Safety Of Direct Oral Anticoagulants Research Articles

Direct oral anticoagulants versus vitamin K antagonists: Which one is more effective in atrial fibrillation.

The optimal approach for anticoagulation in patients with bioprosthetic valves and atrial fibrillation (AF) remains a subject of debate. A meta-analysis using updated evidence to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) compared to vitamin K antagonists (VKAs) in patients with AF and bioprosthetic valves to address this controversy. A comprehensive search was conducted in multiple databases, including PubMed, Scopus, Web of Science, ProQuest, and the Cochrane Central Register of Controlled Trials, up until March 2023. The search aimed to identify relevant randomized controlled trials (RCTs) that examined the efficacy and safety outcomes of both direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) in patients with bioprosthetic valves and atrial fibrillation. The primary outcomes of interest were major bleeding and all-cause mortality. Our study demonstrated that despite the difference was not significant, the hazard of all-cause mortality was 2.5% higher in the DOAC group (HR = 1.03, 95% CI = [0.88, 1.19], p-value = .75). Similarly, the hazard of stroke (HR = 1.03, 95% CI = [0.87, 1.32], p-value = .71) and major bleeding (HR = 1.11, 95% CI = [0.89, 1.38], p-value = .36) were found to be respectively 3.2 and 10.7% higher in the DOAC group, although the difference was not significant. However, the hazard of intracranial hemorrhage was found to be 28.8 lower in the DOAC treatment group (HR = 0.71, 95% CI = [0.39, 1.31], p-value = .27), which again was not statistically significant. Our meta-analysis demonstrates that in patients undergoing bioprosthetic valve surgery and presenting with AF afterward, DOAC and VKA are similar regarding life-threatening and all-cause mortality outcomes, including major bleeding, stroke, and intracranial hemorrhage.

Direct oral anticoagulants versus warfarin for the treatment of inferior vena cava thrombus.

To evaluate the efficacy and safety of direct oral anticoagulants (DOACs) compared to warfarin in patients with inferior vena cava (IVC) thrombus. This was a single-system, retrospective cohort study of hospitalized adult patients with IVC thrombus treated with a DOAC or warfarin therapy. The primary efficacy endpoint was the thrombus resolution on imaging, and the primary safety endpoint was major bleeding, both assessed within 6 months of hospital discharge. Secondary endpoints included hospitalization for a bleeding-related event, pulmonary embolism, or death within 6 months of hospital discharge. A total of 33 patients were included in the study. Twenty-three (70%) patients received a DOAC, and 10 (30%) received warfarin. Of the 10 patients with repeat imaging available, complete resolution was noted in two (33%) DOAC patients and no warfarin patients (p = .5). Major bleeding occurred in two (8.7%) DOAC patients and one (10%) warfarin patient (p = .9). No significant differences in secondary endpoints were observed between groups. There were no differences in efficacy and safety between patients receiving DOACs or warfarin for the treatment of IVC thrombus, although results are limited by the small patient population and number of patients with repeat imaging available.

Direct oral anticoagulants for the treatment of splanchnic vein thrombosis: A state of art.

Splanchnic vein thrombosis (SVT) is a manifestation of venous thromboembolism in an unusual site. Portal, mesenteric, and splenic veins are the most common vessels involved in SVT which occurs mainly in patients with liver cirrhosis, although non-cirrhotic patients could be affected as well. Thrombosis of hepatic veins, also known as Budd-Chiari syndrome, is another manifestation of SVT. Prompt diagnosis and intervention are mandatory in order to increase the recalization rate and reduce the risk of thrombus progression and hypertensive complications. Traditional anticoagulation with heparin and vitamin-K antagonists is the treatment of choice in these cases. However, recent studies have shown promising results on the efficacy and safety of direct oral anticoagulants (DOACs) in this setting. Available results are mainly based on retrospective studies with small sample size, but first clinical trials have been published in the last years. This manuscript aims to provide an updated overview of the current evidence regarding the role of DOACs for SVT in both cirrhotic and non-cirrhotic patients.

