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A Six-week versus Three-month Duration of Anticoagulation for Acute Provoked Venous Thromboembolism in Patients < 21 Years Old: Results of the Multinational Kids-DOTT Randomized Controlled Trial

N.A. Goldenberg1,2, S. Schulman3, J.M. Kittelson4, T.C. Abshire5,6, M. Bonaca4,7, J.F. Casella8, R.A. Dale7, J.L. Halperin9, F. Hamblin2, C.M. Kessler10,11, M.J. Manco-Johnson4, R.F. Sidonio12,13, A.C. Spyropoulos14,15,16, P.G. Steg17, A.G.G. Turpie3, W.R. Hiatt4,7, Kids-DOTT Trial Investigators§ and the ATLAS Group

1Johns Hopkins University, St. Petersburg, United States, 2Johns Hopkins All Children’s Hospital, St. Petersburg, United States, 3McMaster University, Hamilton, Canada, 4University of Colorado, Aurora, United States, 5Medical College of Wisconsin, Milwaukee, United States, 6Versiti Blood Research Institute, Milwaukee, United States, 7CPC Clinical Research, Aurora, United States, 8Johns Hopkins University, Baltimore, United States, 9Icahn School of Medicine at Mount Sinai, New York, United States, 10Georgetown University, Washington, United States, 11Lombardi Cancer Center, Washington, United States, 12Emory University, Atlanta, United States, 13Children’s Healthcare of Atlanta, Atlanta, United States, 14Zucker School of Medicine at Hofstra, Manhasset, United States, 15Northwell, Manhasset, United States, 16Feinstein Institutes for Medical Research, Manhasset, United States, 17Universite de Paris, Paris, France

Abstract Number: LB 01.3

Meeting: ISTH 2021 Congress

Theme: Venous Thromboembolism » VTE Treatment

Background: In patients <21 years old with acute provoked venous thromboembolism (VTE), the optimal duration of anticoagulant therapy is unknown.

Aims: We sought to compare the net clinical benefit, as measured by the 1-year risks of symptomatic recurrent VTE and clinically-relevant bleeding, of a shortened (6-week) versus conventional  (3-month) duration of anticoagulation for the treatment of first-episode acute provoked VTE in patients <21 years of age.

Methods: Following local institutional review board approval and with informed consent provided, patients <21 years old with acute provoked VTE were enrolled across 42 centers in 5 countries in an NIH-funded prospective, randomized, open-label, blinded-endpoint trial (Kids-DOTT, NCT00687882). Patients whose repeat imaging at 6 weeks post-diagnosis did not show complete veno-occlusion were randomized to discontinue anticoagulation or to continue for an additional 6 weeks. The primary efficacy and safety endpoints were symptomatic recurrent VTE and clinically-relevant bleeding within 1 year. The primary analysis was non-inferiority in the per-protocol (PP) and intention-to-treat (ITT) populations, for which 95% confidence intervals (CI) in the absolute risk differences (ARDs; 6-week minus 3-month risk) in both endpoints were evaluated.

Results: In both the PP (n=297) and ITT (n=417) populations, baseline patient and VTE characteristics (Table 1) were well-balanced between treatment arms. Kaplan-Meier estimated 1-year risks in the PP population were: primary efficacy, 0.66% (95% CI: 0.00%, 1.95%) [6 weeks] and 0.70% (95% CI: 0.00, 2.07%)  [3 months]; primary safety, 0.65% (95% CI: 0.00%, 1.91%) [6 weeks] and 0.70% (95% CI: 0.00, 2.06%) [3 months]. The 6-week regimen was shown non-inferior to the 3-month regimen in both the PP and ITT populations (Figure 1).

Figure 1

Conclusions: For patients <21 years old with acute provoked VTE whose repeat imaging at 6 weeks shows no complete veno-occlusion, discontinuing anticoagulation is appropriate, with low risks of symptomatic recurrent VTE and clinically-relevant bleeding.Table 1

To cite this abstract in AMA style:

Goldenberg NA, Schulman S, Kittelson JM, Abshire TC, Bonaca M, Casella JF, Dale RA, Halperin JL, Hamblin F, Kessler0 CM, Manco-Johnson MJ, Sidonio RF, Spyropoulos AC, Steg PG, Turpie AGG, Hiatt WR, Kids-DOTT Trial Investigators§ and the ATLAS Group . A Six-week versus Three-month Duration of Anticoagulation for Acute Provoked Venous Thromboembolism in Patients < 21 Years Old: Results of the Multinational Kids-DOTT Randomized Controlled Trial [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/a-six-week-versus-three-month-duration-of-anticoagulation-for-acute-provoked-venous-thromboembolism-in-patients-21-years-old-results-of-the-multinational-kids-dott-randomized-controlled-trial/. Accessed September 22, 2023.

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