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.
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.
Graeme J. Hankey
Courtesy of the American Heart Association
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
- 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
- In older people, risk increased by one-third for every 10 years of
- A prior stroke or transient ischemic attack increased the risk by
- 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
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
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
“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:
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.