BACKGROUND & AIMS: :Objective: Atrial fibrillation (AF) is present in up to 17% of patients in skilled nursing facilities (SNFs). This study compared healthcare resource utilization (HRU) and costs between AF patients initiating rivaroxaban or warfarin in SNFs.Methods: Using de-identified claims from Optum Clinformatics Extended Data Mart (1 January 2013 to 31 December 2017), this retrospective cohort study indexed AF patients with first SNF admission during which rivaroxaban or warfarin was initiated within 3 days of admission. To adjust for selection bias, inverse probability of treatment weighting (IPTW) was applied for baseline characteristics. Logistic regression and generalized linear models were used to compare HRU and costs.Results: 519 rivaroxaban and 1129 warfarin patients met inclusion criteria. After IPTW, the cohorts were well balanced for baseline characteristics. The average length of index SNF stay was 32.07 and 37.44 days for rivaroxaban and warfarin patients, respectively. During SNF stay, rivaroxaban patients had 27% lower odds of hospitalization (p < .0001), 2.7 fewer international normalized ratio (INR) tests per-patient-per-month (PPPM; p < .001), and 2.3 fewer pathology/laboratory encounters PPPM (p < .0001) than warfarin patients. All-cause healthcare costs were $2638 lower with rivaroxaban versus warfarin (p < .0001) during the index SNF stay, with lower medical costs (p < .0001) but higher pharmacy costs (p < .0001). Total all-cause healthcare costs 100 days post-index SNF were $8746 lower with rivaroxaban versus warfarin (p < .0001).Conclusions: In the SNF setting, AF patients treated with rivaroxaban had 5-day shorter length of stay, lower HRU, and lower all-cause total and medical costs compared to warfarin, despite higher treatment costs. These findings may help inform clinical decision-making to reduce economic burden.

背景与目标： ：目的：熟练护理机构（SNFs）中多达17％的患者存在房颤（AF）。这项回顾性队列研究对AF进行回顾性队列研究，该研究采用了Optum Clinformatics Extended Data Mart（2013年1月1日至2017年12月31日）的去身份化声明，比较了在SNFs中开始利伐沙班或华法林的AF患者之间的医疗资源利用率（HRU）和成本。首次SNF入院的患者，在入院后3天内开始使用利伐沙班或华法林。为了调整选择偏倚，对基线特征应用了处理权重的逆概率（IPTW）。结果：519例利伐沙班和1129例华法林患者符合入选标准。在IPTW之后，队列的基线特征得到了很好的平衡。利伐沙班和华法林患者的平均SNF停留天数分别为32.07天和37.44天。在SNF停留期间，利伐沙班患者的住院几率降低27％（p <<。0001），每患者每月每国际患者归一化比率（INR）测试降低2.7（PPPM; p <<。001），病理/降低2.3实验室比华法林患者遇到PPPM（p <<。0001）。在SNF指数停留期间，利伐沙班与华法林的全因医疗费用降低了2638美元（p << 0.0001），医疗费用较低（p << 0.0001），但药房费用较高（p <0.000.0001）。利伐沙班与华法林相比，指数化后SNF 100天全因医疗费用降低了$ 8746（p <.0001）。结论：在SNF情况下，利伐沙班治疗的AF患者住院时间短了5天，HRU较低，尽管治疗费用较高，但与华法林相比，全因总费用和医疗费用较低。这些发现可能有助于临床决策，以减轻经济负担。

BACKGROUND & AIMS: :Randomized controlled trials leading to the approval of apixaban and rivaroxaban for venous thromboembolism (VTE) did not include patients with upper extremity deep vein thrombosis (UE-DVT). We sought to evaluate the safety and effectiveness of rivaroxaban and apixaban for the treatment of acute UE-DVT. Consecutive patients with VTE enrolled into the Mayo Clinic VTE Registry, between March 1, 2013 and December 31, 2019, were followed prospectively. Clinical, demographic and imaging data were collected at the time of study recruitment. Patients with a diagnosis of acute UE-DVT who received rivaroxaban, apixaban, LMWH or warfarin were included. Recurrent VTE, major bleeding, clinical-relevant non-major bleeding (CRNMB), and death were assessed at 3-month intervals. During the study period, 210 patients with acute UE-DVT were included; 63 were treated with apixaban, 39 with rivaroxaban, and 108 with LWMH and/or warfarin. Overall 51% had catheter-associated UE-DVT, 60% had a diagnosis of malignancy, and 14% had concurrent pulmonary embolism. Malignancy was more common in patients treated with LMWH/warfarin (67% vs 52%, P = .03). At 3 months of follow up, one (0.9%) recurrent VTE occurred in a patient treated with LMWH/warfarin and one (1.0%) patient treated with apixaban or rivaroxaban (P = .97). Major bleeding occurred in three patients treated with LMWH/warfarin, and in none of those treated with apixaban or rivaroxaban (P = .09). Clinical-relevant non-major bleeding occurred in one patient (0.9%) treated with LWMH/warfarin and two patients (2.0%) treated with apixaban or rivaroxaban (P = .53). Treatment of UE-DVT with apixaban or rivaroxaban appears to be as safe and effective as LMWH/warfarin.

背景与目标： ：导致apixaban和rivaroxaban批准用于静脉血栓栓塞（VTE）的随机对照试验不包括上肢深静脉血栓形成（UE-DVT）的患者。我们试图评估利伐沙班和阿哌沙班治疗急性UE-DVT的安全性和有效性。在2013年3月1日至2019年12月31日期间，对进入Mayo诊所VTE注册中心的VTE连续患者进行了随访。在研究募集时收集了临床，人口统计学和影像学数据。包括接受利伐沙班，阿哌沙班，LMWH或华法林诊断为急性UE-DVT的患者。每三个月评估一次复发性VTE，大出血，临床相关的非大出血（CRNMB）和死亡。在研究期间，共纳入210例急性UE-DVT患者。 63例接受阿哌沙班治疗，39例接受利伐沙班治疗，108例接受LWMH和/或华法林治疗。总体上51％的患者有导管相关的UE-DVT，60％的患者被诊断为恶性肿瘤，而14％的患者同时发生了肺栓塞。在LMWH /华法林治疗的患者中，恶性肿瘤更为常见（67％vs 52％，P = 0.03）。在随访的3个月中，接受LMWH /华法林治疗的患者发生1例（0.9％）复发性VTE，接受阿哌沙班或利伐沙班治疗的患者1例（1.0％）发生（P = 0.97）。 LMWH /华法林治疗的三例患者发生大出血，而阿哌沙班或利伐沙班治疗的患者均未发生大出血（P = 0.009）。 LWMH /华法林治疗的一名患者（0.9％）和阿哌沙班或利伐沙班治疗的两名患者（2.0％）发生了与临床相关的非重大出血（P = 0.53）。用apixaban或rivaroxaban治疗UE-DVT似乎与LMWH /华法林一样安全有效。

