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Background: The aim of the study was to describe the clinical and endoscopic characteristics and management of severe acute gastrointestinal (GI) bleeding in patients treated with direct oral anticoagulants (DOACs). Methods: Patients hospitalized for severe GI bleeding under DOAC therapy were identified in 36 centres between June 2013 and March 2016. Clinical outcomes including re-bleeding, major cerebral and cardiovascular events or all-cause mortality were assessed initially and 30 days after admission. Results: A total of 59 patients with anonymized detailed endoscopy reports for severe GI bleeding were considered. Mean age was 79.3 ± 10.0 years and 61.3% of patients were men. Patients had histories of hypertension (65.6%), heart failure (29.5%), coronary artery disease (27.9%), stroke (19.7%) and peripheral vascular disease (36.1%). Life-threatening bleeding was observed in 42.6%. Mean number of packed red blood cells transfused was 3.4 (range 1–31). Aetiology of bleeding (identified in 66.2% of cases) was peptic gastroduodenal ulcers (22%), diverticula (11.9%), angiodysplasia (8.5%), colorectal neoplasia (5.1%) and anorectal causes (5.1%). Endoscopic haemostasis was performed in 37.7% of patients. A low haemoglobin level was predictive of life-threatening bleeding and death in multivariate analysis. All-cause mortality rate at day 30 was 11.8%. Conclusions: In this cohort of elderly patients with multiple comorbidities treated with DOACs, the main cause of severe acute GI bleeding was peptic gastroduodenal ulcer and mortality was high.

Background: Gastrointestinal angiodysplasias (GIADs) could be responsible for recurrent bleeding and severe anemia. Somatostatin analogs could reduce transfusion requirements in these patients but no randomized controlled study is available. The main objective of the ANGIOPAS phase II double-blinded randomized, noncomparative study was to assess the effectiveness of pasireotide-LAR in reducing transfusion requirements in patients with refractory GIADs bleeding. Methods: A total of 22 patients with transfusion requirements ⩾6 units of packed red blood cells (pRBCs) during the 6 months prior to inclusion were randomized to receive pasireotide-LAR 60 mg ( n = 10) or placebo ( n = 12) every 28 days for 6 months. Patients were then followed for an additional 6 months after stopping treatment. Results: The pasireotide-LAR and placebo groups were equivalent for age, sex, comorbidities and transfusion requirement during the reference period (median 13 and 9.5 pRBCs). A 50 and 83% success rate (success defined as a decrease of at least 30% of transfused pRBCs) was observed in the pasireotide-LAR arm in the Intent to Treat (ITT) and per protocol (PP) analysis respectively. The need for transfusion during the intervention period was 3 pRBC units in the pasireotide-LAR group (range 0–26) and 11.5 pRBC units in the placebo group (range 0–23). Overall, three cases with glycemic control impairment were observed in the pasireotide-LAR group including one de novo diabetes. Conclusion: This double-blinded noncomparative randomized phase II study suggests, for the first time, the effectiveness of pasireotide-LAR 60 mg every 28 days to decrease the transfusion requirement in patients with recurrent bleeding due to GIADs.

The use of direct oral anticoagulants (DOACs) was an important step forward in the management of atrial fibrillation and venous thromboembolism (VTE). The DOACs, anti-IIa for dabigatran and anti-Xa for rivaroxaban, apixaban and edoxaban, all have a rapid onset of action and a short half life. There is no need for routine hemostasis testing for treatment monitoring of a DOAC. Compared with vitamin K antagonists (VKAs), DOACs may increase the risk of gastrointestinal bleeding (relative risk 1.25). Withholding the DOAC treatment, evaluating the time of the last intake and estimating the patient’s renal function are the first steps in the management of gastrointestinal bleeding. For patients without impaired renal function, achieving low coagulation takes around 24 h after the last intake of a DOAC. The use of DOAC antagonists will be helpful in controlling bleeding in the most severe and urgent situations. Idarucizumab is available for clinical use for dabigatran and andexanet is currently being reviewed by drug agencies for rivaroxaban, apixaban and edoxaban. It is important to assess the bleeding risk associated with the planned procedure, and the patient’s renal function before withholding DOAC therapy for a scheduled intervention. It is mandatory to strengthen the local hemostasis strategies in DOAC-treated patients undergoing a therapeutic endoscopic procedure. Resuming or not resuming anticoagulation with a DOAC after bleeding or a risky procedure depends on the thrombotic and bleeding risk as well as the procedure involved. This discussion should always involve the cardiologist and decisions should be taken by a pluridisciplinary team.