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Re: Shahim et al., 2024 "Cholinesterase inhibitors are associated with reduced mortality in patients with Alzheimer's disease and previous myocardial infarction". Re:Shahim 等人,2024 胆碱酯酶抑制剂与降低阿尔茨海默病患者和既往心肌梗塞患者的死亡率有关。
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-14 DOI: 10.1093/ehjcvp/pvae041
Arina A Tamborska, Charles F Bray, Tobias Kurth
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引用次数: 0
GPVI inhibition: Advancing antithrombotic therapy in cardiovascular disease. 将 GPVI 作为有效的抗血栓靶点。
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-14 DOI: 10.1093/ehjcvp/pvae018
Alexandre Slater, Sophia Khattak, Mark R Thomas

Glycoprotein (GP) VI (GPVI) plays a major role in thrombosis but not haemostasis, making it a promising antithrombotic target. The primary role of GPVI on the surface of platelets is a signalling receptor for collagen, which is one of the most potent thrombotic sub-endothelial components that is exposed by atherosclerotic plaque rupture. Inhibition of GPVI has therefore been investigated as a strategy for treatment and prevention of atherothrombosis, such as during stroke and acute coronary syndromes. A range of specific GPVI inhibitors have been characterized, and two of these inhibitors, glenzocimab and revacept, have completed Phase II clinical trials in ischaemic stroke. In this review, we summarize mechanisms of GPVI activation and the latest progress of clinically tested GPVI inhibitors, including their mechanisms of action. By focusing on what is known about GPVI activation, we also discuss whether alternate strategies could be used to target GPVI.

糖蛋白(GP)VI 在血栓形成中起着重要作用,但不止血,因此是一个很有前景的抗血栓靶点。GPVI 在血小板表面的主要作用是作为胶原蛋白的信号受体,而胶原蛋白是动脉粥样硬化斑块破裂时暴露出来的最有效的血栓形成内皮下成分之一。因此,人们将抑制 GPVI 作为治疗和预防动脉粥样硬化血栓形成(如中风和急性冠状动脉综合征)的一种策略进行了研究。一系列特异性 GPVI 抑制剂已被证实,其中两种抑制剂--格仑珠单抗和雷帕塞已完成缺血性中风的 II 期临床试验。在本综述中,我们总结了 GPVI 的激活机制和临床试验 GPVI 抑制剂的最新进展,包括其作用机制。我们将重点放在已知的 GPVI 激活机制上,并讨论是否也可以采用其他策略来靶向 GPVI。
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引用次数: 0
Safety and effectiveness of glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: insights from the SPUM-ACS study. 糖蛋白 IIb/IIIa 抑制剂在急性冠状动脉综合征中的安全性和有效性:SPUM-ACS 研究的启示。
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-14 DOI: 10.1093/ehjcvp/pvae024
Francesco Bruno, Florian A Wenzl, Ovidio De Filippo, Simon Kraler, Federico Giacobbe, Marco Roffi, Olivier Muller, Lorenz Räber, Christian Templin, Gaetano Maria De Ferrari, Fabrizio D'Ascenzo, Thomas F Lüscher

Aims: Data on glycoprotein IIb/IIIa inhibitor (GPI) use in real-world acute coronary syndrome (ACS) patients following the introduction of potent P2Y12 inhibitors and newer-generation stents are scant. Here, we aimed to assess the utilization, effectiveness, and safety of GPI in a large prospective multicentre cohort of contemporary ACS patients.

Methods and results: SPUM-ACS prospectively recruited patients presenting with ACS between 2009 and 2017. The primary endpoint of the present study was major adverse cardiovascular events (MACE), a composite of all-cause death, non-fatal myocardial infarction, and non-fatal stroke at 1 year. Secondary endpoints were defined as any bleeding events, Bleeding Academic Research Consortium (BARC) 3-5 bleeding, and net adverse cardiovascular events (NACE). A total of 4395 ACS patients were included in the analysis. GPI-treated patients had more total coronary artery occlusion (56% vs. 35%, P < 0.001) and thrombus (60% vs. 35%, P < 0.001) at angiography. Among the propensity score-matched (PSM) population (1992 patients equally split into two groups), GPI-treated patients showed lower risk of MACE [PSM adjusted hazard ratio (HR) 0.70, 95% CI 0.49-0.99], but a higher risk of any (PSM adjusted HR 1.46, 95% CI 1.06-1.99) and major bleedings (PSM adjusted HR 1.73, 95% CI 1.09-2.76), resulting in a neutral effect on NACE (PSM adjusted HR 0.87, 95% CI 0.65-1.17). These results remained consistent across all subgroups.

