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

Autor:	Bleker SM, Brekelmans MPA, Eerenberg ES, Cohen AT, Middeldorp S, Raskob G, Büller HR
Jazyk:	angličtina
Zdroj:	Thrombosis and haemostasis [Thromb Haemost] 2017 Oct; Vol. 117 (10), pp. 1944-1951. Date of Electronic Publication: 2017 Nov 28.
DOI:	10.1160/TH16-12-0946
Abstrakt:	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 towards a less severe presentation was observed for patients treated with fXa inhibitors. Clinical course was classified as severe in 22% of the fXa inhibitor and 25% of the VKA associated bleeds (OR 0.83, 95% CI 0.47-1.46). In conclusion, FXa inhibitor associated major bleeding events had a significantly less severe presentation and a similar course compared to VKA. This finding was consistent for different types of bleeding. Competing Interests: Dr. Bleker has nothing to disclose. Dr. Brekelmans has nothing to disclose. Dr. Eerenberg reports personal fees from CSL Behring, grants from Sanquin, grants from Baxter, outside the submitted work. Dr. Cohen reports grants and personal fees from Bristol-Myers Squibb, Pfizer Limited, and personal fees from Boehringer Ingelheim, Johnson & Johnson, Portola, Sanofi Aventis, XO1, Janssen, Bayer HealthCare and grants from Daiichi Sankyo, outside the submitted work. Dr. Middeldorp reports grants and personal fees from GSK, BMS/Pfizer, Aspen, and Daiichi Sankyo, personal fees from Bayer, Boehringer Ingelheim, and grants from Sanquin, outside the submitted work. Dr. Raskob reports personal fees from Daiichi Sankyo, Itreas, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Isis Pharmaceuticals, Janssen, Pfizer and Portola, outside the submitted work. Dr. Buller reports grants and personal fees from Daiichi Sankyo, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Isis Pharmaceuticals, GSK, Roche, Sanofi, Thrombogenics, outside the submitted work. (Schattauer GmbH.)
Databáze:	MEDLINE
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