- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
- Patients diagnosed with atrial fibrillation who also have a previous history of falls should receive anticoagulation therapy with apixaban to prevent strokes.
- Note that the group with a history of falls had similar adjusted rates of stroke or systemic embolism and hemorrhagic stroke, but higher rates of major bleeding and mortality.
ROME — Patients diagnosed with atrial fibrillation who also have a previous history of falls should receive anticoagulation therapy with apixaban (Eliquis) to prevent strokes, researchers said here.
In a subset analysis of the 753 patients with a history of falls in the ARISTOTLE trial, no patients taking apixaban experienced intracranial bleeding versus five (0.85%) on warfarin, reported Christopher Granger, MD, of Duke University Medical Center in Durham, N.C., and colleagues at the European Society of Cardiology annual meeting.
ARISTOTLE demonstrated that apixaban was superior to warfarin in preventing stroke and bleeding episodes.
“These are small numbers, but it is consistent with the idea that the safety profile of apixaban is something that could be very important in the high-risk population that has fallen,” Granger said. “I would extend this to all the non-vitamin K anticoagulants — they all have this characteristic of less intracranial bleeding.”
“A prior history of falls is a commonly cited reason for concern for risk of bleeding with anticoagulation,” the authors explained, even though little is known about the relative increased risk of bleeding and of stroke among patients on anticoagulants with history of falls, and whether the relative benefits of apixaban versus warfarin are consistent in this population.
“This is an extremely important and underappreciated clinical issue,” Granger told MedPage Today. “Patients with atrial fibrillation are at substantial risk of stroke, which are preventable with anticoagulants. But at least half the time anticoagulants are not being used, and a substantial part of the reason is because of concern of frailty, bleeding, and falls – and particularly falls.”
Granger’s group evaluated the ARISTOTLE data and determined that about 5% of the 18,000 people in the study had a history of falls. They found that 753 (4.6%) of patients had a history of falls in the past year at baseline. They were compared with 15,738 patients recruited in ARISTOTLE without a history of falls.
Compared with patients without a history of falls, those with a prior history of falls were:
- Older: median age 75 versus 70
- More likely to be female
- Have dementia, depression, osteoporosis, and fractures
- Have more prior bleeding of most types
- Have higher CHADS score (mean 2.53 versus 2.14)
- Have higher HAS-BLED score (mean 2.40 versus 1.77)
- Higher rates of study drug discontinuation
The group with a history of falls had similar adjusted rates of stroke or systemic embolism and hemorrhagic stroke, but higher rates of major bleeding (HR 1.39, 95% CI 1.05 to 1.85) and mortality (HR 1.70, 95% CI 1.36 to 2.14).
“The benefits of apixaban, compared with warfarin, on stroke/systemic embolism, bleeding, myocardial infarction, and death were preserved, irrespective of history of falls,” the authors noted.
“These patients were at higher risk of adverse outcomes, such as mortality, a 30% higher risk of stroke, and a two-fold higher risk of intracranial bleeding, including subdural bleeding, and a greater likelihood of fracture,” Granger explained. “There is about a 1% risk of intracranial bleeding among patients who have a history of falls and about a 0.55% risk in people who did not have a history of falls. The rate of stroke or symptomatic embolism was about 2% in patients with a history of falls compared to about 0.9% of those without a history of falls. Because anticoagulation therapy reduced the risk of stroke by two-thirds, you can extrapolate that anticoagulant therapy far outweighs the risk of intracranial bleeding.”
He said that the substudy indicated that patients with a history of falls “seem to do reasonably well with anticoagulation in respect to the risk-benefit; secondly, apixaban seemed to be particularly good treatment for this high-risk population.”
The overall take-home message is that these patients with a history of falls should be treated with anticoagulants.
“All too often these people are not being treated, and they are having preventable strokes,” he said, adding that “it is most important to get patients on some anticoagulation, even warfarin. It is much better than nothing or just aspirin.”
Granger said that uptake of that message has been slow in the medical community. “The change in the proportion of people being treated has been very modest and we are trying to sort through the reasons for this,” he noted. A concern among healthcare providers about bleeding risks is one reason why, he added.
In commenting on the trial, Richard Becker, MD, chief of cardiology at the University of Cincinnati College of Medicine, agreed, telling MedPage Today that “the medical community … has appreciated the role of falls in patients who are anticoagulated. We may have overestimated the risk, and therefore have not offered anticoagulation for patients who may have benefited from its use in terms of reducing the risk of strokes, in particular.”
“If a physician believes that a patient can be safely treated with anticoagulation, then apixaban would be a better choice than warfarin under those circumstances,” said Becker, who was not involved in the study.
Granger disclosed relevant relationships with Pfizer, BMS, Boehringer Ingelheim, Bayer, Janssen, and Daiichi Sankyo.
Becker disclosed no relevant relationships with industry.
Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco
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