Conclusions: In patients with ACS undergoing percutaneous coronary intervention and receiving potent P2Y12 inhibitors, we observed a reduced risk of MACE and an increased risk of major bleedings at 1 year in patients treated with GPI. Although the routine use of GPI is currently not recommended, they might be considered in selected patients following a personalized balancing between ischaemic and bleeding risks.

目的:在强效P2Y12抑制剂和新一代支架问世后,有关糖蛋白IIb/IIIa抑制剂(GPI)在实际ACS患者中使用情况的数据很少。在此,我们旨在评估 GPI 在当代 ACS 患者大型前瞻性多中心队列中的使用情况、有效性和安全性:SPUM-ACS前瞻性地招募了2009年至2017年间的ACS患者。本研究的主要终点是主要不良心血管事件(MACE),即一年内全因死亡、非致死性心肌梗死(MI)和非致死性卒中的复合终点。次要终点定义为任何出血事件、BARC 3-5 级出血和净不良心血管事件(NACE)。共有 4395 名 ACS 患者被纳入分析。GPI治疗患者的冠状动脉全闭塞率更高(56% vs 35%,pConclusion):在接受 PCI 并接受强效 P2Y12 抑制剂治疗的 ACS 患者中,我们观察到接受 GPI 治疗的患者 MACE 风险降低,1 年后大出血风险增加。虽然目前不建议常规使用 GPI,但在平衡缺血和出血风险后,可考虑在特定患者中使用 GPI。
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引用次数: 0
Oral anticoagulation in patients with left ventricular thrombus: a systematic review and meta-analysis. 左心室血栓患者的口服抗凝药--系统回顾和荟萃分析。
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-14 DOI: 10.1093/ehjcvp/pvae042
Paul M Haller, Niema Kazem, Stefan Agewall, Claudio Borghi, Claudio Ceconi, Dobromir Dobrev, Elisabetta Cerbai, Erik Lerkevang Grove, Juan Carlos Kaski, Basil S Lewis, Alexander Niessner, Bianca Rocca, Giuseppe Rosano, Gianluigi Savarese, Renate B Schnabel, Anne Grete Semb, Samuel Sossalla, Sven Wassmann, Patrick Sulzgruber

Aims: Direct oral anticoagulants (DOACs) are increasingly used off-label to treat patients with left ventricular thrombus (LVT). We analysed available meta-data comparing DOACs and vitamin K antagonists (VKAs) for efficacy and safety.

Methods: We conducted a systematic search and meta-analysis of observational and randomized data comparing DOACs vs. VKAs in patients with LVT. Endpoints of interest were stroke or systemic embolism, thrombus resolution, all-cause death, and a composite bleeding endpoint. Estimates were pooled using a random-effects model meta-analysis, and their robustness was investigated using sensitivity and influential analyses.

Results: We identified 22 articles (18 observational studies, 4 small randomized clinical trials) reporting on a total of 3587 patients (2489 VKA vs. 1098 DOAC therapy). The pooled estimates for stroke or systemic embolism [odds ratio (OR): 0.81; 95% confidence interval (CI): 0.57, 1.15] and thrombus resolution (OR: 1.12; 95% CI: 0.86, 1.46) were comparable, and there was low heterogeneity overall across the included studies. The use of DOACs was associated with lower odds of all-cause death (OR: 0.65; 95% CI: 0.46, 0.92) and a composite bleeding endpoint (OR: 0.67; 95% CI: 0.47, 0.97). A risk of bias was evident particularly for observational reports, with some publication bias suggested in funnel plots.

Conclusion: In this comprehensive analysis of mainly observational data, the use of DOACs was not associated with a significant difference in stroke or systemic embolism, or thrombus resolution, compared with VKA therapy. The use of DOACs was associated with a lower rate of all-cause death and fewer bleeding events. Adequately sized randomized clinical trials are needed to confirm these findings, which could allow a wider adoption of DOACs in patients with LVT.

