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1.
Non-Vitamin K Antagonists Versus Warfarin in Patients with Atrial Fibrillation and Bioprosthetic Valves: A Systematic Review and Meta-Analysis.
Cardoso, R, Ternes, CMP, Justino, GB, Fernandes, A, Rocha, AV, Knijnik, L, d'Avila, A, Lopes, RD
The American journal of medicine. 2022;(2):228-234.e1
Abstract
BACKGROUND Patients with atrial fibrillation and bioprosthetic valves are at high risk for thromboembolic events. The pooled efficacy and safety of non-vitamin K oral anticoagulants (NOACs), as a class, relative to warfarin in this population is not well-known. We aimed to compare the efficacy and safety of NOACs relative to warfarin in patients with bioprosthetic valves or valve repair. METHODS We systematically searched EMBASE, PubMed, and Cochrane databases for randomized controlled trials comparing NOACs to warfarin in patients with atrial fibrillation and bioprosthetic valves or valve repair. We pooled outcomes for stroke or systemic embolism, ischemic stroke, hemorrhagic stroke, and major bleeding. RESULTS We included 4 trials with 1379 patients, of whom 723 (52.4%) received a NOAC. Mean follow-up ranged from 90 days to 2.8 years. In the pooled analysis, stroke or systemic embolism was significantly lower in patients treated with NOACs (1.9%) compared with warfarin (3.7%) (odds ratio [OR] 0.43; 95% confidence interval [CI] 0.22-0.85; P = .02). Ischemic stroke (OR 0.72; 95% CI 0.18-2.93), hemorrhagic stroke (OR 0.18; 95% CI 0.03-1.05), cardiovascular death (OR 0.78; 95% CI 0.38-1.62), and all-cause mortality (OR 0.94; 95% CI 0.55-1.62) were not significantly different among groups. Major bleeding was significantly lower in patients treated with NOAC (2.8%) compared with warfarin (4.7%) (OR 0.49; 95% CI 0.28-0.88; P = .02). CONCLUSIONS In patients with atrial fibrillation and bioprosthetic valves or valve repair, NOACs are associated with a reduced incidence of thromboembolic events and major bleeding as compared with warfarin. Thus, NOACs may be considered a preferred option for this patient population.
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2.
Meta-Analysis of Direct Oral Anticoagulants Compared With Vitamin K Antagonist for Left Ventricle Thrombus.
Mir, T, Sattar, Y, Attique, HB, Hussain, T, Alraies, MC, Sheikh, M, Qureshi, WT
Cardiovascular revascularization medicine : including molecular interventions. 2022;:141-146
Abstract
BACKGROUND The use of direct oral anticoagulants (DOAC) in preference to vitamin K antagonists (VKA) as a treatment of left ventricle (LV) thrombus is controversial. METHODS Literature search for full-text articles and conference abstracts was performed using PubMed, EMBASE databases search was performed to identify articles that compared use of DOAC vs. VKA in patients with LV thrombus. The primary outcome was composite failure or adverse effects of DOAC and VKA. Other outcomes were resolution of thrombus, systemic thromboembolism, major bleeding, and mortality. Pooled odds ratio (OR) with 95% confidence interval (CI) were computed using random effects model. RESULTS Seven studies with 1003 patients (mean age DOAC = 58.8 years and VKA = 58.9 year, 55.5% males) were included in this study. There were 306 (30.5%) patients that were treated with DOAC and 697 (69.5%) patients were treated with VKA. Overall, there were no significant differences between both agents in terms of composite failure/adverse effects, resolution of thrombus, systemic embolism, major bleeding, or mortality. CONCLUSION In this pooled analysis, outcomes in patients on DOAC were comparable to VKA. The hypothesis generated could suggest DOAC could be used interchangeably with VKA in patients with LV thrombus. Randomized trials are needed for generalization of results.
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3.
Comparison of outcomes of direct-acting oral anticoagulants vs. vitamin K antagonists in patients with bioprosthetic heart valves or valve repair: a systematic review and meta-analysis.
