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Rehabilitation effects of game therapy in people living with dementia: A systematic review and meta‐analysis

Abstract

Background

As a devastating neurodegenerative disease, Alzheimer's disease (AD) imposes a considerable direct and indirect financial burden. However, effective drug treatment options are limited. In recent years, game therapy has become a research hotspot in this field.

Aims

The purpose of this study was to synthesize the conclusions of existing studies and integrate the data to evaluate the effects of game therapy on people living with dementia (PLWD).

Methods

We included randomized clinical trials and quasi-experimental studies which assessed the impacts of game therapy on PLWD and took cognitive function, quality of life, and depression as outcome indicators. Two trained researchers independently screened the studies, evaluated the quality, and extracted the data. Statistical analysis was performed by Review Manager (Revman) 5.3 and STATA16.0 software.

Results

There were 12 studies involving 877 PLWD included, total. The results of the meta-analysis demonstrated that the Mini-Mental State Examination (MMSE) scores of the test group were significantly higher than that of the control group (SMD = 2.69, 95% CI [1.88, 3.51], p < .01), and the Cornell Scale for Depression in Dementia scores of the test group were significantly lower than those of the control group (SMD = −4.28, 95% CI [−6.96, −1.60], p < .01); but in terms of quality of life (SMD = 0.17, 95% CI [−0.82, 1.16], p = .74), the difference was not statistically significant.

Linking Evidence to Action

Game therapy can improve cognitive function and depression in PLWD. The combination of different types of games can improve the different clinical symptoms of PLWD, and different intervention time also have different effects on the outcome, which shows that we can develop unique, systematic, safe, and scientific game intervention programs for PLWD to improve their cognitive function and depression.

The application of infrared thermography technology in flap: A perspective from bibliometric and visual analysis

Abstract

The application of infrared thermography technology (IRT) in flap has become a major focus of research, as it provides a non-invasive, real-time, and quantitative approach for monitoring flap perfusion. In this regard, we conducted a comprehensive visualization and scientometric analysis to systematically summarize and discuss the current state of research in this field. We systematically reviewed publications on the application of IRT in flap procedures from 1999 to 2022, using the Web of Science Core Collection (WoSCC). Through scientometric analysis, we examined annual trends, affiliations, countries, journals, authors, and their relationships, providing insights into current hotspots and future developments in this area. We analysed 522 English studies and found a steady increase in annual publications. The United States and Germany had the highest publication rates, with Beth Israel Deaconess Medical Center and Shanghai Jiaotong University being leading institutions. Notably, Lee BT and Alex Keller emerged as influential authors in this field. Compared to existing techniques, infrared-based technology offers significant advantages for non-invasive monitoring of flap perfusion, including simplicity of operation and objective results. Future trends should focus on interdisciplinary collaborations to develop new infrared devices and achieve intelligent image processing, enabling broader application in various clinical scenarios. This bibliometric study summarizes the progress and landscape of research on ‘the Application of infrared thermography technology in flap’ over the past two decades, providing valuable insights and serving as a reliable reference to drive further advancements and spark researchers' interest in this field.

Prevalence and associated factors of chemotherapy‐related cognitive impairment in older breast cancer survivors

Abstract

Aims

To examine the prevalence and associated factors of chemotherapy-related cognitive impairment (CRCI) in older breast cancer survivors (BCS).

Design

Systematic review.

Data Sources

We searched EMBASE, PubMed, PsychInfo, CINAHL, Cochrance Library, Web of Science, CNKI and SinoMed, without language restrictions, for studies published from the establishment of the database to September 2022.

Review Methods

Two researchers independently examined the full texts, data extraction and quality assessment, and any discrepancies were resolved through discussion with a third reviewer. Quality of evidence was assessed using the Newcastle-Ottawa Scale and the Agency for Healthcare Research and Quality Scale.

