direct oral anticoagulants

直接口服抗凝剂
  • 文章类型: Journal Article
    背景:由于一些研究已经检查了直接口服抗凝药(DOACs)在治疗内脏静脉血栓形成(SVT)患者中的应用,我们进行了一项荟萃分析,以评估DOACs与维生素K拮抗剂(VKAs)在该人群中的安全性和有效性.
    方法:我们使用PubMed进行了全面的搜索,Embase,和Cochrane图书馆数据库,直到2024年6月。我们使用比值比(OR)和95%置信区间(CIs)作为比较DOAC和VKAs的效果指标。
    结果:共纳入9项观察性研究。汇总分析显示,与VKAs(55.3%)相比,DOAC(71.4%)的完全再通率更高。虽然没有统计学意义(OR1.95;95CI0.70至5.44)。对于SVT扩展,观察到有利于DOAC的显著效应(OR0.12;95CI0.03至0.54)。在其他疗效结果或安全性结果方面没有发现显著差异,除了大出血,DOAC显著降低(OR0.27;95CI0.13至0.56)。
    结论:DOAC在SVT延长和大出血方面优于VKAs,提示DOAC可能是治疗室上性心动过速的有利治疗选择。
    BACKGROUND: Since several studies have examined the use of direct oral anticoagulants (DOACs) in treating patients with splanchnic vein thrombosis (SVT), we conducted a meta-analyses to assess the safety and efficacy of DOACs compared to vitamin K antagonists (VKAs) in this population.
    METHODS: We conducted a comprehensive search using the PubMed, Embase, and Cochrane Library databases until June 2024. We used odds ratios (ORs) and 95% confidence intervals (CIs) as the effect measures to compare DOACs with VKAs.
    RESULTS: A total of 9 observational studies were included. The pooled analysis revealed that a trend towards higher complete recanalization rates with DOACs (71.4%) compared to VKAs (55.3%), though not statistically significant (OR 1.95; 95%CI 0.70 to 5.44). For SVT extension, a significant effect was observed favoring DOACs (OR 0.12; 95%CI 0.03 to 0.54). No significant differences were found in other efficacy outcomes or safety outcomes, except for major bleeding, which was significantly lower with DOACs (OR 0.27; 95%CI 0.13 to 0.56).
    CONCLUSIONS: DOACs are superior to VKAs in SVT extension and major bleeding, suggesting that DOACs may be a favorable treatment option in the treatment of SVT.
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  • 文章类型: Journal Article
    《日本老年心房颤动登记处》为30,000名日本老年患者(年龄≥75岁)的非瓣膜性心房颤动(NVAF)提供了真实见解,包括>2,000名年轻人。我们旨在按年龄和口服抗凝剂(OAC)类型调查这些患者的预后。
    这个前景,多中心,观察,队列,为期2年的随访研究包括能够参加医院访问的患有NVAF的老年患者。卒中/全身栓塞事件(SEE)的发生率,大出血,颅内出血(ICH),心血管死亡,全因死亡,按年龄评估主要不良心血管或神经系统事件(MACNE).发病率随着年龄的增长而显著增加。Stroke/SEE,大出血,年龄≥90岁患者的ICH发病率趋于稳定。直接OAC(DOAC)产生的事件发生率与华法林在所有年龄组和终点,除了90岁以上患者的大出血。DOAC(vs.华法林)与较低的卒中/SEE风险显着相关,大出血,≥80-<85岁组的ICH,≥75-<80岁组的心血管疾病和全因死亡减少。在≥90岁亚组中,大出血史是全因死亡的危险因素.
    虽然DOAC与华法林为预防中风提供了潜在的益处,在年龄≥90岁的人群中,在减少大出血方面存在局限性,表明极低剂量DOAC对该人群有潜在益处。
    UNASSIGNED: The All Nippon Atrial Fibrillation In the Elderly Registry provides real-world insights into non-valvular atrial fibrillation (NVAF) in >30,000 elderly Japanese patients (aged ≥75 years), including >2,000 nonagenarians. We aimed to investigate outcomes in these patients by age and oral anticoagulant (OAC) type.
