Venous thromboembolism - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main VTE page for regimens that include active treatment.


VTE primary prophylaxis

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
O'Brien et al. 2023 (PREVAPIX-ALL) 2015-10-22 to 2021-06-04 Phase 3 (C) Apixaban Did not meet primary endpoint of composite of symptomatic or clinically unsuspected venous thromboembolism

No treatment.

References

  1. PREVAPIX-ALL: O'Brien SH, Rodriguez V, Lew G, Newburger JW, Schultz CL, Orgel E, Derr K, Ranalli MA, Esbenshade AJ, Hochberg J, Kang HJ, Dinikina Y, Mills D, Donovan M, Dyme JL, Favatella NA, Mitchell LG; PREVAPIX-ALL investigators. Apixaban versus no anticoagulation for the prevention of venous thromboembolism in children with newly diagnosed acute lymphoblastic leukaemia or lymphoma (PREVAPIX-ALL): a phase 3, open-label, randomised, controlled trial. Lancet Haematol. 2024 Jan;11(1):e27-e37. Epub 2023 Nov 16. link to original article PubMed NCT02369653

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Gärdlund et al. 1996 1988-1991 Phase 3 (C) UFH; SC Did not meet primary endpoint of necropsy-verified pulmonary embolism of predefined clinical relevance
Hull et al. 2010 (EXCLAIM) 2002-02 to 2006-03 Phase 3 (C) Enoxaparin Inferior composite VTE rate
Kakkar et al. 2011 (LIFENOX) 2008-01 to 2010-09 Phase 3 (C) Enoxaparin Did not meet primary endpoint of death rate at 30 days
Spyropoulos et al. 2018 (MARINER) 2014-06 to 2018-01 Phase 3 (C) Rivaroxaban Did not meet primary endpoint of symptomatic VTE or death due to VTE
Khorana et al. 2019 (CASSINI) Not reported Phase 3 (C) Rivaroxaban Did not meet primary endpoint of objectively confirmed proximal DVT in a lower limb, PE, symptomatic DVT in an upper limb or distal DVT in a lower limb, and death from VTE up to 180 days
Mottier et al. 2023 (SYMPTOMS) 2015-09 to 2020-09 Phase 3 (C) Enoxaparin Did not meet primary endpoint of symptomatic VTE at 30 days

No active treatment.

References

  1. Gärdlund B; Heparin Prophylaxis Study Group. Randomised, controlled trial of low-dose heparin for prevention of fatal pulmonary embolism in patients with infectious diseases. Lancet. 1996 May 18;347(9012):1357-61. link to original article PubMed
  2. EXCLAIM: Hull RD, Schellong SM, Tapson VF, Monreal M, Samama MM, Nicol P, Vicaut E, Turpie AG, Yusen RD; EXCLAIM (Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization) study. Extended-duration venous thromboembolism prophylaxis in acutely ill medical patients with recently reduced mobility: a randomized trial. Ann Intern Med. 2010 Jul 6;153(1):8-18. link to original article PubMed NCT00077753
  3. LIFENOX: Kakkar AK, Cimminiello C, Goldhaber SZ, Parakh R, Wang C, Bergmann JF; LIFENOX Investigators. Low-molecular-weight heparin and mortality in acutely ill medical patients. N Engl J Med. 2011 Dec 29;365(26):2463-72. link to original article PubMed NCT00622648
  4. MARINER: Spyropoulos AC, Ageno W, Albers GW, Elliott CG, Halperin JL, Hiatt WR, Maynard GA, Steg PG, Weitz JI, Suh E, Spiro TE, Barnathan ES, Raskob GE; MARINER Investigators. Rivaroxaban for thromboprophylaxis after hospitalization for medical illness. N Engl J Med. 2018 Sep 20;379(12):1118-1127. Epub 2018 Aug 26. link to original article PubMed NCT02111564
  5. CASSINI: Khorana AA, Soff GA, Kakkar AK, Vadhan-Raj S, Riess H, Wun T, Streiff MB, Garcia DA, Liebman HA, Belani CP, O'Reilly EM, Patel JN, Yimer HA, Wildgoose P, Burton P, Vijapurkar U, Kaul S, Eikelboom J, McBane R, Bauer KA, Kuderer NM, Lyman GH; CASSINI Investigators. Rivaroxaban for thromboprophylaxis in high-risk ambulatory patients with cancer. N Engl J Med. 2019 Feb 21;380(8):720-728. link to original article PubMed NCT02555878
  6. SYMPTOMS: Mottier D, Girard P, Couturaud F, Lacut K, Le Moigne E, Paleiron N, Guellec D, Sanchez O, Cogulet V, Laporte S, Marhic G, Mismetti P, Presles E, Robert-Ebadi H, Mahé I, Plaisance L, Reny JL, Darbellay Farhoumand P, Cuvelier C, Le Henaff C, Lambert Y, Danguy Des Deserts M, Rousseau Legrand C, Boutreux S, Bleher Y, Decours R, Trinh-Duc A, Armengol G, Benhamou Y, Daumas A, Guyot SL, De Carvalho H, Lamia B, Righini M, Meyer G, Le Gal G. Enoxaparin versus Placebo to Prevent Symptomatic Venous Thromboembolism in Hospitalized Older Adult Medical Patients. NEJM Evidence. NEJM Evid. 2023 Aug;2(8):EVIDoa2200332. Epub 2023 Jun 27. link to original article PubMed NCT02379806