Results

The seven included studies showed that the estimated prevalence of CRCI in older BCS ranged from 18.6% to 27% on objective neuropsychological tests and from 7.6% to 49% on subjective cognitive assessments. The areas most affected were attention, memory, executive functioning and processing speed. CRCI was associated with 10 factors in six categories, including sociodemographic (e.g. age, education level), physiological (e.g. sleep disorders, fatigue and comorbidities), psychological (e.g. anxiety, depression), treatment modalities (e.g. chemotherapy cycles, chemotherapy regimens), genetic (e.g. APOE2, APOE4) and lifestyle factor (e.g. physical inactivity).

Conclusion

CRCI is multifactorial and has a relatively high prevalence. However, the results of subjective and objective cognitive examinations were inconsistent, possibly due to variations in tools used to evaluate different definitions of CRCI. Nevertheless, as there are few published studies of older BCS, this conclusion still require verification by well-designed studies in the future.

Impact

We found that the prevalence of CRCI in older adults is relatively high and multifactorial, providing evidence for further health care for this population.

No Patient or Public Contribution

There was no patient or public involvement.

A bibliometric study: Relevant studies on scar laser therapy since the 21st century

Abstract

To summarise research studies on scar laser therapy since the 21st century using bibliometric methods, and to speculate on the possible development in the future. The literature about scar laser therapy in Web of Science database was searched. CiteSpace and VOSviewer were used to analyse main countries, institutions, journals,subject hotspots and trends, etc. A total of 884 papers have been published since the 21st century. These publications were written by 653 authors from 515 institutions in 58 countries. The United States published 287 papers in this field and ranks first. Laser in Surgery and Medicine is the most widely published journal, with Shumaker as the core author. The main keyword clustering includes terms such as combination therapy, wound healing, fractional photothermolysis, experience, scar formation, etc. CiteSpace and VOSviewer were used to sort out and summarise the countries, institutions, authors, journals, research hotspots and frontier topics of related literature about scar laser therapy since the 21st century. The current situation of its application and basic scientific research in clinical treatments were summarised briefly. This provides a new idea for the development and research of scar laser therapy in the future.

Comparison of the effects of laparoscopic and open hysterectomy on surgical site wound infections in patients with endometrial cancer: A meta‐analysis

Abstract

This meta-analysis aimed to compare laparoscopic hysterectomy (LH) and open hysterectomy (OH) in terms of surgical site wound infection, length of hospital stay, and postoperative complications in patients with endometrial cancer (EC). PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, VIP, and Wanfang databases were comprehensively searched for studies on OH and LH for EC published between 2008 and July 2023, in any language. The literature was screened according to the inclusion and exclusion criteria, and the quality of the included case–control studies was assessed using the Newcastle-Ottawa Scale. Data were collated and analysed using Stata 17.0 software. A total of 1245 articles were screened according to the search strategy, and ultimately 15 studies were included in this meta-analysis, with a total of 1606 patients with EC, of which 751 were treated with LH and 855 with OH. The results showed that the rate of postoperative wound infection was significantly higher (OR: 0.290; 95% CI: 0.169–0.496, p < 0.001), the length of hospital stay was significantly longer (SMD: −1.976, 95% CI: −2.669 to −1.283, p < 0.001), and the incidence of postoperative complications was significantly higher (OR: 0.366; 95% CI: 0.280–0.478, p < 0.001) in the OH group than in the LH group. This study showed that LH was superior to OH for the treatment of EC and is associated with a lower rate of wound infection, shorter length of hospitalisation, and a reduced risk of complications. Thus, our findings support the choice of LH over OH for EC.

Impact of type 2 diabetes on surgical site infections and prognosis post orthopaedic surgery: A systematic review and meta‐analysis

Abstract

Background

The escalating prevalence of type 2 diabetes raises concerns about adverse postoperative outcomes like surgical site infections (SSIs) and deep vein thrombosis (DVT) in orthopaedic surgeries. This meta-analysis aims to resolve inconclusive evidence by systematically quantifying the risks in type 2 diabetic patients compared to non-diabetic individuals.