BACKGROUND & AIMS: BACKGROUND:During long-term anticoagulation in atrial fibrillation, temporary interruptions (TIs) of therapy are common, but the relationship between patient outcomes and TIs has not been well studied. We sought to determine reasons for TI, the characteristics of patients undergoing TI, and the relationship between anticoagulant and outcomes among patients with TI. METHODS AND RESULTS:In the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF), a randomized, double-blind, double-dummy study of rivaroxaban and warfarin in nonvalvular atrial fibrillation, baseline characteristics, management, and outcomes, including stroke, non-central nervous system systemic embolism, death, myocardial infarction, and bleeding, were reported in participants who experienced TI (3-30 days) for any reason. The at-risk period for outcomes associated with TI was from TI start to 30 days after resumption of study drug. In 14 236 participants who received at least 1 dose of study drug, 4692 (33%) experienced TI. Participants with TI were similar to the overall ROCKET AF population in regard to baseline clinical characteristics. Only 6% (n=483) of TI incidences involved bridging therapy. Stroke/systemic embolism rates during the at-risk period were similar in rivaroxaban-treated and warfarin-treated participants (0.30% versus 0.41% per 30 days; hazard ratio [confidence interval]=0.74 [0.36-1.50]; P=0.40). Risk of major bleeding during the at-risk period was also similar in rivaroxaban-treated and warfarin-treated participants (0.99% versus 0.79% per 30 days; hazard ratio [confidence interval]=1.26 [0.80-2.00]; P=0.32). CONCLUSIONS:TI of oral anticoagulation is common and is associated with substantial stroke risks and bleeding risks that were similar among patients treated with rivaroxaban or warfarin. Further investigation is needed to determine the optimal management strategy in patients with atrial fibrillation requiring TI of anticoagulation. CLINICAL TRIAL REGISTRATION URL:http://www.clinicaltrials.gov. Unique identifier: NCT00403767.

背景与目标： 背景：在房颤的长期抗凝治疗期间，治疗的临时中断（TIs）很常见，但是患者预后与TIs之间的关系尚未得到很好的研究。我们试图确定TI的原因，TI患者的特征以及TI患者中抗凝剂与预后之间的关系。
方法和结果：在利伐沙班每日一次中，口服，直接因子Xa抑制与维生素K拮抗剂预防房颤的中风和栓塞试验（ROCKET AF）进行了一项随机，双盲，双盲研究的利伐沙班和在因任何原因经历过TI（3-30天）的参与者中，报告了非瓣膜性房颤中的华法林，基线特征，治疗和预后，包括中风，非中枢神经系统全身性栓塞，死亡，心肌梗塞和出血。与TI相关的结局的风险期是从TI开始到恢复研究药物后的30天。在接受至少1剂研究药物的14236名参与者中，有4692名（33％）经历了TI。就基线临床特征而言，TI的参与者与整个ROCKET AF人群相似。 TI发生率中只有6％（n = 483）涉及桥接治疗。在风险期中，利伐沙班治疗和华法林治疗的参与者中风/全身性栓塞发生率相似（每30天0.30％比0.41％；危险比[置信区间] = 0.74 [0.36-1.50]； P = 0.40） 。在利伐沙班治疗和华法林治疗的受试者中，处于危险期的大出血风险也相似（每30天0.99％比0.79％；危险比[置信区间] = 1.26 [0.80-2.00]； P = 0.32） 。
结论：口服抗凝治疗的TI很常见，并且与利伐沙班或华法林治疗的患者发生中风的风险和出血的风险相似。需要进一步研究以确定需要抗凝TI的房颤患者的最佳治疗策略。
临床试验注册网址：http：//www.clinicaltrials.gov。唯一标识符：NCT00403767。

BACKGROUND & AIMS: :Rivaroxaban (Xarelto(®)), a direct factor Xa inhibitor, is approved for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF) in Canada or those with nonvalvular AF (NVAF) in the EU, US and Japan. It is administered at a fixed oral dose and generally does not require routine monitoring of coagulation parameters. In the ROCKET AF trial in patients with NVAF and a moderate to high risk of stroke, oral rivaroxaban 20 mg once daily (15 mg once daily in patients with moderate renal impairment) was noninferior to oral dose-adjusted warfarin once daily in preventing primary endpoint events (i.e. stroke and systemic embolism) in the per-protocol population (primary noninferiority analysis) and superior in the on-treatment safety population (primary superiority analysis). Several ROCKET AF subgroup analyses indicated that the treatment effect of rivaroxaban was consistent across patient subgroups stratified according to baseline factors, including the presence or absence of previous stroke or transient ischaemic attack. Patients with moderate renal impairment receiving the reduced rivaroxaban dosage (15 mg once daily) showed a treatment effect consistent with that seen with rivaroxaban 20 mg once daily in patients with normal renal function. The tolerability profile of rivaroxaban was generally acceptable in ROCKET AF, with no significant difference between rivaroxaban and warfarin in the incidence of major or nonmajor clinically-relevant bleeding events (primary safety endpoint). In the Japanese ROCKET AF trial, rivaroxaban 15 mg once daily (10 mg once daily in patients with moderate renal impairment) was noninferior to oral dose-adjusted warfarin once daily in the incidence of major or nonmajor clinically-relevant bleeding (primary study outcome). Thus, rivaroxaban is a reasonable alternative to warfarin for the prevention of stroke and systemic embolism in patients with NVAF.

