NOAC

NOAC
  • 文章类型: Journal Article
    简介:虽然根据最近的数据,2019年急性冠状病毒病(COVID-19)会影响心血管(CV)系统,据报道,在长期随访(FU)期间,CV风险也增加.除了COVID-19幸存者的其他CV病理学,观察到心律失常事件和心源性猝死(SCD)的风险增加.虽然出院后预防血栓的建议在这一人群中相互矛盾,出院后预防性短期利伐沙班治疗取得了有希望的结果.然而,迄今为止,该方案对心律失常发生率的影响尚未得到评估.方法:探讨该疗法的疗效,我们进行了一个中心,1804年连续的回顾性分析,2020年4月至12月期间住院的COVID-19幸存者。患者接受出院后30天使用利伐沙班10mg每天(QD)的血栓预防治疗方案(利伐沙班组(Riva);n=996)或不进行血栓预防(对照组(Ctrl);n=808)。新发心房颤动(AF)住院,我们在12个月FU[FU:347(310/449)天]内调查了新的更高程度的房室传导阻滞(AVB)和SCD的发生率.结果:基线特征无差异(CtrlvsRiva:年龄:59.0(48.9/66.8)vs57(46.5/64.9)岁,p=n.s.;男性:41.5%对43.7%,p=n.s.),并在两组之间观察到相关CV疾病的病史。虽然两组均未报告AVB的住院情况,新房颤的相关住院率(0.99%,n=8/808)以及高SCD事件发生率(2.35%,n=19/808)在Ctrl中看到。出院后早期预防性利伐沙班治疗减轻了这些心脏事件(AF:n=2/996,0.20%,p=0.026和SCD:n=3/996,0.30%,p<0.001),这也是在应用逻辑回归模型进行倾向评分匹配后观察到的(AF:χ2统计量=6.45,p=0.013,SCD:χ2统计量=9.33,p=0.002)。值得注意的是,两组均未出现大出血并发症.结论:COVID-19住院后的前12个月内出现房性心律失常和SCD事件。出院后延长利伐沙班预防性治疗可减少住院COVID-19幸存者的房颤和SCD新发。
    Introduction: While acute Coronavirus disease 2019 (COVID-19) affects the cardiovascular (CV) system according to recent data, an increased CV risk has been reported also during long-term follow-up (FU). In addition to other CV pathologies in COVID-19 survivors, an enhanced risk for arrhythmic events and sudden cardiac death (SCD) has been observed. While recommendations on post-discharge thromboprophylaxis are conflicting in this population, prophylactic short-term rivaroxaban therapy after hospital discharge showed promising results. However, the impact of this regimen on the incidence of cardiac arrhythmias has not been evaluated to date. Methods: To investigate the efficacy of this therapy, we conducted a single center, retrospective analysis of 1804 consecutive, hospitalized COVID-19 survivors between April and December 2020. Patients received either a 30-day post-discharge thromboprophylaxis treatment regimen using rivaroxaban 10 mg every day (QD) (Rivaroxaban group (Riva); n = 996) or no thromboprophylaxis (Control group (Ctrl); n = 808). Hospitalization for new atrial fibrillation (AF), new higher-degree Atrioventricular-block (AVB) as well as incidence of SCD were investigated in 12-month FU [FU: 347 (310/449) days]. Results: No differences in baseline characteristics (Ctrl vs Riva: age: 59.0 (48.9/66.8) vs 57 (46.5/64.9) years, p = n.s.; male: 41.5% vs 43.7%, p = n.s.) and in the history of relevant CV-disease were observed between the two groups. While hospitalizations for AVB were not reported in either group, relevant rates of hospitalizations for new AF (0.99%, n = 8/808) as well as a high rate of SCD events (2.35%, n = 19/808) were seen in the Ctrl. These cardiac events were attenuated by early post-discharge prophylactic rivaroxaban therapy (AF: n = 2/996, 0.20%, p = 0.026 and SCD: n = 3/996, 0.30%, p < 0.001) which was also observed after applying a logistic regression model for propensity score matching (AF: χ 2-statistics = 6.45, p = 0.013 and SCD: χ 2-statistics = 9.33, p = 0.002). Of note, no major bleeding complications were observed in either group. Conclusion: Atrial arrhythmic and SCD events are present during the first 12 months after hospitalization for COVID-19. Extended prophylactic Rivaroxaban therapy after hospital discharge could reduce new onset of AF and SCD in hospitalized COVID-19 survivors.
