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Risk for intracranial hemorrhage low with rivaroxaban
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International Stroke Conference 2012
NEW ORLEANS — During 2 years, 172 of the 14,264 participants in the ROCKET AF trial experienced an intracranial hemorrhage, at a rate of about 0.68% per year, according to a subanalysis of the trial.
The ROCKET AF steering committee and researchers investigated predictors associated with intracranial hemorrhage in patients with nonvalvular atrial fibrillation who were randomly assigned to rivaroxaban (Xarelto, Janssen) or warfarin in the large, randomized ROCKET AF trial. None of the study participants had experienced intracranial hemorrhage at enrollment, but 53% experienced a prior stroke. During follow-up, intracerebral hemorrhage (n=128) was the most common intracranial hemorrhage event; subarachnoid hemorrhage, subdural hemorrhage and extradural hemorrhage also occurred.
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Patients taking rivaroxaban had a significantly lower risk for intracranial hemorrhage vs. those taking warfarin (P=.019). However, use of aspirin or a thienopyridine at baseline was associated with an increased risk for intracranial hemorrhage.
The new study identified five risk factors — independent of treatment — that increased the likelihood that AF patients would suffer intracranial hemorrhage:
- Black patients had a 4.2-fold increased risk compared with whites; Asian patients had a twofold risk. Other races/ethnicities did not have a higher risk.
- In older people, risk increased by one-third for every 10 years of age.
- A prior stroke or transient ischemic attack increased the risk by 51%.
- Decreased levels of serum albumin increased the risk by 42% for every 0.5 g/L decrease in albumin.
- A low platelet count also increased the risk for intracranial bleeding.
Creatinine clearance was not associated with intracranial hemorrhage after accounting for other variables in the model.
These findings apply only to nonvalvular AF patients at moderate or high risk for stroke, such as those enrolled in the ROCKET AF trial, according to Graeme J. Hankey, MD, FRCP, FRACP, neurologist at Royal Perth Hospital and University of Western Australia.
“The message is that high-risk people [may want to] consider lowering their BP, asking whether [they] need additional clopidogrel and perhaps considering whether rivaroxaban might be a more appropriate treatment,” Hankey said during a press conference.
The researchers concluded that these data require testing in other AF populations.
“Anticoagulant drugs can prevent ischemic strokes, but, paradoxically, they can cause intracranial bleeding, including hemorrhagic strokes,” Hankey stated in a press release. “We have to be very careful about giving anticoagulants to patients at risk for bleeding into the brain, and therefore need to be able to identify who those patients are.” – by Katie Kalvaitis
For more information:
- Hankey GJ. Abstract #152. Presented at: the American Stroke Association’s International Stroke Conference 2012; Feb. 1-3, 2012; New Orleans.
Disclosure: Dr. Hankey has received honoraria from Bayer, Boehringer Ingelheim and Sanofi Aventis. The ROCKET AF trial was supported by research grants from Bayer HealthCare and Johnson & Johnson.
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