目的:直接口服抗凝剂(DOAC)越来越多地被用于治疗左心室血栓(LVT)患者。我们分析了现有的荟萃数据,比较了 DOAC 和维生素 K 拮抗剂(VKAs)的疗效和安全性:我们对 LVT 患者中 DOAC 与 VKAs 比较的观察性和随机数据进行了系统检索和荟萃分析。研究终点为中风或全身性栓塞、血栓溶解、全因死亡和综合出血终点。使用随机效应模型荟萃分析对估计值进行汇总,并使用敏感性分析和影响分析对其稳健性进行研究:我们确定了 22 篇文章(18 项观察性研究、4 项小型随机临床试验),共报告了 3,587 名患者(2,489 名患者接受 VKA 治疗,1,098 名患者接受 DOAC 治疗)。中风或全身性栓塞(OR 0.81;95% CI [0.57,1.15])和血栓溶解(OR 1.12;95% CI [0.86,1.46])的汇总估计值相当,纳入研究的总体异质性较低。使用 DOAC 可降低全因死亡几率(OR 0.65;95%CI [0.46;0.92])和复合出血终点(OR 0.67;95%CI [0.47;0.97])。特别是观察性报告存在明显的偏倚风险,漏斗图显示了一些发表偏倚:在这项以观察性数据为主的综合分析中,与 VKA 治疗相比,使用 DOACs 与中风、全身性栓塞或血栓溶解的显著差异无关。使用 DOACs 与较低的全因死亡率和较少的出血事件有关。需要进行足够规模的随机临床试验来证实这些研究结果,这样才能在 LVT 患者中更广泛地采用 DOACs。
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引用次数: 0
The search for the holy grail: the balance between the risk of thrombosis and bleeding in patients. 寻找圣杯:患者血栓形成和出血风险之间的平衡。
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-14 DOI: 10.1093/ehjcvp/pvae052
Stefan Agewall
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引用次数: 0
Reply to 'Cholinesterase inhibitors are associated with reduced mortality in patients with Alzheimer's disease and previous myocardial infarction'. 对 "胆碱酯酶抑制剂与降低阿尔茨海默病患者和既往心肌梗死患者的死亡率有关 "的答复
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-14 DOI: 10.1093/ehjcvp/pvae023
Bahira Shahim, Hong Xu, Maria Eriksdotter
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引用次数: 0
After 30 years, the first endothelin-receptor antagonist (Aprocitentan) is approved for the treatment of arterial hypertension. 30 年后,首个内皮素受体拮抗剂(Aprocitentan)被批准用于治疗动脉高血压。
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-14 DOI: 10.1093/ehjcvp/pvae035
Juan Tamargo
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引用次数: 0
Comparative cardiovascular and renal effectiveness of empagliflozin and dapagliflozin: Scandinavian cohort study. 安帕格列净和达帕格列净对心血管和肾脏疗效的比较:斯堪的纳维亚队列研究。
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-14 DOI: 10.1093/ehjcvp/pvae045
Arvid Engström, Jonas Söderling, Anders Hviid, Björn Eliasson, Soffia Gudbjörnsdottir, Viktor Wintzell, Kristian Hveem, Christian Jonasson, Mads Melbye, Björn Pasternak, Peter Ueda

Aims: To assess the comparative cardiovascular and renal effectiveness and safety of empagliflozin vs. dapagliflozin among patients with type 2 diabetes in routine clinical practice.

Methods and results: Cohort study using data from nationwide registers in Sweden, Denmark, and Norway, from June 2014 to June 2021 included 141 065 new users of empagliflozin and 58 306 new users of dapagliflozin. Coprimary outcomes were major cardiovascular events (myocardial infarction, stroke, and cardiovascular death), heart failure (hospitalization or death because of heart failure) and serious renal events (renal replacement therapy, hospitalization for renal events, and death from renal causes). Secondary outcomes were the individual components of the primary outcomes, any cause death, and diabetic ketoacidosis. Use of empagliflozin vs. dapagliflozin was associated with similar risk of major cardiovascular events [adjusted incidence rate: 15.9 vs. 15.8 events per 1000 person-years; HR 1.02, (95% confidence interval 0.97-1.08)], heart failure [6.5 vs. 6.3 events per 1000 person-years; HR 1.05 (0.97-1.14)] and serious renal events [3.7 vs. 4.1 events per 1000 person-years; HR 0.97 (0.87-1.07)]. In secondary outcome analyses, the HRs for use of empagliflozin vs. dapagliflozin were 1.00 (0.93-1.07) for myocardial infarction, 1.03 (0.95-1.12) for stroke, 1.01 (0.92-1.13) for cardiovascular death, 1.06 (1.00-1.11) for any cause death, 0.77 (0.60-0.99) for renal replacement therapy, 1.20 (0.75-1.93) for renal death, 1.01 (0.90-1.12) for hospitalization for renal events and 1.12 (0.94-1.33) for diabetic ketoacidosis.

