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Vascular and Endovascular Surgery Aug 2024This systematic review and network meta-analysis aimed to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) in adults aged 75 and over undergoing... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
This systematic review and network meta-analysis aimed to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) in adults aged 75 and over undergoing acute venous thromboembolism (VTE) treatment.
METHODS
PubMed, Embase and the CENTRAL were searched up to 25 December 2023. The incidence of VTE recurrence and bleeding events was assessed. Employing a frequentist network meta-analysis approach, interventions not directly compared could be indirectly assessed through the 95% confidence interval (CI), enhancing the interpretability of the search results. The surface under the cumulative ranking curves (SUCRA) was utilized to generate the relative ranking probabilities for each group.
RESULTS
Our study, analysing 6 randomised controlled trials with 3665 patients, compares direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) in adults aged 75 and over with acute venous thromboembolism. Edoxaban reduces VTE recurrence risk compared with VKAs (risk ratio [RR] .50, 95% CI 0.27 - .95), while apixaban significantly decreases bleeding risk compared with VKAs (RR .23, 95% CI 0.08 - .69), edoxaban (RR .28, 95% CI 0.09 - .86) and rivaroxaban (RR .28, 95% CI 0.09 - .86). Despite low overall evidence quality, apixaban consistently ranks highest for both efficacy and safety. Findings underscore the nuanced efficacy-safety balance in this population, emphasizing cautious interpretation due to evidence limitations.
CONCLUSION
Apixaban emerges as a favourable choice for acute VTE treatment in the elderly, displaying reduced bleeding risk compared to other treatments while maintaining comparable efficacy. Future studies should explore diverse anticoagulants efficacy and safety in older populations. Additionally, clinical prediction models tailored to geriatric cohorts are crucial for guiding treatment duration decisions.
Topics: Humans; Venous Thromboembolism; Network Meta-Analysis; Aged; Randomized Controlled Trials as Topic; Hemorrhage; Administration, Oral; Risk Factors; Treatment Outcome; Recurrence; Age Factors; Female; Male; Aged, 80 and over; Risk Assessment; Factor Xa Inhibitors; Anticoagulants; Acute Disease
PubMed: 38706248
DOI: 10.1177/15385744241253201 -
Thrombosis Research Jun 2024This systematic review assesses the likelihood of developing dementia and cognitive impairment in patients with atrial fibrillation (AF) receiving non-vitamin K... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This systematic review assesses the likelihood of developing dementia and cognitive impairment in patients with atrial fibrillation (AF) receiving non-vitamin K antagonist oral anticoagulants (NOACs) as opposed to vitamin K antagonists (VKAs).
METHODS
We performed a systematic review with meta-analysis and trial sequential analysis (TSA), which encompassed both randomized controlled trials (RCTs) and observational studies. The objective was to assess the impact of NOACs and VKAs on the incidence of dementia in individuals diagnosed with AF.
RESULTS
Out of 1914 studies that were screened, 31 studies were included in the final analysis, which consisted of nine RCTs or their subsequent post-hoc analyses, in addition to 22 observational studies. The meta-analysis shows that NOACs were associated with a decreased probability of developing dementia of any cause [Rate Ratio (RR): 0.88; 95 % confidence interval (95 % CI): 0.82-0.94], especially in patients below the age of 75 (RR: 0.78; 95 % CI: 0.73-0.84). Consistent patterns were observed across all forms of dementia and cognitive function decline. The overall evidence indicates notable variability in the outcome with a moderate-to-low degree of certainty. The TSA suggests that the total sample size of the included trials (155,647 patients) was significantly smaller than the required information size of 784,692 patients to discern the true effect of NOAC versus VKA in terms of reducing dementia risk.
CONCLUSION
NOACs may reduce the likelihood of developing dementia in patients with AF, particularly in those under the age of 75. This review highlights the urgent necessity for thorough research to determine the efficacy of NOACs in safeguarding cognitive health.