    UNASSIGNED: This prospective, multicenter, observational, cohort, 2-year follow-up study included elderly patients with NVAF who were able to attend hospital visits. The incidences of stroke/systemic embolic events (SEE), major bleeding, intracranial hemorrhage (ICH), cardiovascular death, all-cause death, and major adverse cardiovascular or neurological events (MACNE) were evaluated by age. Incidence rates increased significantly with age. Stroke/SEE, major bleeding, and ICH incidences plateaued in patients aged ≥90 years. Direct OACs (DOACs) yielded a numerically lower event incidence vs. warfarin in all age groups and endpoints, except for major bleeding in patients aged ≥90 years. DOACs (vs. warfarin) were significantly associated with a lower risk of stroke/SEE, major bleeding, and ICH in the ≥80-<85 years group, and reduced cardiovascular and all-cause death in the ≥75-<80 years group. In the ≥90 years subgroup, major bleeding history was a risk factor for all-cause death.
    UNASSIGNED: Although DOAC vs. warfarin offers potential benefits for stroke prevention, limitations occurred in reducing major bleeding among those aged ≥90 years, indicating a potential benefit of very-low-dose DOAC for this demographic.
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  • 文章类型: Journal Article
    西班牙医学肿瘤学会(SEOM)最近于2019年发布了有关静脉血栓栓塞(VTE)和癌症的临床指南,并于2020年进行了部分更新。在这一新的指南更新中,SEOM试图纳入最近的证据,基于对文献的批判性回顾,为癌症患者VTE的预防和治疗管理提供实用的当前建议。包括目前推荐的治疗方案(低分子量肝素[LMWHs]或直接作用的口服抗凝剂[DOACs])的管理和/或选择存在争议的特殊临床情况。
    The Spanish Society of Medical Oncology (SEOM) last published clinical guidelines on venous thromboembolism (VTE) and cancer in 2019, with a partial update in 2020. In this new update to the guidelines, SEOM seeks to incorporate recent evidence, based on a critical review of the literature, to provide practical current recommendations for the prophylactic and therapeutic management of VTE in patients with cancer. Special clinical situations whose management and/or choice of currently recommended therapeutic options (low-molecular-weight heparins [LMWHs] or direct-acting oral anticoagulants [DOACs]) is controversial are included.
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  • 文章类型: Journal Article
    背景:轻度创伤性脑损伤(mTBI)具有很大的风险,尤其是在接受抗凝治疗的老年人群中。由于存在迟发性颅内出血(d-ICH)的风险,因此对这些患者从急诊科(ED)出院的安全性进行了辩论。
    目的:为了比较结果,包括d-ICH,接受抗凝治疗并出现mTBI的老年患者在初次头部CT扫描阴性后入院与出院之间的关系.
    方法:我们在ChaimSheba医疗中心进行了一项回顾性观察研究,评估1598例接受抗凝治疗并出现mTBI和最初头部CT扫描阴性的老年患者的结局。患者要么入院24小时观察(A组,n=829)或立即从ED出院(B组,n=769)。主要结果是14天内d-ICH的发生率。
    结果:在纳入研究的1598名患者中,46名入院患者和1名出院患者在14天内返回进行重复CT,确定出院患者的无症状出血。入院患者30天时的死亡率明显高于出院患者(4.8%vs.1.8%,p=0.001),尽管两组的死亡原因与头部损伤无关。
    结论:在接受mTBI和初始CT阴性的抗凝治疗的老年患者中,与出院相比,入院与更高的d-ICH风险相关.这些发现对这一高风险人群的临床决策具有重要意义。
    BACKGROUND: Mild traumatic brain injuries (mTBIs) pose a significant risk, particularly in the elderly population on anticoagulation therapy. The safety of discharging these patients from the emergency department (ED) with a negative initial computed tomography (CT) scan has been debated due to the risk of delayed intracranial hemorrhage (d-ICH).
    OBJECTIVE: To compare outcomes, including d-ICH, between elderly patients on anticoagulation therapy presenting with mTBI who were admitted versus discharged from the ED after an initial negative head CT scan.
    METHODS: We conducted a retrospective observational study at the Chaim Sheba Medical Center, assessing outcomes of 1598 elderly patients on anticoagulation therapy who presented with mTBI and an initial negative head CT scan. Patients were either admitted for 24-h observation (Group A, n = 829) or discharged immediately from the ED (Group B, n = 769). The primary outcome was incidence of d-ICH within 14 days.