背景与目标： ：Rivaroxaban（Xarelto（®））是Xa的直接抑制剂，已被批准用于预防加拿大的房颤（AF）或欧盟，美国和日本的非瓣膜性AF（NVAF）患者的中风和全身性栓塞。它以固定的口服剂量给药，通常不需要常规监测凝血参数。在ROCKET AF试验中，对于具有NVAF和中度至高中风风险的患者，口服利伐沙班每天20 mg一次（对于中度肾功能不全的患者每天15 mg一次）在预防主要终点方面不逊于口服剂量调整的华法林符合协议的人群发生的事件（即中风和全身性栓塞）（主要为非劣效性分析）和接受治疗的安全性人群中的主要事件（即主要优势分析）。若干ROCKET AF亚组分析表明，利伐沙班的治疗效果在根据基线因素（包括是否存在先前的中风或短暂性脑缺血发作）进行分层的患者亚组中是一致的。中度肾功能不全的患者接受减低的利伐沙班剂量（每天15 mg一次）显示出与肾功能正常的患者每日一次利伐沙班20 mg一致的治疗效果。利伐沙班的耐受性在ROCKET AF中通常是可以接受的，利伐沙班和华法林在重大或非重大临床相关出血事件（主要安全终点）的发生率方面无显着差异。在日本的ROCKET AF试验中，利伐沙班每天15毫克一次（中度肾功能不全患者每天10毫克一次）在重大或非重大临床相关出血发生率方面不次于口服剂量调整的华法林（初步研究结果） 。因此，利伐沙班是华法林的合理替代品，可预防NVAF患者的中风和全身性栓塞。

BACKGROUND & AIMS: BACKGROUND:This phase 3 trial compared the efficacy and safety of rivaroxaban, an oral direct inhibitor of factor Xa, with those of enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplasty. METHODS:In this randomized, double-blind study, we assigned 4541 patients to receive either 10 mg of oral rivaroxaban once daily, beginning after surgery, or 40 mg of enoxaparin subcutaneously once daily, beginning the evening before surgery, plus a placebo tablet or injection. The primary efficacy outcome was the composite of deep-vein thrombosis (either symptomatic or detected by bilateral venography if the patient was asymptomatic), nonfatal pulmonary embolism, or death from any cause at 36 days (range, 30 to 42). The main secondary efficacy outcome was major venous thromboembolism (proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death from venous thromboembolism). The primary safety outcome was major bleeding. RESULTS:A total of 3153 patients were included in the superiority analysis (after 1388 exclusions), and 4433 were included in the safety analysis (after 108 exclusions). The primary efficacy outcome occurred in 18 of 1595 patients (1.1%) in the rivaroxaban group and in 58 of 1558 patients (3.7%) in the enoxaparin group (absolute risk reduction, 2.6%; 95% confidence interval [CI], 1.5 to 3.7; P<0.001). Major venous thromboembolism occurred in 4 of 1686 patients (0.2%) in the rivaroxaban group and in 33 of 1678 patients (2.0%) in the enoxaparin group (absolute risk reduction, 1.7%; 95% CI, 1.0 to 2.5; P<0.001). Major bleeding occurred in 6 of 2209 patients (0.3%) in the rivaroxaban group and in 2 of 2224 patients (0.1%) in the enoxaparin group (P=0.18). CONCLUSIONS:A once-daily, 10-mg oral dose of rivaroxaban was significantly more effective for extended thromboprophylaxis than a once-daily, 40-mg subcutaneous dose of enoxaparin in patients undergoing elective total hip arthroplasty. The two drugs had similar safety profiles. (ClinicalTrials.gov number, NCT00329628.)

背景与目标： 背景：这项3期试验比较了口服Xa因子直接抑制剂利伐沙班和依诺肝素对全髋关节置换术患者延长血栓预防的疗效和安全性。
方法：在这项随机，双盲研究中，我们分配4541名患者，使其在手术后开始每天一次接受10 mg口服利伐沙班治疗，或者在手术前一天晚上开始皮下每天一次接受40 mg依诺肝素的治疗，再加上安慰剂片或注射。主要疗效结果是深静脉血栓形成（有症状或如果患者无症状则可通过双侧静脉造影检查发现），非致命性肺栓塞或任何原因在36天时死亡（30至42天）。次要疗效的主要结果是主要的静脉血栓栓塞（近端深静脉血栓形成，非致命性肺栓塞或静脉血栓栓塞死亡）。主要安全结果是大出血。
结果：优势分析共纳入3153例患者（1388例除外），安全性分析共4433例（108例除外）。利伐沙班组1595例患者中有18例（1.1％）发生了主要疗效，依诺肝素组1558例中58例（3.7％）发生了（绝对风险降低2.6％； 95％置信区间[CI]为1.5至1.5）。 3.7； P <0.001）。利伐沙班组1686例患者中有4例发生严重静脉血栓栓塞（0.2％），依诺肝素组1678例患者中有33例（2.0％）发生（绝对风险降低1.7％; 95％CI为1.0至2.5; P <0.001 ）。利伐沙班组2209例患者中有6例发生大出血（0.3％），依诺肝素组2222例患者中有2例（0.1％）（P = 0.18）。
结论：对于行择期全髋关节置换术的患者，每天口服10 mg利伐沙班对延长血栓预防效果比每天一次40 mg皮下剂量依诺肝素有效。两种药物的安全性相似。 （ClinicalTrials.gov编号，NCT00329628。）

BACKGROUND & AIMS: :The localized activation of coagulation in vascular malformations can lead to a consumptive coagulopathy characterized by elevated D-dimers and a consumption of fibrinogen and platelets, eventually giving rise to a bleeding tendency. By reducing coagulation activation, anticoagulant treatment with heparin is able to limit this haemostatic dysregulation and the associated bleeding diathesis. Here, we present a case of a consumptive coagulopathy due to a large venous malformation with a sustained correction of the fibrinogen depletion and associated bleeding tendency both with subcutaneous enoxaparin and with the oral factor Xa inhibitor rivaroxaban.