Topics: Humans; Atrial Fibrillation; Anticoagulants; Administration, Oral; Dementia; Cognitive Dysfunction; Randomized Controlled Trials as Topic; Cognition Disorders; Aged
PubMed: 38704897
DOI: 10.1016/j.thromres.2024.04.032 -
Cureus Apr 2024The objective of the study is mentioned, but it could be further clarified by explicitly stating the aim to compare the effectiveness and safety of direct oral... (Review)
Review
Comparison of Effectiveness and Safety of Direct-Acting Oral Anticoagulants and Vitamin K Agonists in Patients With Atrial Fibrillation and End-Stage Kidney Disease: A Systematic Review and Meta-Analysis.
The objective of the study is mentioned, but it could be further clarified by explicitly stating the aim to compare the effectiveness and safety of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) specifically in patients with atrial fibrillation (AF) and end-stage renal disease (ESRD). We conducted a thorough electronic search of the literature, encompassing databases such as PubMed, EMBASE, Cochrane Library, and Web of Science from their inception up to March 5, 2024. Furthermore, we meticulously examined the bibliographies of included studies to identify additional relevant literature. The reporting of this meta-analysis adhered to the guidelines outlined in the Preferred Reporting of Systematic Review and Meta-analysis guidelines. The endpoints evaluated in this meta-analysis included all-cause mortality, stroke or systemic embolism, and major bleeding. Data analysis was carried out utilizing RevMan Version 5.4 (Cochrane, London, United Kingdom). Dichotomous outcomes, including all-cause mortality, stroke or systemic embolism, and major bleeding, were presented as risk ratios (RRs) with corresponding 95% confidence intervals (CI). A total of 11 studies were incorporated in this meta-analysis, comprising a pooled sample size of 44,863 participants with AF. The pooled analysis revealed no significant disparity between DOACs and VKAs concerning stroke or systemic embolism (RR: 0.93, 95% CI: 0.77 to 1.14) and all-cause mortality (RR: 0.86, 95% CI: 0.74 to 1.00). However, there was a noteworthy reduction in the risk of major bleeding events associated with DOACs compared to VKAs (RR: 0.84, 95% CI: 0.73 to 0.96). Consequently, DOACs may be considered a viable alternative to warfarin in patients with ESRD. However, we need further larger clinical trials to validate these findings.
PubMed: 38699102
DOI: 10.7759/cureus.57447 -
Thrombosis Research Jun 2024Recommendations about proper anticoagulation in obese patients, body mass index (BMI) > 30 kg/m2, are not yet clearly defined. Obese patients were included in... (Meta-Analysis)
Meta-Analysis
Obese patients with atrial fibrillation are more efficiently protected from thrombosis under warfarin or xabans compared to non-obese patients; a systematic review and Meta-analysis of six randomized controlled trials.
INTRODUCTION
Recommendations about proper anticoagulation in obese patients, body mass index (BMI) > 30 kg/m2, are not yet clearly defined. Obese patients were included in randomized controlled trials comparing new anticoagulants (NOACs) with warfarin in patients with atrial fibrillation or thromboembolism.
METHODS
We performed a medline search entering proper criteria and finally 6 post-hoc analysis of RCTs, reporting outcome according to BMI, were included in this meta-analysis. Two major outcomes were considered end points in our meta-analysis; thrombosis, including ischemic cerebral events (transient or not) and venous thrombosis (DVD) /pulmonary embolism (PE) and bleeding, including major bleeding and clinically relevant non-major bleeding.
RESULTS
In the NOACs treated group, thrombosis occurred less frequently in obese vs non-obese patients; RR and 95 % CI 0,75 (0,58-0,97), p = 0,03, while low heterogeneity was observed (I 40 %). In the warfarin treated subgroup there was statistically significant difference with less thrombotic events occurring in the obese vs non-obese patients; RR and (95 % CI) 0,80 (0,66-0,98), p = 0,03, and heterogeneity was low (I = 24 %). This protective effect called the obesity paradox is limited to obese patients anticoagulated for non-valvular atrial fibrillation (NVAF); RR (95 % CI) was 0,70 (0,58-0,85) p = 0,03 and I = 24 %. Bleeding events were similar under both NOACs and warfarin in obese vs non-obese analysis.