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  • 文章类型: Journal Article
    心房颤动(AF)是最常见的持续性心律失常,并且与中风和全身性血栓栓塞的风险显着增加有关。随着2009年第一种非维生素K拮抗剂直接口服抗凝剂(NOAC)的成功引入,维生素K拮抗剂的作用已在大多数临床环境中被取代,除非在少数禁用NOAC的条件下。在过去的十年中,在不同临床场景中使用NOAC的数据一直在积累,现在有必要为房颤患者提供更复杂的策略。JACC:亚洲最近任命了一个工作组,以总结有关房颤中风预防的最新信息。该声明的目的是在日常实践中提供可能的治疗选择。本地可用性,成本,和患者的合并症也应考虑。最终决定可能仍然需要个性化,并基于临床医生的判断。这是声明的第二部分。
    Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated with substantial increases in the risk for stroke and systemic thromboembolism. With the successful introduction of the first non-vitamin K antagonistdirect oral anticoagulant agent (NOAC) in 2009, the role of vitamin K antagonists has been replaced in most clinical settings except in a few conditions for which NOACs are contraindicated. Data for the use of NOACs in different clinical scenarios have been accumulating in the past decade, and a more sophisticated strategy for patients with AF is now warranted. JACC: Asia recently appointed a working group to summarize the most updated information regarding stroke prevention in AF. The aim of this statement is to provide possible treatment options in daily practice. Local availability, cost, and patient comorbidities should also be considered. Final decisions may still need to be individualized and based on clinicians\' discretion. This is part 2 of the statement.
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  • 文章类型: Systematic Review
    UNASSIGNED:经皮冠状动脉介入治疗的房颤患者的抗栓治疗在临床实践中面临着主要的治疗问题。
    UNASSIGNED:我们首先进行了贝叶斯网络荟萃分析,以研究不同抗血栓治疗方案的安全性和有效性。只有PubMed的随机对照试验,WebofScience,Cochrane中央控制试验登记册,Embase,和中国国家知识基础设施被纳入我们的研究。本研究采用贝叶斯随机效应模型。主要安全性和有效性结果是根据心肌梗死溶栓(TIMI)标准的大出血和试验定义的主要不良心血管事件。分别。次要安全性结果为TIMI合并严重和轻微出血,试验定义的原发性出血事件,颅内出血.次要疗效结果是全因或心血管死亡率,心肌梗塞,中风,支架内血栓形成,和住院。
    UNASSIGNED:对来自5项随机对照试验的11,532名患者进行了分析,其中8,426人为男性。与维生素K拮抗剂(VKA)加P2Y12抑制剂相比,对于VKA联合双联抗血小板治疗(DAPT),TIMI大出血的比值比(95%可信区间)为1.70(0.77-3.80),1.20(0.30-4.60)利伐沙班加P2Y12抑制剂,利伐沙班加DAPT为1.00(0.25-3.90),达比加群+P2Y12抑制剂为0.76(0.21-2.80),阿哌沙班加P2Y12抑制剂为0.71(0.25-2.10),阿哌沙班加DAPT为1.40(0.52-3.80),依度沙班+P2Y12抑制剂为1.00(0.27-4.00)。对于试验定义的主要不良心血管事件,与VKA加P2Y12抑制剂相比,VKA加DAPT的比值比(95%可信区间)为1.10(0.61-2.00),1.20(0.45-3.70)利伐沙班加P2Y12抑制剂,1.10(0.38-3.20)利伐沙班加DAPT,1.10(0.43-3.10)达比加群+P2Y12抑制剂,阿哌沙班加P2Y12抑制剂为1.00(0.47-2.20),阿哌沙班加DAPT为0.99(0.46-2.20),依度沙班+P2Y12抑制剂为1.20(0.43-3.40)。除试验定义的主要不良心血管事件外,阿哌沙班加P2Y12抑制剂是安全性结局中排名最高的,VKA加P2Y12抑制剂是疗效结局中排名最高的。
    UNASSIGNED:阿哌沙班联合P2Y12抑制剂似乎与较少的出血并发症有关,同时保留了抗血栓的疗效。此外,对于大多数功效指标,VKA加P2Y12抑制剂的排名仍然很高。
    未经批准:[www.crd.约克。AC.英国/普华永道/],标识符[CRD42020149894]。
    UNASSIGNED: Antithrombotic therapy for patients with atrial fibrillation undergoing percutaneous coronary intervention is facing major treatment problems in clinical practice.