Efficacy and safety of direct oral anticoagulants vs vitamin K antagonists in patients with atrial fibrillation and end-stage renal disease on hemodialysis: A systematic review and meta-analysis

BackgroundThe prevalence of atrial fibrillation (AF) in individuals with end-stage renal disease (ESRD) on chronic hemodialysis is increasing. The optimal anticoagulant choice in this population is unclear since these patients were excluded from the pivotal randomized controlled trials (RCTs) of direct oral anticoagulants (DOACs) vs. vitamin K antagonists (VKAs) in the general AF population. We aimed to assess the efficacy and safety of DOACs vs. VKAs in patients with AF and ESRD on chronic hemodialysis through a systematic review and meta-analysis of all available evidence. Patients/MethodsWe performed a systematic search in MEDLINE and Scopus for RCTs or observational studies of patients with AF and ESRD on chronic hemodialysis who were treated with DOACs or VKAs. The outcomes of interest included ischemic stroke, the composite of ischemic stroke or systemic embolism, major bleeding, gastrointestinal bleeding, minor bleeding events and all-cause mortality. ResultsAmong 397 studies identified from the literature search, six studies (three RCTs and three observational studies) were included in the meta-analysis. Compared with VKA-treated patients, those treated with DOACs had similar risk of ischemic stroke (RR:0.76, 95% CI:0.41–1.41), ischemic stroke or systemic embolism (RR:0.65, 95% CI:0.38–1.10), major bleeding (RR:0.79, 95% CI:0.49–1.28) and all-cause death (RR:0.79, 95% CI:0.56–1.12). The risk of gastrointestinal bleeding was lower in DOAC- vs VKA-treated patients in three eligible observational studies (RR:0.73, 95% CI: 0.54–0.99, I2 = 79%) but this was not confirmed in two eligible RCTs (RR:0.69, 95% CI: 0.33–1.43, I2 = 0%). ConclusionsAmong AF patients with ESRD on chronic hemodialysis, the risk of ischemic stroke, ischemic stroke or systemic embolism, minor bleeding, major bleeding, and all-cause mortality is similar in patients treated with DOACs compared to VKAs. Given that the meta-analysis of RCTs on gastrointestinal bleeding did not confirm the results of the meta-analysis of the observational studies, it cannot be concluded that gastrointestinal bleeding is lower among DOAC-treated patients. Protocol registrationPROSPERO CRD42023391966

Trial sequential analysis of efficacy and safety of direct oral anticoagulants and vitamin K antagonists against left ventricular thrombus

Meta-analysis may increase the risk of random errors. Trial sequential analysis (TSA) has been developed to adjust for these random errors. We conducted TSA on the efficacy and safety of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) in left ventricular thrombus (LVT) patients in order to estimate how many additional patients should be required to draw definite conclusions. PubMed, Scopus, and Cochrane Library databases were searched for articles directly comparing DOACs and VKAs for LVT in LV thrombus resolution, stroke, any thromboembolism, major bleeding, any bleeding, and all-cause death. TSA was conducted with a cumulative Z-curve, monitoring boundaries, and required sample size. A simulated trial was run and TSA estimated the sample sizes of trials needed to draw definite conclusions. Of 4749 articles, 25 studies were used for the analysis. TSA revealed the current sample size already demonstrated superiority of DOACs in LV thrombus resolution and stroke, and futility in any thromboembolism and all-cause death. Two other outcomes did not achieve the required sample size. The sample size of new trials needed to demonstrate the superiority of DOACs over VKAs was estimated 400 for any bleeding. Corresponding trials needed to demonstrate no significant differences could be estimated for major bleeding and any bleeding (n = 200 and n = 2000, respectively). Current results show that the sample size required to draw definite conclusions was not reached for two outcomes, and there was a risk of random error. Further randomized controlled trials with sample sizes estimated by TSA will work effectively to obtain valid conclusions.