CONCLUSIONS
Obese patients anticoagulated for NVAF with either standard dose of xabans or INR guided warfarin are more efficiently protected against thrombosis compared to non-obese patients.
Topics: Humans; Atrial Fibrillation; Warfarin; Obesity; Anticoagulants; Randomized Controlled Trials as Topic; Thrombosis; Hemorrhage; Factor Xa Inhibitors
PubMed: 38696925
DOI: 10.1016/j.thromres.2024.04.022 -
The Cochrane Database of Systematic... May 2024During vascular interventions, connections that link arteries, veins, or synthetic grafts, which are known as an 'anastomosis', may be necessary. Vascular anastomoses... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
During vascular interventions, connections that link arteries, veins, or synthetic grafts, which are known as an 'anastomosis', may be necessary. Vascular anastomoses can bleed from the needle holes that result from the creation of the anastomoses. Various surgical options are available for achieving hemostasis, or the stopping of bleeding, including the application of sealants directly onto the bleeding vessels or tissues. Sealants are designed for use in vascular surgery as adjuncts when conventional interventions are ineffective and are applied directly by the surgeon to seal bleeding anastomoses. Despite the availability of several different types of sealants, the evidence for the clinical efficacy of these hemostatic adjuncts has not been definitively established in vascular surgery patients.
OBJECTIVES
To evaluate the benefits and harms of sealants as adjuncts for achieving anastomotic site hemostasis in patients undergoing vascular surgery.
SEARCH METHODS
The Cochrane Vascular Information Specialist conducted systematic searches of the following databases: the Cochrane Vascular Specialised Register via the Cochrane Register of Studies; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via Ovid; Embase via Ovid ; and CINAHL via EBSCO. We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform for clinical trials. Reference lists of included trials and relevant reviews were also searched. The latest search date was 6 March 2023.
SELECTION CRITERIA
We included randomized controlled trials that compared fibrin or synthetic sealant use with alternative interventions (e.g. manual compression, reversal of anticoagulation) for achieving anastomotic-site hemostasis in vascular surgery procedures. We included participants who underwent the creation of an anastomosis during vascular surgery. We excluded non-vascular surgery patients.
DATA COLLECTION AND ANALYSIS
We have used standard Cochrane methods. Our primary outcomes were time to hemostasis, failure of hemostatic intervention, and intraoperative blood loss. Our secondary outcomes were operating time, death from bleeding complications up to 30 days, postoperative bleeding up to 30 days, unplanned return to the operating room for bleeding complications management up to 30 days, quality of life, and adverse events. We used GRADE to assess the certainty of evidence for each outcome.
MAIN RESULTS
We found 24 randomized controlled trials that included a total of 2376 participants who met the inclusion criteria. All trials compared sealant use with standard care controls, including oxidized cellulose, gelatin sponge, and manual compression. All trials were at high risk of performance bias, detection bias, and other sources of bias. We downgraded the certainty of evidence for risk of bias concerns, inconsistency, imprecision and possible publication bias. Combining data on time to hemostasis showed that sealant use may reduce the mean time to hemostasis compared to control (mean difference (MD) -230.09 seconds, 95% confidence interval (CI) -329.24 to -130.94; P < 0.00001; 7 studies, 498 participants; low-certainty evidence). Combining data on failure of hemostatic intervention showed that sealant use may reduce the rate of failure compared to control, but the evidence is very uncertain (risk ratio (RR) 0.46, 95% CI 0.35 to 0.61; P < 0.00001; 17 studies, 2120 participants; very low-certainty evidence). We did not detect any clear differences between the sealant and control groups for intraoperative blood loss (MD -32.69 mL, 95% CI -96.21 to 30.83; P = 0.31; 3 studies, 266 participants; low-certainty evidence); operating time (MD -18.72 minutes, 95% CI -40.18 to 2.73; P = 0.09; 4 studies, 436 participants; low-certainty evidence); postoperative bleeding (RR 0.78, 95% CI 0.59 to 1.04; P = 0.09; 9 studies, 1216 participants; low-certainty evidence), or unplanned return to the operating room (RR 0.27, 95% CI 0.04 to 1.69; P = 0.16; 8 studies, 721 participants; low-certainty evidence). No studies reported death from bleeding or quality of life outcomes.
