‐uptake scaffold in lithium‐metal batteries. The ring‐sliding motion of polyrotaxane endows PRPAA with extraordinary elasticity, which enables the CNT network to endure stress during repeated lithium uptake–release cycles. By utilizing this elastic binder, the CNT network exhibits enhanced cycling stability.
Optimal antiplatelet monotherapy during the chronic maintenance period in patients who undergo coronary stenting is unknown. We aimed to compare head to head the efficacy and safety of aspirin and ...clopidogrel monotherapy in this population.
We did an investigator-initiated, prospective, randomised, open-label, multicentre trial at 37 study sites in South Korea. We enrolled patients aged at least 20 years who maintained dual antiplatelet therapy without clinical events for 6–18 months after percutaneous coronary intervention with drug-eluting stents (DES). We excluded patients with any ischaemic and major bleeding complications. Patients were randomly assigned (1:1) to receive a monotherapy agent of clopidogrel 75 mg once daily or aspirin 100 mg once daily for 24 months. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and Bleeding Academic Research Consortium (BARC) bleeding type 3 or greater, in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02044250.
Between March 26, 2014, and May 29, 2018, we enrolled 5530 patients. 5438 (98·3%) patients were randomly assigned to either the clopidogrel group (2710 49·8%) or to the aspirin group (2728 50·2%). Ascertainment of the primary endpoint was completed in 5338 (98·2%) patients. During 24-month follow-up, the primary outcome occurred in 152 (5·7%) patients in the clopidogrel group and 207 (7·7%) in the aspirin group (hazard ratio 0·73 95% CI 0·59–0·90; p=0·0035).
Clopidogrel monotherapy, compared with aspirin monotherapy during the chronic maintenance period after percutaneous coronary intervention with DES significantly reduced the risk of the composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and BARC bleeding type 3 or greater. In patients requiring indefinite antiplatelet monotherapy after percutaneous coronary intervention, clopidogrel monotherapy was superior to aspirin monotherapy in preventing future adverse clinical events.
ChongKunDang, SamJin, HanMi, DaeWoong, and the South Korea Ministry of Health and Welfare.
Objectives/Hypothesis
There may be an interobserver variation in the diagnosis of laryngeal disease based on laryngoscopic images according to clinical experience. Therefore, this study is aimed to ...perform computer‐assisted diagnosis for common laryngeal diseases using deep learning‐based disease classification models.
Study Design
Experimental study with retrospective data
Methods
A total of 4106 images (cysts, nodules, polyps, leukoplakia, papillomas, Reinke's edema, granulomas, palsies, and normal cases) were analyzed. After equal distribution of diseases into ninefolds, stratified eightfold cross‐validation was performed for training, validation process and remaining onefold was used as a test dataset. A trained model was applied to test sets, and model performance was assessed for precision (positive predictive value), recall (sensitivity), accuracy, F1 score, precision–recall (PR) curve, and PR‐area under the receiver operating characteristic curve (PR‐AUC). Outcomes were compared to those of visual assessments by four trainees.
Results
The trained deep neural networks (DNNs) outperformed trainees' visual assessments in discriminating cysts, granulomas, nodules, normal cases, palsies, papillomas, and polyps according to the PR‐AUC and F1 score. The lowest F1 score and PR‐AUC of DNNs were estimated for Reinke's edema (0.720, 0.800) and nodules (0.730, 0.780) but were comparable to the mean of the two trainees' F1 score with the best performances (0.765 and 0.675, respectively). In discriminating papillomas, the F1 score was much higher for DNNs (0.870) than for trainees (0.685). Overall, DNNs outperformed all trainees (micro‐average PR‐AUC = 0.95; macro‐average PR‐AUC = 0.91).
Conclusions
DNN technology could be applied to laryngoscopy to supplement clinical assessment of examiners by providing additional diagnostic clues and having a role as a reference of diagnosis.
