Thrombosis Research 151, Suppl. 1 (2017) S1–S5 Uterine bleeding during anticoagulation in women with venous thromboembolism Farès Moustafa a, *, Sonia Fernández b , Carmen Fernández-Capitán c , José Antonio Nieto d , José María Pedrajas e , Adriana Visoná f , Beatriz Valero g , Pablo Javier Marchena h , Andrei Braester i , Manuel Monreal j , and the RIETE Investigators** a Department of Emergency, Clermont-Ferrand University Hospital, Clermont-Ferrand, France b Department of Internal Medicine, Hospital Universitario Germans Trias i Pujol de Badalona, Barcelona, Spain c Department of Internal Medicine, Hospital Universitario La Paz, Madrid, Spain d Department of Internal Medicine, Hospital General Virgen de la Luz, Cuenca, Spain e Department of Internal Medicine, Hospital Clínico San Carlos, Madrid, Spain f Department of Vascular Medicine, Ospedale Castelfranco Veneto, Castelfranco Veneto, Italy g Department of Internal Medicine, Hospital General Universitario de Alicante, Alicante, Spain h Department of Internal Medicine and Emergency, Parc Sanitari Sant Joan de Deu-Hospital General, Barcelona, Spain i Department of Haematology, Galilee Medical Center, Nahariya, Israel j Department of Internal Medicine, Hospital Universitario Germans Trias i Pujol de Badalona, Barcelona, Universidad Católica de Murcia, Spain ARTICLE INFO ABSTRACT Keywords: Uterine bleeding Anticoagulant therapy Venous thromboembolism A real-life study Background: Women presenting with uterine bleeding during the course of anticoagulant therapy for venous thromboembolism (VTE) present a difficult therapeutic dilemma due to the absence of evidence-based rec- ommendations. Methods: We used the RIETE (Registro Informatizado Enfermedad TromboEmbólica) database to assess the clinical characteristics of women presenting with uterine bleeding during anticoagulation for VTE, its fre- quency, time course, management and 30-day outcomes. Results: As of October 2016, 31,951 women with VTE were recruited in RIETE. During the course of antico- agulant therapy, 53 (0.17%) developed major uterine bleeding, 118 (0.37%) non-major uterine bleeding and 948 (2.97%) had major bleeding in other sites. Median time elapsed from VTE to bleeding was: 32, 71 and 22 days, respectively. Mean age was: 56 ± 17, 52 ± 20 and 75 ± 14 years, respectively. Women with major uter- ine bleeding more likely had cancer (51%), anemia (72%), raised platelet count (19%) or recent major bleeding (11%) at VTE presentation than those in the other subgroups. During the first 30 days after bleeding, 17%, 1.7% and 31% of women died, respectively. Of 11 women with uterine bleeding who died, 9 (82%) had cancer, two (18%) died of bleeding and one (9.1%) died of pulmonary embolism after discontinuing anticoagulation. Conclusions: Uterine bleeding during the course of anticoagulation for VTE is not uncommon and mostly af- fects young women. Those with cancer, anaemia, raised platelet count or recent bleeding at baseline are at an increased risk for uterine bleeding during anticoagulation. © 2017 Elsevier Ltd. All rights reserved. 1. Introduction Abnormal uterine bleeding is a relatively common complication in women receiving anticoagulant therapy for venous thromboem- bolism (VTE) [1–3]. In the literature, there is scarce information on its frequency, the clinical characteristics of these women, the time course and the severity of bleeding [1,4,5]. Most of the published in- formation came from randomized clinical trials with strict inclusion and exclusion criteria, and limited follow-up [6]. Thus, although randomized clinical trials provide high-level evidence on the effi- * Corresponding author: Farès Moustafa, MD, Service des urgences, Hôpital Gabriel Montpied, 58 rue Montalembert, F-63003 Clermont-Ferrand Cedex 1, France. Tel.: +33 624366369. E-mail address: fmoustafa@chu-clermontferrand.fr (F. Moustafa). ** A full list of RIETE investigators is given in the appendix. 0049-3848/$ – see front matter © 2017 Elsevier Ltd. All rights reserved. cacy and safety of therapeutic interventions, they generally involve well-defined study populations that exclude complex patients and do not provide data on the management of bleeding [1,7,8]. This is important since uterine bleeding in women receiving anticoagulant therapy for VTE presents a dilemma because the potential benefits of anticoagulation must be weighed against the risk of inducing re-bleeding. RIETE (R egistro I nformatizado E nfermedad T romboE mbólica) is a multicenter, ongoing, international (Spain, Belgium, Czech Republic, France, Greece, Israel, Italy, Latvia, Republic of Macedonia, Switzer- land, United States, Canada, Ecuador and Venezuela enroll patients) observational registry of consecutive patients with symptomatic, objectively confirmed, acute VTE (ClinicalTrials.gov identifier: NC- T02832245). Data from this registry have been used to evaluate outcomes after acute VTE, such as the frequency of recurrent VTE, bleeding and mortality, and risk factors for these outcomes [9–13].