    RESULTS: Among the 1598 patients included in the study, 46 admitted patients and 1 discharged patient returned within 14 days for repeat CT, identifying one asymptomatic hemorrhage in the discharged patient. Mortality at 30 days was significantly higher in admitted patients compared to discharged patients (4.8% vs. 1.8%, p = 0.001), though cause of death was unrelated to head injury in both groups.
    CONCLUSIONS: In elderly patients on anticoagulation with mTBI and a negative initial CT, admission was associated with a higher risk of d-ICH compared to discharge. These findings have implications for clinical decision-making in this high-risk population.
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  • 文章类型: Journal Article
    背景:由于标准抗凝治疗的局限性,儿童急性静脉血栓栓塞症(VTE)面临着独特的挑战。在这里,我们旨在系统回顾评价直接口服抗凝药(DOACs)在急性VTE儿科患者中的疗效和安全性的随机对照试验(RCTs).
    方法:搜索PubMed和Embase数据库,以比较DOAC与标准抗凝治疗在小儿VTE患者中的RCT。疗效结果包括VTE复发和全因死亡率,而安全性结局包括大出血和其他不良事件.
    结果:纳入了三个RCT,790名参与者。与标准抗凝相比,DOACs显示VTE复发风险降低(风险差异[RD]=-3%,95%置信区间[CI]:-6%至0%,P=0.04)和任何不良事件的风险增加(RD=8%,95%CI:1%至14%,P=0.02)。全因死亡率没有发现显著差异,大出血,临床相关非大出血,或DOAC组和对照组之间的总出血。
    结论:DOAC,主要是达比加群和利伐沙班,在减少儿科患者的VTE复发方面不劣于标准抗凝剂,具有可比的安全性。进一步的研究对于证实这些发现至关重要。
    BACKGROUND: Acute venous thromboembolism (VTE) in children presents unique challenges due to the limitations of standard anticoagulation therapies. Herein, we aimed to systematically review randomized controlled trials (RCTs) evaluating the efficacy and safety of direct oral anticoagulants (DOACs) in pediatric patients with acute VTE.
    METHODS: PubMed and Embase databases were searched for RCTs comparing DOACs to standard anticoagulation in pediatric VTE patients. Efficacy outcomes included VTE recurrence and all-cause mortality, while safety outcomes comprised major bleeding and other adverse events.
    RESULTS: Three RCTs with 790 participants were included. When compared with standard anticoagulation, DOACs demonstrated a reduced risk of VTE recurrence (risk difference[RD] = -3%, 95% confidence interval[CI]: -6% to 0%, P = 0.04) and an increased risk of any adverse event (RD = 8%, 95% CI: 1% to 14%, P = 0.02). No significant differences were found in all-cause mortality, major bleeding, clinically relevant non-major bleeding, or total bleeding between the DOAC and control groups.
    CONCLUSIONS: DOACs, primarily dabigatran and rivaroxaban, are non-inferior to standard anticoagulants in reducing VTE recurrence in pediatric patients, with comparable safety profiles. Further research is essential to confirm these findings.
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  • 文章类型: Systematic Review
    背景:直接口服抗凝剂(DOAC)已广泛应用于成人血栓形成的预防。然而,DOAC对需要抗凝治疗的先天性或获得性心脏病患儿的疗效尚不清楚.
    方法:我们系统地搜索了PubMed的数据库,Embase,还有Cochrane图书馆,以及ClinicalTrials.gov注册表和世界卫生组织的国际临床试验注册平台,直到2024年6月,以确定相关的随机临床试验(RCT)。如果纳入研究的数量少于5项,我们进行了叙述性审查,以评估DOAC在儿科患者中的作用。
    结果:纳入4项研究。在宇宙研究中,2%的利伐沙班组和9%的阿司匹林组发生血栓事件,36%和41%的出血事件,分别。ENNOBLE-ATE研究显示,依多沙班组无血栓栓塞事件,SOC组为1.7%(率差异:-0.07%,95%CI:-0.22至0.07%)。大出血率相似(率差异:-0.03%,95%CI:-0.18~0.12%)。SAXOPHONE试验显示两组均无血栓栓塞事件,大出血发生率相似(-0.8%,95%CI:-8.1至3.3%)。在多样性审判中,81%的达比加群患者达到了主要结局,而SOC组为59.3%(赔率:0.342,95%CI:0.081-1.229)。两组均无大出血。
    结论:现有研究表明,DOAC的使用有望成为预防和治疗患有心脏病的儿科患者血栓栓塞的有效和安全的替代方案。
    BACKGROUND: Direct oral anticoagulants (DOACs) have been widely applied in adults for thrombosis prophylaxis. However, the effect of DOACs in pediatric patients with congenital or acquired heart diseases who need anticoagulation therapy remains unclear.
