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Safety and Efficacy of Vitamin K Antagonists vs. Novel Oral Anticoagulants in Patients With Left Ventricular Thrombus: A Meta-Analysis.

ABSTRACT: Aims: A meta-analysis was conducted to evaluate the safety and efficacy of novel oral anticoagulants (NOACs) compared with vitamin K antagonists (VKAs) in patients with left ventricular thrombus (LVT). Methods and Results: We searched PubMed, Web of Science, and Cochrane Library for cohort studies comparing the use of VKAs vs. NOACs for the treatment of LVT from the earliest date available to September 30, 2020. The predetermined efficacy and safety outcomes included thromboembolic events, resolution of LVT, clinically significant bleedings, and all-cause death. Fixed-effects model was used to estimate the pooled effects. Publication bias analyses and sensitivity analyses were conducted to check the robustness of results. A total of 6 studies enrolling 837 patients (mean age 60.2 ± 1.6 years; 77.2% were male) were included. We found no significant differences in thromboembolic events [relative risk (RR) 1.69, 95% confidence interval (CI) 0.94-3.06, P 0.08, I² 12.7%], the rate of resolution of thrombus (RR 1.08, 95% CI 0.96-1.21, P 0.21, I² 4.8%), and clinically significant bleedings (RR 0.70, 95% CI 0.37-1.32, P 0.27, I² 0%) between the VKAs and NOACs group. Additionally, no significant difference in all-cause mortality was found between the two groups (RR 1.24, 95% CI 0.79-1.96, P 0.35, I² 0.0%). Sensitivity analyses, using the "1-study removed" method, detected no significant differences. Conclusion: NOACs and VKAs have similar efficacy and safety in treating LVT, prompting the inference that NOACs are the possible alternatives of VKAs in LVT therapy.

SUBMITTER: Xuan H

PROVIDER: S-EPMC8118127 | biostudies-literature |

REPOSITORIES: biostudies-literature

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

Project description: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.

| S-EPMC10425444 | biostudies-literature

Therapeutic efficacy of direct oral anticoagulants and vitamin K antagonists for left ventricular thrombus: Systematic review and meta-analysis.

Project description:BackgroundAlthough several meta-analyses have compared efficacies of vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) for treatment of left ventricular thrombus (LVT), those meta-analyses included no single-arm studies.Methods and resultsPubMed, Scopus, and the Cochrane Library databases were searched for articles investigating thrombus resolution, stroke, any thromboembolism, major bleeding, any bleeding, or all-cause death in LVT treated with VKAs or DOACs, and single-class meta-analyses were also included (PROSPERO database, CRD42021230849). Event rates were pooled using a random effects model. Meta-regression analysis was performed to explore factors that may influence outcomes. 2,612 patients from 23 articles were included (VKAs: 2,004, DOACs: 608). There were no significant differences between VKAs and DOACs in the frequency of thrombus resolution (VKAs: 0.75 [95% confidence interval; 0.67 to 0.81], DOACs: 0.75 [0.67 to 0.82]), stroke (VKAs: 0.06 [0.04 to 0.10], DOACs: 0.02 [0.01 to 0.01]), any thromboembolism (VKAs: 0.08 [0.05 to 0.13], DOACs: 0.03 [0.01 to 0.10]), major bleeding (VKAs: 0.06 [0.04 to 0.09], DOACs: 0.03 [0.01 to 0.06]), any bleeding (VKAs: 0.08 [0.05 to 0.12], DOACs: 0.08 [0.06 to 0.10]), and all-cause death (VKAs: 0.07 [0.04 to 0.13], DOACs: 0.09 [0.05 to 0.16]). Meta-regression analysis revealed that increased duration of follow-up was associated with lower-rates of stroke (estimate: -0.040, p = 0.0495) with VKAs, but not with DOACs. There was significant publication bias for thrombus resolution, stroke, any thromboembolism, any bleeding, and all-cause death.ConclusionsEfficacy and adverse outcomes of therapy with DOACs and VKAs do not differ. Randomized controlled trials are needed to determine the optimal anticoagulant strategy.

| S-EPMC8312978 | biostudies-literature

Meta-analysis comparing direct oral anticoagulants versus vitamin K antagonists in patients with left ventricular thrombus.

