Left Ventricular Thrombus Therapy With Direct Oral Anticoagulants Versus Vitamin K Antagonists: A Systematic Review and Meta-Analysis

Saleiro, C; Lopes, João; Campos, Diana Catarina Ferreira de; Puga, L; Costa, Marco; Gonçalves, Lino; Teixeira, Rogério

doi:10.1177/1074248420977567

Cited by 13 publications

(24 citation statements)

References 49 publications

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“…Previous meta-analyses have not examined stroke as an individual outcome, but rather a composite SSE, making this the first review to demonstrate this statistically significant difference. 7 , 34 , 35 , 36 However, this finding must be contextualized by the limitations of the primary studies, including the inherent bias of cohort studies and the lack of an adjusted analysis. Further studies—ideally in the form of adequately powered RCTs—are required to substantiate this finding.…”

Section: Discussionmentioning

confidence: 99%

“…Although previous reviews have included data from case reports and observational studies, ours is the first to include data from 2 RCTs. 34 , 35 , 36 , 41 Additionally, previously published meta-analyses have examined fewer outcomes and focused on composite SSE. 7 , 34 , 35 , 36 In contrast, our meta-analysis examined 6 different safety and efficacy outcomes, and assessed stroke and SE as individual outcomes in addition to the composite SSE that previous reviews have examined.…”

Section: Discussionmentioning

confidence: 99%

“… 34 , 35 , 36 , 41 Additionally, previously published meta-analyses have examined fewer outcomes and focused on composite SSE. 7 , 34 , 35 , 36 In contrast, our meta-analysis examined 6 different safety and efficacy outcomes, and assessed stroke and SE as individual outcomes in addition to the composite SSE that previous reviews have examined. By doing so, we are the first review to identify a statistically significant reduction in stroke with DOAC use.…”

Section: Discussionmentioning

confidence: 99%

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

2021

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Left ventricular (LV) thrombus formation complicates 15% of acute myocardial infarctions (MIs), and it is even more common in conditions of impaired LV systolic function. [1][2][3] If left untreated, up to 20% of patients can have significant complications, including stroke and systemic embolism. 3 Current consensus guidelines recommend the use of vitamin K antagonists (VKAs) to treat LV thrombi following acute MIs for 3-6 months. 4,5 Direct oral anticoagulants (DOACs) are a preferred alternative to VKAs, as they have lower bleeding rates, fewer drug interactions, rapid onset of action, and decreased need for monitoring. 6 However, the use of DOACs for this indication remains off-label. Many observational studies have shown comparable safety and efficacy of DOACs to VKAs in the management of LV thrombi. [7][8][9] However, a recent large cohort study identified a higher risk of stroke or systemic embolism with DOACs, calling into question their use in the treatment of LV thrombi. 10 The aim of this systematic review and meta-analysis was to compare the safety and efficacy of DOACs to VKAs in the ABSTRACT Background: There 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. Methods: A 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. Results: Sixteen 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; I 2 = 0%), systemic embolism (OR 0.77, 95% CI 0.41-1.44; P = 0.41; I 2 = 0%), stroke or systemic embolism (OR 0.83, 95% CI 0.53-1.33; P = 0.45; I 2 = 33%), mortality (OR 1.01, 95% CI 0.64-1.57; P = 0.98; I 2 = 0%) or LV thrombus resolution (OR 1.29, 95% CI 0.83-1.99; P = 0.26; I 2 = 56%).

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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

2021

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“…In recent years, the number of DOAC-related publications has increased dramatically, and articles reporting the efficacy and safety of DOACs in treatment of LVT are becoming increasingly common. To the best of our knowledge, six systematic reviews and meta-analyses comparing VKAs and DOACs for the treatment of LVT have been published in the last several years [17][18][19][20][21][22]. Table 2 summarizes characteristics and main findings of previous meta-analyses and our study.…”

Section: Previous Studiesmentioning

confidence: 98%

“…Recently, several meta-analysis articles have been published comparing VKAs and DOACs in treatment of LVT [17][18][19][20][21][22][23][24]. However, these meta-analyses included only direct comparative studies between VKAs and DOACs, and did not include single-arm studies.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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Background Although 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 results PubMed, 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. Conclusions Efficacy and adverse outcomes of therapy with DOACs and VKAs do not differ. Randomized controlled trials are needed to determine the optimal anticoagulant strategy.

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

Kitano

Nabeshima

Kataoka

et al. 2023

Sci Rep

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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.

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Left Ventricular Thrombus Therapy With Direct Oral Anticoagulants Versus Vitamin K Antagonists: A Systematic Review and Meta-Analysis

Cited by 13 publications

References 49 publications

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

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

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

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

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