    METHODS: We systematically searched the databases of PubMed, Embase, and the Cochrane Library, as well as the ClinicalTrials.gov registry and the World Health Organization\'s International Clinical Trials Registry Platform until June 2024 to identify relevant randomized clinical trials (RCTs). If the number of included studies was less than 5, we performed a narrative review to assess the effect of DOACs in pediatric patients.
    RESULTS: Four studies were included. In the UNIVERSE study, thrombotic events occurred in 2% of the rivaroxaban group and 9% of the aspirin group, with bleeding events in 36% and 41%, respectively. The ENNOBLE-ATE study showed no thromboembolic events in the edoxaban group and 1.7% in the SOC group (rate difference: -0.07%, 95% CI: -0.22 to 0.07%). Major bleeding rates were similar (rate difference: -0.03%, 95% CI: -0.18 to 0.12%). The SAXOPHONE trial showed no thromboembolic events in either group and similar major bleeding rates (-0.8%, 95% CI: -8.1 to 3.3%). In the DIVERSITY trial, 81% of dabigatran patients achieved the primary outcome versus 59.3% in the SOC group (Odds ratio: 0.342, 95% CI: 0.081-1.229). No major bleeding occurred in either group.
    CONCLUSIONS: Existing studies suggest that the use of DOACs hold promise as an effective and safe alternative for preventing and treating thromboembolism in pediatric patients with heart conditions.
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  • 文章类型: Journal Article
    心房颤动(AF)是发病率和死亡率的主要因素。卒中预防仍是房颤管理的主要手段。血栓形成的确切机制尚不清楚。然而,因素,如拉伸诱导的纤维化,内皮功能障碍,心房收缩紊乱,和血栓前状态已被假定为房颤的发展。各种风险评估策略已被确认用于确定房颤患者中风的风险。其中充血性心力衰竭,高血压,年龄≥75,糖尿病,中风,血管疾病,年龄在65~74岁之间,女性(CHA2DS2-VASc)评分仍是最终的危险分层工具.在最长的时间里,维生素K拮抗剂(VKA)是唯一可用的口服抗凝剂,但与出血风险增加相关.最近,直接口服抗凝药(DOAC)在预防卒中和降低颅内出血事件方面获得批准,并被认为比华法林更有效,更安全或更安全.本文还阐明了DOAC的药效学和药代动力学。这篇综述文章汇编了当前关于DOAC作用的循证数据,揭示它们的潜在机制,并比较其与华法林预防房颤卒中的疗效。
    Atrial fibrillation (AF) is a predominant contributor to morbidity and mortality, and stroke prevention remains the mainstay for the management of AF. The precise mechanism involved in thrombus formation remains unknown. However, factors such as stretch-induced fibrosis, endothelial dysfunction, disordered atrial contractions, and pro-thrombotic states have been postulated for the development of AF. Various risk assessment strategies have been acknowledged for determining the risk of stroke in AF, of which the congestive heart failure, hypertension, age ≥75, diabetes, stroke, vascular disease, age between 65-74, and female sex (CHA2DS2-VASc) score remains the ultimate risk stratification tool. For the longest time, vitamin K antagonists (VKA) were the only oral anticoagulants available but were associated with an increased risk of bleeding. Recently, direct oral anticoagulants (DOACs) were approved and considered more efficient and safer than or as secure as warfarin in stroke prevention and lowering intra-cranial bleeding events. The pharmacodynamics and pharmacokinetics of DOACs were also clarified in this article. This review article compiles current evidence-based data on the role of DOACs, uncovering their underlying mechanisms, and comparing their efficacy with warfarin in stroke prevention in AF.
