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Renal Failure Dec 2024This review aims to evaluate the safety and efficacy of apixaban vs. vitamin K antagonists (VKAs) in patients on dialysis. (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
This review aims to evaluate the safety and efficacy of apixaban vs. vitamin K antagonists (VKAs) in patients on dialysis.
METHODS
All types of studies published on PubMed, Embase, CENTRAL, and Web of Science up to 10 September 2023 and comparing outcomes of apixaban vs. VKA in dialysis patients were eligible.
RESULTS
Two randomized controlled trials (RCTs) and six retrospective studies were included. Apixaban treatment was associated with significantly lower risk of major bleeding (RR: 0.61; 95% CI: 0.48, 0.77; = 50%) and clinically relevant non-major bleeding (RR: 0.82, 95% CI: 0.68, 0.98, = 9%) compared to VKA. Meta-analysis also showed that the risk of gastrointestinal bleeding (RR: 0.74, 95% CI: 0.64, 0.85, = 16%) and intracranial bleeding (RR: 0.64, 95% CI: 0.49, 0.84, = 0%) was significantly reduced with apixaban. Meta-analysis showed no difference in the risk of ischemic stroke (RR: 0.40, 95% CI: 0.06, 2.69, = 0%), mortality (RR: 1.26, 95% CI: 0.74, 2.16, = 94%) and recurrent venous thromboembolism (RR: 1.02, 95% CI: 0.87, 1.21, = 0%) between the two groups. Subgroup analysis of RCTs showed no difference in bleeding outcomes.
CONCLUSIONS
Low-quality evidence from a mix of RCTs and retrospective studies shows that apixaban may have better safety and equivalent efficacy as compared to VKA in dialysis patients. Apixaban treatment correlated with significantly reduced risk of major bleeding and clinically relevant nonmajor bleeding in observational studies but not in RCTs. The predominance of retrospective data warrants caution in the interpretation of results.
Topics: Humans; Anticoagulants; Factor Xa Inhibitors; Hemorrhage; Pyrazoles; Pyridones; Randomized Controlled Trials as Topic; Renal Dialysis; Vitamin K
PubMed: 38770962
DOI: 10.1080/0886022X.2024.2349114 -
Heart & Lung : the Journal of Critical... 2024Since the introduction of direct oral anticoagulants (DOACs) and their comparison with vitamin K antagonists (VKAs), conflicting results have been reported regarding the... (Meta-Analysis)
Meta-Analysis Review
Evaluation of the safety and efficacy of direct oral anticoagulants compared with vitamin-k antagonists in the treatment of left ventricular thrombosis. A systematic review and meta-analysis.
BACKGROUND
Since the introduction of direct oral anticoagulants (DOACs) and their comparison with vitamin K antagonists (VKAs), conflicting results have been reported regarding the optimal treatment for left ventricular thrombosis (LVT).
OBJECTIVES
In this meta-analysis, we intend to comprehensively evaluate the safety and efficacy of these treatments.
METHODS
All clinical trials and cohorts that compared the efficacy or safety of VKAs with DOACs in the treatment of LVTs were systematically searched until April 15, 2023.
RESULTS
The results of 32 studies with a pooled sample size of 4213 patients were extracted for meta-analysis. DOACs, especially rivaroxaban and apixaban, cause faster resolution, lower mortality, and fewer complications (SSE and bleeding events) than VKAs in the management of LVTs.
CONCLUSION
Compared with VKAs, DOACs result in significantly faster (only rivaroxaban) and safer resolution of left ventricular thrombosis.
Topics: Humans; Vitamin K; Thrombosis; Heart Ventricles; Administration, Oral; Anticoagulants; Factor Xa Inhibitors; Rivaroxaban; Heart Diseases; Pyrazoles; Pyridones
PubMed: 38754272
DOI: 10.1016/j.hrtlng.2024.04.019 -
The American Journal of Cardiology May 2024Left atrial or left atrial appendage thrombosis (LAT) is contraindicated for cardiac ablation (CA) or cardioversion (CV) of atrial fibrillation (AF). This study was... (Meta-Analysis)
Meta-Analysis
Atrial Thrombosis Prevalence Before Cardioversion or Catheter Ablation of Atrial Fibrillation: An Updated Systematic Review and Meta-Analysis of Direct Oral Anticoagulants Versus Vitamin K Antagonists.
