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(HealthNewsDigest.com) – DALLAS, April 25, 2012 — Some patients with irregular heartbeats who are taken off anti-clotting medication face a high risk of stroke or blood clotting within a month, according to new research presented at the American Heart Association’s Emerging Science Series webinar.
Patients with certain types of atrial fibrillation, or irregular heartbeat, take these drugs to reduce the risks of clots that could lead to a stroke. Sometimes they are instructed to stop taking the medication temporarily before surgery or permanently because of side effects.
“No matter what drug they are on, patients who need anticoagulation
revert back to their intrinsic risk of stroke and embolism after
discontinuation, so it shouldn’t be done lightly,” said Manesh Patel,
M.D., lead author and assistant professor of medicine at the Duke
University School of Medicine. “Unfortunately, it’s unclear how to
provide optimal anti-coagulation coverage during periods of
transition.”
Researchers analyzed data from a clinical trial known as ROCKET AF,
finding the risk is similar whether patients are taking the drug
warfarin or the newer anticoagulant rivaroxaban. Rivaroxaban is taken
once daily and doesn’t require the frequent monitoring of warfarin,
which requires frequent dose-adjustment.
In ROCKET AF, rivaroxaban was found to be as effective as warfarin in
preventing stroke and blood clots in more than 14,000 patients with
atrial fibrillation. Patients also had no greater risk of bleeding.
However, concerns persisted about possible increased rates of stroke
and blood clots after discontinuing rivaroxaban, which led to a warning
in the prescribing information.
Because of these concerns, the researchers analyzed strokes and blood
clots that occurred following temporary interruptions, and between 3
and 30 days after early drug discontinuation or the transition to
warfarin at the study’s end.
Strokes and blood clots occurred:
— At similar rates with both drugs after a temporary interruption —
6.20/100 patient-years for those on rivaroxaban vs. 5.05/100
patient-years for those taking warfarin;
— At similar rates in both drugs after permanently stopping the medicines
— 25.60/100 patient-years for people taking rivaroxaban (vs. 23.38/100
patient-years for those on warfarin;
— More often in the transition from rivaroxaban to open label therapy
(6.42/100 patient-years) vs. warfarin (1.73/100 patient-years). However,
the risk seems to be high only for stroke. There was no difference
between the drugs when investigators evaluated all blood clot-related
events (including strokes, heart attack and vascular death) within 30
days of stopping medication.
Co-authors are: Anne S. Hellkamp, M.S.; Yuliya Lokhnygina, Ph.D.;
Jonathan P. Piccini, M.D.; Guohua Pan, Ph.D.; Daniel E. Singer, M.D.;
Werner Hacke, M.D., Ph.D.; Günter Breithardt, M.D.: Jonathan L.
Halperin, M.D.; Graeme J. Hankey, M.D.; Richard C. Becker, M.D.;
Christopher C. Nessel, M.D.; Scott D. Berkowitz, M.D.; Robert M.
Califf, M.D.; Keith A.A. Fox, M.B., Ch.B.; and Kenneth W. Mahaffey,
M.D. Disclosures are on the abstract.
The research is funded by the Duke Clinical Research Institute, Johnson
& Johnson, and Bayer HealthCare AG.
More information about atrial fibrillation is at heart.org/afib. For
more about stroke visit strokeassociation.org.
Statements and conclusions of study authors published in American Heart
Association scientific journals or presented at American Heart
Association conferences are solely those of the study authors and do
not necessarily reflect the association’s policy or position. The
association makes no representation or guarantee as to their accuracy
or reliability. The association receives funding primarily from
individuals; foundations and corporations (including pharmaceutical,device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are
available at www.heart.org/corporatefunding.
NR12 — 1062 (ESS/Patel)
Additional resources, including multimedia, are available on the right
column of this link:
http://newsroom.heart.org/pr/aha/_prv-stroke-risk-high-when-anti-clotti
ng-232260.aspx
heart.org and strokeassociation.org
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