{"id":21067,"date":"2022-02-17T05:10:00","date_gmt":"2022-02-16T21:10:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=21067"},"modified":"2022-02-17T05:45:06","modified_gmt":"2022-02-16T21:45:06","slug":"jama%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a6%e5%91%a8%e4%b8%8e3%e4%b8%aa%e6%9c%88%e6%8a%97%e5%87%9d%e6%b2%bb%e7%96%97%e5%af%b921%e5%b2%81%e4%bb%a5%e4%b8%8b%e5%90%88%e5%b9%b6%e8%af%b1%e5%9b%a0","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=21067","title":{"rendered":"[JAMA\u53d1\u8868\u8bba\u6587]\uff1a6\u5468\u4e0e3\u4e2a\u6708\u6297\u51dd\u6cbb\u7597\u5bf921\u5c81\u4ee5\u4e0b\u5408\u5e76\u8bf1\u56e0\u7684VTE\u60a3\u8005\u75c5\u60c5\u590d\u53d1\u4e0e\u51fa\u8840\u4e8b\u4ef6\u7684\u5f71\u54cd"},"content":{"rendered":"\n

Original Investigation January 11, 2022<\/p>\n\n\n\n

Effect of Anticoagulant Therapy for 6 Weeks vs 3 Months on Recurrence and Bleeding Events in Patients Younger Than 21 Years of Age With Provoked Venous Thromboembolism: The Kids-DOTT Randomized Clinical Trial<\/h1>\n\n\n\n

Neil A.\u00a0Goldenberg,\u00a0John M.\u00a0Kittelson,\u00a0Thomas C.\u00a0Abshire,\u00a0et al<\/h3>\n\n\n\n

JAMA.\u00a0<\/em>2022;327(2):129-137.<\/h3>\n\n\n\n

doi:10.1001\/jama.2021.23182<\/h3>\n\n\n\n

Abstract<\/p>\n\n\n\n

Importance<\/strong>  Among patients younger than 21 years of age, the optimal duration of anticoagulant therapy for venous thromboembolism is unknown.<\/p>\n\n\n\n

Objective<\/strong>  To test the hypothesis that a 6-week duration of anticoagulant therapy for provoked venous thromboembolism is noninferior to a conventional 3-month therapy duration in patients younger than 21 years of age.<\/p>\n\n\n\n

Design, Setting, and Participants<\/strong>  Randomized clinical trial involving 417 patients younger than 21 years of age with acute, provoked venous thromboembolism enrolled at 42 centers in 5 countries from 2008-2021. The main exclusions were severe anticoagulant deficiencies or prior venous thromboembolism. Patients without persistent antiphospholipid antibodies and whose thrombi were resolved or not completely occlusive upon repeat imaging at 6 weeks after diagnosis underwent randomization. The final visit for the primary end points occurred in January 2021.<\/p>\n\n\n\n

Interventions<\/strong>  Total duration for anticoagulant therapy of 6 weeks (n\u2009=\u2009207) vs 3 months (n\u2009=\u2009210) for provoked venous thromboembolism.<\/p>\n\n\n\n

Main Outcomes and Measures<\/strong>  The primary efficacy and safety end points were centrally adjudicated symptomatic recurrent venous thromboembolism and clinically relevant bleeding events within 1 year blinded to treatment group. The primary analysis was noninferiority in the per-protocol population. The noninferiority boundary incorporated a bivariate trade-off that included an absolute increase of 0% in symptomatic recurrent venous thromboembolism with an absolute risk reduction of 4% in clinically relevant bleeding events (1 of 3 points on the bivariate noninferiority boundary curve).<\/p>\n\n\n\n

Results<\/strong>  Among 417 randomized patients, 297 (median age, 8.3 [range, 0.04-20.9] years; 49% female) met criteria for the primary per-protocol population analysis. The Kaplan-Meier estimate for the 1-year cumulative incidence of the primary efficacy outcome was 0.66% (95% CI, 0%-1.95%) in the 6-week anticoagulant therapy group and 0.70% (95% CI, 0%-2.07%) in the 3-month anticoagulant therapy group, and for the primary safety outcome, the incidence was 0.65% (95% CI, 0%-1.91%) and 0.70% (95% CI, 0%-2.06%). Based on absolute risk differences in recurrent venous thromboembolism and clinically relevant bleeding events between groups, noninferiority was demonstrated. Adverse events occurred in 26% of patients in the 6-week anticoagulant therapy group and in 32% of patients in the 3-month anticoagulant therapy group; the most common adverse event was fever (1.9% and 3.4%, respectively).<\/p>\n\n\n\n

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Conclusions and Relevance<\/strong>  Among patients younger than 21 years of age with provoked venous thromboembolism, anticoagulant therapy for 6 weeks compared with 3 months met noninferiority criteria based on the trade-off between recurrent venous thromboembolism risk and bleeding risk.<\/p>\n\n\n\n

Trial Registration<\/strong>  ClinicalTrials.gov Identifier: NCT00687882<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Original Investigation January 11, 2022 […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21067"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21067"}],"version-history":[{"count":2,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21067\/revisions"}],"predecessor-version":[{"id":21315,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21067\/revisions\/21315"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21067"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21067"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21067"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}