Left atrial or left atrial appendage thrombosis (LAT) is contraindicated for cardiac ablation (CA) or cardioversion (CV) of atrial fibrillation (AF). This study was aimed to compare the frequency of LAT detected by transesophageal echocardiography (TEE) before CA or CV in patients with AF treated with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs). We searched PubMed, Scopus, Web of Science, and Cochran Library databases from inception through July 13, 2023 to select studies reporting data on LAT identification before CA or CV using TEE in patients with AF treated with DOACs or VKAs. Pooled odds ratios (ORs) with 95% confidence interval were calculated with a random-effects model. Studies retrieved were 50 (38 observational), 29 on CA, 15 on CV, and 6 on both procedures (17,096 patients on DOACs and 13,666 on VKAs). The overall prevalence of LAT was smaller in DOACs than in VKAs, with an OR of 0.66 (0.52 to 0.84), confirmed at sensitivity analysis and in most subgroups. This finding was consistent for the 3 most reported DOACs: the pooled OR for LAT was 0.68 (0.50 to 0.90) in apixaban, 0.67 (0.51 to 0.88) in dabigatran, 0.61 (0.43 to 0.89) in rivaroxaban, and 1.10 (0.74 to 1.64) in edoxaban (not significant). In conclusion, in this large meta-analysis in patients with AF, the prevalence of LAT by TEE evaluation performed before CV or CA appears lower in those treated with DOACs than in those on VKAs. Additional research may help in better understanding differences between these classes of anticoagulant drugs in the setting of protection against AF-related left atrial thrombotic formation.
Topics: Humans; Atrial Fibrillation; Electric Countershock; Prevalence; Anticoagulants; Thrombosis; Heart Diseases; Catheter Ablation; Vitamin K; Administration, Oral; Stroke
PubMed: 38458580
DOI: 10.1016/j.amjcard.2024.02.042 -
Critical Care Medicine May 2024Four-factor prothrombin complex concentrate (4-PCC) is recommended for rapid reversal of vitamin K antagonists (VKAs) such as warfarin, yet optimal dosing remains... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Four-factor prothrombin complex concentrate (4-PCC) is recommended for rapid reversal of vitamin K antagonists (VKAs) such as warfarin, yet optimal dosing remains uncertain.
DATA SOURCES
A systematic review was conducted of PubMed, Embase, and Ovid MEDLINE (Wolters Kluwer) databases from January 2000 to August 2023 for clinical studies comparing fixed- vs. variable-dose 4-PCC for emergent VKA reversal with at least one reported clinical outcome.
STUDY SELECTION
Abstracts and full texts were assessed independently and in duplicate by two reviewers.
DATA EXTRACTION
Data were extracted independently and in duplicate by two reviewers using predefined extraction forms.
DATA SYNTHESIS
The analysis comprised three randomized trials and 16 cohort studies comprising a total of 323 participants in randomized trials (161 in fixed dosage and 162 in variable dosage) and 1912 patients in cohort studies (858 in fixed-dose and 1054 in variable dose). Extracranial bleeding was the predominant indication, while intracranial hemorrhage varied. Overall, a fixed-dose regimen may be associated with a lower dose of 4-PCC and results in a reduction in 4-PCC administration time compared with a variable-dose regimen. A fixed-dose regimen also likely results in increased clinical hemostasis. While there is no clear difference between the two regimens in terms of achieving a goal international normalized ratio (INR) less than 2, a fixed-dose regimen is less likely to achieve a goal INR less than 1.5. High certainty evidence indicates that the fixed-dose regimen reduces both mortality and the occurrence of thromboembolic events. Additional subgroup analyses provides exploratory data to guide future studies.
CONCLUSIONS
A fixed-dose regimen for 4-PCC administration provides benefits over a variable-dose regimen in terms of dose reduction, faster administration time, improved clinical hemostasis, and reduced mortality and thromboembolic events. Further studies are warranted to better refine the optimal fixed-dose regimen.
Topics: Humans; Blood Coagulation Factors; Anticoagulants; Hemorrhage; Thromboembolism; International Normalized Ratio; Fibrinolytic Agents; Vitamin K; Retrospective Studies
PubMed: 38353592
DOI: 10.1097/CCM.0000000000006212 -
BMJ Open Jan 2024The objective of the current study is to compare the treatment effects of different vitamins on essential hypertension to provide an initial basis for developing... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
The objective of the current study is to compare the treatment effects of different vitamins on essential hypertension to provide an initial basis for developing evidence-based practices.