Systematic Review and Meta-Analysis of Direct Oral Anticoagulants Versus Warfarin in Atrial Fibrillation With Low Stroke Risk

Pivotal trials comparing direct oral anticoagulants (DOACs) against warfarin in patients with atrial fibrillation (AF) predominantly involved patients with high stroke risk. This study aimed to evaluate the efficacy and safety of DOAC versus warfarin in patients with low stroke risk. An online literature search was conducted to retrieve studies comparing clinical outcomes between patients treated with DOAC versus warfarin for AF, reporting outcomes for patients at low or minimal risk of stroke (CHA2DS2-VASc scores ranging from 0 to 2 or CHADS2 scores ranging from 0 to 1). The primary outcome was the occurrence of stroke or systemic embolism. Secondary outcomes included major bleeding, intracranial hemorrhage, and all-cause mortality. Hazard ratios for all outcomes were pooled in random-effects meta-analyses. A network meta-analysis of individual DOACs versus warfarin was also conducted. In total, 11 studies (132,980 patients) were included. DOAC was associated with a significantly lower risk of stroke or systemic embolism (hazard ratio0.85, 95% confidence interval0.75 to 0.96, p=0.008, I2=0%), major bleeding, intracranial hemorrhage, and mortality compared with warfarin. This benefit persisted even when study arms which had CHA2DS2-VASc scores of 2 were excluded. When restricted to 3 studies investigating only patients with a single nongender-related stroke risk factor, significant benefit was seen only for the outcome of major bleeding. In the network meta-analysis, only dabigatran was superior to warfarin for all 4 outcomes. In conclusion, DOACs should be the standard of care in low-risk patients with AF who require anticoagulation. In particular, dabigatran appears to have the best balance of stroke prevention and reduction in major bleeding.

Recurrent bleeding during standard anticoagulant therapy in comorbid patients with atrial fibrillation: a clinical case report

The question of the safety of direct oral anticoagulants (DOACs), despite their high efficacy in the prevention of thrombotic events in atrial fibrillation (AF), remains relevant due to the risk of developing hemorrhagic events while taking standard doses, which requires a thorough personalized approach. The article presents a clinical case of the development of spontaneous hematomas on the skin of the upper and lower extremities and hemarthrosis of the knee joint while taking 20 mg of rivaroxaban in a 72-year-old patient with AF without impaired renal and hepatic function. Due to the increase in the residual plasma concentration of rivaroxaban, a pharmacogenetic study and the Thrombodynamics (TD) test were performed. A pharmacogenetic study did not reveal significant gene polymorphisms associated with the metabolism of rivaroxaban. However, TD allowed us to confirm the presence of significant hypocoagulation at the peak of the residual blood concentration of the drug in the blood, which could cause recurrent hemorrhagic events in the patient. In addition, the patient is taking amiodarone at a dosage of 200 mg per day, which does not allow us to rule out drug-drug interaction, despite the inconsistency of the literature data.

Current insights into the possible role of laboratory monitoring of effectiveness and safety of direct oral anticoagulants

The article is devoted to the discussion of modern approaches to the use of laboratory methods to improve the tactics of using direct oral anticoagulants (DOACs) therapy. Clinical situations in which it may be reasonable to use data on the blood concentration of DOACs are given, including very old age, a marked deviation from the norm of body weight or impaired renal function. Data on the role of measuring the blood level of DOACs are considered in cases of the development of diseases or complications in which information is required on the preservation of the anticoagulant effect of DOACs, for example, in the development of severe bleeding or the need for urgent surgical intervention. The advantages and limitations of modern laboratory methods for assessing the blood concentration of DOACs are discussed. It is emphasized that one of the main advantages of using DOACs is the absence of the need to monitor laboratory parameters in most patients. Data from pharmacological studies are presented that may be useful in explaining the mechanisms that determine the higher safety of some DOACs compared to others. Promising methods for assessing the blood level of DOACs, as well as the possibility of using less specific reagents for assessing the concentration of DOACs, are considered. The possibility of using less specific, but more accessible methods for assessing the blood concentration of factor Xa inhibitors, in particular, a reagent for assessing the level of the antifactor, which is used to determine the blood level of heparin, is being considered. The opinions of experts on the role of assessing the blood level of DOACs and the possibility of tactics for selecting doses of DOACs based on laboratory analysis data are given.

