Drug Safety Research Unit, Southampton, United Kingdom.
University of Portsmouth, Portsmouth, United Kingdom.
PLoS One. 2020 Oct 9;15(10):e0240489. doi: 10.1371/journal.pone.0240489. eCollection 2020.
Although the direct oral anticoagulant rivaroxaban is recommended for stroke prevention in patients with non-valvular atrial fibrillation based on Phase III clinical trials, there is still a need for additional safety data from everyday clinical practice. The ROSE study was initiated to collect further information on the safety and utilisation of rivaroxaban in a broader range of patient groups in routine clinical practice.
The ROSE study was conducted in hospitals in England and Wales. Consenting adults with non-valvular atrial fibrillation newly started on rivaroxaban were eligible and followed up for 12 weeks. Data was derived through secondary use of medical records. The primary outcome was major bleeding within gastrointestinal, urogenital and intracranial sites. A total of 4846 patients were enrolled in the study September 2013 to January 2016, 965 of which were treated with rivaroxaban for non-valvular atrial fibrillation. The median age in the rivaroxaban non-valvular atrial fibrillation cohort was 76 years, 53.6% were male. The median HAS-BLED score was 2 and the median CHA2DS2-VASc score was 4. The risk of major bleeding within each of the primary sites of gastrointestinal, urogenital and intracranial during the 12 week observation period was low (0.2%; n = 2). The risk of major bleeding in all sites was 1.0% (n = 10) at a rate of 5.5 events per 100 patient years.
In terms of the primary outcome risk of major bleeding within gastrointestinal, urogenital and intracranial sites during the 12 week observation period, the risk estimates in the non-valvular atrial fibrillation rivaroxaban user population were low (<1%), and consistent with risk estimated from clinical trial data and in routine clinical practice.
尽管基于 III 期临床试验，直接口服抗凝剂利伐沙班被推荐用于预防非瓣膜性房颤患者的中风，但仍需要来自日常临床实践的额外安全性数据。ROSE 研究旨在收集更广泛的患者群体在常规临床实践中使用利伐沙班的安全性和使用情况的进一步信息。
ROSE 研究在英格兰和威尔士的医院进行。新开始使用利伐沙班的非瓣膜性房颤成人患者符合条件，并随访 12 周。数据来源于病历的二次使用。主要结局是胃肠道、泌尿生殖道和颅内部位的主要出血。2013 年 9 月至 2016 年 1 月期间，共有 4846 名患者入组该研究，其中 965 名患者接受利伐沙班治疗非瓣膜性房颤。利伐沙班非瓣膜性房颤队列的中位年龄为 76 岁，53.6%为男性。中位 HAS-BLED 评分为 2 分，中位 CHA2DS2-VASc 评分为 4 分。在 12 周观察期间，每个主要胃肠道、泌尿生殖道和颅内部位的主要出血风险均较低（0.2%；n=2）。所有部位的大出血风险为 1.0%（n=10），发生率为每 100 患者年 5.5 例事件。
就主要结局（12 周观察期间胃肠道、泌尿生殖道和颅内部位的主要出血风险）而言，非瓣膜性房颤利伐沙班使用者人群的风险估计值较低（<1%），与临床试验数据和常规临床实践中的风险估计值一致。