DESIGN
Systematic review and network meta-analysis.
DATA SOURCES
Five electronic databases (PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov) were searched from their inception to 25 September 2023.
OUTCOMES
The primary outcomes were the difference between the intervention group and the control group in changes in office systolic blood pressure (SBP) and office diastolic blood pressure (DBP) from baseline. The secondary outcomes were the difference between the intervention group and the control group in changes in 24-hour mean ambulatory systolic blood pressure (24 hours SBP), 24-hour mean ambulatory diastolic blood pressure (24 hours DBP) and heart rate (HR) from baseline.
RESULTS
A total of 23 studies comparing five vitamins (vitamin B, vitamin C, vitamin D, vitamin E, folic acid) and involving 2218 participants were included. The included trials were all vitamin versus placebo, so the network was star-shaped. Among the five vitamins, only vitamin E was significantly more effective at reducing SBP (mean difference: -14.14 mm Hg, 95% credible intervals: -27.62 to -0.88) than placebo. In addition, no evidence was found that any of the five vitamins influenced DBP, 24 hours SBP, 24 hours DBP, or HR. The dose of vitamins, geographical region and percentage of males (only SBP) might be sources of heterogeneity. Sensitivity and subgroup analysis revealed that the effect of vitamin intervention on blood pressure varies according to different doses of vitamins.
CONCLUSIONS
According to the results, vitamin E might be an effective measure to reduce SBP, but more research is needed to validate this finding.
PROSPERO REGISTRATION NUMBER
CRD42022352332.
Topics: Adult; Male; Humans; Vitamin D; Ascorbic Acid; Hypertension; Folic Acid; Riboflavin; Vitamin E; Network Meta-Analysis; Vitamins; Essential Hypertension; Blood Pressure; Vitamin A; Vitamin K
PubMed: 38296289
DOI: 10.1136/bmjopen-2023-074511 -
Journal of Nutritional Science 2024Cardiovascular disease (CVD) is one of the most important diseases which controlling its related risk factors, such as metabolic and inflammatory biomarkers, is... (Meta-Analysis)
Meta-Analysis Review
Cardiovascular disease (CVD) is one of the most important diseases which controlling its related risk factors, such as metabolic and inflammatory biomarkers, is necessary because of the increased mortality risk of that. The aim of our meta-analysis is to reveal the general effect of vitamin K supplementation on its related risk factors. Original databases were searched using standard keywords to identify all randomized clinical trials (RCTs) investigating the effects of vitamin K on CVD. Pooled weighted mean difference (WMD) and 95 % confidence intervals (95 % CI) were achieved by random-model effect analysis for the best estimation of outcomes. The statistical heterogeneity was determined using the Cochran's test and statistics. Seventeen studies were included in this systematic review and meta-analysis. The pooled findings showed that vitamin K supplementation can reduce homeostatic model assessment insulin resistance (HOMA-IR) (WMD: -0⋅24, 95 % CI: -0⋅49, -0⋅02, = 0⋅047) significantly compared to the placebo group. However, no significant effect was observed on other outcomes. Subgroup analysis showed a significant effect of vitamin K2 supplementation compared to vitamin K1 supplementation on HOMA-IR. However, no significant effect was observed on other variables. Also, subgroup analysis showed no potential effect of vitamin K supplementation on any outcome and omitting any articles did not affect the final results. We demonstrated that supplementation with vitamin K has no effect on anthropometrics indexes, CRP, glucose metabolism, and lipid profile factors except HOMA-IR.
Topics: Humans; Dietary Supplements; Vitamin K; Blood Glucose; Insulin Resistance; Cardiovascular Diseases
PubMed: 38282652
DOI: 10.1017/jns.2023.106 -
Journal of Thrombosis and Thrombolysis Mar 2024In patients with atrial fibrillation (AF) and normal or slightly impaired renal function, the use of direct oral anticoagulants (DOACs) is preferable to vitamin K... (Meta-Analysis)
Meta-Analysis
Direct oral anticoagulants versus vitamin K antagonists in patients with atrial fibrillation and stage 5 chronic kidney disease under dialysis: A systematic review and meta-analysis of randomized controlled trials.
BACKGROUND
In patients with atrial fibrillation (AF) and normal or slightly impaired renal function, the use of direct oral anticoagulants (DOACs) is preferable to vitamin K antagonists (VKAs). However, in patients undergoing hemodialysis, the efficacy, and safety of DOACs compared with VKAs are still unknown.
