BACKGROUND & AIMS: Importance:The risk of osteoporotic fracture with dabigatran use in patients with nonvalvular atrial fibrillation (NVAF) is unknown. Objective:To investigate the risk of osteoporotic fracture with dabigatran vs warfarin in patients with NVAF. Design, Setting, and Participants:Retrospective cohort study using a population-wide database managed by the Hong Kong Hospital Authority. Patients newly diagnosed with NVAF from 2010 through 2014 and prescribed dabigatran or warfarin were matched by propensity score at a 1:2 ratio with follow-up until July 31, 2016. Exposures:Dabigatran or warfarin use during the study period. Main Outcomes and Measures:Risk of osteoporotic hip fracture and vertebral fracture was compared between dabigatran and warfarin users using Poisson regression. The corresponding incidence rate ratio (IRR) and absolute risk difference (ARD) with 95% CIs were calculated. Results:Among 51 496 patients newly diagnosed with NVAF, 8152 new users of dabigatran (n = 3268) and warfarin (n = 4884) were matched by propensity score (50% women; mean [SD] age, 74 [11] years). Osteoporotic fracture developed in 104 (1.3%) patients during follow-up (32 dabigatran users [1.0%]; 72 warfarin users [1.5%]). Results of Poisson regression analysis showed that dabigatran use was associated with a significantly lower risk of osteoporotic fracture compared with warfarin (0.7 vs 1.1 per 100 person-years; ARD per 100 person-years, -0.68 [95% CI, -0.38 to -0.86]; IRR, 0.38 [95% CI, 0.22 to 0.66]). The association with lower risk was statistically significant in patients with a history of falls, fractures, or both (dabigatran vs warfarin, 1.6 vs 3.6 per 100 person-years; ARD per 100 person-years, -3.15 [95% CI, -2.40 to -3.45]; IRR, 0.12 [95% CI, 0.04 to 0.33]), but not in those without a history (0.6 vs 0.7 per 100 person-years; ARD per 100 person-years, -0.04 [95% CI, 0.67 to -0.39]; IRR, 0.95 [95% CI, 0.45 to 1.96]) (P value for interaction, <.001). Conclusions and Relevance:Among adults with NVAF receiving anticoagulation, the use of dabigatran compared with warfarin was associated with a lower risk of osteoporotic fracture. Additional study, perhaps including randomized clinical trials, may be warranted to further understand the relationship between use of dabigatran vs warfarin and risk of fracture.

背景与目标：

BACKGROUND & AIMS: :Dabigatran was non-inferior to warfarin for prevention of recurrent venous thromboembolism (VTE), and dabigatran had a lower rate of bleeding compared with warfarin in two large-scale randomised trials, RE-COVER and RE-COVER II. In this study, we investigate the efficacy and safety of dabigatran versus warfarin according to the index event that qualified the patient for enrollment, either symptomatic pulmonary embolism (PE) with or without deep-vein thrombosis (DVT), or DVT alone. We then analyse the anticoagulant effect of dabigatran vs warfarin on patients enrolled with PE. The pooled dataset for the efficacy analysis consisted of 2553 and 2554 patients who were randomised to dabigatran and warfarin, respectively. Recurrent VTE/VTE-related death during the study period and additional 30-day follow-up occurred in 2.7 % of all patients on dabigatran and in 2.4 % on warfarin (hazard ratio [HR] 1.09 [95 % confidence interval 0.77, 1.54]). In patients with PE as their index event, recurrent VTE/VTE-related death occurred in 2.9 % vs 3.1 % of patients (HR 0.93 [0.53, 1.64]). There were significantly fewer major bleeding events in patients treated with dabigatran than with warfarin (HR 0.60 [0.36, 0.99]). The pattern was similar both in patients with PE and in those with DVT alone as the index event. These analyses of the pooled dataset from the RE-COVER and RE-COVER II trials indicate that dabigatran is as effective as warfarin in preventing recurrent VTE, regardless of whether patients present with symptomatic PE (with or without DVT) or with symptomatic DVT alone. Dabigatran was also associated with a lower risk of bleeding than warfarin, regardless of the index event.