Project description:Current American College of Cardiology/American Heart Association guidelines for stroke or ST-elevation myocardial infarction recommend the use of oral vitamin K antagonists (VKAs) as a first-line anticoagulant. Although several studies have compared the use of direct oral anticoagulants (DOACs) to VKAs for left ventricular thrombus (LVT) anticoagulation therapy, they are small scale and have produced conflicting results. Thus, this meta-analysis was performed to aggregate these studies to better compare the efficacy and safety of DOACs with VKAs in patients with LVT. Cochrane Library, Google Scholar, MEDLINE, and Web of Science database searches through January 10, 2021 were performed. Eight studies evaluating stroke or systemic embolism (SSE), six studies for LVT resolution, and five studies for bleeding were included. There were no statistically significant differences in SSE (OR 0.89; 95% CI 0.46, 1.71; p = 0.73; I2 = 45%) and LVT resolution (OR 1.13; 95% CI 0.75, 1.71; p = 0.56; I2 = 1%) between DOAC and VKA (reference group) therapy. DOAC use was significantly associated with lower bleeding event rates compared to VKA use (OR 0.61; 95% CI 0.40, 0.93; p = 0.02; I2 = 0%). DOACs may be feasible alternative anticoagulants to vitamin K antagonists for LV thrombus treatment. Randomized controlled trials directly comparing DOACs with VKAs are needed.

| S-EPMC8177531 | biostudies-literature

Direct Oral Anticoagulants vs Vitamin K Antagonists in Left Ventricular Thrombi: A Systematic Review and Meta-analysis.

Project description:BackgroundThere is increasing interest in direct oral anticoagulants (DOACs), given their safety and convenience in atrial fibrillation, compared with vitamin K antagonists (VKAs). However, the use of DOACs in left ventricular (LV) thrombi is considered off-label, with current guidelines recommending VKAs. The aim of this meta-analysis was to compare the safety and efficacy of DOACs to VKAs in the management of LV thrombi.MethodsA systematic search was conducted for studies published between January 1, 2009 and January 31, 2021 in PubMed, Embase, and CENTRAL. Included studies compared DOACs to VKAs for the treatment of LV thrombi and reported on relevant outcomes. Odds ratios (ORs) were pooled with a random-effects model.ResultsSixteen cohort studies and 2 randomized controlled trials were identified, which included 2666 patients (DOAC = 674; VKA = 1992). Compared with VKAs, DOACs were associated with a statistically significant reduction in stroke (OR 0.63, 95% confidence interval [CI] 0.42-0.96; P = 0.03; I 2 = 0%). There were no significant differences in bleeding (OR 0.72, 95% CI 0.50-1.02; P = 0.07; I2 = 0%), systemic embolism (OR 0.77, 95% CI 0.41-1.44; P = 0.41; I2 = 0%), stroke or systemic embolism (OR 0.83, 95% CI 0.53-1.33; P = 0.45; I2 = 33%), mortality (OR 1.01, 95% CI 0.64-1.57; P = 0.98; I2 = 0%) or LV thrombus resolution (OR 1.29, 95% CI 0.83-1.99; P = 0.26; I2 = 56%).ConclusionsWithin the context of low-quality evidence, there was a statistically significant reduction in stroke among those treated with DOACs, without an increase in bleeding. There were no significant differences in systemic embolism, stroke or systemic embolism, mortality, or LV thrombus resolution, suggesting that DOACs may be a reasonable option for treatment of LV thrombi.

| S-EPMC8531230 | biostudies-literature

Assessment of non-vitamin K antagonist oral anticoagulants for the management of left ventricular thrombus.