AUTHORS' CONCLUSIONS
Based on meta-analysis of 24 trials with 2376 participants, our review demonstrated that sealant use for achieving anastomotic hemostasis in vascular surgery patients may result in reduced time to hemostasis, and may reduce rates of hemostatic intervention failure, although the evidence is very uncertain, when compared to standard controls. Our analysis showed there may be no differences in intraoperative blood loss, operating time, postoperative bleeding up to 30 days, and unplanned return to the operating room for bleeding complications up to 30 days. Deaths and quality of life could not be analyzed. Limitations include the risk of bias in all studies. Our review has demonstrated that using sealants may reduce the time required to achieve hemostasis and the rate of hemostatic failure. However, a significant risk of bias was identified in the included studies, and future trials are needed to provide unbiased data and address other considerations such as cost-effectiveness and adverse events with sealant use.
Topics: Humans; Randomized Controlled Trials as Topic; Anastomosis, Surgical; Vascular Surgical Procedures; Hemostasis, Surgical; Hemostatics; Fibrin Tissue Adhesive; Blood Loss, Surgical; Tissue Adhesives
PubMed: 38695613
DOI: 10.1002/14651858.CD013421.pub2 -
Arquivos Brasileiros de Cardiologia 2024Coronavirus disease 2019 (COVID-19) is associated with hypercoagulability. It remains uncertain whether ongoing anticoagulation for atrial fibrillation (AF) in patients... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Coronavirus disease 2019 (COVID-19) is associated with hypercoagulability. It remains uncertain whether ongoing anticoagulation for atrial fibrillation (AF) in patients who later contract COVID-19 improves clinical outcomes.
OBJECTIVES
To compare chronic oral anticoagulation with no previous anticoagulation in patients with AF who contracted a COVID-19 infection concerning the outcomes of all-cause mortality, COVID-19 mortality, intensive care unit (ICU) admission, and hospitalization.
METHODS
We systematically searched PubMed, Embase, and Cochrane Library for eligible studies from inception to December 2022. We included studies comparing COVID-19 outcomes in patients with versus without prior chronic anticoagulation for AF. Risk ratios (RR) with 95% confidence intervals (CI) were pooled with a random-effects model. The level of significance was set at p < 0.05. Quality assessment and risk of bias were performed according to Cochrane recommendations.
RESULTS
Ten studies comprising 1,177,858 patients with COVID-19 and AF were identified, of whom 893,772 (75.9%) were on prior chronic anticoagulation for AF. In patients with COVID-19, being on chronic anticoagulation for AF significantly reduced all-cause mortality (RR 0.75; 95% CI 0.57 to 0.99; p = 0.048; I2 = 89%) and COVID-19-related mortality (RR 0.76; 95% CI 0.72 to 0.79; p < 0.001; I2 = 0%) when compared with no prior anticoagulation. In contrast, there was no difference between groups regarding hospitalization (RR 1.08; 95% CI 0.82 to 1.41; p = 0.587; I2 = 95%) or ICU admission (RR 0.86; 95% CI 0.68 to 1.09; p = 0.216; I2 = 69%).
CONCLUSIONS
In this meta-analysis, chronic anticoagulation for patients with AF who contracted COVID-19 was associated with significantly lower rates of all-cause mortality and COVID-19-related mortality as compared with no previous anticoagulation.