Methods

The meta-analysis was conducted adhering to the PRISMA guidelines and based on the PICO framework. Four primary databases were searched: PubMed, Embase, Web of Science and the Cochrane Library, with no temporal restrictions. Studies included were either prospective or retrospective cohort studies published in English or Chinese, which assessed orthopaedic surgical outcomes among adult type 2 diabetic and non-diabetic patients. The meta-analysis employed the Newcastle–Ottawa Scale for quality assessment and used both fixed-effect and random-effects models for statistical analysis based on the level of heterogeneity.

Results

Out of 951 identified articles, nine studies met the inclusion criteria. The odds ratio (OR) for developing postoperative SSIs among diabetic patients was 1.63 (95% CI: 1.19–2.22), indicating a significantly elevated risk compared to non-diabetic subjects. Conversely, no statistically significant difference in the risk of postoperative DVT was found between the two groups (OR: 0.82; 95% CI: 0.55–1.22). Sensitivity analysis confirmed the stability of these outcomes.

Conclusions

Patients with type 2 diabetes are at a higher risk of developing SSIs post orthopaedic surgery compared to non-diabetic individuals. However, both groups demonstrated comparable risks for developing postoperative DVT.

Quercetin and its derivatives for wound healing in rats/mice: Evidence from animal studies and insight into molecular mechanisms

Abstract

Aimed to clarify the effect of quercetin and its derivatives on wound healing in animal experiments. PubMed, Embase, Science Direct, Web of Science, SinoMed, Vip Journal Integration Platform, China National Knowledge Infrastructure and WanFang databases were searched for animal experiments investigating the effect of quercetin and its derivatives on wound healing to April 2023. The Review Manager 5.4 software was used to conduct meta-analysis. Eighteen studies were enrolled in this article. According to the SYRCLE's RoB tool assessment, these studies exposed relatively low methodological quality. It was shown that animals with cutaneous wound receiving quercetin had faster wound healing in wound closure (%) than the control group. Moreover, the difference in efficacy gradually emerged after third day (WMD = 7.13 [5.52, 8.74]), with a peak reached on the tenth day after wounding (WMD = 19.78 [17.82, 21.74]). Subgroup analysis revealed that quercetin for wound closure (%) was independent of the types of rats and mice, wound area and with or without diabetes. Clear conclusion was also shown regarding the external application of quercetin for wound healing (WMD = 17.77 [11.11, 24.43]). A significant reduction in the distribution of inflammatory cells occurred in the quercetin group. Quercetin could increase blood vessel density (WMD = 1.85 [0.68, −3.02]), fibroblast distribution and collagen fraction. Biochemical indicators, including IL-1β, IL-10, TNF-α, TGF-β, vascular endothelial growth factor (VEGF), hydroxyproline and alpha-smooth muscle actin (α-SMA), had the consistent results. Quercetin and its derivatives could promote the recovery of cutaneous wound in animals, through inhibiting inflammatory response and accelerating angiogenesis, proliferation of fibroblast and collagen deposition.

Prevalence of wound infections and postoperative complications after total elbow arthroplasty for rheumatoid arthritis: A meta‐analysis

Abstract

This study aimed to systematically evaluate the prevalence of surgical site wound infections and postoperative complications after total elbow arthroplasty (TEA) in patients with rheumatoid arthritis (RA) for clinical research and application. Embase, PubMed, Cochrane Library, CNKI, VIP, CBM, and Wanfang databases were electronically searched to collect clinical studies on the application of TEA in the treatment of RA from inception to August 2023. Two independent researchers performed literature screening, data extraction, and quality assessment. A meta-analysis was performed using the R 4.3.1 software. Overall, 26 studies with a total of 2374 patients were included. The results of the meta-analysis revealed that after TEA in patients with RA, the prevalence of surgical site wound infections and postoperative complications was 3.37% (95% confidence interval [CI]: 2.68%–4.13%), and 31.63% (95% CI: 24.97%–38.28%), respectively. The prevalence of surgical site wound infections is low, whereas that of postoperative complications is high; thus, the safety of TEA remains debatable. Owing to limitations on the quality and number of included studies, the findings need to be verified in higher-quality studies.