Tang, LL, Liang, SW, Shi, HL, Ye, JJ
European review for medical and pharmacological sciences. 2021;(15):5006-5017
Abstract
OBJECTIVE To compare the outcomes between direct-acting oral anticoagulants and vitamin K antagonists, particularly for risk of stroke and bleeding, among patients with atrial fibrillation (AF) and bioprosthetic heart valve replacement or repair. MATERIALS AND METHODS A systematic search was conducted in the PubMed, Scopus, Cochrane Database of Systematic Reviews and Google scholar databases. Studies that were done in patients with AF who underwent bioprosthetic heart valve replacement or repair and that compared the outcomes between the use of direct-acting oral anticoagulants (DOACs) and vitamin K antagonists were eligible for inclusion. Studies that were preferably randomized controlled trials or adopted a cohort approach or retrospective data-based studies were considered for inclusion. The strength of association was presented in the form of pooled hazards risk (HR). Statistical analysis was done using STATA version 16.0. RESULTS A total of 8 articles were included in the meta-analysis. There were no significant differences in the risk of "all-cause stroke" [HR 0.72, 95% CI: 0.39, 1.34] and ischemic stroke [HR 0.79, 95% CI: 0.49, 1.29] between the two groups. The risk of "any bleeding" [HR 0.74, 95% CI: 0.64, 0.87], major bleeding [HR 0.60, 95% CI: 0.42, 0.86] and intra-cranial bleeding [HR 0.54, 95% CI: 0.36, 0.81] was much lower in those that received DOAC compared to warfarin. Compared to those receiving warfarin, those on DOACs had substantially reduced risk of any clinical thromboembolic events [HR 0.52, 95% CI: 0.39, 0.70]. No significant differences were noted for all-cause mortality [HR 0.88, 95% CI: 0.74, 1.05], cardiovascular events/myocardial infarction (MI) [HR 0.58, 95% CI: 0.33, 1.04] and and readmission rates [HR 0.85, 95% CI: 0.62, 1.18]. CONCLUSIONS Findings suggest that the use DOACs in patients with AF with bioprosthetic valve replacement or repair is comparatively better than vitamin K antagonists in reducing the risk of bleeding and thrombo-embolic events. Future studies with a randomized design and larger sample sizes are needed to further substantiate these findings.
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Meta-Analysis Investigating the Role of Direct Oral Anticoagulants Versus Vitamin K Antagonists in the Treatment of Left Ventricular Thrombi.
Saleh, Y, Al-Abcha, A, Abdelkarim, O, Abdelnabi, M, Almaghraby, A
The American journal of cardiology. 2021;:126-128
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Meta-Analysis Comparing Direct Oral Anticoagulants to Vitamin K Antagonists for The Management of Left Ventricular Thrombus.
Abdelaziz, HK, Megaly, M, Debski, M, Abdelrahman, A, Abdelaziz, S, Kamal, D, Patel, B, More, R, Choudhury, T
Expert review of cardiovascular therapy. 2021;(5):427-432
Abstract
Introduction: To compare vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) treatment in patients with left ventricular (LV) thrombus. The primary outcome was stroke or systemic embolism (SSE). Secondary outcomes were thrombus resolution, bleeding, and death.Areas covered: Five observational studies were included (total n = 700; VKAs n = 480; DOACs n = 220). There was a trend toward less SSE with VKAs compared to DOACs (5.2% vs. 9%; odds ratio [OR] = 0.54, 95% confidence interval [CI] = 0.29-1.01, p = 0.05). No significant difference between VKAs and DOACs in rates of thrombus resolution (61.6% vs. 56.8%; OR = 1.00, 95% CI = 0.58-1.73, p = 0.99), bleeding (8.2% vs. 4.4%; OR = 1.62, 95% CI = 0.69-3.77, p = 0.27), or death (12.7% vs. 11.8%; OR = 1.09, 95% CI = 0.59-2.0, p = 0.79) was noted. In non-primary percutaneous coronary intervention setting, VKAs were associated with less SSE in prespecified analysis (5.2% vs.10.6%; OR = 0.48, 95% CI = 0.25-0.93, p = 0.03).Expert opinion: The current meta-analysis suggests a trend toward higher SSE with the use of DOACs compared to VKAs. Our recommendation is for VKAs to retain the preferred management of LV thrombus with cautious off-label use of DOACs.