背景与目标： : 在预防复发性静脉血栓栓塞 (VTE) 方面，达比加群不逊于华法林，在两项大规模随机试验 (RE-COVER和RE-COVER II) 中，达比加群的出血率低于华法林。在这项研究中，我们根据符合患者入组条件的指数事件 (有症状的肺栓塞 (PE) 伴或不伴深静脉血栓形成 (DVT) 或单独DVT)，研究达比加群与华法林的疗效和安全性。然后，我们分析达比加群与华法林对PE患者的抗凝作用。用于疗效分析的汇总数据集由2553和2554名患者组成，他们分别被随机分配到达比加群和华法林。在研究期间和额外的30天随访期间，达比加群所有患者的2.7   % 和华法林的2.4   % 发生了VTE/VTE相关的复发性死亡 (风险比 [HR] 1.09 [95  % 置信区间0.77，1.54])。以PE为指标事件的患者中，2.9   % 比3.1   % 的患者发生VTE/VTE相关的复发性死亡 (HR 0.93 [0.53，1.64])。与华法林相比，达比加群治疗的患者的主要出血事件显著减少 (HR 0.60 [0.36，0.99])。PE患者和单纯DVT患者的模式相似。这些来自RE-COVER和RE-COVER II试验的汇总数据集的分析表明，无论患者是否出现有症状的PE (有或没有DVT) 或单独有症状的DVT，达比加群在预防复发性VTE方面与华法林一样有效。无论指数事件如何，达比加群的出血风险也低于华法林。

BACKGROUND & AIMS: BACKGROUND AND OBJECTIVE:To evaluate the cost-effectiveness of new anticoagulants and warfarin in the prevention of stroke in Chinese patients with atrial fibrillation (AF). METHODS:The Markov model was constructed to compare patients' quality-adjusted life-years (QALYs) using drug cost, the cost of the examination after taking a drug, and the incremental cost of other treatments. Both dabigatran (110 and 150 mg, twice a day) and rivaroxaban (20 mg, once a day) were compared with warfarin (3-6 mg, once a day). Willingness to pay, three times the 2018 China GDP per capita (9481.88 $), was the cost-effect threshold in our study. RESULTS:The total cost were was 5317.31$, 29673.33$, 23615.49$, and 34324.91$ for warfarin, rivaroxaban, dabigatran 110 mg bid, and dabigatran 150 mg bid, respectively. The QALYs for each of the four interventions were 11.07 years, 15.46 years, 12.4 years, and 15 years, respectively. The cost-effectiveness analysis of the three new oral anticoagulants and warfarin showed that the incremental cost-effectiveness ratio (ICER) was 5548.07$/QALY when rivaroxaban was compared with warfarin. Rivaroxaban was the most cost-effective choice and warfarin was the least. CONCLUSIONS:In Chinese patients with AF, although warfarin is cheaper, rivaroxaban has a better cost-effectiveness advantage from an economic point of view.

背景与目标：

BACKGROUND & AIMS: -2

背景与目标： -2

BACKGROUND & AIMS: Importance:Dabigatran and rivaroxaban are non-vitamin K oral anticoagulants approved for stroke prevention in patients with nonvalvular atrial fibrillation (AF). There are no randomized head-to-head comparisons of these drugs for stroke, bleeding, or mortality outcomes. Objective:To compare risks of thromboembolic stroke, intracranial hemorrhage (ICH), major extracranial bleeding including major gastrointestinal bleeding, and mortality in patients with nonvalvular AF who initiated dabigatran or rivaroxaban treatment for stroke prevention. Design, Setting, and Participants:Retrospective new-user cohort study of 118 891 patients with nonvalvular AF who were 65 years or older, enrolled in fee-for-service Medicare, and who initiated treatment with dabigatran or rivaroxaban from November 4, 2011, through June 30, 2014. Differences in baseline characteristics were adjusted using stabilized inverse probability of treatment weights based on propensity scores. The data analysis was performed from May 7, 2015, through June 30, 2016. Exposures:Dabigatran, 150 mg, twice daily; rivaroxaban, 20 mg, once daily. Main Outcomes and Measures:Adjusted hazard ratios (HRs) for the primary outcomes of thromboembolic stroke, ICH, major extracranial bleeding including major gastrointestinal bleeding, and mortality, with dabigatran as reference. Adjusted incidence rate differences (AIRDs) were also estimated. Results:A total of 52 240 dabigatran-treated and 66 651 rivaroxaban-treated patients (47% female) contributed 15 524 and 20 199 person-years of on-treatment follow-up, respectively, during which 2537 primary outcome events occurred. Rivaroxaban use was associated with a statistically nonsignificant reduction in thromboembolic stroke (HR, 0.81; 95% CI, 0.65-1.01; P = .07; AIRD = 1.8 fewer cases/1000 person-years), statistically significant increases in ICH (HR, 1.65; 95% CI, 1.20-2.26; P = .002; AIRD = 2.3 excess cases/1000 person-years) and major extracranial bleeding (HR, 1.48; 95% CI, 1.32-1.67; P < .001; AIRD = 13.0 excess cases/1000 person-years), including major gastrointestinal bleeding (HR, 1.40; 95% CI, 1.23-1.59; P < .001; AIRD = 9.4 excess cases/1000 person-years), and with a statistically nonsignificant increase in mortality (HR, 1.15; 95% CI, 1.00-1.32; P = .051; AIRD = 3.1 excess cases/1000 person-years). In patients 75 years or older or with CHADS2 score greater than 2, rivaroxaban use was associated with significantly increased mortality compared with dabigatran use. The excess rate of ICH with rivaroxaban use exceeded its reduced rate of thromboembolic stroke. Conclusions and Relevance:Treatment with rivaroxaban 20 mg once daily was associated with statistically significant increases in ICH and major extracranial bleeding, including major gastrointestinal bleeding, compared with dabigatran 150 mg twice daily.