Conclusion: Use of empagliflozin and dapagliflozin was associated with similar risk of cardiovascular and renal outcomes, mortality, and diabetic ketoacidosis.

目的:在常规临床实践中,评估恩格列净与达帕格列净对2型糖尿病患者心血管和肾脏有效性和安全性的比较:队列研究使用瑞典、丹麦和挪威2014年6月至2021年6月期间全国范围内的登记数据,包括141065名安帕格列净新用户和58306名达帕格列净新用户。主要结果为重大心血管事件(心肌梗死、中风和心血管死亡)、心力衰竭(因心力衰竭住院或死亡)和严重肾脏事件(肾脏替代治疗、因肾脏事件住院和因肾脏原因死亡)。次要结果为主要结果的各个组成部分、任何原因导致的死亡和糖尿病酮症酸中毒:结果:使用empagliflozin与使用dapagliflozin发生重大心血管事件的风险相似(调整后发病率分别为15.9%和15.8%):15.9 vs. 15.8次/1000人-年;HR 1.02 [95% CI 0.97-1.08])、心力衰竭(6.5 vs. 6.3次/1000人-年;HR 1.05 [0.97-1.14])和严重肾脏事件(3.7 vs. 4.1次/1000人-年;HR 0.97 [0.87-1.07])的风险相似。在次要结局分析中,使用empagliflozin与dapagliflozin相比,心肌梗死的HR为1.00(0.93-1.07),中风为1.03(0.95-1.12),心血管死亡为1.01(0.92-1.13),任何原因死亡为1.06(1.00-1.11)、肾脏替代治疗0.77(0.60-0.99)、肾脏死亡1.20(0.75-1.93)、肾脏事件住院1.01(0.90-1.12)、糖尿病酮症酸中毒1.12(0.94-1.33):使用empagliflozin和dapagliflozin与心血管和肾脏结局、死亡率和糖尿病酮症酸中毒的风险相似。
{"title":"Comparative cardiovascular and renal effectiveness of empagliflozin and dapagliflozin: Scandinavian cohort study.","authors":"Arvid Engström, Jonas Söderling, Anders Hviid, Björn Eliasson, Soffia Gudbjörnsdottir, Viktor Wintzell, Kristian Hveem, Christian Jonasson, Mads Melbye, Björn Pasternak, Peter Ueda","doi":"10.1093/ehjcvp/pvae045","DOIUrl":"10.1093/ehjcvp/pvae045","url":null,"abstract":"<p><strong>Aims: </strong>To assess the comparative cardiovascular and renal effectiveness and safety of empagliflozin vs. dapagliflozin among patients with type 2 diabetes in routine clinical practice.</p><p><strong>Methods and results: </strong>Cohort study using data from nationwide registers in Sweden, Denmark, and Norway, from June 2014 to June 2021 included 141 065 new users of empagliflozin and 58 306 new users of dapagliflozin. Coprimary outcomes were major cardiovascular events (myocardial infarction, stroke, and cardiovascular death), heart failure (hospitalization or death because of heart failure) and serious renal events (renal replacement therapy, hospitalization for renal events, and death from renal causes). Secondary outcomes were the individual components of the primary outcomes, any cause death, and diabetic ketoacidosis. Use of empagliflozin vs. dapagliflozin was associated with similar risk of major cardiovascular events [adjusted incidence rate: 15.9 vs. 15.8 events per 1000 person-years; HR 1.02, (95% confidence interval 0.97-1.08)], heart failure [6.5 vs. 6.3 events per 1000 person-years; HR 1.05 (0.97-1.14)] and serious renal events [3.7 vs. 4.1 events per 1000 person-years; HR 0.97 (0.87-1.07)]. In secondary outcome analyses, the HRs for use of empagliflozin vs. dapagliflozin were 1.00 (0.93-1.07) for myocardial infarction, 1.03 (0.95-1.12) for stroke, 1.01 (0.92-1.13) for cardiovascular death, 1.06 (1.00-1.11) for any cause death, 0.77 (0.60-0.99) for renal replacement therapy, 1.20 (0.75-1.93) for renal death, 1.01 (0.90-1.12) for hospitalization for renal events and 1.12 (0.94-1.33) for diabetic ketoacidosis.</p><p><strong>Conclusion: </strong>Use of empagliflozin and dapagliflozin was associated with similar risk of cardiovascular and renal outcomes, mortality, and diabetic ketoacidosis.</p>","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2024-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11411209/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141450195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Use of proton pump inhibitors is associated with increased risk of out-of-hospital cardiac arrest in the general population: a nested case-control study. 使用质子泵抑制剂与普通人群院外心脏骤停风险增加有关:一项巢式病例对照研究。
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-14 DOI: 10.1093/ehjcvp/pvae020
Talip E Eroglu, Ruben Coronel, Gunnar H Gislason