Level of Evidence
3 Laryngoscope, 131:2558–2566, 2021
The electrochemical properties of yolk–shell‐structured, multi‐component, transition‐metal oxides have not yet been properly compared to those of hollow‐structured or nanoscale powders. In this ...study, yolk–shell, hollow, and single‐crystalline ZnCo2O4 powders with uniform compositions are prepared by using simple gas‐phase reaction methods. Double‐shelled ZnCo2O4 yolk–shell powder is prepared directly from the spray solution by using spray pyrolysis. Single‐crystalline ZnCo2O4 nanopowder is prepared by means of flame spray pyrolysis. The yolk–shell ZnCo2O4 powder shows higher charge and discharge capacities than the hollow and single‐crystalline powders. The yolk–shell, hollow, and single‐crystalline ZnCo2O4 powders deliver discharge capacities of 753, 586, and 206 mAh g−1, respectively, after 200 cycles at a charge/discharge rate of 3 A g−1, and the corresponding capacity retentions measured after the first cycle are 99, 74, and 27 %, respectively. The yolk–shell ZnCo2O4 powders are structurally stable during cycling and have good electrochemical properties even at high current densities.
Heroes in a double shell: Double‐shelled ZnCo2O4 yolk–shell powder with a complex composition is prepared directly from the sucrose‐containing spray solution by using spray pyrolysis within a short residence time. The yolk–shell ZnCo2O4 powder displayed better cycling and rate performances than those of the hollow and single‐crystalline powders, and have good electrochemical properties even at high current densities.
A novel anode material for sodium‐ion batteries consisting of 3D graphene microspheres divided into several tens of uniform nanospheres coated with few‐layered MoS2 by a one‐pot spray pyrolysis ...process is prepared. The first discharge/charge capacities of the composite microspheres are 797 and 573 mA h g−1 at a current density of 0.2 A g−1. The 600th discharge capacity of the composite microspheres at a current density of 1.5 A g−1 is 322 mA h g−1. The Coulombic efficiency during the 600 cycles is as high as 99.98%. The outstanding Na ion storage properties of the 3D MoS2–graphene composite microspheres may be attributed to the reduced stacking of the MoS2 layers and to the 3D structure of the porous graphene microspheres. The reduced stacking of the MoS2 layers relaxes the strain and lowers the barrier for Na+ insertion. The empty nanospheres of the graphene offer voids for volume expansion and pathways for fast electron transfer during repeated cycling.
3D MoS2–graphene composite microspheres consisting of multiple nanospheres are prepared by a one‐pot spray pyrolysis process with high scale‐up potential. The 3D MoS2–graphene composite microspheres show high reversible capacity and long cycle stability as anode materials for sodium‐ion batteries. The facile and continuous synthesis of 3D graphene‐based composite microspheres could be applied to the potential materials for various fields including energy storage.
Adjuvant chemotherapy after surgery improves survival of patients with stage II–III, resectable gastric cancer. However, the overall survival benefit observed after adjuvant chemotherapy is moderate, ...suggesting that not all patients with resectable gastric cancer treated with adjuvant chemotherapy benefit from it. We aimed to develop and validate a predictive test for adjuvant chemotherapy response in patients with resectable, stage II–III gastric cancer.
In this multi-cohort, retrospective study, we developed through a multi-step strategy a predictive test consisting of two rule-based classifier algorithms with predictive value for adjuvant chemotherapy response and prognosis. Exploratory bioinformatics analyses identified biologically relevant candidate genes in gastric cancer transcriptome datasets. In the discovery analysis, a four-gene, real-time RT-PCR assay was developed and analytically validated in formalin-fixed, paraffin-embedded (FFPE) tumour tissues from an internal cohort of 307 patients with stage II–III gastric cancer treated at the Yonsei Cancer Center with D2 gastrectomy plus adjuvant fluorouracil-based chemotherapy (n=193) or surgery alone (n=114). The same internal cohort was used to evaluate the prognostic and chemotherapy response predictive value of the single patient classifier genes using associations with 5-year overall survival. The results were validated with a subset (n=625) of FFPE tumour samples from an independent cohort of patients treated in the CLASSIC trial (NCT00411229), who received D2 gastrectomy plus capecitabine and oxaliplatin chemotherapy (n=323) or surgery alone (n=302). The primary endpoint was 5-year overall survival.