背景与目标：

BACKGROUND & AIMS: -2

背景与目标： -2

BACKGROUND & AIMS: :Dabigatran etexilate (DE), a direct-acting, oral inhibitor of thrombin, significantly reduces the risk of stroke compared with traditional anticoagulants, without increasing the risk of major bleeding. However, studies on the fate of cerebral tissue after ischemic stroke in patients receiving DE are sparse and the role of dabigatran-mediated reduction of thrombin in this context has not yet been investigated. Here, we investigated whether pretreatment with DE reduces thrombin-mediated pro-inflammatory mechanisms and leakage of the blood-brain barrier (BBB) following ischemic stroke in rats. Male Wistar rats received DE (15 mg/kg) or a vehicle solution 1 hour before transient middle cerebral artery occlusion (tMCAO) for 90 minutes. Infarct volume, neurologic outcome and intracranial hemorrhage (ICH) were determined after tMCAO. Thrombin generation was indirectly assessed by measuring thrombin/antithrombin III complex. Microvascular patency was evaluated histologically. Cytokine expression and immunoreactivity of cluster of differentiation (CD) 68 were examined to characterize inflammatory processes after pretreatment with DE. BBB integrity was examined by quantifying brain edema. Rats given DE revealed a significant reduction in infarct size without an increase in ICH and significant recovery of neurologic deficits compared to controls. Administration of DE decreased thrombin generation and thrombus formation, dampened the CD68-immunoreactivity and attenuated pro-inflammatory cytokine expression in the cerebral parenchyma ipsilateral to the ischemic lesion. BBB permeability was unaltered following treatment with DE. In summary, prophylactic anticoagulation with DE improves stroke outcome by reducing thrombin-induced inflammation and thrombus formation without increasing the rate of ICH.

背景与目标： : 达比加群酯 (DE) 是一种直接作用的口服凝血酶抑制剂，与传统抗凝剂相比，可显着降低中风的风险，而不会增加大出血的风险。然而，关于接受DE的缺血性卒中患者脑组织命运的研究很少，达比加群介导的凝血酶减少在这种情况下的作用尚未得到研究。在这里，我们研究了DE预处理是否可以减少大鼠缺血性中风后凝血酶介导的促炎机制和血脑屏障 (BBB) 的泄漏。雄性Wistar大鼠在短暂性大脑中动脉闭塞 (tMCAO) 90分钟前1小时接受DE (15 mg/kg) 或赋形溶液。tMCAO后确定梗塞体积，神经系统结果和颅内出血 (ICH)。通过测量凝血酶/抗凝血酶III复合物间接评估凝血酶的产生。组织学评估微血管通畅性。检查了细胞因子表达和分化簇 (CD) 68的免疫反应性，以表征用DE预处理后的炎症过程。通过量化脑水肿来检查BBB完整性。与对照组相比，给予DE的大鼠显示梗死面积显着减少，而ICH却没有增加，神经功能缺损也明显恢复。施用DE可减少凝血酶的产生和血栓形成，抑制CD68-immunoreactivity并减弱缺血性病变同侧脑实质中促炎性细胞因子的表达。用DE处理后，BBB渗透性没有改变。总之，DE预防性抗凝可通过减少凝血酶诱导的炎症和血栓形成而不增加ICH的发生率来改善卒中结局。

