APEX: Primary Efficacy and Safety Results

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Presentation transcript:

APEX: Primary Efficacy and Safety Results Cohort 1 D-dimer ≥ 2 ULN Cohort 2 D-dimer ≥ 2 ULN or Age ≥ 75 Overall p = 0.054 RRR 19.4% p = 0.029 RRR 20.0% p = 0.006 RRR 24.0% 12 VTE Events Major Bleeding 7.05% 7.03% 5.63% 5.30% 6 Incidence (%) 2 p = 0.72 p = 0.56 p = 0.55 Enoxaparin Betrixaban Enoxaparin Betrixaban Enoxaparin Betrixaban Median treatment duration: 9 days of enoxaparin 36 days of betrixaban Cohen AT et al NEJM 2016;375(6):534-44

Symptomatic VTE 1.84% 1.44% p=0.004 Enoxaparin 1.04% 0.93% Betrixaban Composite of Symptomatic Proximal or Distal DVT, Non-Fatal PE, or VTE-related Death Probability of Symptomatic Event (%) Time (Days) Enoxaparin Betrixaban 1.44% 0.93% Through Visit 3 HR = 0.65 (0.42, 0.99) ARR = 0.51% NNT = 196 p=0.043 Through End of Trial* HR = 0.56 (0.38, 0.84) ARR = 0.80% NNT = 125 p=0.004 1.84% 1.04% Parenteral Therapy Visit 3 Cohen AT et al NEJM 2016;375(6):534-44 *End of Trial defined as final follow-up visit (30 + 5 days after Visit 3) 2

During Standard prophylaxis period: Symptomatic Events

Extended betrixaban period to Day 6-35: Symptomatic Event

Follow-up period to End of Study (after 35-42 days): Symptomatic Event

Major Bleeding: KM Estimates and Hazard Ratios Betrixaban Enoxaparin Hazard Ratio (95% CI) p-value Standard prophylaxis period Major Bleeding 9/3714 (1.37%) 9/3716 (2.86%) 1.07 (0.43-2.71) 0.88 Extended betrixaban period 16/3645 (0.53%) 12/3632 (0.33%) 1.33 (0.63-2.81) 0.45 Follow-up period 0/3488 0/3510 -

Kaplan‑Meier Plots for Adjudicated Major Bleeding Events through Seven Days after Discontinuation of All Study Medication