We identified four classifier genes related to relevant gastric cancer features (GZMB, WARS, SFRP4, and CDX1) that formed the single patient classifier assay. In the validation cohort, the prognostic single patient classifier (based on the expression of GZMB, WARS, and SFRP4) identified 79 (13%) of 625 patients as low risk, 296 (47%) as intermediate risk, and 250 (40%) as high risk, and 5-year overall survival for these groups was 83·2% (95% CI 75·2–92·0), 74·8% (69·9–80·1), and 66·0% (60·1–72·4), respectively (p=0·012). The predictive single patient classifier (based on the expression of GZMB, WARS, and CDX1) assigned 281 (45%) of 625 patients in the validation cohort to the chemotherapy-benefit group and 344 (55%) to the no-benefit group. In the predicted chemotherapy-benefit group, 5-year overall survival was significantly improved in those patients who had received adjuvant chemotherapy after surgery compared with those who received surgery only (80% 95% CI 73·5–87·1 vs 64·5% 56·8–73·3; univariate hazard ratio 0·47 95% CI 0·30–0·75, p=0·0015), whereas no such improvement in 5-year overall survival was observed in the no-benefit group (72·9% 66·5–79·9 in patients who received chemotherapy plus surgery vs 72·5% 65·8–79·9 in patients who only had surgery; 0·93 0·62–1·38, p=0·71). The predictive single patient classifier groups (chemotherapy benefit vs no-benefit) could predict adjuvant chemotherapy benefit in terms of 5-year overall survival in the validation cohort (pinteraction=0·036 in univariate analysis). Similar results were obtained in the internal evaluation cohort.
The single patient classifiers validated in this study provide clinically important prognostic information independent of standard risk-stratification methods and predicted chemotherapy response after surgery in two independent cohorts of patients with resectable, stage II–III gastric cancer. The single patient classifiers could complement TNM staging to optimise decision making in patients with resectable gastric cancer who are eligible for adjuvant chemotherapy after surgery. Further validation of these results in prospective studies is warranted.
Ministry of ICT and Future Planning; Ministry of Trade, Industry, and Energy; and Ministry of Health and Welfare.
Herein, state-of-the-art research advances in South Korea regarding the development of chemical sensing materials and fully integrated Internet of Things (IoT) sensing platforms were comprehensively ...reviewed for verifying the applicability of such sensing systems in point-of-care testing (POCT). Various organic/inorganic nanomaterials were synthesized and characterized to understand their fundamental chemical sensing mechanisms upon exposure to target analytes. Moreover, the applicability of nanomaterials integrated with IoT-based signal transducers for the real-time and on-site analysis of chemical species was verified. In this review, we focused on the development of noble nanostructures and signal transduction techniques for use in IoT sensing platforms, and based on their applications, such systems were classified into gas sensors, ion sensors, and biosensors. A future perspective for the development of chemical sensors was discussed for application to next-generation POCT systems that facilitate rapid and multiplexed screening of various analytes.
Objectives/Hypothesis
Poor nutritional status in patients with head and neck squamous cell carcinoma (HNSCC) is associated with tumor progression and survival. This study examined the prognostic ...value of nutritional and hematological markers in patients with HNSCC who received definitive treatments.
Study Design
A prospective observational cohort study.
Methods
This study included 338 consecutive patients who underwent surgery and/or radiotherapy/chemoradiotherapy for treatment‐naïve HNSCC. Body weight and nutritional and hematological parameters were regularly measured before and after treatment. Univariate and multivariate analyses using Cox proportional hazards models were performed to identify factors associated with disease‐free survival (DFS), cancer‐specific survival (CSS), and overall survival (OS).
Results
Body weight, serum total protein and albumin levels, and hematological variables significantly decreased after treatment. Univariate analyses illustrated that age, tumor site, T and N classifications, overall stage, pretreatment serum albumin (<3.5 g/dL) and hemoglobin (<12 g/dL) levels, and neutrophil‐lymphocyte ratio were significantly associated with DFS, CSS, and OS (all P < .05). Multivariate analyses identified age, tumor site, N classification, and pretreatment albumin levels as independent predictors of DFS, CSS, and OS (all P < .05). Patients with low serum albumin levels prior to treatment experienced approximately sixfold increases in the risks of tumor progression and cancer‐specific and overall mortality compared to the findings in their counterparts.
Conclusions
Our results suggest that pretreatment serum albumin levels predict DFS, CSS, and OS in patients who received definitive treatment for HNSCC. These findings might help to predict treatment outcome and guide nutritional intervention in patients with HNSCC.
Level of Evidence
2b. Laryngoscope, 127:E437–E442, 2017
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