Project description:Although several studies have assessed the effect of non-vitamin K antagonist oral anticoagulants (NOACs) relative to that of vitamin K antagonists (VKAs) in patients with left ventricular thrombus, the results remain controversial. Herein, a meta-analysis was performed to compare the effectiveness and safety of NOACs versus VKAs for the treatment of left ventricular thrombus. We systematically searched the Cochrane Library, PubMed and Embase databases until November 2020 for studies that compared the effects of NOACs versus VKAs in patients with left ventricular thrombus. The treatment effects were expressed as odds ratios (ORs) with 95% confidence intervals (CIs) and pooled by a random-effects model. Seven retrospective studies involving 865 patients with left ventricular thrombus (266 NOAC and 599 VKA users) were included. The pooled analysis suggested no difference in the rate of thrombus resolution between the NOAC and VKA groups (OR = 0.83, 95% CI 0.61-1.13). There were also no differences in the rates of stroke or systemic embolism (OR = 0.62, 95% CI 0.20-1.97), bleeding events (OR = 0.73, 95% CI 0.37-1.45), or all-cause death (OR = 0.92, 95% CI 0.50-1.69) between patients treated with NOACs and those treated with VKAs. In addition, the rates of thrombus resolution, stroke or systemic embolism, bleeding events, and all-cause death between NOAC- and warfarin-treated patients were also similar. Our current evidence suggested that NOAC and VKA users had similar rates of thrombus resolution and clinical outcomes among patients with left ventricular thrombus. Further large-scale prospective studies should confirm our results.

| S-EPMC8207971 | biostudies-literature

Direct oral anticoagulants (DOAC) versus vitamin K antagonist in left ventricular thrombus: An updated meta‐analysis

Project description: Not available

| S-EPMC10667961 | biostudies-literature

Direct Oral Anticoagulants Versus Vitamin K Antagonists for the Treatment of Left Ventricular Thrombus: An Updated Meta-Analysis of Cohort Studies and Randomized Controlled Trials.

Project description:AbstractLeft ventricular thrombi (LVTs) increase the risk of stroke, systemic embolism, and subsequent death. Current guidelines recommend vitamin K antagonists (VKAs) as first-line treatment for LVT. Direct oral anticoagulants (DOACs) are increasingly used as alternatives to warfarin for the treatment of LVT. However, the efficacy and safety of DOACs versus VKAs remain controversial. Thus, we conducted an updated meta-analysis of DOACs versus VKAs for LVT treatment. We systematically searched PubMed, Embase, ClinicalTrials, and Cochrane Library databases for relevant articles published before December 11, 2021. The relative risks (RRs) with 95% confidence intervals (CIs) were calculated for each study. The meta-analysis included 12 cohort studies and 3 randomized controlled trials with a total of 2334 patients. We found that DOACs had a lower risk of clinically significant bleeding than VKAs (RR = 0.6; 95% CI, 0.39 to 0.90; P = 0.01; I2 = 0%). There was no difference in LVT resolution (RR = 1.01; 95% CI, 0.93 to 1.09; P = 0.48; I2 = 0%), stroke and/or systematic embolic events (RR = 0.87; 95% CI, 0.11 to 1.55; P = 0.2; I2 = 30%), and all-cause mortality (RR = 0.9; 95% CI, 0.58 to 1.4; P = 0.65; I2 = 0%). Overall, DOACs are noninferior to warfarin in LVT treatment but have a lower risk of clinically significant bleeding. This suggests that DOACs might be better alternatives to warfarin for LVT treatment.

| S-EPMC9162267 | biostudies-literature

Direct Oral Anticoagulants Versus Warfarin in the Treatment of Left Ventricular Thrombus.

Project description:BackgroundUse of direct oral anticoagulants (DOACs) for the treatment of left ventricular (LV) thrombus has gained considerable interest.ObjectiveWe aimed to evaluate if DOACs are effective in the treatment of LV thrombus compared with warfarin.MethodsWe evaluated the medical records of patients diagnosed with a new LV thrombus at a tertiary medical center. The primary outcome was the composite of thrombus persistence, stroke, or systemic embolism. We adjusted for potential confounders using multiple logistic regression. The safety outcome was the composite of hemorrhagic stroke or bleeding requiring blood transfusion.ResultsA total of 129 patients were treated with warfarin and 22, with a DOAC. In unadjusted analysis, 54.3% of patients treated with warfarin met criteria for the efficacy outcome as compared with 40.9% of patients treated with a DOAC (P = 0.25). In adjusted analysis, no difference between groups was observed (odds ratio = 0.39; 95% CI = 0.14-1.06; P = 0.07 for DOAC vs warfarin). In all, 3.9% of patients treated with warfarin met safety criteria as compared with 4.5% of patients treated with a DOAC. A total of 8 patients in the warfarin group had a stroke or systemic embolism as compared with 0 patients in the DOAC group (P = 0.37).Conclusion and relevanceOur data suggest that DOACs may be reasonable alternatives for treatment of LV thrombus. When added to the totality of available studies, this study demonstrates that the effectiveness of DOACs in LV thrombus remains uncertain. Randomized clinical trials are needed.

