Case report

An 84-year-old man with a known atrial fibrillation, anticoagulated with dabigatran at 150 mg/12 h, type 2 diabetes and COPD, presented to the Emergency Room due to melena without hemodynamic derangement over a 48 hour period. In 2014, a 6 mm ileal angiodysplasia was identified as a possible cause of an episode of gastrointestinal bleeding after gastroscopy, colonoscopy and videocapsule. The first analytical exam identified hemoglobin levels at 10.1 g/dl, international normalized ratio (INR) of 1.3 and a cephalin time of 50.8 s; the rest of parameters were normal. His condition suddenly deteriorated in the Emergency Room, with hypotension, anemia and a massive melena; 5 g of i.v. idarucizumab were administered in ten minutes, a transfusion was performed and a gastroscopy and colonoscopy did not identify a source of the bleeding. His condition rapidly improved and there were no further signs of bleeding. Dabigatran was resumed on the sixth day. There has been no rebleeding or thromboembolic events after six months of follow-up.

Discussion

Idarucizumab is the first antidote available against DOAC. The most rigorous analysis that led to its approval is the RE-VERSE-AD study ³. In this study, 45.5% of hemorrhages were gastrointestinal bleeds with a median time to bleeding cessation of 2.5 hours. Recent data indicate that anticoagulation can be resumed within 24 hours once the bleeding is under control. Therefore, dabigatran was probably restarted later than necessary in the current case ^1,3. Even though idarucizumab is already included in some clinical guidelines, it is important to highlight some points. Firstly, there are no studies with survival as primary outcome; most of the research in this area has focused on laboratory parameters. In addition, the largest published cohorts were funded by the pharmaceutical company that markets dabigatran and idarucizumab, which could have introduced bias in the results ². Furthermore, post-marketing experience in gastrointestinal bleeding is scarce and only data from clinical cases and small case series are available (Table 2). Finally, idarucizumab is expensive and dabigatran clearance is rapid (half-life of 13 h) if renal function is normal. Therefore, its use should be restricted to severe cases or a recent intake of dabigatran. In our case, the severity of the bleeding justified the use of idarucizumab, which had excellent results.

Table 1 Idarucizumab in gastrointestinal bleeding 

GIB: gastrointestinal bleeding; UGIB: upper gastrointestinal bleeding; LGIB: lower gastrointestinal bleeding; CRD: chronic renal disease; MOF: multiple organ failure; INR: international normalized ratio.