BACKGROUND & AIMS: :The direct thrombin inhibitor dabigatran etexilate is currently in phase III of development for the prophylaxis and treatment of thromboembolic disorders, with three trials completed in primary venous thromboembolism (VTE) prevention. Dabigatran etexilate is an orally administered prodrug, which is rapidly absorbed and converted to the active form, dabigatran. Dabigatran has been shown to specifically and reversibly inhibit thrombin, the key enzyme in the coagulation cascade. Studies in healthy volunteers and in patients undergoing orthopaedic surgery have indicated that dabigatran has a predictable pharmacokinetic/pharmacodynamic profile, allowing for a fixed-dose regimen. Peak plasma concentrations of dabigatran are reached approximately 2 hours after oral administration in healthy volunteers, with no unexpected accumulation of drug concentrations upon multiple dosing. Excretion is predominantly via the renal route as unchanged drug. Dabigatran is not metabolized by cytochrome P450 isoenzymes. The small differences in dabigatran pharmacokinetics associated with age and gender are attributed to variations in renal function. Additional studies have shown that the pharmacokinetic/pharmacodynamic profile of dabigatran is consistent across a range of patient populations, with no effect of moderate hepatic impairment being observed. Drug-drug interactions are not observed with concomitant administration of atorvastatin, diclofenac or digoxin. The pharmacodynamic profile of dabigatran demonstrates effective anticoagulation combined with a low risk of bleeding. Further phase III studies are ongoing, including acute VTE treatment and stroke prevention in atrial fibrillation; the results obtained so far show that dabigatran etexilate is well tolerated and effective in the treatment and prevention of thromboembolic events.

背景与目标： : 直接凝血酶抑制剂达比加群酯目前处于预防和治疗血栓栓塞性疾病的III期开发阶段，完成了预防原发性静脉血栓栓塞 (VTE) 的三项试验。达比加群酯是一种口服前药，可迅速吸收并转化为活性形式达比加群。达比加群已被证明可以特异性和可逆地抑制凝血酶，凝血酶是凝血级联反应中的关键酶。在健康志愿者和接受骨科手术的患者中进行的研究表明，达比加群具有可预测的药代动力学/药效学特征，可以采用固定剂量的方案。在健康志愿者中，口服给药后约2小时达到达比加群的血浆峰值浓度，多次给药后没有意外的药物浓度积累。排泄主要通过肾脏途径作为未改变的药物。达比加群不被细胞色素P450同工酶代谢。与年龄和性别相关的达比加群药代动力学的微小差异归因于肾功能的变化。其他研究表明，达比加群的药代动力学/药效学特征在一系列患者人群中是一致的，没有观察到中度肝损害的影响。阿托伐他汀，双氯芬酸或地高辛的同时给药未观察到药物相互作用。达比加群的药效学特征表明，抗凝有效，出血风险低。进一步的III期研究正在进行中，包括房颤的急性VTE治疗和中风预防; 到目前为止获得的结果表明，达比加群酯具有良好的耐受性，并且在治疗和预防血栓栓塞事件方面有效。

BACKGROUND & AIMS: :Idarucizumab is the first Food and Drugs Administration (FDA) approved reversal agent for anticoagulant dabigatran, a direct thrombin inhibitor. Emerging evidence suggests idarucizumab can improve clinical outcome following dabigatran-associated hemorrhage, however, its specific use in intracranial hemorrhage has been poorly described. The aim of this study was to systematically review the available literature of idarucizumab in the setting of dabigatran-associated ICH to evaluate its efficacy in the stabilizing/resolving of the primary hemorrhage. A systematic search of 7 electronic databases from their earliest records to August 2018 was conducted following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. There were 864 articles identified for screening against selection criteria. The search identified 9 articles to be included in our analysis, describing hemorrhage outcomes in 23 dabigatran-associated cases of ICH managed by idarucizumab. Mean overall age was 76.2 years, with 43% females, and bleeding was subdural, subarachnoid and intracerebral in 43%, 13% and 43% cases respectively. Surgical intervention was pursued in 48% of cases. During the course of the hospitalization, the hemorrhages stabilized/resolved in 87% of patients, and worsened in 13%. In-hospital complications occurred in 4% of cases, and mortality occurred in 4% of cases as well. The available literature suggests that idarucizumab can be applied in the setting of ICH, for its therapeutic effect in patients presenting with dabigatran-associated ICH appears acceptable with no compromise to clinical safety. However, currently there is a paucity of data about various aspects that are involved in other aspects of ICH treatment, including recovery, that limits the significance of the current literature. As more evidence is published relating specifically to long-term ICH outcomes that have been treated by idarucizumab, we will be better placed to establish the optimal role of idarucizumab in the setting of dabigatran-associated ICH.