背景与目标： ：血管畸形中凝血的局部激活会导致消耗性凝血病，其特征为D-二聚体升高以及纤维蛋白原和血小板的消耗，最终导致出血倾向。通过减少凝血激活，用肝素进行的抗凝治疗能够限制这种止血功能失调和相关的出血情况。在这里，我们介绍了由于皮下依诺肝素和口服因子Xa抑制剂rivaroxaban引起的大静脉畸形，纤维蛋白原消耗的持续矫正以及相关的出血倾向而导致的消耗性凝血病。

BACKGROUND & AIMS: :Bleeding is the most feared and difficult to predict adverse event of anticoagulation. We sought to investigate whether calibrated automated thrombography (CAT) parameters are associated with minor bleeding (MB) in anticoagulated patients following venous thromboembolism (VTE). Enrolled were 132 patients on rivaroxaban, 145 on vitamin K antagonists (VKA) and 31 controls who stopped anticoagulation. Prior to the next dose of the anticoagulant, we measured CAT parameters, along with rivaroxaban concentration and INR. During a median follow-up of 10 months, we recorded minor and major bleedings. On rivaroxaban, 27 (20.5%) patients with MB had longer time to start thrombin generation, lower peak thrombin generation and lower endogenous thrombin potential compared with subjects without MB (all p < 0.001). All CAT parameters, except for peak thrombin generation (p = 0.049), were similar in VKA patients with (n = 25, 17.2%) vs. without MBs. By logistic regression, time to start thrombin generation (p = 0.007) and unprovoked VTE (p = 0.041) independently predicted MBs on rivaroxaban. Major bleedings were more frequent in patients with MBs (17.3% vs. 1.8%, p < 0.001). Abnormal CAT parameters characterize VTE patients prone to MBs on rivaroxaban, but not on VKA. Time to start thrombin generation measured about 24 h since the last rivaroxaban dose might help predict MBs.

背景与目标： ：出血是最令人恐惧和最难以预测的抗凝不良事件。我们试图调查在静脉血栓栓塞（VTE）后抗凝患者中，校准的自动血栓成像（CAT）参数是否与轻微出血（MB）相关。入选了132例使用rivaroxaban的患者，145例使用维生素K拮抗剂（VKA）的患者和31例停止抗凝治疗的对照组。在下一次服用抗凝剂之前，我们测量了CAT参数以及利伐沙班的浓度和INR。在10个月的中位随访期间，我们记录了轻度和重度出血。在利伐沙班上，与无MB的受试者相比，27名（20.5％）的MB患者开始凝血酶的时间更长，凝血酶的峰值生成量较低，内源性凝血酶的潜能较低（所有p <0.001）。 VKA患者（n = 25，17.2％）与未使用MBs的患者相比，除凝血酶峰值峰值（p = 0.049）外，所有CAT参数均相似。通过逻辑回归，开始凝血酶生成的时间（p = 0.007）和无缘无故的VTE（p = 0.041）独立预测了利伐沙班上的MB。 MBs患者的大出血发生率更高（17.3％vs. 1.8％，p <0.001）。 CAT参数异常是在利伐沙班上VBE患者倾向于MB的特征，而在VKA上则不然。从最后一次利伐沙班剂量起大约24小时开始测量凝血酶生成的时间，可能有助于预测MB。

BACKGROUND & AIMS: RATIONALE:Data on nonvitamin K antagonist oral anticoagulant being used for the treatment of LAA thrombi are limited only in nonvalvular atrial fibrillation. There are no data on the antithrombotic efficacy and safety of nonvitamin K antagonist oral anticoagulant in the resolution of left atrial appendage (LAA) thrombi in patients with rheumatic mitral stenosis. PATIENT CONCERNS:A 49-year-old woman with known rheumatic mitral stenosis and atrial fibrillation was referred for percutaneous transvenous mitral commissurotomy because of progressive dyspnea on exertion over a period of 3 months. DIAGNOSES:Transesophageal echocardiography (TEE) demonstrated a large LAA thrombus protruding into left atria cavity before the procedure. INTERVENTIONS:Direct factor Xa (FXa) inhibitor rivaroxaban (20 mg/d) was started for the patient. After 3 weeks of rivaroxaban treatment TEE showed a relevantly decreased thrombus size, and a complete thrombus resolution was achieved after 5 weeks of anticoagulant therapy with the FXa inhibitor. OUTCOMES:To the best of our knowledge, this is the first documented case of large LAA thrombus resolution with nonvitamin K antagonist oral anticoagulant in severe mitral stenosis, and in which percutaneous transvenous mitral commissurotomy was performed subsequently. LESSONS:The report indicated that rivaroxaban could be a therapeutic option for mitral stenosis patients with LAA thrombus. Further study is required before the routine use of rivaroxaban in patients with rheumatic mitral stenosis and atrial fibrillation.

背景与目标： 理由：仅用于非瓣膜性房颤的非维生素K拮抗剂口服抗凝剂用于治疗LAA血栓的数据有限。目前尚无关于非维生素K拮抗剂口服抗凝剂对风湿性二尖瓣狭窄患者左心耳（LAA）血栓形成的抗血栓形成功效和安全性的数据。
患者担忧：一名49岁的已知风湿性二尖瓣狭窄和心房纤颤的妇女因在3个月的劳累期间进行性呼吸困难而接受经皮经皮二尖瓣合缝术。
诊断：经食道超声心动图（TEE）证实，术前有较大的LAA血栓伸入左心房腔。
干预措施：患者开始使用直接因子Xa（FXa）抑制剂利伐沙班（20 mg / d）。利伐沙班治疗3周后，TEE显示血栓大小相应减少，用FXa抑制剂进行抗凝治疗5周后，血栓完全消退。
结果：就我们所知，这是首次记录的严重二尖瓣狭窄合并非维生素K拮抗剂口服抗凝剂的大面积LAA血栓形成病例，随后进行了经皮经皮静脉二尖瓣合缝术。
经验教训：该报告指出，利伐沙班可以作为二尖瓣狭窄合并LAA血栓的患者的治疗选择。风湿性二尖瓣狭窄和房颤患者常规使用利伐沙班之前，需要进一步研究。