Comparing the efficacy of chlorhexidine and povidone–iodine in preventing surgical site infections: A systematic review and meta‐analysis

Abstract

Surgical site infections (SSIs) post-surgery impact patient health and raise healthcare costs. This meta-analysis examines the efficacy of antiseptics, chlorhexidine and povidone–iodine, in reducing SSIs, including various types, to settle ongoing debates on their comparative effectiveness. A systematic literature search conforming to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines was executed on four established databases without temporal restrictions. Only randomized controlled trials (RCTs) including patients aged 18 years or older undergoing clean or potentially contaminated surgeries were included. Two independent evaluators carried out study selection, data extraction and quality assessment, adhering to Cochrane Collaboration's risk of bias tool. Statistical analyses were performed using chi-square tests and the I 2 index to evaluate heterogeneity, and meta-analyses were conducted employing either fixed-effects or random-effects models as warranted by the heterogeneity assessments. A total of 16 RCTs were included after rigorous selection from an initial pool of 1742 articles. The studies demonstrated low levels of heterogeneity, supporting the use of a fixed-effects model. Chlorhexidine exhibited statistically lower rates of overall SSIs (RR 0.75; 95% CI 0.64–0.88; p < 0.001), superficial SSIs (RR 0.62; 95% CI 0.47–0.82; p < 0.001) and deep SSIs compared to povidone–iodine. The study furnishes compelling evidence in favour of chlorhexidine as a more efficacious antiseptic agent over povidone–iodine in minimizing the risk of various types of SSIs.

Ultrasound in paediatric surgery: A meta‐analysis review of its influence on postoperative wound healing and infection rates

Abstract

Ultrasound (US) has traditionally been recognised for its imaging capabilities, but its emerging role as a therapeutic modality in postoperative wound management, especially in paediatric care, has garnered significant attention. This meta-analysis aimed to evaluate the influence of US on postoperative wound healing and infection rates in paediatric patients. From an initial pool of 1236 articles, seven were deemed suitable for inclusion. Postoperative wound healing was assessed using the Redness, Edema, Ecchymosis, Discharge, and Approximation (REEDA) scale. Notably, there was a significant difference in wound healing patterns between the US-treated and control groups (I 2 = 94%, standardized mean difference [SMD]: −4.60, 95% confidence intervals [CIs]: −6.32 to −2.88, p < 0.01), as illustrated in Figure 4. Additionally, a marked difference in wound infection rates was observed between the groups (I 2 = 93%, SMD: −5.86, 95% CIs: −9.04 to −2.68, p < 0.01), as portrayed in Figure 5. The findings underscore the potential benefits of US in enhancing postoperative wound healing and reducing infection rates in paediatric surgical settings. However, the application of US should be judicious, considering the nuances of individual patient needs and clinical contexts.

Effect of segmental versus lobectomy in minimally invasive surgery on postoperative wound complications in lung cancer patients: A meta‐analysis

Por: Jin Zhou · Wei Wang

Abstract

It is still a matter of debate whether the surgical segmentectomy and lobectomy of lung cancer are comparable in the incidence of perioperative wound complications. An extensive review of the literature through August 2023 was carried out with a critical review of four databases. Following the acceptance and elimination criteria set out in the trial, as well as a qualitative assessment of the literature, this resulted in a review of related research that compared the results of both lobectomy and partial resection in the management of lung cancer. The analysis of the data was performed with the RevMan 5.3 software, and the 95% confidence interval [CI] and odds ratio [OR] were performed with either stationary or random-effect models. It is concluded that the operation time of lobectomy is shorter than that of sectioning in the treatment of segmentectomy (mean difference [MD], −38.62; 95% CI, −41.96, −35.28; p < 0.0001). But the rate of postoperative wound infection (OR, 0.62; 95% CI, 0.18, 2.15; p = 0.45) and intraoperative blood loss (MD, 17.54; 95% CI, −4.19, 39.26; p = 0.11) were not significantly different for them. Thus, for those who have received a pulmonary carcinoma operation, different operative methods might not have an impact on the incidence of postoperative wound infections. The operative procedure appears to have a major impact on the length of the operation in patients.

