Division of Hematology/Oncology/BMT, Nationwide Children's Hospital, The Ohio State University, 700 Children's Drive, Columbus, OH, 43205, USA.
Department of Pediatrics, The Ohio State University College of Medicine, Columbus, OH, USA.
J Thromb Thrombolysis. 2023 Jul;56(1):27-36. doi: 10.1007/s11239-023-02806-w. Epub 2023 Apr 24.
Evidence-based anticoagulation programs usually serve a local, adult patient population. Here we report outcomes for a regional combined pediatric-adult program.
The aims of this study were: (1) Compare the pre- vs. post-implementation quality of therapy (% time in therapeutic range (%TTR) and compliance). (2) Assess anticoagulant-relevant outcomes (bleeding and thrombotic complications).
Data were collected for the years 2014-2019. Rosendaal linear interpolation was used to calculate %TTR. Bleeding complications were categorized using ISTH-SSC standard nomenclature and new thrombotic events were reviewed.
The patients were divided into a long-term warfarin group (N = 308), 80.2% of whom had cardiac-related therapeutic indications (median age 24y), and a second group (N = 114) comprised of short-term and non-warfarin long-term anticoagulation (median age 16y). Median %TTR for those on long-term warfarin was 78.9%. The incidence of major and clinically relevant non-major bleeding events was 1.65 and 2.43 /100 person-years of warfarin use, respectively. Thromboembolism (TE) incidence was 0.78/100 patient-years of warfarin use. Neither bleeding nor thrombosis was associated with %TTR (p = 0.48). Anticoagulant indication was the only variable associated with bleeding risk (p = 0.005). The second group had no on-therapy TE events but 7.9% experienced bleeding. Complete data were available for a randomly sampled pre-program warfarin group (N = 26). Median %TTR improved from 17.5 to 87% pre- vs. post-implementation. Similarly, compliance (defined as ≥ 1 INR/month) improved by 34.3%.
In conclusion, this program significantly improved and sustained %TTR and compliance. The lack of association between bleeding and thrombosis events and %TTR may be related to the high median %TTR (> 70%) achieved by this approach.
循证抗凝方案通常服务于当地的成年患者群体。在这里,我们报告了一个区域性的儿科-成人联合方案的结果。
本研究的目的是:(1)比较实施前后治疗质量(%治疗范围内时间(%TTR)和依从性)。(2)评估抗凝相关结局(出血和血栓并发症)。
数据收集自 2014 年至 2019 年。采用 Rosendaal 线性插值法计算%TTR。出血并发症采用 ISTH-SSC 标准命名法进行分类,并回顾新的血栓事件。
患者分为长期华法林组(N=308),其中 80.2%有心脏相关的治疗指征(中位年龄 24 岁),和第二组(N=114)由短期和非华法林长期抗凝组成(中位年龄 16 岁)。长期华法林组的中位%TTR 为 78.9%。主要和临床相关非重大出血事件的发生率分别为 1.65 和 2.43/100 人年华法林使用率。血栓栓塞(TE)的发生率为 0.78/100 人年华法林使用率。出血和血栓均与%TTR 无关(p=0.48)。抗凝指征是唯一与出血风险相关的变量(p=0.005)。第二组无治疗性 TE 事件,但有 7.9%发生出血。我们获得了一个随机抽样的预方案华法林组(N=26)的完整数据。中位%TTR 从实施前的 17.5%提高到实施后的 87%。同样,依从性(定义为≥1INR/月)提高了 34.3%。
总之,该方案显著提高并维持了%TTR 和依从性。出血和血栓事件与%TTR 之间缺乏关联可能与该方法实现的高中位%TTR(>70%)有关。