Efficacy and safety of direct oral anticoagulants in the pediatric population: a systematic review and a meta-analysis

BackgroundDirect oral anticoagulants (DOACs) represent a cornerstone of adult venous thromboembolism (VTE) treatment. Recently, randomized controlled trials (RCTs) investigating DOACs in pediatrics have been performed. ObjectivesTo evaluate the efficacy and safety of DOACs in the pediatric population. MethodsWe systematically searched MEDLINE (PubMed), EMBASE, and ClinicalTrials.gov from initiation up to August 20, 2022, for RCTs comparing DOACs to standard of care (SOC) in patients aged <18 years according to PRISMA guidelines (PROSPERO registration CRD42022353870). The primary analysis was performed according to the anticoagulation intensity and clinical setting (ie, prophylaxis in cardiac disease or treatment in VTE). Efficacy outcomes were all-cause mortality and VTE. Safety outcomes were major bleeding (MB), clinically relevant non-MB, any bleeding, serious adverse events, and discontinuation due to adverse events (AEs). ResultsSeven RCTs were included in the systematic review and 6 in the meta-analysis (3 prophylaxis in cardiac disease and 3 treatment in VTE). DOACs showed a significant reduction of VTE recurrence for treatment (odds ratio [OR] = 0.42; 95% CI, 0.19–0.94) and a nonsignificant reduction in VTE occurrence in prophylaxis (OR = 0.22; 95% CI, 0.03–1.55). No differences were observed for any bleeding, serious AEs, and MB in prophylaxis. Nonsignificant trends were observed for clinically relevant non-MB, MB in treatment, and discontinuation due to AE in prophylaxis. We found a significant increase in discontinuation due to AE in treatment. ConclusionsDOAC treatment seems to reduce VTE compared with SOC without major safety issues in the pediatric population, whereas DOAC prophylaxis seems at least comparable to SOC.

Efficacy and safety of direct oral anticoagulants in older adults with atrial fibrillation: a prospective single-centre cohort study.

Direct oral anticoagulants (DOACs) are underused in the elderly, regardless the evidence in their favour in this population. We prospectively enrolled anticoagulant-naïve patients aged ≥ 75years who started treatment with DOACs for atrial fibrillation (AF) and stratified them in older adults (aged 75-84years) and extremely older adults (≥ 85years). Thrombotic and hemorrhagic events were evaluated for 12months follow-up. We enrolled 518 consecutive patients. They were mostly aged 75-84years (299 patients; 57.7%) vs. ≥ 85years (219 patients; 42.3%). Extremely older adults showed higher incidence of all the endpoints (systemic cardioembolism [HR 3.25 (95% CI 1.71-6.18)], major bleeding [HR 2.75 (95% CI 1.77-4.27)], and clinically relevant non-major bleeding [HR 2.13 (95% CI 1.17-3.92)]) vs. older adults during the first year after starting anticoagulation. In patients aged ≥ 85years, no difference in the aforementioned endpoints was found between those receiving on-label vs. off-label DOACs. In the extremely older adults, chronic kidney disease, polypharmacy, use of antipsychotics, and DOAC discontinuation correlated with higher rates of thrombotic events, whereas a history of bleeding, Charlson Index ≥ 6, use of reduced DOAC dose, absence of a caregiver, use of non-steroidal anti-inflammatory drugs (NSAIDs), and HAS-BLED score ≥ 3 were associated with major bleedings. Naïve patients aged ≥ 85 who started a DOAC for AF are at higher risk of thrombotic and bleeding events compared to those aged 75-84years in the first year of therapy. History of bleeding, HAS-BLED score ≥ 3 and use of NSAIDs are associated with higher rates of major bleeding.