Identification and validation of aging-related genes in atrial fibrillation

by Yong Zhou, Chao Sun, Yingxu Ma, Yunyin Huang, Keke Wu, Shengyuan Huang, Qiuzhen Lin, Jiayi Zhu, Zuodong Ning, Ningyuan Liu, Tao Tu, Qiming Liu

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in the clinic. Aging plays an essential role in the occurrence and development of AF. Herein, we aimed to identify the aging-related genes associated with AF using bioinformatics analysis. Transcriptome profiles of AF were obtained from the GEO database. Differential expression analysis was performed to identify AF-specific aging-related genes. GO and KEGG enrichment analyses were performed. Subsequently, the LASSO, SVM-RFE, and MCC algorithms were applied to screen aging-related genes. The mRNA expression of the screened genes was validated in the left atrial samples of aged rapid atrial pacing-induced AF canine models and their counterparts. The ROC curves of them were drawn to evaluate their diagnostic potential. Moreover, CIBERSORT was used to estimate immune infiltration. A correlation analysis between screened aging-related genes and infiltrating immune cells was performed. A total of 24 aging-related genes were identified, which were found to be mainly involved in the FoxO signaling pathway, PI3K-Akt signaling pathway, longevity regulating pathway, and peroxisome according to functional enrichment analysis. LASSO, SVM-RFE, and MCC algorithms identified three genes (HSPA9, SOD2, TXN). Furthermore, the expression levels of HSPA9 and SOD2 were validated in aged rapid atrial pacing-induced AF canine models. HSPA9 and SOD2 could be potential diagnostic biomarkers for AF, as evidenced by the ROC curves. Immune infiltration and correlation analysis revealed that HSPA9 and SOD2 were related to immune cell infiltrates. Collectively, these findings provide novel insights into the potential aging-related genes associated with AF. HSPA9 and SOD2 may play a significant role in the occurrence and development of AF.

Interventions to treat patients with blood blister-like aneurysms of the internal carotid artery: a protocol for a network meta-analysis

Por: Li · Y. · Yang · X. · Zhou · H. · Li · H. · Zheng · J. · Li · L. · Hui · X.
Introduction

Blood blister-like aneurysm (BBA) is a special type of intracranial aneurysm with relatively low morbidity and high mortality. Various microsurgical techniques and endovascular approaches have been reported, but the optimal management remains controversial. For a better understanding of the treatment of BBA patients, a network meta-analysis that comprehensively compares the effects of different therapies is necessary.

Methods and analysis

This protocol has been reported following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Related studies in the following databases will be searched until November 2022: PubMed, Embase, Scopus, Web of Science, Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP and Wanfang. Randomised controlled trials (RCTs) and non-randomised studies comparing at least two different interventions in BBA patients will be included. Quality assessment will be conducted using Cochrane Collaboration’s tool or Newcastle-Ottawa Scale based on their study designs. The primary outcome is the composite of the incidences of intraoperative bleeding, postoperative bleeding and postoperative recurrence. The secondary outcome is an unfavourable functional outcome. Pairwise and network meta-analyses will be conducted using STATA V.14 (StataCorp, College Station, Texas, USA). Mean ranks and the surface under the cumulative ranking curve will be used to evaluate every intervention. Statistical inconsistency assessment, subgroup analysis, sensitivity analysis and publication bias assessment will be performed.

Ethics and dissemination

Ethics approval is not necessary because this study will be based on publications. The results of this study will be published in a peer-reviewed journal.

PROSPERO registration number

CRD42022383699.