    UNASSIGNED: We firstly conducted a Bayesian network meta-analysis to study the safety and efficacy of different antithrombotic regimens. Only randomized controlled trials from PubMed, Web of Science, Cochrane Central Register of Controlled Trials, Embase, and China National Knowledge Infrastructure were included in our study. The Bayesian random-effects model was used in this study. The primary safety and efficacy outcomes were major bleeding according to the criteria of Thrombolysis In Myocardial Infarction (TIMI) and trial-defined major adverse cardiovascular events, respectively. The secondary safety outcomes were combined TIMI major and minor bleeding, trial-defined primary bleeding events, and intracranial hemorrhage. The secondary efficacy outcomes were all-cause or cardiovascular mortality, myocardial infarction, stroke, stent thrombosis, and hospitalization.
    UNASSIGNED: Total of 11,532 patients from the five randomized controlled trials were analyzed, of whom 8,426 were male. Compared with vitamin K antagonist (VKA) plus P2Y12 inhibitor, the odds ratios (95% credible intervals) for TIMI major bleeding were 1.70 (0.77-3.80) for VKA plus dual antiplatelet therapy (DAPT), 1.20 (0.30-4.60) for rivaroxaban plus P2Y12 inhibitor, 1.00 (0.25-3.90) for rivaroxaban plus DAPT, 0.76 (0.21-2.80) for dabigatran plus P2Y12 inhibitor, 0.71 (0.25-2.10) for apixaban plus P2Y12 inhibitor, 1.40 (0.52-3.80) for apixaban plus DAPT, and 1.00 (0.27-4.00) for edoxaban plus P2Y12 inhibitor. For trial-defined major adverse cardiovascular events, compared with VKA plus P2Y12 inhibitor, the odds ratios (95% credible intervals) were 1.10 (0.61-2.00) for VKA plus DAPT, 1.20 (0.45-3.70) for rivaroxaban plus P2Y12 inhibitor, 1.10 (0.38-3.20) for rivaroxaban plus DAPT, 1.10 (0.43-3.10) for dabigatran plus P2Y12 inhibitor, 1.00 (0.47-2.20) for apixaban plus P2Y12 inhibitor, 0.99 (0.46-2.20) for apixaban plus DAPT, and 1.20 (0.43-3.40) for edoxaban plus P2Y12 inhibitor. Apixaban plus P2Y12 inhibitor was the highest-ranking of safety outcomes and VKA plus P2Y12 inhibitor was the highest-ranking of efficacy outcomes other than trial-defined major adverse cardiovascular events.
    UNASSIGNED: Apixaban plus P2Y12 inhibitor seems to be linked with fewer bleeding complications while retaining antithrombotic efficacy. Moreover, for most efficacy indicators, the ranking of VKA plus P2Y12 inhibitor is still very high.
    UNASSIGNED: [www.crd.york.ac.uk/prospero/], identifier [CRD42020149894].
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  • 文章类型: Comparative Study
    我们比较了非维生素K拮抗剂口服抗凝剂(NOAC)和华法林在2型糖尿病(T2DM)患者中出血和心血管疾病(CVD)事件的风险。
    从40个英国普通诊所(1/4/2017-30/9/2018)中确定了862名患有T2DM的NOAC事件用户和626名患有T2DM的华法林事件用户。结果包括因出血而住院,自第一次抗凝剂处方后12个月内,CVD和因CVD而再次住院,从相关的住院数据中确定。应用锥形匹配方法来形成比较队列:粗化的精确匹配将比较限制在缺陷和特征充分重叠的区域:(i)人口统计学特征;(ii)临床测量;(iii)既往出血和CVD病史;(iv)出血处方;(v)抗高血压治疗;(vi)抗糖尿病治疗。熵平衡顺序平衡NOAC和华法林用户的(i-vi)分布。加权逻辑回归模型估计结果优势比(OR),使用来自步骤i-vi的熵平衡权重。
    NOAC(n=582)与匹配/平衡华法林(n=486)出血的12个月OR为1.93(95%置信区间0.97-3.84),2.14(1.03-4.44),2.31(1.10-4.85),2.42(1.14-5.14),2.41(1.12-5.18),和2.51(1.17-5.38)通过步骤i-vi。通过步骤i-vi的NOAC治疗,CVD再住院的ORs增加:2.21(1.04-4.68),2.13(1.01-4.52),2.47(1.08-5.62),2.46(1.02-5.94),2.51(1.01-6.20),和2.66(1.02-6.94)。
    与意外使用华法林相比,T2DM患者意外使用NOAC与出血住院和CVD再住院风险增加相关。对于T2DM,在处方NOAC作为第一抗凝治疗时需要谨慎。需要在外部数据集中进行进一步的大规模复制研究。
    We compared the risk of bleeding and cardiovascular disease (CVD) events between non-vitamin K antagonist oral anticoagulant (NOAC) and warfarin in people with type 2 diabetes (T2DM).
