Gue Ying, Bloomfield Dan, Freedholm Debra, Lip Gregory Y H
Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, Liverpool L14 3PE, UK.
The Department of Cardiovascular and Metabolic Medicine, University of Liverpool, Liverpool L69 3BX, UK.
J Clin Med. 2024 Apr 15;13(8):2277. doi: 10.3390/jcm13082277.
The prevention of stroke in patients with atrial fibrillation (AF) involves the use of oral anticoagulation, commonly in the form of direct oral anticoagulants (DOACs). However, it comes with an increased risk of bleeding, and therefore, counselling patients on their individual risks is important. Although the majority of patients initiated on DOACs have been represented within the clinical trials, some cohorts are under-represented in whom clinicians cannot practice evidence-based medicine. Utilising the pooled clinical trial (CT) data sourced from Medidata Enterprise Data Store, five recent open-label industry-sponsored AF trials were compared with real-world data (RWD) sourced from the HealthVerity™ Marketplace with the occurrence of bleeding events as the primary outcome of interest. A total of 64,421 patients were included in the analysis, with 3207 patients from the clinical DOAC trials and 61,214 patients from the RWD cohort. Overall, the patients from the RWD cohort had more co-morbidities, were older (72.2 ± 11.9 vs. 65.3 ± 10.7 years old, < 0.001), had higher mean CHADSVASc (3.98 ± 1.9 vs. 2.87 ± 1.73, < 0.001), and HAD-BLED scores (2.13 ± 1.02 vs. 1/04 ± 0.93, < 0.001) when compared to the trial data. When comparing the incidence of the first major bleed at 12 months post-treatment initiation, rates in the RWD cohort were significantly higher (10.69 vs. 18.97 per 100 person-years). The impact of co-morbidities such as age, CHADSVASc, and HAD-BLED scores was similar in both cohorts; however, there was an under-representation of older females and more co-morbid patients within the clinical trial cohort. DOAC-treated patients have a higher bleeding incidence rate in the RWD cohort than in clinical trials. This can be explained by the older patient age group with more complex medical h istories and higher HAS-BLED scores. The under-representation of higher-risk patients and lower proportion of females within clinical trials should be addressed to better translate clinical trial data into real-world clinical practice.
预防心房颤动（AF）患者发生中风需要使用口服抗凝药，通常采用直接口服抗凝剂（DOACs）的形式。然而，这会增加出血风险，因此，向患者咨询其个人风险非常重要。尽管大多数开始使用DOACs的患者已纳入临床试验，但一些队列的代表性不足，临床医生无法在这些队列中实施循证医学。利用从Medidata企业数据存储中获取的汇总临床试验（CT）数据，将最近五项由行业赞助的开放标签AF试验与从HealthVerity™市场获取的真实世界数据（RWD）进行比较，以出血事件的发生作为主要关注结果。分析共纳入64421例患者，其中3207例来自临床DOAC试验，61214例来自RWD队列。总体而言，与试验数据相比，RWD队列中的患者合并症更多、年龄更大（72.2±11.9岁对65.3±10.7岁，P<0.001）、平均CHADSVASc更高（3.98±1.9对2.87±1.73，P<0.001）以及HAD-BLED评分更高（2.13±1.02对1.04±0.93，P<0.001）。在比较治疗开始后12个月时首次严重出血的发生率时，RWD队列中的发生率显著更高（每100人年10.69对18.97）。年龄、CHADSVASc和HAD-BLED评分等合并症的影响在两个队列中相似；然而，临床试验队列中老年女性和合并症更多的患者代表性不足。DOAC治疗的患者在RWD队列中的出血发生率高于临床试验。这可以用年龄较大、病史更复杂且HAS-BLED评分更高的患者群体来解释。应解决临床试验中高风险患者代表性不足和女性比例较低的问题，以便更好地将临床试验数据转化为实际临床实践。
