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Table 1 Summary of design characteristics for the 14 selected studies

From: Derivation of the non-inferiority margin for the evaluation of direct oral anticoagulants in the treatment of venous thromboembolism

Study Patient population Acute therapy Long-term therapy Experimental treatment duration Window for analysis of recurrent VTE
Barritt [7] PE Intravenous UFH q6h vs placebo VKA. PT 2.0–3.0 times control vs placebo 14 days 3 months
Hull [8] DVT Intravenous UFH VKA started on day 10, PT 1.5–2.0 vs subcutaneous UFH bid 6 weeks for calf DVT and 12 weeks for proximal DVT 3 months
Holmgren [9] DVT UFH VKA started on day 1, TT 5–14% 1 month vs 6 months 3 months
Lagerstedt [10] Isolated calf DVT Intravenous UFH VKA started on day 1, INR 2.5–4.2 vs placebo 3 months 3 months
Hull [11] Proximal DVT Intravenous UFH vs subcutaneous UFH VKA started on day 6 or 7, INR 2.0–3.0 3 months 3 months
Brandjes [12] Proximal DVT Intravenous UFH vs placebo VKA started on day 1, INR 2.0–3.0 6 months 3 months
Raschke [13] DVT or PE Intravenous weight-based UFH vs ‘standard care’ UFH nomogram VKA started after day 2 Not specified or monitored 3 months
Levine [14] Proximal DVT Intravenous UFH VKA INR 2.0–3.0 vs placebo 4 weeks vs 12 weeks 3 months
Schulman [15] DVT or PE Intravenous UFH or subcutaneous LMWH VKA started on day 1, INR 2.00–2.85 6 weeks vs 6 months 3 months
Agnelli [16] Idiopathic proximal DVT Intravenous UFH or subcutaneous LMWH VKA INR 2.0–3.0 vs no treatment Months 4–12 vs no treatment Months 4–12
Agnelli [17] PE Intravenous UFH or subcutaneous LMWH VKA INR 2.0–3.0 vs no treatment Months 4–12 vs no treatment Months 4–12
Kearon [18] Idiopathic DVT or PE Intravenous UFH or subcutaneous LMWH VKA INR 2.0–3.0 vs placebo Months 4–24 vs no treatment Months 4–24
Pinede [19] DVT or PE Intravenous UFH or subcutaneous LMWH VKA INR 2.0–3.0 Months 4–6 vs no treatment Months 4–6
Schulman [20] First recurrent DVT or PE Intravenous UFH or subcutaneous LMWH VKA INR 2.00–2.85 vs no treatment Indefinitely vs none Month 6 onwards
  1. bid: twice daily; DVT: deep vein thrombosis; INR: international normalised ratio; PE: pulmonary embolism; PT: prothrombin time; q6h: every 6 hours; TT: thrombin time; UFH: unfractionated heparin; VKA: vitamin K antagonist; VTE: venous thromboembolism.