Topics: Humans; Atrial Fibrillation; COVID-19; Anticoagulants; Hospitalization; SARS-CoV-2; Intensive Care Units
PubMed: 38695466
DOI: 10.36660/abc.20230470 -
Annals of Medicine and Surgery (2012) May 2024Recent guidelines suggest that antiplatelet therapy (APT) is the standard of care in the absence of long-term oral anticoagulation (OAC) indications in patients... (Review)
Review
Efficacy and outcomes of antiplatelet therapy versus oral anticoagulants in patients undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis.
BACKGROUND
Recent guidelines suggest that antiplatelet therapy (APT) is the standard of care in the absence of long-term oral anticoagulation (OAC) indications in patients post-transcatheter aortic valve replacement (TAVR). The superiority of one method over the other remains controversial.
MATERIALS AND METHODS
Several databases, including MEDLINE, Google Scholar, and EMBASE, were electronically searched. The primary endpoint was the all-cause mortality (ACM) rate. Secondary endpoints included cardiovascular death, myocardial infarction (MI), stroke/TIA, haemorrhagic stroke, bleeding events, systemic embolism, and valve thrombosis in post-TAVR patients receiving APT and oral anticoagulants (OACs). Forest plots were generated using Review Manager version 5.4, with a value less than 0.05 indicating statistical significance. Subgroup analysis was performed to explore potential sources of heterogeneity.
RESULTS
Twelve studies were selected. No significant differences were observed in APT and OAC group for ACM [risk ratio (RR): 0.67; 95% CI:0.45-1.01; =0.05], cardiovascular death [RR:0.91; 95% CI:0.73-1.14; =0.42], MI [RR:1.69; 95% CI:0.43-6.72; =0.46], Stroke/TIA [RR:0.79; 95% CI:0.58-1.06; =0.12], ischaemic stroke [RR:0.83; 95% CI:0.50-1.37; =0.47], haemorrhagic stroke [RR:1.08; 95% CI: 0.23-5.15; =0.92], major bleeding [RR:0.79; 95% CI:0.51-1.21; =0.28], minor bleeding [RR:1.09; 95% CI: 0.80-1.47; =0.58], life-threatening bleeding [RR:0.85; 95% CI:0.55-1.30; =0.45], any bleeding [RR:0.98; 95% CI:0.83-1.15; =0.78], and systemic embolism [RR:0.87; 95% CI:0.44-1.70; =0.68]. The risk of valve thrombosis was higher in patients receiving APT than in those receiving OAC [RR:2.61; 95% CI:1.56-4.36; =0.0002].
CONCLUSIONS
Although the risk of valve thrombosis increased in patients receiving APT, the risk of other endpoints was comparable between the two groups.
PubMed: 38694361
DOI: 10.1097/MS9.0000000000001908 -
Clinical Cardiology May 2024The use of extracorporeal membrane oxygenation (ECMO) is associated with complex hemostatic changes. Systemic anticoagulation is initiated to prevent clotting in the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The use of extracorporeal membrane oxygenation (ECMO) is associated with complex hemostatic changes. Systemic anticoagulation is initiated to prevent clotting in the ECMO system, but this comes with an increased risk of bleeding. Evidence on the use of anti-Xa-guided monitoring to prevent bleeding during ECMO support is limited. Therefore, we aimed to analyze the association between anti-factor Xa-guided anticoagulation and hemorrhage during ECMO.
METHODS
A systematic review and meta-analysis was performed (up to August 2023).
PROSPERO
CRD42023448888.
RESULTS
Twenty-six studies comprising 2293 patients were included in the analysis, with six works being part of the meta-analysis. The mean anti-Xa values did not show a significant difference between patients with and without hemorrhage (standardized mean difference -0.05; 95% confidence interval [CI]: -0.19; 0.28, p = .69). We found a positive correlation between anti-Xa levels and unfractionated heparin dose (UFH; pooled estimate of correlation coefficients 0.44; 95% CI: 0.33; 0.55, p < .001). The most frequent complications were any type of hemorrhage (pooled 36%) and thrombosis (33%). Nearly half of the critically ill patients did not survive to hospital discharge (47%).