Improving post‐acute stroke follow‐up care by adopting telecare consultations in a nurse‐led clinic: Study protocol of a hybrid implementation‐effectiveness trial

Abstract

Aim

To evaluate the clinical effectiveness and implementation strategies of telecare consultations in post-stroke nurse-led clinics.

Background

Telecare consultations could be an alternative to conventional in-person consultations and improve continuity of care for stroke survivors following their discharge from hospital. Previous studies utilizing telecare consultations only focused on testing their clinical effectiveness on stroke survivors; the appropriateness and feasibility of adopting this new delivery modality in a real-world setting were not examined.

Design

A Type II hybrid effectiveness-implementation design will be adopted.

Methods

Eligible stroke survivor participants will be randomly assigned to the intervention group (telecare consultation) or control group (usual in-person clinic consultation). Both groups will receive the same nursing intervention but delivered through different channels. The Reach, Effectiveness, Adoption, Implementation, Maintenance framework will be used to evaluate the clinical effectiveness and implementation outcomes. The primary outcome is the non-inferiority of the degree of disability between the two groups at 3 months into the intervention and at 3 months post-intervention. The paper complies with the SPIRIT guidelines for study protocols adapted for designing and reporting parallel group randomized trials.

Conclusion

The findings of this study will provide key insights into the processes for implementing and adopting telecare consultations into long-term services for post-stroke patients.

Impact

This study contributes to the translation of telecare consultations for stroke survivors into real-life settings. If effective, this program may provide guidance for expanding telecare consultations to other post-stroke nurse-led clinics or to patients with other chronic diseases.

Trial Registration

This study has been registered at clinicaltrials.gov (identifier: NCT05183672). Registered on 10 January 2022.

Attentive immobility: Investigating the emotional-cognitive mechanism underlying conspiracy mentality and Covid-19 preventive behaviors

by Shuguang Zhao, Jue Zhou, Ting Wang

While conspiracy theories have received extensive attention in the realm of misinformation, there has been limited research exploring the impact of conspiracy mentality on individuals’ preventive behaviors during acute public health crises. This study investigates how conspiracy mentality may affect compliance with preventive health measures necessary to fight the COVID-19 pandemic, and the underlying emotional and cognitive mediators. Data was collected through a survey among 1878 Chinese respondents at the conclusion of the pandemic. The results indicate that individuals with higher levels of conspiracy mentality are significantly less engaged in preventive behaviors. Furthermore, this correlation is mediated by a sequence of mediating factors, starting from anger leading to institutional distrust and fear leading to perceived risk. Conspiracists’ response mode can be described as a state of "attentive immobility," in which the impact of heightened institutional distrust outweighs their perceptions of risk, ultimately reducing engagement in preventive behaviors during crises. These findings underscore the importance of debunking initiatives that aim to address and mitigate the negative consequences of conspiracy mentality by targeting the mediating psychological processes during future pandemic threats.

Do residential patterns affect women’s labor market performance? An empirical study based on CHFS data

by Siyan Zhou, Qing Wang

Based on China Household Finance Survey (CHFS) data from 2019, this paper explores the impact of the residential pattern of coresidence with parents on the labor market performance of women in married families with minor children. The study finds that coresidence with parents significantly increases the possibility of female labor market participation and positively impacts women’s employment income. To overcome the potential endogeneity problem of residential patterns, this paper uses the Heckman two-step method and the conditional mixed process estimation method (CMP method) for regression, and the conclusions remain robust. The mechanism analysis shows that coresidence with parents has both grandchild care and elderly care factors, which have a spillover effect and a crowding-out effect on female labor market performance, respectively. Since the spillover effect is more significant than the crowding-out effect, coresidence with parents positively impacts women’s labor market performance. The heterogeneity analysis shows that in terms of labor force participation rate, coresidence with parents has a more significant impact on women in families with children aged 0–6, women in families without boys, and women in families with employed husbands. In terms of income, coresidence with parents has a more significant impact on women in families with employed husbands. This study provides a new perspective for promoting female labor market performance and can serve as a reference for future policy formulation.