    862 Incident NOAC users and 626 incident warfarin users with T2DM were identified from within 40 UK general practice (1/4/2017-30/9/2018). Outcomes included incident hospitalisation for bleeding, CVD and re-hospitalisation for CVD within 12 months since first anticoagulant prescription, identified from linked hospitalisation data. A tapered matching method was applied to form comparison cohorts: coarsened exact matching restricted the comparison to areas of sufficient overlap in missingness and characteristics: (i) demographic characteristics; (ii) clinical measurements; (iii) prior bleeding and CVD history; (iv) prescriptions with bleeding; (v) anti-hypertensive treatment(s); (vi) anti-diabetes treatment(s). Entropy balancing sequentially balanced NOAC and warfarin users on their distribution of (i-vi). Weighted logistic regression modelling estimated outcome odds ratios (ORs), using entropy balancing weights from steps i-vi.
    The 12-month ORs of bleeding with NOAC (n = 582) vs matched/balanced warfarin (n = 486) were 1.93 (95% confidence interval 0.97-3.84), 2.14 (1.03-4.44), 2.31 (1.10-4.85), 2.42 (1.14-5.14), 2.41 (1.12-5.18), and 2.51 (1.17-5.38) through steps i-vi. ORs for CVD re-hospitalisation was increased with NOAC treatment through steps i-vi: 2.21 (1.04-4.68), 2.13 (1.01-4.52), 2.47 (1.08-5.62), 2.46 (1.02-5.94), 2.51 (1.01-6.20), and 2.66 (1.02-6.94).
    Incident NOAC use among T2DM is associated with increased risk of bleeding hospitalisation and CVD re-hospitalisation compared with incident warfarin use. For T2DM, caution is required in prescribing NOACs as first anticoagulant treatment. Further large-scale replication studies in external datasets are warranted.
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  • 文章类型: Journal Article
    Warfarin is the standard of care and NOAC (Novel oral anticoagulants) are a group of newer drugs for such purposes. NOAC has a generally better profile (Clear interaction, less side effect, require less monitoring). However, its efficacy on valvular atrial fibrillation remains unclear.
    We researched literature articles from Embase, Cochrane and PubMed. Then we meta-analysed these six articles to assess pooled estimate of relative risk (RR) and 95% confidence intervals (Cl) using random-effects model for stroke, systemic embolic event, major bleeding and all-cause mortality. Heterogeneity across study was tested with Cochran\'s Q Test and I2 Test. The bias of studies was first tested by examining the symmetry of Funnel Plot. Cochrane\'s Collaboration Tool was also used to report any presented bias.
    We collected 496 articles in total and finally we included six articles in our meta-analysis. For SSEE (Stroke, Systemic Embolic Event), the pooled relative risk showed a significantly better clinical outcome of NOAC (RR: 0.66; 95% CI: 0.46 to 0.95). However, there is no significant difference in major bleeding (RR: 0.714, 95% CI:0.46 to 1.11) and all-cause mortality (RR: 0.84, 95% CI: 0.58 to 1.21).
    Compared to Warfarin, NOAC is significantly more protective against the embolic event, but no significant difference in lowering risk of major bleeding, all-cause mortality or all aspects of post-TAVI (Trans-catheter aortic valve implantation).