Effectiveness and Safety of Direct Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation Patients With Extreme Obesity

Direct oral anticoagulants (DOACs) are a favored treatment to prevent stroke in patients with atrial fibrillation (AF). There are limited data concerning the efficacy and safety of DOACs in obese. Obesity leads to wide structural and physiological changes that may affect the pharmacokinetics and pharmacodynamics of drugs. The optimal dosing strategies for DOACs in this significant and growing sub-group remain unknown. The study aimed to evaluate on a large scale the safety and efficacy of DOAC treatment in extreme obese patients with AF. In this retrospective cohort study, we included patients with AF treated with DOACs. Patients were divided according to body mass index (BMI). Study outcomes included stroke, major bleeding, and death. Between 2012 and 2017, 5183 patients with AF were included in the analysis (2,688, 2137, and 358 patients had a BMI <30, 30 to 40, and >40 accordingly). There was no significant difference in the prevalence of ischemic events (9.9%, 8.2%, and 7.5% of patients with BMI <30, 30 to 40, and >40, respectively, p=0.088), major bleeding events (13%, 14.1%, and 11.2% of patients with BMI <30, 30 to 40, and >40, respectively, p value = 0.257) or net ischemic and major bleeding events (18.7%, 18.7%, and 15.4% of patients with BMI <30, 30 to 40, and >40 respectively, p=0.297) between the BMI groups. In conclusion, DOACs treatment for prevention of ischemic events in AF is effective and safe through the BMI spectrum, including extreme obesity.

Effectiveness and safety of direct oral anticoagulants versus warfarin in patients with atrial fibrillation and advanced kidney disease

BackgroundThe effectiveness and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) and advanced kidney disease (AKD) has not been fully established.ObjectivesTo determine the effectiveness and safety related to pooled or specific DOACs to that with warfarin in patients with AF and AKD.MethodsPatients with AF and AKD (estimated glomerular filtration rate < 30 mL/min) who received DOAC or warfarin from July 2011 to December 2020 were retrospectively identified in a medical center in Taiwan. Primary outcomes were hospitalized for stroke/systemic embolism and major bleeding. Secondary outcomes included any ischemia and any bleeding.ResultsA total of 1,011 patients were recruited, of whom 809 (80.0%) were in the DOACs group (15.3% dabigatran, 25.4% rivaroxaban, 25.2% apixaban, and 14.1% edoxaban), and 202 (20.0%) in the warfarin group. DOACs had considerably lower risks of stroke/systemic embolism (adjusted hazard ratio [aHR] 0.29; 95% CI, 0.09–0.97) and any ischemia (aHR, 0.42; 95% CI, 0.22–0.79), but had comparable risks of major bleeding (aHR, 0.99; 95% CI, 0.34–2.92) and any bleeding (aHR, 0.74; 95% CI, 0.50–1.09) than warfarin. Apixaban was linked to considerably lower risks of any ischemia (aHR, 0.13; 95% CI, 0.04–0.48) and any bleeding (aHR, 0.53; 95% CI, 0.28–0.99) than warfarin.ConclusionAmong patients with AF and AKD, DOACs were linked to a lower risk of ischemic events, and apixaban was linked to a lower risk of any ischemia and any bleeding than warfarin.

The Effectiveness and Safety of Direct Oral Anticoagulants in Obese Patients With Atrial Fibrillation: A Network Meta-Analysis.