Machine learning and single‐cell transcriptome profiling reveal regulation of fibroblast activation through THBS2/TGFβ1/P‐Smad2/3 signalling pathway in hypertrophic scar

Abstract

Hypertrophic scar (HS) is a chronic inflammatory skin disorder characterized by excessive deposition of extracellular matrix, and the mechanisms underlying their formation remain poorly understood. We analysed scRNA-seq data from samples of normal skin and HS. Using the hdWGCNA method, key gene modules of fibroblasts in HS were identified. Non-negative matrix factorization was employed to perform subtype analysis of HS patients using these gene modules. Multiple machine learning algorithms were applied to screen and validate accurate gene signatures for identifying and predicting HS, and a convolutional neural network (CNN) based on deep learning was established and validated. Quantitative reverse transcription-polymerase chain reaction and western blotting were performed to measure mRNA and protein expression. Immunofluorescence was used for gene localization analysis, and biological features were assessed through CCK8 and wound healing assay. Single-cell sequencing revealed distinct subpopulations of fibroblasts in HS. HdWGCNA identified key gene characteristics of this population, and pseudotime analysis was conducted to investigate gene variation during fibroblast differentiation. By employing various machine learning algorithms, the gene range was narrowed down to three key genes. A CNN was trained using the expression of these key genes and immune cell infiltration, enabling diagnosis and prediction of HS. Functional experiments demonstrated that THBS2 is associated with fibroblast proliferation and migration in HS and affects the formation and development of HS through the TGFβ1/P-Smad2/3 pathway. Our study identifies unique fibroblast subpopulations closely associated with HS and provides biomarkers for the diagnosis and treatment of HS.

Early 6 months usage of single anTiplAtelet OR anTicoAgulant followed by single antiplatelet after transcatheter aortic valve replacement: protocol for a multicentre, open-label, randomised controlled clinical trial

Por: Hu · X. · Xu · H. · Wang · C. · Wang · Y. · Wang · Y. · Zhou · D. · Zhu · Q. · Xu · K. · Yang · J. · Zhang · H. · Jiang · N. · Zhang · J. · Fang · Z. · Fu · G. · Guo · Y. · Li · Y. · Wang · M. · Feng · D. · Niu · G. · Zhang · E. · Chen · Y. · Ye · Y. · Wu · Y.
Introduction

The strategy for initiating antithrombotic therapy to prevent bioprosthetic valve thrombosis (BPVT) after transcatheter aortic valve replacement (TAVR) remains uncertain. There is still lacking evidence on the efficacy and safety of early 6 months usage of single-antiplatelet therapy (SAPT) or oral anticoagulant (OAC) after TAVR in patients without anticoagulant indications.

Methods and analysis

This is a multicentre, randomised controlled, open-label trial, and 650 patients undergoing TAVR from 13 top TAVR centres in China will be recruited. Each eligible participant will be randomly assigned to two groups (1:1 ratio) as (1) SAPT (aspirin 75–100 mg for 6 months) group or (2) OAC group (warfarin, therapeutic international normalised ratio at 1.8–2.5 for 6 months), both followed by sequential aspirin 75–100 mg for 6 months. Participants in both groups will be invited for three follow-up visits of 1, 6 and 12 months after discharge. We will use both the net clinical benefit endpoint (composite of all-cause mortality, myocardial infarction, stroke/transient ischaemic attacks, peripheral artery thrombosis, intracardiac thrombosis and major bleeding and disabling or life-threatening bleeding) and the BPVT endpoint evaluated by four-dimensional CT as our primary endpoints. P value of

Ethics and dissemination

The present study was approved by the Institutional Review Boards at Fuwai Hospital, National Center for Cardiovascular Diseases of China (Approval No. 2023-1947). All patients will be informed of the details of the study and will sign an informed consent prior to inclusion in the study. Results of this study will be published in a peer-reviewed journal.

Trial registration number

NCT05375474.

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