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Intravascular ultrasound-guided percutaneous coronary intervention has been shown to result in superior clinical outcomes compared with angiography-guided percutaneous coronary intervention. However, insufficient data are available concerning the advantages of intravascular ultrasound guidance for patients with an acute coronary syndrome. This trial aimed to investigate whether the use of intravascular ultrasound guidance, as compared with angiography guidance, improves the outcomes of percutaneous coronary intervention with contemporary drug-eluting stents in patients presenting with an acute coronary syndrome. In this two-stage, multicentre, randomised trial, patients aged 18 years or older and presenting with an acute coronary syndrome at 58 centres in China, Italy, Pakistan, and the UK were randomly assigned to intravascular ultrasound-guided percutaneous coronary intervention or angiography-guided percutaneous coronary intervention. Patients, follow-up health-care providers, and assessors were masked to random assignment; however, staff in the catheterisation laboratory were not. The primary endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularisation at 1 year after randomisation. This trial is registered at ClinicalTrials.gov, NCT03971500, and is completed. Between Aug 20, 2019 and Oct 27, 2022, 3505 patients with an acute coronary syndrome were randomly assigned to intravascular ultrasound-guided percutaneous coronary intervention (n=1753) or angiography-guided percutaneous coronary intervention (n=1752). 1-year follow-up was completed in 3504 (>99·9%) patients. The primary endpoint occurred in 70 patients in the intravascular ultrasound group and 128 patients in the angiography group (Kaplan-Meier rate 4·0% vs 7·3%; hazard ratio 0·55 [95% CI 0·41–0·74]; p=0·0001), driven by reductions in target vessel myocardial infarction or target vessel revascularisation. There were no significant differences in all-cause death or stent thrombosis between groups. Safety endpoints were also similar in the two groups. In patients with an acute coronary syndrome, intravascular ultrasound-guided implantation of contemporary drug-eluting stents resulted in a lower 1-year rate of the composite outcome of cardiac death, target vessel myocardial infarction, or clinically driven revascularisation compared with angiography guidance alone. The Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and Jiangsu Provincial & Nanjing Municipal Clinical Trial Project. For the Mandarin translation of the abstract see Supplementary Materials section.

Following percutaneous coronary intervention with stent placement to treat acute coronary syndromes, international clinical guidelines generally recommend dual antiplatelet therapy with aspirin plus a P2Y12 receptor inhibitor for 12 months to prevent myocardial infarction and stent thrombosis. However, data on single antiplatelet therapy with a potent P2Y12 inhibitor earlier than 12 months after percutaneous coronary intervention for patients with an acute coronary syndrome are scarce. The aim of this trial was to assess whether the use of ticagrelor alone, compared with ticagrelor plus aspirin, could reduce the incidence of clinically relevant bleeding events without an accompanying increase in major adverse cardiovascular or cerebrovascular events (MACCE). In this randomised, placebo-controlled, double-blind clinical trial, patients aged 18 years or older with an acute coronary syndrome who completed the IVUS-ACS study and who had no major ischaemic or bleeding events after 1-month treatment with dual antiplatelet therapy were randomly assigned to receive oral ticagrelor (90 mg twice daily) plus oral aspirin (100 mg once daily) or oral ticagrelor (90 mg twice daily) plus a matching oral placebo, beginning 1 month and ending at 12 months after percutaneous coronary intervention (11 months in total). Recruitment took place at 58 centres in China, Italy, Pakistan, and the UK. Patients were required to remain event-free for 1 month on dual antiplatelet therapy following percutaneous coronary intervention with contemporary drug-eluting stents. Randomisation was done using a web-based system, stratified by acute coronary syndrome type, diabetes, IVUS-ACS randomisation, and site, using dynamic minimisation. The primary superiority endpoint was clinically relevant bleeding (Bleeding Academic Research Consortium [known as BARC] types 2, 3, or 5). The primary non-inferiority endpoint was MACCE (defined as the composite of cardiac death, myocardial infarction, ischaemic stroke, definite stent thrombosis, or clinically driven target vessel revascularisation), with an expected event rate of 6·2% in the ticagrelor plus aspirin group and an absolute non-inferiority margin of 2·5 percentage points between 1 month and 12 months after percutaneous coronary intervention. The two co-primary endpoints were tested sequentially; the primary superiority endpoint had to be met for hypothesis testing of the MACCE outcome to proceed. All principal analyses were assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT03971500, and is completed. Between Sept 21, 2019, and Oct 27, 2022, 3400 (97·0%) of the 3505 participants in the IVUS-ACS study were randomly assigned (1700 patients to ticagrelor plus aspirin and 1700 patients to ticagrelor plus placebo). 12-month follow-up was completed by 3399 (>99·9%) patients. Between month 1 and month 12 after percutaneous coronary intervention, clinically relevant bleeding occurred in 35 patients (2·1%) in the ticagrelor plus placebo group and in 78 patients (4·6%) in the ticagrelor plus aspirin group (hazard ratio [HR] 0·45 [95% CI 0·30 to 0·66]; p<0·0001). MACCE occurred in 61 patients (3·6%) in the ticagrelor plus placebo group and in 63 patients (3·7%) in the ticagrelor plus aspirin group (absolute difference –0·1% [95% CI –1·4% to 1·2%]; HR 0·98 [95% CI 0·69 to 1·39]; pnon-inferiority<0·0001, psuperiority=0·89). In patients with an acute coronary syndrome who had percutaneous coronary intervention with contemporary drug-eluting stents and remained event-free for 1 month on dual antiplatelet therapy, treatment with ticagrelor alone between month 1 and month 12 after the intervention resulted in a lower rate of clinically relevant bleeding and a similar rate of MACCE compared with ticagrelor plus aspirin. Along with the results from previous studies, these findings show that most patients in this population can benefit from superior clinical outcomes with aspirin discontinuation and maintenance on ticagrelor monotherapy after 1 month of dual antiplatelet therapy. The Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and the Jiangsu Provincial & Nanjing Municipal Clinical Trial Project. For the Mandarin translation of the abstract see Supplementary Materials section.