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Cost-Effectiveness of Direct Non-Vitamin K Oral Anticoagulants Versus Vitamin K Antagonists for the Management of Patients with Non-Valvular Atrial Fibrillation Based on Available "Real-World" Evidence: The Italian National Health System Perspective.
Lorenzoni, V, Pirri, S, Turchetti, G
Clinical drug investigation. 2021;(3):255-267
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Abstract
BACKGROUND AND OBJECTIVE The increasing availability of real-world evidence (RWE) about safety and effectiveness of direct non-vitamin K oral anticoagulants (DOACs) for the management of atrial fibrillation (AF) offers the opportunity to better understand the clinical and economic implications of DOACs versus vitamin K antagonists (VKAs). The objective of this study was to compare the economic implications of DOACs and VKAs using data from real-world evidence in patients with AF. METHODS A Markov model simulating the lifetime course of patients diagnosed with non-valvular AF was used to evaluate the cost-effectiveness of DOACs (i.e., rivaroxaban, dabigatran and apixaban) versus VKAs from the Italian National Health System (INHS) perspective. The model was made up of data from the literature and a meta-analysis of RWE on the incidence of stroke/systemic embolism (SE), major bleeding (MB), intracranial haemorrhage (ICH) and all-cause mortality (ACM); direct costs included drug costs, costs for drug monitoring, and management of events from official national lists. One-way and probabilistic sensitivity analyses (PSA) were used to assess the robustness of the results. RESULTS Results from the meta-analysis showed that apixaban had a high probability of being the most effective for stroke/SE, MB and ACM. Despite their higher acquisition costs, the cost-effectiveness analysis showed all DOACs involved a saving when compared with VKAs, with per-patient savings ranging between €4647 (rivaroxaban) to €6086 (apixaban). Moreover, all DOACs indicated a gain both in quality-adjusted life-years and life-years. According to PSA, findings related to apixaban were consistent, while for dabigatran and rivaroxaban PSA revealed a higher degree of uncertainty. CONCLUSIONS The beneficial effect of DOACs on containing events showed in RWE had the potential to offset drug-related costs, thus improving the sustainability of treatment for non-valvular AF in daily clinical practice.
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Meta-analysis comparing direct oral anticoagulants versus vitamin K antagonists in patients with left ventricular thrombus.
Kido, K, Ghaffar, YA, Lee, JC, Bianco, C, Shimizu, M, Shiga, T, Hashiguchi, M
PloS one. 2021;(6):e0252549
Abstract
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.
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The Role of Direct Oral Anticoagulants Versus Vitamin K Antagonists in the Treatment of Left Ventricular Thrombi: A Meta-Analysis and Systematic Review.
Al-Abcha, A, Herzallah, K, Saleh, Y, Mujer, M, Abdelkarim, O, Abdelnabi, M, Almaghraby, A, Abela, GS
American journal of cardiovascular drugs : drugs, devices, and other interventions. 2021;(4):435-441
Abstract
BACKGROUND Direct oral anticoagulants (DOACs) have a well-established role in the treatment of deep vein thrombosis and pulmonary embolism and in the reduction of thromboembolism in nonvalvular atrial fibrillation. However, limited evidence supports their role in patients with left ventricular thrombi. METHODS The PubMed, EMBASE, and Cochrane databases were searched for relevant articles published from inception to 1 August 2020. We included studies evaluating the effect of DOACs versus vitamin K antagonists (VKAs) in patients with left ventricular thrombi. The primary outcome was thrombus resolution, and the secondary outcomes were major bleeding and stroke or systemic embolization (SSE). RESULTS Five retrospective observational studies were included, with a total of 857 patients. VKAs and DOACs had a similar rate of thrombus resolution (odds ratio [OR] 0.97; 95% confidence interval [CI] 0.57-1.65; p = 0.90). Our analysis also demonstrated a similar rate of major bleeding (OR 0.62; 95% CI 0.27-1.44; p = 0.27) and SSE (OR 1.86; 95% CI 0.99-3.50; p = 0.05) between the two treatment groups. CONCLUSION In patients with left ventricular thrombi, DOACs and VKAs are associated with similar rates of thrombus resolution, major bleeding, and SSE.
