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Clin Cardiol. 2015 Feb;38(2):63-8. doi: 10.1002/clc.22373. Epub 2015 Jan 14.

Characterizing major bleeding in patients with nonvalvular atrial fibrillation: a pharmacovigilance study of 27 467 patients taking rivaroxaban.

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1
Department of Cardiology, Naval Medical Center, Portsmouth, Virginia.

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.

PMID:
25588595
DOI:
10.1002/clc.22373
[Indexed for MEDLINE]
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