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： 背景与目的：评价新型抗凝药和华法林在中国房颤患者中的预防成本效益。
方法：建立马尔可夫模型以比较使用药物成本，服药后检查的成本以及其他治疗的增量成本的患者的质量调整生命年（QALYs）。将达比加群（110和150 mg，每天两次）和利伐沙班（20 mg，每天一次）与华法林（3-6 mg，每天一次）进行比较。在我们的研究中，支付意愿是2018年中国人均GDP（9481.88 $）的三倍。
结果：华法林，利伐沙班，达比加群110 mg出价和达比加群150 mg出价的总成本分别为5317.31 $，29673.33 $，23615.49 $和34324.91 $。四种干预措施的QALYs分别为11.07年，15.46年，12.4年和15年。三种新型口服抗凝药和华法林的成本效益分析表明，将利伐沙班与华法林比较时，增量成本效益比（ICER）为5548.07 $ / QALY。利伐沙班是最具成本效益的选择，而华法林则是最少的选择。
结论：在中国房颤患者中，尽管华法林价格便宜，但从经济角度考虑，利伐沙班具有更好的成本效益优势。

BACKGROUND & AIMS: OBJECTIVE:Rivaroxaban (BAY 59-7939) is an oral, direct Factor Xa (FXa) inhibitor being developed for the prevention and treatment of thromboembolic disorders. This analysis aimed to define population models for the pharmacokinetics (PK) and pharmacodynamics (PD) ofrivaroxaban in healthy males. METHODS:Non-linear, mixed-effect modeling was used to analyze rivaroxaban plasma concentration and PD data (FXa activity and clotting tests) from subjects in a phase I, multiple-ascending-dose study. Subjects received 5 mg rivaroxaban once, twice or three times daily, or 10, 20 or 30 mg rivaroxaban twice daily. RESULTS:The population PK of rivaroxaban were well described by an oral, two-compartment model with first-order absorption and elimination from the central compartment. Population mean estimates for apparent oral clearance and volume of distribution for the central compartment were 9.2 1/h and 55 1, respectively, with moderate inter-individual variability (17.4% and 30.7%, respectively). Total volume of distribution for rivaroxaban at steady state was approximately 70 1. Residual (unexplained) variability was 25%. FXa activity correlated with rivaroxaban plasma concentrations following an inhibitory Emax model; prothrombin time (PT) and rivaroxaban plasma concentrations correlated with a linear model, with a slope of 4.6 s/(100 microg/1). Inter-individual variability was low for the correlation with PT. The models derived were used to define sampling windows for population PK/PD modeling in Phase II studies. CONCLUSIONS:This analysis confirms that rivaroxaban has predictable, dose-proportional PK and PD. The linear correlation between rivaroxaban plasma concentrations and PT suggests that this test might be useful to assess rivaroxaban exposure in patients, if required.

背景与目标： 目的：Rivaroxaban（BAY 59-7939）是一种口服直接Xa因子（FXa）抑制剂，正在开发用于预防和治疗血栓栓塞性疾病。该分析旨在为健康男性中的利伐沙班的药代动力学（PK）和药效动力学（PD）定义种群模型。
方法：在第一阶段多剂量研究中，非线性混合效应模型用于分析利伐沙班的血浆浓度和PD数据（FXa活性和凝结试验）。受试者每天一次，两次或三次接受5毫克rivaroxaban，或每天两次接受10、20或30毫克rivaroxaban。
结果：利伐沙班的种群PK通过口服，两室模型被很好地描述，该模型具有一阶吸收和从中央室消除的作用。中央隔室的表观口腔清洁度和分布体积的总体平均估计分别为9.2 1 / h和55 1，个体之间的差异性中等（分别为17.4％和30.7％）。利伐沙班在稳定状态下的总分配量约为70 1.残余（无法解释的）变异性为25％。在抑制性Emax模型下，FXa活性与利伐沙班血浆浓度相关。凝血酶原时间（PT）和利伐沙班血浆浓度与线性模型相关，斜率为4.6 s /（100 microg / 1）。与PT的相关性，个体间变异性较低。在第二阶段研究中，使用导出的模型来定义用于人口PK / PD建模的采样窗口。
结论：该分析证实利伐沙班具有可预测的，与剂量成比例的PK和PD。利伐沙班血浆浓度与PT之间的线性相关性表明，如果需要的话，该试验对于评估利伐沙班患者的暴露可能是有用的。

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： 重要性：达比加群和利伐沙班是经批准用于非瓣膜性房颤（AF）患者的中风预防的非维生素K口服抗凝剂。这些药物在中风，出血或死亡率方面没有随机的头对头比较。
目的：比较开始使用达比加群或利伐沙班治疗的非瓣膜性房颤患者的血栓栓塞性中风，颅内出血（ICH），主要颅外出血（包括主要胃肠道出血）和死亡率的风险。
设计，背景和参与者：2011年11月对118891名65岁以上老年非瓣膜性房颤患者进行回顾性新使用者队列研究，参加了有偿服务的Medicare，并从2011年11月4日开始使用达比加群或利伐沙班治疗，直到2014年6月30日为止。基线特征的差异是根据倾向得分，使用稳定的治疗权重的逆概率进行调整的。数据分析的时间为2015年5月7日至2016年6月30日。
暴露：达比加群150毫克，每日两次；利伐沙班，20毫克，每天一次。
主要结果和措施：以达比加群为参考，对血栓栓塞性中风，ICH，主要颅外出血（包括主要胃肠道出血）和死亡率的主要结局调整后的危险比（HRs）。还估计了调整后的发病率差异（AIRD）。
结果：总共有52240例达比加群治疗和66651例利伐沙班治疗的患者（女性占47％）分别进行了15524和20199人年的治疗随访，其中发生了2537例主要预后事件。利伐沙班的使用与血栓栓塞性卒中的统计学上无统计学意义的降低（HR，0.81； 95％CI，0.65-1.01； P = .07； AIRD = 1.8病例/ 1000人-年）相比，ICH的统计学显着增加（HR， 1.65; 95％CI，1.20-2.26; P = .002; AIRD = 2.3超标病例/ 1000人年）和严重颅外出血（HR，1.48; 95％CI，1.32-1.67; P <.001; AIRD =每1 000人年增加13.0例），包括主要胃肠道出血（HR，1.40; 95％CI，1.23-1.59; P <.001; AIRD = 9.4超病情况/ 1000人年），且统计上无显着增加死亡率（HR，1.15； 95％CI，1.00-1.32； P = .051； AIRD = excess3.1超重病例/ 1000人年）。在75岁或以上或CHADS2评分大于2的患者中，与达比加群相比，利伐沙班的使用与死亡率显着增加有关。使用利伐沙班的ICH过量率超过了其降低的血栓栓塞性卒中率。
结论与相关性：与每日两次两次达比加群150 mg相比，每日一次利伐沙班20 mg治疗与ICH和主要颅外出血（包括主要胃肠道出血）的统计学显着增加相关。