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Direct Oral Anticoagulant for the Treatment of VTE in Cancer Patients: A Systematic Review and Meta-analysis.
Dong, S, Zhang, Y, Li, Y, Li, Y, Miao, Y, Zhao, R, Zhai, S
The Annals of pharmacotherapy. 2021;(4):430-439
Abstract
BACKGROUND Recent clinical guidelines suggest direct oral anticoagulants (DOACs) as treatment for cancer-associated thrombosis (CAT), but the strength of such recommendations was not clear. Newly released trials add uncertainties to the benefit and risk assessment between DOACs and conventional therapy (low-molecular-weight heparin [LMWH] or vitamin K antagonists [VKAs]). OBJECTIVE To evaluate the efficacy and safety of DOACs in patients with CAT, as compared with LMWH and VKAs. METHODS PubMed, EMBASE, Cochrane Library, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched. Randomized controlled trials (RCTs) that reported outcomes of DOACs for treating CAT were included. Relative risk (RR), risk difference, and 95% CIs were pooled using the Mantel-Haenszel method. RESULTS A total of 8 RCTs were included. DOACs significantly reduced VTE recurrence (RR = 0.59; 95% CI = 0.48-0.73) compared with conventional therapy. Results were similar in the LMWH and VKA subgroups. DOACs had a higher, though nonsignificant, risk of major bleeding compared with LMWH (RR = 1.33; 95% CI = 0.94-1.89) but lower risk of major bleeding compared with VKAs (RR = 0.60; 95% CI = 0.39-0.93). Findings were consistent across patients with active cancer and history of cancer. CONCLUSION AND RELEVANCE DOACs have better efficacy to prevent recurrent VTE compared with conventional therapy. Regarding the safety profile, DOACs may carry higher risk of bleeding compared with LMWH but lower risk of bleeding compared with VKAs. Further studies are needed to inform the optimal anticoagulation approach for different types of cancers.
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Direct Oral Anticoagulants Versus Vitamin-K Antagonist After PCIs in Patients With AF: A Meta-analysis of Cardiac Ischemic Events.
Cordero, A, Ferreiro, JL, Bertomeu-González, V, Rodríguez-Mañero, M, Fácila, L, Escribano, D, Sanchez-Recalde, A, Zuazola, P, Ruiz-Nodar, JM, González-Juanatey, JR
Journal of cardiovascular pharmacology. 2021;(2):164-169
Abstract
BACKGROUND Clinical trials have assessed the effect of direct oral antagonists (DOACs) in patients with atrial fibrillation (AF) after percutaneous coronary interventions (PCI). Studies were designed to test the effect on bleeding incidence, but concerns related to safety on ischemic events remain. METHODS We performed a meta-analysis with currently available studies involving DOACs versus Vitamin-K antagonist (VKA) in patients with AF after PCI. The primary endpoint was the incidence of cardiac ischemic events, including myocardial infarction and stent thrombosis. Secondary endpoints were the incidence of stroke, all-cause mortality, and major bleeding. RESULTS Eleven thousand twenty-three patients were included in the analysis: 5510 receiving DOACs and 5513 VKA. A total of 190 cases of myocardial infarction were registered in patients treated with DOACs and 177 in patients on VKA, and no statistical difference was noted [relative risk (RR): 1.07 95% confidence interval (CI) 0.88-1.31]. The incidence of stent thrombosis was very low with no differences between both treatment strategies (RR: 1.14 95% CI 0.76-1.71). The incidence of cardiac ischemic events was the same in patients receiving DOACs or VKA (HR 1.09 95% CI 0.91-1.30). No differences were observed in the incidence of stroke (RR: 0.86 95% CI 0.61-1.23) or mortality (RR: 1.09, 95% CI 0.90-1.31). Treatment with DOACs was associated with 34% reduction in major bleeding (RR: 0.66, 95% CI 0.54-0.81). CONCLUSIONS Treatment with DOACs in patients with AF after a PCI do not increase the risk of cardiac ischemic events, stroke, or death and reduce the incidence of major bleeding by 34% as compared with VKA.