Risk factors and prevention of dabigatran‐related gastrointestinal bleeding in patients with atrial fibrillation

Abstract

IntroductionDabigatran, as compared with warfarin, was associated with lower rates of stroke and systemic embolism with similar rates of major hemorrhage. But it has a significantly higher risk of gastrointestinal bleeding (GIB). There are limited data on how to prevent GIB from dabigatran and what are the risk factors.MethodsWe performed a retrospective cohort study of patients with atrial fibrillation who have ever taken dabigatran for thromboprophylaxis from October 2010 to February 2013.ResultsA total of 247 patients were identified. There were 10 (4%) patients who developed GIB (6 (6.5%) in PPI/H2RA users vs 4 (2.6%) in non‐PPI/H2RA users; P = .184). History of GIB within 1 year prior to dabigatran initiation and HAS‐BLED score ≥3 are independent risk factors for GIB, with odds ratio of 25.14 (95% CI, 2.85‐221.47; P < .01) and 5.85 (95% CI, 1.31‐26.15; P = .021), respectively.ConclusionIn this real‐world cohort, PPI/H2RA use was not associated with reduced GIB events. HAS‐BLED score ≥3 and prior history of GIB within 1 year are independent risk factors for GIB among dabigatran users.

An Exploratory Association Analysis of ABCB1 rs1045642 and ABCB1 rs4148738 with Non-Major Bleeding Risk in Atrial Fibrillation Patients Treated with Dabigatran or Apixaban

“…In the present study, bleedings appeared in 7.34% NOAC-treated patients. Phase III randomized trials comparing NOACs with warfarin and real-world studies [ 40 , 41 ] estimated the bleeding risk at 1 to 3% per year, and discontinuation of NOACs was less prevalent than with VKA [ 41 ]. As well, both individual studies and meta-analyses have shown that NOACs are associated with a lower incidence of fatal bleedings, lower in-hospital mortality, and a better evolution of patients suffering from bleedings, even intracranial ones [ 27 ].…”

“…During the follow-up period, we did not register major bleedings, only CRNMB and minor bleeding episodes, easily managed by gastroenterologists and treating cardiologists. Generally, non-major bleedings were more common than the major ones in NOACs randomized trials [ 43 ] and real-world studies [ 40 , 41 ]. As shown before, also in our study, in the vast majority, predominated lower GIB [ 44 ] possible by incomplete absorption of the active substance in the upper tract and increased NOACs availability in the lower tract [ 45 ].…”

“…A direct comparative study between NOACs also confirmed that the risk of bleeding increases with age [ 49 ]. Also, in real-world NOACs studies history of GIB, alcohol consumption, and renal and hepatic dysfunction resulted in an increase in the incidence of GIB compared to that reported in randomized trials [ 40 ]. The concomitant administration of several drugs whose metabolic pathways are common with those of NOACs (P-gp or CYP 3 A 4 inhibitors) increases plasma levels and the risk of bleeding [ 17 ].…”

Gastrointestinal Bleeding in Patients Admitted to Cardiology: risk factors and a new risk score

“…Meanwhile, we found that there was no significant differences in PPI between the two groups and had no protective effect on the incidence of GIB. Similarly, previous studies had reported that PPI could not decrease the incidence of GIB in patients after anticoagulant therapy with dabigatran [15]. It was noteworthy that a study that 46,301 patients with dual antiplatelet therapy after myocardial infarction were recruited, reported PPI could reduce the risk of GIB, However, long-term outcomes needed to be further observed [16].…”

Optical assessment of alterations of microrheologic and microcirculation parameters in cardiovascular diseases

“…As a rule, monitoring the effectiveness of the treatment carried out is not sufficient, especially when using the so-called New Oral Anticoagulants (NOAC), for which the necessary laboratory tests have not been developed yet. However, overdose and uncontrolled intake of anticoagulants and antiplatelet agents can cause serious hemorrhagic complications [12,13]. On the other hand, insufficiently effective antiplatelet therapy leads to complications of different kinds, associated with the risk of increased thrombosis.…”