Credit: CDC
A post-marketing study in patients with non-valvular atrial fibrillation (NVAF) suggests that rates and patterns of major bleeding associated with the use of rivaroxaban in routine clinical practice are generally consistent with those observed in a previous phase 3 trial.
The new study, which included more than 27,000 patients, showed a low rate of major bleeding. And gastrointestinal bleeding was more common than intracranial hemorrhage.
While the results are not intended for a direct comparison, the researchers said these data are generally consistent with data from the ROCKET-AF trial.
The results, published in Clinical Cardiology, are the initial findings from an ongoing, 5-year, observational study of patients using rivaroxaban daily over the course of their lives.
“These findings reaffirm the safety profile of Xarelto [rivaroxaban],” said study author W. Frank Peacock, MD, of the Baylor College of Medicine in Houston, Texas.
“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.”
Dr Peacock and his colleagues analyzed data from January 1, 2013, to March 31, 2014, evaluating major bleeding in 27,467 NVAF patients treated with rivaroxaban in a real-world, clinical setting.
There were a total of 496 major bleeding events in 478 patients. So the incidence of major bleeding was 2.86 per 100 person-years, which was generally consistent with the rate reported in the ROCKET-AF trial.
Most bleeds were gastrointestinal (88.5%), followed by intracranial (7.5%). Fourteen patients each experienced 2 major bleeding events, and 2 patients each experienced 3 events.
Major bleeding was more likely in females and older patients. The incidence of major bleeding was 2.68 for males and 2.99 for females. The mean age of patients with major bleeding was 78.4, compared to 75.7 for those without major bleeding.
Comorbidities tended to be more prevalent among patients who experienced major bleeding. The most common were hypertension (95.6% vs 75.8%), coronary heart disease (64.2% vs 36.7%), heart failure (48.5% vs 23.7%), and renal disease (38.7% vs 16.7%).
Patients with major bleeding were less likely to be on medications such as statins, proton pump inhibitors, and amiodarone—29.1% vs 36.6%.
Fourteen patients died while in the hospital for major bleeding, for a fatal bleeding rate of 0.08 per 100 person-years. None of these patients had multiple bleeding events.
Fatal bleeding events included intracranial hemorrhage with intracerebral bleeding (n=7), gastrointestinal hemorrhage not otherwise specified (n=3), blood in the stool (n=2), subdural hemorrhage (n=1), and intracranial hemorrhage not otherwise specified (n=1).
Patients’ mean age at death was 82.4 years, and the mean time from hospitalization for the bleeding event to death was 3.9 days.
This ongoing study is funded by Janssen Scientific Affairs, LLC, and Bayer Healthcare, the companies developing rivaroxaban.