BACKGROUND & AIMS: Importance:The COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) randomized clinical trial was stopped early owing to the efficacy of low-dose rivaroxaban plus aspirin in preventing major cardiovascular events. The main reason for early trial termination was the effect of combination therapy on reducing ischemic strokes. Objective:To analyze the association between low-dose rivaroxaban with or without aspirin and different ischemic stroke subtypes. Design, Setting, and Participants:This is a secondary analysis of a multicenter, double-blind, randomized, placebo-controlled study that was performed in 33 countries from March 12, 2013, to May 10, 2016. Patients with stable atherosclerotic vascular disease were eligible, and a total of 27 395 participants were randomized and followed up to February 6, 2017. All first ischemic strokes and uncertain strokes that occurred by this date were adjudicated using TOAST (Trial of Org 10172 in Acute Stroke Treatment) criteria. The analysis of ischemic stroke subtypes was evaluated using an intention-to-treat principle. Statistical analysis was performed from March 12, 2013, to February 6, 2017. Interventions:Participants received rivaroxaban (2.5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban (5 mg twice a day), or aspirin (100 mg once a day). Main Outcomes and Measures:Risk of ischemic stroke subtypes during follow-up. Results:A total of 291 patients (66 women; mean [SD] age, 69.4 [8.5] years; 43 [14.8%] had a previous nonlacunar stroke) experienced an ischemic stroke. During the study, 49 patients (16.8%) received a diagnosis of atrial fibrillation. Applying TOAST criteria, 59 strokes (20.3%) were cardioembolic, 54 strokes (18.6%) were secondary to greater than 50% stenosis of the ipsilateral internal carotid artery, 42 strokes (14.4%) had a negative evaluation that met criteria for embolic stroke of undetermined source, and 21 strokes (7.2%) were secondary to small vessel disease. There were significantly fewer cardioembolic strokes (hazard ratio [HR], 0.40 [95% CI, 0.20-0.78]; P = .005) and embolic strokes of undetermined source (HR, 0.30 [95% CI, 0.12-0.74]; P = .006) in the combination therapy group compared with the aspirin-only group. A trend for reduction in strokes secondary to small vessel disease (HR, 0.36 [95% CI, 0.12-1.14]; P = .07) was not statistically significant. No significant difference was observed between the 2 groups in strokes secondary to greater than 50% carotid artery stenosis (HR, 0.85 [95% CI, 0.45-1.60]; P = .61). Rivaroxaban, 5 mg, twice daily showed a trend for reducing cardioembolic strokes compared with aspirin (HR, 0.57 [95% CI, 0.31-1.03]; P = .06) but was not associated with reducing other stroke subtypes. Conclusions and Relevance:For patients with systemic atherosclerosis, low-dose rivaroxaban plus aspirin was associated with large, significant reductions in cardioembolic strokes and embolic strokes of undetermined source. However, these results of exploratory analysis need to be independently confirmed before influencing clinical practice. Trial Registration:ClinicalTrials.gov identifier: NCT01776424.

背景与目标： 重要性：由于低剂量利伐沙班加阿司匹林在预防重大心血管事件中的功效，COMPASS（使用抗凝策略的人的心血管结局）随机临床试验已提前停止。提前终止试验的主要原因是联合治疗对减少缺血性卒中的作用。
目的：分析有或没有阿司匹林的低剂量利伐沙班与不同缺血性中风亚型的相关性。
设计，背景和参与者：这是一项多中心，双盲，随机，安慰剂对照研究的二次分析，该研究于2013年3月12日至2016年5月10日在33个国家/地区进行。稳定的动脉粥样硬化性血管疾病患者符合条件，共有27395名参与者被随机分组​​，并随访至2017年2月6日。使用TOAST（急性卒中治疗中的组织10172试验）对截至该日期发生的所有首次缺血性卒中和不确定性卒中进行判定。缺血性中风亚型的分析使用意向性治疗原则进行评估。从2013年3月12日至2017年2月6日进行统计分析。
干预措施：参与者接受利伐沙班（每天两次2.5毫克）加阿司匹林（每天一次100毫克），利伐沙班（每天两次5毫克）或阿司匹林（每天一次100毫克）。
主要结果和措施：随访期间缺血性中风亚型的风险。
结果：总共291例患者发生了缺血性中风（66名女性；平均[SD]年龄为69.4 [8.5]岁； 43名[14.8％]患有先前的非腔隙性中风）。在研究过程中，有49位患者（16.8％）被诊断为房颤。采用TOAST标准，心脏栓塞59例（20.3％），同侧颈内动脉狭窄大于50％继发54例（18.6％），符合栓塞性中风标准的阴性评估为42例（14.4％）来源不明，其中21例（7.2％）中风是继发于小血管疾病。心脏栓塞卒中（危险比[HR]，0.40 [95％CI，0.20-0.78]； P = .005）和未确定来源的栓塞卒中（HR，0.30 [95％CI，0.12-0.74]； P与单纯阿司匹林组相比，联合治疗组==。006）。继发于小血管疾病的卒中减少的趋势（HR，0.36 [95％CI，0.12-1.14]； P = .07）没有统计学意义。在颈动脉狭窄大于50％的继发卒中中，两组之间未观察到显着差异（HR，0.85 [95％CI，0.45-1.60]； P = 61）。与阿司匹林（HR，0.57 [95％CI，0.31-1.03]； P = .06）相比，每日两次5 mg利伐沙班有降低心脏栓塞性中风的趋势，但与减少其他中风亚型无关。
结论和相关性：对于系统性动脉粥样硬化患者，低剂量利伐沙班加阿司匹林可显着减少心脏栓塞性卒中和未确定来源的栓塞性卒中。但是，探索性分析的这些结果需要在影响临床实践之前进行独立确认。
试用注册：ClinicalTrials.gov标识符：NCT01776424。