Atrial fibrillation (AF) is a cardiac condition characterized by an irregular heart rhythm, which is increasingly prevalent in the modern era.All international guidelines strongly advise the administration of anticoagulants to individuals with AF who are at high risk of stroke. These guidelines recommend the use of direct oral anticoagulants (DOACs) over warfarin because warfarin is significantly associated with increased rates of major bleeding, numerous interactions with food and drugs, and the necessity for frequent monitoring. The aim of thisstudy is to compare the effectiveness and safety of direct oral anticoagulants (DOACs) in obese patients with atrial fibrillation. Two authors independently conducted a comprehensive literature search using electronic databases including PubMed, CINAHL, and EMBASE from inception to June 1, 2023.The efficacy outcomeassessed in this meta-analysis included the composite of stroke and systemic embolism. For safety analysis, major bleeding events were compared among the study groups.Eleven studies fulfilled all the inclusion criteria and were included in the present meta-analysis enrolling 144,502 patients.In this study, DOACs demonstrate superior efficacy in preventing stroke/systemic embolism compared to warfarin. Among the DOACs, apixaban emerged as the most effective, followed by rivaroxaban, warfarin, and dabigatran. In terms of safety, apixaban was also found to be the most favorable treatment option, followed by rivaroxaban, dabigatran, and warfarin. In summary, our study concludes that apixaban exhibited greater effectiveness and safety when compared to other DOACs and warfarin in obese patients with AF.

Meta-Analysis Assessing Efficacy and Safety of Vitamin K Antagonists Versus Direct Oral Anticoagulants for Atrial Fibrillation After Transcatheter Aortic Valve Implantation

Patients who underwent transcatheter aortic valve implantation (TAVI) with concomitant atrial fibrillation (AF) are at a higher risk for thromboembolic and bleeding events. The optimal antithrombotic strategy for patients with AF after TAVI remains unclear. We sought to determine the comparative efficacy and safety of direct oral anticoagulants (DOAC) versus oral vitamin K antagonists (VKAs) in these patients. Electronic databases such as PubMed, Cochrane, and Embase databases were searched till January 31, 2023, for relevant studies evaluating clinical outcomes of VKA versus DOAC in patients with AF after TAVI. Outcomes assessed were (1) all-cause mortality, (2) stroke, (3) major/life-threatening bleeding, and (4) any bleeding. Hazard ratios (HRs) were pooled in meta-analysis using random effect model. Nine studies (2 randomized and 7 observational) were included in systematic review, and 8 studies with 25,769 patients were eligible to be included in the meta-analysis. The mean age of the patients was 82.1years, and 48.3% were male. Pooled analysis using random-effects model showed no statistically significant difference in all-cause mortality (HR 0.91, 95% confidence interval [CI] 0.76 to 1.10, p=0.33), stroke (HR 0.96, 95% CI 0.80 to 1.16, p=0.70), and major/life-threatening bleeding (HR 1.05, 95% CI 0.82 to 1.35, p=0.70) in patients that received DOAC compared with oral VKA. Risk of any bleeding was lower in the DOAC group compared with oral VKA (HR 0.83, 95% CI 0.76 to 0.91, p=0.0001). In patients with AF, DOACs appear to be a safe alternative oral anticoagulation strategy to oral VKA after TAVI. Further randomized studies are required to confirm the role of DOACs in those patients.

Current Issues of the Use and Efficacy of Direct Oral Anticoagulants According their Pharmacogenetic Features

Despite the proven efficacy and relative safety of direct oral anticoagulants (DOAC), the issue of reducing the risk of complications associated with their use, depending on the genetic characteristics of patients, remains controversial. A personalized approach to the selection of DOAC should be developed. In this article, we review the available information on the feasibility of prescribing DOAC to patients with various diseases associated with hypercoagulation and on pharmacogenetic aspects of the DOAC application. The need for further research is substantiated, along with the importance of a wider introduction of the molecular-biological analysis of gene polymorphisms, whose presence affects the efficacy and safety of these drugs. In the course of the work, publications from the MedScape, PubMed, and eLIBRARY databases were analyzed.

