{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T08:16:41Z","timestamp":1790669801042,"version":"4.1.0"},"reference-count":20,"publisher":"Georg Thieme Verlag KG","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Thromb Haemost"],"published-print":{"date-parts":[[2017]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>Factor Xa (fXa)-inhibitors are as effective and safer than vitamin-K\u2013antagonists (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\u20130.97). 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\u20131.46). 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.<\/jats:p>","DOI":"10.1160\/th16-12-0946","type":"journal-article","created":{"date-parts":[[2017,8,17]],"date-time":"2017-08-17T08:15:34Z","timestamp":1502957734000},"page":"1944-1951","source":"Crossref","is-referenced-by-count":41,"title":["Clinical impact of major bleeding in patients with venous thromboembolism treated with factor Xa inhibitors or vitamin K antagonists"],"prefix":"10.1160","volume":"117","author":[{"given":"Elise","family":"Eerenberg","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Cohen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saskia","family":"Middeldorp","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary","family":"Raskob","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harry","family":"B\u00fcller","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzanne","family":"Bleker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marjolein","family":"Brekelmans","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2017,11,28]]},"reference":[{"key":"10.1160\/TH16-12-0946-1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1302507"},{"key":"10.1160\/TH16-12-0946-2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1007903"},{"key":"10.1160\/TH16-12-0946-3","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1113572"},{"key":"10.1160\/TH16-12-0946-4","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1306638"},{"key":"10.1160\/TH16-12-0946-5","first-page":"Cd010957","volume":"6","author":"Robertson","year":"2015","journal-title":"Cochrane Database Syst Rev"},{"key":"10.1160\/TH16-12-0946-6","first-page":"Cd010956","volume":"6","author":"Robertson","year":"2015","journal-title":"Cochrane Database Syst Rev"},{"key":"10.1160\/TH16-12-0946-7","doi-asserted-by":"publisher","DOI":"10.1160\/TH14-04-0346"},{"key":"10.1160\/TH16-12-0946-8","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3026(16)30111-9"},{"key":"10.1160\/TH16-12-0946-9","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2016.11.117"},{"key":"10.1160\/TH16-12-0946-10","doi-asserted-by":"crossref","unstructured":"Brekelmans MP, Scheres LJ, Bleker SM, et al. Abnormal vaginal bleeding in women with venous thromboembolism treated with apixaban or warfarin. Thromb Haemost 2017; Epub ahead of print","DOI":"10.1160\/TH16-11-0874"},{"key":"10.1160\/TH16-12-0946-11","doi-asserted-by":"publisher","DOI":"10.1155\/2013\/973710"},{"key":"10.1160\/TH16-12-0946-12","unstructured":"Gouin B, Blondon M, Jimenez D, et al. Clinical prognosis of non-massive central and non-central pulmonary embolism: a registry-based cohort study. Chest 2016; Epub ahead of print"},{"key":"10.1160\/TH16-12-0946-13","doi-asserted-by":"publisher","DOI":"10.1111\/jth.13051"},{"key":"10.1160\/TH16-12-0946-14","doi-asserted-by":"publisher","DOI":"10.1160\/TH15-11-0892"},{"key":"10.1160\/TH16-12-0946-15","doi-asserted-by":"publisher","DOI":"10.1160\/TH16-02-0137"},{"key":"10.1160\/TH16-12-0946-16","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538-7836.2005.01204.x"},{"key":"10.1160\/TH16-12-0946-17","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1510991"},{"key":"10.1160\/TH16-12-0946-18","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1607887"},{"key":"10.1160\/TH16-12-0946-19","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.113.002332"},{"key":"10.1160\/TH16-12-0946-20","doi-asserted-by":"publisher","DOI":"10.1016\/j.annemergmed.2013.02.008"}],"container-title":["Thrombosis and Haemostasis"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1160\/TH16-12-0946.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2018,3,20]],"date-time":"2018-03-20T02:16:35Z","timestamp":1521512195000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1160\/TH16-12-0946"}},"subtitle":["An individual patient data meta-analysis"],"short-title":[],"issued":{"date-parts":[[2017]]},"references-count":20,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2017,11,7]]},"published-print":{"date-parts":[[2017]]}},"URL":"https:\/\/doi.org\/10.1160\/th16-12-0946","relation":{},"ISSN":["0340-6245","2567-689X"],"issn-type":[{"value":"0340-6245","type":"print"},{"value":"2567-689X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017]]}}}