PURPOSE
To review current evidence about the safety and efficacy of DOACs compared to VKAs, in patients with AF and chronic kidney disease under hemodialysis.
METHODS
We systematically searched PubMed, Scopus, and Cochrane databases for RCTs comparing DOACs with VKAs for anticoagulation in patients with AF on dialysis therapy. Outcomes of interest were: (1) stroke; (2) major bleeding; (3) cardiovascular mortality; and (4) all-cause mortality. Statistical analysis was performed using RevMan 5.1.7 and heterogeneity was assessed by I statistics.
RESULTS
Three randomized controlled trials were included, comprising a total of 383 patients. Of these, 218 received DOACs (130 received apixaban; 88 received rivaroxaban), and 165 were treated with VKAs (116 received warfarin; 49 received phenprocoumon). The incidence of stroke was significantly lower in patients treated with DOACs (4.7%) compared with those using VKAs (9.5%) (RR 0.42; 95% CI 0.18-0.97; p = 0.04; I = 0%). However, the difference was not statistically significant in the case of ischemic stroke specifically (RR 0.42; 95% CI 0.17-1.04; p = 0.06; I = 0%). As for the major bleeding outcome, the DOAC group (11%) had fewer events than the VKA group (13.9%) but without statistical significance (RR 0.75; 95% CI 0.45-1.28; p = 0.29; I = 0%). There was no significant difference between groups regarding cardiovascular mortality (RR 1.23; 95% CI 0.66-2.29; p = 0.52; I = 13%) and all-cause mortality (RR 0.98; 95% CI 0.77-1.24; p = 0.84; I = 16%).
CONCLUSION
This meta-analysis suggests that in patients with AF on dialysis, the use of DOACs was associated with a significant reduction in stroke, and a numerical trend of less incidence of major bleeding compared with VKAs, but in this case with no statistical significance. Results may be limited by a small sample size or insufficient statistical power.
Topics: Humans; Atrial Fibrillation; Renal Dialysis; Randomized Controlled Trials as Topic; Anticoagulants; Hemorrhage; Stroke; Kidney Failure, Chronic; Fibrinolytic Agents; Vitamin K; Administration, Oral
PubMed: 38281231
DOI: 10.1007/s11239-023-02945-0 -
American Journal of Cardiovascular... Mar 2024Sex, age, medical history, treatment, tobacco use, and race (SAMe-TTR) score helps detect patients at risk of suboptimal anticoagulation control. A score above two... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Sex, age, medical history, treatment, tobacco use, and race (SAMe-TTR) score helps detect patients at risk of suboptimal anticoagulation control. A score above two suggests poor control; however, non-Caucasian status being assigned two points might hinder the recognition of poor control in patients of other races.
OBJECTIVE
To evaluate the SAMe-TTR score's ability to predict poor anticoagulation control [defined as time in therapeutic range (TTR) < 60-70%] in Asian and non-Asian populations on vitamin K antagonists (VKAs).
METHODS
We searched PubMed, Cochrane Library, Scopus, SpringerLink, and Web of Science using the keyword "SAMe-TTR." Articles published before April 2022 were screened. We gathered mean TTR and diagnostic accuracy data for different SAMe-TTR thresholds and conducted meta-analyses using random-effects models.
RESULTS
A total of 30 studies were included (N = 36,690). The overall mean TTR differences were - 4.88 and - 6.41 for the cutoffs of ≥ 3 and ≥ 4, respectively. For non-Asian patients, the mean TTR differences were - 3.86, - 5.12, and - 8.09 for the cutoffs ≥ 2, ≥ 3, and ≥ 4, respectively. For Asian patients, the mean TTR differences were - 3.99 and - 4.07 for the cut-offs ≥ 3 and ≥ 4, respectively. The highest positive likelihood ratio (LR+) for the Asian subgroup was 1.17 [95% confidence interval (CI): 1.06-1.28; I = 0%, p heterogeneity = 0.500] at cutoff ≥ 4 and for the non-Asian subgroup, at cut-off ≥ 3, the LR+ was 1.24 (95% CI 1.14-1.34; I = 0% p heterogeneity = 0.455). The lowest LR- was found at a lower cutoff for both races (at cutoff ≥ 3 and ≥ 2 for Asian and non-Asian subgroups, respectively). The pooled results of other accuracy parameters were modest at all cutoffs, except for the sensitivity at cutoff ≥ 3 in the Asian subgroup (83.05%).