ПРИМЕНЕНИЕ ПРЯМЫХ ПЕРОРАЛЬНЫХ АНТИКОАГУЛЯНТОВ У ПОЖИЛЫХ ПАЦИЕНТОВ С ОНКОЛОГИЧЕСКИМИ ЗАБОЛЕВАНИЯМИ

Venous thromboembolism is a common complication in elderly patients, especially in the presence of cancer. Currently used for thromboprophylaxis, vitamin K antagonists and low molecular weight heparins are effective, but have a number of disadvantages, which leads to a rare prescription of anticoagulant therapy in elderly patients. Modern studies have shown that direct oral anticoagulants (DOACs) can also be effective and safe in this category of patients, and the convenience of their use increases patient adherence to treatment. However, elderly patients have a number of features that must be considered when prescribing anticoagulant therapy. So, in the presence of renal failure or impaired liver function, it is necessary to consider the possibility of adjusting the prescribed dose. And in connection with the polypharmacy common in old age and the drug interactions associated with it, it is necessary to carefully consider all the drugs taken by the patient for their compatibility and, if necessary, make replacements. This review presents data on the efficacy and safety of DOACs in elderly patients, as well as presents and systematizes various clinical situations when therapy correction or careful monitoring is required.

Phenotype-directed clinically driven low-dose direct oral anticoagulant for atrial fibrillation.

Clinically-driven dose reduction of direct oral anticoagulants in individuals with atrial fibrillation is prevalent worldwide. However, a paucity of evidence to tailor dose selection remained as clinical unmet need. Current doses of anticoagulant were determined largely by landmark clinical trials, in which the enrolled subjects were carefully selected and without major comorbidities. Our study reviewed the relevant real-world studies in specific patient phenotypes, including renal and hepatic diseases, elderly, low body weight, Asiansand presence of concomitant drug-drug interactions. Thorough investigations toward the efficacy and safety of direct oral anticoagulants in reduced doses will facilitate substituting current universal approach with individualized prescriptions.

Comparing the efficacy and safety of direct oral anticoagulants with vitamin K antagonist in patients with atrial fibrillation and chronic kidney disease stages IV and V: systematic review and meta-analysis

Aim. This study aims to compare efficacy and safety of direct oral anticoagulants (DOAC) with vitamin K antagonist (VKA) in patients with atrial fibrillation (AF) and chronic kidney disease (CKD) stages IV and V.Material and methods. We systematically searched the PubMed, Google Scholar, Web of Science databases from 1990 to 2022 and included all published studies that compared DOACs with VKA in patients with atrial fibrillation and chronic kidney disease stages IV and V. To search the articles, we used the PICO strategy: Patient, Intervention, Comparison, Outcome of Interest. Data extraction was undertaken by five independent researches, and then a meta-analysis was performed.Results. Out of all, 6 studies were included in the meta-analysis: 3 randomized controlled trials (n=353) and 3 retrospective analyses (n=37470). The efficacy of DOACs was comparable with VKA. In terms of safety, DOACs and VKA also showed no statistical differences: hemorrhagic stroke, major/minor/gastrointestinal bleeding, general mortality.Conclusion. In terms of efficacy and safety, the indicators of DOACs and VKA were generally comparable.

Efficacy and Safety of Direct Oral Anticoagulants in Patients With Atrial Fibrillation Combined With Hypertension: A Multicenter, Retrospective Cohort Study.

