Clinical impact of major bleeding in patients with venous thromboembolism treated with factor Xa inhibitors or vitamin K antagonists

Thrombosis and Haemostasis
Suzanne M BlekerHarry R Büller

Abstract

Factor Xa (fXa)-inhibitors are as effective and safer than vitamin-K-antagonists (VKA) in the treatment of venous thromboembolism (VTE). We previously classified the severity of clinical presentation and course of all major bleeding events from the EINSTEIN, AMPLIFY and HOKUSAI-VTE trials separately. The current aim was to combine these findings in order to increase precision, assess a class effect and analyse presentation and course for different types of bleeding, i. e. intracranial, gastro-intestinal, and other. We classified the clinical presentation and course of all major bleeding events using pre-defined criteria. Both classifications comprised four categories; one being the mildest, and four the most severe. Odds ratios (OR) were calculated for all events classified as category three or four between fXa-inhibitors and VKA recipients. Also, ORs were computed for different types of bleeding. Major bleeding occurred in 111 fXa-inhibitor recipients and in 187 LMWH/VKA recipients. The clinical presentation was classified as category three or four in 35% and 48% of the major bleeds in fXa inhibitor and VKA recipients, respectively (OR 0.59, 95% CI 0.36-0.97). For intracranial, gastro-intestinal and other bleeding a trend towa...Continue Reading

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Citations

Jun 18, 2020·Research and Practice in Thrombosis and Haemostasis·Rupert BauersachsGerald Soff
Jun 18, 2020·Research and Practice in Thrombosis and Haemostasis·Roisin BavaliaMichiel Coppens
Dec 13, 2017·The New England Journal of Medicine·Gary E RaskobUNKNOWN Hokusai VTE Cancer Investigators
Oct 21, 2020·Journal of Thrombosis and Thrombolysis·James ZhangMarc Carrier
May 20, 2020·The British Journal of Surgery·F I MulderN van Es
Jun 23, 2018·Clinical and Applied Thrombosis/hemostasis : Official Journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis·Elise SchapkaitzBarry F Jacobson
Jun 21, 2019·Journal of Thrombosis and Haemostasis : JTH·Ingrid M BistervelsSaskia Middeldorp
Nov 16, 2019·The European Respiratory Journal·Frits I MulderNick van Es
Apr 5, 2019·VASA. Zeitschrift für Gefässkrankheiten·Antoine FayolIsabelle Mahé
Jul 27, 2018·Research and Practice in Thrombosis and Haemostasis·Tzu-Fei WangDavid Garcia
Dec 5, 2018·The New England Journal of Medicine·Marc CarrierUNKNOWN AVERT Investigators
Aug 9, 2020·Journal of Thrombosis and Haemostasis : JTH·Laura FrancoGiancarlo Agnelli
Aug 9, 2019·Journal of Internal Medicine·O AvneryUNKNOWN RIETE Investigators
Oct 17, 2020·Thrombosis Research·Joseph R ShawPhilip Wells

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