Aims: Proton pump inhibitors (PPIs) impair cardiac repolarization, prolong the QT interval, and may potentially be pro-arrhythmic. However, the risk of out-of-hospital cardiac arrest (OHCA) is scarcely investigated. We studied whether past or current PPI use is associated with OHCA in the general population.

Methods and results: We conducted a nationwide nested case-control study with OHCA-cases of presumed cardiac causes and age/sex/OHCA-date-matched non-OHCA-controls from the general population. Exposure to PPI was categorized into three mutually exclusive groups of current-, past-, and non-use. Conditional logistic regression analyses with adjustments for risk factors of OHCA were used to calculate the odds ratio (OR) of OHCA comparing PPI use with non-users. We identified 46 578 OHCA cases and 232 890 matched non-OHCA controls (mean: 71 years, 68.8% men). PPI was used by 8769 OHCA-cases and 21 898 non-OHCA controls, and current use of PPI was associated with increased odds of OHCA compared with non-users [OR: 1.32 (95% CI: 1.28-1.37)], while past use conferred no increase in the odds of OHCA [OR: 1.01 (95% CI: 0.98-1.04)]. This increased odds of OHCA occurred in both sexes. Finally, the ORs remained elevated when we repeated the analyses in individuals without registered ischaemic heart disease [OR: 1.36 (95% CI: 1.31-1.41)], without heart failure [OR: 1.33 (95% CI: 1.29-1.38)], or without any cardiovascular comorbidities [OR: 1.84 (95% CI: 1.70-2.00)]. Also, the OR remained elevated when H2-antagonists served as the reference group [OR: 1.28 (95% CI: 1.11-1.47)].

Conclusion: PPI use is associated with an increased risk of OHCA in the general population. Considering the widespread use of PPIs, this study raises concerns and the need for awareness to balance the benefit and risk of treatment.

目的:质子泵抑制剂(PPIs)会损害心脏复极化,延长 QT 间期,并可能导致心律失常。然而,院外心脏骤停(OHCA)的风险却鲜有研究。我们研究了在普通人群中,过去或现在使用 PPI 是否与 OHCA 相关:我们在全国范围内开展了一项巢式病例对照研究,研究对象为推测为心脏原因导致的 OHCA 病例以及与年龄/性别/OHCA 日期相匹配的非 OHCA 病例。PPI暴露分为三个相互排斥的组别,即当前使用、过去使用和未使用。在对 OHCA 风险因素进行调整后,采用条件逻辑回归分析计算使用 PPI 与未使用 PPI 的 OHCA 机率比 (OR)。我们发现了 46578 例 OHCA 病例和 232890 例匹配的非 OHCA 对照者(平均 71 岁,68.8% 为男性)。有 8769 例 OHCA 患者和 21898 例非 OHCA 对照者使用了 PPI,与未使用 PPI 的患者相比,当前使用 PPI 与 OHCA 发生几率增加有关(OR:1.32 [95%-CI:1.28-1.37]),而过去使用 PPI 不会增加 OHCA 发生几率(OR:1.01 [95%-CI:0.98-1.04])。OHCA几率的增加在男女两性中均有发生。最后,当我们对无登记缺血性心脏病(OR:1.36 [95%-CI:1.31-1.41])、无心力衰竭(OR:1.33 [95%-CI:1.29-1.38])或无任何心血管合并症(OR:1.84 [95%-CI:1.70-2.00])的个体重复进行分析时,OR 值仍然升高。此外,以 H2-拮抗剂作为参照组时,OR 值仍然升高(OR:1.28 [95%-CI:1.11-1.47]):结论:在普通人群中,使用 PPI 与 OHCA 风险增加有关。考虑到 PPIs 的广泛使用,本研究引起了人们的关注,需要提高人们的认识,以平衡治疗的益处和风险。
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引用次数: 0
Edoxaban for 12 vs. 3 months in cancer-associated isolated distal deep vein thrombosis according to different doses: insights from the ONCO DVT study. 不同剂量的埃多沙班治疗癌症相关孤立远端深静脉血栓 12 个月与 3 个月:ONCO深静脉血栓研究的启示。
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-08-14 DOI: 10.1093/ehjcvp/pvae028
Ryuki Chatani, Yugo Yamashita, Takeshi Morimoto, Nao Muraoka, Michihisa Umetsu, Yuji Nishimoto, Takuma Takada, Yoshito Ogihara, Tatsuya Nishikawa, Nobutaka Ikeda, Kazunori Otsui, Daisuke Sueta, Yukari Tsubata, Masaaki Shoji, Ayumi Shikama, Yutaka Hosoi, Yasuhiro Tanabe, Kengo Tsukahara, Naohiko Nakanishi, Kitae Kim, Satoshi Ikeda, Kazunori Mushiake, Kazushige Kadota, Koh Ono, Takeshi Kimura