Background The PREVENT randomized control trial monitored progression to chronic breast cancer-related lymphedema (cBCRL) following intervention for subclinical breast cancer-related lymphedema (sBCRL) assessed by bioimpedance spectroscopy (BIS) versus tape-measure (TM). This multi-institutional trial demonstrated a 92% risk reduction of developing cBCRL. This secondary analysis reviews the timing of sBCRL and cBCRL following breast cancer (BC) treatment. Patients and Methods Women at risk of cBCRL ( n = 919) were screened regularly up to 36 months after BC treatment using either BIS or TM. Following diagnosis of sBCRL, patients underwent a 4-week compression sleeve intervention. The time in months from BC treatment to detection was reviewed at 3-month intervals. Results In total 209 patients developed sBCRL (BIS: n = 89, TM: n = 120) and were eligible for intervention. 30 progressed to cBCRL postintervention (BIS: 7, TM: 23). More than half of patients had measurements consistent with sBCRL within 9 months of BC treatment. Patients continued to have initial detections of sBCRL, regardless of screening method, with rates remaining consistent in years two and three ( p > 0.242) post surgery. Additionally, 39 patients progressed to cBCRL without developing sBCRL or receiving intervention across the 3-year period. Conclusions The timing of sBCRL detection demonstrates that patients continue to be at risk years after treatment and may continue to progress to cBCRL years after surgery. Early detection of sBCRL allows for early intervention decreasing the likelihood of progression to cBCRL. Patients should continue to be monitored for a minimum of 3 years following completion of cancer treatment. Specifically, careful targeted monitoring over the initial 9-month period is important.

This study was conducted to examine the effectiveness of a virtual reality communication simulation (VRCS) in teaching communication skills in fundamentals of nursing practicum. Effective communication skills are an integral part of the nursing profession and the foundation of high-quality nursing care. Effective communication not only addresses the needs of patients but is also necessary for maintaining patient safety. Many studies have reported the inadequacy of nursing students in communicating with patients. Nursing students often experience stress due to their lack of adequate skills to communicate effectively with patients and their family members. A pragmatic randomized controlled trial research with four within-subjects assessments (at the baseline (T0), 1st week (T1) and 3rd week (T2) of the clinical practice and 1 week after the end of the clinical practice (T3)) and between-subjects assessments. Eighty-four nursing students at a university of Science and Technology in central Taiwan. The students were randomly assigned to an experimental group (n = 42) and a control group (n = 42). The experimental group received a VRCS, whereas the control group received the nurse-patient communication teaching video. The data were collected from April 2022 to August 2022. The Kalamazoo Essential Element Communication Checklist, Communication Self-Assessment Scale, Learning Satisfaction Questionnaire and Stress Scale for Nursing Students in Clinical Practice were used for data collection. At baseline, the control group had higher scores on communication ability and confidence compared with the experimental group (t = -3.91, p <.001; and t = -2.35, p =.021). In the first week of clinical practice, the experimental group had significantly higher mean scores for communication ability compared with the control group (β = 15.99, 95 % confidence interval [CI] 13.79, 18.18) and communication confidence and learning satisfaction compared with controls at T1, T2 and T3 of the clinical practice (all, p <.001). The clinical practice stress scores of the experimental group were significantly lower than those of the control group at T1, T2 and T3 of the clinical practice (all, p <.05). The newly developed VRCS is acceptable and worthwhile for training nursing students to develop communication abilities. This study suggests that VRCS practice should be arranged as early as possible in fundamentals of nursing practice courses and before the fundamentals of nursing practicum so as to facilitate the learning of effective communication. Follow-up research is needed to evaluate the long-term effects of virtual reality education in nursing practice.