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  • 文章类型: Clinical Trial
    Non-vitamin K antagonist oral anticoagulants (NOACs) are replacing warfarin and heparins in several clinical situations. With varying modes of action, the effects of NOACs on thrombus formation, integrity, and lysis is unknown. To determine whether two techniques of thrombelastography (TEG) and a micro-plate assay (MPA) provide novel data on thrombus formation, integrity and lysis in those taking a NOACs compared to warfarin and a control group taking aspirin. We assessed thrombogenesis, clot integrity and fibrinolysis in blood (TEG) and plasma (MPA) from 182 atrial fibrillation patients-50 on aspirin, 50 on warfarin, and 82 on a NOAC (17 apixaban, 19 dabigatran and 46 rivaroxaban). Eleven of 16 TEG indices and 4 of 5 MPA indices differed (p ≤ 0.01) between those on aspirin, warfarin or a NOAC. Three TEG indices and 4 MPA indices differed (p < 0.01) between the NOACs. Time to initiation of clot formation was most rapid on apixaban, then rivaroxaban and slowest on dabigatran. The rate of clot formation was most rapid on dabigatran, then apixaban, and slowest on rivaroxaban. Clot density was greatest on rivaroxaban, then apixaban, but weakest on dabigatran. The rate of clot dissolution was most rapid in apixaban, then dabigatran, and slowest on rivaroxaban. The TEG and MPA identify major differences in thrombogenesis and fibrinolysis in different NOACs. These techniques may have value in investigating the effects of these drugs on haemostasis in a clinical setting, and in identifying those in need of targeted therapy.
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  • 文章类型: Journal Article
    背景:尚未进行汇总分析来评估非维生素K拮抗剂口服抗凝药(NOAC)与华法林在房颤(AF)和心力衰竭(HF)患者亚组中的疗效和安全性,包括最近的随机对照试验(RCTs)的edoxaban数据。
    方法:使用Cochrane图书馆进行了全面的文献检索,MEDLINE,和Scopus数据库从成立到2015年4月。采用RevMan5.3软件进行统计分析。
    结果:纳入四个随机对照试验:32512例房颤合并HF患者中的19122例被分配到NOAC(13384例接受单/高剂量NOAC方案),和13390华法林。在有HF的AF患者中,单/高剂量NOAC显著降低卒中/全身栓塞(SE)事件的风险14%[几率0.86,95%可信区间(CI)0.76-0.98),大出血风险降低24%(OR0.76,95%CI0.67-0.86).对于低剂量NOAC方案,对于卒中或SE事件的疗效与华法林相当(OR1.02,95%CI0.86~1.21),且大出血减少的趋势不显著.无论高或低剂量NOAC,合并HF的AF患者的大出血和卒中/SE的发生率与无HF的患者相似.与无HF的房颤患者相比,NOACs伴HF的房颤患者颅内出血风险降低41%(OR0.59,95%CI0.40-0.87)。
    结论:在心力衰竭的房颤患者中,单/高剂量NOAC方案具有更好的疗效和安全性,但低剂量方案的疗效和安全性与华法林相似.与无HF的房颤患者相比,NOAC同样有效,甚至更安全(颅内出血更少)。
    BACKGROUND: No pooled analysis has been undertaken to assess the efficacy and safety of the non-vitamin K antagonist oral anticoagulants (NOACs) compared with warfarin in the subgroup of patients with atrial fibrillation (AF) and heart failure (HF), including edoxaban data from recent randomized controlled trials (RCTs).
    METHODS: Comprehensive literature searches were conducted using the Cochrane Library, MEDLINE, and Scopus databases from inception to April 2015. Statistical analyses were performed using RevMan 5.3 software.
    RESULTS: Four RCTs were included: 19 122 of 32 512 AF patients with HF were allocated to a NOAC (13 384 receiving single-/high-dose NOAC regimens), and 13 390 to warfarin. Among AF patients with HF, single/high-dose NOACs significantly reduced the risk of stroke/systemic embolic (SE) events by 14% [odds ratio0.86, 95% confidence interval (CI) 0.76-0.98), and had a 24% lower risk of major bleeding(OR 0.76, 95% CI 0.67-0.86). For low-dose NOAC regimens, comparable efficacy to warfarin for stroke or SE events (OR 1.02, 95% CI 0.86-1.21) and a non-significant trend for lower major bleeding was observed. Regardless of high- or low-dose NOAC, the incidences of both major bleeding and stroke/SE in AF patients with HF were similar to those without HF. Atrial fibrillation patients with HF on NOACs had a 41% lower risk of intracranial haemorrhage compared with those without HF (OR 0.59, 95% CI 0.40-0.87).
    CONCLUSIONS: Among AF patients with HF, single-/high-dose NOAC regimens have a better efficacy and safety profile, but low-dose regimens had similar efficacy and safety to warfarin. NOACs were similarly effective or even safer (less intracranial haemorrhage) in AF patients with HF compared with those without HF.
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