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  • 文章类型: Journal Article
    维生素K拮抗剂(VKAs)已被推荐为左心室血栓形成(LVT)患者的一线抗凝剂。直接口服抗凝剂(DOAC)被用作抗凝护理标准的替代品。这项荟萃分析的目的是比较VKAs和DOAC治疗LVT患者的疗效和安全性。
    通过搜索PubMed,WebofScience,和Embase。主要结局包括卒中或全身性栓塞(SSE),血栓分辨率,出血事件。使用固定效应或随机效应模型估计具有95%置信区间(CI)的合并风险比(RR)。
    纳入了17项研究。汇总估计显示,与VKAs(RR=1.07,95%CI:0.97,1.18;p=0.193)相比,DOAC在预防SSE(RR=0.96,95%CI:0.80,1.16;p=0.677)和血栓分辨率方面具有相当的功效。DOAC显著降低LVT患者卒中风险(RR=0.68,95%CI:0.47,1.00;p=0.048)。然而,在高质量研究的敏感分析中未观察到这种效应(RR=0.69,95%CI:0.47,1.02;p=0.06).就安全结果而言,DOACs具有相似的出血事件风险(RR=1.12,95%CI:0.80,1.57;p=0.386)和临床相关出血事件风险(RR=0.49,95%CI:0.23,1.03;p=0.060)。荟萃回归分析表明,没有变量(研究设计,伴随抗血小板药物,随访时间,LVT的主要原因,样本量,DOAC的类型)对SSE的风险有影响,血栓消退和出血事件。基于抗血小板使用和治疗转换的亚组分析显示,不同治疗方案的患者之间没有显着差异。
    根据目前的证据,DOAC和VKA在LVT患者中提供了相似的有效和安全结局.
    UNASSIGNED: Vitamin K antagonists (VKAs) have been recommended as first-line anticoagulants for patients with left ventricular thrombosis (LVT). Direct oral anticoagulants (DOACs) are used as an alternative to the standard of care in anticoagulation. The aim of this meta-analysis was to compare the efficacy and safety of VKAs and DOACs in the treatment of patients with LVT.
    UNASSIGNED: Studies were identified by searching the PubMed, Web of Science, and Embase. The main outcomes included stroke or systemic embolism (SSE), thrombus resolution, and bleeding events. The pooled risk ratio (RR) with 95% confidence intervals (CIs) was estimated with fixed effect or random effect models.
    UNASSIGNED: Seventeen studies were included. Pooled estimate showed that DOACs had comparable efficacy in prevention of SSE (RR = 0.96, 95% CI: 0.80, 1.16; p = 0.677) and thrombus resolution as compared with VKAs (RR = 1.07, 95% CI: 0.97, 1.18; p = 0.193). DOACs significantly decreased the risk of stroke in patients with LVT (RR = 0.68, 95% CI: 0.47, 1.00; p = 0.048). However, this effect was not observed in the sensitive analysis by high-quality studies (RR = 0.69, 95% CI: 0.47, 1.02; p = 0.06). In terms of safety outcomes, DOACs had similar risk of bleeding events (RR = 1.12, 95% CI: 0.80, 1.57; p = 0.386) and clinically relevant bleeding events (RR = 0.49, 95% CI: 0.23, 1.03; p = 0.060). Meta-regression analysis demonstrated that none of the variables (study design, concomitant antiplatelet medication, duration of follow-up, primary cause of LVT, sample size, types of DOACs) had an impact on the risk of SSE, thrombus resolution and bleeding events. Subgroup analysis based on the use of antiplatelet and treatment switching revealed that there were no significant differences among patients with different treatment regimens.
    UNASSIGNED: Based on the present evidence, both DOACs and VKA offered similar effective and safe outcomes in patients with LVT.