Objective To construct a prediction model based on peritumoral radiomics signatures from CT images and investigate its efficiency in predicting early recurrence (ER) of hepatocellular carcinoma (HCC) after curative treatment. Materials and methods In total, 156 patients with primary HCC were randomly divided into the training cohort (109 patients) and the validation cohort (47 patients). From the pretreatment CT images, we extracted 3-phase two-dimensional images from the largest cross-sectional area of the tumor. A region of interest (ROI) was manually delineated around the lesion for tumoral radiomics (T-RO) feature extraction, and another ROI was outlined with an additional 2 cm peritumoral area for peritumoral radiomics (PT-RO) feature extraction. The least absolute shrinkage and selection operator (LASSO) logistic regression model was applied for feature selection and model construction. The T-RO and PT-RO models were constructed. In the validation cohort, the prediction efficiencies of the two models and peritumoral enhancement (PT-E) were evaluated qualitatively by receiver operating characteristic (ROC) curves, calibration curves and decision curves and quantitatively by area under the curve (AUC), the category-free net reclassification index (cfNRI) and integrated discrimination improvement values (IDI). Results By comparing AUC values, the prediction accuracy in the validation cohort was good for the PT-RO model (0.80 vs. 0.79, P  = 0.47) but poor for the T-RO model (0.82 vs. 0.62, P  < 0.01), which was significantly overfitted. In the validation cohort, the ROC curves, calibration curves and decision curves indicated that the PT-RO model had better calibration efficiency and provided greater clinical benefits. CfNRI indicated that the PT-RO model correctly reclassified 47% of ER patients and 32% of non-ER patients compared to the T-RO model (P < 0.01); additionally, the PT-RO model correctly reclassified 24% of ER patients and 41% of non-ER patients compared to PT-E ( P  = 0.02). IDI indicated that the PT-RO model could improve prediction accuracy by 0.22 (P < 0.01) compared to the T-RO model and by 0.20 ( P  = 0.01) compared to PT-E. Conclusion The CT-based PT-RO model can effectively predict the ER of HCC and is more efficient than the T-RO model and the conventional imaging feature PT-E.

Exercise-induced muscle damage (EIMD) is characterized by a reduction in functional performance, disruption of muscle structure, production of reactive oxygen species, and inflammatory reactions. Ginseng, along with its major bioactive component ginsenosides, has been widely employed in traditional Chinese medicine. The protective potential of American ginseng (AG) for eccentric EIMD remains unclear. Twelve physically active males (age: 22.4 ± 1.7 years; height: 175.1 ± 5.7 cm; weight: 70.8 ± 8.0 kg; peak oxygen consumption [V˙O2peak] 54.1 ± 4.3 mL/kg/min) were administrated by AG extract (1.6 g/day) or placebo (P) for 28 days and subsequently challenged by downhill (DH) running (−10% gradient and 60% V˙O2peak). The levels of circulating 8-iso-prostaglandin F 2α (PGF2α), creatine kinase (CK), interleukin (IL)-1β, IL-4, IL-10, and TNF-α, and the graphic pain rating scale (GPRS) were measured before and after supplementation and DH running. The results showed that the increases in plasma CK activity induced by DH running were eliminated by AG supplementation at 48 and 72 h after DH running. The level of plasma 8-iso-PGF2α was attenuated by AG supplementation immediately (p = 0.01 and r = 0.53), 2 h (p = 0.01 and r = 0.53) and 24 h (p = 0.028 and r = 0.45) after DH running compared with that by P supplementation. Moreover, our results showed an attenuation in the plasma IL-4 levels between AG and P supplementation before (p = 0.011 and r = 0.52) and 72 h (p = 0.028 and r = 0.45) following DH running. Our findings suggest that short-term supplementation with AG alleviates eccentric EIMD by decreasing lipid peroxidation and promoting inflammatory adaptation.