Background: The ONCO DVT study revealed the superiority of 12-month relative to 3-month edoxaban treatment for cancer-associated isolated distal deep vein thrombosis (DVT) regarding the thrombotic risk.

Methods and results: In this pre-specified subgroup analysis of the ONCO DVT study, we stratified the patients into those with a standard edoxaban dose (60 mg/day; N = 151) and those with a reduced edoxaban dose (30 mg/day; N = 450) and evaluated the clinical outcomes for the 12- and 3-month treatments. The cumulative 12-month incidence of symptomatic recurrent venous thromboembolism was lower in the 12-month than 3-month group for both the 60 mg (1.3% vs. 11.6%, P = 0.02; odds ratio [OR], 0.12; 95% confidence interval [CI], 0.01-0.97) and 30 mg (1.1% vs. 7.6%, P = 0.002; OR, 0.14; 95% CI, 0.03-0.60) edoxaban subgroups, which was consistent across the edoxaban doses without a significant interaction (P = 0.90). The 12-month cumulative incidence of major bleeding was higher in the 12-month group than in the 3-month group for the 60 mg edoxaban subgroup (14.3% vs. 4.4%, P = 0.046; OR, 3.61; 95% CI, 0.97-13.52), whereas it did not significantly differ between the two groups for the 30 mg edoxaban subgroup (8.7% vs. 8.6%, P = 0.89; OR, 0.97; 95% CI, 0.49-1.91), signalling there was a potential interaction (P = 0.07).

Conclusions: A 12-month edoxaban regimen for cancer-associated isolated distal DVT was consistently superior to a 3-month regimen, across the edoxaban doses for the thrombotic risk. However, caution was suggested for the standard dose of edoxaban due to the potential for an increased risk of bleeding with prolonged anticoagulation therapy.

Trial registration number: NCT03895502 (ONCO DVT Trial): https://classic.clinicaltrials.gov/ct2/show/NCT03895502.

背景:ONCO DVT研究显示,在血栓形成风险方面,对癌症相关孤立远端深静脉血栓形成(DVT)患者进行为期12个月的依多沙班治疗优于为期3个月的依多沙班治疗:在ONCO深静脉血栓研究的这一预先指定的亚组分析中,我们将患者分为服用标准埃多沙班剂量(60毫克/天;N=151)的患者和服用减量埃多沙班剂量(30毫克/天;N=450)的患者,并评估了12个月和3个月治疗的临床结果:60毫克组12个月的症状性复发性静脉血栓栓塞症累积发生率低于3个月组(1.3% vs. 11.6%,P=0.02;几率比[OR],0.12;95% CI,0.01-0.97)和30 mg(1.1% vs. 7.6%,P=0.002;OR,0.14;95% CI,0.03-0.60)埃多沙班亚组,这在不同埃多沙班剂量之间是一致的,没有显著的交互作用(P =0.90)。在 60 毫克埃多沙班亚组中,12 个月组的大出血累积发生率高于 3 个月组(14.3% 对 4.4%,P=0.046;OR,3.61;95% CI,0.97-13.52)。52),而在30毫克埃多沙班亚组中,两组之间没有显著差异(8.7% vs. 8.6%,P=0.89;OR,0.97;95% CI,0.49-1.91),表明存在潜在的相互作用(P=0.07):就血栓风险而言,12个月的依多沙班方案治疗癌症相关孤立远端深静脉血栓一直优于3个月的方案。然而,由于长期抗凝治疗可能会增加出血风险,因此建议谨慎使用标准剂量的依多沙班。
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引用次数: 0
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European Heart Journal - Cardiovascular Pharmacotherapy
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