BACKGROUND & AIMS: :Rivaroxaban has been found to be noninferior to warfarin for preventing stroke or systemic embolism in patients with high-risk atrial fibrillation (AF) and is associated with a lower rate of intracranial hemorrhage. To assess the cost-effectiveness of rivaroxaban compared to adjusted-dose warfarin for the prevention of stroke in patients with AF, we built a Markov model using a United States payer/Medicare perspective and a lifetime time horizon. The base-case analysis assumed a cohort of patients with AF 65 years of age with a congestive heart failure, hypertension, age, diabetes, stroke (2 points) score of 3 and no contraindications to anticoagulation. Data sources included the Rivaroxaban Once-daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET-AF) and other studies of anticoagulation. Outcome measurements included costs in 2011 United States dollars, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). Patients with AF treated with rivaroxaban lived an average of 10.03 QALYs at a lifetime treatment cost of $94,456. Those receiving warfarin lived an average of 9.81 QALYs and incurred costs of $88,544. The ICER for rivaroxaban was $27,498 per QALY. These results were most sensitive to changes in the hazard decrease of intracranial hemorrhage and stroke with rivaroxaban, cost of rivaroxaban, and time horizon. Monte Carlo simulation demonstrated rivaroxaban was cost-effective in 80% and 91% of 10,000 iterations at willingness-to-pay thresholds of $50,000 and $100,000 per QALY, respectively. In conclusion, this Markov model suggests that rivaroxaban therapy may be a cost-effective alternative to adjusted-dose warfarin for stroke prevention in AF.

背景与目标： Rivaroxaban被认为在预防高危房颤（AF）患者中风或全身性栓塞方面不逊于华法林，并且与颅内出血发生率较低相关。为了评估利伐沙班与调整剂量华法林相比预防房颤患者卒中的成本效益，我们使用美国付款人/医疗保险的观点和终生时间范围建立了马尔可夫模型。基本病例分析假设一组年龄在65岁以下的房颤患者，其充血性心力衰竭，高血压，年龄，糖尿病，中风（2分）得分为3，无抗凝禁忌症。数据来源包括利伐沙班每日一次口服直接因子Xa抑制与房颤中风和栓塞试验的维生素K拮抗作用比较（ROCKET-AF）以及其他抗凝研究。成果衡量标准包括2011年的美元成本，质量调整生命年（QALY）和增量成本效益比（ICER）。利伐沙班治疗的房颤患者平均生活10.03 QALYs，终生治疗费用为94,456美元。那些接受华法林治疗的患者平均生活了9.81个QALYs，费用为88,544美元。利伐沙班的ICER为每QALY 27,498美元。这些结果对利伐沙班引起的颅内出血和中风的危险性降低，利伐沙班的花费和时间跨度的变化最为敏感。蒙特卡洛模拟显示，利伐沙班在10,000次迭代的80％和91％的成本效益阈值分别为每QALY 50,000美元和100,000美元。总之，该马尔可夫模型表明，利伐沙班治疗可能是一种替代成本合理的华法林的经济有效替代方案，可用于预防房颤。

BACKGROUND & AIMS: :This study aimed to compare the efficacy and safety of aspirin, rivaroxaban and low-molecular-weight heparin (LMWH) for post total knee arthroplasty (TKA) deep vein thrombosis (DVT) prophylaxis. Between July 2011 and July 2013, a prospective randomized controlled trial was performed on 324 patients with osteoarthritis who underwent primary unilateral TKA. Twelve hours after the surgery, Group A was given oral rivaroxaban at a dose of 10 mg/day. Group B was given subcutaneous LMWH at a dose of 4000 AxaIU (0.4 ml)/day and Group C was given oral aspirin at a dose of 100 mg/day. All three groups were treated for 14 days, and all of the patients were followed for 4 weeks. The incidence of DVT, dominant/hidden blood loss, the incidence of wound complications and the incidence of subcutaneous ecchymosis in the affected extremities were compared between the three groups. The incidence of DVT was lower in Group A compared with the other two groups [3 (2.94%) vs. 14 (12.50%), P = 0.029; 3 (2.94%) vs. 18 (16.36%), P = 0.017]. However, hidden blood loss [1.71 (1.19-2.97) vs. 1.18 (0.77-2.31), P = 0.009; 1.71 (1.19-2.97) vs. 1.30 (0.61-2.43), P = 0.004] and wound complications [5 (4.90) vs. 3 (2.67), P = 0.027; 5 (4.90) vs. 2 (1.82), P = 0.014] were more common in Group A than in the other groups. There were no significant differences between Group B and Group C in the incidence of DVT [14 (12.50%) vs. 18 (16.36%), P = 0.831], hidden blood loss [1.18 (0.77-2.31) vs. 1.30 (0.61-2.43), P = 0.327] or wound complications [3 (2.67) vs. 2 (1.82), P = 0.209]. No significant differences in the incidence of limb swelling were found between the three groups [38 (37.25%) vs. 28 (25.00%) vs. 24 (21.82%), P = 0.247]. Group A had a higher incidence of subcutaneous ecchymosis in the affected extremities than Group C [74 (72.55%) vs. 54 (49.09%), P = 0.039], but there were no significant differences between Groups A and B [74 (72.55%) vs. 62 (55.36%), P = 0.193] or between Groups B and C [62 (55.36%) vs. 54 (49.09%), P = 0.427]. Rivaroxaban has a positive anticoagulation effect but leads to increases in both postoperative blood loss and wound complications in patients. Hence, clinicians using rivaroxaban for anticoagulant therapy should closely monitor the changes in the hemoglobin level and wound healing and promptly supplement blood volume and provide other symptomatic and supportive treatments. No significant difference in post-TKA DVT prophylaxis was found between aspirin and LMWH, and the former can be used as part of a multimodal anticoagulation therapy.