背景与目标： : Idarucizumab是第一个食品和药物管理局 (FDA) 批准的抗凝剂达比加群 (一种直接凝血酶抑制剂) 逆转剂。新的证据表明，idarucizumab可以改善达比加群相关出血后的临床结局，然而，其在颅内出血中的具体应用还没有得到很好的描述。这项研究的目的是系统地回顾idarucizumab在达比加群相关ICH的背景下的可用文献，以评估其在稳定/解决原发性出血中的功效。按照系统评价和荟萃分析 (PRISMA) 指南的首选报告项目，对7个电子数据库从最早记录到2018年8月进行了系统搜索。有864篇文章被确定用于根据选择标准进行筛选。搜索确定了9篇文章纳入我们的分析，描述了由idarucizumab管理的23例达比加群相关ICH病例的出血结果。平均年龄76.2岁，女性43% 例，硬膜下、蛛网膜下腔和脑内出血分别为43% 例、13% 例和43% 例。在48% 病例中进行了手术干预。在住院期间，87% 患者出血稳定/缓解，13% 恶化。4% 病例发生院内并发症，4% 病例也发生死亡率。现有文献表明，idarucizumab可用于ICH的治疗，因为其在出现达比加群相关ICH的患者中的治疗效果似乎可以接受，而不会损害临床安全性。但是，目前缺乏有关ICH治疗其他方面 (包括恢复) 的各个方面的数据，这限制了当前文献的重要性。随着更多的证据被公布，特别是与经过idarucizumab治疗的长期ICH结局有关，我们将更好地确定idarucizumab在dabigatran相关ICH中的最佳作用。

BACKGROUND & AIMS: :: Atrial fibrillation is the most common arrhythmia in over-midlife patients. In addition to systolic heart failure, cerebral thromboembolism represents the most dramatic complication of this rhythm disorder, contributing to morbidity and mortality. Traditionally, anticoagulation has been considered the main strategy in preventing stroke and systemic embolism in atrial fibrillation patients and vitamin K-dependent antagonists have been widely used in clinical practice. Recently, the development of direct oral anticoagulants has certainly improved the management of this disease, providing, for the first time, the opportunity to go beyond vitamin K-dependent antagonists limits. In the RE-LY trial, dabigatran 150 mg twice daily was superior to warfarin in the prevention of stroke or systemic embolism and dabigatran 110 mg twice daily was noninferior. Both doses greatly reduced hemorrhagic stroke, and dabigatran 110 mg twice daily significantly reduced major bleeding compared with warfarin. Based on these results, dabigatran, a direct thrombin inhibitor, was the first direct oral anticoagulant to receive the regulatory approval for nonvalvular atrial fibrillation patients. To date, a specific reversal agent has just been approved as an antidote for this molecule. This review provides a summary of randomized trials, postmarket registries and specific clinical-settings summary on dabigatran in nonvalvular atrial fibrillation.

背景与目标： 心房颤动是中年以上患者最常见的心律失常。除收缩性心力衰竭外，脑血栓栓塞是这种节律紊乱最严重的并发症，可导致发病率和死亡率。传统上，抗凝被认为是预防房颤患者中风和全身性栓塞的主要策略，而维生素k依赖性拮抗剂已广泛用于临床实践。最近，直接口服抗凝剂的发展无疑改善了该疾病的治疗，首次提供了超越维生素k依赖性拮抗剂限制的机会。在RE-LY试验中，达比加群150  mg每日两次在预防中风或全身性栓塞方面优于华法林，达比加群110  mg每日两次不劣。两种剂量都大大减少了出血性中风，与华法林相比，达比加群110每日两次，显著减少了大出血。基于这些结果，直接凝血酶抑制剂达比加群是第一种获得非瓣膜性房颤患者监管批准的直接口服抗凝剂。迄今为止，一种特定的逆转剂刚刚被批准作为该分子的解毒剂。这篇综述提供了关于达比加群在非瓣膜性房颤中的随机试验，上市后注册和特定临床设置摘要的摘要。

