Grundtvig Josefine, Gaist David, Christensen Louisa, Ovesen Christian, Havsteen Inger, Iversen Helle K, Christensen Thomas, Lilja-Cyron Alexander, Kruuse Christina, Ægidius Karen, Rosenbaum Sverre, Meden Per, Marstrand Jacob, Steiner Thorsten, Christensen Hanne
Department of Neurology, Copenhagen University Hospital, Bispebjerg, Copenhagen, Capital Region, Denmark.
Research Unit for Neurology, Odense University Hospital, Odense, Region of Southern Denmark, Denmark.
Age Ageing. 2025 Mar 28;54(4). doi: 10.1093/ageing/afaf091.
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.
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.
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.
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.
我们假设，在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）试验中的患者（关键试验参与者），并探讨了（i）现实生活中使用DOAC或维生素K拮抗剂（VKA）并发生脑出血的患者与（ii）试验中的患者与现实生活中OAC-ICH患者的卒中前发病情况是否具有可比性。
COOL-ICH队列包括来自丹麦首都地区的401例急性、连续的OAC-ICH患者（272例VKA-ICH，129例DOAC-ICH）。试验中的患者的风险因素和发病情况从出版物中获取。
现实生活中，DOAC使用者和VKA使用者的风险因素、CHADS2和Charlson合并症指数具有可比性。DOAC使用者的卒中前改良Rankin量表（mRS）高于VKA使用者（mRS中位数1比0，P = 0.002）。DOAC使用者中女性更多（53%对39%，P = 0.009）。与试验中的患者相比，现实生活中的患者年龄更大，女性比例更高。CHADS2评分具有可比性。
总之，现实生活中DOAC-ICH患者和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中的患者相比也是如此。然而，现实生活中的患者，尤其是使用DOAC的患者，比试验中的患者年龄更大，女性更常见。令人欣慰的是，现实生活中的患者和试验中的患者合并症负担相似。尽管如此，本报告强调了在心血管试验中招募足够数量的老年人和女性的重要性，以确保有足够的安全数据为这些非常普遍的患者亚组提供处方建议。
Zotero 插件