背景与目标： ：本研究旨在比较阿司匹林，利伐沙班和低分子量肝素（LMWH）在全膝关节置换术后（TKA）预防深静脉血栓形成（DVT）的有效性和安全性。在2011年7月至2013年7月之间，对324例行原发性单侧TKA的骨关节炎患者进行了一项前瞻性随机对照试验。手术后十二小时，给A组口服利伐沙班口服，剂量为10μg/天。 B组给予皮下注射LMWH，剂量为4000 AxaIU（0.4μml）/天，C组给予口服阿司匹林，剂量为100μgIU/天。三组均治疗14天，所有患者均随访4周。比较了三组患肢的DVT发生率，显性/隐性失血，伤口并发症的发生率和皮下瘀斑的发生率。与其他两组相比，A组的DVT发生率较低[3（2.94％）vs. 14（12.50％），P = 0.029; 3（2.94％）对18（16.36％），P = 0.017]。然而，隐性失血[1.71（1.19-2.97）对1.18（0.77-2.31），P = 0.009； 1.71（1.19-2.97）对1.30（0.61-2.43），P = 0.004]和伤口并发症[5（4.90）对3（2.67），P = 0.027； A组中5（4.90）vs. 2（1.82），P2 = 0.014]比其他组更常见。 B组和C组之间DVT的发生率无显着差异[14（12.50％）vs. 18（16.36％），P = 0.831]，隐性失血[1.18（0.77-2.31）vs.1.30（0.61） -2.43），P = 0.327]或伤口并发症[3（2.67）对2（1.82），P = 0.209]。三组之间肢体肿胀的发生率没有显着差异[38（37.25％）vs. 28（25.00％）vs. 24（21.82％），P = 0.247]。 A组患肢皮下瘀斑的发生率高于C组[74（72.55％）vs. 54（49.09％），P = 0.039]，但A组和B组之间无显着差异[74（72.55） ％）vs. 62（55.36％），P = 0.193]或在B组和C组之间[62（55.36％）vs. 54（49.09％），P = 0.427]。利伐沙班具有积极的抗凝作用，但会导致术后失血量增加和患者伤口并发症增加。因此，使用利伐沙班进行抗凝治疗的临床医生应密切监测血红蛋白水平和伤口愈合的变化，并迅速补充血容量并提供其他对症和支持治疗。阿司匹林和LMWH在TKA预防DVT预防方面无显着差异，前者可作为多模式抗凝治疗的一部分。

BACKGROUND & AIMS: BACKGROUND:Standard therapy for cancer-associated venous thromboembolism (VTE) is low-molecular-weight heparin. The use of direct oral anticoagulants for cancer-associated VTE has increased; however, their efficacy and safety in lung cancer patients remain unclear. OBJECTIVES:We examined the efficacy and safety of rivaroxaban compared with dalteparin for cancer-associated VTE in patients with primary lung cancer. METHODS:A single-center retrospective study of 204 patients with primary lung cancer who were prescribed rivaroxaban (n = 131) or dalteparin (n = 73) for VTE was performed. The primary endpoint was a composite event including recurrence and major or clinically relevant nonmajor bleeding. Secondary endpoints included the incidence of recurrence, major and clinically relevant nonmajor bleeding, all-cause mortality, and bleeding or pulmonary embolism-related mortality. RESULTS:The composite event occurred in 38 (29.0) and 12 (16.4%) patients in the rivaroxaban and dalteparin (p = 0.045) groups, respectively. The multivariate Cox proportional hazards model for age, Eastern Cooperative Oncology Group performance score, and bleeding risk factors revealed the rivaroxaban group showed a 1.176-fold composite event risk without statistical significance (0.595-2.324, p = 0.641). There was no statistically significant intergroup difference for the incidence of VTE recurrence (5.3% in the rivaroxaban group versus 2.7% in the dalteparin group, p = 0.495) and major or clinically relevant nonmajor bleeding (23.7% in the rivaroxaban group versus 13.7% in the dalteparin group, p = 0.089). There was no significant difference in the all-cause mortality rate (hazard ratio 0.864, 95% CI 0.624-1.196, p = 0.337). CONCLUSIONS:There was no difference in the safety and efficacy profile of rivaroxaban compared with dalteparin. Therefore, rivaroxaban may be a valuable treatment option for lung cancer-associated VTE.

背景与目标： 背景：癌症相关的静脉血栓栓塞症（VTE）的标准疗法是低分子量肝素。直接口服抗凝剂用于与癌症相关的VTE的使用有所增加；然而，它们在肺癌患者中的疗效和安全性尚不清楚。
目的：我们研究了利伐沙班与达肝素相比对原发性肺癌患者与癌症相关的VTE的有效性和安全性。
方法：对204例原发性肺癌患者进行单中心回顾性研究，他们接受利伐沙班（n = 131）或达肝素（n = 73）的VTE处方。主要终点为复合事件，包括复发和重大或临床相关的非重大出血。次要终点包括复发率，重大和临床相关的非重大出血，全因死亡率以及与出血或肺栓塞相关的死亡率。
结果：利伐沙班和达肝素（p = 0.045）组分别发生38例（29.0）和12例（16.4％）患者的复合事件。年龄，东部合作肿瘤小组表现评分和出血危险因素的多变量Cox比例风险模型显示，利伐沙班组的复合事件风险为1.176倍，无统计学意义（0.595-2.324，p = 0.641）。 VTE复发的发生率在两组间均无统计学差异（利伐沙班组为5.3％，达肝素组为2.7％，p = 0.495）以及重大或临床相关的非重大出血（利伐沙班组为23.7％，而利伐沙班组为13.7％）。达肝素组，p = 0.089）。全因死亡率没有显着差异（危险比0.864，95％CI 0.624-1.196，p = 0.337）。
结论：利伐沙班与达肝素相比，安全性和疗效无差异。因此，利伐沙班可能是与肺癌相关的VTE的一种有价值的治疗选择。