Whether there are differences in direct oral anticoagulants efficacy and safety in patients with atrial fibrillation (AF) combined with hypertension is unclear. We therefore conducted a multicenter retrospective cohort study to assess the differences in the efficacy and safety of direct oral anticoagulants in patients with AF combined with hypertension. This multicenter retrospective cohort study was based on data from 15 centers in China and included 2086 patients with AF. We divided the patients into dabigatran and rivaroxaban groups according to their direct oral anticoagulants. Propensity score matching was used to balance the covariates between the groups. Due to our limited sample size, the number of cases of some clinical events with low incidence was small. During a mean follow-up period of 10 months, a total of 268 (12.9%) bleeding events occurred, including 27 (1.3%) major bleeding events and 241 (11.6%) minor bleeding events, and 45 (2.2%) thromboembolic events. In patients with AF combined with hypertension, rivaroxaban was associated with a higher major bleeding incidence than dabigatran (odds ratio [OR], 2.89 [95% confidence interval [CI, 1.22-6.87]; P = .012). In contrast, the risk of thromboembolism and minor bleeding was similar for rivaroxaban (OR, 0.55 [95%CI, 0.29-1.01]; P = .069) and dabigatran (OR, 0.82 [95%CI, 0.63-1.08]; P = .150). Based on the results of this study, in patients with AF and hypertension treated with direct oral anticoagulants, the incidence of thromboembolism and minor bleeding was not statistically different between dabigatran and rivaroxaban, but compared with rivaroxaban, dabigatran was associated with a lower risk of major bleeding.

PO-01-063 THE EFFICACY AND SAFETY OF DIRECT ORAL ANTICOAGULANTS VERSUS VITAMIN K ANTAGONISTS FOR ATRIAL FIBRILLATION IN PATIENTS ON HEMODIALYSIS: A META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS

Vitamin K antagonists (VKAs), including warfarin, have been considered the mainstay in the treatment of atrial fibrillation (AF) in patients with end-stage renal disease, warranting hemodialysis. Direct oral anticoagulants (DOACs) have been extensively prescribed for multiple indications; however, hemodialysis patients were excluded from most of the DOACs randomized controlled trials (RCTs). Therefore, the efficacy and safety of DOACs vs. VKAs in hemodialysis patients are still inconclusive. We aim to investigate the safety and efficacy of DOACs versus VKAs for the treatment of AF in hemodialysis patients. We conducted a systematic review and meta-analysis synthesizing RCT, which were retrieved by systematically searching: PubMed, EMBASE, Web of Science, SCOPUS, and Cochrane through November 25th, 2022. We used the fixed-effect model to pool the risk ratio (RR) with a 95% confidence interval (CI). Three RCTs with a total of 341 patients (176 in the DOACs group and 165 in the VKAs group) were included in our analysis. For the DOACs arm, two RCTs investigated apixaban, and another investigated rivaroxaban, while for the VKAs arm, two RCTs investigated warfarin and another investigated phenprocoumon. There was no difference between DOACs and VKAs regarding all-cause mortality (RR: 0.99 with 95% CI [0.76, 1.30], P= 0.96), cardiovascular mortality (RR: 1.35 with 95% CI [0.71, 2.60], P= 0.36), non-cardiovascular mortality (RR: 0.75 with 95% CI [0.53, 1.05], P= 0.09), sudden mortality (RR: 1.33 with 95% CI [0.53, 3.33], P= 0.54), any cerebrovascular event (RR: 0.52 with 95% CI [0.21, 1.29], P= 0.16), ischemic stroke (RR: 0.51 with 95% CI [0.19, 1.37], P= 0.18), hemorrhagic stroke (RR: 0.61 with 95% CI [0.10, 3.70], P= 0.59), acute coronary syndrome (RR: 1.27 with 95% CI [0.57, 2.81], P= 0.56), major bleeding (RR: 0.82 with 95% CI [0.47, 1.43], P= 0.48), and minor bleeding (RR: 1.18 with 95% CI [0.79, 1.78], P= 0.42). In AF patients who are on hemodialysis, DOACs and VKAs were similar in terms of efficacy and safety outcomes. However, evidence is still scarce, which warrants more large-scale RCTs to investigate the potentiality of DOACs in this cohort.