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The aim of this study was to investigate possible risk factors associated with major bleeding in VTE-patients treated with NOACs. In this retrospective register-based study we screened the Swedish anticoagulation register <jats:italic>Auricula<\/jats:italic> (during 2012.01.01\u20132017.12.31) to find patients and used other national registers for outcomes. Primary endpoint was major bleeding defined as bleeding leading to hospital care. Multivariate Cox-regression analysis was used to reveal risk factors. 18 219 patients with NOAC due to VTE were included. 85.6% had their first VTE, mean age was 69.4\u00a0years and median follow-up time was 183\u00a0days. The most common NOAC was rivaroxaban (54.8%), followed by apixaban (42.0%), dabigatran (3.2%) and edoxaban (0.1%). The rate of major bleeding was 6.62 (95% CI 6.19\u20137.06) per 100 treatment years in all patients and 11.27 (CI 9.96\u201312.57) in patients above 80\u00a0years of age. Statistically independent risk factors associated with major bleeding were age (normalized HR 1.38, CI 1.27\u20131.50), earlier major bleeding (HR 1.58, Cl 1.09\u20132.30), COPD (HR 1.28, CI 1.04\u20131.60) and previous stroke (HR 1.28, Cl 1.03\u20131.58) or transient ischemic attack (TIA) (HR 1.33, Cl 1.01\u20131.76). Prior warfarin treatment was protective (HR 0.67, CI 0.58\u20130.78). This real world cohort shows a high bleeding rate especially among the elderly and in patients with previous major bleeding, COPD and previous stroke or TIA. This should be considered when deciding on treatment duration and NOAC dose in these patients.<\/jats:p>","DOI":"10.1007\/s11239-020-02319-w","type":"journal-article","created":{"date-parts":[[2020,11,2]],"date-time":"2020-11-02T18:02:48Z","timestamp":1604340168000},"page":"315-323","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Bleeding risk in patients with venous thromboembolic events treated with new oral anticoagulants"],"prefix":"10.1007","volume":"52","author":[{"given":"Niklas","family":"Wallvik","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henrik","family":"Renlund","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anders","family":"Sj\u00e4lander","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,11,2]]},"reference":[{"issue":"4","key":"2319_CR1","doi-asserted-by":"publisher","first-page":"692","DOI":"10.1111\/j.1538-7836.2007.02450.x","volume":"5","author":"IA Naess","year":"2007","unstructured":"Naess IA, Christiansen SC, Romundstad P, Cannegieter SC, Rosendaal FR, Hammerstr\u00f8m J (2007) Incidence and mortality of venous thrombosis: a population-based study. 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A.S was the principal investigator of the RE-VERSE AD study in Sweden and has received consultancy or lecture fees from Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Merck Sharp and Dohme, Takeda Pharma and Pfizer.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of University. Dnr 2015\/145-31.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Article was accepted for publication by all authors.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}