Previous studies primarily demonstrated that transfemoral transcatheter aortic valve replacement (TAVR) with self-expanding valve appeared to be a safe and feasible treatment for patients with pure native aortic regurgitation (AR). However, the routine application of transfemoral TAVR for pure AR patients lacks support from randomized trials. SEASON-AR trial is a prospective, multicenter, randomized, controlled, parallel-group, open-label trial, involving at least 20 sites in China, aiming to enroll 210 patients with pure native severe AR and high surgical risk. All enrolled patients are randomly assigned in a 1:1 fashion to undergo transfemoral TAVR with VitaFlowTM valve and receive guideline-directed medical therapy (GDMT) or to receive GDMT alone. The primary endpoint is the rate of major adverse cardiac events (MACE) at 12 months after the procedure, defined by the composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure. The major secondary endpoints encompass various measures, including procedure-related complications, device success, 6-minute walk distance, and the occurrence of each individual component of the primary endpoint. After hospital discharge, follow-up was conducted through clinical visits or telephone contact at 1, 6, and 12 months. The follow-up will continue annually until 5 years after the index procedure to assess the long-term outcomes. SEASON-AR trial is the first study designed to investigate the clinical efficacy and safety of transfemoral TAVR with a self-expanding valve in patients with pure native severe AR with inoperable or high-risk, as compared to medical treatment only.

•Compared to DP-EES, PCI of CTOs with BP-SES showed noninferiority in terms of late lumen loss at 12-month follow-up.•Despite the nonsignificantly higher J-CTO score was observed in the DP-EES group, it showed no statistical association between J-CTO score and angiographic endpoints except for MLD. Our objective was to compare the efficacy and safety of a drug-eluting stent featuring an abluminal bioabsorbable sirolimus-containing polymer coating (BP-SES) with an everolimus-eluting stent with a durable polymer (DP-EES) in patients undergoing percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs). TARGET CTO is a multicenter, open-label, noninferiority trial that randomized patients to either BP-SES or DP-EES in a 1:1 fashion following successful CTO re-canalization. The primary endpoint that was powered for noninferiority assessment is in-stent late lumen loss (LLL) at 12 months. A total of 206 subjects underwent randomization, with 103 assigned to the BP-SES group and 103 to the DP-EES group. Baseline clinical and angiographic characteristics were comparable. The primary endpoint demonstrated noninferiority for the BP-SES group compared to the DP-EES group (0.21 ± 0.43 mm vs 0.21 ± 0.33 mm; P = .934, 2-sided; difference 0.01mm [BP-SES minus DP-EES]; 95% CI: -0.13 to 0.12 mm; p noninferiority < .001,1-sided). No significant differences were observed in secondary angiographic or clinical endpoints. The rates of 12-month in-stent and in-segment binary restenosis in the BP-SES group and the DP-EES group were similar (6.8% vs 7.5%, P = .86; and 8.1% vs 8.8%; P = .89, respectively). Although there was a trend favoring the BP-SES group, the difference between the BP-SES group and DP-EES group at 12 months in target lesion failure (2.1% vs 8.0%, P = .054) and target lesion revascularization (2.1% vs 7.1%, P = .089) did not reach statistical significance. No definite or probable stent thromboses were reported in either group. Compared to DP-EES, PCI of CTOs with BP-SES showed similar results in terms of late loss and binary restenosis at the 12-month follow-up. ClinictalTrial.gov, number NCT03040934

Intravascular imaging (IVI)- guided percutaneous coronary intervention (PCI) can improve clinical outcomes compared with angiography guidance in patients with complex lesions or acute coronary syndrome. However, the impact of this approach among diabetic patients remains unknown. IVI-DIABETES trial is an investigator-initiated, prospective, international, multicenter, randomized trial, involving at least 30 sites, aiming to enroll 1,332 diabetic patients with obstructive coronary artery disease undergoing PCI. All enrolled patients are randomly assigned in a 1:1 fashion to undergo IVI- guided PCI or angiography- guided PCI. The choice between intravascular ultrasound or optical coherence tomography is at the discretion of the operator. The primary endpoint is target vessel failure (TVF) at 12 months, defined by the composite of cardiac death, target vessel myocardial infarction (MI), or clinically-driven target vessel revascularization. The major secondary endpoint is TVF without procedure-related MI. After hospital discharge, follow-up is conducted through clinical visits or telephone contact at 1, 6, and 12 months. The follow-up will continue annually until 5 years after the index procedure to assess the long-term outcomes. IVI-DIABETES trial is the first study designed to investigate the clinical efficacy and safety of IVI-guided PCI in diabetic patients compared to angiography-guided PCI. clinicaltrials.gov, NCT06380868.