Journal of thrombosis and haemostasis : JTH · 2024
Duration of anticoagulation for venous thromboembolism in pediatric patients: Evaluation of the Duration of Therapy for Thrombosis in Children (Kids-DOTT) trial outcomes at 2 years.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеEquivalence TrialПоддержка NIH: внешняя программаНазвание и аннотация: Перевод в очереди
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Goldenberg Neil A, Schulman Sam, Kittelson John M, Abshire Thomas C, Casella James F, Dale Rita, Halperin Jonathan L, Hanson Jade, Kessler Craig M, Manco-Johnson Marilyn J, McDevitt Laurel, Sidonio Robert F, Spyropoulos Alex C, Steg P Gabriel, Bonaca Marc P, Multicenter Evaluation of the Duration of Therapy for Thrombosis in Children (Kids-DOTT) Trial Investigators and the Antithrombotic Trials Leadership and Steering (ATLAS) Group
Аннотация
BACKGROUND: The Multicenter Evaluation of the Duration of Therapy for Thrombosis in Children multinational, randomized clinical trial revealed noninferiority of a 6-week vs 3-month duration of anticoagulation for the treatment of provoked venous thromboembolism (VTE) in patients <21 years old in regard to net clinical benefit at 1 year.
OBJECTIVES: To evaluate noninferiority at 2 years.
METHODS: Patients whose repeat imaging 6 weeks after VTE diagnosis did not show complete veno-occlusion were randomized to discontinue anticoagulation vs receive a total 3-month course and followed for 2 years for the occurrence of symptomatic recurrent VTE (efficacy outcome) and clinically relevant bleeding (safety outcome). Outcomes were centrally adjudicated, and net clinical benefit was compared between treatment arms via a prespecified bivariate noninferiority boundary, using 95% CIs in absolute risk differences between treatment arms.
RESULTS: Kaplan-Meier estimates of 2-year cumulative incidences in the 6-week and 3-month arms of the intention-to-treat population (n = 417) were 1.7% (95% CI, 0%, 3.7%) and 2.9% (95% CI, 0.3%, 5.4%), respectively, for symptomatic recurrent VTE and 1.1% (95% CI, 0%, 2.5%) and 3.2% (95% CI, 0.6%, 5.7%), respectively, for clinically relevant bleeding. Bivariate analysis of the absolute risk differences in the intention-to-treat population demonstrated that a 6-week anticoagulation duration was noninferior to a 3-month course.
CONCLUSION: These findings support durability of the Kids-DOTT randomized clinical trial findings of net clinical benefit at 2 years.
OBJECTIVES: To evaluate noninferiority at 2 years.
METHODS: Patients whose repeat imaging 6 weeks after VTE diagnosis did not show complete veno-occlusion were randomized to discontinue anticoagulation vs receive a total 3-month course and followed for 2 years for the occurrence of symptomatic recurrent VTE (efficacy outcome) and clinically relevant bleeding (safety outcome). Outcomes were centrally adjudicated, and net clinical benefit was compared between treatment arms via a prespecified bivariate noninferiority boundary, using 95% CIs in absolute risk differences between treatment arms.
RESULTS: Kaplan-Meier estimates of 2-year cumulative incidences in the 6-week and 3-month arms of the intention-to-treat population (n = 417) were 1.7% (95% CI, 0%, 3.7%) and 2.9% (95% CI, 0.3%, 5.4%), respectively, for symptomatic recurrent VTE and 1.1% (95% CI, 0%, 2.5%) and 3.2% (95% CI, 0.6%, 5.7%), respectively, for clinically relevant bleeding. Bivariate analysis of the absolute risk differences in the intention-to-treat population demonstrated that a 6-week anticoagulation duration was noninferior to a 3-month course.
CONCLUSION: These findings support durability of the Kids-DOTT randomized clinical trial findings of net clinical benefit at 2 years.