BACKGROUND & AIMS: BACKGROUND:This register-based observational study compares dabigatran to warfarin for secondary stroke prevention in atrial fibrillation patients among both "new starters" on dabigatran and "switchers" to dabigatran from warfarin. METHODS:We identified, in nationwide Danish registries, 2398 patients with atrial fibrillation and a history of stroke/transient ischemic attack, making a first-time purchase of dabigatran 110 mg twice a day (bid; D110) and 150 mg bid (D150). Patients were categorized as either vitamin K antagonist (VKA) naive or experienced. Warfarin controls were identified using a complete (for VKA-naive dabigatran patients) or matched sampling approach (for VKA-experienced dabigatran patients). Subjects were followed for an average of 12.6 months for stroke and transient ischemic attacks. Confounder-adjusted Cox regression models were used to compare event rates between treatments. RESULTS:Among patients with a history of stroke/transient ischemic attack and prior VKA experience, switching to dabigatran was associated with an increased stroke/transient ischemic attack rate for both dabigatran doses compared with continuing on warfarin (D110 hazard ratio [HR] 1.99; 95% confidence interval [CI], 1.42-2.78; D150 HR 2.34; 95% CI, 1.60-3.41). Among prior stroke/transient ischemic attack patients who were new starters on dabigatran or warfarin, the rate of stroke/transient ischemic attack for both doses of dabigatran was similar to or lower than warfarin (D110 HR 0.64; 95% CI, 0.50-0.80; D150 HR 0.92l; 95% CI, 0.73-1.15). CONCLUSIONS:In this register-based study, VKA-experienced patients with a history of stroke or transient ischemic attack who switched to dabigatran therapy had an increased rate of stroke compared with patients persisting with warfarin therapy.

背景与目标：

BACKGROUND & AIMS: BACKGROUND:The distribution of activated partial thromboplastin time (APTT) in nonvalvular atrial fibrillation (NVAF) patients under dabigatran therapy remains to be clarified. METHODS AND RESULTS:The study population was 196 NVAF patients who were treated with dabigatran in 2011 (126 with 220 mg/day). The APTT values showed a wide distribution among the patients, especially in those with a reduced dose, who seemed to show a high value even in patients without contraindications. CONCLUSIONS:We found a wide distribution of APTT in NVAF patients under dabigatran treatment. High APTT might help screen for bleeding risks among patients under dabigatran, but requires future investigation.

背景与目标：

BACKGROUND & AIMS: :Eosinophilic pleural effusions (EPE) account for 5%-8% of all exudative pleural effusions. A pleural effusion is defined as eosinophilic if it contains 10% or more eosinophils. We present the case of a 70-year-old man with EPE, blood eosinophilia and pericardial effusion due to dabigatran, a novel anti-thrombin agent.

背景与目标： : 嗜酸性胸腔积液 (EPE) 占所有渗出性胸腔积液的5%-8%。胸腔积液如果含有10% 或多个嗜酸性粒细胞，则定义为嗜酸性粒细胞。我们介绍了一名70岁的男性，由于新型抗凝血酶剂达比加群而患有EPE，血液嗜酸性粒细胞增多和心包积液。

BACKGROUND & AIMS: BACKGROUND:Cerebral microthromboembolism after atrial fibrillation (AF) ablation has been reported in 4-20% with perioperative warfarin. Dabigatran is a new anticoagulant in patients with nonvalvular AF. We investigated the incidence of asymptomatic cerebral microthromboembolism after AF ablation with perioperative warfarin or dabigatran using diffusion-weighted and T2-weighted magnetic resonance imaging (MRI). METHODS AND RESULTS:Our study included 210 consecutive patients with AF (111 paroxysmal and 99 persistent) who underwent complex fractionated atrial electrogram-guided ablation (combined with pulmonary vein isolation, n = 110). Catheter irrigation was performed in all cases. Uninterrupted warfarin therapy was used in 180 patients (warfarin group) and interrupted only on the morning of the procedure with dabigatran in 30 (dabigatran group). All patients underwent cerebral MRI the day after ablation. New microthromboemboli were detected in 10.0% of the warfarin group and 26.7% of the dabigatran group (P < 0.05). The incidence of hemopericardium treated with pericardiocentesis was lower in the warfarin group than in the dabigatran group (2.5% vs 11.1%, P < 0.05). In multivariate analysis, the use of cardioversion was a predictor of new microthromboembolism development after AF ablation. CONCLUSIONS:The incidence of asymptomatic cerebral microthromboembolism and hemopericardium after AF ablation was significantly lower with perioperative warfarin therapy than with dabigatran therapy. Dabigatran may not be an effective alternative to warfarin for AF ablation, especially in patients who undergo cardioversion.

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