{"title":"急性无并发症B型主动脉夹层初始胸腔血管内修复与药物治疗的长期结果：来自日本全国索赔数据库的真实证据-一项回顾性队列研究","authors":"Yuki Kimura, Hiroshi Ohtsu, Naohiro Yonemoto, Nobuyoshi Azuma, Kazuhiro Sase","doi":"10.1136/bmjsit-2024-000361","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Design: </strong>A retrospective cohort study using propensity score matching (PSM) to balance baseline characteristics.</p><p><strong>Setting: </strong>Japanese nationwide health insurance claims database, between 1 January 2015 and 31 December 2023.</p><p><strong>Participants: </strong>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.</p><p><strong>Main outcome measures: </strong>The primary outcomes were aorta-related events and all-cause mortality. The secondary outcome was the frequency of follow-up CT imaging every year.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"7 1","pages":"e000361"},"PeriodicalIF":1.6000,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12323521/pdf/","citationCount":"0","resultStr":"{\"title\":\"Long-term outcomes of initial thoracic endovascular repair versus medical therapy in acute uncomplicated type B aortic dissection: real-world evidence from a nationwide claims database in Japan - a retrospective cohort study.\",\"authors\":\"Yuki Kimura, Hiroshi Ohtsu, Naohiro Yonemoto, Nobuyoshi Azuma, Kazuhiro Sase\",\"doi\":\"10.1136/bmjsit-2024-000361\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>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.</p><p><strong>Design: </strong>A retrospective cohort study using propensity score matching (PSM) to balance baseline characteristics.</p><p><strong>Setting: </strong>Japanese nationwide health insurance claims database, between 1 January 2015 and 31 December 2023.</p><p><strong>Participants: </strong>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.</p><p><strong>Main outcome measures: </strong>The primary outcomes were aorta-related events and all-cause mortality. The secondary outcome was the frequency of follow-up CT imaging every year.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":33349,\"journal\":{\"name\":\"BMJ Surgery Interventions Health Technologies\",\"volume\":\"7 1\",\"pages\":\"e000361\"},\"PeriodicalIF\":1.6000,\"publicationDate\":\"2025-08-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12323521/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMJ Surgery Interventions Health Technologies\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1136/bmjsit-2024-000361\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMJ Surgery Interventions Health Technologies","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1136/bmjsit-2024-000361","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"SURGERY","Score":null,"Total":0}
Long-term outcomes of initial thoracic endovascular repair versus medical therapy in acute uncomplicated type B aortic dissection: real-world evidence from a nationwide claims database in Japan - a retrospective cohort study.
Objectives: 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.
Design: A retrospective cohort study using propensity score matching (PSM) to balance baseline characteristics.
Setting: Japanese nationwide health insurance claims database, between 1 January 2015 and 31 December 2023.
Participants: 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.
Main outcome measures: The primary outcomes were aorta-related events and all-cause mortality. The secondary outcome was the frequency of follow-up CT imaging every year.
Results: 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.
Conclusions: 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.
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