Kimura Yuki, Ohtsu Hiroshi, Yonemoto Naohiro, Azuma Nobuyoshi, Sase Kazuhiro
Clinical Pharmacology and Regulatory Science, Juntendo University School of Medicine Graduate School of Medicine, Bunkyo-ku, Japan.
Faculty of Health Data Science, Juntendo University, Urayasu-city, Japan.
BMJ Surg Interv Health Technol. 2025 Aug 4;7(1):e000361. doi: 10.1136/bmjsit-2024-000361. eCollection 2025.
To compare the long-term outcomes of initial thoracic endovascular aortic repair (TEVAR) versus initial medical therapy (iMT) in patients with acute uncomplicated type B aortic dissection (uTBAD), using real-world evidence from a nationwide claims database in Japan. This study aligns with stage 4 of the Idea, Development, Exploration, Assessment, and Long-term Study (IDEAL) framework for surgical innovation.
A retrospective cohort study using propensity score matching (PSM) to balance baseline characteristics.
Japanese nationwide health insurance claims database, between 1 January 2015 and 31 December 2023.
Among 40 229 cases with tentative codes for aortic dissection (International Classification of Diseases-10: I71.0), 4995 met all eligibility criteria for acute uTBAD. Among these patients, 96 underwent TEVAR in the subacute phase (15-90 days post diagnosis), while 4899 were managed with iMT. After PSM, 96 TEVAR cases were matched to 480 iMT cases in a 1:5 ratio.
The primary outcomes were aorta-related events and all-cause mortality. The secondary outcome was the frequency of follow-up CT imaging every year.
After PSM, the baseline characteristics of both groups were balanced. Median age was 56 years (IQR: 50-62 years) in both groups, and follow-up duration was similar (TEVAR: 31 months; iMT: 28 months, p=0.84).At 60 months, Kaplan-Meier estimates showed an aorta-related event rate of 21.9% (95% CI: 12.6% to 36.4%) for TEVAR and 19.9% (95% CI: 15.6% to 25.2%) for iMT (p=0.99).All-cause mortality was 4.4% (95% CI: 1.4% to 13.6%) for TEVAR and 6.6% (95% CI: 4.0% to 10.6%) for iMT (p=0.70). No significant differences were observed.
While aorta-related events accumulated steadily in the crude iMT group, no survival benefit was observed for subacute TEVAR. These findings support ongoing randomized controlled trials and show the utility of claims-based analyses in IDEAL Stage 4.
利用日本全国索赔数据库中的真实世界证据，比较急性单纯性B型主动脉夹层（uTBAD）患者初始胸主动脉腔内修复术（TEVAR）与初始药物治疗（iMT）的长期疗效。本研究符合手术创新的理念、开发、探索、评估和长期研究（IDEAL）框架的第4阶段。
一项回顾性队列研究，采用倾向评分匹配（PSM）来平衡基线特征。
2015年1月1日至2023年12月31日期间的日本全国健康保险索赔数据库。
在40229例有主动脉夹层暂定编码（国际疾病分类-10：I71.0）的病例中，4995例符合急性uTBAD的所有纳入标准。在这些患者中，96例在亚急性期（诊断后15-90天）接受了TEVAR，而4899例接受了iMT治疗。PSM后，96例TEVAR病例与480例iMT病例按1:5的比例匹配。
主要结局为主动脉相关事件和全因死亡率。次要结局是每年随访CT成像的频率。
PSM后，两组的基线特征得到平衡。两组的中位年龄均为56岁（IQR：50-62岁），随访时间相似（TEVAR：31个月；iMT：28个月，p=0.84）。在60个月时，Kaplan-Meier估计显示TEVAR组的主动脉相关事件发生率为21.9%（95%CI：从12.6%至36.4%），iMT组为19.9%（95%CI：从15.6%至25.2%）（p=0.99）。TEVAR组的全因死亡率为4.4%（95%CI：从1.4%至13.6%），iMT组为6.6%（95%CI：从4.0%至10.6%）（p=0.70）。未观察到显著差异。
虽然在未经调整的iMT组中主动脉相关事件稳步累积，但亚急性期TEVAR未观察到生存获益。这些发现支持正在进行的随机对照试验，并显示了基于索赔分析在IDEAL第4阶段的效用。