| S-EPMC8842988 | biostudies-literature

New Oral Anticoagulants vs. Vitamin K Antagonists Among Patients With Cardiac Amyloidosis: Prognostic Impact.

Project description:Background: Atrial arrhythmia (AA) is common among patients with cardiac amyloidosis (CA), who have an increased risk of intracardiac thrombus. The aim of this study was to explore the prognostic impact of vitamin K-antagonists (VKA) and direct oral anticoagulants (DOAC) in patients with CA. Methods and Results: 273 patients with CA and history of AA with long term anticoagulation-69 (25%) light chain amyloidosis (AL), 179 (66%) wild-type transthyretin amyloidosis (ATTRwt) and 25 (9%) variant transthyretin amyloidosis (ATTRv)-were retrospectively included between January 2012 and July 2020. 147 (54%) and 126 (46%) patients received VKA and DOAC, respectively. Patient receiving VKA were more likely to have AL with renal dysfunction, higher NT-proBNP and troponin levels. Patients with ATTRwt were more likely to receive DOAC therapy. There were more bleeding complications among patients with VKA (20 versus 10%; P = 0.013) but no difference for stroke events (4 vs. 2%; P = 0.223), as compared to patients with DOAC. A total of 124 (45%) patients met the primary endpoint of all-cause mortality: 96 (65%) and 28 (22%) among patients with VKAs and DOACs, respectively (P < 0.001). After multivariate analysis including age and renal function, VKA was no longer associated with all-cause mortality. Conclusion: Among patients with CA and history of AA receiving oral anticoagulant, DOACs appear to be at least as effective and safe as VKAs.

| S-EPMC8670403 | biostudies-literature

Warfarin versus direct oral anticoagulants for treating left ventricular thrombus: a systematic review and meta-analysis.

Project description:BackgroundLeft ventricular thrombus (LVT) is not uncommon and pose a risk of systemic embolism, which can be mitigated by adequate anticoagulation. Direct oral anticoagulants (DOACs) are increasingly being used as alternatives to warfarin for anticoagulation, but their efficacy and safety profile has been debated. We aim to compare the therapeutic efficacy and safety of DOACs versus warfarin for the treatment of LVT.MethodologyWe systematically searched PubMed/Medline, Google Scholar, Cochrane library, and LILCAS databases from inception to 14th August 2020 to identify relevant studies comparing warfarin and DOACs for LVT treatment and used the pooled data extracted from retrieved studies to perform a meta-analysis.ResultsWe report pooled data on 1955 patients from 8 studies, with a mean age of 61 years and 59.7 years in warfarin and DOACs group, respectively. The pooled odds ratio for thrombus resolution was 1.11 (95% CI 0.51-2.39) on comparing warfarin to DOAC, but it did not reach a statistical significance (p = 0.76). The pooled risk ratio (RR) of stroke or systemic embolization and bleeding in patients treated with warfarin vs DOACs was 1.04 (95% CI 0.64-1.68; p = 0.85), and 1.15 (95% CI 0.62-2.13; p = 0.57), respectively; with an overall RR of 1.09 (95% CI 0.70-1.70; p = 0.48) for mortality.ConclusionsDOACs appears to be non-inferior or at least as effective as warfarin in the treatment of left ventricular thrombus without any statistical difference in stroke or bleeding complications.

| S-EPMC7849079 | biostudies-literature

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