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  • 文章类型: Journal Article
    关于左心室血栓(LVT)的药物治疗的建议是基于ST段抬高型心肌梗死(STEMI)指南;然而,LVT的病因发生了改变。由于缺乏关于心力衰竭人群LVT治疗的证据,目前的心力衰竭指南不包括LVT治疗.我们试图回顾过去12年中LVT的病因和抗血栓治疗的变化,并从单个中心的经验中探讨抗凝治疗的影响。
    从2009年1月到2021年6月,我们在单个中心研究了1675例出院诊断为LVT的患者,以调查其临床特征,全因死亡的发生率,心血管死亡,缺血性卒中,主要不良心脑血管事件(MACCE),全身性栓塞(SE),和大出血事件。根据患者出院时是否接受口服抗凝治疗分为抗凝组和非抗凝组。
    该研究包括909名患者(抗凝,510;无抗凝,399).虽然整体抗血小板治疗急剧下降,与2009年(29.6%)相比,2021年接受口服抗凝治疗的LVT患者更多(74.0%).此外,每年有超过一半的患者出现射血分数(HFrEF)降低的心力衰竭.在3.8年的随访期间,全因死亡率为17.3%。心血管死亡的发生率,中风,MACCE,SE,大出血为16.0%,3.3%,19.8%,5.1%,和1.7%,分别。抗凝组扩张型心肌病的比例明显高于非抗凝组(24.7%vs.5.5%,p<0.001),和较低的LVEF(34.0vs.41.0,p<0.001)。抗凝组在长期随访中出现不良事件的概率也较高(p>0.05)。多变量竞争风险回归模型发现两组间6个终点均无显著差异(均P>0.05)。通过匹配和加权数据分析发现了类似的结果。糖尿病(危险比(HR),1.42;95%置信区间(CI),1.04-1.93;p=0.027),肾功能不全(HR,2.36;95%CI,1.60-3.50;p<0.001),既往卒中病史(HR,1.60;95%CI,1.13-2.29;p=0.009),和HFrEF(HR,2.54;95%CI,1.78-3.64;p<0.001)是MACCE风险增加的预测因子。
    心力衰竭,而不是急性心肌梗塞,是目前LVT的主要原因。观察到非抗凝组预后更好的趋势。多变量,匹配和加权分析显示,抗凝治疗对预后无改善.我们的研究并没有否定抗凝的疗效,但建议需要加强抗凝管理以获得更好的疗效。
    UNASSIGNED: Recommendations for drug treatment of left ventricular thrombus (LVT) are based on the ST-segment elevation myocardial infarction (STEMI) guidelines; however, the etiology of LVT has changed. Due to the lack of evidence regarding LVT treatment in the heart failure population, current heart failure guidelines do not cover LVT treatment. We sought to review the etiology of LVT and changes in antithrombotic therapy over the previous 12 years and explore the impact of anticoagulation treatment from a single center\'s experience.
    UNASSIGNED: From January 2009 to June 2021, we studied 1675 patients with a discharge diagnosis of LVT at a single center to investigate the clinical characteristics, incidence of all-cause death, cardiovascular death, ischemic stroke, major adverse cardiac and cerebrovascular events (MACCE), systemic embolism (SE), and major bleeding events. Patients were divided into an anticoagulant group and a non-anticoagulant group according to whether they received oral anticoagulant therapy at discharge.
    UNASSIGNED: The study included 909 patients (anticoagulation, 510; no anticoagulation, 399). While overall antiplatelet therapy dramatically decreased, more patients with LVT received oral anticoagulation in 2021 (74.0%) than in 2009 (29.6%). In addition, more than half of the patients had heart failure with reduced ejection fraction (HFrEF) each year. The all-cause mortality was 17.3% during 3.8 years of follow-up. The incidences of cardiovascular death, stroke, MACCE, SE, and major bleeding were 16.0%, 3.3%, 19.8%, 5.1%, and 1.7%, respectively. The anticoagulation group had a significantly higher proportion of dilated cardiomyopathy than the non-anticoagulation group (24.7% vs. 5.5%, p < 0.001), and a lower LVEF (34.0 vs. 41.0, p < 0.001). The anticoagulation group also had a higher probability of adverse events on long-term follow-up (p > 0.05). A multivariable competing risk regression model found no significant difference in all six endpoints between the groups (all p > 0.05). Similar results were found by matched and weighted data analysis. Diabetes mellitus (hazard ratio (HR), 1.42; 95% confidence interval (CI), 1.04-1.93; p = 0.027), renal insufficiency (HR, 2.36; 95% CI, 1.60-3.50; p < 0.001), history of previous stroke (HR, 1.60; 95% CI, 1.13-2.29; p = 0.009), and HFrEF (HR, 2.54; 95% CI, 1.78-3.64; p < 0.001) were predictors of increased risk of MACCE.
    UNASSIGNED: Heart failure, rather than acute myocardial infarction, is currently the primary cause of LVT. A trend towards better prognosis in the no anticoagulation group was noted. Multivariable, matching and weighting analysis showed no improvement in prognosis with anticoagulant therapy. Our study does not negate the efficacy of anticoagulation but suggests the need to strengthen the management of anticoagulation in order to achieve better efficacy.
