Risk-factors and multimorbidity in oral anticoagulant-related intracerebral haemorrhage: a comparison of patients in pivotal trials and real life

IF 6 2区医学 Q1 GERIATRICS & GERONTOLOGY

Age and ageing Pub Date : 2025-04-16 DOI:10.1093/ageing/afaf091

Josefine Grundtvig, David Gaist, Louisa Christensen, Christian Ovesen, Inger Havsteen, Helle K Iversen, Thomas Christensen, Alexander Lilja-Cyron, Christina Kruuse, Karen Ægidius, Sverre Rosenbaum, Per Meden, Jacob Marstrand, Thorsten Steiner, Hanne Christensen

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引用次数: 0

Abstract

Background We hypothesised that morbidity burden was higher in real-life patients with oral anticoagulant-related intracerebral haemorrhage (OAC-ICH) than direct oral anticoagulant (DOAC) trial-life patients (pivotal trial participants) and explored if pre-stroke morbidity was comparable (i) in real-life patients on DOAC or vitamin K antagonist (VKA) with ICH, and (ii) in trial-life patients versus real-life patients with OAC-ICH. Methods The COOL-ICH cohort included 401 acute, consecutive patients with OAC-ICH (272 VKA-ICH, 129 DOAC-ICH) from the Capital Region of Denmark. Risk-factors and morbidity in trial-life patients were retrieved from publications. Results Risk-factors, CHADS2 and Charlson Comorbidity Index were comparable in DOAC vs VKA users in real-life. Pre-stroke modified Rankin Scale (mRS) was higher in DOAC users than in VKA users (median mRS 1 vs 0, P = 0.002). More DOAC users were women (53% vs 39%, P = 0.009). Compared to trial-life patients, age and proportion of women were higher in real-life patients. CHADS2-scores were comparable. Conclusion In conclusion, burden of risk-factors and comorbidities were similar in real-life patients with DOAC-ICH and VKA-ICH, as well as in real-life patients compared to trial-life patients. However, real-life patients especially those on DOAC, were older and more frequently women than trial-life patients. It is reassuring that burden of comorbidity was similar in real-life and trial-life patients. Nevertheless, this report underlines the importance of recruiting adequate numbers of older people and women to cardio-vascular trials to ensure sufficient safety data to advice prescriptions in these very prevalent sub-groups of patients.

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口服抗凝剂相关脑出血的危险因素和多发病：关键试验和现实生活中患者的比较

背景我们假设现实生活中口服抗凝剂相关脑出血（OAC-ICH）患者的发病负担高于直接口服抗凝剂（DOAC）试验生活患者（关键试验参与者），并探讨了(i) 现实生活中服用 DOAC 或维生素 K 拮抗剂 (VKA) 的 ICH 患者和 (ii) 试验生活患者与现实生活中 OAC-ICH 患者的卒中前发病率是否具有可比性。方法 COOL-ICH 队列包括丹麦首都地区的 401 名急性、连续 OAC-ICH 患者（272 名 VKA-ICH 患者，129 名 DOAC-ICH 患者）。从出版物中检索了试验期患者的风险因素和发病率。结果在现实生活中，DOAC 与 VKA 使用者的风险因子、CHADS2 和 Charlson 合并指数相当。与 VKA 使用者相比，DOAC 使用者卒中前的修正 Rankin 量表（mRS）更高（mRS 中位数为 1 vs 0，P = 0.002）。更多的 DOAC 使用者是女性（53% 对 39%，P = 0.009）。与试验生活期患者相比，实际生活期患者的年龄和女性比例更高。CHADS2 评分相当。结论总之，现实生活中的 DOAC-ICH 和 VKA-ICH 患者的风险因素和合并症负担相似，现实生活中的患者与试验生活中的患者相比也相似。不过，现实生活中的患者，尤其是使用 DOAC 的患者，与试验生活中的患者相比，年龄更大，女性更多。令人欣慰的是，现实生活中的患者和试验生活中的患者的合并症负担相似。不过，本报告强调了在心脑血管试验中招募足够数量的老年人和女性患者的重要性，以确保获得足够的安全性数据，为这些发病率极高的亚组患者提供处方建议。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Age and ageing 医学-老年医学

CiteScore

9.20

自引率

6.00%

发文量

796

审稿时长

4-8 weeks

期刊介绍： Age and Ageing is an international journal publishing refereed original articles and commissioned reviews on geriatric medicine and gerontology. Its range includes research on ageing and clinical, epidemiological, and psychological aspects of later life.