Safety and Effectiveness of Apixaban in Very Elderly Patients with Atrial Fibrillation: A Retrospective Analysis of Japanese Administrative Claims Data.

IF 3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
Ako Matsuo-Ohsawa, Jun Katada, Shun Kohsaka
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引用次数: 0

Abstract

Introduction: Anticoagulation is a well-established treatment for patients with atrial fibrillation (AF) for the prevention of stroke/systemic embolism (SE). However, although nearly all elderly patients with AF are at risk for thrombotic events, they also have a heightened risk of bleeding, and evidence regarding the optimal anticoagulation regimen in very elderly patients remains limited. This study aimed to evaluate the safety and effectiveness of apixaban versus warfarin in a cohort of very elderly patients with AF in Japan.

Methods: This was a retrospective analysis of administrative claims for patients with AF newly initiated on apixaban or warfarin from acute care hospitals. Clinical and demographic characteristics were balanced between cohorts using an inverse probability of treatment weighting with stabilized weights (s-IPTW) method. Prespecified subgroup analyses were also conducted to assess treatment interaction with some baseline/demographic factors.

Results: A total of 77,814 eligible patients with AF were balanced between the apixaban group (N = 33,834) and warfarin group (N = 43,671) using s-IPTW. The incidence of stroke/SE-primary effectiveness outcome-was 55.8 and 75.2 per 1000 person-years and that of major bleeding-primary safety outcome-was 17.3 and 25.3 per 1000 person-years in the apixaban and warfarin groups, respectively. Apixaban was associated with a significantly lower risk of stroke/SE (hazard ratio [HR], 0.75; 95% confidence interval [CI] [0.71-0.80], P < 0.001) and major bleeding (HR, 0.69; 95% CI [0.62-0.76], P < 0.001). Consistent trends were observed across all prespecified secondary outcomes. Additionally, there was no evidence of interaction between treatment and the variables examined, such as age, number of medications, Charlson Comorbidity Index, and activities of daily living.

Conclusions: In very elderly patients with AF, apixaban was associated with a significantly lower risk of stroke/SE and bleeding compared with warfarin.

Trial registration: ClinicalTrials.gov identifier NCT05438888.

阿哌沙班治疗高龄心房颤动的安全性和有效性:日本行政索赔数据的回顾性分析。
抗凝治疗是房颤(AF)患者预防卒中/全身性栓塞(SE)的一种行之有效的治疗方法。然而,尽管几乎所有老年房颤患者都有血栓形成事件的风险,但他们也有较高的出血风险,而且关于老年患者最佳抗凝治疗方案的证据仍然有限。本研究旨在评价阿哌沙班与华法林在日本一组老年房颤患者中的安全性和有效性。方法:回顾性分析急性护理医院新开始使用阿哌沙班或华法林治疗的房颤患者的行政索赔。使用稳定权重(s-IPTW)方法的治疗加权逆概率来平衡各队列之间的临床和人口学特征。还进行了预先指定的亚组分析,以评估治疗与一些基线/人口因素的相互作用。结果:使用s-IPTW在阿哌沙班组(N = 33,834)和华法林组(N = 43,671)之间平衡了77,814例符合条件的房颤患者。在阿哌沙班组和华法林组中,卒中/ se2主要有效性结局的发生率分别为55.8 / 1000人年和75.2 / 1000人年,主要出血主要安全性结局的发生率分别为17.3 / 1000人年和25.3 / 1000人年。阿哌沙班与卒中/SE风险显著降低相关(风险比[HR], 0.75;95%可信区间[CI] [0.71-0.80], P结论:与华法林相比,在高龄房颤患者中,阿哌沙班与卒中/SE和出血的风险显著降低相关。试验注册:ClinicalTrials.gov识别码NCT05438888。
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来源期刊
Cardiology and Therapy
Cardiology and Therapy CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
5.30
自引率
0.00%
发文量
38
审稿时长
6 weeks
期刊介绍: Aims and Scope Cardiology and Therapy is an international, open access, peer reviewed (single-blind), rapid-publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of cardiovascular therapies and interventions, including devices. Studies relating to diagnosis and diagnostics, pharmacoeconomics, public health, quality of life, as well as patient care, management and education are also encouraged. Areas of focus include, but are not limited to, ischaemic heart disease and acute cardiac care, myocardial, valvular, pericardial and congenital heart disease, vascular and pulmonary disease (including hypertension), arrhythmias, heart failure, non-invasive diagnostic techniques, and invasive and interventional cardiology as well as cardiovascular surgery. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols and short communications such as commentaries and editorials. Cardiolology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. Rapid Publication The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of cardiovascular therapies. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning authors will always have an editorial contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. Digital Features and Plain Language Summaries Cardiology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’. For examples of digital features please visit our showcase page https://springerhealthcare.com/expertise/publishing-digital-features/ Publication Fees Upon acceptance of your article for publication, authors will be required to pay the mandatory Rapid Service Fee of £3650/€4500/$5100. The journal will consider fee discounts for developing countries and this is decided on a case by case basis. Open Access All articles published by Cardiology and Therapy are published open access. Peer Review Process Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria. At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case by case basis and should be sent to the journal editor. Preprints We encourage posting of preprints of primary research manuscripts on preprint servers, authors’ or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. Authors should disclose details of preprint posting during the submission process or at any other point during consideration in one of our journals. Once the preprint is published, it is the author’s responsibility to ensure that the preprint record is updated with a publication reference, including the DOI and a URL link to the published version of the article on the journal website. Copyright Cardiology and Therapy is published under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. For more information about the Creative Commons Attribution-Noncommercial License, click here: http://creativecommons.org/licenses/by-nc/4.0. Contact For more information about the journal, including pre-submission enquiries, please contact matthew.evans@springer.com
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