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  • 文章类型: Journal Article
    现实世界,观察性研究调查了直接口服抗凝剂(DOAC)用于非瓣膜性心房颤动(NVAF)患者大出血(MH)预防卒中的安全性.我们进行了系统评价和荟萃分析,以研究遵循PRISMA指南的DOAC与其他DOAC和维生素K拮抗剂(VKAs)的比较安全性。我们根据国际血栓和止血协会声明定义MH,或将其定义为颅内,胃肠,泌尿生殖系统,呼吸,在使用国际疾病统计分类代码进行患者选择的研究中,空洞和肌肉骨骼出血。
    我们系统地调查了两个数据库(Medline,Embase),直到2021年4月,收集观察性研究并提取风险比(HR),对我们感兴趣的结果有95%的置信区间(CI)。根据DOAC给药的其他亚组分析,先前诊断为慢性肾脏病,中风的先前诊断,以前使用VKA的历史,用户年龄,进行了用户的性别和研究人口地理区域。所有分析均采用随机效应模型进行。
    从这个搜索,纳入55项研究,进行76项比较。使用利伐沙班的MH风险高于使用达比加群的风险(HR:1.32,95%CI:1.21-1.45,I2:12.39%),但与使用VKA相似(HR:0.94,95%CI:0.87-1.02,I2:76.57%)。使用达比加群的MH风险低于使用VKA的风险(HR:0.75,95%CI:0.64-0.90,I2:87.57%)。与使用阿哌沙班相关的MH风险低于使用达比加群的风险(HR:0.75,95%CI:0.64-0.88,I2:58.66%),使用利伐沙班(HR:0.58,95%CI:0.50-0.68,I2:74.16%)和使用VKA(HR:0.60,95%CI:0.55-0.65,I2:58.83%)。我们前述的亚组分析揭示了类似的结果。
    所有,与达比加群相比,阿哌沙班的MH风险降低,利伐沙班和VKA。与利伐沙班和VKA相比,达比加群降低了MH风险。
    UNASSIGNED: Real-world, observational studies have investigated the safety profile of Direct Oral Anticoagulants (DOACs) on Major Hemorrhage (MH) used for stroke prevention in Non-Valvular Atrial Fibrillation (NVAF). We performed a systematic review and meta-analysis to investigate the comparative safety of DOACs versus other DOACs and versus Vitamin K Antagonists (VKAs) adhering to PRISMA guidelines. We defined MH according to the International Society on Thrombosis and Haemostasis statement or as the composite outcome of intracranial, gastrointestinal, genitourinary, respiratory, cavitary and musculoskeletal bleeding in case of studies using International Statistical Classification of Diseases codes for patient selection.
    UNASSIGNED: We systematically investigated two databases (Medline, Embase) until April of 2021, gathered observational studies and extracted hazard ratios (HRs) with 95% confidence intervals (CI) on our outcome of interest. Additional subgroup analyses according to DOAC dosing, prior diagnosis of chronic kidney disease, prior diagnosis of stroke, history of previous use of VKA, the users\' age, the users\' gender and study population geographic region were conducted. All analyses were performed with a random-effects model.
    UNASSIGNED: From this search, 55 studies were included and 76 comparisons were performed. The MH risk associated with Rivaroxaban use was higher than the risk with Dabigatran use (HR: 1.32, 95% CI: 1.21-1.45, I 2 : 12.39%) but similar to VKA use (HR: 0.94, 95% CI: 0.87-1.02, I 2 : 76.57%). The MH risk associated with Dabigatran use was lower than the risk with VKA use (HR: 0.75, 95% CI: 0.64-0.90, I 2 : 87.57%). The MH risk associated with Apixaban use was lower than the risk with Dabigatran use (HR: 0.75, 95% CI: 0.64-0.88, I 2 : 58.66%), with Rivaroxaban use (HR: 0.58, 95% CI: 0.50-0.68, I 2 : 74.16%) and with VKA use (HR: 0.60, 95% CI: 0.55-0.65, I 2 : 58.83%). Our aforementioned subgroup analyses revealed similar results.
    UNASSIGNED: All in all, Apixaban was associated with a reduced MH risk compared to Dabigatran, Rivaroxaban and VKA. Dabigatran was associated with a reduced MH risk compared to both Rivaroxaban and VKA.
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