CONCLUSIONS
The most appropriate tool for anticoagulation monitoring in ECMO patients is uncertain. Our analysis did not reveal a significant difference in anti-Xa levels in patients with and without hemorrhagic events. However, we found a moderate correlation between anti-Xa and the UFH dose, supporting its utilization in monitoring UFH anticoagulation. Given the limitations of time-guided monitoring methods, the role of anti-Xa is promising and further research is warranted.
Topics: Extracorporeal Membrane Oxygenation; Humans; Hemorrhage; Factor Xa Inhibitors; Anticoagulants; Blood Coagulation; Factor Xa; Risk Factors
PubMed: 38693831
DOI: 10.1002/clc.24273 -
British Journal of Neurosurgery Apr 2024In patients with traumatic intracranial haemorrhage (tICH) there is significant risk of both venous thromboembolism (VTE) and haemorrhage progression. There is a paucity... (Review)
Review
INTRODUCTION
In patients with traumatic intracranial haemorrhage (tICH) there is significant risk of both venous thromboembolism (VTE) and haemorrhage progression. There is a paucity of literature to inform the timing of pharmacological thromboprophylaxis (PTP) initiation.
AIM
This meta-analysis aims to summarise the current literature on the timing of PTP initiation in tICH.
METHODS
This meta-analysis followed the Methodological Expectations of Cochrane Intervention Reviews checklist and the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Following the literature search, studies were matched against the criteria for inclusion. Data from included studies was pooled, analysed using random-effect analysis and presented as forest plots of risk ratios, except one result reported as difference of means. The ROBINS-I tool was used to assess the risk of bias in the studies. The GRADE approach was taken to assess the quality of included studies. Heterogeneity of studies was assessed using Tau2. Funnel plots were generated and used in conjunction with Harbord's test and Rucker's arcsine to assess for small-study effect including publication bias.
RESULTS
A total of 9927 ICH patients who received PTP were included from 15 retrospective observational cohort studies, 4807 patients received early PTP, the remaining 5120 received late PTP. The definition of early was dependent on the study but no more than 72-hours after admission. The mean age of the included cohort was 45.3 (std dev ±9.5) years, and the proportion of males was 71%. Meta-analysis indicated that there was a significant difference between early and late groups for the rate of VTE (RR, 0.544; p = 0.000), pulmonary embolus (RR, 0.538; p = 0.004), deep vein thrombosis (RR, 0.484; p = 0.000) and the intensive care unit length of stay (difference of means, -2.021; 95% CI, -2.250, -1.792; p = 0.000; Tau2 = 0.000), favouring the early group. However, the meta-analysis showed no significant difference between the groups for the rate of mortality (RR, 1.008; p = 0.936), tICH progression (RR, 0.853; p = 0.157), and neurosurgical intervention (RR, 0.870; p = 0.480).
CONCLUSION
These findings indicated that early PTP appears to be safe and effective in patients with tICH.
PubMed: 38688329
DOI: 10.1080/02688697.2024.2339357 -
Hamostaseologie Apr 2024It is an honor and a great pleasure for us to be guest editors for this special issue of , which addresses important issues surrounding the complex of venous...
It is an honor and a great pleasure for us to be guest editors for this special issue of , which addresses important issues surrounding the complex of venous thromboembolism (VTE). In February 2023, the revised guideline on "Diagnostics and Therapy of Venous Thrombosis and Pulmonary Embolism" has been published on the website of the Association of the Scientific Medical Societies in Germany (AWMF)1. This guideline was drawn up under the leadership of the German Society of Angiology (DGA), and representatives of 17 scientific societies contributed to its content. As an S2k guideline, its recommendations are consensus based and are the result of a systematic review and evaluation of current evidence and consideration of the benefits and harms of diagnostic and therapeutic options. In this special issue, guideline authors provide a comprehensive overview of selected guideline topics which might be of clinical relevance to our readers and our community of haemostaseologists.
Topics: Humans; Germany; Venous Thromboembolism; Practice Guidelines as Topic; Anticoagulants; Pulmonary Embolism
PubMed: 38688265
DOI: 10.1055/a-2239-0770