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Major bleeding rates for rivaroxaban similar in real-world, clinical trial settings
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The major bleeding rate associated with rivaroxaban in a real-world clinical setting was similar to that observed in clinical trials, and fatal bleeds were rare, according to the results of a large observational study.
Researchers queried US Department of Defense electronic health records to determine major bleeding rates and demographics for those with nonvalvular atrial fibrillation prescribed rivaroxaban (Xarelto, Janssen Pharmaceuticals) for prevention of stroke and systemic embolism.
“These findings reaffirm the safety profile of Xarelto,” researcher W. Frank Peacock, MD, FACEP, said in a press release. “We anticipate future findings from this 5-year observational study will continue to provide real-world information about the use of Xarelto in routine clinical practice.”
Peacock and colleagues identified 27,467 people with nonvalvular AF assigned rivaroxaban between 2013 and March 2014. Major bleeding was determined by an algorithm identifying bleeding-related hospitalizations from a primary discharge diagnosis.
Peacock, associate chair and research director of the department of emergency medicine at Baylor College of Medicine, Houston, and colleagues documented 496 major bleeding events among 478 patients during the evaluated time period. The incidence rate was 2.86 (95% CI, 2.61-3.13) per 100 person-years overall, 2.68 (95% CI, 2.37-3.04) per 100 person-years for men and 2.99 (95% CI, 2.63-3.41) per 100 person-years for women.
They found that those who experienced a major bleeding event were older than those who did not (mean age, 78.4 years vs. 75.7 years).
Compared with those who did not have a major bleeding event, those who did had higher rates of hypertension (95.6% vs. 75.8%), CAD (64.2% vs. 36.7%), HF (48.5% vs. 23.7%) and renal disease (38.7% vs. 16.7%), according to the researchers. The mean CHA2DS2-VASc score was 4.8 (standard deviation, 1.5) among those with a major bleed and 3.7 (standard deviation, 1.7) in those without one.
Of those who had a major bleeding event, 63.2% were assigned 20 mg rivaroxaban, 32.2% were assigned 15 mg and 4.6% were assigned 10 mg, whereas 4% were assigned warfarin within the 30 days before a major bleeding event, Peacock and colleagues found.
The most common types of major bleeding were gastrointestinal (88.5%) and intracranial (7.5%), according to the researchers. A transfusion was received by 46.7% of those with a major bleeding event, but no patients exhibited sufficient evidence of receiving any type of clotting factor, they wrote.
There were 14 deaths (mean age, 82.4 years) during hospitalization for major bleeding within the study population, with a fatal bleeding incidence rate of 0.08 (95% CI, 0.05-0.14) per 100 person-years, Peacock and colleagues found.
“These outcomes are similar to those reported in the registration trial (eg, ROCKET AF), and add valuable complementary safety data associated with rivaroxaban use in the post-marketing place,” the researchers wrote. Although a direct comparison between trials was not intended, the reported rate in ROCKET AF for major bleeding associated with rivaroxaban was 3.6 per 100 person-years, they noted.
Disclosure: The study was funded by Janssen Scientific Affairs and Bayer Healthcare. Peacock reports various financial ties with Abbott, Alere, Banyan, BG Medicine, Beckman, Boehringer Ingelheim, Cardiorentis, Instruments Labs, Janssen, Portola, Prevencio, Roche, The Medicine Company and ZS Pharma. See the full study for a list of the researchers’ relevant financial disclosures.
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