TY - JOUR
T1 - Clinical Impact of Bleeding in Cancer-Associated Venous Thromboembolism: Results from the Hokusai VTE Cancer Study
AU - Kraaijpoel, Noémie
AU - di Nisio, Marcello
AU - Mulder, Frits I.
AU - van Es, Nick
AU - Beyer-Westendorf, Jan
AU - Carrier, Marc
AU - Garcia, David
AU - Grosso, Michael
AU - Kakkar, Ajay K.
AU - Mercuri, Michele F.
AU - Middeldorp, Saskia
AU - Hernandez, Cristhiam Rojas
AU - Santamaria, Amparo
AU - Schwocho, Lee
AU - Segers, Annelise
AU - Verhamme, Peter
AU - Wang, Tzu-Fei
AU - Weitz, Jeffrey I.
AU - Zhang, George
AU - Zwicker, Jeffrey I.
AU - Büller, Harry R.
AU - Raskob, Gary E.
PY - 2018
Y1 - 2018
N2 - In the Hokusai VTE Cancer study, edoxaban was non-inferior to dalteparin for the composite outcome of recurrent venous thromboembolism (VTE) and major bleeding in 1,050 patients with cancer-associated VTE. The absolute rate of recurrent VTE was 3.4% lower with edoxaban, whereas the absolute rate of major bleeding was 2.9% higher. The present analysis focuses on the sites, clinical presentation, course and outcome of bleeding events, and the associated tumour types. Major bleeds and their severity (categories 1-4) were blindly adjudicated by a committee using a priori defined criteria, and data were analysed in the safety population. Major bleeding occurred in 32 of 522 patients given edoxaban (median treatment duration, 211 days) and in 16 of 524 patients treated with dalteparin (median treatment duration, 184 days); no patients had more than one major bleed. There were no fatal bleeds with edoxaban, and two with dalteparin. Severe bleeding at presentation (category 3 or 4) occurred in 10 (1.9%) and 11 (2.1%) patients in the edoxaban and dalteparin groups, respectively. The excess of major bleeding with edoxaban was confined to patients with gastrointestinal cancer. However, severe major bleeding at presentation (category 3 or 4) in this sub-group occurred in 5 of 165 (3.0%) and in 3 of 140 (2.1%) patients given edoxaban or dalteparin, respectively. In conclusion, this analysis suggests that while oral edoxaban is an appropriate alternative to subcutaneous dalteparin for treatment of cancer-associated VTE, the use of edoxaban in patients with gastrointestinal cancer requires careful benefit-risk weighting.
AB - In the Hokusai VTE Cancer study, edoxaban was non-inferior to dalteparin for the composite outcome of recurrent venous thromboembolism (VTE) and major bleeding in 1,050 patients with cancer-associated VTE. The absolute rate of recurrent VTE was 3.4% lower with edoxaban, whereas the absolute rate of major bleeding was 2.9% higher. The present analysis focuses on the sites, clinical presentation, course and outcome of bleeding events, and the associated tumour types. Major bleeds and their severity (categories 1-4) were blindly adjudicated by a committee using a priori defined criteria, and data were analysed in the safety population. Major bleeding occurred in 32 of 522 patients given edoxaban (median treatment duration, 211 days) and in 16 of 524 patients treated with dalteparin (median treatment duration, 184 days); no patients had more than one major bleed. There were no fatal bleeds with edoxaban, and two with dalteparin. Severe bleeding at presentation (category 3 or 4) occurred in 10 (1.9%) and 11 (2.1%) patients in the edoxaban and dalteparin groups, respectively. The excess of major bleeding with edoxaban was confined to patients with gastrointestinal cancer. However, severe major bleeding at presentation (category 3 or 4) in this sub-group occurred in 5 of 165 (3.0%) and in 3 of 140 (2.1%) patients given edoxaban or dalteparin, respectively. In conclusion, this analysis suggests that while oral edoxaban is an appropriate alternative to subcutaneous dalteparin for treatment of cancer-associated VTE, the use of edoxaban in patients with gastrointestinal cancer requires careful benefit-risk weighting.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85050854571&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/30060256
U2 - https://doi.org/10.1055/s-0038-1667001
DO - https://doi.org/10.1055/s-0038-1667001
M3 - Article
C2 - 30060256
SN - 0340-6245
VL - 118
SP - 1439
EP - 1449
JO - Thrombosis and haemostasis
JF - Thrombosis and haemostasis
IS - 8
ER -