Real-world effects of medications for stroke prevention in atrial fibrillation: protocol for a UK population-based non-interventional cohort study with validation against randomised trial results.
Real-world effects of medications for stroke prevention in atrial fibrillation: protocol for a UK population-based non-interventional cohort study with validation against randomised trial results.
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药物预防房颤患者卒中的真实效果：一项基于英国人群的非干预性队列研究方案，并根据随机试验结果进行验证
DOI：
10.1136/bmjopen-2020-042947
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发表时间：
2021-04-15
期刊：
影响因子：
2.9
通讯作者：
Wing K
中科院分区：
文献类型：
--
作者：
Powell EM;Douglas IJ;Gungabissoon U;Smeeth L;Wing K
房颤患者心率不规则，卒中风险增加；使用抗凝药物进行预防性治疗可降低这种风险。直接作用口服抗凝剂（DOACs）已被批准为维生素K拮抗剂（如华法林）的替代品。监管机构对药物在常规临床实践中的有效性很感兴趣；然而，关于非介入性数据是否适合回答有关药物有效性和最合适的方法的问题，仍然存在不确定性。在这项研究中，我们将使用阿哌沙班减少房颤卒中和其他血栓栓塞事件（ARISTOTLE）的数据——DOAC阿哌沙班的关键试验——来验证评估抗凝治疗效果的非介入方法。然后，这些方法可以应用于分析被排除在亚里士多德之外或代表性不足的人的治疗效果。来自ARISTOTLE的患者特征将用于从两个英国电子健康记录（EHR）数据库（临床实践研究数据链Gold和Aurum）中选择具有相似基线特征的患者队列（2013年1月1日至2019年7月31日）。在EHR治疗组之间的匹配中，将探索倾向评分匹配和粗化精确匹配等方法，以确定获得平衡队列的最佳方法。将计算EHR试验类似队列结果的绝对和相对风险，并与亚里士多德结果进行比较；如果结果被认为是相容的，那么用于匹配电子病历治疗组的方法就可以用于在更长的暴露时间内和在试验中未研究的特殊患者组中检查药物有效性。这项研究已经得到了英国药品和保健产品监管机构独立科学咨询委员会的批准。研究结果将在科学出版物和有关会议上传播。
Patients with atrial fibrillation experience an irregular heart rate and have an increased risk of stroke; prophylactic treatment with anticoagulation medication reduces this risk. Direct-acting oral anticoagulants (DOACs) have been approved providing an alternative to vitamin K antagonists such as warfarin. There is interest from regulatory bodies on the effectiveness of medications in routine clinical practice; however, uncertainty remains regarding the suitability of non-interventional data for answering questions on drug effectiveness and on the most suitable methods to be used. In this study, we will use data from Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE)—the pivotal trial for the DOAC apixaban—to validate non-interventional methods for assessing treatment effectiveness of anticoagulants. These methods could then be applied to analyse treatment effectiveness in people excluded from or under-represented in ARISTOTLE. Patient characteristics from ARISTOTLE will be used to select a cohort of patients with similar baseline characteristics from two UK electronic health record (EHR) databases, Clinical Practice Research Datalink Gold and Aurum (between 1 January 2013 and 31 July 2019). Methods such as propensity score matching and coarsened exact matching will be explored in matching between EHR treatment groups to determine the optimal method of obtaining a balanced cohort. Absolute and relative risk of outcomes in the EHR trial-analogous cohort will be calculated and compared with the ARISTOTLE results; if results are deemed compatible the methods used for matching EHR treatment groups can then be used to examine drug effectiveness over a longer duration of exposure and in special patient groups of interest not studied in the trial. The study has been approved by the Independent Scientific Advisory Committee of the UK Medicines and Healthcare Products Regulatory Agency. Results will be disseminated in scientific publications and at relevant conferences.
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影响因子：
8.3
作者：
WOLF, PA;ABBOTT, RD;KANNEL, WB
通讯作者：
KANNEL, WB
影响因子：
5.7
作者：
Adderley, Nicola Jaime;Ryan, Ronan;Marshall, Tom
通讯作者：
Marshall, Tom
DOI：
10.1016/j.jstrokecerebrovasdis.2004.06.003
发表时间：
2004-07-01
期刊：
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
影响因子：
--
作者：
Adamson, Joy;Beswick, Andy;Ebrahim, Shah
通讯作者：
Ebrahim, Shah
影响因子：
3.7
作者：
Gallagher, Arlene M.;Williams, Tim;de Vries, Frank
通讯作者：
de Vries, Frank
非瓣膜房颤的新华法林患者中的远程INR值和结果。
影响因子：
2.4
作者：
Nelson, Winnie W.;Wang, Li;Baser, Onur;Damaraju, Chandrasekharrao V.;Schein, Jeffrey R.
通讯作者：
Schein, Jeffrey R.