CONCLUSION
Our study results suggest that a higher SAMe-TTR score resulted in a greater reduction of TTR among Asian and all races. The accuracy parameters showed the highest sensitivity for poor TTR at the SAMe-TTR cutoff of ≥ 3 for Asian patients. However, the ability to identify patients likely to have poor TTR was limited. Further research is needed to enhance the risk assessment for poor anticoagulation control with VKAs.
REGISTRATION
The protocol of this systematic review was registered in the International Prospective Register of Scientific Reviews: PROSPERO, registration number CRD42021291865.
Topics: Humans; Stroke; Atrial Fibrillation; Risk Factors; Vitamin K; Anticoagulants; International Normalized Ratio
PubMed: 38252269
DOI: 10.1007/s40256-023-00623-3 -
Current Problems in Cardiology Mar 2024Pulmonary hypertension (PH) is a known chronic condition that can lead to increased morbidity and mortality. Patients who develop PH due to thromboembolic disease are... (Meta-Analysis)
Meta-Analysis Review
Pulmonary hypertension (PH) is a known chronic condition that can lead to increased morbidity and mortality. Patients who develop PH due to thromboembolic disease are catalogued as chronic thromboembolic pulmonary hypertension (CTEPH). Anticoagulation remains a topic of interest in these patients. PUBMED, EMBASE and COCHRANE databases were searched by two investigators until December 2023. Information was analyzed for all-cause mortality, venous thromboembolism and major bleeding. We included a total of 10 studies in this meta-analysis. Our pooled analysis demonstrated that DOACs were non-inferior in all-cause mortality [OR 0.88, 95 % CI (0.48, 1.61)], venous thromboembolism [OR 1.00, 95 % CI (0.50, 1.98)] and major bleeding [OR 0.78, 95 % CI (0.43, 1.40)] when compared to VKAs. In conclusion, our meta-analysis supports the use of DOACs in patients with CTEPH. Further randomized trials are still needed to confirm our results in terms of safety and mortality.
Topics: Humans; Venous Thromboembolism; Hypertension, Pulmonary; Anticoagulants; Hemorrhage; Fibrinolytic Agents; Vitamin K; Administration, Oral
PubMed: 38184126
DOI: 10.1016/j.cpcardiol.2024.102377 -
International Urology and Nephrology Jun 2024Patients with atrial fibrillation (AF) and end-stage renal disease on chronic hemodialysis are at risk for thromboembolic and bleeding events. We aimed to perform a... (Meta-Analysis)
Meta-Analysis Comparative Study
PURPOSE
Patients with atrial fibrillation (AF) and end-stage renal disease on chronic hemodialysis are at risk for thromboembolic and bleeding events. We aimed to perform a meta-analysis to evaluate the safety and efficacy of direct oral anticoagulants (DOACs) compared with vitamin K antagonists (VKAs) in this population.
METHODS
We systematically searched PubMed, Excerpta Medica Database (EMBASE) and Cochrane Library for randomized controlled trials (RCTs) comparing DOACs with VKAs in patients with AF on chronic hemodialysis from inception to February 2023 in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Outcomes were reported using risk ratios (RRs) with 95% confidence intervals (CIs). Statistical analyses were performed using R version 4.2.2.
RESULTS
We selected three RCTs including 341 patients, of whom 176 (51.6%) were randomized to DOACs. Follow-up ranged from 174 days to 3.38 years. There was no significant difference between groups in terms of cardiovascular mortality (RR 1.34; 95% CI 0.69-2.60; p = 0.39), all-cause mortality (RR 0.96; 95% CI 0.72-1.27; p = 0.77), ischemic/uncertain type of stroke or transient ischemic attack (RR 0.50; 95% CI 0.19-1.35; p = 0.17), or major or life-threatening bleeding (RR 0.70; 95% CI 0.39-1.25; p = 0.22).
CONCLUSION
In this meta-analysis of three RCTs, no significant difference was observed between DOACs and VKAs in cardiovascular mortality, all-cause mortality, ischemic/uncertain type of stroke or transient ischemic attack, or major or life-threatening bleeding in patients with AF on chronic hemodialysis.
Topics: Humans; Atrial Fibrillation; Renal Dialysis; Vitamin K; Randomized Controlled Trials as Topic; Administration, Oral; Anticoagulants; Kidney Failure, Chronic
PubMed: 38153665
DOI: 10.1007/s11255-023-03889-3