Characterizing Major Bleeding in Patients With Nonvalvular Atrial Fibrillation: A Pharmacovigilance Study of 27 467 Patients Taking Rivaroxaban

Abstract

Background:In nonvalvular atrial fibrillation (NVAF), rivaroxaban is used to prevent stroke and systemic embolism. Objective: To evaluate major bleeding (MB) in NVAF patients treated with rivaroxaban in a real-world clinical setting. Methods: From January 1, 2013, to March 31, 2014, US Department of Defense electronic health care records were queried to describe MB rates and demographics. Major bleeding was identified using a validated algorithm. Results: Of 27 467 patients receiving rivaroxaban, 496 MB events occurred in 478 patients, an incidence of 2.86 per 100 person-years (95% confidence interval: 2.61-3.13). The MB patients were older, mean (SD) age of 78.4 (7.7) vs 75.7 (9.7) years, compared with non-MB patients. Patients with MB had higher rates of hypertension (95.6% vs 75.8%), coronary artery disease (64.2% vs 36.7%), heart failure (48.5% vs 23.7%), and renal disease (38.7% vs 16.7%). Of MB patients, 63.2% were taking 20 mg, 32.2% 15 mg, and 4.6% 10 mg of rivaroxaban. Four percent of MB patients took warfarin within the prior 30 days. Major bleeding was most commonly gastrointestinal (88.5%) or intracranial (7.5%). Although 46.7% of MB patients received a transfusion, none had sufficient evidence of receiving any type of clotting factor. Fourteen died during their MB hospitalization, yielding a fatal bleeding incidence rate of 0.08 per 100 person-years (95% confidence interval: 0.05-0.14). Mean age at death was 82.4 years. Conclusions: In this large observational study, the MB rate was generally consistent with the registration trial results, and fatal bleeds were rare.

CHADS2 risk score and rate of stroke or systemic embolism and major bleeding in patients with non-valvular atrial fibrillation receiving non-vitamin K antagonist oral anticoagulants

“…A similar relationship, as in the aforementioned studies reporting the relationship between the CHADS 2 risk score and the rate of major bleeding, was also described in a recent analysis of the large database of the United States Department of Defense concerning electronic medical records of 27,467 patients with AF treated with rivaroxaban between February 1, 2013 and March 31, 2014 17 . The mean CHADS 2 score was 2.2 and 496 major bleeding events were recorded in 478 patients, a rate of 2.86% per person years.…”

Rivaroxaban-induced chest wall spontaneous expanding hematoma

“…These factors include certain types of solid tumors such as gastric, neck or lung cancer, thrombocytopenia, platelet dysfunction, prior surgeries, metastatic disease, myelosuppressive chemotherapy and use of vascular endothelial growth factor (VEGF) receptor tyrosinekinase inhibitors (13). Since there is no reported score assessing the risk of bleeding, an individual approach to assess the bleeding risk is essential when anticoagulant treatment is initiated especially in certain cancer patients, those with renal impairment, hypertension, coronary heart disease, heart failure and the very elderly (8,12,13).…”

Use of new anticoagulants for the treatment of venous thromboembolism in the context of the results of the XALIA study — clinical trials and routine clinical practice

“…In case of the Post-Marketing Safety Surveillance carried out in the USA on the basis of the data obtained from the medical database of the Department of Defense in the period from January 2013 to October 2014, in the population of 27 467 patients in whom anticoagulant treatment with rivaroxaban was used for the first time due to atrial fibrillation, major bleeding complications were reported in 2.89% of patients per year [41].…”